A peer-reviewed journal of medical science, social science in

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Indexed in MEDLINE,
PubMed, and PubMed Central
National Library of Medicine
PRSRT STD
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PAID
PORTLAND OR
PERMIT NO 1452
Volume 19 No. 3 — Summer 2015
500 NE Multnomah St, Suite 100
Portland, Oregon 97232
Change Service Requested
Summer 2015
Volume 19 No. 3
A peer-reviewed journal of medical science,
social science in medicine, and medical humanities
Original Research & Contributions
4 Characteristics of Newly Enrolled Members
of an Integrated Delivery System after the
Affordable Care Act
11 A Metrics Taxonomy and Reporting Strategy
for Rule-Based Alerts
21 “Getting off the Bus Closer to Your Destination”:
Patients’ Views about Pharmacogenetic Testing
29 A Community-Based Hip Fracture Registry:
Population, Methods, and Outcomes
THE PERMANENTE JOURNAL
Follow @PermanenteJ
Printed on acid free paper.
The Permanente Journal
Summer 2015
Volume 19 No. 3
ISSN 1552-5767
37 Utility of the Multinational Association for
Supportive Care in Cancer (MASCC) Risk
Index Score as a Criterion for Nonadmission in
Febrile Neutropenic Patients with Solid Tumors
48 Evidence-Based Referral: Effects of the
Revised “Youth Fit 4 Life” Protocol on Physical
Activity Outputs
54 Relationship between Participation in
Patient- and Family-Centered Care Training and
Communication Adaptability among Medical
Students: Changing Hearts, Changing Minds
59 A Ten-Year Case-Control Study of Passive
Smoke Exposure as a Risk Factor for Pertussis
in Children
Special Report
64 2014 Hypertension Guideline: Recommendation
for a Change in Goal Systolic Blood Pressure
Commentary
81 Does Consuming Sugar and Artificial
Sweeteners Change Taste Preferences?
Special Report
85 New Kid on the Block Turns Ten!
The Brief, Remarkable History of the
National Physicians Alliance
Narrative Medicine
90 Suicide is a Baobab Tree:
A Narrative Medicine Case Study
NOW AVAILABLE:
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BOOKS PUBLISHED BY
PERMANENTE AUTHORS:
Summer 2015/ Volume 19 No. 3
PermanenteJournal
The
Mission: The Permanente Journal advances
knowledge in scientific research, clinical
medicine, and innovative health care delivery.
Circulation: 25,000 print readers per
quarter, 6900 eTOC readers, and in
2014, TPJ content had 1 million page
views—760,000 of those on TPJ articles
on PubMed. Viewers visited from
187 countries/territories.
ON THE COVER:
Rocky Perspective
by David L Shenson, MD
This photograph was
taken at Ruby Beach, on
the Olympic Peninsula in
Washington. The contrast
in depth of field creates an
interesting perspective of
these stones ground smooth
by the elements and the
passage of time.
Dr Shenson is an Internist at the Mt Scott
Medical Office in Clackamas, OR. More
of his photography may be viewed at:
www.davidshenson.com.
ORIGINAL RESEARCH
& CONTRIBUTIONS
4 Characteristics of Newly Enrolled
Members of an Integrated
Delivery System after the Affordable
Care Act.
Elizabeth A Bayliss, MD, MSPH;
Jennifer L Ellis, MSPH; Mary Jo Strobel,
RN, MBA; Deanna B McQuillan, MA;
Irena B Petsche, PhD; Jennifer C
Barrow, MSPH; Arne Beck, PhD
Of 89,289 newly enrolled non-Medicare
members, 25.3% completed the Brief Health
Questionnaire between 1/1/2014, and
8/31/2014. Of these, 3593 respondents
were insured through Medicaid, 9434
through the individual health exchange,
and 9521 through primarily commercial
plans. Of Medicaid, exchange, and
commercial members, 19.5%, 7.1%,
and 5.3%, respectively, self-reported fair
or poor health; 12.9%, 2.0%, and 3.3%
of each group self-reported 2 or more
Emergency Department visits during the
previous year; and 8.1%, 4.3%, and 4.4%
self-reported an inpatient admission during
the previous year.
11 A Metrics Taxonomy and Reporting
Strategy for Rule-Based Alerts.
Michael Krall, MD, MS; Alexander
Gerace
An action-oriented alerts taxonomy
according to structure, actions, and
implicit intended process outcomes
using a set of 333 rule-based alerts at
Kaiser Permanente Northwest (KPNW)
was developed. The authors identified 9
major and 17 overall classes of alerts and
developed a specific metric approach for
5 of these classes, including the 3 most
numerous ones in KPNW, accounting for
224 (67%) of the alerts.
21 “Getting off the Bus Closer to Your
Destination”: Patients’ Views about
Pharmacogenetic Testing.
Susan Brown Trinidad, MA; Tara B Coffin, MEd; Stephanie M Fullerton, DPhil;
James Ralston, MD, MPH; Gail P Jarvik,
MD, PhD; Eric B Larson, MD, MPH
96
CME EVALUATION FORM
The authors conducted focus groups with
patients prescribed antidepressants (pilot
session plus 2 focus groups, n = 27);
patients prescribed carbamazepine
(2 focus groups, n = 17); and healthy
patients (2 focus groups, n = 17). Although
participants understood the potential
advantages of pharmacogenetic testing,
many felt that the risks (discrimination,
stigmatization, physician overreliance on
genomic results, and denial of certain
medications) may outweigh the benefits.
These concerns were shared across
groups but were more strongly expressed
among participants with chronic mental
health diagnoses.
29 A Community-Based Hip Fracture
Registry: Population, Methods,
and Outcomes.
Maria C S Inacio, PhD; Jennifer M
Weiss, MD; Alex Miric, MD; Jessica J
Hunt, MA; Gary L Zohman, MD;
Elizabeth W Paxton, MA
Cases of hip fracture recorded from
1/2009 to 12/2011 were ascertained using
the Kaiser Permanente Hip Fracture
Registry. The registry collects information
on patient, procedure, surgeon, facility,
and surgical outcomes. The population
(N = 12,562) was predominantly white,
women, and older (≥ 75 years), and
32% had at least 5 comorbidities. The
average length of follow-up was 1.1 years.
Hemiarthroplasty was the most common
procedure (33.1%). Most fractures were
treated by medium-volume surgeons
at high-volume facilities. The 90-day
readmission rate was 22.1%, and the
mortality rate was 12.3%.
37 Utility of the Multinational Association
for Supportive Care in Cancer (MASCC)
Risk Index Score as a Criterion for
Nonadmission in Febrile Neutropenic
Patients with Solid Tumors.
Roger A Bitar, MD, MPH
Febrile neutropenic episodes in patients
with solid tumors were identified
electronically from 10/1/2008 to
11/15/2010. Inclusion criteria were met
in 198 episodes. Sensitivity, specificity,
and positive and negative predictive
values of the MASCC risk index score vs
complications were, respectively, 94%,
29.6%, 57.7%, and 82.9%. An MASCC risk
index score of 21 or greater could not be
used as a criterion for “no complication/
do not admit.” Inability to eat should be an
admission criterion.
48 Evidence-Based Referral: Effects of
the Revised “Youth Fit 4 Life” Protocol
on Physical Activity Outputs.
James J Annesi, PhD, FAAHB, FTOS,
FAPA; Linda L Vaughn, MS, MBA
The authors contrasted 2 physical activity/
nutrition treatments on the basis of social
cognitive and self-efficacy theory, and a
comparison condition, on time in moderateto-vigorous physical activity (MVPA) during
the 45-min/day physical activity segment of
elementary after-school care. The Revised
Youth Fit 4 Life protocol that sought to
maximize participants’ cardiovascular
physical activity appeared to improve upon
the Original Youth Fit For Life treatment on
time in MVPA. Thus, pediatricians might
have confidence in referring their patients
to such evidence-based approaches.
Instant Work-Ups: A Clinical Guide
to Obstetric and Gynecologic Care
Theodore X O’Connell, Kathleen Dor
ISBN-10: 1416054618
ISBN-13: 978-1416054610
Philadelphia, PA; Saunders: 2008
Paperback: 268 pages
$31.95
Glimpses in Time
Nicholas Morell
ISBN-10: 1483690202
ISBN-13: 978-1483690209
Bloomington, IN: Xlibris; 2013
$19.99
If you are a Permanente author and would like your book cited here,
send an e-mail to max.l.mcmillen@kp.org.
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from The Permanente Journal.
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ISSN 1552-5767
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The Permanente Journal/ Summer 2015/ Volume 19 No. 3
For information and/or rates for placing an
announcement here, please contact amy.r.eakin@kp.org.
CME credits are available
online at www.tpjcme.org.
The mail-in CME form can
be found on page 96.
54 Relationship between Participation
in Patient- and Family-Centered
Care Training and Communication
Adaptability among Medical Students:
Changing Hearts, Changing Minds.
Lisa Rossignol, MA
A census of 43 third-year medical students
at the University of New Mexico School of
Medicine participated in Parents Reaching
Out: Families as Faculty program during
their pediatric rotation. Analysis of variance
revealed statistical significance for the factor
“appropriate disclosure” (meaning students
have become more sensitive to the level
of intimacy that the other person is seeking and the student is willing to offer more
information). There was a positive correlation between pretest and posttests in social
experience, wit, and social confirmation.
59 A Ten-Year Case-Control Study of
Passive Smoke Exposure as a Risk
Factor for Pertussis in Children.
Mark A Schmidt, PhD, MPH; Samantha K
Kurosky, MS; John P Mullooly, PhD; Colleen Chun, MD; Sheila Weinmann, PhD
The authors conducted a matched casecontrol study of laboratory-confirmed
pertussis cases, occurring from 1/1/1996
to 12/31/2005, in children up to 12 years of
age who were members of a large managed
care organization. Sixty-five laboratoryconfirmed cases of pertussis were identified. Using multivariable conditional logistic
regression analysis, the authors did not
detect a statistically significant association
between pertussis and household passive
exposure to cigarette smoking.
Special Report
64 2014 Hypertension Guideline:
Recommendation for a Change in
Goal Systolic Blood Pressure.
Joel Handler, MD
The 2014 Kaiser Permanente Care Management Institute National Hypertension
Guideline was developed to assist primary
care physicians and other health care
professionals in the outpatient treatment of
uncomplicated hypertension in adult men
and nonpregnant women aged 18 years
and older. A major practice change is the
recommendation for goal systolic blood
pressure less than 150 mmHg in patients
aged 60 years and older who are treated
for hypertension in the absence of diabetes
or chronic kidney disease. This article
describes the reasons for, evidence for, and
consequences of the change, and includes
the guideline.
SOUL OF THE HEALER
20 Pinnacle
Brad Christian McDowell, MD
28Seville
Samuel H Glassner, MD
CASE REPORTS
74 Beer Potomania—An Unusual Cause of
Hyponatremia. Dean A Kujubu, MD;
Ardeshir Khosraviani, MD
The first case of severe hyponatremia,
since referred to as beer potomania, in a
heavy beer drinker patient was reported in
1972. Excessive consumption of beer in
particular, which has a low solute content,
may result in severe hyponatremia. We
report a case of severe hyponatremia that
occurred in a patient who, owing to his
underlying colon cancer, was drinking beer
and ingesting little food.
CLINICAL MEDICINE
77 Dermatologic Diagnosis: Leukocytoclastic Vasculitis. Joseph Einhorn, MD;
Joel T Levis, MD, PhD, FACEP, FAAEM
Leukocytoclastic vasculitis (LCV), also
termed hypersensitivity vasculitis, is a
small-vessel vasculitis. The skin is the
organ most commonly involved in LCV.
Typical presentation is a painful, burning
rash predominantly in the lower extremities. The most common skin manifestation
is palpable purpura. Other skin manifestations include maculopapular rash, bullae,
papules, plaques, nodules, ulcers, and
livedo reticularis.
79 ECG Diagnosis: Hyperacute T Waves.
After QT prolongation, hyperacute T waves
are the earliest-described electrocardiographic sign of acute ischemia, preceding
ST-segment elevation. The principle entity
to exclude is hyperkalemia—this T-wave
morphology may be confused with the
hyperacute T wave of early transmural
myocardial infarction.
COMMENTARY
81 Does Consuming Sugar and Artificial
Sweeteners Change Taste Preferences?
Carole Bartolotto, MA, RD
Americans consume 22.3 teaspoons of
added caloric sweeteners a day. Sweeteners
range from 180 to 13,000 times sweeter
than sugar. In summer 2014, 20 people from
Kaiser Permanente California facilities cut
out all added sugars and artificial sweeteners
for 2 weeks: 95% of participants found that
sweet foods and drinks tasted sweeter or
too sweet, 75% found that other foods tasted
sweeter, and 95% said moving forward
they would use less or even no sugar.
Additionally, 86.6% of participants stopped
craving sugar after 6 days.
Special Report
85 New Kid on the Block Turns Ten!
The Brief, Remarkable History of
the National Physicians Alliance.
Jean Silver-Isenstadt, MD, PhD
Founded in 2005 by General Surgeon
Lydia J Vaias, MD, MPH, the National
Physicians Alliance is a 501c3 public
charity with a mission to create research
and education programs that promote
health and foster active engagement
of physicians with their communities to
achieve high-quality, affordable health
care for all. The National Physicians
Alliance offers a professional home to
physicians across medical specialties
who share a commitment to professional integrity and health justice. As
the organization celebrates its tenth
birthday, the history and scope of this
mission-aligned group is described.
NARRATIVE MEDICINE
90 Suicide is a Baobab Tree:
A Narrative Medicine Case Study.
Adriano Machado Facioli, PhD; Fábio
Ferreira Amorim, MD, PhD; Karlo
Jozefo Quadros de Almeida, MD;
Eliana Mendonça Vilar Trindade, PhD
Like the baobab, when suicide or a
suicide attempt occurs, suicidal ideations are well cultivated and have
often already been repeatedly planted.
Consequently, suicide is often difficult to
prevent: once the death seed is planted;
it is difficult to recreate life. Every year,
more than 800,000 people die by suicide worldwide.
95 Why a Hanging Man Dances.
Gurpreet Kaur Padam, MD
“Do you know why a hanging man
dances?” asked Mr B. He was once
an intensely independent man, now 80
years old and afflicted with end-stage
lung disease. He appeared tired, repositioning himself with great effort to sitting
at the edge of the bed, tightly holding
onto the bed sheets as if clenching to a
life that was slowly escaping him. “No.
I don’t want anything that will make me
live longer.”
ONLINE
ONLY
See page 2 for additional content
from The Permanente Journal
available online only.
73Dorothy’s View
Bridget Bourgon, PA-C
80 So Much Sky
Sharon Lee Hostler, MD
1
ONLINE
ONLY
Available at: www.thepermanentejournal.org/Issues/2015/Summer.html
CASE REPORTS
CLINICAL MEDICINE
Pneumomediastinum Diagnosed on
Ultrasound in the Emergency Department:
A Case Report.
Hilary FH Beason, MD; Joshua E Markowitz,
MD, RDMS, FACEP
Image Diagnosis: Inferior Mesenteric
Vein Thrombosis.
Avin Aggarwal, MBBS; Shashank Garg, MBBS
An emergency ultrasound performed at
bedside helped to confirm and to expedite
the diagnosis of esophageal perforation in a
23-year-old man. To our knowledge, this is the
first published report of using ultrasound as an
aid in the diagnosis of Boerhaave syndrome
by diagnosing pneumomediastinum in an
adult male.
Case Report: Pulmonary Papillomatosis
in a Patient Presenting with Cough and
Hemoptysis.
Zhou Zhang, MD; Melisa Chang, MD;
Luis M Moreta-Sainz, MD
A previously healthy patient was seen in the
Emergency Department for evaluation of a
one-month history of cough and one-day
history of hemoptysis. This case report,
from a pulmonologist’s perspective, includes
a comprehensive review of the patient’s
clinical presentation and outcome, as well
as a discussion of recurrent respiratory
papillomatosis.
A 59-year-old man presented to the
gastroenterology clinic with 2 weeks of
worsening lower back pain. There was
associated poor appetite, fatigue, night
sweats, and chills. The patient’s medical
history was significant for well-controlled
hypertension and sigmoid diverticulosis.
The thrombosis probably resulted from
inflammation in the adjacent diverticulum.
BOOK REVIEW
The Body Keeps the Score: Brain, Mind,
and Body in the Healing of Trauma.
Review by Albert Ray, MD
This book explores the ways that patients and
healers can develop the skills to appropriately
evaluate historic traumatic events and how
to successfully begin treating them. From
the scientifically oriented physician, the
biochemical, physiologic, and anatomic effects
of trauma on the body are well explored in
this detailed exposé. What is more important
though is the invisible mark that is embedded
permanently on the mind and body by past
traumatic events
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Copyright © 2015 The Permanente Journal
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PermanenteJournal
The
EDITOR-IN-CHIEF: Tom Janisse, MD, MBA
ASSOCIATE EDITOR-IN-CHIEF: Lee Jacobs, MD
SENIOR EDITORS
Vincent Felitti, MD Preventive Medicine, Book Reviews
Gus M Garmel, MD, FACEP, FAAEM Clinical Medicine
Arthur Klatsky, MD Original Articles
Eric Macy, MD Research
Scott Rasgon, MD Corridor Consult
ASSOCIATE EDITORS
Mikel Aickin, PhD
Biostatistics
James J Annesi, PhD, FAAHB, FTOS, FAPA
Health Behavior Research
Marthie Baker, MS, MA, RN
Nursing Research and Practice
Ricky Chen, MD
Medicine in Society
Gary W Chien, MD
Surgery
Carrie Davino-Ramaya, MD
National Practice Guidelines
Charles Elder, MD
Integrative Medicine
Philip I Haigh, MD, MSc, FRCSC, FACS
Surgery
Robert Hogan, MD
Family Medicine,
Health Information Technology
David Riley, MD
Case Reports
Ruth Shaber, MD
Women’s Health
John Stull, MD, MPH
Spirit of Medicine Dialogues
KM Tan, MD
Continuing Medical Education
Calvin Weisberger, MD
Cognitive Clinical Medicine
Winston F Wong, MD, MS
Community Benefit, Disparities
Improvement and Quality Initiatives
Scott S Young, MD
Care Management Institute
EDITORIAL & PUBLISHING OFFICE
Merry Parker
Managing Editor & Publisher
Lynette Leisure
Creative Director
Amy Eakin
Business & Publishing Operations Manager
Max McMillen, ELS
Senior Editor & Staff Writer
Christopher Dauterman, MBA
Web Developer & Analyst
Ian Kimmich, ELS
Copy Editor & Publishing Coordinator
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EDITORIAL BOARD
Maher A Abbas, MD, FACS, FASCRS
Chief, Digestive Disease Institute,
Cleveland Clinic, Abu Dhabi, UAE;
Professor of Surgery, Cleveland
Clinic Lerner College of Medicine
of Case Western Reserve University,
Cleveland, Ohio
Richard Abrohams, MD
Internal Medicine and Geriatrics,
The Southeast Permanente Medical
Group, Atlanta, Georgia
Fábio Ferreira Amorim, MD, PhD
Professor of Medicine, Escola
Superior de Ciências da Saúde in
the Department of Research and
Scientific Communication, Brasilia,
Brazil
Stanley W Ashley, MD
Chief Medical Officer, Brigham and
Women’s Hospital; Frank Sawyer
Professor of Surgery, Harvard Medical
School; Attending Surgeon, Gastrointestinal Cancer Center, Dana Farber
Cancer Institute; Chief, General
Surgery, Harvard Vanguard Medical
Associates, Boston, Massachusetts
Thomas Bodenheimer, MD
Professor, Dept of Family and
Community Medicine, University
of California, San Francisco
Brian Budenholzer, MD
Associate Clinical Professor in the
Department of Family Medicine at
the Brody School of Medicine at
East Carolina University, Greenville,
North Carolina
Ellen Cosgrove, MD
Vice Dean, Academic Affairs and
Education, University of Nevada, Las
Vegas School of Medicine, Las Vegas,
Nevada
Quentin Eichbaum, MD, PhD, MPH,
MFA, MMCH, FCAP
Assistant Dean for Program Development; Associate Director of Transfusion Medicine; Associate Professor
of Pathology; Associate Professor of
Medical Education and Administration; Director, Fellowship Program
in Transfusion Medicine; Member,
Vanderbilt Institute for Global
Health; Vanderbilt University School
of Medicine, Nashville, Tennessee
Linda Fahey, RN, NP, MSN
Regional Manager, Quality and
Patient Safety, Patient Care Services,
Kaiser Permanente, Southern
California, Pasadena
Adrianne Feldstein, MD, MS
Associate Medical Director, Quality
Services, Kaiser Permanente
Northwest; Investigator, Center for
Health Research, Portland, Oregon
Richard Frankel, PhD
Professor of Medicine and Psychiatry,
University of Indiana School of
Medicine, Indianapolis
Carol Havens, MD
Family Practice and Addiction
Medicine, Director of Clinical
Education, The Permanente Medical
Group, Oakland, California
Alexander M Carson, RN, PhD
Associate Dean of Research and
Enterprise at the Institute of Health,
Medical Sciences and Society at
Glyndwr University in Wrexham,
Wales, United Kingdom
James T Hardee, MD
Rita Charon, MD, PhD
Professor of Medicine, Founder and
Executive Director of the Program
in Narrative Medicine at Columbia
University Medical Center, New York,
New York
Arthur Hayward, MD
Internal Medicine and Geriatrics,
CMI Clinical Lead for Elder Care;
Assistant Clinical Professor, Division
of General Medicine, Dept of
Internal Medicine, Oregon Health
Sciences University, Portland
Dan Cherkin, PhD
Senior Research Investigator, Group
Health Cooperative, and Affiliate
Professor, Dept of Family Medicine
and School of Public Health—Health
Services, University of Washington,
Seattle
Marilyn Chow, RN, DNSc, FAAN
Vice President, Patient Care Services,
Kaiser Foundation Health Plan;
Associate Clinical Professor, Dept of
Community Health Systems, School
of Nursing, University of California,
San Francisco
Robert R Cima, MD, FACS, FASCRS
Associate Professor of Surgery,
Division of Colon and Rectal Surgery;
Vice Chairman, Department of
Surgery, Mayo Clinic, Rochester,
Minnesota
Internal Medicine, Colorado
Permanente Medical Group;
Associate Clinical Professor of
Medicine, University of Colorado
School of Medicine, Westminster
Catherine Hickie, MBBS
Director of Clinical Training,
Bloomfield Hospital, Greater Western
Area Health Service; Conjoint Senior
Lecturer in Psychiatry, University of
New South Wales, Australia
Thomas E Kottke, MD
Medical Director for Population
Health, HealthPartners; Consulting
Cardiologist, HealthPartners Medical
Group; Senior Clinical Investigator,
HealthPartners Institute for
Education and Research; Professor of
Medicine, University of Minnesota,
Minneapolis
Tieraona Low Dog, MD
Director of Education, Program in
Integrative Medicine, University of
Arizona; Clinical Assistant Professor,
Department of Medicine, Clinical
Lecturer, University of Arizona
College of Pharmacy, Tucson
Lewis Mehl-Madrona, MD, PhD, MPhil
Director of Geriatric Education, Maine
Dartmouth Family Medicine Residency;
Director of Education and Training,
Coyote Institute, Augusta, Maine
Michel M Murr, MD, FACS
Professor of Surgery, Director of
Bariatric Surgery, University of South
Florida Health Science Center,
Tampa, Florida
Sylvestre Quevedo, MD
Department of Medicine and Global
Health Sciences, University of
California, San Francisco
Ilan Rubinfeld, MD, MBA, FACS, FCCP
Director, Surgical Intensive Care;
Associate Program Director,
General Surgery Residency; Henry
Ford Hospital, Detroit, Michigan;
Assistant Professor of Surgery, Wayne
State University School of Medicine,
Detroit, Michigan
Marilyn Schlitz, PhD
Ambassador for Creative Projects
and Global Affairs, and Senior
Scientist, Institute of Noetic Sciences,
Petaluma, California
Audrey Shafer, MD
Associate Professor, Dept of
Anesthesia, Co-Director, Biomedical
Ethics & Medical Humanities
Scholarly Concentration, Stanford
University School of Medicine, Palo
Alto, California
Mark Snyder, MD
Specialist Leader, Electronic
Medical Record Implementation
and Physician Adoption; Deloitte
Consulting, LLP, McLean, Virginia
Swee Yaw Tan, MBchB (Edin),
MRCP (UK), ACSM, FAMS
Senior Consultant Cardiologist,
National Heart Centre, Adjunct
Assistant Professor Duke National
University of Singapore Graduate
Medical School, Singapore
William L Toffler, MD
Professor of Family Medicine;
Director of Predoctoral Education,
Oregon Health and Sciences
University, Portland
Paul Wallace, MD
Senior Vice President and Director,
Center for Comparative Effectiveness
Research, The Lewin Group, Falls
Church, Virginia
Tom Janisse, MD, MBA, Publisher
The Permanente Journal is published
by The Permanente Press
3
ORIGINAL RESEARCH & CONTRIBUTIONS
Characteristics of Newly Enrolled Members of an Integrated
Delivery System after the Affordable Care Act
Elizabeth A Bayliss, MD, MSPH; Jennifer L Ellis, MSPH; Mary Jo Strobel, RN, MBA;
Deanna B McQuillan, MA; Irena B Petsche, PhD; Jennifer C Barrow, MSPH; Arne Beck, PhD
Perm J 2015 Summer;19(3):4-10
http://dx.doi.org/10.7812/TPP/14-193
ABSTRACT
Context: Little is known about the health status and care needs of new enrollees
in health plans since implementation of the Affordable Care Act.
Objective: To describe characteristics of new members of an integrated delivery
system during early phases of implementation of the act.
Design: Descriptive analysis of ongoing collection of operational data.
Main Outcome Measures: The 11-question Brief Health Questionnaire, which
was administered to new members of Kaiser Permanente Colorado who had benefits
effective on or after January 1, 2014. Bivariate analyses compared characteristics of
new enrollees by benefit.
Results: Of 89,289 newly enrolled non-Medicare members, 22,548 (25.3%)
completed the Brief Health Questionnaire between January 1, 2014, and August 31,
2014. Of these, 3593 respondents were insured through Medicaid, 9434 through
the individual health exchange, and 9521 through primarily commercial plans.
Of Medicaid, exchange, and commercial members, 19.5%, 7.1%, and 5.3%, respectively, self-reported fair or poor health; 12.9%, 2.0%, and 3.3% of each group
self-reported 2 or more Emergency Department visits during the previous year; and
8.1%, 4.3%, and 4.4% self-reported an inpatient admission during the previous year.
During the preceding year, 31.5% of Medicaid, 30.8% of exchange, and 12.6% of
commercial members were uninsured longer than 8 months.
Conclusion: Systematic collection of patients’ self-reported information can
enhance traditional approaches to initiating care, inform operational planning, and
describe newly enrolled populations. Newly enrolled Medicaid beneficiaries may
have more initial health care needs than new exchange or commercial members;
however, health differences between the latter two groups are subtle.
INTRODUCTION
The first open enrollment period
under the Affordable Care Act (ACA)1
resulted in an estimated eight million
individuals gaining insurance coverage
through exchanges and an additional six
million through Medicaid expansions
nationally.2-5 Published estimates of
health status for those likely to gain new
coverage under the ACA vary widely and
are based on limited data.6-8
Accurate and timely information on
the care needs of individuals who are
either newly insured or transitioning
between care plans under the ACA are
important because these needs will affect demand for a range of primary and
specialty care services.6,8 Most methods
for predicting health care resource needs
rely on models that incorporate measures of previous service use, morbidity
burden, and socioeconomic factors.
These factors are strong predictors of
future service needs, as are self-reported
health and functional status.9-17 However, morbidity and utilization data are
unavailable before engagement with the
health care system.
In the absence of preexisting information on newly enrolled individuals, realtime data collection on health-related
characteristics can inform care delivery
and resource planning. Operations leaders and researchers in Kaiser Permanente
Colorado (KPCO) collaborated to develop a brief health screening questionnaire to anticipate the potential health
care needs of newly enrolled members.
The goal of the Brief Health Questionnaire (BHQ) is twofold: 1) to identify
care needs that can be met before traditional primary care appointments and
2) to characterize the newly enrolled
member population. This brief report
describes characteristics of new KPCO
members during early phases of the
ACA implementation.
METHODS
A not-for-profit, integrated health
care delivery system, KPCO provides
services in Denver and other metropolitan areas along the Colorado
“Front Range” to the north and south
of Denver. New members were defined
as individuals who had no previous
enrollment in KPCO and had new
benefits effective on or after January
1, 2014. For families with more than
one new enrollee, each individual was
eligible to respond to the BHQ. We
defined insurance type as Medicaid,
individual exchange, and all other
(composed primarily of large- and
small-group commercial members).
New Medicare members were excluded.
The 11-question BHQ addresses the
following domains: general health status,
specific chronic illnesses, prescription
Elizabeth A Bayliss, MD, MSPH, is the Director of Scientific Development at the Institute for Health Research in Denver, CO.
E-mail: elizabeth.bayliss@kp.org. Jennifer L Ellis, MSPH, is a Biostatistician at the Institute for Health Research in Denver, CO.
E-mail: jenn.l.ellis@kp.org. Mary Jo Strobel, RN, MBA, is a Regional Administrator of Population Health of Population and
Prevention Services for Kaiser Permanente in Denver, CO. E-mail: maryjo.strobel@kp.org. Deanna B McQuillan, MA, is a Project
Manager for the Institute for Health Research in Denver, CO. E-mail: deanna.b.mcquillan@kp.org. Irena B Petsche, PhD, is a
Senior Strategy Consultant in Strategy Management for Kaiser Permanente in Denver, CO. E-mail: irena.b.petsche@kp.org.
Jennifer C Barrow, MSPH, is a Portfolio Manager at the Institute for Health Research in Denver, CO. E-mail: jennifer.c.barrow@kp.org.
Arne Beck, PhD, is the Director for Quality Improvement and Strategic Research at the Institute for Health Research in Denver, CO.
E-mail: arne.beck@kp.org.
4
Characteristics of Newly Enrolled Members of an Integrated Delivery System after the Affordable Care Act
medications, depression screening,
pregnancy, financial constraints, prioryear hospitalizations, Emergency
Department (ED) use, and insurance
coverage.10,18-26 The BHQ is provided in
the Appendix: Brief Health Questionnaire (available online at: www.thepermanentejournal.org/files/Summer2015/
Questionnaire.pdf ). Before administration, the questionnaire was pilot tested
on 35 new members to assess comprehension and completion time. Starting
in late 2013, the BHQ was offered to
any new non-Medicare member calling
for an appointment and was accessible
on the KPCO Web site. After scheduling of an appointment, new members
were asked for permission to “route
the call to a New Member Specialist
for assistance with ‘onboarding.’” This
specialist then asked the BHQ questions
and entered responses into the member’s
electronic health record (EHR).
Data collection is ongoing and evolving for this operational project. For
example, Community Specialists still
reach out to new Medicaid members to
assess health and community resource
needs. Additionally, new members are
now directed (via a welcome telephone
call and mailed identification card insert) to a 1-stop shop for all their onboarding needs, which include selecting
a primary care physician, understanding
benefits and care delivery options, registering on the KPCO Web site, and
administration of the BHQ. This New
Member Team is also responsible for
outreach to new members within their
first 90 days of coverage.
Table 1. Characteristics of new members responding to the Brief Health
Questionnaire between January 1, 2014, and August 31, 2014 (N = 22,548)a
New member
Medicaid
characteristic
(n = 3593), No. (%)
Sex Female
2097 (58.4)
Male
1496 (41.6)
Unknown
0
Age group, years
0-9
553 (15.4)
10-19
353 (9.8)
20-29
567 (15.8)
30-39
580 (16.1)
40-49
547 (15.2)
50-59
694 (19.3)
≥ 60
299 (8.3)
Response format
Web portal
111 (3.1)
completion
Telephone
3482 (96.9)
completion
Benefit start month
January
179 (5.0)
February
365 (10.2)
March
495 (13.8)
April
592 (16.5)
May
586 (16.3)
June
513 (14.3)
July
406 (11.3)
August
457 (12.7)
Individual on
exchange
(n = 9434), No. (%)
Other
(n = 9521), No. (%)
5511 (58.4)
3923 (41.6)
0
5406 (56.8)
4112 (43.2)
3 (0)
0.0414b
683 (7.2)
547 (5.8)
1477 (15.7)
1715 (18.2)
1477 (15.7)
2160 (22.9)
1375 (14.6)
1865 (19.6)
1104 (11.6)
1832 (19.2)
1699 (17.8)
1310 (13.8)
1251 (13.1)
460 (4.8)
< 0.0001
98 (10.5)
918 (9.6)
< 0.0001c
8447 (89.5)
8603 (90.4)
3094 (32.8)
710 (7.5)
1104 (11.7)
1357 (14.4)
2293 (24.3)
422 (4.5)
305 (3.2)
149 (1.6)
3324 (34.9)
986 (10.4)
910 (9.6)
985 (10.4)
979 (10.3)
746 (7.8)
1098 (11.5)
493 (5.2)
p value
RESULTS
< 0.0001
Some percentages may not total to 100% because of rounding.
Nonsignificant differences between Medicaid and exchange: sex (p = 0.9564). Nonsignificant differences
between Medicaid and other: sex (p = 0.1537).
c
Nonsignificant differences between exchange and other: response format (p = 0.0604).
a
b
If new members responded “yes”
to any BHQ question, New Member
Specialists made telephone appointments for follow-up encounters on the
basis of prespecified rules. All BHQs
completed on the KPCO Web site
were automatically routed to appropriate EHR in-baskets for follow-up.
Pharmacists contacted new members
regarding refills on prescription medications; Nurse Care Managers assessed
those reporting fair or poor health
status, specific chronic conditions, a
“positive” depression screen (a Patient
Health Questionnaire-2 score of 3 or
greater27), or potential high morbidity as indicated by hospitalization and
emergency service use. Social workers
and Community Specialists evaluated
reports of financial and social needs.
The Obstetrics Department arranged for
necessary prenatal care. Documentation
of follow-up encounters was entered in
the EHR for use at the point of care. Use
of the questionnaire is ongoing.
We compared demographic characteristics and BHQ responses across groups
of new members (Medicaid, exchange,
and other) using χ2 tests. We also conducted two descriptive subanalyses
comparing 1) individuals who reported
having no insurance for more than eight
months during the previous year with
those insured for that entire year and 2)
BHQ respondents and nonrespondents.
The KPCO institutional review board
reviewed the protocol for the BHQ
program and analyses, and determined
that it met criteria for an operations intervention with intent to publish, rather
than human subjects research.
A total of 89,289 members were
newly enrolled between January 1,
2014, and August 31, 2014. Of these,
22,548 (25.3%) completed a BHQ
by August 31, 2014. By insurance
type, 3593 respondents were insured
through Medicaid, 9434 through the
individual health exchange, and 9521
through other mechanisms, primarily
large and small group commercial plans.
These responses represented 43.2%
(3593/8318) of new Medicaid enrollees,
26.8% (9434/35,113) of new exchange
enrollees, and 20.8% (9521/45,858) of
5
Table 2. Responses to Brief Health Questionnaire between January 1, 2014, and August 31,
2014, by insurance category (N = 22,548)a
Response
General health
Medicaid
(n = 3593), No. (%)
Excellent
703 (19.6)
Very good
974 (27.1)
Good
1118 (31.1)
Fair
517 (14.4)
Poor
184 (5.1)
Missing/no answer
97 (2.7)
Self-reported chronic conditions
Asthma
301 (8.4)
Diabetes
207 (5.8)
Heart disease
95 (2.6)
High blood pressure
494 (13.8)
Positive depression screen
424 (11.8)
Other health considerations
Pregnant
48 (1.3)
Current prescription
1347 (37.5)
medications
Health conditions interfere
1102 (30.7)
with daily activity
Emergency Department visits in past year
None
2322 (64.6)
1 time
705 (19.6)
2+ times
462 (12.9)
Missing data
104 (2.9)
Inpatient admissions in past year
None
3199 (89.0)
1 time
231 (6.4)
2+ times
59 (1.6)
Missing data
104 (2.9)
Insurance during past year
Had insurance for whole year
1132 (31.5)
No insurance for 1-4 months
230 (6.4)
No insurance for 5-8 months
167 (4.7)
No insurance for > 8 months
1132 (31.5)
Prefer not to answer
12 (0.3)
Missing data
920 (25.6)
Reported financial constraint
Health affected by difficulty
823 (22.9)
paying for food, medicine,
rent, utilities
Any positive BHQ response
2185 (60.8)
Individual
on exchange
(n = 9434), No. (%)
Other
(n = 9521), No. (%)
2893 (30.7)
3370 (35.7)
2421 (25.7)
565 (6.0)
106 (1.1)
79 (0.8)
3381 (35.5)
3377 (35.5)
2209 (23.2)
426 (4.5)
75 (0.8)
53 (0.6)
< 0.0001
648 (6.9)
439 (4.7)
213 (2.3)
1239 (13.1)
441 (4.7)
609 (6.4)
290 (3.1)
149 (1.6)
778 (8.2)
325 (3.4)
0.0003
< 0.0001
< 0.0001
< 0.0001
< 0.0001
80 (0.9)
3847 (40.8)
124 (1.3)
3342 (35.1)
0.0048
< 0.0001
1506 (16.0)
1280 (13.4)
< 0.0001
8150 (86.4)
1007 (10.7)
191 (2.0)
86 (0.9)
7927 (83.3)
1212 (12.7)
316 (3.3)
66 (0.7)
< 0.0001
8938 (94.7)
343 (3.6)
60 (0.6)
93 (1.0)
9035 (94.9)
360 (3.8)
60 (0.6)
66 (0.7)
< 0.0001
3893 (41.3)
877 (9.3)
484 (5.1)
2906 (30.8)
40 (0.4)
1234 (13.1)
4499 (47.3)
660 (6.9)
274 (2.9)
1199 (12.6)
20 (0.2)
2869 (30.1)
< 0.0001
867 (9.2)
512 (5.4)
< 0.0001
5264 (55.8)
4630 (48.6)
< 0.0001
p valueb
b
Nonsignificant differences between Medicaid and exchange: heart disease (p = 0.1947); high blood pressure (p = 0.3551).
Nonsignificant differences between Medicaid and other: pregnancy (p = 0.8803). Nonsignificant differences between exchange
and other: asthma (p = 0.1913); prior-year inpatient admissions (p = 0.1632).
BHQ = Brief Health Questionnaire.
a
6
other new enrollees. Most (91.0%) of
the BHQ data were collected through
telephone calls, with the remainder collected through the KPCO patient portal
into the EHR. Responses for new members under age 18 years were provided
by parents or guardians.
Table 1 lists demographic characteristics of new members by insurance
category. New Medicaid and exchange
members were older than other/commercial members (mean ages for Medicaid, exchange, and other were 33.8,
40.0, and 29.5 years, respectively). Approximately 58% of respondents were
female. Table 2 summarizes responses
to the BHQ questions across insurance
groups. Fair or poor health was selfreported by 19.5%, 7.1%, and 5.3% of
Medicaid, exchange, and other groups,
respectively. A greater proportion of
Medicaid enrollees (30.7%) reported
physical functioning interfering with
health, and a greater proportion of
exchange enrollees (40.8%) reported
prescription medication use. Of BHQ
respondents, 11.8% of Medicaid,
4.7% of exchange, and 3.4% of other/
commercial enrollees screened positive
for possible depression. During the
preceding year there was a greater difference in self-reported ED utilization
across groups than in self-reported
inpatient hospital admissions, with
12.9% of Medicaid enrollees reporting
2 or more ED visits (compared with
2.0% of exchange and 3.3% of other
new members), but less than 2% of all
groups reporting 2 or more inpatient
admissions. Comparable percentages
of Medicaid and exchange enrollees
(just over 30%) reported no insurance
during more than 8 months during the
previous year, compared with 12.6%
of other beneficiaries. All variable differences across groups of enrollees
were significant at p < 0.001 except for
sex, which was significant at p < 0.05.
Of new Medicaid enrollees, 60.8%
were referred for any additional services on the basis of BHQ responses,
compared with 55.8% of new exchange
enrollees and 48.6% of other enrollees
(p < 0.001). The highest percentage of
referrals across insurance groups was
because of prescription medication use.
Table 3. Brief Health Questionnaire characteristics and responses (N = 14,761) by prior-year insurance: insured for entire year
versus no insurance for more than 8 monthsa
Characteristic or
response
Medicaid (n = 2264)
Insured
Not insured
(n = 1132), No. (%) (n = 1132), No. (%)
Sex
Female
768 (67.8)
Male
364 (32.2)
Unknown
0
Age group, years
0-9
1 (0.1)
10-19
48 (4.2)
20-29
262 (23.1)
30-39
260 (23.0)
40-49
200 (17.7)
50-59
233 (20.6)
≥ 60
128 (11.3)
General health
Excellent
151 (13.3)
Very good
323 (28.5)
Good
406 (35.9)
Fair
174 (15.4)
Poor
77 (6.8)
Missing/no answer
1 (0.1)
Self-reported chronic condition
Asthma
124 (11.0)
Diabetes
95 (8.4)
Heart disease
35 (3.1)
High blood pressure
211 (18.6)
Other health considerations
Current prescription
592 (52.3)
medication
Positive depression
132 (11.7)
screen
Pregnant
22 (1.9)
Health condition
417 (36.8)
interferes with daily
activity
Emergency Department visits in past year
None
716 (63.3)
1 time
240 (21.2)
2+ times
176 (15.6)
Missing data
0
Inpatient admissions in past year
None
1008 (89.1)
1 time
99 (8.8)
2+ times
24 (2.1)
Missing data
1 (0.1)
Self-reported financial constraints
Health affected by
218 (19.3)
difficulty paying for food,
medicine, rent, utilities
Individual on exchange (n = 6799)
Insured
Not insured
(n = 3893), No. (%)
(n = 2906), No. (%)
Other (n = 5698)
Insured
Not insured
(n = 4499), No. (%) (n = 1199), No. (%)
638 (56.4)
494 (43.6)
0
2310 (59.3)
1583 (40.7)
0
1731 (59.6)
1175 (40.4)
0
2792 (62.1)
1706 (37.9)
1 (0)
630 (52.5)
569 (47.5)
0
0
8 (0.7)
208 (18.4)
202 (17.8)
246 (21.7)
340 (30.0)
128 (11.3)
3 (0.1)
43 (1.1)
624 (16.0)
737 (18.9)
676 (17.4)
1076 (27.6)
734 (18.9)
0
21 (0.7)
455 (15.7)
612 (21.1)
562 (19.3)
794 (27.3)
462 (15.9)
4 (0.1)
95 (2.1)
1119 (24.9)
1094 (24.3)
876 (19.5)
942 (20.9)
369 (8.2)
0
29 (2.4)
391 (32.6)
310 (25.9)
247 (20.6)
171 (14.3)
51 (4.3)
119 (10.5)
282 (24.9)
436 (38.5)
218 (19.3)
75 (6.6)
2 (0.2)
1151 (29.6)
1537 (39.5)
974 (25.0)
201 (5.2)
24 (0.6)
6 (0.2)
581 (20.0)
1022 (35.2)
968 (33.3)
277 (9.5)
54 (1.9)
4 (0.1)
1190 (26.5)
1848 (41.1)
1227 (27.3)
197 (4.4)
31 (0.7)
6 (0.1)
204 (17.0)
418 (34.9)
415 (34.6)
133 (11.1)
28 (2.3)
1 (0.1)
126 (11.1)
79 (7.0)
45 (4.0)
203 (17.9)
319 (8.2)
184 (4.7)
103 (2.7)
565 (14.5)
218 (7.5)
176 (6.1)
73 (2.5)
483 (16.6)
411 (9.1)
193 (4.3)
105 (2.3)
547 (12.2)
87 (7.3)
48 (4.0)
27 (2.3)
128 (10.7)
442 (39.1)
1957 (50.3)
1130 (38.9)
2209 (49.1)
349 (29.1)
209 (18.5)
155 (4.0)
195 (6.7)
166 (3.7)
104 (8.7)
13 (1.2)
458 (40.5)
36 (0.9)
603 (15.5)
25 (0.9)
576 (19.8)
82 (1.8)
696 (15.5)
22 (1.8)
251 (20.9)
742 (65.6)
249 (22.0)
139 (12.3)
2 (0.2)
3430 (88.1)
396 (10.2)
65 (1.7)
2 (0.1)
2496 (85.9)
343 (11.8)
65 (2.2)
2 (0.1)
3851 (85.6)
521 (11.6)
124 (2.8)
3 (0.1)
975 (81.3)
159 (13.3)
65 (5.4)
0
1041 (92.0)
77 (6.8)
3697 (95.0)
165 (4.2)
2793 (96.1)
93 (3.2)
4292 (95.4)
171 (3.8)
1138 (94.9)
49 (4.1)
13 (1.2)
1 (0.1)
28 (0.7)
3 (0.1)
15 (0.5)
5 (0.2)
33 (0.7)
3 (0.1)
11 (0.9)
1 (0.1)
452 (39.9)
196 (5.0)
499 (17.2)
176 (3.9)
204 (17.0)
Insured is defined as reporting being insured for entire previous year; uninsured is defined as being uninsured for more than 8 months during the previous year. Sample for this subanalysis
does not include respondents reporting either 1 to 4 months or 5 to 8 months without insurance during the previous year. Some percentages may not total to 100% because of rounding.
a
7
Rates of
chronic
disease are
notoriously
difficult
to predict
because
individuals
who are
unable to
access care
may be
unaware of
diagnoses.
The pattern of new Medicaid enrollees having greater morbidity than new
exchange or other new enrollees was also
evident in proportions of self-reported
chronic conditions. Asthma was reported by 8.4% of new Medicaid enrollees,
6.9% of new exchange enrollees, and
6.4% of new other enrollees (p = 0.003).
Diabetes was reported by 5.8%, 4.7%,
and 3.1% of each group, respectively;
heart disease by 2.6%, 2.3%, and 1.6%;
and high blood pressure by 13.8%,
13.1%, and 8.2% (p < 0.001 for all).
Descriptive subanalyses of new members previously uninsured for more than
8 months vs those insured for the entire
year are listed in Table 3. In each benefit
group, the previously uninsured individuals report slightly higher rates of fair
or poor health, and of health interfering with daily activity, but they do not
report greater rates of specific chronic
conditions. A higher proportion of
individuals in the previously uninsured
subpopulations had a positive depression screen, and a higher proportion
reported financial constraints.
Table 4 compares BHQ respondents
vs nonrespondents. Compared with
nonrespondents, respondents were significantly more likely to be female, to be
older, and to carry Medicaid or exchange
insurance (p < 0.001).
DISCUSSION
Accurate information on the health
status and care needs of individuals
enrolling in insurance plans during the
early phases of the ACA implementation can help optimize care delivery for
newly insured and transitioning populations. This snapshot of new members
in an integrated delivery system in the
Denver Front Range area suggests that
new Medicaid enrollees are less healthy
than new exchange and new commercial
members are; however, differences between new exchange enrollees and new
commercial members are more subtle.
We found that 19.5% of new Medicaid members and 7.1% of new exchange
members overall had fair or poor health.
In the smaller subsample of individuals
without previous insurance, 25.9% of
new Medicaid members and 11.4%
of new exchange members reported
fair or poor health. Our Medicaid
findings are consistent with previous
estimates6,7,28 that proportions of the
ACA target population with fair or
poor health would range from 10% to
25%, with the greater burden falling on
individuals below 200% of the Federal
Poverty Level. However, the general
health status in new exchange enrollees
in this population is somewhat better
than these predictions.6,7,28 It is also
Table 4. Brief Health Questionnaire (BHQ) new member respondents versus
nonrespondents (N = 89,289)a
Characteristic
Sex
Female
Male
Unknown
Age group, years
0-9
10-19
20-29
30-39
40-49
50-59
≥ 60
Insurance
Medicaid
Individual on exchange
Other
a
8
No BHQ
(n = 66,741), No. (%)
BHQ
(n = 22,548), No. (%)
31,743 (47.6)
34,976 (52.4)
22 (0)
13,014 (57.7)
9531 (42.3)
3 (0)
< 0.0001
11,031 (16.5)
6739 (10.1)
13,312 (20.0)
12,029 (18.0)
9202 (13.8)
9749 (14.6)
4679 (7.0)
3101 (13.8)
2004 (8.9)
3876 (17.2)
3994 (17.7)
3334 (14.8)
4105 (18.2)
2134 (9.5)
< 0.0001
4725 (7.1)
25,679 (38.5)
36,337 (54.4)
3593 (15.9)
9434 (41.8)
9521 (42.2)
< 0.0001
p value
somewhat better than a national population of nongroup enrollees (individuals
who purchased their own insurance)
surveyed after ACA implementation in
Spring 2014, in which 14% reported
fair or poor health.29 It is possible that
our results reflect characteristics of Colorado residents—which may differ from
a nationally representative sample—or
that individuals enrolling in Year 1 of the
ACA may have better health status than
those who remain uninsured. Ongoing
surveillance of health status among the
newly insured will help clarify their
health status and care needs and should
inform service requirements for integrated and other delivery systems.
Rates of chronic disease are notoriously difficult to predict because individuals who are unable to access care
may be unaware of diagnoses. Estimates
of heart disease in our Medicaid and
exchange sample to date (2% to 3%)
are comparable to literature-based predictions, whereas the rate of asthma in
BHQ respondents (6.4% to 8.4%) is
comparable to rates in previously uninsured populations, but half of asthma
rates in Medicaid populations.7,30 Published estimates suggest depression rates
in the range of 2% to 17% for Medicaid
and exchange enrollees.7,30 Although
BHQ respondents had positive depression screens within this range, their
diagnoses of depression require further
evaluation.27
In 2011, the Kaiser Family Foundation predicted that 65% of exchange
purchasers would have been previously
uninsured.30 We found that previous
insurance coverage was not comprehensive for any of the 3 groups, and
that just over 30% of new Medicaid
and exchange enrollees reported being
uninsured for more than 8 months during the previous year. These proportions
may be slightly skewed by missing data,
but they are lower than the 57% national figure reported in a 2014 Kaiser
Family Foundation survey.29 They may
also reflect the insurance marketplace in
Colorado and uptake of exchange plans
by both insured and uninsured individuals. (Our sample does not include
the small-business exchange.)
New Medicaid members reported
greater past utilization of the ED than
did other respondents. Studies of Medicaid expansions suggest that this pattern
may continue after obtaining insurance,
although it may be modified by effective
primary care relationships.23,31 In the
longer term, gaining insurance benefits
increases utilization of health care resources, improves mental and physical
health, increases the use of preventive
services, and decreases mortality for
both Medicaid and non-Medicaid populations.28,32-34 Optimizing long-term
health outcomes will require maximizing both informational and interpersonal continuity of care for patients
who may move between Medicaid and
exchange benefit categories and between
being insured and uninsured.
Although patient-reported data on
health status, physical function, emotional well-being, and other constructs
are predictive of mortality and utilization, and can guide interventions to improve the quality of care, such measures
have previously been used almost exclusively in the context of research rather
than care delivery.10,35-38 Recently, health
assessments have been incorporated into
care delivery for defined populations
such as seniors, employees, and Health
Plan members.39 The BHQ assessment
exemplifies how patient-reported data
can be systematically collected to inform
care delivery, especially in light of 2014
net growth of approximately 15%, compared with previous annual net growth
rates in the range of 2% to 3% for the
delivery system. To date, approximately
54% of all BHQ respondents have been
referred for either care management or
pharmacy services. Future retrospective analyses will determine whether
referrals for early medication and care
management affect more distal health
outcomes such as hospitalization and
disease-specific adverse events.
Our study has several limitations.
Medicaid enrollees enrolling in KPCO
were a relatively small subset of all
Colorado Medicaid beneficiaries. New
KPCO exchange enrollees reflect an
approximate 38% share of the Colorado exchange marketplace and only
represent those who selected a single
integrated delivery system. Newly
enrolled patients in other delivery systems and settings will have different
characteristics. This sample primarily
reflects a subset of members who contacted the delivery system during the
first 6 months of enrollment, and data
collection was limited by the capacity
of the call center’s service associates. As
illustrated in Table 4, there were a number of demographic differences between
BHQ respondents and nonrespondents.
Respondents to the BHQ are also more
likely to have used health care services.
These comparisons support (but do
not confirm) a hypothesis that new
enrollees with higher morbidity were
initial users of the delivery system and
more likely to complete a BHQ. Finally,
most of the responses were obtained via
telephone; although responses obtained
through the Web portal may be systematically different, Web-based responses
represent a very small proportion of
the total and are unlikely to bias the
results. Our preliminary cross-sectional
description must be supplemented
with longitudinal assessments that link
patient-reported BHQ responses with
subsequent utilization patterns and
that link all of these factors with robust
health outcomes.
CONCLUSION
This description suggests that newly
enrolled Medicaid beneficiaries may
have more initial health care needs
than either new exchange or commercial members; however, health differences between the latter 2 groups in
this population sample are more subtle.
The Congressional Budget Office estimates that by 2023, insurance will
be obtained by 13 million individuals
through Medicaid expansions and by
24 million through exchange-based
plans.40 There is likely to be increasing
movement of individuals across benefit
categories, as well as increasing inclusion
of previously insured populations in
Medicaid and exchange insurance plans.
Adequately informing care delivery for
this changing landscape will require an
understanding of which subpopulations
are likely to transition between benefit
categories and between delivery systems
and settings, and which subpopulations risk adverse health outcomes as
a function of these transitions. Further
evaluation of needs assessments, such
as the BHQ process, will inform the
development of systematic interventions
to optimize health outcomes in newly
enrolled populations. v
Disclosure Statement
The author(s) have no conflicts of interest to
disclose.
Acknowledgments
This project was supported by a grant from the
Kaiser Permanente Garfield Memorial Fund.
Kathleen Louden, ELS, of Louden Health
Communications provided editorial assistance.
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Change Then
Changing doctors is with some people a far less serious matter than a change of shirts.
— G Frank Lydston, MD, 1858-1923, American urologist and transplant surgeon
10
A Metrics Taxonomy and Reporting Strategy for Rule-Based Alerts
Michael Krall, MD, MS; Alexander Gerace
Perm J 2015 Summer;19(3):11-19
ABSTRACT
Context: Because institutions rely on rule-based alerts as an important component of their safety and quality strategies, they should determine whether the alerts
achieve the expected benefit.
Objective: To develop and to test a method of reporting outcome metrics for
rule-based electronic health record alerts on a large scale.
Methods: We empirically developed an action-oriented alerts taxonomy according to structure, actions, and implicit intended process outcomes using a set of 333
rule-based alerts at Kaiser Permanente Northwest. Next we developed a method for
producing metrics reports for alert classes. Finally, we applied this method to alert taxa.
Main Outcome Measures: Outcome measures were the successful development of a rule-based alerts taxonomy and the demonstration of its application in
a reporting strategy.
Results: We identified 9 major and 17 overall classes of alerts. We developed a
specific metric approach for 5 of these classes, including the 3 most numerous ones
in our institution, accounting for 224 (67%) of our alerts. Some alert classes do not
readily lend themselves to this approach.
Conclusions: We developed a taxonomy for rule-based alerts and demonstrated its
application in developing outcome metrics reports on a large scale. This information
allows tuning or retiring alerts and may inform the need to develop complementary
or alternative approaches to address organizational imperatives. A method that assigns alerts to classes each amenable to a particular reporting strategy could reduce
the difficulty of producing metrics reports.
INTRODUCTION
Rule-based alerting within electronic
health records (EHRs) is a common
approach to addressing safety, quality,
and workflow issues in health care.
Most mature EHR installations have
alerts of this type and some, including ours, have hundreds. Stage 2 of
the Center for Medicare and Medicaid
Services Meaningful Use incentive program requires that eligible providers
and hospitals implement at least five
clinical decision-support interventions,
most of which will be rule-based alerts.
Because institutions look to clinical
decision support and rule-based alerts
as an important component of their
return-on-investment strategy for their
EHR investment, it is imperative to
know whether the alerts are not only
“working” (firing as designed) but are
achieving intended benefits.1 This understanding is fundamental to improving clinical decision support and may
suggest the necessity for considering
additional or alternative strategies to
achieve strategic goals. A recent publication of the American Health Lawyers
Association on minimizing EHR-related
safety events specifically called out alert
metrics beyond simply override rate as
an important determinant of safety in
these systems.2
Knowledge engineers and builders of
alerts typically believe, often with limited or no data, that the ones they deploy
are functioning well, are well received by
their target audience, and are achieving
their intended goals. Tools within EHRs
to evaluate these beliefs are generally
very limited. Alert structures can be
complex, and achieving an understanding of their performance characteristics
and effectiveness can prove difficult. To
develop a detailed understanding of the
functioning and outcomes of an alert
usually requires creating an individualized report. There are few reports of
systematic approaches to monitoring
alerts.3 We set out to develop one.
Objective
Our goal was to develop and test a
framework for reporting performance
metrics for rule-based EHR alerts at
scale. Our intention was to achieve alert
outcome reports that extend beyond
basic metrics and include process outcomes. As a preliminary step we set out
to develop a new action-oriented classification system or taxonomy of alerts
on the basis of their structure, especially
intended and optimized to facilitate
outcomes metrics. Existing taxonomies
would not suffice because they do not
readily map to a measurement framework.4-8 We sought to generate metrics
in sets rather than one by one to reduce
the time and expense of developing
and maintaining performance metrics
for alerts.
Background
In a proposed five-level evaluation hierarchy of rule-based alert performance,
“firing rates” are at the lowest and most
commonly reported level. Rates by role
such as nurse or physician, specialty
such as family medicine or general surgery, site of care such as inpatient or
ambulatory, department or unit such as
intensive care or urgent care, time of day
Michael A Krall, MD, MS, is a part-time Physician Lead for Clinical Decision Support for The Permanente
Federation. He retired from Northwest Permanente in 2014 after 30 years practicing Family Medicine and
after 20 years engaged in clinical informatics. Dr Krall was the Director of Clinical Decision Support and
Knowledge Management for Northwest Permanente. E-mail: michael.krall@kp.org. Alexander Gerace is an
Information Analyst for Care Delivery Analytics for Northwest Permanente. E-mail: alexander.x.gerace@kp.org.
11
or week, and similar factors can extend
this metric. The second level is “acceptance” and “override” rates. Proximate
“action taken” by users in response to
the alert is the next highest level. The
fourth level is a measure of intermediate
process goals or outcomes achievement.
Finally, the highest level is a measure of
patient health goals or outcomes or clinician goals or outcomes achievement.
Each successive level in the evaluation
hierarchy is more difficult to create. In
this report we chose to focus on the
fourth level, process goals and outcomes.
For most alerts, knowing that they
fire frequently or infrequently and
have a high or low acceptance rate
yields only a limited understanding of
whether their explicit recommendations
were followed or if they were effective
in achieving their intended goals. Was
the safe practice followed or the unsafe
practice averted? Was the evidencebased treatment prescribed? Was the
cost-effective choice made, the recommended documentation performed, the
dose modified, the procedure ordered
or performed? These are “level 4” questions in the hierarchy introduced above.
Ultimately, was care improved and the
desired health or clinician outcome
achieved? These are “level 5” questions.
For most alerts, firing, override, and
proximate action-taken rates do not
answer these higher-order questions because action on the alert may not be the
same as action on the triggering event.
In EHRs, alerts may be built with a
number of available user actions. In the
Epic 2012 and earlier versions (Madison, WI) EHR, for example, standard
controls include “accept” and “cancel”
buttons that take these actions on the
alert. However, there may be additional
actions such as “open an order set,”
“create an order,” or “navigate” to the
Problem, Allergy, or Medication List
activities to perform an operation, and
such actions are intended to address
the triggering condition. It is possible
for users to “cancel” an alert yet still
perform the recommended operation,
such as order a laboratory procedure.
Alternatively it is possible to “accept”
the alert but fail to perform the operation. For example, the user can open an
order set attached to an alert and choose
12
not to sign the recommended order, or
can navigate to an allergy or medication list and decide not to perform the
recommended update. Thus reports that
simply count these actions may generate
inaccurate and misleading information
about alert effectiveness and desired
outcomes. In the end, what we want
to know is whether the recommended
operation was performed, regardless of
whether it was done as a direct result
of the alert.
A reporting strategy that disengages
the outcome from a direct action of the
alert creates the additional complexity
of determining the optimal time frame
for measurement. The measurement interval could be defined as immediately
proximate to the alert firing (or viewing,
in the case of alerts that do not pop up),
as the less stringent “any time within
the encounter” definition, or as another
predefined interval (such as within eight
hours of firing). In the first instance,
“credit” is assigned to the alert only if
the recommended action occurred as a
direct result of or immediately following
the alert. An order or action fulfilling the
recommendation that was placed later in
the same encounter would not count as
alert “success.” In the second instance,
any fulfilling order or action that was
taken within the same encounter would
count, even though it is not certain that
the action taken was directly caused by
the alert. In the inpatient setting, where
the entire stay might be considered the
encounter, this definition could cause
difficulty in interpretation. Here the
third approach, crediting actions that
occurred within a specified time window, such as within an eight-hour shift,
might be more meaningful. Conceptually, this requires an approach to metrics
similar to an intention-to-treat analysis
of a randomized control study.
Complete assessment of the appropriateness of a specific alert, the user’s
response to that alert, or level five patient or clinician outcomes requires
a broader analysis to include patient,
user, and environmental factors. Because an automated batch processing
of alerts cannot achieve that level of
investigation, a more realistic goal is to
develop a report that would allow categorizing alerts into those appearing to
be “high,” “low,” and “intermediate” in
performance. An institution might then,
for example, choose to direct its efforts
at improving, eliminating, or better
understanding those alerts with “low”
performance. To do so might require
a more in-depth assessment, possibly
including medical chart reviews. McCoy et al9 published a framework for
evaluating alert appropriateness.
To develop a detailed model of alert
metrics, it is necessary to have a common understanding of the structure or
“anatomy” of an alert. There have been a
number of clinical decision support and
alert taxonomies developed for different
purposes.4-8 In 2007, Wright et al7 at
Partners Healthcare System developed
a taxonomy for rule-based decision
support. They included four functional
components they termed triggers, input
data, interventions, and offered choices.
Later, the National Quality Forum
Clinical Decision Support Expert Panel8
proposed a modification of this classification. They replaced “offered choices”
with “action steps.” Triggers are the user
actions that can invoke an alert. These
actions might include, for example,
entering or signing an order, opening
a chart or a specific screen, or entering
documentation. Input data are the elements in the record that might modify
the alert performance. Input data might
be information about the patient (eg,
age, gender, diagnoses, preferences),
National Quality Forum Taxonomy:
Selected EpicCare Examples
Triggers
Open chart, open order entry
Enter order, enter diagnosis
File flow sheet
Input data
Age, gender, comorbidities
Provider type, role
Encounter type
Interventions
Display message in Navigator
Send in-basket message
Add modifier
Pop-up message
Action steps
Accept or Cancel alert
Enter order
Open order set
Figure 1. Distribution of alerts at Kaiser Permanente Northwest by class, 2013.
about the user (eg, specialty, role, experience, preferences), or about the environment (eg, time of day or week, unit,
department, or setting). Interventions
refer to computer-human interface actions and the manner in which the alert is
displayed, such as via a pop-up message.
In some cases the intervention might
happen without user awareness, such as
if the alert action is to set a modifier or to
trigger an asynchronous alert (occurring
at a remote time or place). Finally, action
steps are recommended or permitted actions that a user can take as a direct result
of the alert. Accepting, canceling, and
overriding (with or without providing
a reason) are the most common actions.
Many more actions may also be available
in alerts, including opening order sets,
accepting an order, and navigating to
another activity such as the medication,
allergy, or problem list. The Sidebar:
National Quality Forum Taxonomy:
Selected EpicCare Examples illustrates
these structural elements with a few examples from the EpicCare EHR. Most
other EHR alerts have similar structure
and comparable examples.
Combining available triggers, inputs,
interventions, and action steps yields a
very large number of possible alert forms,
particularly since an alert may incorporate more than one element for each
functional component. For example,
one alert could have an enter-diagnosis
and enter-order trigger, multiple data
inputs, and both a pop-up display and
an in-basket notification. Alerts may also
have more than one permissible or recommended action step. This complexity
is a major reason why it is difficult to create generalized alert outcome reports. For
each alert it is necessary both to define
its structure and to declare which actions
constitute a desired outcome or “success.”
Previous taxonomies are not classified by
actions taken (such as create or modify
an order) and do not attempt to address
alert outcomes.
METHODS
This work was developed at Kaiser
Permanente Northwest (KPNW), a
Region of the Kaiser Permanente Health
Care program located in Oregon and
Southwest Washington. The Region
employs approximately 1000 physicians
and cares for approximately 500,000
Health Plan members. KPNW began
implementation of EpicCare in 1994,
and it was fully implemented in ambulatory clinics by 1997. The inpatient system was implemented in 2008. KPNW
owns and operates 2 hospitals and about
40 outpatient clinic sites, most of which
are large and multispecialty.
We took an empirical approach to
developing the alert metrics taxonomy.
Each of 333 active, production rulebased alerts in our system was assigned
to a class on the basis of its structure
and intended outcome. If an existing
class did not adequately encompass the
alert in question, a new class was added
or an existing class was modified. This
process was iteratively repeated until
all alerts were assigned and the remaining classes were coherent. Where alerts
had characteristics of more than one
class, they were assigned on the basis of
their apparent primary intention. For
example, an alert that recommended
substitution of a particular medication
for another (a substitution action) but
also facilitated documentation of allergy
to the recommended choice via a link
to the allergy activity (a documentation
action) was classified according to the
primary intention of substitution. In
order to limit project scope, standard,
vendor-supplied drug-drug and drugallergy alerts were excluded from this
analysis. This was deemed appropriate
for several reasons. In the Epic EHR
such alerts are presented with a different utility. Although they do conform to
the same four-element National Quality
Forum functional taxonomy, they have
a different data and reporting structure
and are very numerous. Moreover, for
these alerts “acceptance” and “override”
rates are more useful metrics because the
valid action steps are fewer and more
straightforward—the user either accepts or overrides the recommendation
to avoid the drug-drug, drug-allergy, or
drug-condition combination. Admittedly, that analysis would necessarily
13
“Y”
“X”
Recommended
#
Recommended
%
TSH WITH REFLEX T4 ORDER ALERT
3171
TSH ONLY ALERT
2373
Total/Average
5544
Alert_Description
“X+Y”
Trigger
#
Trigger
%
Trigger+Recommended
#
Trigger+Recommended
%
None
#
None
%
Total
#
59.8%
931
17.5%
868
16.4%
337
6.4%
5307
49.3%
1363
28.3%
953
19.8%
128
2.7%
4817
54.8%
2294
22.7%
1821
18.0%
465
4.6%
10124
Figure 2. Substitute Order Alert with example report: “X” is the procedure that triggered the best-practice alert, “Y” the recommended substitute order, “X+Y”
represents encounters in which both tests were ordered and “none” in which neither test was ordered.  2014 Epic Systems Corporation. Used with permission.
FT4 = free thyroid; T4 = thyroid hormone; TSH = thyroid stimulating hormone; W = with.
be more complex if one considered the
possible override reasons that may be
required or optionally provided or the
alternative actions such as updating
medication or allergy lists.
Following development of an initial
taxonomy, we turned attention to designing a report creation methodology.
Starting with the classes with the largest
number of members, we examined a
representative alert from each class. For
each, we developed a formulaic description of the triggering event and recommended outcome. Then we used the
data model and data in Clarity, Epic’s
analytical database, to create a report
comparing initial with final conditions
to determine alert outcome. We started
with the appropriate trigger table in the
reporting data warehouse. For example,
we used one table for procedure triggers
and another for generic medications.
Next, we created a subquery that defines the recommended result, such as
a substituted or additional procedure or
medication, for each alert in the given
class. This recommended result might
have been contained, for example, in
an order set or in an order attached directly to the alert. We joined this table
to the triggered alert by its identifier,
the alert locator ID. Next we created a
subquery to determine whether the alert
trigger and/or the recommended result
was ordered or created in a valid time
interval, as discussed above. For ambulatory alerts we defined this interval as
within the particular patient encounter,
usually an office visit or telephone call.
Finally, we created a summary report.
RESULTS
Each alert is unique, owing to its
complex structure and specific clinical
or operational intention. Nevertheless,
through empirical analysis, it appears
that there are a manageable number of
major structural classes for alert metrics, and these constitute the proposed
taxonomy (see Sidebar: Alert Metrics
Taxonomy). Each of these classes has
a generalized structure that can be
expressed in narrative. Substitution
alerts, for example, are those in which
a clinician orders a test, procedure, or
treatment, or enters a diagnosis or finding and the alert recommends a second
test, procedure, or finding instead, such
as “Replace the order for ‘Chest X-ray
AP/LAT’ with an order for ‘Chest X-ray
two-views.’” The substitutions are usually of the same type (eg, test for test or
diagnosis for diagnosis) but could be of
mixed type (eg, medication for procedure). In this case, a trigger “X” causes the
alert to recommend substituting an item
or action “Y.” Corollary-type alerts are
similar.10 In these cases, however, a trigger
“X” generates a recommendation of an
additional “Y.” For example, “In addition
to the order for digoxin, please order a
serum potassium and creatinine.” Corollary recommendations may be single or
multiple (“Y” and “Y1” and “Yn”), and
like substitution alerts, the recommendations may be of the same or mixed type.
Alert Metrics Taxonomy
Substitution
Substitute-Order
Substitute-Medication
Substitute-Documentation
Corollary
Corollary-Order
Corollary-Medication
Corollary-Documentation
Modify
Modify-Order
Modify-Medication
Modify-Documentation
Create
Create-Order
Create-Medication
Create-Documentation
Create-Communication
Remove
Remove-Order
Remove-Medication
Perform
Perform-Procedure
Perform-Documentation
Informational only
Send communication
Other
14
The other alert classes follow similar
patterns. Modify-type alerts recommend changes to new or existing orders or documentation—for example,
“Decrease the dosage of digoxin on the
basis of the patient’s serum creatinine.”
Create alerts recommend new orders or
documentation, such as “The patient is
due for a mammogram. Please sign the
attached mammogram order.” Remove
alerts recommend that existing orders
or documentation are canceled—for
example, “It appears that the patient
no longer requires a follow-up CT
[computed tomography] scan. If this is
correct, please cancel this order.” Perform alerts recommend the execution
of specific actions, such as “Because of
the elevated initial blood pressure, please
repeat a blood pressure in 5 minutes and
document in the chart.” Informational
Only alerts provide a message without
the expectation of a particular action
that is captured within the system—for
example, “There is a regionwide shortage of influenza vaccine.” Alerts might
“Y”
“X”
send communication through a variety
of means including in-basket messages
or messages to pagers, faxes, phones,
or Internet-enabled devices. Because
this taxonomy is not exhaustive, there
is necessarily an Other category. In our
analysis, the alerts that fell into this
category were “one-offs” and did not
lend themselves to additional characterization at this time. An example of
such an alert is a single one that automatically adds a modifier or marker to
the patient’s chart if he is a man older
“X+Y”
Recommended
#
Recommended
%
Trigger
#
Trigger
%
Trigger+Recommended
#
Trigger+Recommended
%
None
#
None
%
Total
#
CONTRAST IMAGING AND NO PRIOR
CREATININE
99
3.3%
938
30.9%
1790
59.0%
206
6.8%
3033
REF EKG
50
5.2%
133
13.7%
723
74.7%
62
6.4%
968
REF EKG WITHIN 30 DAYS
67
8.2%
112
13.7%
589
71.8%
52
6.3%
820
REF PODIATRY OTHER
14
0.8%
732
42.9%
853
50.0%
107
6.3%
1706
LACTATE WITH BLOOD CULTURES ED
3
0.2%
125
8.5%
1337
91.0%
5
0..3%
1470
REF TSH NOT ON MEDS
10
1.5%
109
15.9%
551
80.2%
17
2.5%
687
REF TSH NOT ON MEDS WITHIN
2 YEARS
8
1.2%
72
10.8%
561
84.0%
27
4.0%
668
REF CBC 4 WEEKS
13
1.0%
138
10.2%
1166
86.4%
32
2.4%
1349
REF URIC ACID
22
5.4%
98
23.9%
240
58.5%
50
12.2%
410
REF URIC ACID WITHIN 6 WEEKS
25
7.1%
73
20.9%
207
59.1%
45
12.9%
350
REF PHOSPHOROUS
21
5.3%
92
23.1%
234
58.7%
52
13.0%
399
Total/Average
332
2.8%
2622
22.1%
8251
69.6%
655
5.5%
11860
Alert_Description
Figure 3. Corollary-type alerts and report. A referral to nephrology for evaluation of acid-base disturbance generated these alerts for tests recommended
before the referral that have not been performed. In the report, “X” is the procedure that triggered the best-practice alert, “Y” the recommended additional
order(s); “X+Y” represents encounters in which both tests were ordered: the desired result in this case.  2014 Epic Systems Corporation. Used with permission.
BUN = blood urea nitrogen; CA = calcium; CBC = complete blood count; CL = chloride; CO2 = carbon dioxide; CR = creatinine; ED = Emergency Department; EKG =
electrocardiogram; GLU = glucose; K = potassium; KPNW = Kaiser Permanente Northwest; NA = sodium; REF = referral; TSH = thyroid stimulating hormone; UA = urinalysis.
15
than age 65 years who has documentation that he is a current or ever-smoker.
This marker, in turn, is used by a second
alert that recommends screening for
abdominal aortic aneurysm. We elected
not to create new classes with only single
members in our data set. The Sidebar:
Alert Metrics Taxonomy also contains
subcategories. More granular specification is important because the reporting
logic differs for procedures, medications,
and documentation.
We assigned each of 333 KPNW
active, in-production, rule-based alerts
to a class. Some alerts recommend or
allow more than one action, such as
substitute an order and perform documentation. As noted, for the purposes
of report creation, simplification, and
this initial stage of development, each
was assigned to one class only on the
basis of their primary or most impactful recommendation. In our system at
this time, 3 of 18 categories accounted
for more than 60% of all alerts, with
Corollary Order, Substitute Medication,
and Create Order contributing 106, 58,
and 46 alerts, respectively (Figure 1).
Categorizing alerts by class allowed us to
develop a reporting strategy that works
for all members of that class, or at least
for those members who do not deviate
too much from a prototypical class representative. The Substitution Order class
offers an example of our approach. In
this case, a user orders test or procedure
“X” and the alert recommends substituting test or procedure “Y” (Figure 2).
Regardless of whether the user accepted
or canceled the alert, or opened or did
not open an attached order set if present,
what we want to know is, at the end of
Figure 4. Substitute Medication Alert and attached ambulatory order set. A benzodiazepine drug was ordered in a patient older than age 64, and a substitution is
recommended and facilitated via the attached ambulatory order set containing condition-specific recommended alternatives. Note that there are both pharmacologic and
nonpharmacologic alternatives. The anxiety treatment options are in an expandable group. Each of these choices is contained in a separate group or item within the
database.  2014 Epic Systems Corporation. Used with permission.
AVS = after-visit summary; Disp-30 = dispense 30; Hx=history of; HEDIS = Healthcare Effectiveness Data and Information Set; OTC = over the counter; PO = by mouth; PRN = when necessary;
R-5 = refill 5 (ie, 5 refills).
16
the measurement period (eg, encounter), which was ordered, “X” or “Y”?
(Ordering both is also possible, which
would usually not be a desired result,
as is ordering neither, which might
or might not be desirable depending
on the situation.) What we need is a
program that can determine for all
alerts of this type, which order(s) were
present in the “result set” at the end of
the encounter. Figure 2 also shows an
example of a report created for 2 alerts
of the Substitution class. In these 2
alerts, the recommended result occurred 54.8% of the time on average.
Corollary Order alerts provide a second example. In these situations, a user
orders test or procedure “X” and the
alert recommends one or more additional test or procedure “Y” (Figure 3).
In these cases, regardless of whether the
user accepted or canceled the alert or
performed other actions as a direct result of the alert, we want to know at the
end of the encounter what was ordered,
“X,” “Y,” both, or neither? Fortunately,
the same approach and logic can be
used to generate reports for these alerts.
The structure is the same and what differs is the definition of success. In this
case, what is desired is “X + Y” and
not “X” or “Y” alone. Using this logic,
a report for this class of alerts can be
generated (Figure 3). In this example,
the recommended result occurred in an
average of 69.6% of cases.
The approach to medication-related
alerts is similar but often more complex. It is unusual for there to be a oneto-one recommendation in medication
substitutions. Usually a class of medications is contraindicated in a population
defined by an age range, laboratory
findings such as renal insufficiency, a
specific genetic marker, or a diagnosis.
The recommended substitution might
depend on other factors including
the initial reason for prescribing the
triggering medication. Thus the recommended substitution values might
be organized and contained in two or
more groups. Furthermore, the valid
medication alternatives themselves
usually constitute a class rather than
a single entity. The reporting program
must be able to detect all the valid substitution values. Figure 4 illustrates a
Substitute Medication alert. In this case
a class of medications is relatively contraindicated in the elderly because of
risks of insomnia, delirium, sedation,
and cognitive impairment. Members
of this medication class are prescribed
for a variety of indications, and recommended alternatives depend on these
reasons. Such condition-dependent
Alert Description
alternatives can be offered within an
order set.
Despite these complexities, it was
possible to develop a program that
can automatically detect the triggers
and recommended substitutions for
medication-related alerts, and produce
a report (Figure 5). Using pharmaceutical classes and generic drugs facilitates
this. We are also able to take advantage
of naming conventions in our order
set development where, for example,
all groups that contain medications
begin with the prefix MED. For the 15
alerts in this example, the average rate
of prescribing the preferred medication
is just 10% (range, 1.5%-54.3%). Because nonpharmacologic therapies may
be very appropriate, prescribing “none”
(neither the trigger nor the recommended alternative medications) might
be considered a positive outcome. Taking the “none” and “Y” results together
yields an overall average success rate
of 24.8% (range, 9.4%-75.5%) for
these alerts.
DISCUSSION
It is difficult to understand or to
improve what isn’t measured or at
least examined. To comprehend which
alerts achieve their intended goals, one
needs more than only rates of firing,
Order Type
None
“X”
“Y”
“X+Y”
Total
ELDERLY AND BENZODIAZEPINES
SmartSet
9.7%
36.9%
6.5%
46.9%
6989
ELDERLY AND SKELETAL MUSCLE RELAXANTS
SmartSet
19.9%
59.4%
8.2%
12.4%
1723
ELDERLY AND Z DRUG SLEEP AGENTS
SmartSet
9.6%
71.5%
11.6%
7.3%
1545
ELDERLY AND ANTIHISTAMINES/ANTICHOLINERGICS
SmartSet
21.8%
51.5%
14.6%
12.1%
1540
ELDERLY FALL RISK AND ANTIPSYCHOTICS/SLEEP MEDICATIONS
SmartSet
11.6%
63.5%
4.5%
20.5%
978
ELDERLY AND LORAZEPAM OR OXAZEPAM
SmartSet
7.7%
83.0%
1.7%
7.7%
951
DRUG INTRCTN CLOPIDOGREL+PO ESOMEPRAZOLE OR OMEPRAZOLE
SingOrd
5.6%
25.9%
20.2%
48.3%
752
ELDERLY FALL RISK OR DEMENTIA+TCA/PROCHLORPERAZINE
SmartSet
29.7%
49.6%
6.6%
14.1%
708
ELDERLY TERTIARY TRICYCLIC ANTIDEPRESSANTS
SmartSet
45.0%
43.9%
4.2%
6.9%
642
ELDERLY AND PROMETHAZINE
SmartSet
20.0%
49.2%
21.1%
9.8%
551
DRUG INTERACTION WARFARIN+SULFA
SmartSet
21.3%
17.7%
54.3%
6.8%
503
DRUG INTERACTION STATIN+GEMFIBROZIL
SmartSet
36.8%
36.2%
22.7%
4.3%
163
ELDERLY AND BUTALBITAL
SmartSet
25.8%
60.6%
8.3%
5.3%
132
ELDERLY AND DESICCATED THYROID
SmartSet
11.1%
86.1%
2.8%
0.0%
72
ELDERLY AND INDOMETHAZINE
SmartSet
18.5%
76.9%
1.5%
3.1%
65
14.8%
48.2%
10.0%
27.0%
17314
Total
Figure 5. Substitute Medication Alerts with results. “X” is the medication that triggered the alert, “Y” is the recommended substitution medication. “X+Y”
represents encounters in which both medications were ordered. This report also indicated whether the medication was ordered via an ambulatory order set
or via an attached single order (SingOrd).
PO = by mouth; TCA = tricyclic antidepressant.
17
acceptance, and override. First, one
needs an explicit understanding and
articulation of the goal. Next, one
needs to determine whether that goal
was achieved. To make this a realistic
endeavor on a large scale, one needs a
systematic approach.
We developed a classification system that allows development of batch
reports on alert process outcomes or
goals. Our initial approach was empiric
and influenced heavily by the existing
alerts in our system. We simplified the
classification system by assigning alerts
to only a single class, even though some
alerts have features of more
than one class. For these
Alert success
reasons, this taxonomy is
results … may
certainly not exhaustive.
seem low and
Other classes of alerts no
disappointing
doubt exist in other systems
… but likely
today and will exist within
will not
our system in the future. We
next created batch reports
surprise those
for some classes of alerts.
experienced
To date, we have dewith alert
veloped reports for the
acceptance and
Corollary-Order, Coroloverride rates.
lary-Medication, CreateOrder, Substitute-Order,
and Substitute-Medication classes of
alerts. These represent the top three
plus two less-frequent classes of alerts
at KPNW, accounting for fully twothirds of our current alerts. The fourth
most common class, Informational
Only, is not amenable to reporting of
this nature because there is no measurable outcome event. Creating outcomes reports for several other classes,
including those related to documentation, may also prove difficult and
require special techniques, structured
data entry, Concept Unique Identifiers, or natural language processing.
In some systems, certain alerts are
designed to allow overrides with rationales, usually selected from a list, with
or without the ability to add free text
comments. We have very few of these
in our system, except in the standard
drug-drug and drug-allergy alerting
activity. A challenging metrics issue is
how to handle such alerts. Examples
of overrides include “patient refused,”
“benefit outweighs risk,” “no good
alternative,” “postponed for medical
18
indications,” or “doubtful allergy.”
When a valid override or postpone reason is selected, this might be counted
as alert success or at least not failure,
but this assumes that only valid reasons
are available for the given alert and that
the reasons are selected with fidelity.
In practice, some alerts are overridden, often at a very high rate, because
the alert is a “false positive” based on
incomplete or faulty data, incorrect
alert logic, or inaccurate knowledge
synthesis. A complete evaluation of the
effectiveness of such an alert could thus
require examining the selected override
or postpone reasons in light of the actual clinical data to determine whether
the reasons were applied appropriately.
We provided examples of metrics
for three classes of alerts. For the
Substitution-Order, Corollary-Order,
and Substitution-Medication alerts we
measured in this way, the desired outcome was achieved on average 54.8%,
69.6%, and 24.8% of the time, respectively. Running the same report with
different alerts, or perhaps even the
same alerts after the alert or the alerting environment was modified, would
probably yield different numbers. An
alert might be modified, for example,
by developing a clearer message, making it more specific by incorporating
exceptions in the logic, or adding a
more useful action step. Examples of
modifying the alerting environment
would be decreasing the overall number of alerts, providing user education,
or changing incentives.
Alert success results such as in our
Substitute-Medication report (Figure
5) may seem low and disappointing to
some people but likely will not surprise
those experienced with alert acceptance
and override rates. The value in having
such data is first that it allows identification and examination of alerts that
appear to be underperforming. Viewing
this data also allows a better understanding of actual alert performance more
generally and might encourage quality
and safety officers, decision-support
developers, and leaders to plan more
realistic and comprehensive safety and
quality strategies, rather than blithely
assuming success from alerts alone.
Findings such as these suggest that
alerts may be part of such a strategy
but often will not be sufficient. The
main outcomes of this study were the
successful development of a rule-based
alerts taxonomy and the demonstration of its application in a reporting
strategy. The full-scale application of
this strategy with detailed outcomes to
a corpus of alerts was out of the scope
for this article and could itself justify a
report. However, even preliminary and
partial review of our alerts using this
approach resulted in the elimination
of several poorly performing alerts and
the modification of others.
Our approach decreases the time and
effort to produce alert process performance metrics reports, making it more
feasible to run them regularly, and this
in turn results in a more complete and
dynamic representation of alert functioning. Because increased complexity
makes measurement more difficult and
costly, alert developers may want to add
complexity and to use extra options
and actions more thoughtfully and
only where they add significant value.
This study has some limitations. A
single author developed and determined
the taxonomy and assigned alerts to the
taxa. Although the primary intention
and contribution of this work was to
develop a reporting framework and approach rather than a broadly applicable
and validated taxonomy, it would be
useful to do this in the future. Two or
more individuals making assignments
with a reported interrater agreement
would add confidence. We examined
alerts in only a single institution using
a single EHR, and we know we have
not exploited all potential alert actions.
There are no doubt alert classes that
we did not identify, and we chose not
to create an alert class containing only
a single member in our data set. Furthermore, we assigned alerts to a single
class, although some have actions that
might place them in more than one.
Alerts assigned to the Other category
underline that the current taxonomy
is not exhaustive. Further study with
additional alerts and at different institutions should result in more classes. The
specifics of our reporting approach will
be generalizable only to a certain extent
because each EHR has its own structure
and data model, although most EHRs
will have similar components. Finally,
this report did not attempt to address
the highest level in the evaluation hierarchy of rule-based alerts performance,
whether patient or clinician goals or
outcomes were achieved.
CONCLUSION
We developed a taxonomy for rulebased alerts and demonstrated its application in developing outcome metrics
reports on a large scale.
CLINICAL RELEVANCE STATEMENT
Understanding whether clinical
decision alerts achieve their intended
function is fundamental to developing
effective alerts and realizing the safety,
quality, and resource benefits of EHRs.
To reach this understanding, individuals and groups charged with developing
and maintaining alerts need enhanced
tools and reports.
The approach presented here allows
nuanced effectiveness reports on a large
scale. v
disclose.
Acknowledgments
We acknowledge Wiley Chan, MD; Dean
Sittig, PhD; Sunshine Sommers, MS, RPh; and
Adam Wright, PhD, for review of the manuscript
and for suggestions. The screenshots of Epic
alerts in Figures 2, 3, and 4 are © 2014 Epic
Systems Corporation. Used with permission.
Mary Corrado, ELS, provided editorial
assistance.
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Our Wit Languisheth
Yet when we content ourselves with their discoveries
[ie, those of ancient Greece], and calmly believe (which is
mere sleepiness) that there is now no more place for new
inventions, the spritely edge of our own wit languisheth, and
we extinguish the lamp which they lighted to our hands.
— William Harvey, MD, 1578-1657, English physician,
first to describe the circulatory system
19
SOUL OF THE HEALER
Pinnacle
photograph
Brad Christian McDowell, MD
This image was captured outside the Denver Art Museum. The sun was aligned behind
the building, and the photograph was later processed in Photoshop to give the final
result. The Denver Art Museum is a must-visit location in Denver, CO.
Dr McDowell is a Plastic Surgeon at the Denver Medical Office in CO.
More of his photography can be viewed online at: www.diversityofvision.com.
20
credits available for this article — see page 96.
“Getting off the Bus Closer to Your Destination”:
Patients’ Views about Pharmacogenetic Testing
James Ralston, MD, MPH; Gail P Jarvik, MD, PhD; Eric B Larson, MD, MPH
Perm J 2015 Summer;19(3):21-27
ABSTRACT
Context: Pharmacogenetic testing, a form of precision medicine, has the potential
to optimize medication choice and dosing. Yet, relatively little is known about the
views of patients—particularly those with chronic psychiatric conditions—with
respect to such testing.
Objective: To explore patients’ beliefs and attitudes regarding pharmacogenetic
testing, with the goal of informing policy development and implementation.
Design: Qualitative study design using semistructured focus groups with adults
enrolled in Group Health Cooperative, a large health maintenance organization in the
Pacific Northwest. We conducted focus groups with patients prescribed antidepressants (pilot session plus 2 focus groups, n = 27); patients prescribed carbamazepine
(2 focus groups, n = 17); and healthy patients (2 focus groups, n = 17).
Results: Although participants understood the potential advantages of pharmacogenetic testing, many felt that the risks (discrimination, stigmatization, physician
overreliance on genomic results, and denial of certain medications) may outweigh
the benefits. These concerns were shared across groups but were more strongly
expressed among participants with chronic mental health diagnoses.
Conclusion: Clinical implementation of pharmacogenetic testing must address
patient concerns about privacy, discrimination, quality of care, and erosion of the
physician-patient relationship.
INTRODUCTION
The existence of interindividual differences in medication response is well
known: variability exists among patients
in terms of drug efficacy, dosage requirements, and susceptibility to adverse
drug reactions. Pharmacogenetics, the
study of how genetic factors influence
pharmacokinetics and drug clearance
first envisioned by Motulsky1 in 1957,
has a growing role in providing clinically useful prescribing guidance.2 The
US Food and Drug Administration
currently lists 139 approved drugs with
pharmacogenomic information in their
labeling, with categories ranging from
information about clinical pharmacology to contraindications, information for
patient counseling, and dosing considerations.3 Boxed warnings, indicating the
potential for serious injury or death for
individuals with specific genotypes, are
in place for select drugs in anesthesiology (codeine), cardiology (clopidogrel),
hematology (lenalidomide), infectious
disease (abacavir), oncology (arsenic
trioxide, everolimus, rasburicase), and
neurology (carbamazepine, valproic
acid).3 The hope is that appropriate
clinical use of pharmacogenetic testing
will contribute to the “triple aim” of
improving population health, enhancing patient care, and controlling medical
costs.4 Pharmacogenomics, along with
related advances in cancer genomic testing, has received new attention with the
launch by President Obama of a new
Precision Medicine Initiative.5
The value of pharmacogenetic testing
will depend in part on its acceptability
to physicians and patients. The literature
contains some data regarding physicians’
views of pharmacogenetic testing,6-10 and
others have explored the views of the
general public,11 but less is known about
patients’ perceptions.12 The objective of
this study was to explore the views of
patients with and without chronic conditions regarding pharmacogenetic testing.
METHODS
Setting and Study Design
This study is part of the Electronic
Medical Records and Genomics Network, a consortium funded by the
National Human Genome Research
Institute to develop approaches to and
investigate the utility of the clinical integration of genomic information.13,14
Our project is a collaboration between
investigators at the Group Health Research Institute and the University of
Washington, with study participants
at Group Health Cooperative, an integrated health care delivery system that
serves more than 600,000 enrollees in
Washington and Idaho.
We selected a focus group method because interactive discussions are optimal
for exploring questions of acceptability, particularly for topics about which
participants may feel underqualified to
opine15-17; participants may feel more
comfortable sharing potentially negative
views because the group format can provide a feeling of “safety in numbers” for
Susan Brown Trinidad, MA, is a Research Scientist in Bioethics and Humanities at the University of Washington in
Seattle. E-mail: sbtrini@uw.edu. Tara B Coffin, MEd, is a Doctoral Candidate in the Institute for Public Health Genetics
at the University of Washington in Seattle. E-mail: tarabethanne@gmail.com. Stephanie M Fullerton, DPhil, is an
Associate Professor in Bioethics and Humanities at the University of Washington in Seattle. E-mail: smfllrtn@uw.edu.
James Ralston, MD, MPH, is an Associate Investigator at the Group Health Research Institute in Seattle, WA. E-mail:
ralston.j@ghc.org. Gail P Jarvik, MD, PhD, is a Professor and Head of the Division of Medical Genetics at the
University of Washington in Seattle. E-mail: pair@uw.edu. Eric B Larson, MD, MPH, is the Executive Director and
Senior Investigator at the Group Health Research Institute in Seattle, WA. E-mail: larson.e@ghc.org.
21
“Getting off the Bus Closer to Your Destination”: Patients’ Views about Pharmacogenetic Testing
participants.18 The study was reviewed
and approved by the Group Health Research Institute Human Subjects Review
Committee, and written informed consent was obtained from all participants.
Sampling Strategy and Recruitment
Prospective participants were English-speaking adults age 18 years and
older identified through Group Health
administrative records. To learn about
the perspectives of different “types” of
patients, we defined 3 patient cohorts
(Table 1). As a proxy for patients who
were likely to have had personal experiences with trial and error in medication
selection, we selected Group Health
enrollees who had been (sequentially)
prescribed multiple antidepressant
medications.19 To elicit the views of
patients for whom pharmacogenetic
testing could possibly help to avoid
adverse drug events, we identified
individuals who had been prescribed
carbamazepine. Carbamazepine has
been associated with Stevens-Johnson
syndrome (toxic epidermal necrolysis)
in patients with the HLA-B*1502 allelic variant of the HLA-B gene, which
is more common in people of Southeast Asian ancestry3; for this reason,
we oversampled for Asian ancestry in
this group. For comparison purposes,
we identified a third cohort of patients
with no particular pharmaceutical concerns or chronic conditions. We mailed
4303 letters to prospective participants
describing the study and inviting them
to call to enroll; 61 did so, for a total
response rate of 1.4%.
Data Collection
In May 2012, we held a pilot session and 2 semistructured focus groups
with the antidepressant cohort and 2
focus groups with patients prescribed
carbamazepine. In July 2012, we conducted 2 focus groups with patients
without chronic illnesses. The investigators used a written discussion guide in
all sessions (Table 2). Each discussion
was cofacilitated by 2 members of the
study team (SBT and SMF, who introduced themselves as researchers from the
University of Washington) and lasted 2
hours. A court transcriptionist attended
each session. We provided an informal
buffet dinner and paid parking, and each
participant was given $50 in cash at the
end of each session.
Data Analysis
Our analytic goal was to produce a
qualitative description of participants’
perceptions of pharmacogenetic testing.20 We used thematic analysis and
a constant comparison approach to
coding.21 Two members of the study
team performed several close readings
Table 1. Focus group composition
Variable
Eligibility criteria
Sex
Male
Female
Age, years
Range
Mean
Race and ethnicity
White
Black
American Indian
Asian
Pacific Islander
Hispanic
Other
Educational attainment
Some high school
High school or GED
Some college
Associate degree
Bachelor’s degree
Master’s degree
PhD
Other advanced degree
Antidepressant cohort
Prescribed ≥ 2
antidepressants in previous
2 years; new antidepressant
prescription within past
3 months, n = 27, No. (%)
Carbamazepine cohort
Currently prescribed
carbamazepine;
oversampled for Asian
ethnicity, n = 17, No. (%)
Healthy cohort
GHC enrollees for at least 2 years;
≤ 2 current prescriptions; exclusions:
mental health diagnoses, current
antidepressant or carbamazepine
prescription, n = 17, No. (%)
Total
n = 61,
No. (%)
10 (37)
17 (63)
5 (29)
12 (71)
7 (41)
10 (59)
22 (36)
39 (64)
22-78
54
21-73
50
21-78
50
21-78
51
23 (85)
1 (4)
1 (4)
1 (4)
0
0
1 (4)
11 (65)
1 (6)
0
2 (12)
0
0
3 (18)
15 (88)
0
0
0
0
2 (12)
2 (12)
49 (80)
2 (3)
1 (2)
3 (5)
0
2 (3)
6 (10)
0
2 (7)
6 (22)
1 (4)
9 (33)
8 (30)
1 (4)
0
0
3 (18)
2 (12)
2 (12)
5 (29)
4 (24)
0
1 (6)
1 (6)
0
0
0
8 (47)
7 (41)
0
1 (6)
1 (2)
5 (8)
8 (13)
3 (5)
22 (36)
19 (31)
1 (2)
2 (3)
GED = general equivalency diploma; GHC = Group Health Cooperative.
22
of the de-identified transcripts. The
lead analyst drafted a codebook of the
major themes, which was revised over
several meetings of the analytic team.
Transcripts and codes were uploaded
into Dedoose (www.dedoose.com),
an online software application for
qualitative analysis. The codebook went
through two substantive revisions before
final coding, including independent
coding of four transcripts by two team
members. The lead analyst performed
final coding, with review by a second
member of the team.
RESULTS
Participants were aware of interindividual differences in medication
response. Many shared stories about
medications that did not work, caused
side effects, or were “too strong” or not
strong enough. Several related having
felt like “guinea pigs” or, in one case,
“a test-tube baby” during a process
of therapeutic trial and error. A participant in one of the antidepressant
groups said, “Sometimes I’ve been
prescribed a medication and then find
out it’s not maybe doing the job. So
we go to the next medication down
the list, whereas, for some people, that
first one works just fine.” The idea that
genetics could make a difference in
drug response was less familiar, but some
participants believed that medication
response could be inherited or shared
within families.
Participants Believed Pharmacogenetic
Testing Could Be Beneficial
Upon introduction to the topic,
of pharmacogenetic testing to optimize
prescribing decisions, and they could
imagine clear benefits from its use. As
one participant put it, “I think it’s a
great idea. Who wouldn’t want more
information about the proper medication to take?” Another compared
pharmacogenetic testing to riding a
bus: “You could jump off anywhere
downtown and get to a store, but you
want to get off closer to the store you’re
going to.” The value of the test could be
even greater in high-stakes situations: a
participant who reported that her child
is currently awaiting a liver transplant
said, “You get the liver, and you’re on
medication for a long time. If there
was a test that would show us which
medications are going to work for him,
we’d be on that so fast! Because that’s a
huge life-or-death deal.”
Participants in the antidepressant and
carbamazepine groups seemed particularly sensitized to the challenges patients
can face in finding the right medication
and avoiding side effects; many related
stories of trial-and-error in the therapeutic odyssey. One person, a participant
in one of the depression groups, shared
her frustration with prior medication
experiences and emphasized the value
of identifying the optimal drug more
quickly:
Even if it takes six months [to get
pharmacogenetic test results], I have
had—looking back, it’s like, you know,
gee, do you think that that particular
drug was what took like four years out
of my life? Yeah. If somebody could
go in there and figure it out in four
months, yeah, that would be better.
A participant in one of the
carbamazepine discussions said, “The
idea that a genetic test—I know there’s
some controversy there—but that it
could help limit, or define, [the best]
medication, that’s very appealing. I
mean, I have had bad years on the
wrong thing.” Another participant in
the same session commented, “If I were
taking lithium, or Depakote, or some
medicine with a lot of side effects, and
this test could say, well, those aren’t
going to help me, I would want to
be taken off of those. So I think there
could be a benefit to having a complete
workup of the information.”
Table 2. Focus group discussion topics
Step
Warm-up and orientation
Goals/subtopics
- Establish rapport within the group
- Introduce pharmacogenetics in a relatable way
Directed pharmacogenetic testing
(for specific medication or class)
- Informed consent
- Pros and cons
- Factors influencing decision making
- Information desired about results
Whole-genome sequencing
(including pharmacogenomic
indication)
- Informed consent
- Pros and cons
- Factors influencing decision making
- Data security
- Information desired about results
Sample questions
Different people respond differently to medications. For
example, codeine—a commonly prescribed pain medication—
just doesn’t work for some people. And some people may have
severe reactions to medications that work just fine for others.
Have you ever heard of anything like this before? Have you
ever heard that genes might play a role in such differences?
Would you want to know if your doctor planned to order a
genetic test before prescribing medication? Would you want
this kind of test if you could find out the drug might not work
for you? Would you want information suggesting that you
may react similarly to related drugs (in addition to the one the
doctor wished to prescribe for your current condition)?
Would you be willing to undergo sequencing before being
prescribed a specific medication (eg, at your annual physical
examination)? What would you want to know about the way(s)
in which your additional genetic test information might be
stored? Eventually such comprehensive genetic testing might
include all genes in the genome, not just those most relevant
to drug prescribing. This might mean that other information
relevant to your current or future health status would also be
generated. What are your impressions about this possibility?
23
Potential Negative Effects on
Quality of Care and the PhysicianPatient Relationship
Some participants felt that physicians might rely too heavily on genetic
results and fail to give due consideration to all possible factors; others
worried that physicians might not
understand how to use this new information appropriately. A participant
in one of the sessions with healthy
patients said, “I can see this testing
as a protection for doctors, kind of a
cop-out. They won’t have to work quite
as hard to dig and find out, ‘What
shall I prescribe this person and how
much?’ Because they will have this [test
result]—‘Oh, okay, we’ll use that.’ So
it’s kind of a protection for doctors.”
The belief that physicians might
regard genetic information as more
important than other data, possibly to
the patient’s detriment, was a strong
motif. Of greatest concern
to participants across all sesOf greatest concern
sions was the possibility that
to participants
physicians might rely excluacross all sessions
sively on pharmacogenetic
was the possibility
test results and disregard
that physicians
patients’ reports about how
might rely
a medication is working (or
failing to work). A number
exclusively on
of patients in the antidepharmacogenetic
pressant and carbamazepine
test results and
cohorts related incidents in
disregard patients’
which they felt that their
reports about how
reports of medication proba medication is
lems had not been taken
working (or failing
seriously or were actually
to work).
contradicted. The following
exchange, which took place
in one of the antidepressant groups,
illustrates several participants’ views:
PARTICIPANT 4: I want to say
that again, what really bothers me the
most: you have something static, which
is your genome, and the way medication reacts is all different. And all other
kinds of physical situations that may
affect that medication. And because [the
genome is] static, would the doctor be
more inclined to say … “I’m sorry, that’s
what the test says”?
PARTICIPANT 1: And look at
you very authoritatively and say, “This
must be in your mind. For all the other
patients, it works fantastically.”
24
PARTICIPANT 6: It’s not the only
piece of information. If you have had
[gastrointestinal] surgery, for example,
and you can’t absorb a medication, that’s
not something that’s going to show up on
your genetic profile.
PARTICIPANT 7: If you have
multiple illnesses, and you take multiple
medications, that’s not going to necessarily show up there either.
Participants voiced concern about the
potential for genetic information to curtail interaction and reduce trust between
physicians and patients. In addition to
wanting physicians to listen to their concerns and take them into consideration
in decision making, participants sought
assurance that, in delivering genetic
results, the physician would assess the
patient’s need for support:
Doctors have all this [genetic] information, and you have to look at a
person’s mental state. Can they handle
certain information, or does that send
them off to suicide? Or what’s it going to do? I was told one time I was
getting tested for cancer, and then the
doctor walked out of the room. I’m
like, “What? What? Who?” I’m sitting
there all by myself. “You’re testing for
cancer?!” So how can you deal with
this information? How is that going
to be handled?
In contrast, a single participant in
the antidepressant group envisioned
pharmacogenetic testing as an important step toward what he considered the
ideal: “the doctor robot,” which would
make all clinical decisions on the basis
of objective data.
Some participants viewed the use of
pharmacogenetic information to deny
a particular “good” medication as a
form of unfair discrimination, as in
this example: “The only thing I don’t
like about [pharmacogenetic testing
is], because of certain percentages, you
might not be good on a certain drug,
maybe, and they make this whole list of
all these good drugs you can’t have. So
they would refuse certain medicines to
you, your whole life.” Another participant stated that if there were only one
medication available to treat a particular,
serious condition, and a pharmacogenetic test indicated that the medication
could cause harm, it should be up to the
patient—not the physician—to decide
whether to take the risk.
Concerns about Access
to Genetic Information
Notwithstanding their belief in the
value of pharmacogenetic testing, participants identified potential drawbacks
to its implementation in the clinic. Concerns about the potential for genetic information to be accessed and (mis)used
by unauthorized persons were expressed
in all groups. Breach of confidentiality;
discrimination in eligibility and coverage for health insurance, long-term care
insurance, and disability insurance;
employment discrimination; being
targeted for pharmaceutical marketing
campaigns; and possible misuse by law
enforcement agencies were of concern
to participants.
Discrimination risks were more
readily and more strongly expressed in
the antidepressant and carbamazepine
groups, together with concerns about
social stigma associated with mental
health diagnoses, as in this example from
the carbamazepine group:
I already have concerns just about
electronic keeping of my records, compared to the way it used to be [when]
it was on all on paper. I have already
experienced the lack of privacy with
my primary doctor … I have mental
health issues, so sometimes without
even asking—they are supposed to be
kept separate—my regular doctor, …
just access[es] the mental health thing,
and start[s] reading this. And they have
already abused it … . That’s why I have
a lot of privacy issues, because I have
seen how it’s easily taken advantage of.
Participants were uncomfortable with
the potential for genetic information to
be shared legally beyond the health care
system, such as with law enforcement
agencies or in legal proceedings (eg, for
disability determinations). A participant
in the antidepressant cohort said:
I wouldn’t mind it so much as part
of my medical record, if my medical
record didn’t go to other people. Like
applying for disability insurance, they go
through medical records, and what they
decide and they define it and interpret
it in their own way. So I would be concerned about if they got ahold of genetic
information and what they would do to
you this time.
Participants across all three cohorts
also expressed concern about access to
pharmacogenetic information within
the health care system. Participants
suggested that genetic information
should be restricted to clinicians with
a clear need to know, and that access
should be limited to data relevant to
a current clinical concern, as in this
comment: “If I could have it on a
microchip somewhere and say, okay,
‘If I’m unconscious, you know, I give
medical permission to read this.’ Yeah,
I probably would go for that. But at the
same time, I might say, ‘Well, I don’t
necessarily want it in the chart where
the person who’s making my appointment can look at it.’” Several other
participants suggested that genetic
information be given directly to the
patient, who would be responsible for
determining when it should be shared.
One participant commented, “It’s us
having power over the information. We
still want to be a very important part of
the equation. And that we get to make
some decisions about how it’s used.”
Patients’ Understanding of
“Genetic Testing” Is Discordant
with Clinicians’ Definition
As designed, the focus group guide
progressed from discussion of a narrow, single-indication pharmacogenetic test—looking at a small portion
of the genome specific to a particular
medication—to discussion of wholegenome sequencing, which would
include pharmacogenetic results. In
each of the sessions, however, we
had substantial difficulty focusing
participants’ conversation on the less
comprehensive test scenario. In other
words, participants considered “genetic testing” to refer to examination
of the entire genome, and most understood the purpose of genetic testing
to be predicting one’s susceptibility
to heritable illness. For example, one
participant in the healthy cohort said,
“I came in with the idea that this is
a testing of your genes, your genetic
makeup, to find out if you are more
predestined for a certain disease ….
Life-threatening things, that’s what
I thought it was all about.” Overall,
participants evinced little understanding of the distinction between singlegene tests, panels, and whole-genome
sequencing. Participants felt that payers (and to a lesser extent, physicians)
would prefer more comprehensive
testing approaches for reasons of efficiency and cost-effectiveness.
Whole-Genome Sequencing Was Viewed
Differently from Narrower Tests
Once we had explained the differences among single-indication testing,
pharmacogenomic panels, and wholegenome sequencing, many participants
told us that they regarded whole-genome
sequencing as a riskier undertaking than
a more narrowly focused test, even if
pharmacogenetic information were the
primary goal of sequencing. With the
generation of additional information,
participants believed, the potential for
misuse and discrimination would increase as well. One participant stated:
I kind of want to know how much
information they can get from that blood
sample. And will they then be able to
go back and use other pieces of that test
in an unrelated way that [doesn’t] have
anything to do with the specific treatment I need at that moment? And I also
want to know, after it’s been utilized for
something specific, if it can be taken
out of my medical record, or once it’s
there, is it there forever? If I’m using it
for something very, very specific, that
sort of works, but they are also getting
information about my IQ, my willingness to work Monday through Friday,
or my need to call in for a vacation day
every three weeks, or three days? I don’t
want that in there.
Several participants pointed to the
1997 science-fiction film GATTACA,22
in which the government constrains
individuals’ life choices on the basis of
their genomes, as a depiction of what
could go wrong if laws and social standards fail to provide appropriate privacy
protections.
Some participants said that comprehensive sequencing would also be
more likely to generate information
they might not want, particularly for
serious health risks they “couldn’t do
anything about.” The potential risks
to other family members, given that
genetic information about one person
says something about their first-degree
relatives, were also of concern.
On the other hand, whole-genome
sequencing was very attractive to a few
participants who reported many seemingly unrelated health problems in
themselves and in their families. One
such participant said:
For me, I would find it beneficial,
because I suffer from a lot of different
ailments. I would definitely be like,
“Yeah, give me that test,” because it
could show that they are treating symptoms of a different ailment. So it doesn’t
add up unless you come in with a sheet
this long [gestures], by the way, all of
this happens. So I think a test like that
could rule out what you are treating
and actually show what you have … .
I would find this would be something
very important to have in my records for
my family to see, simply because of my
family history. My daughter is autistic.
And then on my mom’s side, we have
tremors, don’t know what causes those.
So it’s definitely something I’m very
interested in.
These individuals expressed great interest in comprehensive testing, which
they thought could provide a coherent
explanation for the multitude of challenges they face.
DISCUSSION
Prior studies on patient views of
pharmacogenetic testing have focused
on the general public and have generally presented hypothetical scenarios
with limited personal relevance to participants.23,24 Others have explored the
perceptions and values of patients undergoing treatment of life-threatening
conditions, who generally express strong
support for treatment-focused genetic
testing and markedly less concern about
the potential risks of discrimination and
breach of privacy.25-27
This study adds to the perspectives
of individuals diagnosed with chronic
mental-health conditions. In speaking with participants in the carbamazepine cohort, we learned that many
had been prescribed carbamazepine
for bipolar disorder rather than seizure
disorders (a common indication for this
25
medication). Our study thus included
a majority of individuals with mental
health diagnoses. Concerns about privacy, discrimination, and unauthorized access to genetic information are
a theme throughout the existing literature.28,29 In this study, participants in
the antidepressant and carbamazepine
groups voiced especially strong concerns
about the potential for stigmatization,
discrimination, and mistreatment resulting from pharmacogenetic testing
and unauthorized access to results.
Although these findings may not generalize across entire populations, they
highlight an underrepresented perspective that is of particular relevance to
ongoing pharmacogenetic research in
neuropsychiatry.2,30,31 Our passive recruitment strategy may have generated
a greater than usual selection bias.
Pharmacogenetics has often been
described as among the most straightforward and near-term applications of
genetic information in personalized
medicine.5,31-34 An important finding
of this study is that some patients who
could potentially benefit from pharmacogenetic testing have substantial,
deeply held concerns about the tradeoffs involved in allowing genetic information to be generated about them
and maintained outside their control.
Our participants were not naïve patients; they were very interested in reducing the time to optimal treatment,
and many told us they had personally
experienced negative effects from current pharmaceutical therapies. Even so,
they did not consider pharmacogenetic
testing of clear benefit. Our findings
are consistent with the results of an
Australian study in which chronically
ill patients endorsed the potential value
of pharmacogenetic testing but emphasized the need for antidiscrimination
measures and a holistic approach to
diagnosis and prescribing. 35 Avoiding a life-threatening drug reaction is
obviously a good thing, but when the
benefits are less compelling, patients
with chronic illnesses—and perhaps
especially those with potentially stigmatizing diagnoses—may decide that
the risks of pharmacogenetic testing
outweigh the benefits.
26
We were struck by the strength and
prevalence of participants’ worries that
physicians might overvalue genetic results to the exclusion of patient reports
and the detriment of the therapeutic
alliance. Although patients understood
that such information could be useful in
achieving optimal treatment outcomes,
they nonetheless expressed misgivings
about the possibility that physicians
would privilege genetic results over
patients’ lived experience. This message
represents an important counterpoint
to the enthusiastic discourse surrounding next-generation sequencing and
personalized medicine. If personalized
medicine is to be fully embraced by
patients, it will be important to ensure
that physicians’ enactment of “personalization” includes responding to the
patient as an individual and not merely
a collection of genomic data.36
Despite the proposed central role of
genetics in the coming era of data-driven
health care, some patients see pharmacogenetic testing as a potential threat
to communication, health care quality,
and the physician-patient relationship.
Participants in this study wanted pharmacogenetic testing and whole-genome
sequencing to complement, not replace,
other information about medication
response.
CONCLUSIONS
The success of precision medicine, or
the provision of “the right drug at the
right dose to the right patient,” will rely
on the broad acceptability of genomic
testing by diverse patient cohorts.5 Our
findings suggest that pharmacogenetic
solutions designed around the needs
and preferences of patients who are basically well may fail to meet the needs of
patients with mental health diagnoses
or other chronic conditions that may
carry social stigma. Health systems and
physician practices considering implementation of pharmacogenetic testing
must address patient concerns about
privacy, discrimination, overreliance
on genomic results, and erosion of the
physician-patient relationship through
public outreach, physician education,
and accountable oversight procedures
and governance. v
Funding: This project was supported by the
National Human Genome Research Institute
(1U01HG006375-01). The study sponsor did
not play a role in study design; data collection,
analysis, or interpretation; writing the report; or
the decision to submit for publication.
disclose.
Acknowledgments
The authors wish to thank Wylie Burke, MD,
PhD for helpful advice in the development of
this manuscript. We also thank Kevin Filocamo
and Kelly Hansen for assistance in coordinating
the focus groups and Aaron Scrol for his help in
preparing Table 1 and obtaining documentation
of IRB review.
assistance.
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Life-Histories
We would wish that … life-histories were found in every family, showing the health
and diseases of its different members. We might thus in time find evidences of
pathological connections and morbid liabilities not now suspected.
— Sir William Withey Gull, MD, 1st Baronet of Brook Street, 1816-1890, English physician,
Fullerian Professor of Physiology, and President of the Clinical Society
27
SOUL OF THE HEALER
Seville
photograph
Samuel H Glassner, MD
This photograph was taken in Seville, Andalusia, Spain in November 2012. Founded in the 8th century, Seville
has been governed by Roman, Muslim, and Christian sovereigns. The city served as a major economic hub during
the centuries of Spanish imperialism, and it remains an important European center for culture and the arts.
Dr Glassner is an Emergency Physician at the Walnut Creek Medical Center in CA.
28
A Community-Based Hip Fracture Registry:
Population, Methods, and Outcomes
Maria C S Inacio, PhD; Jennifer M Weiss, MD; Alex Miric, MD; Jessica J Hunt, MA;
Gary L Zohman, MD; Elizabeth W Paxton, MA
Perm J 2015 Summer;19(3):29-36
ABSTRACT
Introduction: Hip fracture is associated with substantial
morbidity and mortality. A large integrated health care system
developed a registry to characterize its current patient population with hip fractures. This report describes the population,
methods used, and outcomes of patients registered during
the initial three years (2009-2011).
Methods: Cases of hip fracture recorded from January 2009
through December 2011 were ascertained using the Kaiser
Permanente Hip Fracture Registry. The registry collects information on patient, procedure, surgeon, facility, and surgical
outcomes. Outcomes monitored included length of stay, readmissions, mortality, revisions, surgical site infections, deep
vein thrombosis, pulmonary embolism, pneumonia, pressure
ulcers, dislocations, and myocardial infarction.
Results: The population (N = 12,562) was predominantly
white (77.8%), women (68.6%), and older (71.6% aged ≥ 75
years), and 32% had at least 5 comorbidities. The average
length of follow-up was 1.1 years (standard deviation = 0.9).
The most prevalent comorbidities were hypertension (70.8%)
and anemia (29.4%). Femoral neck fractures (54.6%) were the
most common fracture type. Hemiarthroplasty was the most
common procedure (33.1%). Most fractures were treated by
medium-volume (10 to 29 cases per year) surgeons (68.4%)
at high-volume (≥ 130 cases per year) facilities (63.0%). The
90-day readmission rate was 22.1%, and the mortality rate
was 12.3%. The most common postoperative complications
were pneumonia (11.4%) and pressure ulcers (2.9%). There
were 2.2 revisions per 100 observation years.
Conclusion: A hip fracture registry provides important
information regarding patient characteristics, intraoperative
practices, and postoperative outcomes, which can be analyzed,
interpreted, and used to reduce morbidity and mortality.
INTRODUCTION
In the US, 306,000 hip fractures occurred in 2010.1 By
2040, it is estimated there will be 500,000 hip fractures per
year.2 Most hip fractures occur among the elderly for whom
complications are common and often life threatening. The
morbidity and mortality associated with hip fractures is
substantial, with reported mortality rates of 16% to 23%
within 1 year after injury.3-5 Although the incidence of hip
fractures may be on the decline, the cost associated with the
treatment of hip fractures, which is among the most costly
orthopedic procedures,6 continues to grow.7,8
The high morbidity, mortality, and cost associated2-6 with
hip fractures emphasizes the need to monitor the outcomes
of these patients, identify risk factors associated with adverse events, and evaluate the comparative effectiveness of
techniques and implants for this high-risk population. These
opportunities for care improvement can significantly reduce
morbidity and mortality associated with these events and
can reduce cost. Patient registries are one potential tool for
monitoring outcomes in a real-world setting. In orthopedic
surgery, arthroplasty registries introduced in the 1970s have
led to a reduction in revision rates by providing feedback to
surgeons on specific implants and techniques.9,10 National
arthroplasty registries have also been critical in early identification of defective implants,11-13 including one of the
most costly orthopedic recalls to date, the DePuy ASR hip
system recall.14 Although the US does not yet have a fully
functional national arthroplasty registry, institutional and
regional registries have contributed to increased patient
safety, quality improvement, identification of clinical best
practices, and cost reduction.15,16
Hip fractures are captured by arthroplasty registries in
some European countries,17-19 Australia,12 New Zealand,20
and Canada.21 In countries such as Norway,22 Sweden,23
and the United Kingdom (UK),24 dedicated hip fracture
registries exist. These hip fracture registries monitor all
procedures used to treat these events.22-24 In the US, singleinstitution studies and large-scale administrative databases
have provided data for evaluation of hip fracture outcomes.25
Although these databases and claims data provide important
information, some gaps in knowledge remain because these
data sources contain limited detail, inaccurate codes, and
unvalidated outcomes. To help fill this gap, Kaiser Permanente (KP), the largest US integrated health care system,
developed the Hip Fracture Registry. The registry is intended
to serve as a quality surveillance tool, and to monitor patients
who undergo a surgical procedure because of a hip fracture.
Maria C S Inacio, PhD, is an Epidemiologist in the Surgical Outcomes and Analysis Department at Kaiser
Permanente in San Diego, CA. E-mail: maria.cs.inacio@kp.org. Jennifer M Weiss, MD, is an Orthopedic Surgeon at
the Sunset Medical Center in Los Angeles, CA. E-mail: jennifer.m.weiss@kp.org. Alex Miric, MD, is an Orthopedic
Surgeon at the Sunset Medical Center in Los Angeles, CA. E-mail: alec.x.miric@kp.org. Jessica J Hunt, MA, is a
Clinical Project Manager in the Surgical Outcomes and Analysis Department at Kaiser Permanente in San Diego, CA.
E-mail: jessica.j.hunt@kp.org. Gary L Zohman, MD, is an Orthopedic Surgeon at the Orange County Medical
Center in CA. E-mail: gary.l.zohman@kp.org. Elizabeth W Paxton, MA, is the Director of the Surgical
Outcomes and Analysis Department at Kaiser Permanente in San Diego, CA. E-mail: liz.w.paxton@kp.org.
29
A Community-Based Hip Fracture Registry: Population, Methods, and Outcomes
It includes information on patient characteristics, surgical
procedures, morbidity and mortality, and characteristics of
both the surgeon and the hospital. The purpose of this report
is to provide an overview of the methods used by the KP Hip
Fracture Registry and to describe the population and outcomes
of patients registered during the first three years (2009-2011).
if they performed 10 to 29 cases per year, and high volume if
they performed 30 or more cases per year. The average annual
hospital volume was also captured by the Hip Fracture Registry.
Hospitals were considered low volume if they treated fewer than
60 cases per year, medium volume if 60 to 129 cases per year,
and high volume if 130 or more cases per year.
METHODS
Setting and Population
Outcomes
KP is an integrated health care system that covers more
than 9.5 million individuals throughout 7 US geographic
Regions. This integrated health care system provides medical
services, owns hospitals, employs its clinicians, and provides
patients with health insurance, ensuring a captured and stable
population. Additionally, a comprehensive integrated electronic medical record (EMR) is used by the system (with full
implementation in 2008), allowing monitoring of patients’
activities using unique identifiers. The KP membership has
been shown to be mostly demographically and socioeconomically representative of the largest geographic areas it covers.26,27
The registry’s target population is patients with fractures of
the femoral neck, intertrochanteric region, or subtrochanteric
region, which comprise nearly all operative, low-energy, fragility-type fractures in the elderly population. Pelvic, acetabular,
distal femur, and shaft fractures are not included in the Hip
Fracture Registry. This report describes patient information
ascertained between January 2009 and December 2011.
Data Collection Procedures
The Hip Fracture Registry identifies relevant hip fracture
cases using International Classification of Diseases, Ninth
Revision, Clinical Modification (ICD-9-CM), diagnostic and
procedure codes recorded into KP’s EMR and administrative
claims. All data are extracted electronically on a quarterly
schedule and sent to a data repository for data management,
validation, and reporting. The Hip Fracture Registry captures
data collected from the 7 geographic Regions of the integrated
health care system. The patients included in this report are
from the 2 largest Regions covered by the Hip Fracture Registry—Northern and Southern California—with 33 Medical
Centers and 474 participating surgeons.
Variables Characterizing Patients,
Surgeries, Surgeons, and Hospitals
The Hip Fracture Registry has information related to the patient, procedure, surgeon, and hospital where the hip fracture
was treated. Patient variables include age, sex, race, American
Society of Anesthesiologists (ASA) score,28 comorbidities,29
and body mass index. Procedure variables include laterality and stipulate whether an open or closed reduction with
internal fixation, internal fixation of bone without fracture
reduction, hemiarthroplasty (partial hip replacement), or total
hip arthroplasty was used to treat the hip fracture. Surgeon
variables include information about total joint arthroplasty
fellowship training as well as average annual volume of hip
fracture surgical cases. Surgeons were classified as low volume
if they performed fewer than 10 cases per year, medium volume
30
The Hip Fracture Registry monitors 10 outcomes associated with hip fractures. These outcomes are length of stay
(LOS), any readmissions within 30 and 90 days, pneumonia,
pressure ulcers, dislocations, myocardial infarction, surgical
site infections (deep and superficial), thromboembolic events
(deep vein thrombosis [DVT] and pulmonary embolism
[PE]), revisions, and mortality. Except for LOS and mortality,
the outcomes were captured using ICD-9-CM diagnosis and
procedure codes recorded into the EMR and administrative
claims.30,31 The outcomes of revisions, surgical site infections,
DVTs, and PEs were adjudicated by clinical content experts
who reviewed the patient charts. The other outcomes were
ascertained using only administrative and EMR data.
Table 1. Characteristics of primary hip fracture cohort
(N = 12,562)
Characteristic
Age, yearsa
< 65
65-74
75-84
≥ 85
Sex
Female
Male
Unknown
ASA category
1 and 2
≥3
Unknown
Diabetes
Race/ethnicityb
White
Hispanic
Asian
Black
Unknown
Multiracial
Other
Native American
Continous variables
Median age, years
Median BMI,c kg/m2
No. (%)
1645 (13.1)
1922 (15.3)
4354 (34.7)
4639 (36.9)
8611 (68.6)
3947 (31.4)
4 (< 0.1)
3143 (25.0)
828 (65.9)
113 (9.1)
3392 (27.0)
9772 (77.8)
1241 (9.9)
719 (5.7)
624 (5.0)
70 (0.6)
63 (0.5)
49 (0.4)
24 (0.2)
82 (73-87)
23.7 (20.8-27.2)
Missing data in < 0.1% (n = 1).
Percentages total to more than 100% because of rounding.
Missing data in 0.7% (n = 92).
ASA = American Society of Anesthesiologists; BMI = body mass index.
a
b
c
Revisions are defined as an operation that required any
implant exchange after the primary hip fracture procedure.
Revisions are tracked for the lifetime of the patient. Surgical
site infections are adjudicated using the guidelines of the Centers for Disease Control and Prevention’s National Healthcare
Safety Network; they include superficial infections that occur
within 30 days and deep infections that occur within 1 year
after an implant procedure.32 Death information was available for all patients (with possible delayed reporting) using
data from the Social Security Administration updated with
information recorded into the EMR.
Statistical Analysis
Descriptive statistics, including frequencies, proportions,
means, standard deviations (SDs), medians, and interquartile
ranges (IQRs), were computed using the software program
SAS 9.2 (SAS Institute Inc, Cary, NC). Crude complication
rates for all outcomes captured by the registry were provided as
proportions of events, with the entire hip fracture population
being included in the denominator. Revision density, which
is the rate of revision per 100 years of observation, was also
provided. Patients were considered lost to follow-up if they
disenrolled from the integrated health care system or died
during the study period.
RESULTS
Characteristics of Patients
Between 2009 and 2011, a total of 12,562 primary hip
fractures were registered in the Hip Fracture Registry. The
median age of the population was 82 (IQR = 73-87) years old,
68.6% were women, and 77.8% were white. See Table 1 for
detailed population characteristics. Only 5.7% of the population had no comorbidities at the time of hip fracture, and
most had multiple comorbidities (Table 2). The most common comorbidities were hypertension (70.8%), deficiency
anemia (29.4%), renal failure (25.2%), fluid and electrolyte
disorders (22.0%), chronic pulmonary disease (21.4%), and
peripheral vascular disease (20.0%).
Table 3 presents the detailed fracture type and procedures
for the population. The most prevalent fracture types were
femoral neck fractures (43%) followed by closed intertrochanteric femoral neck fractures (36.0%). The most common
procedures for hip fracture treatment were hemiarthroplasty
(33.1%), open reduction of fracture with internal fixation
(29.7%), and closed reduction of fracture with internal fixation (23.8%).
Outcomes after Hip Fractures
The median LOS at hospitals for patients with a hip fracture was 4 days (IQR = 3-6 days). Within 90 days of the
primary hip fracture, 22.1% of patients were readmitted to
the hospital and 12.3% died. The most common complication in this population was pneumonia (11.4%), followed by
pressure ulcers (2.9%), and DVT (1.4%). Revisions occurred
in 2.4% of patients (or 2.2 revisions/100 years of observation). The average follow-up duration for patients was 1.1
years (SD = 0.9), and 2.6% were lost to follow-up (Table 4).
Participating Hospitals and Surgeons
Of the 12,562 hip fractures, 13.7% were treated by surgeons with joint arthroplasty fellowship training. The median
number of hip fracture cases a surgeon treated yearly was 18
(IQR = 13-24), and most surgeons were considered medium
volume (10 to 29 cases per year; 68.4%; Table 5). The median
number of cases per hospital treated yearly was 167 (IQR =
114-219), and most of the cases were treated in high-volume
hospitals (63.0%; Table 5).
Table 2. Comorbidity profile of primary hip fracture cohort
Comorbidity parameter
Total number in cohort
Comorbidities (at least 1)
Number of comorbiditiesa
0
1
2
3
4
≥5
Specific conditionsb
AIDS
Alcohol abuse
Chronic blood loss anemia
Chronic pulmonary disease
Coagulopathy
Congestive heart failure
Deficiency anemias
Depression
Drug abuse
Fluid and electrolyte disorders
Hypertension
Hypothyroidism
Liver disease
Lymphoma
Metastatic cancer
Other neurologic disorders
Paralysis
Peptic ulcer disease, bleeding
Peripheral vascular disease
Psychoses
Pulmonary circulation disease
Renal failure
Rheumatoid arthritis/collagen
vascular disease
Solid tumor without metastasis
Valvular disease
Weight loss
No. (%)
12,562 (100.0)
11,648 (92.7)
716 (5.7)
1395 (11.1)
1976 (15.7)
2242 (17.9)
2068 (16.5)
3967 (31.6)
25 (0.2)
498 (4.0)
485 (3.9)
2685 (21.4)
961 (7.7)
1943 (15.5)
3696 (29.4)
1063 (8.5)
114 (0.9)
2769 (22.0)
8887 (70.8)
2462 (19.6)
331 (2.6)
165 (1.3)
461 (3.7)
2201 (17.5)
629 (5.0)
7 (0.1)
2515 (20.0)
1513 (12.0)
593 (4.7)
3162 (25.2)
529 (4.2)
381 (3.0)
1381 (11.0)
1598 (12.7)
Elixhauser comorbidity measures. Diabetes and obesity are omitted from this list
because they are obtained from different sources. Diabetes data are obtained
from regional diabetic registries, and obesity data are obtained from body mass
index measurements. Both comorbidities are included in Table 1.
AIDS = acquired immunodeficiency syndrome.
a
b
31
DISCUSSION
A Hip Fracture Registry was established to capture detailed
information on hip fractures treated surgically in the KP
integrated health care system. The current registered cohort
was treated by 474 surgeons across 33 hospitals. The population identified by this registry is similar to the populations
captured in other hip fracture registries, but some important
differences were identified. Operative practices and outcomes
associated with procedures differ in certain instances from
those previously reported in the literature.
Patients included in the registry were mostly women, elderly, white, and had multiple comorbid conditions. Women
constituted 68.6% of the population, which is similar to the
70% figure reported by other registries12,18,22-24 and agrees
Table 3. Patient-specific diagnosis and procedure type in primary hip fracture cohorta
Diagnostic codes
Total
Fracture type
Intracapsular (733.14, 820.00,
820.01, 820.02, 820.03, 820.09)
Extracapsular (820.20, 820.21,
820.22, 821.00)
Other/cannot be determined
(820.8, other)
ICD-9 code specific
733.14: Pathologic fracture neck
of femur
820.00: Fracture, femur neck;
closed; intracapsular section,
unspecified
closed; epiphysis (separation)
(upper), transepiphyseal
closed; midcervical section,
transcervical NOS
820.03: Fracture, femur
neck; closed; base of neck,
cervicotrochanteric section
closed; other, head of femur,
subcapital
neck; pertrochanteric, closed;
trochanteric section, unspecified,
trochanter: NOS, greater, lesser
intertrochanteric section
subtrochanteric section
820.8: Fracture; unspecified part
of neck of femur, closed, hip NOS,
neck of femur NOS
821.00: Fracture; closed;
unspecified part of femur, thigh,
upper leg
Other diagnosis
Total,
No. (%)
12,562 (100.0)
Hemiarthroplasty
(code 81.52),
No. (%)
4163 (33.1)
Internal fixation,
with open
reduction of
fracture (code
79.35), No. (%)
3731 (29.7)
Internal fixation,
with closed
reduction of
fracture (code
79.15), No. (%)
2989 (23.8)
Internal fixation,
without fracture
reduction (code
78.55), No. (%)
1127 (9.0)
Total hip
arthroplasty
(code 81.51),
No. (%)
270 (2.1)
Other,
No. (%)
282 (2.2)
2603 (20.7)
1317 (31.6)
347 (9.3)
510 (17.1)
285 (25.3)
82 (30.4)
62 (22.0)
5671 (45.2)
147 (3.5)
2995 (80.3)
1880 (62.9)
543 (48.2)
21 (7.8)
85 (30.1)
4288 (34.1)
2699 (64.8)
389 (10.4)
599 (20.0)
299 (26.5)
167 (61.9)
135 (47.9)
665 (5.3)
248 (6.0)
151 (4.1)
114 (3.8)
117 (10.4)
15 (5.6)
20 (7.1)
78 (0.6)
50 (1.2)
3 (0.1)
16 (0.5)
4 (0.4)
2 (0.7)
3 (1.1)
50 (0.4)
0 (0.0)
4 (0.1)
1 (0.0)
21 (1.9)
0 (0.0)
24 (8.5)
118 (0.9)
81 (2.0)
5 (0.1)
26 (0.9)
3 (0.3)
3 (1.1)
0 (0.0)
260 (2.1)
112 (2.7)
73 (2.0)
38 (1.3)
24 (2.1)
11 (4.1)
2 (0.7)
1432 (11.4)
826 (19.8)
111 (3.0)
315 (10.5)
116 (10.3)
51 (18.9)
13 (4.6)
286 (2.3)
17 (0.4)
164 (4.4)
66 (2.2)
26 (2.3)
2 (0.7)
11 (3.9)
4517 (36.0)
123 (3.0)
2338 (62.7)
1602 (53.6)
411 (36.5)
16 (5.9)
27 (9.6)
706 (5.6)
6 (0.1)
414 (11.1)
205 (6.9)
68 (6.0)
2 (0.7)
11 (3.9)
3964 (31.6)
2550 (61.3)
343 (9.2)
568 (19.0)
264 (23.4)
162 (60.0)
77 (27.3)
162 (1.3)
1 (0.0)
79 (2.1)
7 (0.2)
38 (3.4)
1 (0.4)
36 (12.8)
324 (2.6)
149 (3.6)
46 (1.2)
31 (1.0)
35 (3.1)
5 (1.9)
58 (20.6)
Some percentages may not total to 100 because of rounding.
ICD-9 = International Classification of Diseases, Ninth Revision; NOS = not otherwise specified.
a
32
with the higher incidence of hip fractures in women around
the world.25 Of the registered patients, nearly 72% were age
75 years or older. This higher age is consistent with that of
the population of hip fracture registries in Norway and the
UK,22,24 but it is slightly younger than reported by arthroplasty
registries. The Australian arthroplasty registry reported that in
its bipolar hemiarthroplasty cohort at least 76% were age 75
years or older and 92% of its monoblock cohort was older than
75 years. This elderly population is consistent with the higher
risk of hip fractures in older patients.25 Racial and ethnicity
data, which are available in our patient population (21.7%
of the population is nonwhite), were not available in other
hip fracture registries and are most likely not captured data
elements because of their countries’ homogenous populations.
This adds value to future findings from the presented registry,
which can contribute information regarding minority groups.
Finally, 65.9% of the patients had an ASA score greater
than 3, indicating substantial systemic disease, which is similar
to the rate reported by the UK registry between 2011 and
2013 (approximately 60%).24 The proportion of patients with
higher ASA score, however, was higher than reported by the
Norwegian Hip Fracture Register (47%),22 which could be
because of their inclusion of younger patients in their registry. We also found a high number of comorbid conditions
in our patient population; 92.7% had at least 1 comorbid
condition, and conditions such as hypertension,
deficiency anemias, renal failure, and fluid and
Racial and
electrolyte disorders were common at the time of
ethnicity data,
the hip fracture hospitalization. Other registries
… available
did not report on specific comorbid conditions,
in
our patient
but a high prevalence of comorbid conditions has
population
(21.7%
been reported by studies using administrative data
are nonwhite),
in the US.2,33
were not available
The most common type of fractures in our
population was intertrochanteric femoral neck
in other hip
fracture (36%, ICD-9-CM 820.21) and unspecifracture registries
fied femoral neck fractures (31.6%, ICD-9-CM
and … adds value
820.8). Because the registry relies on ICD-9-CM
… regarding
codes for identifying type of fracture, it cannot
minority groups.
determine with certainty whether cases with unspecified location fracture codes are intracapsular
vs extracapsular, or displaced vs undisplaced fractures. It can,
however, determine the main treatment groups from the
combination of ICD-9-CM procedure codes and diagnoses.
Table 4. Postoperative outcomes of primary hip fracture cohort by procedure typea
Hemiarthroplasty
(code 81.52),
Postoperative outcome
Total, No. (%)
No. (%)
Total
12,562 (100.0)
4163 (33.1)
Mortality, utilization, and outcomes identified with administrative/EMR data
Death within 30 days
783 (6.2)
291 (7.0)
Death within 90 days
1546 (12.3)
563 (13.5)
Death (ever)
3278 (26.1)
1160 (27.9)
Readmission within 30 days
1532 (12.2)
568 (13.6)
Readmission within 90 days
2775 (22.1)
978 (23.5)
Pneumonia
1427 (11.4)
496 (11.9)
Pressure ulcers
365 (2.9)
141 (3.4)
Dislocation
114 (0.9)
89 (2.1)
Myocardial infarction
110 (0.9)
27 (0.7)
Median length of stay, days (IQR)b
4 (3-6)
4 (4-6)
Validated outcomesc
Revision (all cause)
305 (2.4)
102 (2.5)
Septic revision
32 (0.3)
23 (0.6)
Revision rate per 100 years
1342 (2.2)
4506 (2.3)
of observation
Deep vein thrombosis
173 (1.4)
65 (1.6)
Pulmonary embolism
156 (1.2)
59 (1.4)
Surgical site infection (any)
136 (1.1)
77 (1.9)
Surgical site infection (deep)
75 (0.6)
47 (1.1)
Surgical site infection (superficial)
61 (0.5)
30 (0.7)
Internal fixation,
with open
reduction of
fracture (code
79.35), No. (%)
3731 (29.7)
Internal fixation,
with closed
reduction of
fracture (code
79.15), No. (%)
2989 (23.8)
Internal
fixation,
without fracture
reduction (code
78.55), No. (%)
1127 (9.0)
Total hip
arthroplasty
(code 81.51),
No. (%)
270 (2.1)
Other,
No. (%)
282 (2.2)
240 (6.4)
481 (12.9)
1002 (26.9)
459 (12.3)
840 (22.5)
441 (11.8)
117 (3.1)
3 (0.1)
29 (0.8)
4 (3-6)
171 (5.7)
340 (11.4)
744 (24.9)
328 (11.0)
630 (21.1)
333 (11.1)
67 (2.2)
1 (0.0)
35 (1.2)
4 (3-5)
61 (5.4)
127 (11.3)
293 (26.0)
145 (12.9)
261 (23.2)
117 (10.4)
25 (2.2)
5 (0.4)
16 (1.4)
4 (3-5)
5 (1.9)
13 (4.8)
35 (13.0)
18 (6.7)
43 (15.9)
24 (8.9)
9 (3.3)
9 (3.3)
3 (1.1)
4 (3-6)
15 (5.3)
22 (7.8)
44 (15.6)
14 (5.0)
23 (8.2)
16 (5.7)
6 (2.1)
7 (2.5)
0 (0.0)
3 (1-5)
81 (2.2)
3 (0.1)
4173 (1.9)
78 (2.6)
1 (0.0)
3216 (2.4)
29 (2.6)
1 (0.1)
1208 (2.4)
7 (2.6)
1 (0.4)
288 (2.4)
8 (2.8)
3 (1.1)
360 (2.2)
57 (1.5)
43 (1.2)
27 (0.7)
12 (0.3)
15 (0.4)
25 (0.8)
33 (1.1)
15 (0.5)
7 (0.2)
8 (0.3)
12 (1.1)
13 (1.2)
6 (0.5)
1 (0.1)
5 (0.4)
8 (3.0)
5 (1.9)
5 (1.9)
3 (1.1)
2 (0.7)
6 (2.1)
3 (1.1)
6 (2.1)
5 (1.8)
1 (0.4)
Some percentages do not total to 100 because of rounding. Codes are from the International Classification of Diseases, Ninth Revision, Clinical Modification.
c
Only crude estimates of incidence are presented. No adjustments for confounders, loss to follow-up, or follow-up time are included (with the exception of the revision rate per 100 years of
observation).
EMR = electronic medical record; IQR = interquartile range.
a
b
33
Table 5. Surgeon and hospital characteristics in primary hip
fracture cohort (N = 12,562)
Characteristic
Joint arthroplasty fellowship training
Yes
No
Unknown
Surgeon volume category, average per yeara
Low (< 10)
Medium (10-29)
High (≥ 30)
Surgeon yearly volume, median (IQR)a
Hospital volume category, average per year
Low (< 60)
Medium (60-129)
High (≥ 30)
Hospital yearly volume, median (IQR)
No. of surgeries (%)
1728 (13.7)
5284 (42.1)
5550 (44.2)
1520 (12.1)
8590 (68.4)
2450 (19.5)
18 (13-24)
207 (1.7)
4439 (35.3)
7916 (63.0)
167 (114-219)
Missing data in < 0.1% (n = 2).
IQR = Interquartile range.
a
By our estimates, at least 43% (n = 5315) of our registered
fractures are intracapsular fractures (2603 from diagnostic
codes only and 2712 from the procedures and diagnoses
combined), making this the most common type of fracture
in our registry, which is in agreement with other registries
where a traditional fracture classification is used. In Sweden,
the UK, and Norway the reported prevalence of intracapsular
fractures is 54%, 58%, and 63%, respectively.
The most common procedures used to treat fractures were
internal fixation and hemiarthroplasty, in agreement with
other registries’ populations. Overall, 33.1% of the cases in
our population were treated with hemiarthroplasty, which is
slightly higher than the overall numbers of 25% reported by
Sweden and 21% by Norway (no overall numbers available for
the UK).22-24 Hemiarthroplasty is the most common procedure
used for treatment of intracapsular fractures in our population (93% had a hemiarthroplasty), and it is also the most
commonly used procedure to address intracapsular fractures
in other registries, although only for displaced intracapsular
fractures (53% Norway, 63% Sweden, and 77.5% UK).22-24
For the second most common fracture in our population,
intertrochanteric femur neck fractures (36%), 96% were
treated with internal fixation: 9% without fracture reduction,
35% with closed reduction, and 52% with open reduction.
This again agrees with the reported internal fixation rate
for these types of fracture in the UK, Sweden, and Norway
(all > 95%).22-24 Finally, the use of total hip arthroplasty for
addressing hip fractures is infrequent (2.1%), and this rate
agrees with the small proportions seen by other registries
(range = 1.1%-5%).
Medium- and high-volume surgeons (89.7%) and hospitals (98.3%) treat the majority of the hip fractures in our
population. This information is not available in the reports
of other dedicated hip fracture registries. The proportion of
patients treated in high volume (63%) hospitals is, however,
34
similar to those reported by studies using Medicare data (approximately 60% consistently from 1991 to 2008).5 Previous
studies evaluating the outcomes of hip fracture treatment by
hospital and surgeon volume suggest surgeon volume is an
important factor when evaluating hip fracture outcomes, but
hospital volume may not be as important.5
Ten postoperative outcomes were available in the KP Hip
Fracture Registry. Mortality, LOS, pressure ulcers, and repeated operations (“reoperations”) are the common outcomes
monitored by the dedicated fracture registries. The incidence
of mortality in our population within 30 days was 6.2%; this
is comparable to mortality in the Norwegian registry (only
a 4-month estimate is available and is 14%)22 and is slightly
lower than in the UK registry (8%).24 This is also consistent
with contemporary estimates from the US Medicare population of 5% to 6%.2,34 The LOS in our cohort was much shorter
(median = 4 days) than that reported by other registries (range
= 11-16 days)23,24 but was similar to the LOS in the US Medicare hip fracture cohort.2,34 Differences in LOS are probably
because of the overall health care system structure and hip
fracture care practices in the various countries. Pressure ulcers
occurred in 2.9% of our population, which is comparable to
the 3.7% reported by the UK hip fracture registry.24 Finally,
the only reoperations monitored by our registry are subsequent
revision procedures (defined as a surgery where one component is either removed and/or replaced for any reason) of the
original hip fracture components, which we found occur at
a rate of 2.2/100 years of observation (2.4% crude overall
revision incidence). This rate is significantly lower than the
18% reoperation rate reported by the Norwegian Hip Fracture
Register, probably because they track all subsequent reoperations and not just revisions.22 Complications related to the hip
fractures such as pneumonia, myocardial infarction, DVT, PE,
dislocations, and surgical site infections also are monitored by
this registry but not by others. These complications, except
for pneumonia, were infrequent (< 1.4%), an incidence that
is mostly consistent with reports from other large hip fracture
cohorts.33,35-39 Pneumonia was the most common complication in our population (11.4%) and was higher than the 5%
reported by a meta-analysis of clinical trials by Lawrence
et al.35 This higher incidence in our cohort could be caused
by our use of administrative data to ascertain the cases without validating them with other records, which was probably
done by the clinical trials included in the meta-analysis study.
This report’s main limitation is the reliance of its data
source, the KP Hip Fracture Registry, on ICD-9-CM diagnostic and procedure codes to determine fracture location and
procedures performed to address these fractures. Information
on whether the fractures were displaced or nondisplaced was
not available. Additionally, confirmation of whether they
were located in the intracapsular or extracapsular area was
not possible in all cases. The Hip Fracture Registry leverages
the existing system’s EMR and administrative data sources to
capture all hip fractures in the system. This is done instead of
relying on the surgeon to report, which would not achieve full
capture of this population. The tradeoff for full case capture
means the Hip Fracture Registry has limited fracture location
information. In addition, procedure codes do not offer information on specific types of hemiarthroplasty procedures
(bipolar or unipolar) or internal fixation (whether screws only,
screws and plates, or intramedullary rods were used). However, this limitation is currently being addressed by the Hip
Fracture Registry by implementing procedure classification
on the basis of the collected implant information from the
procedure. This work is under development, but we hope to
include it in future reports on the registry’s cohort.
Other limitations were a lack of certain comorbidity information, such as osteoporosis and intestinal disorders, which
were not captured by the validated comorbidity algorithm
used by the registry. Additionally, this report was descriptive
and did not evaluate relationships between specific variables
and outcomes associated with hip fracture procedures. No
inferences can be made regarding the outcomes and specific
treatments presented in this report.
Our report strengths include the description of a fully captured hip fracture population in a large and diverse integrated
health care system in the US. Using unique identifiers and the
EMR, the Hip Fracture Registry captured the full spectrum of
care delivered to these patients after surgery and prospectively
monitored several outcomes associated with these events in addition to the traditional outcomes tracked by other studies and
registries. Some of the outcomes monitored (ie, surgical site
infection, DVT, PE, reoperation, and revision surgery) are also
adjudicated using additional sources, which guarantees a high
internal validity for these data elements. Additionally, because
data for the Hip Fracture Registry are captured electronically,
possible response bias introduced by relying on clinicians to
report events and complete the required registry information
was nonexistent. Finally, the population captured included
cases from a large number of hospitals and surgeons with a
wide variety of surgical experience, which is representative of
the larger orthopedic community.
CONCLUSION
A community-based registry of hip fractures was used
to identify a contemporaneous cohort of patients with hip
fractures who were mostly women, elderly, and white, with
substantial multimorbidity. The KP Hip Fracture Registry
population was treated predominantly with internal fixations
or hemiarthroplasty procedures, which were performed primarily in high-volume hospitals by medium-volume surgeons.
The incidence of 30-day mortality, readmission, and pneumonia was high in this patient population, and the incidence of
other monitored complications was relatively low.
Using a hip fracture registry to understand patients and
procedures performed to treat hip fractures, as well as the
possible complications and outcomes associated with these
events, can give orthopedic clinicians a major advantage in
planning for the care of these patients. v
The author(s) have no conflicts of interest to disclose.
Acknowledgment
We acknowledge all the Kaiser Permanente orthopedic surgeons who
contribute to the National Implant Registries and the Surgical Outcomes
and Analysis Department, which coordinates Registry operations.
Kathleen Louden, ELS, of Louden Health Communications provided
editorial assistance.
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36. Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and
postoperative complications on mortality after hip fracture in elderly people:
prospective observational cohort study. BMJ 2005 Dec 10;331(7529):1374. DOI:
http://dx.doi.org/10.1136/bmj.38643.663843.55.
37. Rosencher N, Vielpeau C, Emmerich J, Fagnani F, Samama CM; ESCORTE
group. Venous thromboembolism and mortality after hip fracture surgery: the
ESCORTE study. J Thromb Haemost 2005 Sep;3(9):2006-14. DOI: http://dx.doi.
org/10.1111/j.1538-7836.2005.01545.x.
38. Edwards C, Counsell A, Boulton C, Moran CG. Early infection after hip
fracture surgery: risk factors, costs and outcome. J Bone Joint Surg Br 2008
Jun;90(6):770-7. DOI: http://dx.doi.org/10.1302/0301-620X.90B6.20194.
39. Duckworth AD, Phillips SA, Stone O, Moran M, Breusch SJ, Biant LC. Deep
infection after hip fracture surgery: predictors of early mortality. Injury 2012
Jul;43(7):1182-6. DOI: http://dx.doi.org/10.1016/j.injury.2012.03.029.
Fixation
I assert that a fractured thigh, if treated by extension only, would be accompanied
with vastly more muscular irritability than if the same case was placed in a modern
appliance, in which the limb was immoveable in the strict meaning of the term fixation.
— Disease of the Hip, Knee and Ankle Joints, Hugh Owens Thomas, MD, 1834-1891,
Welsh surgeon who is considered to be the father of orthopaedic surgery in Britain
36
Utility of the Multinational Association for Supportive Care in Cancer
(MASCC) Risk Index Score as a Criterion for Nonadmission in Febrile
Neutropenic Patients with Solid Tumors
Perm J 2015 Summer;19(3):37-47
ABSTRACT
Objectives: This retrospective study was initiated in febrile neutropenic inpatients
with solid tumors in 4 community hospitals, to discover how the Multinational
Association for Supportive Care in Cancer (MASCC) risk index score (RIS) of 21 or
greater correlated with complications occurring in 198 episodes: whether it could
help determine which patients not to admit, the savings of not admitting patients
without complications, and whether an algorithm could facilitate management of
those not admitted.
Methods: Febrile neutropenic episodes in patients with solid tumors were identified electronically between October 1, 2008, and November 15, 2010. Electronic
charts were reviewed manually for inclusion criteria and data extraction. Episodes
were stratified by an MASCC RIS below 21 or 21 or greater. Complications were
correlated with the index.
Results: Inclusion criteria were met in 198 episodes. Sensitivity, specificity, and
positive and negative predictive values of the MASCC RIS vs complications were
94%, 29.6%, 57.7%, and 82.9%, respectively. In episodes with an RIS 21 or greater,
42.3% had complications, misclassifying to low risk 69 episodes with complications.
“Unable to eat” correlated with complications in 84% of episodes. In 3 patients
stratified to no complication, a complication developed 24 hours after admission.
Conclusions: An MASCC RIS of 21 or greater could not be used as a criterion for
“no complication/do not admit.” Inability to eat should be an admission criterion.
Savings of approximately $1 million per 100 uncomplicated admissions could be
realized if appropriate criteria for nonadmission could be devised. An algorithm to
facilitate outpatient management is suggested.
INTRODUCTION
Treatment of malignancies is routine
in community hospitals. Chemotherapy, one of the common forms of treatment, frequently results in neutropenic
fever. Guidelines for the management
of febrile neutropenia include antimicrobial therapy and, for patients with
solid tumors, antecedent granulocyte
colony-stimulating factor.1,2 Before these
guidelines, virtually all febrile neutropenic patients were hospitalized. However,
the depth and duration of neutropenia
in patients receiving chemotherapy for
hematologic and lymphoproliferative
neoplasms is more profound than that
occurring following chemotherapy for
patients with solid tumors; thus, complications following chemotherapy for
solid tumors are less frequent. Some
investigators postulated that patients
not experiencing complications would
not need hospitalization, and thus, they
have striven to identify these noncomplicated cases prospectively and manage
them on an outpatient basis, resulting
in substantial savings.
To this end, a stratification tool, the
Multinational Association for Supportive Care in Cancer (MASCC) risk index
score (RIS) was developed to predict the
risk of serious complications. These risk
criteria are listed in the Sidebar: Klastersky Criteria.3
There are 2 important features to
note. First, only 2 of the 10 Klastersky
criteria are objective, which introduces
a problem in the methods. There is no
objective definition of these criteria:
confusion or altered mental state, such
as the Glasgow Coma Scale; congestive
heart failure requiring treatment, such
as pulmonary edema with a Pao2 below
60 mmHg; bleeding severe enough to
require transfusion, such as a hemoglobin level below 7 g/dL; arrhythmia
or electrocardiographic changes requiring treatment, such as systolic blood
pressure (BP) below 90 mmHg; or
renal failure requiring treatment, such
as a creatinine level above 4 mg/dL.
Furthermore, the last criterion is completely subjective: “other complications
judged serious and clinically significant
by the investigator.” Second, an exclusion to this criterion was included as a
footnote: “Viral or fungal, microbiologically documented primary infection
during the febrile episode, without any
described complication and resolving
under therapy, was considered a part
of the infectious process and was not
considered a serious complication.”3p3040
Table 1 lists the components of the
MASCC RIS.3 (Note that only 4 of
the 7 criteria are objective. Burden of
illness, chronic obstructive pulmonary
disease (COPD), and “no dehydration”
are not objective criteria.) An MASCC
RIS of 21 or above equals a low risk of
complications; an MASCC RIS below
21 equals a high risk of complications.
Using an MASCC RIS of 21 or greater
as low risk, only 6% of a validation group
(n = 551) experienced serious complications compared with 39% who had a
score below 21. Validation of this index
Roger A Bitar, MD, MPH, is a Consultant with Mission Infectious Disease and Infusion Consultants, Inc, in Poway, CA,
and a former Infectious Disease Specialist at the San Diego Medical Center. E-mail: rbitar0304@att.net.
37
Utility of the MultinationalAssociation for Supportive Care in Cancer (MASCC)
RiskofIndex
as a Criterion
for Nonadmission
in FebrileCare
Neutropenic
Patients
with Solid
Utility
the Score
Multinational
Association
for Supportive
in Cancer
(MASCC)
RiskTumors
Index
Score as a Criterion for Nonadmission in Febrile Neutropenic Patients with Solid Tumors
METHODS
Patient Selection
Table 1. Components of the Multinational Association for Supportive Care
in Cancer Indexa
Clinical characteristic
Burden of illness (1 of the 3 options only):
No or mild symptoms
Moderate symptoms
Scoreb
5
3
Severe symptoms
0
No hypotension (systolic BP > 90 mmHg)
No chronic obstructive pulmonary disease
Solid tumor or no prior fungal infection in patient with hematologic neoplasm
5
4
4
No dehydration (hydration with IV fluids not required)
Outpatient at onset of fever
Age < 60 years
3
3
2
Burden of illness, no chronic obstructive pulmonary disease, and no dehydration are not objective criteria.
Maximum score: 26 (5 + 5 + 4 + 4 + 3 + 3 + 2). Low risk for complication = score ≥ 21; high risk for
complication = score < 21.
BP = blood pressure; IV = intravenous.
a
b
has been declared in publications from
academic (university) medical centers.
However, the definitions in all these
studies (eg, burden of illness, COPD,
or dehydration) were not consistently
provided, and the mix of patients with
solid vs hematologic and lymphoproliferative neoplasms was not the same, raising the question of whether the results
are comparable.4-8
The current retrospective study of
inpatients from 4 community hospitals
Klastersky criteria1
Systolic blood pressure (BP) < 90 mmHg or need
for [vaso]pressor support to maintain BP
Arterial oxygen pressure (Pao2) ≤ 60 mmHg
while breathing room air or need for mechanical
ventilation
Intensive care unit admission
Disseminated intravascular coagulation
Confusion or altered mental state
Congestive cardiac failure seen on chest x-ray and
requiring treatment
Bleeding severe enough to require transfusion
Arrhythmia or ECG [electrocardiographic]
changes requiring treatment
Renal failure requiring investigation and/or treatment with IV [intravenous] fluids, dialysis, or any
other intervention
Other complications judged serious and clinically
significant by the investigator
1. Klastersky J, Paesmans M, Rubenstein EB, et al. The Multinational
Association for Supportive Care in Cancer risk index: a multinational
scoring system for identifying low-risk febrile neutropenic cancer
patients. J Clin Oncol 2000 Aug;18(16):3038-51.
38
was devised to answer the following
questions.
1.How many times were the named
items in the Klastersky criteria used as
reasons for admission to the hospital
by the general internists admitting patients? (As noted earlier, when a febrile
neutropenic patient with an infection
makes initial contact with a health care
practitioner for that febrile episode,
the Klastersky criteria do not consider
that infection a complication, and, in
addition, there are unnamed complications in the Klastersky criteria.)
2.Are there additional complications,
not listed by name in the Klastersky
criteria, that a physician might consider important in the nonadmission
decision?
3.Would the course of patients stratified to the low-risk category (MASCC
RIS ≥ 21) be without serious complications and, thus, be able to be
managed as outpatients (ie, stratified
to “Do not admit”)?
4.If inpatients with an MASCC RIS of
21 or higher did experience complications, what were they and on what
day of hospitalization did they occur?
5.If the patients with an MASCC RIS
of 21 or above were not admitted and
experienced complications, what management algorithm could be proposed
to identify these complications early?
6.What savings would be realized if all
the patients without serious complications were not admitted to the
hospital?
Management of febrile neutropenic
patients, at the time of this study and at
the medical centers listed, was admission
to the hospital, evaluation in the usual
manner with appropriate laboratory
tests and imaging studies, administration of granulocyte colony-stimulating
factor (89%), and antimicrobial agents.
All but 10 patients received acceptable
antimicrobial regimens. Charts were retrospectively reviewed for the following
inclusion criteria: adult inpatients with
solid tumors who became neutropenic
(absolute neutrophil count < 500/μL,
except for 2 that were 600/uL) after chemotherapy, who were given an admission
or discharge diagnosis of neutropenic
fever, who had documented fever by
self-report or on admission, and who
received antimicrobial therapy for neutropenic fever. Patients younger than 18
years and those whose admissions lasted
less than 24 hours were excluded. All
inpatient electronic medical records of
patients admitted to 4 Kaiser Permanente (KP) hospitals in California were
searched for drug-induced neutropenia
(International Classification of Diseases,
Ninth Revision, code 288.0) and feverpresenting conditions classified elsewhere (code 780.61). The hospitals were
San Diego Medical Center (admissions
from October 1, 2008, to November 15,
2010); Irvine Medical Center and Anaheim Medical Center (Orange County;
admissions from October 1, 2008, to
April 30, 2010); and Woodland Hills
Medical Center (admissions from October 1, 2008, to April 30, 2010). The
charts of these patient episodes were
sequentially and manually screened for
inclusion criteria and reviewed in detail.
If inclusion criteria were met, data were
extracted.
Data included: age, sex, admission
date, discharge date, death date, the
type of solid tumor, whether it was
metastatic beyond local nodes, admitting physician’s reason for admission, length of stay (LOS), reason for
extended hospital stay, intensive care
unit care, comfort care, other diagnoses in the problem list which might be
considered immunocompromising,
Utilityofofthethe
Multinational
Association
forSupportive
CareinCancer
(MASCC)
IndexScore
aCriterionforNonadmissioninFebrileNeutropenicPatientswithSolidTumors
Utility
Multinational
Association
for Supportive
Care in
CancerRisk
(MASCC)
RiskasIndex
smoking status, diagnosis of COPD,
occurrence of fever associated with
neutropenia, days to temperature
≤ 37.5 and ≤ 38 C, an ANC < 500 cells/uL,
return of ANC to greater than
500 cells/uL, duration of neutropenia,
death, reception of filgrastim before
and subsequently after admission,
gastrointestinal symptoms (nausea,
vomiting, diarrhea, abdominal pain,
“unable to eat,”), serum biochemical
tests (creatinine > 2 mg/dL, potassium
< 3 mEq/L, sodium of < 130 mEq/L,
phosphorus of < 2.7 mg/dL), density/
intensity of chemotherapy, types of
infections, positive bacterial cultures,
microorganisms isolated, antimicrobial
agents prescribed when outpatient and
inpatient, results of pertinent imaging
studies, MASCC RIS components,
and medical complications listed in the
Klastersky criteria.
All febrile neutropenic patient episodes meeting inclusion criteria were
divided into 2 groups on the basis of
complications: Group 1, no complication (equivalent to “do not admit”),
or Group 2, complication (equivalent to “admit”). Group 1 (n = 100)
had only fever and neutropenia, had
none of the medical complications
(Table 2) on admission or within 24
hours of admission, and were able to
eat. Group 2 (n = 98) had 1 or more
of the complications listed in Table 2
at admission or within 24 hours of
admission. There were 3 patients in
Group 1 in whom complications
developed 24 hours after admission,
which if they had been present on
presentation would have classified
each patient into Group 2 initially.
Each patient episode was assigned to
an MASCC RIS of 21 or greater or
below 21, and these scores were correlated with the no complication and
complication groups (Figure 1). The
KP Southern California institutional
review board approved the study.
Medical Centers
In 2012, beds and discharges per
month were as follows: San Diego,
392 beds and 32,491 discharges;
Orange County, 350 beds (2 hospitals),
28,564 discharges; and Woodland
Hills, 262 beds and 13,741 discharges.
All 4 hospitals fall into the tertiary care
category, providing a full range of basic
and sophisticated diagnostic and treatment services, including many specialized services.
Statistical Analysis
A sample size of 200 episodes was
chosen as the basis for another study,
not yet published, from which this
analysis was done. Two episodes did
not meet criteria, leaving 198 episodes.
Standard methods of calculating sensitivity, specificity, positive predictive
value, and negative predictive value
were used. The Wilcoxon rank sum
test was used to compare for those who
were unable to eat and for those who
were able to eat.
RESULTS
Patient characteristics are shown in
Table 3.
Klastersky Criteria versus Complications
Table 2 lists the components of the
Klastersky criteria; complications,
which includes the reasons for admission and subsequent complications;
the MASCC RIS; and LOS. There
are 69 patients in Table 2 who had an
MASCC RIS of 21 or above and had
reasons for admission and/or complications. Only 20 patients of the 69 had
complications named in the Klastersky
criteria as a reason for admission. If the
Klastersky criteria were to be applied,
the other 49 reasons for admission
would have to be assumed to fall into
the last Klastersky category, “other
complications judged serious or clinically significant by the investigator.”
Thirty-eight patients were unable to
eat, 22 had identified infections, 21
could be considered to have mucositis,
and 5 were found to have typhlitis.
Risk Index Score versus Complications
The sensitivity of the MASCC RIS
was 94% (94 of 100 episodes) with
a 95% confidence interval (CI) of
87.4% to 97.8%, and specificity was
29.6% (29/98; 95% CI = 20.8% to
39.7%). The positive predictive valve
was 57.67% (94/163; 95% CI = 49.7%
to 65.4%), and the negative predictive
valve was 82.9% (29/35; 95% CI =
66.34% to 93.4%).
Figure 1. Assignment of episodes of febrile neutropenia to Multinational Association for Supportive Care in Cancer (MASCC) risk index score (RIS)
and complications.a
a
Three complications occurred after admission to the hospital in patients stratified to “no complication” and would have occurred on an outpatient basis if the patients
had not been admitted.
39
RiskofIndex
as a Criterion
for Nonadmission
in FebrileCare
Neutropenic
Patients
with Solid
Utility
the Score
Multinational
Association
for Supportive
in Cancer
(MASCC)
RiskTumors
Index
Table 2. Klastersky criteria and complications in 69 patients with an MASCC RIS > 21
Patient
episode
number
Klastersky criteria
(named)
Klastersky criteria
(Presumed to be in ”Other complications
by the investigator”)
Reason for
admission
Complication after
admission
MASCC
RIS
Length
of stay,
days
1
None
None
Cellulitis
None
21
3
2
SBP < 90 mmHg/need for
vasopressors
Nausea, vomiting
SBP < 98 mmHg in a 90 year old
None
21
5
3
None
Unable to eat
Unable to eat, mucositis
None
21
5
4
None
Unable to eat, K 2.9 mEq/L
Unable to eat, K 2.9 mEq/L
Day 3: K 3 mEq/L
21
5
5
None
Unable to eat, nausea, diarrhea,
abdominal pain
Unable to eat, nausea, diarrhea,
abdominal pain
None
21
5
6
None
Unable to eat, nausea, vomiting,
abdominal pain
abdominal pain
None
21
5
7
vasopressors
Diarrhea
Diarrhea/SBP < 90 mmHg
None
21
6
8
Arrhythmia, ECG changes
Unable to eat, nausea, vomiting
Unable to eat, nausea, vomiting, atrial flutter
None
21
6
9
None
Unable to eat, difficulty swallowing
Unable to eat, difficulty swallowing
None
21
6
10
None
Nausea, vomiting
Nausea, vomiting, bacteremia
None
21
7
11
None
Nausea, abdominal pain, K < 3 mEq/L
Nausea, abdominal pain, Typhlitis, K < 3 mEq/L
None
21
7
12
None
Unable to eat, diarrhea
Unable to eat, diarrhea
Stomatitis
21
7
13
None
Nausea, vomiting,
Nausea, Vomiting, positive blood culture
None
21
7
14
vasopressors, arrhythmia, ECG
changes
Nausea, vomiting
Nausea, vomiting,
Low SBP within first 24 hours,
SVT 3 days
21
8
15
vasopressors, bleeding
requiring transfusion
Penile bleeding
Penile bleeding
Day 3: Na 124 mEq/L, Day 4:
SBP < 90 mmHg, Day 7: fluid
overload
21
9
16
Confusion, altered mental state
Unable to eat
Unable to eat, confusion, brain metastases
None
21
9
17
None
Unable to eat, nausea, diarrhea
Unable to eat, nausea, diarrhea, C diff
Day 2: K 2.6 mEq/L, Day 5: atrial
fibrillation
21
11
18
None
Unable to eat, nausea, abdominal pain
Unable to eat, nausea, abdominal pain,
mucositis
Day 5: K 2.3 mEq/L, required
TPN, fever
21
13
19
None
Unable to eat, nausea, vomiting, diarrhea,
lower GI bleeding, K 2.8 mEq/L, Mg 0.8 mEq/L
lower GI bleeding, K 2.8 mEq/L, Mg 0.8 mEq/L
None
21
15
20
vasopressors, ICU admission
Unable to eat, diarrhea, K 2.2 mEq/L
Unable to eat, diarrhea, mucositis,
K 2.2 mEq/L
Day 4: hypotension, ICU,
pneumonia, C diff, MI
21
18
21
None
Unable to eat, nausea, vomiting, diarrhea
C diff
None
21
19
22
Renal failure
Nausea, vomiting, abdominal pain
Nausea, vomiting, abdominal pain, ARF,
bilateral hydronephrosis
Day 10: K 2.9 mEq/L, Day 14:
colostomy
21
20
23
Confusion, altered mental state
Unable to eat
Unable to eat, cellulitis, mucositis
Day 4: confusion, carcinomatous
meningitis
21
29
24
None
Unable to eat, abdominal pain, inpatient
chemotherapy required,
Unable to eat, abdominal pain, SBO
Inpatient chemotherapy required,
neutropenia, fever, bacteremia
21
31
25
None
Nausea, diarrhea, abdominal pain
Nausea, diarrhea, abdominal pain, typhlitis
None
22
4
26
None
None
Pleural effusion
None
22
6
27
None
K 2.2 mEq/L, Hb 6.6 g/dL
Bacteremia, K 2.2 mEq/L, decubitus
débridement
Day 2: Hb 6.6 g/dL
22
6
28
None
Nausea, K 2.6 mEq/L
Nausea, K 2.6 mEq/L
None
22
6
29
vasopressors, confusion,
altered mental state, or seizure
Nausea, vomiting, diarrhea, abdominal
pain, K 2 mEq/L,
pain, altered mental state
Day 2: K 2 mEq/L, Day 3 SBP <
90 mmHg
22
8
30
SBP < 90 mmHg/need
for vasopressors, Pao2
< 60 mmHg/need for ventilation
Impending hip fracture
Impending hip fracture
Day 3: hypotension, Day 5:
hypoxia, ARDS
22
8
31
None
Unable to eat, difficulty swallowing, Day 4:
K 5.6 mEq/L, Day 9: K 6.1 mEq/L
Unable to eat, difficulty swallowing,
mucositis
Day 4: K 5.6 mEq/L, Day 9: K
6.1 mEq/L
22
10
32
Pao2 < 60 mmHg/need for
ventilation,
Nausea, diarrhea
Nausea, diarrhea, dehydration, Cr 2.7 mg/dL
Day 3: hypoxia: Day 4: Cr 5.3 mg/dL,
Day 6: colitis, hemodialysis
22
11
33
None
Na 126 mEq/L
Pneumonia, Na 126 mEq/L
None
23
3
34
None
Nausea, diarrhea, abdominal pain, Na 118
Nausea, diarrhea, abdominal pain,
hypotension, Na 118 mEq/L
None
23
3
(Continued on next page.)
40
Utilityofofthethe
Multinational
Association
forSupportive
CareinCancer
(MASCC)
IndexScore
Utility
Multinational
Association
for Supportive
Care in
CancerRisk
(MASCC)
RiskasIndex
(Continued from previous page.)
Patient
episode
number
Klastersky criteria
(named)
Klastersky criteria
(Presumed to be in ”Other complications
by the investigator”)
Reason for
admission
Complication after
admission
MASCC
RIS
Length
of stay,
days
35
None
difficulty swallowing, Hb 6.6 g/dL
difficulty swallowing
Day 2: Hb 6.6 g/dL
23
6
36
None
None
Pneumonia
None
23
7
37
None
Unable to eat, nausea, vomiting, diarrhea
abdominal pain, mucositis, colitis
None
23
8
38
None
abdominal pain, intestinal perforation
abdominal pain, intestinal perforation
None
23
8
39
None
abdominal pain, SBO
abdominal pain SBO
None
23
10
40
None
Unable to eat
None
24
3
41
None
Cellulitis
None
24
5
42
None
Unable to eat, nausea
Unable to eat, nausea, difficulty swallowing,
mucositis
None
24
5
43
None
Unable to eat
None
24
5
44
None
pain
pain, typhlitis
None
24
6
45
None
None
Abscess
None
24
6
46
vasopressors
None
Perirectal abscess
Day 1: hypotension
24
6
47
None
Unable to eat, nausea, vomiting, mucositis
None
24
6
48
vasopressors
Unable to eat
Unable to eat
Day 3: hypotension
24
7
49
Pao2 < 60 mmHg/need for
ventilation, arrhythmia, ECG
changes
None
Syncope, K 2.1 mEq/L
Day 2: SVT, hypoxia
24
8
50
None
Nausea, vomiting, abdominal pain, colitis
None
24
8
51
None
Unable to eat, diarrhea, K 2.5 mEq/L
Unable to eat, diarrhea, difficulty
swallowing, mucositis, K 2.5 mEq/L
None
24
8
52
None
K 2.7 mEq/L
difficulty swallowing, K 2.7 mEq/L
None
24
8
53
None
None
Bacteremia
ARF
24
12
54
None
None, chest pain
Chest pain
None
24
13
55
None
intractable hiccups
esophagitis
Day 1: intractable hiccups
24
20
56
None
None
26
3
57
None
None
Cellulitis
None
26
4
58
None
pain
pain, typhlitis
None
26
4
59
None
Nausea, vomiting, abdominal pain, typhlitis
None
26
5
60
None
Unable to eat, abdominal pain
Unable to eat, abdominal pain, typhlitis
None
26
5
61
None
Day 1: perianal herpes simplex
virus
26
5
62
None
Nausea, diarrhea, K 2.6 mEq/L
Nausea, diarrhea, K 2.6 mEq/L
Enterovaginal fistula
26
6
63
None
Unable to eat, vomiting, abdominal pain
Unable to eat, vomiting, abdominal pain,
mucositis
None
26
7
64
None
abdominal pain, hypokalemia
abdominal pain, enteritis
Low K
26
7
65
None
Unable to eat, nausea, vomiting, rectal pain
Unable to eat, nausea, vomiting, rectal pain
None
26
9
66
None
Hb < 6 g/dL, unable to eat, abdominal pain,
K 2.9 mEq/L
Unable to eat, abdominal pain, Hb 5.4 g/dL,
K 2.9 mEq/L
None
26
9
67
None
Unable to eat, nausea, difficulty swallowing
Unable to eat, nausea, mucositis,
difficulty swallowing
None
26
10
68
None
Unable to eat, nausea
Unable to eat, nausea, mucositis
Day 2: fever, Day 6: ARF
26
11
69
None
abdominal pain
abdominal pain, esophagitis, colitis
Day 6: ARF
26
13
ARDS = acute respiratory distress syndrome; ARF = acute renal failure; C diff = Clostridium difficile; Cr = creatinine; ECG = electrocardiogram; GI = gastrointestinal tract; Hb = hemoglobin; ICU = intensive
care unit admission; K = potassium; MASCC = Multinational Association for Supportive Care in Cancer; Mg = magnesium; MI = myocardial infarction; Na = sodium; Pao2 = partial pressure of oxygen;
RIS = risk index score; SBO = small-bowel obstruction; SBP = systolic blood pressure; SVT = supraventricular tachycardia; TPN = total parenteral nutrition.
41
RiskofIndex
as a Criterion
for Nonadmission
in FebrileCare
Neutropenic
Patients
with Solid
Utility
the Score
Multinational
Association
for Supportive
in Cancer
(MASCC)
RiskTumors
Index
Table 3. Characteristics of 198 patient episodes of solid tumors,a
Characteristic
Age, years
Median
Range
Sex
Male
Female
Neoplasms
Breast
Gastrointestinal
Lung
Sarcoma
Head and neck
Ovary
Prostate
Bladder
Testis
PNET
Unknown
Melanoma
Uterus
Total neoplasms
Comorbidities
Diabetes mellitus
CKD stage ≥ 3
Cirrhosis
Rheumatoid arthritis
Systemic lupus
CREST
Polymyalgia rheumatica
Transplant
Anti-TNF
Hepatitis B
Hepatitis C
HIV infection
Hypogammaglobulinemia
Hemochromatosis
Ulcerative colitis
Other
Unable to eat
GCSF, inpatient after admission
GCSF, outpatient before admission
Chemotherapy density and intensity
meeting GCSF criteria
Documented infection
Antimicrobials before admission
Adequate antimicrobial regimen on
admission
No. of
patients
(%)
MASCC RIS
score < 21
(n = 35), no. (%)
MASCC RIS
score ≥ 21
(n = 163), no. (%)
61
18-86
67.5
35-81
59
18-86
57 (29)
141 (71)
17
18
40
123
93 (47.0)
39 (19.7)
18 (9.1)
12 (6.1)
9 (4.5)
8 (4.0)
7 (3.5)
4 (2.0)
2 (1.0)
2 (1.0)
2 (1.0)
1 (0.5)
1 (0.5)
198 (100)
7 (20.0)
6 (17.1)
7 (20.0)
5 (14.3)
2 (5.7)
3 (8.6)
2 (5.7)
2 (5.7)
0 (0)
1 (2.9)
0 (0)
0 (0)
0 (0)
35 (100)
86 (52.8)
33 (20.3)
11 (6.8)
7 (4.3)
7 (4.3)
5 (3.1)
5 (3.1)
2 (1.2)
2 (1.2)
1 (0.6)
2 (1.2)
1 (0.6)
1 (0.6)
163 (100)
16 (8.1)
18 (9.1)
2 (1.0)
2 (1.0)
0 (0)
0 (0)
2 (1.0)
1 (0.5)
1 (0.5)
4 (11.4)
6 (17.1)
1 (2.9)
1 (2.9)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
15 (9.2)
12 (7.4)
1 (0.6)
1 (0.6)
0 (0)
1 (0.6)
2 (1.2)
1 (0.6)
1 (0.6)
1 (0.5)
5 (2.5)
1 (0.5)
2 (1.0)
2 (1.0)
1 (0.5)
0 (0)
0 (0)
0 (0)
0 (0)
1 (2.9)
0 (0)
1 (0.6)
5 (3.1)
1 (0.6)
2 (1.2)
1 (0.6)
1 (0.6)
54 (27.3)
177 (89.4)
33 (16.7)
51 (25.8)
16 (45.7)
31 (88.6)
6 (17.1)
5 (14.3)
38 (23.3)
146 (89.6)
27 (16.6)
46 (28.2)
38 (19.2)
18 (9.1)
187 (94.4)
12 (34.3)
4 (11.4)
34 (97.1)
26 (16)
14 (8.6)
153 (93.9)
Some percentages may not total to 100 because of rounding.
CKD = chronic kidney disease; CREST = calcinosis, Raynaud syndrome, esophageal dysmotility, sclerodactyly,
and telangiectasia; GCSF = granulocyte colony-stimulating factor; HIV = human immunodeficiency virus; MASCC
= Multinational Association for Supportive Care in Cancer; PNET = primitive neuroectodermal tumor; RIS = risk
index score; TNF = tumor necrosis factor.
a
42
There were 163 inpatient episodes
with an MASCC RIS of 21 or higher.
Sixty-nine of these had complications
and/or reasons for admission on presentation. Thirty-eight of the 69 were unable to eat; 32 of the 38 had reasons for
admission and/or complications. The
other 31 of the 69 patients, those who
were able to eat, required admission for
various other reasons. See Table 2 for the
reasons for admission and subsequent
complications of the 32 episodes.
There were 35 episodes with an
MASCC RIS below 21 (high risk for
complication). Six of these patient episodes were misclassified by the MASCC
RIS because no complication occurred
that required hospitalization. The mean
LOS for these 6 patients was 4.7 days
(5, 3, 5, 5, 4, and 6 days, the last with a
urinary tract infection that could have
been treated orally with ciprofloxacin)
compared with a mean LOS of 4.6 days
for Group 1 and 7.6 days for Group 2.
Inability to Eat
Inability to eat was considered a serious complication and reason for admission; thus, it placed a patient episode
in Group 2: complication. There were
54 episodes of 198 in which patients
were unable to eat, 38 of whom had an
MASCC RIS of 21 or above and 16
of whom had a score below 21. These
38 patient episodes were a subset of
the 69 discordant patient episodes with
an MASCC RIS of 21 or greater and a
complication (Table 2). Inability to eat
was associated with other serious complications in 32 of 38 episodes (84%). The
38 patients who were unable to eat had
a mean LOS of 9.66 days compared with
the mean LOS of the 31 patients who
could eat, 7.0 days (p = 0.08 by Wilcoxon
rank sum test). The mean MASCC RIS
of those unable to eat and those able to
eat was 23.1 and 22.8, respectively.
Correlation of Index
with Other Outcomes
There was no useful correlation between the MASCC RIS and either the
days to a body temperature at or below
37.5°C or the LOS (data not shown).
Table 4 shows a correlation with deaths
and the potential cost savings of preventing hospital admission (Table 5).
Utilityofofthethe
Multinational
Association
forSupportive
CareinCancer
(MASCC)
IndexScore
Utility
Multinational
Association
for Supportive
Care in
CancerRisk
(MASCC)
RiskasIndex
DISCUSSION
If patients with identified infections;
intractable vomiting and diarrhea, either of the latter caused by mucositis
or another complication; and inability
to eat are included in the patients to
whom the MASCC RIS is applied, the
sensitivity of an MASCC RIS of 21 or
greater to identify patients as a criterion
for nonadmission was high (94%), but
the positive predictive value was only
57.7% and the specificity only 29.6%.
The range of the specificity of the
MASCC RIS in some published studies (Table 6) varied from 40% to 95%
(mean = 67.5%) in prospective studies and from 52% to 63.7% (mean =
60.9%) in retrospective studies. The
variance of the specificity in these studies and the present study has not been
explained, and a detailed analysis is beyond the scope of this article; however,
a more detailed analysis is available in
the guideline from the American Society
of Clinical Oncology (ASCO).9 In most
of these publications, it is not clear if
patients, presenting with identifiable
infections; intractable vomiting and
diarrhea, either of the latter caused by
mucositis or another complication; and
the inability to eat and swallow medications were excluded before the calculation of the MASCC RIS because these
clinical features were considered aspects
of the febrile neutropenic syndrome and
not complications. Thus, study design
is a possible factor accounting for the
variance. Another factor might be that
the median age of the patients in the
studies listed in the references was about
51 years compared with 61 years in the
present study. In the MASCC RIS, 2
points are awarded for age younger than
60 years, indicating that those patients
aged 60 years or older are at increased
risk of complications. As noted earlier,
in 69 of 163 inpatient episodes with an
MASCC RIS of 21 or more, admission
was necessary because of complications
present on admission or which occurred
during hospitalization (Table 2). The
patients with these 69 misclassified inpatient episodes would not have been
admitted if an MASCC RIS of 21 or
greater was used as the criterion for
nonadmission. If these patients were
not admitted, the complications that
occurred during hospitalization would
have occurred outside the hospital, resulting in either reevaluation in a health
care setting or death.
There were also 3 inpatient episodes
with an MASCC RIS of 21 or above
(Group 1), in which a complication
occurred 24 hours after admission, a
complication that would have been
Table 4. Patient deaths
MASCC
RIS
13
19
19
19
Circumstances and causes
leading to death
Bacteremia, Staphylococcus aureus
Readmitted with intestinal perforation,
died same day
Unable to eat, became obtunded
on TPN
Pneumonia
Death
related
to initial
infection
Yes
No
Comfort
care
Yes
No
No
Yes
Yes
Yes
Clostridium difficile, low BP, ICU,
HAP, AMI
SBO, died 31 days after admission
Encephalopathy
No
Yes
No
No
Yes
Yes
No
No
Yes
22
Multiple intraabdominal, extraintestinal
air-fluid levels
ARDS, progressive hypoxemia,
hypotension
Diarrhea, colitis, ARF, hypotension
Yes
Planned for
next day
Yes
23
Sepsis, then acute hypotension
Yes
Yes
23
Admitted with SBO and discharged;
readmitted following week with
intestinal perforation, intraabdominal
abscess (declined abcess drainage)
Fluid overload, failed to respond to
diuresis
Readmitted obtunded, ARF,
hypotensive
New SVT, hypoxemia
No
No
No
Yes
No
No
21
21
21
22
22
24
24
24
Neoplasm
Sarcoma
Advanced lung
cancer
Advanced ovarian
cancer
Lung cancer
Advanced
esophageal cancer
Colon cancer
Advanced breast
cancer
Advanced
endometrial cancer
Advanced prostate
cancer
Advanced lung
cancer
Advanced breast
cancer
Ovarian cancer
Death after
discharge,
within 28 days
of admissiona
No
No
Duration of
neutropenia/
length of stay,
days
7/7
3/8
Days to temperature
≤ 38°C/days to
temperature ≤ 37.5°C
6/6
8/8
No
2 / 18
1/2
No
1/4
1/1
No
9 / 18
3/3
No
No
6 / 31
1 / 29
1/1
7/9
Yes
5/6
2/4
No
2/8
8/8
No
4/8
4/4
No
2/3
1/3
Yes
3/4
3/3
No
6/9
6/9
No
Metastatic; primary
cancer not known
Breast cancer
Yes
3 / 14
3/8
Yes
Gastric cancer
No
8/8
4/7
“No” = died in hospital.
AMI = acute myocardial infarction; ARDS = acute respiratory distress syndrome; ARF = acute renal failure; BP = blood pressure; HAP = hospital-acquired pneumonia; ICU = intensive care
unit admission; MASCC = Multinational Association for Supportive Care in Cancer; RIS = risk index score; SBO = small-bowel obstruction; SVT = supraventricular tachycardia; TPN = total
parenteral nutrition.
a
43
RiskofIndex
as a Criterion
for Nonadmission
in FebrileCare
Neutropenic
Patients
with Solid
Utility
the Score
Multinational
Association
for Supportive
in Cancer
(MASCC)
RiskTumors
Index
Table 5. Savings of preventing hospital admission
Savings
Approximate cost of 1 day of hospitalization (2012 US dollars)
Number of patient episodes
Number of patient episode days x number of patient episodes
Estimated cost of hospitalization (2012 US dollars)
best managed in the hospital. If the
patients had not been admitted, or had
been admitted and discharged after
24 hours of observation, they would
have experienced these complications
as outpatients. Those complications
were hypokalemia (serum potassium
concentration of 2.9 mEq/L) on Day
2, hypophosphatemia (phosphorus level
of 2.2 mg/dL) on Day 3, and recurrent
fever on Day 4. An additional 52-yearold woman, not identified as feeling or
appearing sick or being dehydrated, had
a temperature of 38.7°C, a BP of 81/54
mmHg, and a pulse of 130/min (3 criteria for systemic inflammatory response
syndrome10) in urgent care. She was
referred to the Emergency Department,
where she was hydrated and placed on
an intravenous antimicrobial regimen.
She was intermittently hypotensive
until the BP finally stabilized 25 hours
and 37 minutes later. Her MASCC RIS
was 21 at the time of admission, but the
RIS would have been different
depending on when, in the
If the MASCC
course of this patient episode,
index were
it was calculated.
to be used to
Because many complicadetermine
tions, such as hypokalemia,
hypophosphatemia, and recur“do not admit,”
rent fever, cannot be predicted
it would have
with an MASCC RIS of 21
to be employed
or higher, use of a protocol,
after determining
algorithm, or guideline seems
whether a person
appropriate to help clinicians
was or was not
decide on the proper manable to eat or
agement. One is the ASCO
swallow …
guideline from 2012, 9 and
another is the National Comprehensive Cancer Network (NCCN)
guideline. 11 The recommended initial observation period in the ASCO
guideline is 4 hours, and in the NCCN
guideline it is 2 to 12 hours. The hypotensive patient described could have
been considered stable at 2 to 4 hours
and possibly discharged to home.
44
No complication
$2124
100
455
$966,420
However, the physician, simply using
clinical judgment, decided this patient
needed admission. This decision was
consistent with the ASCO guideline,
which clearly states that a patient with
criteria for systemic inflammatory response syndrome should be admitted.
Therefore, following the ASCO guideline
would have ensured admission for this
last patient, but using an MASCC RIS
of 21 or higher would not. The limitataion of the MASCC RIS is evident by
consulting Table 4 of the ASCO guideline (available at: http://jco.ascopubs.
org/content/31/6/794/T4.expansion.
html).9 The table lists 41 exclusions
(42 if the footnote regarding systemic
inflammatory response syndrome is
included) to using an MASCC RIS of
21 or greater as a criterion for treating a febrile neutropenic patient as
an outpatient.9 Furthermore, neither
the NCCN guideline for the management of nonadmitted patients nor the
ASCO guideline specify frequency of
laboratory testing for these potential
outpatients. Rubenstein et al12 suggested
obtaining a complete blood cell count
every other day and biochemical panels
on Day 7 or the last day of observation.
If the biochemical panels for the patients
with hypokalemia and hypophosphatemia had been drawn on Day 7, a delay
in detection would have occurred. The
protocol for patients discharged from the
hospital on a regimen of oral antimicrobial therapy in the article by Klastersky
et al13 included temperature recorded every 6 hours, laboratory tests every other
day for 5 days, and phone contact with
the patient every other day. The ASCO
guideline recommends daily telephone
contact and “frequent evaluation for at
least 3 days in clinic or at home.”
Data in the present study support
the ASCO guideline for management
of these patients. Although the ASCO
guideline recognizes the lack of data
supporting multiple aspects of outpatient management, modifications to
the guideline, following discharge to
an outpatient setting, could include
recording the patient’s vital signs approximately every 6 to 8 hours, establishing phone contact with the patient
or caregiver within 8 to 12 hours following discharge, and serum biochemical
tests (electrolytes, creatinine, calcium,
phosphorus, and magnesium) daily or
every other day for 3 times, or until
results are normal.
Importance of Inability to Eat
This study chose inability to eat, as
an admission criterion, vs inability to
swallow oral medications because “unable to eat” was recorded in the progress
notes. In my view, neither is adequate
or objective because outpatients need
both adequate nutrition and appropriate medications. Some patients who
are unable to eat can swallow oral
medications, and some patients who
are unable (or unwilling) to swallow
oral medications are able and willing
to swallow nutritional liquid drinks.
Inability to swallow oral medications
is considered by the ASCO guideline
to be an exclusion for outpatient management. It is not named as one of the
complications in the Klastersky criteria. In the study by Klastersky et al,13
which identified patients who were
stable and ready for discharge from the
hospital after 24 hours of observation,
the equivalent of “unable to eat”—
“able to swallow”—was employed after
stratification by the MASCC index and
was not incorporated into the MASCC
index. Those unable to swallow were
excluded from early discharge despite
an MASCC RIS of 21 or higher. If the
MASCC RIS were to be used to determine “do not admit,” it would have to
be employed after determining whether
a person was or was not able to eat or
swallow, or the criterion “unable to eat/
unable to swallow oral medications”
would have to be incorporated into the
MASCC RIS.
As noted earlier, inability to eat was
associated with other serious complications, and all physicians admitting
patients in this study considered it a criterion for admission. However, because
Utilityofofthethe
Multinational
Association
forSupportive
CareinCancer
(MASCC)
IndexScore
Utility
Multinational
Association
for Supportive
Care in
CancerRisk
(MASCC)
RiskasIndex
there are 42 exclusions in the ASCO
guideline9 for managing a patient as an
outpatient, as mentioned earlier, there
is questionable utility to modifying the
MASCC RIS to include “unable to eat/
unable to swallow oral medications.”
That inability to eat is important has
been highlighted in a study by Escalante
et al,14 who noted that 80% of patients
with Grade 3 or higher mucositis required admission. The NCCN guideline
also includes Grades 3 to 4 mucositis as
a criterion for high risk. Until patients
who are unable to eat or to swallow oral
medications, yet who have no other
complications, can be managed as outpatients, they will require admission.
are objective; 2) the majority, 49 of the
69, of the complications experienced
by the patients in this study with an
MASCC RIS of 21 or higher were not
among the named complications; and 3)
inability to eat and inability to swallow
are not named.
The MASCC RIS of 21 or above is
inadequate for the nonadmission decision for these reasons: 1) only 4 of the
7 components of the MASCC RIS are
objective; 2) it misclassified to low risk
42.3% of patient episodes with complications; 3) it has to be checked against
42 other exclusions based on the ASCO
guideline9; and 4) “unable to eat/unable
to swallow” are not incorporated.
Limitations of Klastersky
Criteria and Index
Alternative to Index
The Klastersky criteria are inadequate
as nonadmission criteria for these reasons: 1) only 2 of the 10 complications
The alternative to the MASCC RIS
is clinical judgment or a more reliable
index. Although the MASCC RIS has
been incorporated into both Infectious
Diseases Society of America1 and ASCO
guidelines,9 I believe a fair question is:
Is this index really superior to clinical
judgment? Furthermore, I believe it
would be beneficial to conduct a study
in which a physician assigns an MASCC
RIS at the point of entry to health care
and again at the point when an admitting physician, blinded to the MASCC
RIS, evaluates the patient regarding admission. The admitting physician would
decide, on the basis of clinical acumen
and the ASCO guideline, whether the
patient should be admitted. The patient
would be observed in the hospital for
24 hours. Complications would be correlated with the MASCC RIS and the
clinical decision.
Savings
The cost of intensive outpatient
management would probably be less
than the cost of inpatient management
Table 6. Sensitivity and specificity of the MASCC RIS in various studies
Source,
year
Uys,8
2004
Type of study
Prospective
Total
Baskaran,5
2008
Retrospective
Total
Innes,6
2008
Prospective
Total
André,18
2010
Prospective
Solid tumor,
lymphoma, %
70
34.5
100
No serious
medical
complication
57
3
60
68
5
73
87
8
95
Not SS/SSh
70
38
108
308
15
323
1349
410
1759
137
Serious
medical
complication
1
19
20
14
29
43
3
2
5
SS/SSh
22
67
89
35
38
73
139
244
383
23
< 21
32
169
Don’t admit
35
58
Admit
67
227
> 21
< 21
94
6
100
69
29
98
163
35
198
MASCC
RIS
> 21
< 21
> 21
< 21
> 21
< 21
56
> 21
< 20
Total
Ahn,19
2011
Retrospective
Total
Paesmans,20
2011
Retrospective
Total
Hui,4
2011
Prospective
Total
Bitar,
2013a
Retrospective
71.5
57
79.7
> 21
< 21
> 21
< 21
> 21
100
Total
Total
58
22
80
82
34
116
90
10
100
92
105
197
343
53
396
1488
654
2142
160
Sensitivity,
%
95
Specificity,
%
95
Deaths,
%
0
36.4
67
7
29
93
91.6
40
70
75
NA
NA
52
1.5
18.9
63.7
1
14.2
95
77
81
1.9
60
9
29.6
4.9
11.4
94
Results of the current study.
MASCC = Multinational Association for Supportive Care in Cancer; NA = not available; RIS = risk index score; SS/SSh = severe sepsis or septic shock.
a
45
RiskofIndex
as a Criterion
for Nonadmission
in FebrileCare
Neutropenic
Patients
with Solid
Utility
the Score
Multinational
Association
for Supportive
in Cancer
(MASCC)
RiskTumors
Index
(approximately $10,000 per uncomplicated admission12). In 1993, Rubenstein
and colleagues12 estimated the medication cost of outpatient management as
$2302 for oral therapy and $7336 for
intravenous therapy, but the total cost
of managing the patients was not provided. Elting et al15 calculated the costs
of outpatient vs inpatient management
in 2008 and found the total cost of inpatient management to be about twice
that of outpatients.
Study Limitations
There are some limitations to this
study. First, as noted earlier, the MASCC
RIS lists only 4 actual objective criteria.
The burden of illness category is purely
subjective, dependent on the recorder
(Table 1). The burden of illness was assigned following a detailed review of the
chart by the physician author and not by
the admitting physician. The physician
reviewing the charts for this study did
review the publication by Pompei and
associates,16 which originally proposed
the burden of illness designation. Although a retrospective chart review has
some element of subjectivity, it is no less
objective than the criteria used to evaluate charts in the original publication by
Klastersky et al.3
Second, this study accepted designations such as COPD, dehydration,
and other terms such as vomiting,
diarrhea, unable to eat, and so on,
without requiring an objective definition. (The ASCO guideline, Table 2,
[available at: http://jco.ascopubs.org/
content/31/6/794/T2.expansion.html]
attempts to address this problem, but
does not resolve it.9)
Third, this was a retrospective review
of the charts by a single physician. However, his experience included more than
37 years as a physician and 23 years as
an infectious disease physician.
Fourth, the definition of febrile neutropenia was based on the admitting
physician’s acceptance of the self-report
of fever or the documentation of fever
in the clinic or Emergency Department
and not a documented temperature of
above 38.3°C on one occasion or above
38°C on 2 or more occasions during a
12-hour period.17
Fifth, this was a study of only febrile
neutropenic patients with solid tumors,
so the sensitivity and specificity of the
MASCC RIS in this study should be
compared only with similar studies of
febrile neutropenic patients with solid
tumors. (Table 6 shows data extracted
from 7 studies with the percentage of
patients with solid tumors or lymphoma
and the sensitivity and specificity of the
MASCC RIS for each.4-6,8,18-20)
CONCLUSIONS
Figure 2. Proposed outpatient management algorithm.b
Modified from the American Society of Clinical Oncology (ASCO) guideline, to include the following:
Patient agrees to outpatient treatment while neutropenic, including potential frequent visits to clinic/hospital.
Residence ≤ 1 hour or ≤ 30 miles (48 km) from clinic or hospital, even in inclement weather.
Patient’s primary care physician and infectious disease physician, or oncologist agrees to outpatient management.
Attendant or attendants who agree to outpatient treatment and are competent at observation and communication,
and at home 24 hours a day until neutropenia and other clinical problems resolve.
Telephone and transportation available 24 hours a day.
Either an oncology or infectious disease nurse practitioner or physician’s assistant or a clinically trained home infusion
pharmacist or clinically trained oncology nurse or infectious disease nurse able to communicate with patient daily.
b
High risk indicates usual clinical criteria for admission (criteria on which a general internist bases a decision to
admit or to not admit) using the 2013 clinical practice guideline from the ASCO, which includes all patients unable
to eat. Low risk indicates absence of usual admission criteria/ASCO guideline.
Ca = calcium; CBC = complete blood count; Cr = creatinine; h = hours; Mg = magnesium; VS = vital signs.
a
46
This study answered the 6 questions
presented in the Introduction. First, of 69
misclassified patients with complications
and an MASCC RIS of 21 or greater,
only 20 had serious complications named
in the Klastersky criteria, meaning that
the other 49 patients had complications
not named and which had to be assumed
to be included in the last component,
“other complications judged serious and
clinically significant by the investigator.”
Second, there were additional complications, not named in the Klastersky
criteria, which were important in the
nonadmission decision, such as inability
to eat (Table 2).
Third, the MASCC RIS of 21 or
greater could not be used to make the
nonadmission decision for a febrile
neutropenic patient with a solid tumor
because, in this study, a score of 21 or
higher misclassified 42.3% of patients
with complications to low risk.
Fourth, 3 patients with an MASCC
RIS of 21 or greater experienced complications 24 hours after admission; the
Utilityofofthethe
Multinational
Association
forSupportive
CareinCancer
(MASCC)
IndexScore
Utility
Multinational
Association
for Supportive
Care in
CancerRisk
(MASCC)
RiskasIndex
complication and the day of occurrence
were noted. Because 2 of the 3 complications that occurred were biochemical
and the additional one was recurrent
fever, the index is unlikely to be able to
predict their occurrence.
Fifth, therefore, an algorithm or
protocol for the management of outpatients is advisable. An algorithm has
been constructed from the implications
of the data in this study and the ASCO
guideline (Figure 2).
Sixth, substantial savings could be
realized if uncomplicated patients could
be managed as outpatients (approximately $1 million per 100 uncomplicated admissions in 2012 dollars).
The possibility of creating an MASCClike RIS from truly objective data, which
could be used to predict complications
and the safety of not admitting a febrile
neutropenic patient, requires further
investigation. v
3.
4.
5.
6.
7.
disclose.
Acknowledgment
The author thanks Elizabeth Le for data
extraction and formulation, without which this
study would not have been possible.
8.
9.
References
1. Freifeld AG, Bow EJ, Sepkowitz KA, et al;
Infectious Diseases Society of America. Clinical
practice guideline for the use of antimicrobial
agents in neutropenic patients with cancer: 2010
update by the Infectious Diseases Society of
America. Clin Infect Dis 2011 Feb 15;52(4):e56-93.
DOI: http://dx.doi.org/10.1093/cid/cir073.
2. Smith TJ, Khatcheressian J, Lyman GH, et al.
2006 update of recommendations for the use
of white blood cell growth factors: an evidencebased clinical practice guideline. J Clin Oncol
10.
2006 Jul 1;24(19):3187-205. DOI: http://dx.doi.
org/10.1200/JCO.2006.06.4451.
Klastersky J, Paesmans M, Rubenstein EB, et al.
The Multinational Association for Supportive
Care in Cancer risk index: a multinational
scoring system for identifying low-risk febrile
neutropenic cancer patients. J Clin Oncol 2000
Aug;18(16):3038-51.
Hui EP, Leung LK, Poon TC, et al. Prediction
of outcome in cancer patients with febrile
neutropenia: a prospective validation of the
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artificial neural network. Support Care Cancer
2011 Oct;19(10):1625-35. DOI: http://dx.doi.
org/10.1007/s00520-010-0993-8.
Baskaran ND, Gan GG, Adeeba K. Applying the
Multinational Association for Supportive Care
in Cancer risk scoring in predicting outcome
of febrile neutropenia patients in a cohort of
patients. Ann Hematol 2008 Jul;87(7):563-9. DOI:
http://dx.doi.org/10.1007/s00277-008-0487-7.
Innes H, Lim SL, Hall A, Chan SY, Bhalla N,
Marshall E. Management of febrile neutropenia
in solid tumours and lymphomas using the
Multinational Association for Supportive Care in
Cancer (MASCC) risk index: feasibility and safety
in routine clinical practice. Support Care Cancer
2008 May;16(5):485-91. DOI: http://dx.doi.
org/10.1007/s00520-007-0334-8.
Carmona-Bayonas A, Gómez J, GonzálezBillalabeitia E, et al. Prognostic evaluation of
febrile neutropenia in apparently stable adult
cancer patients. Br J Cancer 2011 Aug 23;
bjc.2011.284.
Uys A, Rapoport BL, Anderson R. Febrile
neutropenia: a prospective study to validate the
Multinational Association of Supportive Care of
Cancer (MASCC) risk-index score. Support Care
Cancer 2004 Aug;12(8):555-60. DOI: http://dx.doi.
org/10.1007/s00520-004-0614-5.
Flowers CR, Seidenfeld J, Bow EJ, et al.
Antimicrobial prophylaxis and outpatient
management of fever and neutropenia in adults
treated for malignancy: American Society of
Clinical Oncology clinical practice guideline. J Clin
Oncol 2013 Feb 20;31(6):794-810. DOI: http://
dx.doi.org/10.1200/JCO.2012.45.8661.
Bone RC, Balk RA, Cerra FB, et al. Definitions
for sepsis and organ failure and guidelines for
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Society of Critical Care Medicine. Chest
1992 Jun;101(6):1644-55. DOI: http://dx.doi.
org/10.1378/chest.101.6.1644.
11. NCCN guidelines: prevention and treatment
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Washington, PA: National Comprehensive Cancer
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www.nccn.org/professionals/physician_gls/f_
guidelines.asp#infections.
12. Rubenstein EB, Rolston K, Benjamin RS, et al.
Outpatient treatment of febrile episodes in low-risk
neutropenic patients with cancer. Cancer 1993
Jun 1;71(11):3640-6. DOI: http://dx.doi.org/
10.1002/1097-0142(19930601)71:11%3C3640::
AID-CNCR2820711128%3E3.0.CO;2-H.
13. Klastersky J, Paesmans M, Georgala A, et al.
Outpatient oral antibiotics for febrile neutropenic
cancer patients using a score predictive for
complications. J Clin Oncol 2006 Sep 1;24(25):
4129-34. DOI: http://dx.doi.org/10.1200/
JCO.2005.03.9909.
14. Escalante CP, Weiser MA, Manzullo E, et al.
Outcomes of treatment pathways in outpatient
treatment of low risk febrile neutropenic
cancer patients. Support Care Cancer 2004
Sep;12(9):657-62. DOI: http://dx.doi.org/10.1007/
s00520-004-0613-6.
15. Elting LS, Lu C, Escalante CP, et al. Outcomes
and cost of outpatient or inpatient management of
712 patients with febrile neutropenia. J Clin Oncol
2008 Feb 1;26(4):606-11. DOI: http://dx.doi.
org/10.1200/JCO.2007.13.8222.
16. Pompei P, Charlson ME, Ales K, MacKenzie CR,
Norton M. Relating patient characteristics at the
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17. Hughes WT, Pizzo PA, Wade JC, Armstrong D,
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clind/15.Supplement_1.S206.
18. André S, Taboulet P, Elie C, et al. Febrile
neutropenia in French emergency departments:
results of a prospective multicentre survey.
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State of Mind
A cancer is not only a physical disease, it is a state of mind.
— Michael Baden, MD, b 1934, physician and forensic pathologist
47
Evidence-Based Referral: Effects of the Revised
“Youth Fit 4 Life” Protocol on Physical Activity Outputs
James J Annesi, PhD, FAAHB, FTOS, FAPA; Linda L Vaughn, MS, MBA
Perm J 2015 Summer;19(3):48-53
ABSTRACT
Background: Lack of physical activity is prevalent in youths. Pediatricians seek referrals to reliably increase outputs, especially in their overweight and underactive patients.
Objective: Within a randomized controlled trial, we contrasted 2 physical activity/nutrition treatments on the basis of social cognitive and self-efficacy theory, and
a comparison condition, on time in moderate-to-vigorous physical activity (MVPA)
during the 45-min/day physical activity segment of elementary afterschool care.
Methods: In youths ranging in age from 9 to 12 years (9.7 ± 0.8 years, overall),
the Original Youth Fit For Life treatment (Original YFFL; n = 49), the Revised Youth
Fit 4 Life treatment (Revised YF4L, n = 43), and a comparison condition of typical
care (Comparison, n = 46) were contrasted using a 3 (groups) × 2 (sexes) analysis
of variance incorporating means of 3 accelerometer measurements over 12 weeks.
Results: There was a significantly greater amount of time in MVPA in the Revised
YF4L group than either the Original YFFL or Comparison groups (F2, 132 = 281.20,
p < 0.001). Boys completed significantly more time in MVPA than girls (F2, 132 =
16.43, p < 0.001); however, there was not a significant group × sex interaction.
Supplementary analyses indicated sedentary time was significantly less by 29% in
the Revised YF4L when contrasted with the Comparison group.
Conclusion: The Revised YF4L protocol that sought to maximize participants’
cardiovascular physical activity appeared to improve upon the Original YFFL treatment on time in MVPA. Thus, pediatricians might have confidence in referring their
patients to such evidence-based approaches. Future research should also evaluate
the effects of YF4L on psychosocial predictors of physical activity and change in
body mass index.
INTRODUCTION
In the US, more than one-third of
youths are presently overweight or
obese.1 Comorbidities include increased
risk for type 2 diabetes, heart disease,
orthopedic injuries, cardiorespiratory problems, and self-esteem issues.2,3
Physical activity among children of all
ages has decreased,4 and this decrease
is associated with an inappropriately
high weight.5 The Centers for Disease
Control and Prevention’s recommendation for physical activity in children is at
least 60 minutes per day of moderateto-vigorous physical activity (MVPA).6
However, a recent population-based
study using accelerometry found that
only 42% of US children ages 9-11 years
attained this volume.7 Consistent with
other research,8 the percentage of boys
attaining the recommended amount of
physical activity (49%) was considerably greater than that of girls (35%).
Notably, the percentages fall to an even
more dismal 8% completing the recommended minimum starting at age 12
(3% for girls).7 Because physical activity
is the strongest predictor of controlling
weight as one ages,9 these patterns of
low activity suggest a continuation of
the obesity epidemic unless substantial
changes occur.
Pediatricians take seriously the need
for children to obtain enough physical
activity to prevent or improve inappropriately high weight, as well as for
promoting cardiovascular fitness. Because pediatricians are not likely to be
in a position to directly provide physical activity to patients, they often seek
community-based resources as referrals.
However, the effectiveness of these resources may vary greatly. For example,
although local sports and recreation programs are widely available, overweight,
deconditioned, and nonathletic children
might feel threatened around more fit
and athletic peers. This might lead to
even less desire for physical activity for
them in the future. Also, many popular
sports (eg, baseball, softball, bowling)
might not provide much MVPA.
Although physical education (PE)
class during the school day provides
an obvious venue for physical activity
in elementary school students, recent
research found that only 27% of a
typical class period of 45 minutes (~12
min) is spent in MVPA.10 This is consistent with earlier findings, 11-13 and
falls significantly short of the Centers
for Disease Control and Prevention’s
recommendations of at least 50% of the
PE class period being in MVPA.14 Fewer
than 4% of elementary schools provide
daily PE, and walking or bicycling to
school and recess time have decreased.4
Although physical activity is associated
with favorable academic performance,15
school administrators have been unwilling to increase or improve PE. Thus, the
highly utilized after-school care setting
has been suggested as important for
facilitating physical activity.16
Although the provision of dedicated
time and space for physical activity
during after-school care is common,
James J Annesi, PhD, FAAHB, FTOS, FAPA, is the Director of Wellness Advancement, YMCA of
Metropolitan Atlanta and Professor in the Department of Health Promotion at Kennesaw State University
in GA. E-mail: jamesa@ymcaatlanta.org. Linda L Vaughn, MS, MBA, is Director of Wellness Initiatives at
the YMCA of Metropolitan Atlanta, GA. E-mail: lindav@ymcaatlanta.org.
48
Evidence-Based Referral: Effects of the Revised “Youth Fit 4 Life” Protocol on Physical Activity Outputs
treatments or protocols have varied
widely in terms of their supervision,
structure, and physical outputs. 16,17
They have ranged from supervised
“free play” (participation optional),
to highly structured protocols based
on accepted theoretical models of
health behavior change. Youth Fit For
Life (YFFL), first evaluated in 2005,18
was one such structured program; it
is based on tenets of social cognitive
theory19 and self-efficacy theory20 such
as building self-regulatory skills and
feelings of ability and mastery, and
utilizing social supports. It included
components of cardiovascular exercise,
resistance exercise, self-regulation skills
building (eg, goal setting, controlled
self-talk), and nutrition education.
Although elementary after-school care
treatments have often been atheoretical and lacking in significant health
outcomes, numerous studies suggested
the positive impact of YFFL on physical activity (both within and outside
of structured settings),21-23 body mass
index (BMI), 24 psychological wellbeing,25-27 and psychosocial predictors
of health behaviors.18,22,23,28 After its
validation, YFFL was made available
nationally as a program certified by the
Research-Tested Intervention Program
of the National Institutes of Health and
the National Cancer Institute (http://
rtips.cancer.gov/rtips/programDetails.do?programId = 293932), usable
within a number of community-based
venues serving elementary school-age
youths. In an effort to better tailor the
treatment processes of the Original
YFFL to specific age ranges, enhance
self-regulatory skills training, improve
participants’ nutrition behaviors, better
address overweight/obesity, and further
increase time in MVPA, a revision of the
YFFL protocol (entitled Youth Fit 4 Life
[YF4L]) was recently developed.
The present preliminary study aimed
to contrast the Revised YF4L with
typical care and the Original YFFL
on time in MVPA during elementary
after-school care, while also considering
the sex of participants. This is the first
investigation on the effects of YF4L,
which sought to extend and improve
upon YFFL by maximizing participants’
time in cardiovascular exercise, making
self-regulation skills more palatable, and
better supporting consistent nutrition
themes. Ages 9-12 were selected for
this investigation because there was a
somewhat different YF4L curriculum
for ages 5-8 and 9-12 (suggesting the
need for separate study). It was expected that the Revised YF4L treatment
would be associated with a significantly
greater duration of time in MVPA, and
significantly less time in sedentary and
light physical activities, than both the
Original YFFL treatment and typical
after-school care processes. Boys were
expected to demonstrate greater time
in MVPA, regardless of group. It was
hoped that this initial validation study
would inform revisions of the YF4L
treatment in regard to its effects on
physical activity outputs. Also, results
might provide data for pediatricians to
assess the usefulness of YF4L for referral
of their patients.
METHODS
Participants
Participants included youths, ages
9-12 years, enrolled in randomly selected elementary after-school care
programs operated by YMCA facilities
in the greater Atlanta, GA, area. Parents/
legal guardians signed written consent
forms, and participants provided verbal
assent to study staff. Institutional review
board approval was received, and processes conformed to the provisions of
the Declaration of Helsinki. An inclusion requirement was attendance in at
least 2 of the 3 monthly measurement
sessions. Data were excluded if a youth
arrived late or left early, demonstrated
inappropriate behavior, or reported an
injury. Thus, the final sample sizes for
the 1) typical after-school care processes
(Comparison, n = 46), 2) Original
YFFL protocol (n = 49), and 3) Revised
YF4L protocol (n = 43) reflected those
adjustments.
The sample size adjustments did not
significantly differ by group (χ2(df = 2)
= 1.09, p = 0.579), with a mean removal
of 26.9% of youths, overall, caused by
the above conditions. There was also
no significant group difference in age
(F2, 135 = 0.90, p = 0.410; overall mean
± SD = 9.7 ± 0.8 years), sex (χ2(df = 2)
= 2.37, p = 0.305; 51.4% girls, overall),
or ethnic grouping (χ2(df = 8) = 14.10,
p = 0.079; 31.9% white, 43.5% African American, 14.5% Hispanic, 6.5%
Asian, and 3.6% of other ethnicities,
overall). On the basis of postal zip codes
of participants’ residences, almost all
were in the middle class.
Measures
Physical activity intensity category
and time were quantified using the
Actigraph GT3X accelerometer (ActiGraph, Pensacola, FL). Consistent with
previous research,29 the monitor was
attached at the left side of the waist
with a belt, over participants’ clothing. A 30-s sampling interval (epoch)
was used to best capture activity patterns found in youths of ages 9 to 12
years.30 The accelerometer recorded 45
minutes (± 1 min) of physical activity
during each of the 3 monthly measurements. No measurements were made
in the initial week of after-school care
because the learning of new physical activity tasks associated with the present
protocols might have affected outputs
most during this time. The ActiGraph
ActiLife data analysis software, version
5.10.0 (ActiGraph, Pensacola, FL),
converted accelerometer counts into
time in sedentary, light, moderate, and
vigorous physical activity on the basis
of cut points established by Evenson,30
which were subsequently determined to
be the most accurate estimations available for ages 5 to 15 years.31 MVPA was
derived by summing the times in moderate and vigorous physical activity.
Several previous studies reported strong
interinstrument reliability of the ActiGraph accelerometer (r = 0.84-0.92).32-34
There were also significant correspondences between scores derived from
the ActiGraph accelerometer and VO2
treadmill testing (r = 0.82-0.87)34 and
doubly labeled water measurements
(r = 0.39-0.54)35 in children within
the age range of this research. It was
suggested that the ActiGraph accelerometer had the largest body of research
supporting its use.36
Procedure
YMCA-based after-school care was
administered in the same elementary
school that participants attended during
49
the school day by the existing afterschool care counselors. Regardless of
group, the school gymnasium was used
for the standard session of 45 min/day
reserved for physical activity. Study staff
secured the accelerometers to each participant’s waist. Although it was obvious
that the accelerometer assessed physical
activity, there was no coaching given
to participants or counselors by study
staff to either maximize or minimize
intensities. As far as possible, all were
kept blind to the purposes of
the study. After-school care
Competition with
counselors were generally unoneself, rather
familiar with PE instruction
than with other
methods before the trainparticipants, was
ing provided on the present
emphasized.
protocols. No counselor was
involved with more than 1
group. The number of participants per
group ranged from 10 to 18, although
not all youths present were included in
this research (owing mostly to an inability of study staff to secure written
consent from parents/guardians).
For the Comparison group, there
was no training provided to afterschool care counselors beyond information needed for supervision of physical
activity in a safe environment. This was
provided during the job orientation.
For this study, counselors were asked to
administer the physical activity component of after-school care in the manner
that was typical for them. Some participants ran, some played skill-games
in small groupings, and some engaged
in primarily sedentary pursuits. It was
also an option for participants to use the
sport or physical activity equipment (eg,
balls and jump ropes) that were stored
in the gymnasium.
For the Original YFFL group, afterschool care counselors were provided
5 hours of training in the protocol’s 4
components: cardiovascular exercise,
strength exercise (via rubber resistance
bands), behavioral skills, and nutrition.
This was supported by an instructor
manual and participant workbook that
guided program processes37 and the required apparatus (eg, balls, bean bags,
resistance bands). In addition to the
behavioral skills (eg, short- and longterm goal setting, obtaining progress
feedback, thought stopping and use of
50
productive self-talk, recruiting social
supports) and nutrition-education
components, 30 to 35 minutes was to
be dedicated to physical activity via
noncompetitive games or tasks that
were designated as either high or moderate intensity. Every attempt was to be
made to keep participants 1) active, 2)
challenging themselves, and 3) fostering feelings of mastery and self-efficacy
regarding their fitness and physical
abilities. The treatment was intended
for ages 5 to 12 years.
For the Revised YF4L group, afterschool care counselors were provided
a newly designed training of approximately 5 hours, a supporting manual,
and apparatus similar to the Original
YFFL.38 There was a separate training
manual for ages 5 to 8 years; however,
only the 9- to 12-year-old version applied here.38 Although application of
behavioral skills training and nutrition
education remained in the Revised
YF4L (in an enhanced form), the
separate strength training component
was omitted. Rather, participants’ own
body weight now replaced use of the
resistance bands in an effort to minimize
time being nearly stationary. Also, both
behavior and nutrition topics were reinforced through the use of a new array
of cardiovascular activities (ie, “content
reinforcement activities”), and new
moderate- and high-intensity tasks were
incorporated. Competition with oneself,
rather than with other participants, was
emphasized. On the basis of earlier research on the Original YFFL,21,23 behavioral skills and their associated graphics
(eg, posters, hand-outs) were intended
to better improve participants’ physical self-concept, fitness goal progress,
and self-efficacy. As with the Original
YFFL, 30 to 35 min/session was to be
dedicated to physical activities, and a
goal of attaining a mean of 25 to 30
minutes in MVPA was set.
Although the physical activity component of after-school care was five
days/week, and the Original YFFL and
Revised YF4L protocols met three days/
week and four days/week, respectively,
analyses were based on single sessions
to facilitate statistical contrasts. All
personal identifiers were removed before data analyses. Fidelity checks for
physical activity programming were
completed once every two weeks by
YMCA wellness staff using a structured
observation form. Any problems were
quickly resolved in association with
the after-school counselor’s supervisor.
Data Analyses
To detect the moderate effect size
found in related analyses and pilot
research39 at the statistical power of
0.80, an overall minimum sample size
of 117 was required.40 The significance
level was set at α = 0.05 (2-tailed). It
was previously suggested that 3 accelerometer measurements foster accuracy in assessing physical activity
outputs in youth.41 Thus, after using
the expectation-maximization algorithm for imputation of missing data
of no more than 1 of the 3 monthly
measurements,42 the mean number of
minutes in each physical activity category (ie, sedentary, light, moderate,
and vigorous) was calculated. There was
no significant difference in scores based
on date of measurement for any of the
physical activity categories.
For the primary analysis, a 2-way between-subjects analysis of variance of 3
(groups) × 2 (sexes) was used to contrast
the Comparison, Original YFFL, and
Revised YF4L groups; boys and girls;
and their interaction on mean number
of minutes in MVPA. Post hoc followup tests using the Least Significant
Difference method were incorporated
for pairwise contrasts. Supplementary
analyses were also completed on each of
the 4 separately measured physical activity intensity categories (ie, sedentary,
light, moderate, and vigorous) in the
same manner. Effect sizes were expressed
as partial eta-square (η2p) where 0.01,
0.06, and 0.14 denote small, moderate,
and large effects, respectively.
RESULTS
Primary Analysis
For MVPA, the main effect for treatment group was significant (F2, 132 =
281.20, p < 0.001, η2p = 0.17). The
main effect for sex was also significant
(F2, 132 = 16.43, p < 0.001, η2p = 0.11).
There was not a significant group × sex
interaction (F2, 132 = 0.54, p = 0.582,
η2p = 0.01). Descriptive statistics and
results of all pairwise post hoc analyses
are given in Table 1.
Supplementary Analyses
For sedentary time, the main effect
for treatment group was significant
(F2, 132 = 5.57, p = 0.005, η2p = 0.08). The
main effect for sex was not significant
(F2, 132 = 1.91, p = 0.169, η2p = 0.01).
There was not a significant group × sex
interaction (F2, 132 = 0.21, p = 0.813,
η2p = 0.003).
For light physical activity, the main
effect for treatment group was not significant (F2, 132 = 2.08, p = 0.130, η2p
= 0.03). The main effect for sex was
significant (F2, 132 = 4.81, p = 0.030,
η2p = 0.04). There was not a significant
group × sex interaction (F2, 132 = 0.29,
p = 0.748, η2p = 0.004).
For moderate physical activity, the
main effect for treatment group was
not significant (F2, 132 = 2.52, p = 0.085,
η2p = 0.04). The main effect for sex was
significant (F2, 132 = 12.01, p = 0.001,
η2p = 0.08). There was not a significant
group × sex interaction (F2, 132 = 1.05,
p = 0.354, η2p = 0.02).
For vigorous physical activity, the
main effect for treatment group was
significant (F2, 132 = 24.13, p < 0.001,
η2p = 0.27). The main effect for sex
was also significant (F2, 132 = 10.04,
p = 0.002, η2p = 0.07). There was not
a significant group × sex interaction
(F2, 132 = 0.37, p = 0.692, η2p = 0.01).
Table 1. Minutes in physical activity intensity categories, by group and
participants’ sex
Boys
Mean ± SD (n)
Group
Moderate-to-vigorous physical activity
Comparison
13.51 ± 5.57 (21)
Original YFFL
14.70 ± 3.46 (28)
Revised YF4L
17.48 ± 4.76 (18)
Overall
15.07* ± 4.75 (67)
Sedentary time
Comparison
11.23 ± 6.69 (21)
Original YFFL
10.12 ± 5.19 (28)
Revised YF4L
7.80 ± 3.05 (18)
Overall
9.84 ± 5.36 (67)
Light physical activity
Comparison
20.26 ± 6.66 (21)
Original YFFL
21.01 ± 2.84 (28)
Revised YF4L
19.67 ± 4.95 (18)
Overall
20.42 ± 4.83 (67)
Moderate physical activity
Comparison
9.54 ± 4.23 (21)
Original YFFL
8.76 ± 2.00 (28)
Revised YF4L
9.98 ± 2.68 (18)
Overall
9.33* ± 3.03 (67)
Vigorous physical activity
Comparison
3.97 ± 2.33 (21)
Original YFFL
5.94 ± 2.42 (28)
Revised YF4L
7.50* ± 3.17 (18)
Overall
5.74 ± 2.91 (67)
Girls
Mean ± SD (n)
Overall
Mean ± SD (n)
9.25 ± 6.32 (25)
11.43 ± 3.69 (21)
15.29 ± 3.43 (25)
12.02 ± 5.32 (71)
11.19a ± 6.30 (46)
13.30a ± 3.88 (49)
16.20b ± 4.14 (43)
13.50 ± 5.26 (138)
12.99 ± 6.69 (25)
10.60 ± 4.23 (21)
9.19 ± 2.69 (25)
10.94 ± 5.06 (71)
12.19a ± 6.68 (46)
10.32 ± 4.76 (49)
8.61b ± 2.90 (43)
10.41 ± 5.22 (138)
22.49 ± 3.42 (25)
22.93 ± 4.50 (21)
20.52 ± 3.91 (25)
21.93*± 4.02 (71)
21.47 ± 5.22 (46)
21.83a ± 3.73 (49)
20.16b ± 4.34 (43)
21.19 ± 4.48 (138)
6.54 ± 4.54 (25)
7.33 ± 2.69 (21)
8.75 ± 2.03 (25)
7.55 ± 3.38 (71)
7.91a ± 4.61 (46)
8.15a ± 2.40 (49)
9.26b ± 2.38 (43)
8.42 ± 3.33 (138)
2.71 ± 1.99 (25)
4.10 ± 1.88 (21)
6.54 ± 2.93 (25)
4.47 ± 2.83 (71)
3.28a ± 2.22 (46)
5.15b ± 2.37 (49)
6.94c ± 3.03 (43)
5.09 ± 2.93 (138)
A different letter superscript adjacent to the mean score (a, b, or c) within the same measure denotes a
statistically significant difference within the post hoc test among the 3 groups (Comparison, Original Youth Fit For
Life [YFFL], Revised Youth Fit 4 Life [YF4L]). For example, in the moderate-to-vigorous physical activity measure,
the Comparison and Original YFFL groups did not significantly differ from each other, but the Revised YF4L group
did significantly differ from both.
An asterisk (*) within the same measure denotes a significantly greater score, by sex.
DISCUSSION
The Revised YF4L treatment was
associated with a significantly greater
duration of time in accelerometermeasured MVPA when contrasted
with typical after-school care and the
Original YFFL protocol. This is an
important finding because numerous
studies suggested the positive effects
of the original theory-based protocol
on various health behaviors and their
psychosocial predictors.18,22-28 For the
Revised YF4L, sedentary time was
also significantly less than with typical
after-school care processes. Consistent
with other research,7 boys were more
active than girls. Although there was
no treatment × sex interaction found,
future research should integrate and
evaluate intervention components that
might increase MVPA specifically for
girls (possibly by incorporating modes
of activity that might be especially appealing to them).
Although it was above the typical
proportion of MVPA/overall time in PE
class previously reported for elementary
school ages,10-13 the goal of 25 to 30 minutes/day in MVPA was not attained. Approximately one-third of the treatment
time presently spent in light physical activity and sedentary time (~9 min/day)
would need to be converted to moderate
and/or vigorous activity to attain that
goal. Although an attempt was made
to reinforce the learning of behavioral
skills and nutrition information through
physical activities, such activities might
also be extended to the time during the
learning process itself to increase total
time in MVPA in the future.
Limitations
Although various ethnicities were
represented, future research should
evaluate the benefit of YF4L specifically in underrepresented and minority
groups, who also tend to have the greatest health risks.1 Replication should also
be completed on the YF4L version for
ages 5 to 8 years. Although limitations
included a lack of data on 1) psychosocial mediators of MVPA; 2) effects on
BMI, nutrition, and changes in MVPA
outside of the programs, and 3) expectation effects (eg, Hawthorne effect;
51
Rosenthal effect),43 these initial findings on the Revised YF4L protocol in
elementary after-school care were informative. Additional validation research is
now required to evaluate effects of YF4L
on BMI and psychosocial factors. Also,
because resistance training was omitted
in the new YF4L curriculum (except for
some body weight resistance incorporated within the increased cardiovascular
exercise time), favorable benefits related
to muscle mass and muscular strength
gains might have been reduced.
CONCLUSION
It is hoped that, ultimately, widespread dissemination of evidence- and
theory-based protocols such as YF4L
will allow pediatricians to have confidence in referring patients in need of
programs for increasing their MVPA
and, possibly, normalizing their BMI.
Involvement from physicians in matters of health behavior change is increasingly warranted and could have
immense pay-offs for the future health
of the nation. v
disclose.
Acknowledgments
We acknowledge Sarah Samter and Brittney
Greenwood for their expertise provided in
the data collection phase of this study. We
also acknowledge contributions provided on
protocol development by the staff of Children’s
Healthcare of Atlanta.
assistance.
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Exercise
Nothing is to be found that can substitute for exercise in any way … .
Exercise will expel the harm done by most of the bad regimens
that most men follow. Not all motion is exercise. Exercise is
powerful or rapid motion or a combination of both, vigorous
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philosopher, astronomer, Torah scholar, and physician
53
Relationship between Participation in Patient- and Family-Centered Care
Training and Communication Adaptability among Medical Students:
Changing Hearts, Changing Minds
Lisa Rossignol, MA
Perm J 2015 Summer;19(3):54-58
ABSTRACT
Background: Patient- and family-centered care (PFCC)
training is an important component of many medical school
curricula in the US.
Purpose: To determine if an existing quantitative measure of
communication adaptability can be used to determine skills
acquired by medical students after PFCC training.
Methods: A census was conducted of 43 third-year medical
students at the University of New Mexico School of Medicine,
Albuquerque, NM. Students participated in the Families as
Faculty program of Parents Reaching Out during their pediatric
rotation. A pretest and posttest of Duran’s 1983 Communicative Adaptability Scale was performed.
Results: A one-way analysis of variance was conducted and
revealed that there was statistical significance for the factor
called appropriate disclosure (p = 0.04). When mean plot was
conducted, there was a positive correlation between pretest
and posttests in social experience, wit, and social confirmation. There was a negative correlation for articulation and
social composure, which was not significant.
Conclusion: The Communicative Adaptability Scale was an
effective way to evaluate communication skills that students
acquire from PFCC training. An increase in appropriate disclosure is an important gain because it means students have
become more sensitive to the level of intimacy that the other
person is seeking and the student is willing to offer more
information. Information sharing is one of the core concepts
of PFCC. Finally, the negative correlation for articulation
and social composure indicate that Families as Faculty may
increase anxiety for medical students, so this is an area of the
education that may need to be revisited.
INTRODUCTION
This study seeks to determine if a standardized measurement
of communicative adaptability can be used to evaluate skills
taught to medical students after patient- and family-centered
care (PFCC) training. PFCC care ensures the health and
well-being of children and their families through a respectful professional-family partnership. It honors the strengths,
cultures, traditions, and expertise that everyone brings to this
relationship. According to the US Maternal and Child Health
Bureau Division of Services for Children with Special Health
Needs, family-centered care is the standard of practice that
results in high-quality services.1
The University of New Mexico in Albuquerque, NM, uses
the services of these two programs: Families as Faculty (FAF),
which is a division of Parents Reaching Out, a statewide nonprofit interested in advocacy for individuals with disabilities,
and the New Mexico Leadership Education in Neurodevelopmental and Related Disabilities, located at the university’s
Center for Development and Disability. Families that have a
child with a disability welcome a medical student from the
University of New Mexico into their home for an informal
visit, in which the family members talk openly about their
collective experience with various practitioners and medical
systems. The goal is that medical students gain insight into
how families function and how they feel about health care,
which leads to the acquisition of communication skills that
deliver greater expressions of respect and dignity, information
sharing, participation, and collaboration.2
Despite several attempts by other universities to study
PFCC training, there has been little success in articulating
what students are learning or how they are being professionally
transformed. Because PFCC training is delivered through the
mode of verbal and nonverbal communication from health
care workers, PFCC education would influence how students
communicate. This study seeks to determine if an existing
construct, the Communicative Adaptability Scale (CAS), is an
effective tool to evaluate whether students acquire the ability
to communicate more effectively because of PFCC training.
LITERATURE REVIEW
The purpose of this literature review is to build the theoretical groundwork for evaluating what effect PFCC education
has on the communication adaptability that medical students
use with patients when they become physicians. This study is
an effort to corroborate the expectations of these programs or
to produce recommended modifications to the programs or
future studies. As knowledge of the concepts of PFCC grow
in popularity among hospital administrators, there continues
to be very little study about the effectiveness of educational
programs on this topic. There has been limited success in
capturing any data about PFCC education and the impact it
Lisa Rossignol, MA, is the current Fellow at the Georgetown Leadership Academy in Cultural Competence and Cultural
and Linguistic Diversity in Santa Fe, NM. She served for two years on the Patient Centered Outcomes Research Initiative
Improving Healthcare Systems Advisory Board, and is now serving as Parent Liaison to the American Academy of
Pediatrics’ Council on Quality Improvement and Patient Safety. NM. E-mail: lnrossignol@gmail.com.
54
Relationshipbetween
Participation
inPatientandFamily-Centered
CareTraining
andTraining
Communication
Relationship
between
Participation
in Patientand Family-Centered
Care
and AdaptabilityamongMedicalStudents:ChangingHearts,ChangingMinds
Communication Adaptability among Medical Students: Changing Hearts, Changing Minds
has on professional-family communication. Cegala and Broz3
posit that of the physician training research that has been
conducted, “Less than 30% of the studies … had a design
adequate for assessing the effects of training interventions
… .” If PFCC training is not working in the manner that is
expected, it may be necessary to modify education programs
or to abandon initiatives altogether.
In exploring this question, it is important to look at a
study that has examined the population of college students
for relationships between communication adaptability and
intercultural apprehension. Duran4 defines communication
adaptability as “the ability to perceive socio-interpersonal
relationships and adapt one’s interaction goals and behaviors accordingly.” Intercultural apprehension is defined as
follows: “One’s level of fear or anxiety associated with interacting with people of different cultures and ethnic and/
or racial groups.”5
Long and Anarbaeva6 used the CAS, which has a high interitem reliability (α = 0.948), and the Personal Report of Intercultural Communication Apprehension, which also has a high
interitem reliability (Cronbach α = 0.941).7 The questionnaire
was completed by 124 graduate and undergraduate students
between the ages of 18 and 45 years. A strong relationship
between the 2 variables was revealed. Long and Anarbaeva
concluded: “As communicative adaptability increased, intercultural communication apprehension decreased.” This study
showed that a clear relationship exists between communication adaptability and intercultural apprehension.
Next, intercultural communication must be linked to
physician-patient relationships. Manderson and Allotey8
defined intercultural or cross-cultural communication as
the “conveying of information and the response to the information in an interaction between members from different
cultures.” They proposed that “In the clinical interaction, this
occurs between individuals from a culture of health professionals and individuals who fall into the category of ‘patient’ or ‘sick
client.’” Manderson and Allotey suggested that the greatest
deficit of the prevailing participatory decision-making model8,9
is that it lacks an education component for the physician. The
participatory decision-making model supposes that the clinician might employ variations of education for the patient but
does not factor the demand for a physician to be educated by a
patient with a different cultural background and belief system.
“These influences affect the development of a sense of the other’s
competence, the practitioner’s sense of the patient’s ability to
comply with treatment, and the practitioner’s ability to deliver
effective treatment.”8
In a study designed to monitor the long-term reproductive health issues of African and Middle Eastern refugees in
Australia, researchers studied 150 women by using quantitative instruments, focus groups, and interviews. They wrote,
“Twenty percent specifically raised issues of communication
difficulties with the health services, which included the lack
of availability of interpreters, the practitioner giving them
information that they perceived to be inappropriate, and an
inability of doctors to ‘hear what they were being told.’”10
Despite the women being from diverse ethnic, economic,
and religious backgrounds, there was a “strong perception of
discrimination, miscommunication and poor quality service
provision within health and welfare agencies.”
Hamilton11 continued the evaluation of the participatory
decision-making model of physician-patient interaction. This
model is taught in most Western universities and assumes
that patients “both linguistically and culturally are equipped
to engage in a discussion with their doctor about diagnosis
and treatment, working together to develop a treatment
management plan.” As was discussed by Manderson and Allotey, patients represent their own culture, which might not
benefit from this traditional model.8 Hamilton proposed that
effective communication by practitioners would require “…
multiple models to accommodate cultural and other differences in their patients.”11
Franck and Callery12 conducted an extensive, critical literature review of all PFCC literature in an attempt to find
operational definitions, themes, constructs, and empirical
indicators. The authors found inconsistency in definition of
terms and in the practical application of PFCC throughout
various systems. The largest deficit cited was that “health professionals’ judgments about the credibility of mothers’ reports
sometimes led them to dismiss important assessments.” Franck
and Callery were unable to find any evidence that education
in PFCC concepts has led to any acquisition of skills and
suggested that the construct of partnership “should lead to
the concept of shared decision-making and subconcept of
participation in decision-making.”
Another study looked at cultural competency, intercultural
communication, and family-centered care even more specifically by examining the experience of professionals working with
children with special health care needs and their parents.13 The
professionals studied were participants in the Virginia Leadership Education in Neurodevelopment and Related Disabilities
program. Participants completed the program between 1996
and 2006 and had been working in their discipline for at least
1 year. The Measure of Processes of Care for Service Providers
was used.14 The device contained 27 questions on a Likert-style
scale that represented 4 factors of family-centered care: 1) showing interpersonal sensitivity, 2) providing general information,
3) communicating specific information about the child, and
4) treating people respectfully. Researchers also included a
qualitative question: “What have been the greatest barriers
to family-centered care in your occupation?”
Thirty-three graduates of the Virginia Leadership Education in Neurodevelopment and Related Disabilities program
replied to the survey, resulting in the identification of five
major qualitative themes: 1) institutional culture, 2) absence
of a care coordinator, 3) insufficient training in intercultural/
interpersonal communication skills, 4) policy factors, and 5)
family factors. Quantitative results showed that “interdisciplinary professionals were providing care consistent with the
principles of PFCC in the areas of treating people respectfully,
communicating specific information to families, and showing
interpersonal sensitivity.” The study recognized the very small
population of respondents and suggested that only those who
were actively engaged in PFCC practices responded. Lotze
55
Relationship between Participation in Patient- and Family-Centered CareTrainingRelationship
and Communication
Adaptability
among
Changing Hearts,
Changing
Minds
between
Participation
in Medical
Patient- Students:
and Family-Centered
Care
Training
and
et al13 also recognized that no data from practitioners existed
before they attended in-depth PFCC training.
Finally, Johnson et al15 addressed the effectiveness of familycentered care education of medical students at the University
of Vermont College of Medicine, Burlington, VT. That program was the template for the FAF program, which Parents
Reaching Out and the University of New Mexico School
of Medicine have used since 1997. When the University of
Vermont medical students completed a visit with their family faculty, they were asked to complete and submit a paper
on “what they learned from the family and how that might
influence their practice in the future.” Three reviewers completed a pilot study that consisted of 45 papers collected from
July 2001 to June 2002 in order to establish a set of themes.
Then, a fourth, independent reviewer was given the task of
reviewing 58 papers that were completed between July 2002
and June 2003 using the categories provided by the pilot
study. An early theme that was found concerned the issues
the families had with physicians; this theme was broken into
14 categories—all consisting of communication failures. The
top 2 most frequent themes were collaboration with families
and listening. The authors proposed that an evaluation of
the application of communication skills resulting from this
program would be an interesting study.
Collectively these studies indicate a need for establishing
measurements for the skill acquisitions that may result from
PFCC training. Although the CAS has been used in very
limited studies, the strong relationship it showed to intercultural apprehension7 makes it a desirable device for evaluating
PFCC training.
The hypothesis of the current research is that PFCC training will result in increased communicative adaptability by
medical students.
numbers were then entered into a chart that sorted the scores
into 6 categories: social experience (the ability to take skills
learned from previous encounters to improve future social
exchanges and enjoy new and challenging social interactions);
wit (skillful, intellectual humor); social composure (a speaker
who appears to be calm and composed); articulation (an
ability to speak clearly and to choose words appropriately);
social confirmation (the ability to appropriately gauge what
another person needs from an interaction); and appropriate disclosure (an ability to divulge or withhold appropriate
amounts of personal information). Students were not provided
with a space for any identifying information or demographic
information for this study.
After completion of the FAF seminar, the medical students
were given the same survey. The posttest was administered,
in paper form, at the end of the debriefing session at Parents
Reaching Out. Again, subjects were not provided space for
any demographic information such as sex, race, or age.
METHODS
RESULTS
After an extensive literature review, I concluded that there
was a need to establish measurements for the skill acquisitions
that may result from PFCC training for medical students. The
CAS has been used in very limited studies, but it has a high reliability and has been used in university students by Long and
Anarbaeva,7 making it a strong device for measuring PFCC
education programs. Although there are several newer, valid
instruments for physicians who practice medicine, there has
been little work looking directly at medical school education
in PFCC or communication training and skills.
A census was conducted of 71 medical students in their
third year at the University of New Mexico School of Medicine
beginning in August 2011 through August 2012. There was a
100% voluntary participation rate. Students participated in
Parents Reaching Out’s FAF program during their pediatric
rotation. A pretest was administered, in paper form, to medical
students during their orientation into the FAF training at the
University of New Mexico Hospital, Albuquerque, NM. The
pretest used the CAS, which has a high interitem reliability
(α = 0.948). The participants were asked to rate themselves
with 30 Likert-style statements, with answers from 1 to 5,
with 1 being “least likely” and 5 being “most likely.” The
56
Table 1. Impact of medical students’ training in patientand family-centered care on factors of Communicative
Adaptability Scale
Factor
Social experience
Wit
Social composure
Articulation
Social confirmation
Appropriate disclosure
df
1, 84
1, 84
1, 84
1, 84
1, 84
1, 84
F ratio
1.60
1.48
0.01
0
1.89
4.39
p valuea
0.21
0.23
0.91
0.96
0.64
0.04
One-way between-groups analysis of variance, with significance < 0.05.
df = degrees of freedom.
a
A one-way between-groups analysis of variance was conducted to explore the impact of PFCC training on medical
students as measured by the CAS. Questionnaires were divided
into pretest and posttests, and means were compared on the
6 factors: social experience, wit, social composure, articulation, social confirmation, and appropriate disclosure. There
was statistical significance at the p < 0.04 for appropriate
disclosure shown in Table 1.
A mean plot was conducted on each of the six factors, which
revealed a positive correlation between pretest and posttests
for each factor except for social composure and articulation,
which illustrated negative slopes (not significant).
DISCUSSION
The CAS questionnaire is a moderately effective way to
evaluate communication skills that students acquire from
PFCC training. An increase in appropriate disclosure is an
important gain because it means students have likely become
more sensitive to the level of intimacy that the other person is
seeking and the student is willing to offer more information.
Information sharing is one of the core concepts of PFCC, so
gains in this factor are important.
Relationshipbetween
Participation
inPatientandFamily-Centered
CareTraining
andTraining
Communication
Relationship
between
Participation
in Patientand Family-Centered
Care
and AdaptabilityamongMedicalStudents:ChangingHearts,ChangingMinds
One possibility is that students learn the importance of articulating their own values about patients and families aloud.
During the FAF presentation, the facilitator displayed a value
statement that said, “We believe all families care deeply about
their children” and continued to discuss the importance of
articulating, to families, that physicians share these values.
The values expressed by PFCC seem to be commonsense,
but patients and families may not believe that physicians
hold these ideas.
Conversely, FAF may increase anxiety for medical students. Although not statistically significant, the mean plots
did show a negative shift of skills relating to comfort with
communicating and the ability to express ideas clearly. This
area of the education may need to be revisited. One possible
explanation for the rise in anxiety levels about communicating
could stem from a new understanding that, to be successful,
the students will have to become more intimate with some
patients who desire interactions that are more intimate. The
medical school curriculum does not necessarily provide instruction on ways to communicate with diverse populations
of patients and families.
Study Limitations
The population size of this study was very small because
the University of New Mexico only admits 60 to 75 students
per year to the School of Medicine, so there is very little
opportunity to increase the study population unless other
universities that use FAF programs participate. At such a
small size, it is difficult to assess outcomes of FAF training,
on 6 factors, accurately. It is possible that a larger study could
reveal more statistical significance between the pretest and
posttest. Also, because this is a census of all medical students
at the University of New Mexico’s School of Medicine in their
third year and pediatric rotation, this information cannot be
generalized to any other population. However, as a steppingstone to more robust, substantial studies into medical school
education, this study provides an important contribution to
the medical literature.
The construction of this specific PFCC training may also
be a factor in the outcome of this study. Although the speakers at the one-hour FAF orientation were almost always the
same, the host families where students went were diverse in
socioeconomic, racial, religious, and ethnic backgrounds.
Future studies may need to conduct research into the type of
messages that are being delivered via the host families. Perhaps
the messages students are receiving are negative or hostile toward physicians, and that accounts for the negative tendency
of posttest scores on the articulation and social composure
elements. Evaluating the messages of host families may allow
future researchers to control and test different styles of messaging or content during family visits to determine whether
family stories have an impact on student experience.
Possible confounding that may have occurred is additional
PFCC training that students received from attending physicians and other residents during their pediatric rotation.
Further study would be beneficial into the other types of
PFCC training the students are receiving during
this rotation or other rotations.
It is possible that students are receiving negative
guidance from other staff that suggests communicating with families is not a high priority and that
they will be penalized for spending too much time
chatting with patients. Despite the possibility of
contrary messages, this study documents that students are experiencing alterations in the way they
perceive and adapt to what the other person needs
from a communication interaction, which is a strong
showing for a training program that is designed to
improve how physicians and patients work together.
The values
expressed
by PFCC
seem to be
commonsense,
but patients
and families
may not
believe that
physicians hold
these ideas.
CONCLUSION
Future studies may seek to link CAS scores with other
measures, such as patient satisfaction scores or safety data. It
is important to understand that this study was not intended
to study physicians who are already practicing, but it may
prove useful to link CAS scores with future performance of
physicians once they have set up their own practice.
Finally, the ultimate goal of this study was to link existing,
highly reliable communication research measures to health
care research. In the past few decades, physicians have begun
to see the benefit of employing communication scholars in
research that involves interaction and messaging. This notion is not to say that physicians are not capable of successful
research involving communication, but that their work can
only be strengthened by interdisciplinary collaboration with
scholars who have the ability to provide new insight into
interactions and relational dynamics. v
Acknowledgment
The author would like to thank Judith White, PhD, Associate Professor
at the University of New Mexico Department of Communication and
Journalism, for her support and guidance. I would also like to acknowledge
Jan Winslow and Cathy Salazar from Parents Reaching Out and Lourdes
Vizcarra, MD, from the University Of New Mexico Continuum of Care
for allowing me to conduct this study. I would also like to acknowledge
Judith Hendry, PhD, Faculty at the University of New Mexico Department
of Communication and Journalism, for inspiring this paper. I would like
to acknowledge my mentor, Tanya Baker McCue and Bryan Wilcox for
reviewing earlier versions of this paper.
This paper was presented at The 5th International Conference on Patientand Family-Centered Care, June 5, 2012, in Washington, DC.
References
1. Maternal and Child Health Bureau [Internet]. [cited 2015 Mar 18]. Available from:
http://mchb.hrsa.gov/chscn/pages/family.htm.
2. Institute for patient- and family-centered care [Internet]. Bethesda, MD: Institute
for Patient- and Family-Centered Care; c2014 [cited 2014 Aug 1]. Available
from: www.ipfcc.org/faq.html.
3. Cegala DJ, Broz SL. Provider and patient communication skills training. In:
Thompson TL, Dorsey A, Miller KI, Parrott R, editors. Handbook of health
communication. Mahwah, NJ: Lawrence Erlbaum Associates, Inc; 2003.
p 95-119.
57
Relationship between Participation in Patient- and Family-Centered CareTrainingRelationship
and Communication
Adaptability
among
Changing Hearts,
Changing
Minds
between
Participation
in Medical
Patient- Students:
and Family-Centered
Care
Training
and
4. Duran RL. Communicative adaptability: a measure of social communicative
competence. Commun Q 1983;31(4):320-6. DOI: http://dx.doi.
org/10.1080/01463378309369521.
5. Neuliep JW, Ryan DJ. The influence of intercultural communication
apprehension and socio-communicative orientation on uncertainty reduction
during initial cross-cultural interaction. Commun Q 1998;46(1):88-99. DOI: http://
dx.doi.org/10.1080/01463379809370086.
6. Long B, Anarbaeva S. Communicative adaptability and intercultural
communication apprehension: gender and cultural differences in college
students [conference paper]. National Communication Association 94th Annual
Convention; 2008 Nov 21-24; San Diego, CA. Washington, DC: National
Communication Association; 2008 Jan. p 1.
7. Neuliep JW, McCroskey JC. The development of intercultural and interethnic
communication apprehension scales. Commun Res Rep 1997;14(2):145-56.
8. Manderson L, Allotey P. Cultural politics and clinical competence in Australian
health services. Anthropol Med 2003;10(1):71-85. DOI: http://dx.doi.
org/10.1080/13648470301266.
9. Kaplan SH, Greenfield S, Gandek B, Rogers WH, Ware JE Jr. Characteristics of
physicians with participatory decision-making styles. Ann Intern Med 1996 Mar
1;124(5):497-504. DOI: http://dx.doi.org/10.7326/0003-4819-124-5-19960301000007.
10. Allotey P, Manderson L, Grover S. The politics of female genital surgery in
displaced communities. Crit Public Health 2001;11(3):189-201. DOI: http://
dx.doi.org/10.1080/09581590110066649.
11. Hamilton J. The collaborative model of doctor-patient consultation—is it always
culturally appropriate? What do doctors and patients need to know to make it
work in intercultural contexts? Med Teach 2009 Feb;31(2):163-5. DOI: http://
dx.doi.org/10.1080/01421590802530914.
12. Franck LS, Callery P. Re-thinking family-centred care across the continuum
of children’s healthcare. Child Care Health Dev 2004 May;30(3):265-77. DOI:
http://dx.doi.org/10.1111/j.1365-2214.2004.00412.x.
13. Lotze GM, Bellin MH, Oswald DP. Family-centered care for children with special
health care needs: are we moving forward? J Fam Soc Work 2010;13(2):100-13.
14. Woodside JM, Rosenbaum PL, King SM, King GA. Family-centered service:
developing and validating a self-assessment tool for pediatric service
providers. Child Health Care 2001;30(3):237-52. DOI: http://dx.doi.org/10.1207/
S15326888CHC3003_5.
15. Johnson AM, Yoder J, Richardson-Nassif K. Using families as faculty in
teaching medical students family-centered care: what are students learning?
Teach Learn Med 2006 Summer;18(3):222-5. DOI: http://dx.doi.org/10.1207/
s15328015tlm1803_6.
The Move to Touch
A practitioner of experience does not seize the patient’s forearm with his hand
as soon as he comes, but first sits down and with a cheerful countenance asks
how the patient finds himself; and if the patient has any fear, he calms him
with entertaining talk, and only after that moves his hand to touch the patient.
— De Medicina, Aulus Aurelius Cornelius Celsus, c 25 BC – c 50 AD, Roman encyclopaedist
58
A Ten-Year Case-Control Study of Passive Smoke Exposure
as a Risk Factor for Pertussis in Children
Mark A Schmidt, PhD, MPH; Samantha K Kurosky, MS; John P Mullooly, PhD; Colleen Chun, MD; Sheila Weinmann, PhD
Perm J 2015 Summer;19(3):59-63
ABSTRACT
Context: Passive exposure to cigarette smoke in the household as a risk factor for
pertussis disease has not been well characterized.
Objective: To determine whether pertussis was associated with household secondhand smoke in children.
Methods: We conducted a matched case-control study of laboratory-confirmed
pertussis cases occurring from January 1, 1996, through December 31, 2005, in
children up to 12 years of age who were members of a large managed care organization. Controls were matched one-to-one on age group and type of Health Plan
account. Passive cigarette smoking was determined through a retrospective review
of the medical records of cases, controls, and their respective household members.
Main Outcome Measures: Cases of pertussis infection were identified from
a microbiology laboratory database and through diagnostic codes from the
International Classification of Diseases, Ninth Revision, with the diagnosis confirmed
by culture or polymerase chain reaction.
Results: Sixty-five laboratory-confirmed cases of pertussis were identified. Cases
and controls were similar in sex (p = 0.73), race (p = 0.57), and receipt of pertussis antigen-containing vaccine (p = 0.24). Using multivariable conditional logistic
regression analysis, we did not detect a statistically significant association between
pertussis and household passive exposure to cigarette smoking (adjusted odds ratio
= 1.2; 95% confidence interval = 0.5-2.9).
Conclusion: Although we did not detect an association in this analysis, the possible relationship between passive exposure to smoking and childhood pertussis
remains an important research question and should be a priority for future studies.
INTRODUCTION
Pertussis, or whooping cough, is a
respiratory tract infection and a major
public health burden because of its high
infectivity and severe manifestations
among infants. Pertussis is caused by
the bacterial species, Bordetella pertussis, which is transmitted from person to
person via aerosolized droplets. Rates
of childhood immunization against
pertussis in the US are high, with more
than 83% of children younger than
age 3 years having received 4 doses of
pertussis antigen-containing vaccine.1
However, children too young to be
fully immunized, older underimmunized children, and immunized teenagers and adults with waned immunity
are at risk of pertussis infection acquired from symptomatically infected
individuals. Whereas adolescents and
adults may have a relatively mild illness,
pertussis in infants is particularly severe. According to the Centers for Disease Control and Prevention in 2011,
infants younger than age 2 months
who were too young to be immunized
accounted for 57% of all infant hospitalizations and 85% of all infant deaths
due to pertussis in the US.2
Passive cigarette smoke exposure
(PSE) in the household as a possible
risk factor for pertussis infection among
children has not been well characterized in the literature. Our prior work
investigating the impact of PSE on
pneumococcal infection3 prompted us
to conduct a case-control study within
the population of a large managed care
organization to compare household
smoking exposure histories recorded in
the electronic medical record (EMR)
of pediatric pertussis cases with those
of matched controls.
METHODS
We conducted our study among the
member population of the Kaiser Permanente Northwest (KPNW) Health
Plan, using a similar protocol and the
same control group described for our
investigation of PSE as a risk factor for
invasive pneumococcal disease.3 We
selected pertussis cases occurring from
January 1, 1996, through December 31,
2005, among KPNW members from
birth through age 12 years. Potential
cases were identified from either of the
following: 1) a microbiology laboratory
database as having pertussis confirmed
by culture, direct fluorescent-antibody
testing, or polymerase chain reaction or
2) the EMR as having a pertussis-related
code from the International Classification of Diseases, Ninth Revision (ICD-9;
033, 033.0, 033.8, 033.9, and 484.3).
When ICD-9 codes were used for case
identification, we manually reviewed
the EMR to exclude those without
documented laboratory confirmation
of pertussis infection.
Mark A Schmidt, PhD, MPH, is a Research Associate for the Center for Health Research Northwest in Portland, OR.
E-mail: mark.a.schmidt@kpchr.org. Samantha K Kurosky, MS, is a Research Associate for the Center for Health Research
Northwest in Portland, OR. E-mail: skurosky@rti.org. John P Mullooly, PhD, is an Emeritus Senior Investigator for the
Center for Health Research Northwest in Portland, OR. E-mail: mullooly@comcast.net. Colleen Chun, MD, is a Pediatric
Infectious Disease Specialist for Northwest Permanente and a Professor of Infectious Diseases at Oregon Health and
Science University in Portland, OR. E-mail: colleen.chun@kp.org. Sheila Weinmann, PhD, is an Investigator for the
Center for Health Research Northwest in Portland, OR. E-mail: sheila.weinmann@kpchr.org.
59
A Ten-Year Case-Control Study of Passive Smoke Exposure as a Risk Factor for Pertussis in Children
Where possible, we used our control
population from the study of invasive
pneumococcal disease. Among this
group, we determined which potential controls were closest in age to our
cases on their “reference date,” defined
as the collection date of the pertussispositive specimen from the case, and
matched 1 control to each pertussis
case, by age group (0-2, 3-5, and 6-12
years) and type of Health Plan account.
We matched controls and cases on the
basis of the reference date to avoid
confounding the relationship between
smoking exposure and pertussis occurrence by secular changes in pertussis incidence and capture of smoking
history within the EMR. Because the
study design involved collecting PSE
information from the EMR of family
members if available to us, we matched
group members based on Health Plan
account (child plus family members
or child alone) to equalize our access
to the family member’s EMR between
cases and their matched controls. For
11 pertussis cases without a suitable
control from this control population,
we randomly selected 1 control for each
case from the KPNW member population, using the same criteria.
We reviewed the health records of
all cases and new controls, plus the
records of their family members where
available, to collect PSE history, using
standardized data collection instruments. We categorized each case and
control as definitely exposed, probably exposed, probably not exposed,
definitely not exposed, or unknown
(Table 1). For all cases and controls,
we collected information about receipt of pertussis antigen-containing
vaccines before the collection date of
the pertussis-positive specimen (cases)
or equivalent reference date (controls)
through electronic abstraction of the
Vaccine Safety Datalink vaccine dataset.4,5 We defined vaccine exposure as
“vaccinated” if the subject had received
Table 1. Categorization of passive household smoking exposure for pertussis
cases and matched controls
Category of exposure
Definitely exposed
Probably exposed
Probably not exposed
Definitely not exposed
Unknown
60
Definition
One or more persons in the household (including babysitter) smokes,
recorded within two years of the reference date (RD). No conflicting
information from family members’ charts. No mention in the child’s
record that adults smoke outside.
Conflicting information on smoking in the household, but at least one
record that someone in the household smokes, or
Meets criteria for “definitely exposed” but the child’s record mentions
that adults smoke outside. Evidence must show that all adults in the
household smoke outside for the child to be classified as “probably
exposed” rather than “definitely exposed,” or
Meets criteria for “definitely exposed” except that the only available
information is recorded more than two years before RD.
One parent is a nonsmoker. No information on smoking status of the
other parent, or
One or more adults quit smoking but either quit within the last five
years or quit at some unknown date, and the child’s record says
household is nonsmoking, or
Any notation in any family member’s record that no one in the
household smokes, or
Both parents are documented nonsmokers or former smokers but
information on at least one parent is more than two years old.
Unequivocal information from a child’s record within two years of
RD that no one in the household smokes, or
Information present within two years before RD that both parents
are nonsmokers. Former smoker parents quit more than five years
before RD.
No smoking-related information found in any family member’s medical
record.
at least one pertussis antigen-containing vaccine before the reference date
or “unvaccinated” if they had not. We
determined whether cases and controls
were up to date with the receipt of
pertussis antigen-containing vaccines,
as appropriate for age, using Advisory
Committee on Immunization Practices
recommendations.6
We constructed conditional logistic
regression models to investigate the
relationship between PSE and pertussis. Our main model included only the
matched case-control pairs for whom
PSE history was categorized for both
members of the pair. Because of the
small number of study participants, we
considered participants to be “exposed”
if they were categorized as “definitely exposed” or “probably exposed.” We considered participants to be “unexposed”
if they were categorized as “definitely
not exposed” or “probably not exposed.”
Variables evaluated for confounding in
multivariable models included sex, race,
history of being breastfed, daycare attendance, and receipt of pertussis antigencontaining vaccine before the reference
date. The latter was retained in the final
multivariable model.
To account for any possible selection
bias related to the exclusion of casecontrol pairs in which at least one of
the members had an unknown PSE history, we conducted a sensitivity analysis,
including all case-control pairs in two
separate models. For Model 1, we compared the combination of unexposed
and unknown pairs with exposed pairs;
for Model 2, we compared the combination of unexposed pairs with exposed
and unknown pairs. We included vaccine history in both models to adjust for
potential confounding.
This protocol was reviewed and approved by the KPNW institutional
review board.
RESULTS
We identified 65 laboratory-confirmed pertussis cases meeting our criteria, 33 of which occurred in infants
younger than 1 year of age. Positive
test results for pertussis included 53
cases confirmed by culture, 5 by direct fluorescent-antibody testing, 4 by
culture and direct fluorescent-antibody
testing, and 3 by polymerase chain reaction. Table 2 describes demographic
and exposure information of pertussis
cases and matched controls. Cases and
controls were similar with respect to sex
(p = 0.73) and white vs nonwhite race
(p = 0.57). A similar proportion of
Table 2. Demographic and exposure characterization of 65 pertussis cases and
matched controls
Demographic
Sex (male)
Race (white)
Age
< 1 yearb
1-2 yearsb
3-5 years
6-12 years
Exposure
Vaccinated against pertussis
Up-to-date vaccination for age
< 1 year
1-2 years
3-5 years
6-12 years
Passive smokec
Exposed
Unexposed
Unknown
Cases, no. (%)a
Controls, no. (%)a
Chi squared p value
33 (51)
18/20 (90)
36 (56)
25/26 (96)
0.73
0.57
33 (51)
7 (11)
7 (11)
18 (28)
23 (35)
17 (26)
7 (11)
18 (28)
44 (68)
34/44 (77)
19/21 (90)
2/3 (67)
1/3 (33)
12/17 (71)
51 (78)
40/51 (78)
11/12 (92)
2/3 (67)
11/12 (92)
16/24 (67)
0.24
0.89
24 (37)
36 (55)
5 (8)
18 (27)
35 (54)
12 (18)
0.69
N = 65 unless otherwise noted (eg, 18/20, in which case n = 20).
Cases were matched to controls in the 0- to 2-year age group; this group had a total of 40 cases and 40
controls.
c
“Exposed” includes participants categorized as “definitely exposed” or “probably exposed.” “Unexposed”
includes participants categorized as “definitely not exposed” or “probably not exposed.”
a
b
Table 3. Adjusted odds ratios of conditional logistic models assessing the
relationship between passive smoke exposure and pertussis, adjusting for
receipt of pertussis vaccine
Variablea
Main analysis
Unexposed
Exposed
Vaccinated
Sensitivity analysis, Model 1
Unexposed + unknown
Exposed
Vaccinated
Sensitivity analysis, Model 2
Unexposed
Exposed + unknown
Vaccinated
Odds ratio (95% CI)b
p value
Reference
1.2 (0.5-2.9)
0.9 (0.5-2.3)
Reference
0.67
0.75
Reference
1.7 (0.8-3.8)
0.5 (0.2-1.2)
Reference
0.19
0.11
Reference
1.1 (0.5-2.3)
0.5 (0.2-1.3)
Reference
0.87
0.15
“Exposed” includes participants categorized as “definitely exposed” or “probably exposed.” “Unexposed”
includes participants categorized as “definitely not exposed” or “probably not exposed.”
b
Conditional adjusted odds ratio for main model included 50 pairs with known passive smoke exposure,
22 of which were discordant. Conditional adjusted odds ratio for sensitivity analysis models included 65 pairs,
35 of which were discordant.
CI = confidence interval.
a
cases (68%; n = 44) and controls (78%;
n = 51) had received a pertussis antigencontaining vaccine (p = 0.24). Among
those vaccinated, a similar proportion
of cases (77%; n = 34) and controls
(40; 78%) were up to date with pertussis vaccination for their age (p = 0.89).
Because cases and controls were similar
by up-to-date vaccination status and
because our small sample size would
potentially limit our ability to consider
additional variables in our main model,
we decided to consider only whether
our subjects were vaccinated or unvaccinated for the remainder of the analysis.
A higher proportion of cases than controls was categorized as exposed to PSE
(37% vs 27%), but the control group
had a higher proportion of subjects with
missing data on PSE (18% in controls
vs 8% in cases).
For 15 (23%) of the case-control
pairs, 1 or both members had unknown
PSE, and these pairs were excluded
from our main-effects analysis. Among
the remaining 50 case-control pairs,
28 (56%) had concordant case-control
exposure histories (7 in which both
members were exposed and 21 in which
both members were unexposed). In our
conditional logistic regression model,
which calculated the odds ratio (OR)
using data from the 22 discordant pairs,
we found no statistically significant relationship between pertussis and PSE in
the household (OR = 1.2; 95% confidence interval [CI] = 0.5-2.8; Table 3).
Our results remained similar after adjusting for receipt of pertussis antigencontaining vaccine (adjusted OR = 1.2;
95% CI = 0.5-2.9). We included the 15
case-control pairs with at least 1 member
with unknown PSE in our sensitivity
analyses. In Model 1, we placed those
with missing PSE data in the unexposed
category; in Model 2, we placed them in
the exposed category. Thus, the range of
ORs that could have resulted from this
study if there had been no missing data
was 1.1 to 1.7.
DISCUSSION
We did not detect an association between laboratory-confirmed pertussis
and PSE in the household in this analysis; however, this remains an important
61
research question to study. In an in
vitro model, cigarette smoke exposure
was associated with an increased number of B pertussis organisms binding to
buccal epithelial cells from nonsmokers compared with unexposed cells.7
Among cigarette smokers, studies have
described decreased mucociliary clearance,8 decreased levels of circulating
immunoglobulins, decreased natural
killer cell activity, depressed neutrophil
chemotaxis and phagocytic activity, and
decreased release of pro-inflammatory
cytokines.9 Cigarette smoking also is
associated with increased permeability
of the respiratory epithelium.10 Further
research is needed to investigate whether
similar immune alterations occur in
children exposed to cigarette smoke.
Among children, PSE has been
associated with an increased risk of
invasive bacterial infections from Streptococcus pneumoniae,11,12 Neisseria meningitidis,13-18 Haemophilus influenzae
type b,18,19 pulmonary Mycobacterium
tuberculosis infection,20 and viral infections, including respiratory syncytial virus.21 In
Among cigarette
addition, smokers with
smokers, studies have
pertussis infection are
described decreased
more infectious than nonmucociliary clearance,
smokers because of greater
decreased levels
severity and duration of
of circulating
cough.22 This is especially
immunoglobulins,
important, as household
decreased natural
members are the estikiller cell activity,
mated source for 60% to
83% of infant cases of
depressed neutrophil
pertussis, and adults have
chemotaxis and
been responsible for inphagocytic activity,
troducing pertussis into
and decreased release
the household in 26% of
of pro-inflammatory
household outbreaks and
cytokines.
for 42% of all household
secondary cases.23-26
Our main study strengths were the
use of information from EMR and
laboratory records, reducing exposure
misclassification and outcome misclassification, and a study period that extended over 10 years. Our main limitation
was the small sample size of the study
population because of a low incidence
of pertussis during the study period.27
Our sample size was further restricted
by incomplete household PSE history
for some study participants, although
62
we accounted for this through our sensitivity analysis and this limitation did
not alter our findings.
3.
CONCLUSION
Pertussis is now considered a resurgent disease; its incidence has increased
overall during the past 3 decades,
with more notable increases and multiple outbreaks since the mid- to late
2000s. 28 In 2012, Oregon had an
outbreak of pertussis and recorded
more than 900 cases (23.3 cases per
100,000)—its highest occurrence since
1953.29 The incidence rate was highest
among infants (253/100,000 persons),
followed by children aged 10 to 14
years (104/100,000), aged 1 to 4 years
(81/100,000), and aged 5 to 9 years
(67/100,000). Twenty-six infants had
severe disease requiring hospitalization.
If PSE is linked to increased risk or
severity of pertussis in childhood, this
would allow targeted education for parents about eliminating household PSE
and would assist clinicians in assessing
the child’s risk for pertussis infection.
Improved documentation of PSE in the
EMR would assist future studies of the
relationship between PSE and pertussis
risk in children. v
disclose.
Financial support: Centers for Disease Control
and Prevention (through agreement 200-200200732 with America’s Health Insurance Plans
[AHIP]). The findings and conclusions in this
report are those of the authors and do not
necessarily represent the views of the funding
agency. The findings and conclusions do not
necessarily represent the views or policies of
the Department of Health and Human Services
or AHIP, nor does mention of trade names,
commercial products, or organizations imply
endorsement by the US Government.
Acknowledgment
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http://dx.doi.org/10.1542/peds.99.6.765.
Chen RT, DeStefano F, Davis RL, et al. The
Vaccine Safety Datalink: immunization research
in health maintenance organizations in the USA.
Bull World Health Organ 2000;78(2):186-94.
Diphtheria, tetanus, and pertussis:
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El Ahmer OR, Essery SD, Saadi AT, et al.
The effect of cigarette smoke on adherence
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j.1574-695X.1999.tb01713.x.
Sherman CB. The health consequences of
cigarette smoking. Pulmonary diseases. Med
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Jones JG, Minty BD, Lawler P, Hulands G,
Crawley JC, Veall N. Increased alveolar
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Tobacco smoke as a risk factor for
meningococcal disease. Pediatr Infect Dis J
org/10.1097/00006454-199710000-00015.
Haneberg B, Tønjum T, Rodahl K, GeddeDahl TW. Factors preceding the onset of
meningococcal disease, with special emphasis
on passive smoking, symptoms of ill health.
NIPH Ann 1983 Dec;6(2):169-73.
Kriz P, Bobak M, Kriz B. Parental smoking,
socioeconomic factors, and risk of invasive
meningococcal disease in children: a population
based case-control study. Arch Dis Child
2000 Aug;83(2):117-21. DOI: http://dx.doi.
org/10.1136/adc.83.2.117.
Lee CC, Middaugh NA, Howie SR, Ezzati M.
Association of secondhand smoke exposure with
pediatric invasive bacterial disease and bacterial
carriage: a systematic review and meta-analysis.
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http://dx.doi.org/10.1371/journal.pmed.1000374.
Murray RL, Britton J, Leonardi-Bee J. Second
hand smoke exposure and the risk of invasive
meningococcal disease in children: systematic
review and meta-analysis. BMC Public Health
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org/10.1186/1471-2458-12-1062.
Pereiró I, Díez-Domingo J, Segarra L, Ballester A,
Albert A, Morant A. Risk factors for invasive
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org/10.1016/j.jinf.2003.10.015.
Arnold C, Makintube S, Istre GR. Day care
attendance and other risk factors for invasive
Haemophilus influenzae type b disease. Am J
Epidemiol 1993 Sep 1;138(5):333-40.
Altet MN, Alcaide J, Plans P, et al. Passive
smoking and risk of pulmonary tuberculosis
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org/10.1016/S0962-8479(96)90052-0.
DiFranza JR, Masaquel A, Barrett AM, Colosia AD,
Mahadevia PJ. Systematic literature review
assessing tobacco smoke exposure as a risk
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disease among infants and young children. BMC
Pediatr 2012 Jun 21;12:81. DOI: http://dx.doi.
org/10.1186/1471-2431-12-81.
De Serres G, Shadmani R, Duval B, et al.
Morbidity of pertussis in adolescents and adults.
J Infect Dis 2000 Jul;182(1):174-9. DOI: http://
dx.doi.org/10.1086/315648.
Baptista PN, Magalhães VS, Rodrigues LC.
The role of adults in household outbreaks of
pertussis. Int J Infect Dis 2010 Feb;14(2):e111-4.
DOI: http://dx.doi.org/10.1016/j.ijid.2009.03.026.
de Greeff SC, Mooi FR, Westerhof A, et al.
Pertussis disease burden in the household:
how to protect young infants. Clin Infect Dis
2010 May 15;50(10):1339-45. DOI: http://dx.doi.
org/10.1086/652281.
Bisgard KM, Pascual FB, Ehresmann KR, et al.
Infant pertussis: who was the source? Pediatr
Infect Dis J 2004 Nov;23(11):985-9. DOI: http://
dx.doi.org/10.1097/01.inf.0000145263.37198.2b.
Wendelboe AM, Njamkepo E, Bourillon A, et al;
Infant Pertussis Study Group. Transmission of
Bordetella pertussis to young infants. Pediatr
Infect Dis J 2007 Apr;26(4):293-9. DOI: http://
dx.doi.org/10.1097/01.inf.0000258699.64164.6d.
27. Bancroft J, Byster L. Selected reportable
communicable disease summary: 20082009—Pertussis [Internet]. Salem, OR:
Oregon Department of Human Services;
2010 Dec [cited 2015 May 13]. Available
from: https://public.health.oregon.gov/
DiseasesConditions/CommunicableDisease/
DiseaseSurveillanceData/AnnualReports/
arpt0809/Documents/arpt0809.pdf.
28. Clark TA. Changing pertussis epidemiology:
everything old is new again. J Infect Dis
2014 Apr 1;209(7):978-81. DOI: http://dx.doi.
org/10.1093/infdis/jiu001.
29. Selected reportable communicable disease
summary: 2012 state of Oregon [Internet].
Portland, OR: Oregon Health Authority;
2013 Sep [cited 2014 Apr 3]. Available
from: http://public.health.oregon.gov/
DiseasesConditions/CommunicableDisease/
DiseaseSurveillanceData/AnnualReports/
arpt2012/Pages/index.aspx.
Pertussis
Fevers attacked boys of four months, of ten months and a little older, countless
numbers of whom died. Principally that common cough, which is usually
called Quinta or Quintana … . Serious are the symptoms of this … .
For they are without this troublesome coughing for … four or five hours
… then this paroxysm of coughing returns, now so severe that blood is
expelled with force through the nose and through the mouth.
— Guillaume de Baillou (Ballonius), 1538-1616, French physician
and considered founder of modern epidemiology
63
Special Report
2014 Hypertension Guideline: Recommendation
for a Change in Goal Systolic Blood Pressure
Joel Handler, MD
Perm J 2015 Summer;19(3):64-72
Editor’s note: A copy of the August 2014 Kaiser Permanente
Adult Hypertension National Guideline follows this article.
ABSTRACT
The 2014 Kaiser Permanente Care Management Institute
National Hypertension Guideline was developed to assist
primary care physicians and other health care professionals
in the outpatient treatment of uncomplicated hypertension in
adult men and nonpregnant women aged 18 years and older.
The new guideline reflects general acceptance, with minor
modifications, of the “Evidence-Based Guideline” report by
the panel members appointed to the National Heart, Lung,
and Blood Institute 8th Joint National Committee. A major
practice change is the recommendation for goal systolic blood
pressure less than 150 mmHg in patients aged 60 years and
older who are treated for hypertension in the absence of
diabetes or chronic kidney disease. This article describes the
reasons for, evidence for, and consequences of the change,
and is followed by the National Guidelines handout.
INTRODUCTION
The 2014 Kaiser Permanente (KP) Care Management Institute National Hypertension Guideline was developed to assist
primary care physicians and other health care professionals
in the outpatient treatment of uncomplicated hypertension
in adult men and nonpregnant women aged 18 years and
older. The new guideline reflects general acceptance of the
“Evidence-Based Guideline” report by the panel members
appointed to the National Heart, Lung, and Blood Institute
(NHLBI) 8th Joint National Committee (JNC 8).1 A major practice change is the recommendation for goal systolic
blood pressure less than 150 mmHg in patients aged 60 years
and older who are treated for hypertension in the absence of
diabetes or chronic kidney disease (CKD) compared with
the previous standard less than 140 mmHg. This change has
major consequences for the routine primary care management
of patients with hypertension.
How Large Is the Affected Population
and How Strong Is the New Recommendation?
Using the results of the National Health and Nutrition
Examination Survey between 2005 and 2010, it has been
estimated that the US treatment-eligible adult hypertension
population would decrease from 20.3% to 19.2% compared
with that of the 7th Joint National Committee guideline,
and the population with treatment-eligible hypertension
who are aged 60 years and older would decline from 68.9%
to 61.2%.2 As of October 2014, with an 85% hypertension
control rate less than 140/90 mmHg, there are 18,690 patients
aged 60 years and older without diabetes or CKD in the KP
Southern California hypertension registry who have systolic
blood pressures of 140 to 149 mmHg and are affected by the
new recommendation. These patients represent 2.5% of the
total KP Southern California adult hypertension registry of
740,003 individuals.
Evidentiary support for this recommendation was strong,
according to the Care Management Institute Grading of
Recommendations Assessment, Development and Evaluation
standard for grading the quality of evidence scale, and it received a strong rating using principles evaluating the strength
of the body of evidence and degree of certainty developed by
the NHLBI before it convened the first JNC 8 panel meeting
in August 2008. This recommendation was a segue from the
relevant Evidence Statements, which evaluated randomized
clinical trials passing scrutiny from a 14-category evidence
assessment scale used by a trained and independent methodology team collaborating with those experts appointed to the
JNC 8 panel. These Evidence Statements are available in the
full online Evidence-Based Guideline report.1
What is the Basis of the Supportive Evidence?
The age 60 years threshold for the systolic blood pressure
target was decided on the basis of the Systolic Hypertension
in the Elderly Program (SHEP) trial findings and the Systolic
Hypertension in Europe (Syst-Eur) trial results.3,4 In these
highly rated randomized controlled trials, stroke, the primary
endpoint, was reduced by 36% and 42%, respectively, and
major cardiovascular events were reduced by 32% and 31%,
respectively. These two large trials containing representative
population samples fulfill the NHLBI strong evidence requirement for multiple supportive randomized controlled trials.
The JNC 8 Evidence Statements 1 to 3 for Clinical Question 2 describe the evidence, and a strong recommendation
is the logical result.1p82-3
There is no evidence from a randomized controlled clinical
trial to support the opinion that a systolic blood pressure goal
less than 140 mmHg in the elderly hypertensive population is
superior to a systolic goal less than 150 mmHg. The absence
Joel Handler, MD, was an Expert Panel Member of the Eighth Joint National Committee on High
Blood Pressure; Hypertension Clinical Lead, Care Management Institute; and Hypertension Lead
for Southern California Kaiser Permanente, Anaheim, CA. E-mail: joel.handler@kp.org.
64
2014 Hypertension Guideline: Recommendation for a Change in Goal Systolic Blood Pressure
of evidence for a lower blood pressure target does not equal
benefit. One opinion properly criticizes the strength of the
Japanese Trial to Assess Optimal Systolic Blood Pressure in
Elderly Hypertensive Patients5 and Valsartan in Elderly Isolated Hypertension Study6 results demonstrating equivalency
of goal systolic pressure less than 140 mmHg compared with
goal systolic pressures less than 150 mmHg and less than
160 mmHg, because these were short-term trials.7 However,
that critique does not offer additional information to the previously published Evidence-Based Guideline Clinical Question 2: Evidence Statement 6, which attached low-quality
evidence to these trials.1p84-5
PROBLEMS WITH USE OF ACHIEVED
BLOOD PRESSURE TRIALS
Achieved blood pressure trials are those in which the intervention is to introduce antihypertensive medication to examine the effect of medication on cardiovascular risk reduction
rather than to examine outcomes achieving a prespecified goal
blood pressure. These trial results should not be used to inform
blood pressure targets because they ask a different question.
Retrospective analyses correlating achieved blood pressures
to outcome measures are inherently biased.
The NHLBI process followed by the panel appointed to
JNC 8 is in agreement with The Cochrane Collaboration
methodologists who independently decided the following:
The cohort of patients with low blood pressure as
identified by achieved blood pressure selects for patients
who did not have sustained elevated blood pressure in the
first place … , for patients in whom the blood pressure
is most easily reduced with low doses of antihypertensive
drugs, for patients with the lowest baseline blood pressure,
and for patients who are most compliant with drug and
non-drug therapy to lower blood pressure … . All of these
factors are also most likely associated with a lower risk of
having an adverse cardiovascular event. The approach
is thus heavily biased for finding [fewer] cardiovascular
events in the patients with lower blood pressure, and thus
must not be encouraged.8
These limitations of analyses based on post hoc achieved
blood pressures were confirmed in an analysis of the African
American Study of Kidney Disease and Hypertension, which
concluded that the retrospective use of achieved blood pressures would have erroneously led to the opposite conclusion
of the intention-to-treat goal blood pressure analysis in this
landmark study.9
The Felodipine Event Reduction study,10 the Perindopril Protection against Recurrent Stroke trial,11 and Blood
Pressure Trialists’ Collaboration reports12-14 purport to show
that additional blood pressure lowering is beneficial. These
are examples of clinical trials and meta-analyses representing on-treatment achieved blood pressure results rather than
intention-to-treat goal blood pressure outcomes and were
rejected by the NHLBI methodology team because of bias.
Notably, reference to mean achieved systolic blood pressures in
the SHEP and Syst-Eur trials of 142 mmHg and 144 mmHg,
respectively, fails to mention the mean achieved systolic blood
pressure in Syst-Eur, which was 151 mmHg.4
The argument to use “totality of evidence” does not constitute sufficient rationale for inclusion of clinical trials and
meta-analyses containing inherent bias.
Where Does the Lower-is-Better Blood Pressure
Hypothesis Originate, and Has It been Validated?
Much of the “lower is better” paradigm is based on strong
prospective observational data of more than 1 million patients
in 61 prospective studies15 as well as on many retrospective
analyses of achieved blood pressures in the clinical trials.
However, the retrospective findings are mixed. A more recent
population-based retrospective cohort study revealed no difference between systolic intensification thresholds of 130 mmHg
to 150 mmHg across a broad spectrum of baseline cardiovascular risk.16 Analyses of large numbers of hypertensive KP
patients with hypertension, as well as US military veterans
with hypertension and CKD, suggest increased mortality
and end-stage kidney disease associated with lower attained
blood pressures.17,18
Does the treatment of blood pressure to lower blood pressure targets, as opposed to higher blood pressure targets,
reverse cardiovascular risk? Seven randomized clinical trials
have investigated this hypothesis in high-risk patients with
CKD, diabetes, older age, and a personal history of stroke.
None has shown significant benefit for meeting the primary
endpoint with more intense antihypertensive therapy that
seeks a lower blood pressure goal.5,6,19-23
WHAT IS THE RISK OF REVERSING POPULATION
GAINS IN CARDIOVASCULAR BENEFIT?
How can we be sure that a higher systolic goal will not reverse gains already made in stroke and cardiovascular disease
reduction? Gains in cardiovascular disease reduction have
been associated with hypertension control, widespread use of
high-potency statins, and improved secondary prevention in
patients with known coronary artery disease and stroke.24,25
Because patients are receiving better overall care, power calculations for recent hypertension treatment trials on the basis of
adverse rates of cardiovascular events for historic cohorts often
fall short of forecasts, leading to underpowering.19,20 Given the
success of population care strategies achieving very high rates
of blood pressure control and eliminating racial performance
gaps in large diverse populations,26-29 we need to ensure that
we use the highest evidence base to define blood pressure
targets. Implementation difficulties and problems with clinical inertia are independent issues and should not be used to
justify inappropriately low blood pressure goals.
What are the Risks of Overtreatment?
Overtreatment needs to be a concern. In the KP Southern California adult hypertension registry in which nearly
90% of patients attained blood pressure control less than
140/90 mmHg, the mean systolic pressure is 127 mmHg,
and almost 10% of patients receiving antihypertensive therapy
have a most recent systolic pressure less than 110 mmHg. The
65
disadvantages of overtreatment include: 1) exposure to side
effects of unnecessary medications and excessive medication
doses; 2) polypharmacy in the elderly30; 3) reduced medication adherence associated with a large number of medications31; 4) a possible increase in falls with serious injury32; 5)
possibly a J- or U-curve increase in cardiovascular risk17; and
6) unnecessary use of limited health care resources, including
office visits, population care outreach, medication prescriptions, and laboratory testing. A general review of 16 treatment
trials indicated the potential for harm with more aggressive
antihypertensive therapy in the absence of benefit.33
Is There a Risk of Changing Goal Blood Pressure
in the Presence of Uncertainty?
How can we be certain that the systolic blood pressure
target less than 150 mmHg for patients with hypertension
aged 60 years and older is accurate? The purpose of guideline development is to gather evidence with the least chance
of bias, and this sort of evidence is best obtained from
higher-quality randomized controlled clinical trials. All the
panelists appointed to JNC 8 concurred with the NHLBI
evidence review process, and, following several straw votes
during more than one year, the final recorded vote
at a face-to-face meeting conducted in Bethesda,
… there is
MD, at the National Institutes of Health on Februgreater certainty
ary 27-28, 2013, on Recommendation 1 was 15 in
defining the age
favor and 2 against. The final recorded vote on the 3
group 60 years
evidence statements supporting Recommendation 1
and older, rather
was unanimously in favor. The SHEP and Syst-Eur
than age 80
trial results3,4 provide strong evidence to support the
years and older,
Evidence-Based Guideline’s recommended goal blood
for goal systolic
pressure in elderly patients. In contrast, there are no
known clinical trials that address goal blood pressure
pressure less
that have examined the 18- to 59-year age stratum,
than 150 mmHg.
and therefore recommendation for less than 140/90
mmHg for this population is based on expert opinion.
There is a need for additional clinical trials examining the
question of goal blood pressure for various populations of hypertensive individuals. Those trials should include examination
of important health outcomes at a goal systolic pressure less than
150 mmHg compared with less than 130 mmHg in elderly patients with diabetes and CKD. There is good evidence to justify
such a randomized clinical trial in patients with diabetes,3,4,34
including Evidence Statement 18 for Clinical Question 2 in
James et al.1 If the ongoing Systolic Blood Pressure Intervention
Trial does not find a significant outcome difference treating to
goal systolic pressure less than 140 mmHg compared with less
than 120 mmHg in patients with CKD, a future trial comparing less than 150 mmHg with less than 130 mmHg would be
justified in this population as well.
IS THE EVIDENCE-BASED GUIDELINE RECOMMENDATION
FOR GOAL SYSTOLIC PRESSURE LESS THAN
150 MMHG FOR AGE 60 AND OLDER AN OUTLIER
COMPARED WITH OTHER GUIDELINES?
Recommendations from the 2013 European Society of
Hypertension/European College of Cardiology for blood
66
pressure goals in the treatment of hypertension in elderly
patients include a few “may consider,” “if treatment is
well tolerated” recommendations along with a top “solid
evidence” recommendation.35 That single, solid-evidence
recommendation targets a goal systolic blood pressure
140 mmHg to 150 mmHg “in the elderly.” In the SHEP
and Syst-Eur trials, “elderly” enrollment began at age 60
years. In an e-mail from Giuseppe Mancia, MD, co-chair of
the European Society of Hypertension/European College of
Cardiology guideline, which was circulated to panel members appointed to JNC 8, elderly was defined as beginning
at age 65 years (G Mancia, MD; personal communication,
2013 Dec).a In a letter to the European Society of Hypertension/European College of Cardiology guideline authors
in the December 2013 issue of the Journal of Hypertension,
a writer expressed concern regarding the new blood pressure goal stating that it was “rational” but worried about the
impact on clinical inertia. In their letter of reply, Mancia
et al36 stated, “Clinical inertia has to be fought … by other
means than by recommending inappropriately low [blood
pressure] targets.”
Therefore, there is fair concordance in the age group targeted for a systolic blood pressure goal target less than 150
mmHg in hypertension guidelines submitted by hypertension
experts on both sides of the Atlantic.
Why Not Make the Threshold for the less than 150 mmHg
Goal Recommendation Age 80 Rather than Age 60?
Given the findings of the SHEP and Syst-Eur trials,3,4 there
is greater certainty defining the age group 60 years and older,
rather than age 80 years and older, for goal systolic pressure
less than 150 mmHg. Only a single trial, the Hypertension
in the Very Elderly Trial, has established goal systolic blood
pressure in the age 80 years and older population less than
150 mmHg, a population described as the “very elderly.”37
A single randomized clinical trial does not constitute sufficient evidence to merit a strong recommendation at this age
level in the presence of multiple randomized clinical trials in
support of the age 60 threshold.
Does the less than 150 mmHg Goal Recommendation
Include Higher Risk Groups?
Epidemiologic data have defined higher cardiovascular risk
strata in the general population, but randomized controlled
clinical trials demonstrating statistically significant reversal
of risk with lower blood pressure goals in higher-risk groups
have been notably absent.5,6,19-23
SHEP and Syst-Eur enrolled patient populations that were
representative of a broad spectrum of cardiovascular risk.
Increasing age alone is a dominant cardiovascular disease risk
factor.15 Additionally, the SHEP trial population included
14% African-American patients compared with 12.6% in
the US population. Both SHEP and Syst-Eur also included
patients with a history of myocardial infarction and stroke.1,3
Sixty-one percent of patients in SHEP had a baseline electrocardiographic abnormality. Thirty percent of patients
in Syst-Eur had a prior “cardiovascular complication.” The
Hypertension in the Very Elderly Trial included patients with
myocardial infarction, stroke, and heart failure.36
Attention has been drawn to the Secondary Prevention
of Small Subcortical Strokes trial comparing goal systolic
pressure less than 150 mmHg to less than 130 mmHg in
patients with a personal history of lacunar stroke.20 Although the primary endpoint of recurrent stroke was nonsignificant ( p = 0.08), c onfidence in tervals (0 .64 to 1. 03)
did not preclude benefit o f t he l ower g oal. F urthermore,
the subgroup of intracerebral hemorrhage was significantly
reduced (p = 0.03).6 However, “there was no heterogeneity
in treatment effect o n t he p rimary o utcome i n a ny o f t he
demographic or clinical subgroups,” the annual primary
stroke rate in the control group was only 2.77% vs 7%
predicted, and intracerebral hemorrhage comprised fewer
than 10% of total strokes.20 The nonstatistically significant
separation of total stroke in the more intensively treated
group compared with the less intensively treated group in the
Secondary Prevention of Small Subcortical Strokes trial was
only 0.5% events per year. Therefore, the evidence favoring
a goal systolic pressure other than lower than 150 mmHg in
hypertensive individuals aged 60 years and older with a
personal history of stroke is speculative.
ENDORSEMENTS OF THE EVIDENCE-BASED GUIDELINE
The American Academy of Family Physicians, representing more than 100,000 primary care physicians, has
endorsed the Evidence-Based Guideline. That approval is
important because nearly all hypertensive patients receive
hypertension care from primary care physicians. Additionally, the National Quality Committee for Quality Assurance has adopted the new reform, and goal systolic blood
pressure less than 150 mmHg in the absence of diabetes is a
2014 performance measure for the Healthcare Effectiveness
Data and Information Set. The Veteran’s Administration and
Department of Defense patient care systems have adopted
goal systolic blood pressure less than 150 mmHg for general
population hypertension patients age 60 and over.38
It will be difficult to reproduce the methodologic rigor and
independent sponsorship of the Evidence-Based Guideline
now that the NHLBI has unfortunately decided to remove itself from stewardship of future hypertension guidelines, and
will not approve any guideline. The level of evidence-based
medicine used to develop this hypertension guideline, on
the basis of Institute of Medicine principles, is unsurpassed.
An essential point is that blood pressure goals for patients
with hypertension must be based on a high degree of evidence, and bias is best removed by reliance on the randomized controlled clinical trials to make this determination.
A common rationale for recommending blood pressure
goals lower than those that are evidence based is to combat
clinical inertia. However, implementation is a separate issue,
and high-performing systems of health care have addressed
clinical inertia successfully.26-29,39 v
a
Cochair, European Society of Hypertension/European College of Cardiology
guideline committee, Milano, Italy.
Acknowledgments
This work was developed under the auspices of Kaiser Permanente’s
National Guideline Program. We would like to recognize the National
Guideline Directors, the Integrated Cardiovascular Health Clinical Leads,
and the Hypertension Guideline Development Team.
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12. Staessen JA, Wang JG, Thijs L. Cardiovascular protection and blood pressure
reduction: a meta-analysis. Lancet 2001 Oct 20;358(9290):1305-15. DOI: http://
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26;359(9303):360. DOI: http://dx.doi.org/10.1016/S0140-6736(02)07527-X.
13. Turnbull F; Blood Pressure Lowering Treatment Trialists’ Collaboration. Effects
of different blood-pressure-lowering regimens on major cardiovascular events:
results of prospectively-designed overviews of randomised trials. Lancet 2003
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14. Blood Pressure Lowering Treatment Trialists’ Collaboration, Sundström J,
Arima H, Woodward M, et al. Blood pressure-lowering treatment based on
cardiovascular risk: a meta-analysis of individual patient data. Lancet 2014 Aug
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15. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies
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22;361(9362):1060. DOI: http://dx.doi.org/10.1016/S0140-6736(03)12816-4.
16. Xu W, Goldberg SI, Shubina M, Turchin A. Optimal systolic blood pressure
target time to intensification, and time to follow-up in treatment of hypertension:
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17. Sim JJ, Shi J, Kovesdy CP, Kalantar-Zadeh K, Jacobsen SJ. Impact of achieved
blood pressures on mortality risk and end-stage renal disease among a large,
diverse hypertension population. J Am Coll Cardiol 2014 Aug 12;64(6):588-97.
DOI: http://dx.doi.org/10.1016/j.jacc.2014.04.065.
18. Kovesdy CP, Bleyer AJ, Molnar MZ, et al. Blood pressure and mortality in US
veterans with chronic kidney disease: a cohort study. Ann Intern Med 2013
Aug 20;159(4):233-42. DOI: http://dx.doi.org/10.7326/0003-4819-159-4201308200-00004.
19. ACCORD Study Group, Cushman WC, Evans GW, Byington RP, et al. Effects of
intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010
Apr 29;362(17):1575-85. DOI: http://dx.doi.org/10.1056/NEJMoa1001286.
20. SPS3 Study Group, Benavente OR, Coffey CS, Conwit R, et al. Blood-pressure
targets in patients with recent lacunar stroke: the SPS3 randomised trial.
Lancet 2013 Aug 10;382(9891):507-15. DOI: http://dx.doi.org/10.1016/S01406736(13)60852-1.
21. Wright JT Jr, Bakris G, Greene T, et al; African American Study of Kidney
Disease and Hypertension Study Group. Effect of blood pressure lowering
and antihypertensive drug class on progression of hypertensive kidney
disease: results from the AASK trial. JAMA 2002 Nov 20;288(19):2421-31.
DOI: http://dx.doi.org/10.1001/jama.288.19.2421. Erratum in: JAMA 2006 Jun
21;295(23):2726. DOI: http://dx.doi.org/10.1001/jama.295.23.2726-c.
22. Klahr S, Levey AS, Beck GJ, et al. The effects of dietary protein restriction and
blood-pressure control on the progression of chronic renal disease. Modification
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877-84. DOI: http://dx.doi.org/10.1056/NEJM199403313301301.
23. Ruggenenti P, Perna A, Loriga G, et al; REIN-2 Study Group. Blood pressure
control for renoprotection in patients with non-diabetic chronic renal disease
(REIN-2): multicentre, randomised controlled trial. Lancet 2005 Mar 12-18;
365(9463):939-46. DOI: http://dx.doi.org/10.1016/S0140-6736(05)71082-5.
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coronary disease, 1980-2000. N Engl J Med 2007 Jun 7;356(23):2388-98. DOI:
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25. Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in
the incidence and outcomes of acute myocardial infarction. N Engl J Med 2010
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26. Jaffe MG, Lee GA, Young JD, Sidney S, Go AS. Improved blood pressure
control associated with a large-scale hypertension program. JAMA 2013
Aug 21;310(7):699-705. DOI: http://dx.doi.org/10.1001/jama.2013.108769.
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jamainternmed.2013.14764.
33. Filippone EJ, Foy A, Newman E. Goal-directed antihypertensive therapy: lower
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dx.doi.org/10.3949/ccjm.78a.10101.
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bmj.317.7160.703. Erratum in: BMJ 1999 Jan 2;318(7175):29. DOI: http://dx.doi.
org/10.1136/bmj.318.7175.29p.
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Jul;31(7):1281-357. DOI: http://dx.doi.org/10.1097/01.hjh.0000431740.32696.cc.
36. Mancia G, Fagard R. New blood pressure control goals, more rational but
facilitating therapeutic inertia?: reply. J Hypertens 2013 Dec;31(12):2462-5.
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CIRCOUTCOMES.109.862714.
Normal
If we possessed instruments delicate enough we might be able to determine what the normal
arterial pressure of a given individual was, and to note any variation from it … . We are … driven
to depend upon the most treacherous of all methods, the impressions conveyed to our minds
through the sensory nerves of the fingers … . By constant practice and study, each physician
makes for himself a standard of atrial pressure which he recognizes as normal.
— The Study of the Pulse, Sir James Mackenzie, MD, 1853-1925,
Scottish cardiologist and pioneer in the study of cardiac arrhythmias
68
Kaiser Permanente National Guideline
Adult Hypertension
CLINICIAN GUIDE
AUGUST 2014
Screening for Hypertension
TOOL 1. Key Points
ff Hypertension is an important and modifiable risk factor
for atherosclerotic cardiovascular disease (ASCVD).
ff For all adults, encourage a heart-healthy lifestyle to reduce
the risk of ASCVD. This includes regular physical activity, weight
reduction and maintenance, smoking cessation, and controlling
blood pressure, cholesterol, and diabetes.
ff For adults aged 60 and older without diabetes or chronic kidney
disease (CKD), treat to a goal systolic blood pressure (SBP)
<150 mmHg and goal diastolic blood pressure (DBP) <90 mmHg.
ff For all adults aged under 60, and those aged 60 and older with
diabetes or chronic kidney disease (CKD), treat to a goal SBP
<140 mmHg and goal DBP <90 mmHg.
Introduction
This Clinician Guide is based on the 2014 KP National Hypertension Guideline. It was developed to assist primary care physicians and other health care
professionals in the outpatient treatment of hypertension in nonpregnant
adults aged 18 and older. The drug treatment algorithm excludes patients
with known stage 4-5 chronic kidney disease, coronary artery disease, and
heart failure. The KP National Hypertension Guideline has adopted the
new recommendations from the 2014 Evidence-Based Guideline for the
Management of High Blood Pressure in Adults: Report From the Panel
Members Appointed to the Eighth Joint National Committee (JNC 8) with
minor modifications. It is not intended or designed as a substitute for the
reasonable exercise of independent clinical judgment by practitioners.
ff Screen all adults aged 18 and older for hypertension.
ff Screen adults with normal blood pressure (<120/<80) every two years.
ff Screen adults with pre-hypertension or cardiovascular risk factors annually.
Treatment Initiation and BP Targets
In addition to lifestyle interventions, the following are recommendations for
the general population without diabetes or chronic kidney disease (CKD):
TOOL 3. Treatment Initiation
Lifestyle modifications:
• Consume a diet that is moderately low-sodium, low-fat with a high intake
of fruits and vegetables (DASH diet)
• Weight reduction - for patients with a BMI ≥25 kg/m2
• Limit alcohol consumption
• Exercise - at a moderate pace to achieve 150 min/week (i.e., 30 min/5
days/week)
• Stop smoking or use of tobacco products
• Assist patients to achieve medication and lifestyle adherence by means of a
vigorous step-care approach to therapy and an organized system of regular medical follow-up and review
• Prescribe once-daily medication and combination therapy, whenever
possible
• Address depression/anxiety issues in order to maximize patient adherence
• Use patient education in conjunction with other strategies, particularly in
the context of team care utilizing nurses and pharmacists
• Educate patients about their goal blood pressure
Presence of DM or CKD?
No
_ Age >
60 years?
Definitions
• Initiate pharmacologic treat-
The KP National Hypertension Guideline Team uses the JNC 7 classification of
hypertension, which is based on the mean of two or more properly measured
seated BP readings on each of two or more office visits.
TOOL 2. Definition of Hypertension (JNC 7)
The JNC 7 Report defines Systolic Blood Presblood pressure (BP) as: sure (SBP) mmHg
Normal
Yes
Yes §
Diastolic Blood Pressure (DBP) mmHg
<120
<80
Prehypertension
120 – 139
80 – 89
Stage I Hypertension
140 – 159
90 – 99
Stage II Hypertension
≥160
≥100
©2015 Kaiser Permanente Care Management Institute
No
ment to lower BP when SBP
>
_150 mmHg or DBP >
_90 mmHg
• Treat to a goal SBP
<150 mmHg and goal DBP
<90 mmHg
• If pharmacologic treatment
for high BP results in lower
achieved SBP (e.g., <140 mmHg)
and treatment is well-tolerated
and without adverse effects
on health or quality of life,
treatment does not need to be
adjusted
• Initiate pharmacologic treatment to
lower BP when SBP >
_140 mmHg or
DBP >
_ 90 mmHg
• Treat to a goal SBP <140 mmHg and
goal DBP <90 mmHg
• Initiate pharmacologic treatment to lower BP in all adults
with CKD*/ diabetes when SBP
>
_140 mmHg or DBP >
_ 90 mmHg
• Treat to a goal SBP <140 mmHg
and goal DBP <90 mmHg
Footnotes
§ Because elderly patients are at
higher risk of side effects of treatment,
including risk of postural hypotension,
check standing blood pressures to
guide treatment decisions.
* When weighing the risks and benefits
of a lower BP goal for people aged
70 years or older with estimated
GFR less than 60 mL/min/ 1.73 m2,
antihypertensive treatment should be
individualized, taking into consideration factors such as frailty, comorbidities, albuminuria, and estimation of
non-age-related eGFR decline (e.g., if
eGFR + ½ age is <85).
KP National Guideline | Adult Hypertension
CLINICIAN GUIDE | AUGUST 2014
GENERAL POPULATION
ff Aged ≥60 years without diabetes or chronic kidney disease (CKD):
• Initiate pharmacologic treatment to lower blood pressure (BP)
when systolic blood pressure (SBP) ≥150 mmHg or diastolic blood
pressure (DBP) ≥90 mmHg.
• Treat to a goal SBP <150 mmHg and goal DBP <90 mmHg.
• If pharmacologic treatment for high BP results in lower achieved SBP (e.g.,
<140 mmHg) and treatment is well-tolerated and without adverse effects
on health or quality of life, treatment does not need to be adjusted.
ff Aged <60 years and those aged > 60 with diabetes or chronic kidney disease (CKD):
• Initiate pharmacologic treatment to lower BP when SBP ≥140 or
DBP ≥90 mmHg.
• Treat to a goal SBP <140 mmHg and goal DBP <90 mmHg.
CHRONIC KIDNEY DISEASE (CKD)
ff N
OTE: When weighing the risks and benefits of a lower BP goal for people
aged 70 years or older with estimated GFR less than 60 mL/min/ 1.73 m2,
antihypertensive treatment should be individualized, taking into consideration factors such as frailty, comorbidities, albuminuria, and estimation of
non-age-related eGFR decline (e.g., if eGFR + ½ age is <85).
TOOL 4. eGFR Calculator
ff eGFR (mL/min/1.73m2) = 186 × SCr -1.154 × age -0.203 (in men)
(in women multiply with 0.74; in Afro-American multiply with 1.21)
RISK OF POSTURAL HYPOTENSION IN THE ELDERLY
ff B
ecause elderly patients are at higher risk of side effects of treatment,
including risk of postural hypotension, check standing blood pressures
to guide treatment decisions.
First-Line Drug Treatment for Hypertension*
ff I n the general nonblack population, including those with diabetes,
initial antihypertensive treatment includes a thiazide-type diuretic,
calcium channel blocker (CCB), angiotensin-converting enzyme
inhibitor (ACEI), or angiotensin receptor blocker (ARB).
ff In the general black population, including those with diabetes, initial
antihypertensive treatment includes a thiazide-type diuretic or CCB.
ff In the population aged ≥18 years with CKD, initial (or add-on)
antihypertensive treatment includes an ACEI or ARB to improve kidney
outcomes. This applies to all CKD patients with hypertension, regardless
of race or diabetes status.
ff Medication up-titrations are recommended at intervals of 2-4 weeks
(for most patients) until control is achieved.
Consider follow-up labs when up-titrating or adding lisinopril,
lisinopril/HCTZ, chlorthalidone, HCTZ, or spironolactone.
*TOOL 5. Management of Adult Hypertension (see next page)
INITIAL COMBINATION TREATMENT OF HYPERTENSION
ff T he main objective of hypertension treatment is to attain and maintain
goal BP.
ff If goal BP is not reached within 4 weeks of treatment, increase the dose
of the initial drug or add a second drug from one of the classes listed for
first-line treatment (thiazide-type diuretic, CCB, ACEI, or ARB).
ff C ontinue to assess BP and adjust the treatment regimen until goal BP
is reached. If goal BP cannot be reached with 2 drugs, add and titrate a
third drug from the list provided. Do not use an ACEI and ARB together in
the same patient.
ff If goal BP cannot be reached using only the drugs listed for first-line
treatment due to a contraindication or need to use more than 3 drugs
to reach goal BP, use antihypertensive drugs from other classes.
ff Consider referral to a hypertension specialist for patients in whom goal
BP cannot be attained using the above strategy or for the management of
complicated patients for whom additional clinical consultation is needed.
STEP-CARE THERAPY
Because most people with hypertension will need more than
one drug to control their hypertension effectively:
ff Initial single-pill combination therapy with lisinopril-hydrochlorothiazide is preferred.
ff For three drugs: If blood pressure is not controlled on a thiazidetype diuretic + ACEI, then use a thiazide-type diuretic plus ACEI plus
dihydropyridine calcium channel blocker.
ff For four drugs: If blood pressure is not controlled on a thiazide-type
diuretic plus ACEI plus dihydropyridine calcium channel blocker, then
use thiazide-type diuretic plus ACEI plus dihydropyridine calcium
channel blocker plus spironolactone or beta-blocker.
Lifestyle Modifications
ff S upplement treatment of uncomplicated hypertension with lifestyle
modifications:
• Consume a diet that is moderately low-sodium, low-fat with
a high intake of fruits and vegetables (DASH diet),
Sodium restriction (≤2.4 gm sodium daily)
• Weight reduction for patients with a BMI ≥25 kg/m2
TOOL 6. BMI Calculator
BMI =
weight (kg)
height squared (m )
2
BMI =
weight (pounds) x 703
height squared (inches2)
• Limit alcohol consumption - no more than one alcoholic drink
(for women) or two alcoholic drinks (for men) daily
• Exercise - at a moderate pace to achieve 150 min/week
(i.e., 30 min/5 days/week)
• Stop smoking or use of tobacco products
ff Encourage adherence to medications and lifestyle modifications:
• A ssist patients to achieve medication and lifestyle adherence by
means of a vigorous step-care approach to therapy and an organized
system of regular medical follow-up and review.
• Prescribe once-daily medication and combination therapy,
whenever possible.
• Address depression and anxiety issues in order to maximize patient
adherence. See KP National Depression Guideline at:
http://cl.kp.org/pkc/national/cmi/programs/depression/guideline/index.html
• Use patient education in conjunction with other strategies, particularly in the context of team care utilizing nurses and pharmacists.
• Educate patients about their goal blood pressure, because patients
who are knowledgeable about their goal BP are more likely to achieve it.
TOOL 5. Management of Adult Hypertension
BLOOD PRESSURE (BP) GOALS
• ≤139/89 mmHg: Aged 18-59, and aged 60 and over with Chronic Kidney Disease (CKD)1 or Diabetes
• ≤149/89 mmHg: Aged 60 and over in the absence of Chronic Kidney Disease (CKD)1 or Diabetes
ACE-Inhibitor 2/ Thiazide Diuretic
Lisinopril / HCTZ (advanced as needed)
20/25 mg X ½ daily
20/25 mg X 1 daily
20/25 mg X 2 daily
If ACEI intolerant or
pregnancy potential
Thiazide Diuretic3
HCTZ 25 mg  50 mg
OR
Chlorthalidone 12.5 mg  25 mg
Pregnancy Potential: Avoid ACE-Inhibitors1
If not in control
For ACEI intolerance due to cough, use ARB3
Add losartan 25 mg daily  50 mg
daily  100 mg daily
Pregnancy Potential: Avoid ARBs1
If not in control
Calcium Channel Blocker2
Add amlodipine 5 mg X ½ daily  5 mg X 1daily  10 mg daily
If not in control
Spironolactone OR Beta-Blocker2
If on thiazide AND eGFR >
_ 60 mL/min/1.73 m2 AND K <4.5
Add spironolactone 12.5 mg daily  25 mg daily
OR
Add atenolol 25 mg daily  50 mg daily (keep heart rate >55)
If not in control
• Consider medication non-adherence.
• Consider interfering agents (e.g., NSAIDs, excess alcohol).
• Consider white coat effect. Consider BP checks by medical assistant (e.g., two checks with 2 readings each, 1 week apart).
• Consider discontinuing lisinopril/HCTZ and changing to chlorthalidone 25 mg plus lisinopril 40 mg daily. Consider additional agents
(hydralazine, terazosin, minoxidil).
• Consider stopping atenolol and adding diltiazem to amlodipine, keeping heart rate >55.
• Avoid using clonidine, verapamil, or diltiazem together with a beta-blocker. These heart rate-slowing drug combinations may cause symptomatic
bradycardia over time.
• Consider secondary etiologies.
• Consider consultation with a hypertension specialist.
1. CKD is defined as albuminuria (>30 mg of albumin/g of creatinine) at any age and any level of GFR, or an estimated GFR or measured GFR <60 mL/min/1.73 m2 in people aged
<70 years. When weighing the risks and benefits of a lower BP goal for people aged 70 years or older with estimated GFR < 60 mL/min/1.73 m2, antihypertensive treatment
should be individualized, taking into consideration factors such as frailty, comorbidities, albuminuria, and estimation of non-age-related eGFR decline (e.g., if eGFR + ½ age is <85).
2. ACE-inhibitors and ARBs are contraindicated in pregnancy and not recommended in most women of childbearing age. calcium channel blockers and spironolactone (Pregnancy Risk Category C), and beta-blockers (Pregnancy Risk Category D) should only be used in pregnancy when clearly needed and the benefits outweigh the potential
hazard to the fetus. In the general black population, including those with diabetes, initial antihypertensive treatment includes a thiazide-type diuretic or CCB.
3. For patients with CKD, age 18-75 and intolerant to ACEI with cough and lacking pregnancy potential, losartan should be started prior to adding thiazide.
Special Considerations
HYPERTENSION TREATMENT FOR WOMEN
OF CHILDBEARING POTENTIAL
ff B
ecause half of all pregnancies are unplanned, unless there is a
compelling indication, do not prescribe medications contraindicated in
pregnancy, such as ACEIs/ARBs, to women of childbearing potential.
ff For women of childbearing potential taking medications contraindicated
in pregnancy, such as ACEIs/ARBs:
• Discuss the potential risks to the fetus should they become pregnant.
• Discuss practicing contraceptive measures with extremely low failure
rates (sterilization, implant, or IUD).
ff Advise women using ACEIs/ARBs to stop these medications and contact
their OB/GYN provider immediately if they become pregnant.
ff Advise women using ACEIs/ARBs for heart failure or cardiomyopathy
and become pregnant to contact their obstetrician immediately.
Their obstetrician, in consultation with cardiology, will substitute a
suitable alternative to avoid decompensation.
LIPID THERAPY IN PATIENTS TAKING HYPERTENSION MEDICATIONS
ff E valuate patients with hypertension for dyslipidemia and initiate or continue statin treatment according to their total cardiovascular risk profile.
ff Refer to the KP National Cardiovascular Risk and Dyslipidemia Clinician
Guide at:
http://cl.kp.org/pkc/national/cmi/programs/dyslipidemia/guideline/index.html
ff Determine the need to initiate or continue lipid-lowering therapy based
on ASCVD risk assessment using the AHA/ACC Pooled Cohort Equations:
http://my.americanheart.org/cvriskcalculator and
http://tools.cardiosource.org/ASCVD-Risk-Estimator/
ASPIRIN THERAPY IN PATIENTS TAKING
HYPERTENSION MEDICATIONS
ff E valuate patients with hypertension for aspirin use and initiate or
continue statin treatment according to their total cardiovascular risk
profile and risk of adverse events
ff Refer to the KP National Aspirin Clinician Guide at:
http://cl.kp.org/national/cmi/programs/cvd_risk_reduction/guideline/index.html
RECOMMENDATIONS FOR PATIENTS WITH
ACEI INTOLERANCE DUE TO COUGH
ff H
CTZ 25 mg, then 50 mg to achieve BP goal
ff Add losartan 25 mg, then 50 mg, then 100 mg to achieve BP goal
ff Add amlodipine 2.5 mg, then 5 mg, then 10 mg to achieve BP goal
TOOL 7. Dosage Range for Selected Antihypertensive Medications*
SELECTED ANTIHYPERTENSIVE MEDICATION
Thiazide-type Diuretics
Thiazide-type Diuretic Single Pill
Combinations
ACE Inhibitors (ACEI)
Long-Acting Dihydropyridine Calcium Channel
Blockers (CCB)
Angiotensin II Receptor Blockers (ARB)
Aldosterone Receptor Blocker
Beta-Blockers (BB)
USUAL DOSAGE RANGE
Chlorthalidone (Hygroton)
12.5 – 25 mg daily
Hydrochlorothiazide (HCTZ) (Esidrix)
HCTZ /lisinopril (Prinzide)
Spironolactone/HCTZ (Aldactazide)
Lisinopril (Zestril, Prinivil)
Captopril (Capoten)
Amlodipine (Norvasc)
Felodipine ER (Plendil)
Nifedipine ER (Procardia XL)
25 – 50 mg daily
10/12.5 mg - 20/25 mg BID
25/25 mg daily
10 – 40 mg daily
12.5 – 50 mg BID
2.5 – 10 mg daily
2.5 – 20 mg daily
30 – 90 mg daily
Losartan (Cozaar)
Spironolactone (Aldactone)
Atenolol (Tenormin)
Bisoprolol (Zebeta)
Carvedilol (Coreg)
Metoprolol (Lopressor)
Metoprolol ER (Toprol XL)
25 – 100 mg daily
12.5 – 25 mg daily
25 – 100 mg total, daily or BID
5 – 10 mg daily
3.125 – 37.5 mg BID
25 – 100 mg BID
25 – 200 mg daily
*Availability of medications may vary depending on regional formularies.
DISCLAIMER
TOOL Overview
TOOL 1.
TOOL 2.
TOOL 3.
TOOL 4.
TOOL 5.
TOOL 6.
TOOL 7.
Key Points
Definition of Hypertension (JNC 7)
Treatment Initiation
eGFR Calculator
Management of Adult Hypertension
BMI Calculator
Dosage Range for Seleceted
Antihypertensive Medications
Page 1
Page 1
Page 1
Page 2
Page 3
Page 2
Page 4
Kaiser Permanente Clinical Practice Guidelines, Clinician Guides, and Clinical Tools/Resources have been developed to assist
clinicians by providing an analytical framework for the evaluation and treatment of selected common problems encountered in
patients. They are not intended to establish a protocol for all patients with a particular condition. While the guidelines provide
one approach to evaluating a problem, clinical conditions may vary significantly from individual to individual. Therefore, the
clinician must exercise independent judgment and make decisions based upon the situation presented. While great care has
been taken to assure the accuracy of the information presented, the reader is advised that KP cannot be responsible for continued currency of the information, for any errors or omissions in this guideline, or for any consequences arising from its use.
These recommendations are not used to make utilization management determinations regarding the medical necessity of a
member’s care.
SOUL OF THE HEALER
Dorothy’s View
photograph
Bridget Bourgon, PA-C
This photograph was taken at sunrise from a hot air balloon above the town of Göreme
in the Cappadocia region of Turkey. Cappadocia is known for its natural pillar-like rock
formations, which ancient peoples carved into houses, churches, and monasteries.
Ms Bourgon is a Physician Assistant in Urgent Care at Kaiser Permanente Orange County in Santa Ana, CA.
73
CASE REPORTS
Beer Potomania—An Unusual Cause of Hyponatremia
Dean A Kujubu, MD; Ardeshir Khosraviani, MD
Perm J 2015 Summer;19(3):74-76
ABSTRACT
The first case of severe hyponatremia, since referred to as
beer potomania, in a heavy beer drinker patient was reported
in 1972. Electrolyte abnormalities are common findings
in patients with a history of heavy alcohol use. Excessive
consumption of beer in particular, which has a low solute
content (sodium concentration, 1.8 mEq/L and potassium
concentration, 7.2 mEq/L), to the exclusion of other solute
intake may result in severe hyponatremia. We report a case of
severe hyponatremia that occurred in a patient who, owing to
his underlying colon cancer, was drinking beer and ingesting
little other food. His hyponatremia improved with increased
solute intake and, upon correction of his serum sodium, he
had no subsequent neurologic sequelae.
INTRODUCTION
The first case of severe hyponatremia in a heavy beer drinker
patient was reported in 1972 by Gwinup et al.1 This condition has since been referred to as beer potomania. Electrolyte
abnormalities are common findings in patients with a history
of heavy alcohol use. In the study by Liamis et al,2 among
hospitalized patients with history of chronic alcohol consumption, 17.3% had hyponatremia. The excessive consumption
of beer in particular, which has a low solute content (sodium
concentration, 1.8 mEq/L; potassium concentration, 7.2
mEq/L), to the exclusion of other solute intake may result in
severe hyponatremia. We report a case of severe hyponatremia
that occurred in a patient who, owing to his underlying colon
cancer, was drinking beer and ingesting little other food. His
hyponatremia improved with increased solute intake and,
upon correction of his serum sodium, he had no subsequent
neurologic sequelae.
CASE PRESENTATION
A Hispanic man, age 84 years, with history of chronic
alcohol abuse and recently diagnosed stage IV sigmoid adenocarcinoma presented to the Emergency Department with
nausea, weakness, decreased appetite, and abdominal pain
for the past 3 to 4 days. The patient had been ingesting approximately 12 cans of beer daily in addition to his usual diet
for the preceding 50 years, but during the week before his
presentation, because of worsening abdominal pain, he was
drinking his habitual quantities of beer but otherwise eating
minimally. On physical examination, his temperature was
37.1°C, blood pressure 142/81 mmHg, pulse rate 78 beats/
min, without orthostatic changes, respiratory rate 18 breaths/
min, and oxygen saturation 97% on room air. He was in no
acute distress and did not appear intravascularly volume depleted. His lungs were clear bilaterally, and his heart sounds
were normal without murmurs. He had tenderness in the epigastric area without rebound tenderness, with normal bowel
sounds and no organomegaly. He was oriented and coherent
in conversation. His neurologic exam and deep tendon reflexes
were normal. He had no tremors.
The patient’s laboratory data showed white blood cells
15.4 × 1000/mcL, hemoglobin 12.7 g/dL, platelets 347 ×
1000/mcL, international normalized ratio 1.1, glucose 160
mg/dL, sodium 116 mEq/L, potassium 4.1 mEq/L, chloride
85 mEq/L, CO2 19 mEq/L, blood urea nitrogen 6 mg/dL,
creatinine 0.58 mg/dL, serum osmolality 250 mOsm/kg, uric
acid 3 mg/dL, phosphorus 2.8 mg/dL, calcium 8.3 mg/dL,
magnesium 1.1 mg/dL, alanine transaminase 20 U/L, aspartate transaminase 27 U/L, total bilirubin 0.8 mg/dL, thyroid
stimulating hormone 2.19 mcIU/ml, albumin 2.8 g/dL, and
cortisol 23.8 mcg/dL. His urinalysis showed specific gravity
1.005, pH 6, negative leukocyte esterase, negative nitrite,
white blood cells 0-2, red blood cells 0-3, urine sodium 35
mEq/L, urine chloride 37 mEq/L, urine potassium 11 mEq/L,
urine creatinine 26 mg/dL, and urine osmolality 182 mOsm/kg.
A computed tomography scan of his abdomen and pelvis
with intravenous contrast revealed a new abscess adjacent to
the previously seen sigmoid carcinoma with local lymphadenopathy and hepatic metastatic disease.
The patient received 1 L of 0.9% sodium chloride intravenously in the Emergency Department and was started on
antibiotics for the sigmoid abscess. The surgical consultant
did not recommend surgical intervention. He received intravenous thiamine and magnesium supplementation for his
history of heavy alcohol drinking and hypomagnesemia. He
was encouraged to increase his oral intake with a normal diet
as tolerated. He subsequently underwent a brisk diuresis of
approximately 1.8 L during the first 8 hours. His intravenous
fluid was promptly discontinued and the patient’s serum sodium was checked every 2 to 3 hours to monitor for overly
rapid correction. His serum sodium increased by 8 mEq/L
in the first 24 hours and 14 mEq/L in the first 48 hours. His
serum sodium remained between 130 mEq/L and 133 mEq/L
Dean A Kujubu, MD, is the Director of the Nephrology Fellowship program at the Los Angeles
Medical Center in CA. E-mail: dean.a.kujubu@kp.org. Ardeshir Khosraviani, MD, is a Nephrology
Fellow at the Los Angeles Medical Center in CA. E-mail: ardeshir.khosraviani@kp.org.
74
CASE REPORTS
Common Causes of Hyponatremia
Hyponatremia with high osmolality
• Hyperglycemia, mannitol infusion, advanced renal failure
Hyponatremia with normal osmolality
• Hyperlipidemia, paraproteinemia
Hyponatremia with low osmolality
• Hypovolemic hyponatremia
– Volume depletion with sodium loss in excess of water
• Hypervolemic hyponatremia
– Heart failure, cirrhosis, nephrotic syndrome
• Euvolemic hyponatremia
– Syndrome of inappropriate antidiuretic hormone,
reset osmostat
– Hypothryoidism, glucocorticoid deficiency, renal failure
– Primary polydipsia, beer potomania, low solute intake
– Medications, including thiazide diuretics
throughout the remainder of his hospitalization. He was closely
observed for any change in his neurologic status or signs and
symptoms of acute alcohol withdrawal. None appeared.
DISCUSSION
The most common electrolyte abnormality seen in clinical
practice is hyponatremia, which is also found in up to 30%
of hospitalized patients.3 In the study by Liamis et al,2 hyponatremia was the third most common electrolyte abnormality
detected in 127 hospitalized chronic alcoholic patients, with
a prevalence of 17.3%. Traditionally, the evaluation of hyponatremia begins with the determination of serum osmolality
followed by a clinical assessment of volume status (see Sidebar:
Common Causes of Hyponatremia). Most clinical hyponatremia is associated with a low serum osmolality.
In patients with normal renal function, excessive water
ingestion does not result in severe hyponatremia because of
the kidneys’ ability to excrete large amounts of free water,
provided the daily dietary intake of solute is normal. For
Management Recommendations for
Hyponatremia Caused by Beer Potomania
• Nothing by mouth except medications for 24 hours
• No intravenous fluids unless symptomatic
• Prescribe intravenous fluids in finite amounts if needed
• Intensive care status
• Check serum sodium every 2 hours
• Goals
– Serum sodium increase < 10 mEq/L in first 24 hours
– Serum sodium increase < 18 mEq/L in first 48 hours
• Reduce serum sodium levels if necessary
• Give any intravenous medications in sugar solution
(5% dextrose in water)
• If caloric intake is needed, use intravenous sugar solution
(5% dextrose in water)
example, if the normal daily intake of solute is between 600
mOsm/day and 900 mOsm/day for an individual on a typical
Western diet, and if the maximal urinary dilution capacity is
50 mOsm/kg, a person with normal kidney function would
be able to excrete between 12 L to 18 L of free water daily
without becoming hyponatremic. In contrast, if such a person
were to have a daily intake of only 200 mOsm to 300 mOsm
solute, his ability to excrete free water becomes limited to
4 L/day to 6 L/day provided he is able to dilute his urine to the
same degree.4 The intake of fluid in excess of this amount will
result in a dilutional hyponatremia. Moreover, the ingestion of
large volumes of fluid in these patients results in the washout
of the medullary urea concentration gradient, reducing the
kidneys’ ability to produce maximally dilute urine.5 When additional solute is provided, a brisk diuresis ensues, resulting in
rapidly increasing serum sodium concentrations, necessitating
careful, frequent monitoring as well as the administration of
electrolyte-free fluids or even antidiuretic hormone analogues
should the serum sodium rise by more than 8 mEq/24 hours
to 10 mEq/24 hours.
Precipitating the osmotic demyelination syndrome (ODS)
in chronically hyponatremic patients by infusing saline load
is a real danger.5 Case reports of ODS with rapid sodium correction in patients with beer potomania have been published.
In a literature review done by Sanghvi et al,6 of 22 patients
with beer potomania, 4 (18%) had ODS. Although infusion of hypertonic saline classically has been associated with
development of ODS, Karp and Laureno7 suggest that the
rapid correction of hyponatremia may occur even with infusion of normal saline or with fluid restriction alone, resulting
in ODS. On the basis of the underlying pathophysiology of
beer potomania, Sanghvi et al6 provided clinical recommendations for the management of these patients (see Sidebar:
Management Recommendations for Hyponatremia Caused
by Beer Potomania).
Because of the potential for overly rapid correction of serum sodium resulting in irreversible neurologic consequences
in these patients with beer potomania, intensive care and
frequent, serial measurements of serum electrolytes are recommended.
Our patient’s history, clinical euvolemic state, and prompt
diuresis in response to 1 L of intravenous normal saline administered in the Emergency Department led us to suspect that he
indeed had beer potomania. Our patient was consuming 12
cans (12 ounces each) of beer daily, which is approximately
4.3 L. According to the published content of beer, our patient’s solute intake was approximately 30 mEq potassium,
7 mEq sodium, 150 g carbohydrate, and 20 g protein per day.
If the metabolism of every 10 g of protein results in the generation of 50 mmoles of urea, we estimate that our patient’s
daily solute intake was in the range of 200 mOsm/day to
250 mOsm/day. Our patient was older so it was unlikely
that he would be able to maximally dilute his urine to
50 mOsm/kg, because with aging the kidneys’ ability to
produce dilute urine declines.8 The capacity is further limited by the washout of his medullary concentration gradient
owing to excessive fluid intake. If the maximally dilute urine
75
CASE REPORTS
our patient could produce was 75 mOsm/kg rather than
50 mOsm/L, with daily solute intake of 200 mOsm/day
to 250 mOsm/day he would need to drink only in excess
of 2.7 L to 3.3 L of fluid per day before he would become
hyponatremic, which was well below the range of his intake.
After the initial correction of his hyponatremia during the
first 48 hours, his serum sodium remained in the range of
130 mEq/L to 133 mEq/L for the rest of his hospitalization.
His persistent hyponatremia was most probably because of an
underlying syndrome of inappropriate antidiuretic hormone
secretion from metastatic cancer or a reset osmostat owing to
his poor nutritional state, malignant tumor, or alcoholism.9,10
His underlying tendency toward hyponatremia prevented his
serum sodium from overcorrecting while his solute intake
increased and his water intoxication resolved. v
Acknowledgment
Mary Corrado, ELS, provided editorial assistance.
References
1. Gwinup G, Chelvam R, Jabola R, Meister L. Beer drinker’s hyponatremia.
Inappropriate concentration of the urine during ingestion of beer. Calif Med 1972
Mar;116(3):78-81.
2. Liamis GL, Milionis HJ, Rizos EC, Siamopoulos KC, Elisaf MS. Mechanisms of
hyponatraemia in alcohol patients. Alcohol Alcohol 2000 Nov-Dec;35(6):612-6.
DOI: http://dx.doi.org/10.1093/alcalc/35.6.612.
3. Upadhyay A, Jaber BL, Madias NE. Incidence and prevalence of
hyponatremia. Am J Med 2006 Jul;119(7 Suppl 1):S30-5. DOI: http://dx.doi.
org/10.1016/j.amjmed.2006.05.005.
4. Berl T. Impact of solute intake on urine flow and water excretion. J Am
Soc Nephrol 2008 Jun;19(6):1076-8. DOI: http://dx.doi.org/10.1681/
ASN.2007091042.
5. Kelly J, Wassif W, Mitchard J, Gardner WN. Severe hyponatraemia secondary
to beer potomania complicated by central pontine myelinolysis. Int J Clin Pract
1998 Nov-Dec;52(8):585-7.
6. Sanghvi SR, Kellerman PS, Nanovic L. Beer potomania: an unusual cause of
hyponatremia at high risk of complications from rapid correction. Am J Kidney
Dis 2007 Oct;50(4):673-80. DOI: http://dx.doi.org/10.1053/j.ajkd.2007.07.015.
7. Karp BI, Laureno R. Pontine and extrapontine myelinolysis: a neurologic
disorder following rapid correction of hyponatremia. Medicine (Baltimore) 1993
Nov;72(6):359-73. DOI: http://dx.doi.org/10.1097/00005792-199311000-00001.
8. Sands JM. Urinary concentration and dilution in the aging kidney.
Semin Nephrol 2009 Nov;29(6):579-86. DOI: http://dx.doi.org/10.1016/j.
semnephrol.2009.07.004.
9. Kahn T. Reset osmostat and salt and water retention in the course of
severe hyponatremia. Medicine 2003 May;82(3):170-6. DOI: http://dx.doi.
org/10.1097/01.md.0000076007.64510.15.
10. DeFronzo RA, Goldberg M, Agus ZS. Normal diluting capacity in hyponatremic
patients. Reset osmostat or a variant of the syndrome of inappropriate
antidiuretic hormone secretion. Ann Intern Med 1976 May;84(5):538-42. DOI:
http://dx.doi.org/10.7326/0003-4819-84-5-538.
Hard Drinking
The effects of hard drinking are flatulence, loss of appetite,
morning sickness, wasting of the flesh and strength, tremblings,
pains of the stomach, cough, jaundice, dropsy, forgetfulness
and inattention, giddiness, diarrhea, broken sleep.
— William Heberden, MD, 1710-1801, English physician
76
CLINICAL MEDICINE
Dermatologic Diagnosis: Leukocytoclastic Vasculitis
Joseph Einhorn, MD; Joel T Levis, MD, PhD, FACEP, FAAEM
Perm J 2015 Summer;19(3):77-78
Leukocytoclastic vasculitis (LCV), also termed hypersensitivity vasculitis, is a small-vessel vasculitis with a reported
incidence rate of about 30 cases per million people per year
and is thought to affect men and women in equal numbers.1,2
The skin is the organ most commonly involved in LCV. Typical presentation is a painful, burning rash predominantly in
the lower extremities (Figure 1), with up to one-third of
patients presenting with trunk and upper extremity involvement.3 The most common skin manifestation of LCV is
palpable purpura.1-3 Other skin manifestations include maculopapular rash, bullae, papules, plaques, nodules, ulcers, and
livedo reticularis.4 Patients with LCV may also present with
arthralgias or arthritis involving the knees or ankles.4 The
differential diagnosis for LCV includes drug reaction with
eosinophilia and systemic symptoms (DRESS) syndrome,
amyloidosis, antiphospholipid syndrome, atrial myxoma,
Behcet disease, Churg-Strauss syndrome, granulomatosis with
polyangiitis, Henoch-Schonlein Purpura, urticarial vasculitis,
immune thrombocytopenic purpura, and meningococcemia.5
Multiple etiologic factors including drugs, infections, foods,
autoimmune diseases, collagen vascular diseases, and malignancies have been associated with LCV.1 Although the exact
pathogenic mechanism remains to be elucidated, circulating
immune complexes are believed to be involved.6
In the evaluation of patients with LCV, laboratory tests
including a complete blood count, erythrocyte sedimentation
rate, biochemistry profile with liver and renal function, and
urinalysis are useful in excluding other vasculitides, determining the presence of systemic disease, and identifying an associated disorder, which can provide prognostic information.4
Patients with suspected LCV presenting to the Emergency
Department may require parenteral analgesics for pain control, and those patients not requiring hospitalization should
be referred to a dermatologist upon discharge. Diagnosis
of LCV is confirmed on histologic examination of a biopsy
from the affected area that demonstrates perivascular and
vascular leukocytic infiltrates along with fibrinoid necrosis.1
Mild, skin-limited LCV does not require treatment apart
from rest, elevation of the legs, ice packs to the affected area,
and removal or treatment of the inciting cause.7 Presence of
arthralgia or arthritis requires use of nonsteroidal antiinflammatory drugs, or a short course of oral steroids (eg, prednisone
or methlprednisolone) at a dose of 1 mg/kg/day for 4 weeks
Figure 1. Lower extremities of a 31-year-old woman presenting to the
Emergency Department. The patient reported several days of arthralgias
and a moderately painful, burning rash involving the legs and extending to
the lower abdomen, preceded by a viral syndrome.
This image demonstrates nonblanching palpable purpura to the lower extremities with
some areas coalescing to form plaques. Findings are consistent with leukocytoclastic
vasculitis.
followed by a steroid taper. Most patients respond to such
treatment.8 A single-pulse dose of intravenous corticosteroids
(eg, methylprednisolone, 15 mg/kg) may be required, followed
by oral corticosteroids in more severe cases. Colchicine has
also reportedly been useful in patients with skin and joint
symptoms, though success in a small, randomized controlled
trial was limited.9 Colchicine should be used with caution in
persons with kidney disease and in pregnant women. Most
patients with cutaneous leukocytoclastic vasculitis are treated
in an outpatient setting. Inpatient care is needed in patients
who have severe systemic vasculitic syndromes and severe
organ dysfunction. In the absence of internal involvement,
the majority of cases of LCV resolve within weeks to months,
with approximately 10% of patients experiencing chronic or
recurrent disease.10 v
Joseph Einhorn, MD, is an Emergency Medicine Resident in the Stanford/Kaiser Emergency Medicine Residency
Program in CA. E-mail: jeinhorn@stanford.edu. Joel T Levis, MD, PhD, FACEP, FAAEM, is a Senior Emergency
Physician at the Santa Clara Medical Center, and Clinical Assistant Professor of Emergency Medicine (Surgery)
at Stanford University. He is the Medical Director for the Foothill College Paramedic Program in Los Altos, CA.
E-mail: joel.levis@kp.org.
77
CLINICAL MEDICINE
Dermatologic Diagnosis: Leukocytoclastic Vasculitis
References
1. Hussain N, Mustafa U, Davis J, et al. Indomethacin-related leukocytoclastic
vasculitis: a case report and review of literature. Case Rep Dermatol 2013
Jan;5(1):33-7. DOI: http://dx.doi.org/10.1159/000348240.
2. González-Gay MA, García-Porrúa C. Systemic vasculitis in adults in
northwestern Spain, 1988-1997. Clinical and epidemiologic aspects. Medicine
(Baltimore) 1999 Sep;78(5):292-308.
3. Brown K, Martin J, Zito S. Severe leukocytoclastic vasculitis secondary to the
use of naproxen and requiring amputation: a case report. J Med Case Rep 2010
Jul 1;4:204. DOI: http://dx.doi.org/10.1186/1752-1947-4-204.
4. Martinez-Taboada VM, Blanco R, Garcia-Fuentes M, Rodriguez-Valverde V.
Clinical features and outcome of 95 patients with hypersensitivity vasculitis.
Am J Med 1997 Feb;102(2):186-91. DOI: http://dx.doi.org/10.1016/S00029343(96)00405-6.
5. Gibson LE. A review of cutaneous vasculitis. Journal of the Egyptian Women’s
Dermatologic Society 2004;1(1):1-15.
6. Mackel SE, Jordon RE. Leukocytoclastic vasculitis. A cutaneous expression of
immune complex disease. Arch Dermatol 1982 May;118(5):296-301. DOI: http://
dx.doi.org/10.1001/archderm.1982.01650170010012.
7. Binamer Y. Dermacase. Can you identify this condition? Drug-induced
leukocytoclastic vasculitis. Can Fam Physician 2013 Jul;59(7):748, 750-1.
8. Fiorentino DF. Cutaneous vasculitis. J Am Acad Dermatol 2003 Mar;48(3):
311-40. DOI: http://dx.doi.org/10.1067/mjd.2003.212.
9. Sais G, Vidaller A, Jucglà A, Gallardo F, Peyrí J. Colchicine in the treatment
of cutaneous leukocytoclastic vasculitis. Results of a prospective, randomized
controlled trial. Arch Dermatol 1995 Dec;131(12):1399-402. DOI: http://dx.doi.
org/10.1001/archderm.1995.01690240061009.
10. Loricera J, Calvo-Río V, Ortiz-Sanjuán F, et al. The spectrum of paraneoplastic
cutaneous vasculitis in a defined population: incidence and clinical features.
Medicine (Baltimore) 2013 Nov;92(6):331-43. DOI: http://dx.doi.org/10.1097/
MD.0000000000000009.
Medicine
The critical sense and sceptical attitude of the Hippocratic school
laid the foundations of modern medicine on broad lines, and we
owe to it: first, the emancipation of medicine from the shackles of
priestcraft and of caste; secondly, the conception of medicine as
an art based on accurate observation, and as a science, an integral
part of the science of man and of nature; thirdly, the high moral
ideals, expressed in that most “memorable of human documents”
(Gomperz), the Hippocratic oath; and fourthly, the conception and
realization of medicine as the profession of a cultivated gentleman.
— Sir William Osler, MD, 1st Baronet, 1849-1919, Canadian physician
and one of four founding professors of Johns Hopkins Hospital
78
CLINICAL MEDICINE
ECG Diagnosis: Hyperacute T Waves
Perm J 2015 Summer;19(3):79
After QT prolongation, hyperacute T waves are
the earliest-described electrocardiographic sign of
acute ischemia, preceding ST-segment elevation.1
Hyperacute T waves are broad-based and symmetrical, usually with increased amplitude and often associated with a depressed ST take off.1 Hyperacute
T waves are most evident in the anterior chest leads
and are more apparent when a previous electrocardiogram is available for comparison.2 Hyperacute
T waves are noted early after the onset of coronary
occlusion and transmural infarction and tend to
be a short-lived structure that evolves rapidly into
ST-segment elevation.3 The electrocardiographic
differential diagnosis of the hyperacute T wave includes both transmural acute myocardial infarction
and hyperkalemia as well as early repolarization, left
ventricular hypertrophy, and acute myopericarditis.4
The principle entity to exclude is hyperkalemia—this T-wave morphology may be confused
with the hyperacute T wave of early transmural
myocardial infarction. In contrast to hyperacute
T waves associated with myocardial ischemia or
infarction, hyperkalemic T waves tend to be narrow
and peaked with a prominent or sharp apex.4 For
patients presenting with hyperacute T waves in the
setting of suspected myocardial ischemia or infarction, treatment includes symptomatic control with
nitroglycerin or morphine, oral antiplatelet agents
(aspirin), consideration of anticoagulation with unfractionated heparin, and obtaining frequent serial
12-lead electrocardiograms (every 5 to 10 minutes).
Prompt consultation with a cardiologist is indicated
in these cases. v
References
1. Goldberger AL. Hyperacute T waves revisited. Am Heart J 1982
Oct;104(4 Pt 1):888-90. DOI: http://dx.doi.org/10.1016/00028703(82)90038-2.
2. Nable JV, Brady W. The evolution of electrocardiographic
changes in ST-segment elevation myocardial infarction.
Am J Emerg Med 2009 Jul;27(6):734-46. DOI: http://dx.doi.
org/10.1016/j.ajem.2008.05.025.
3. Morris F, Brady WJ. ABC of clinical electrocardiography: acute
myocardial infarction—part I. BMJ 2002;324:831. DOI: http://
dx.doi.org/10.1136/bmj.324.7341.831.
4. Brady W, Morris F. Electrocardiographic abnormalities
encountered in acute myocardial infarction. J Accid Emerg Med
2000 Jan;17(1):40-45. DOI: http://dx.doi.org/10.1136/emj.17.1.40.
Figure 1. 12-lead electrocardiogram from a 47-year-old
man presenting to the
Emergency Department with
left-sided chest discomfort,
now resolved following
sublingual nitroglycerin.
Demonstrates normal sinus
rhythm with nonspecific ST-T
wave changes including flattening of T waves in the inferior and
lateral leads.
Figure 2. 12-lead electrocardiogram from same patient,
obtained 90 minutes later,
with patient now experiencing 5/10 left-sided chest
discomfort.
Demonstrates large, symmetric
T waves with depressed STsegment take off consistent
with hyperacute T waves in the
anterior leads V2-V4.
Figure 3. 12-lead electrocardiogram from same
patient as Figures 1 and 2,
obtained 10 minutes after
the electrocardiogram in
Figure 2.
Demonstrates > 1 mm
ST-segment elevation in the
anterior leads V2-V4, consistent
with an acute anterior wall
myocardial infarction.
Figure 4. 12-lead electrocardiogram from a 73-year-old
man with end-stage renal
disease and hyperkalemia
(serum potassium
7.6 mEq/L).
Demonstrates peaked T waves
in leads V3 and V4, consistent
with hyperkalemia.
Joel T Levis, MD, PhD, FACEP, FAAEM, is a Senior Emergency Physician at the Santa Clara Medical Center,
and Clinical Assistant Professor of Emergency Medicine (Surgery) at Stanford University. He is the Medical
Director for the Foothill College Paramedic Program in Los Altos, CA. E-mail: joel.levis@kp.org.
79
SOUL OF THE HEALER
So Much Sky
Colored pencils on paper
3” x 6”
Sharon Lee Hostler, MD
This image was sketched outside the Mabel Dodge Luhan House at the 2014 Taos Writing Workshop.
The artist, who grew up in the Green Mountains of Vermont and practices medicine near the Blue Ridge Mountains
of Virginia, saw the brilliant blue sky over Taos as dwarfing all, even the towering mountains of New Mexico.
Dr Hostler is the McLemore Birdsong Professor of Pediatrics at the University of Virginia School of
Medicine and Vice Provost for Faculty Development at the University of Virginia in Charlottesville.
80
COMMENTARY
Does Consuming Sugar and Artificial Sweeteners
Change Taste Preferences?
Carole Bartolotto, MA, RD
Perm J 2015 Summer;19(3):81-84
INTRODUCTION
ABSTRACT
Americans consume a lot of sugar, primarily from sweeteners that are added to
processed foods and beverages. Data from the US Department of Agriculture reveals
that in 2013, Americans consumed 22.3 teaspoons of added caloric sweeteners a
day, which is significantly more than the American Heart Association’s recommendation. Artificial and alternative sweeteners have also been added to a plethora of
foods. These sweeteners range from about 180 times sweeter to as much as 13,000
times sweeter than sugar. Consumption of both sugar and artificial sweeteners may
be changing our palates or taste preferences over time, increasing our desire for
sweet foods. Unfortunately, the data on this are lacking. In the summer of 2014, a
group of 20 people from Kaiser Permanente facilities throughout California agreed
to cut out all added sugars and artificial sweeteners for 2 weeks and then complete
a survey to determine whether their taste preferences had changed. After the 2-week
challenge, 95% of participants (18 out of 19 respondents) found that sweet foods
and drinks tasted sweeter or too sweet, 75% (15 out of 20 respondents) found that
other foods tasted sweeter, and 95% (19 out of 20 respondents) said moving forward
they would use less or even no sugar. Additionally, 86.6% of participants (13 out
of 15 respondents) stopped craving sugar after 6 days. Although this was a small
survey, the results suggest that using a 2-week sugar challenge can help to reset taste
preferences and make consuming less or no sugar easier. Physicians should consider recommending a sugar and artificial sweetener challenge to all their patients,
especially those with obesity, diabetes, or cardiovascular disease.
Figure 1. Sources of added sugars in the diets of the US population, ages 2 years and older, National
Health and Nutrition Examination Survey 2005-2006.
Sugars are simple carbohydrates found
naturally in fruit and milk. Although we
do get some of the sugar we consume
from these foods, much of our intake
comes from sugars that are added to processed foods and beverages. Cane sugar,
high-fructose corn syrup, agave, honey,
evaporated cane juice, and other forms
of sugar are added to products such as
sodas, cakes, cookies, and candies. They
are also added to many processed foods
such as breakfast cereals, pasta sauce,
yogurt, soymilk, barbeque sauce, and
bottled teas. In fact, using their new online database, the Environmental Working Group has found that almost 60% of
the 80,000 products evaluated contained
added sugar.1,2 For examples of sugar
content in commonly consumed foods,
see Sidebar: Examples of the Amounts of
Sugar Found in Processed and Restaurant
Foods and Drinks.
According to the Dietary Guidelines
for Americans 2010, our biggest source
of sugar is sugary drinks, which supply
35.7% of our intake.3 Almost 13% of
the sugar we consume is from grainbased desserts, such as cookies, cakes,
muffins, and scones (Figure 1).3
Most people have a natural propensity
for sweet foods and beverages. Data from
the US Department of Agriculture reveals
that in 2013, Americans consumed 22.3
teaspoons of added caloric sweeteners a
day. This includes sugar, high-fructose
corn syrup, and other sweeteners.4 The
consumption of sugars and sugary
drinks has been linked with obesity,
diabetes, heart disease, hypertension,
impaired lipid metabolism, inflammation, and an increase in cravings and
feelings of hunger, which is why major
health organizations have weighed in on
how much we should consume.5-13
Carole Bartolotto, MA, RD, is a Senior Consultant for Regional Health Education for the
Southern California Permanente Medical Group. E-mail: carole.a.bartolotto@kp.org.
81
COMMENTARY
Does Consuming Sugar and Artificial Sweeteners Change Taste Preferences?
New Recommendations for Sugar
In 2009, for the first time ever, the
American Heart Association came out with
recommendations for sugar consumption.7
For women, they recommend consuming
no more than 6 teaspoons or 100 calories
of added sugar each day. This is equivalent
to about 24 g of sugar. For men, they recommend no more than 9 teaspoons or 150
calories of added sugar a day. This is equal to
about 35 g of sugar. It is interesting to note
that one 12-ounce can of cola has about
10 teaspoons of sugar, putting the drinker,
whether a man or a woman, over the limit
recommended by the American Heart Association with just one item.
The World Health Organization’s new
draft guidelines say sugar consumption
should be less than 10% of total energy intake per day, but a reduction to below 5%
would have added benefits.14 Five percent
of 2000 calories would be 100 calories
(around 6 teaspoons or 24 g) of sugar per day.
Sugar, Artificial Sweeteners, and Health
Artificial sweeteners have also been
added to a plethora of foods for those
who want a sweet taste without the
calories. These sweeteners range from
about 180 times sweeter to as much
as 13,000 times sweeter than sugar.15
Recent research has linked artificial
sweeteners to a number of health problems, including metabolic syndrome, a
decrease in kidney function, and possibly even a disruption in the regulation of blood sugar caused by changes
in the microbiota.16-18 Although more
research is needed, these observational
and preliminary data have caused
many to rethink their use of artificial
sweeteners.
In addition to the health problems
associated with the use of sugars and
artificial sweeteners, their consumption
may be changing our palates or taste
preferences over time, increasing our
Examples of the Amounts of Sugar Found in Processed
and Restaurant Foods and Drinks
• 1 tsp sugar = 4 g
• Kiwi Strawberry Vitamin Water, 20 oz bottle—32 g1
• Yoplait Original Mountain Blueberry Yogurt, 6 oz—26 g2
• Oscar Mayer Lunchables Ham and Cheddar Cracker Stackers (with fruit
punch)—31 g3
• Silk Very Vanilla Soy Milk, 1 cup—15 g4
• Sweet Baby Rays Barbecue Sauce, 2 tbsp—16 g5
• Kellogg’s Smart Start Strong Heart Antioxidants Cereal, 1 cup—14 g6
• Starbucks Blueberry Scone—20 g7
• Subway 6” BBQ Oven Roasted Chicken Melt—17 g8
• Panda Express Orange Chicken (2 Entrée meal) with chow mein—47 g9
• California Pizza Kitchen Thai Crunch Salad (full)—48 g10
1. Glaceau vitamin water focus kiwi-strawberry nutrient enhanced water beverage from Vitaminwater [Internet].
Washington, DC: Nutritionix; last updated 2014 Dec 30 [cited 2015 Mar 17]. Available from: www.nutritionix.
com/vitaminwater/glaceau-vitamin-water-focus-kiwi-strawberry-nutrient-enhanced-water-beverage.
2. Calories in Yoplait Original Mountain Berry Yogurt [Internet]. San Francisco, CA: MyFitnessPal, Inc; 20052015 [cited 2015 Mar 17]. Available from: www.myfitnesspal.com/food/calories/yoplait-original-mountainberry-yogurt-73025358.
3. Nutrition information, diet info and calories in ham and cheddar stackers from Lunchables [Internet].
Spokane, WA: Albertsons; 2015 [cited 2015 Apr 6]. Available from: www.albertsons.com/pd/Oscar-MayerLunchables/Ham-and-Cheddar-Cracker-Stackers-Lower-Fat/11-oz/044700361177/.
4. Silk very vanilla soy milk: nutrition [Internet]. Broomfield, CO: WhiteWave Foods; 2015 [cited 2015 Mar 17].
Available from: http://silk.com/products/very-vanilla-soymilk.
5. Sweet Baby Ray’s Barbecue Sauce nutrition facts [Internet]. Henderson, NV: CalorieLab, Inc; 20002015 [cited 2015 Mar 17]. Available from: http://calorielab.com/brands/sweet-baby-rays-barbecuesauce/136/2005455.
6. Kellogg’s Smart Start Strong Heart Antioxidants cereal [Internet]. Battle Creek, MI: Kellogg Co; 2015 [cited 2015
Mar 17]. Available from: www.kelloggs.com/en_US/kelloggs-smart-start-strong-heart-antioxidants-cereal.html.
7. Blueberry scone [Internet]. Seattle, WA: Starbucks Coffee Company; c2015 [cited 2015 Feb 6]. Available
from: www.starbucks.com/menu/food/bakery/blueberry-scone.
8. BBQ oven roasted chicken melt [Internet]. Milford, CT: Doctor’s Associates, Inc; 2015 [cited 2015 Feb 6]. Available
from: www.subway.com/menu/product.aspx?CC=USA&LC=ENG&MenuTypeId=1&MenuId=53&ProductId=291.
9. Nutrition & allergen information [Internet]. Rosemead, CA: Panda Restaurant Group, Inc; 2015 [cited 2015
Feb 6]. Available from: https://s3.amazonaws.com/PandaExpressWebsite/files/pdf/Nutrition.pdf .
10. Nutritional menu guide [Internet]. Los Angeles, CA: California Pizza Kitchen, Inc; 2014 Jul [cited 2015 Feb
6]. Available from: http://info.cpk.com/documents/nutrition_facts.pdf.
82
desire for sweet foods. Unfortunately,
the data on this are lacking.
I asked Marion Nestle, PhD, for her
thoughts on the impact of sugar and
artificial sweeteners on the palate. She
told me, “Sugar is sweet and everyone
loves it. Artificial sweeteners give the
illusion of sweetness and not everyone
loves them. People get used to a level of
sweetness that tastes good to them. The
more sugar we eat, the more it takes to
reach that taste point. To people deprived of sugar (do any still exist?), even
a little tastes delicious. At this point,
just about everyone would be healthier
eating less sugar and enjoying it more”
(Marion Nestle, PhD, personal communication; 2014 Oct 24).a
AN ALTERED PALATE
I have seen for myself the impact that
sugar can have on taste preferences. As
a child I loved sugar. I was the one who
ate 7 cupcakes at a birthday party and
would eat all my Easter candy in a day.
For a number of reasons, I decided to
cut out sugar when I was in my late 20s.
Two things happened pretty quickly:
1) I found out I did not crave sugar
once I cut it out, and 2) other foods
tasted sweeter to me, foods that had
never tasted sweet before, such as Wheat
Thins. I realized that my palate appeared
to be changing in response to the lack
of sugar in my diet, just as the palate
can change when salt is limited.19 This
idea was supported by what happened
one day when I made a smoothie for
several friends using only strawberries
and bananas. The smoothie tasted great
to me and was really sweet. However,
to my surprise, every one of my friends
said it was too sour and they wanted to
add sugar.
I also noticed that people who consumed a lot of artificial sweeteners
seemed to have an altered palate. A
case in point is a friend who uses artificial sweeteners every day. One year at
Thanksgiving she added several packets
of an artificial sweetener to a dessert
because it was not sweet enough for
her. Although it was more than sweet
enough for everyone else, her copious
use of artificial sweeteners seemed to
have altered her palate and made supersweet foods normal for her.
COMMENTARY
THE SUGAR CHALLENGE
Because there is a lack of data on the
impact of sugar and artificial and alternative sweeteners on the palate, I decided to
try a 2-week sugar and artificial sweetener
challenge and then look at its impact on
taste. In the summer of 2014, a group of
20 people from Kaiser Permanente facilities throughout California agreed to try
the challenge (see Sidebar: Sugar and Artificial Sweetener Challenge Instructions).
After the two-week challenge, I asked
the participants to fill out a survey to
determine whether their palate had
changed (see Sidebar: Survey Results of
the Two-Week Challenge).
Some comments about the challenge were
• “I think this challenge really helped
me to reset my palate. Before the
challenge I did not eat a lot of
sugar, but would put stevia in my
Sugar and Artificial Sweetener Challenge Instructions
For two weeks, cut out all added sugars and artificial sweeteners.
1.Do not add any form of sugar (see list below) or any alternative sweeteners to foods
or drinks! Avoid artificial and alternative sweeteners including Sweet ‘N Low, Equal,
Splenda, monk fruit, neotame, stevia, and xylitol, etc. No added sweeteners!
2.Avoid all sweetened sodas, bottled teas, sports drinks, energy drinks, fruit drinks
and juice (even 100% juice), specialty coffee drinks, and any other liquid with
added sweeteners.
3.Cut out any foods that have a lot of added sugar or any artificial sweeteners such as
cookies, cake, candy, yogurt, soy or almond milk, breakfast cereals, energy bars, or
other foods. Read labels! Aim for food with 5 g or less of added sugar. Look at the
ingredient lists of foods you eat for other names for sugar such as the following:
Sucrose
High-fructose corn syrup Honey
Corn syrup
Maple syrup
Molasses
Agave
Evaporated cane juice
Barley malt
Dextrose
Coconut palm sugar
Cane sugar
Grape sugar
Turbinado sugar
Raw sugar
Brown sugar
Powdered sugar
Brown rice syrup
Date sugar
Note: Plain unsweetened milk and yogurt and fruit contain natural sugar, which is
fine because it is not added sugar. Limit dried fruits to 2 servings per day and fresh
fruits to 4 to 5 servings per day.
Survey Results of the Two-Week Challenge
Participants craved sugar after cutting it out, but cravings went away for
• 53.3% of participants after 3 days (8 out of 15 people responding)
• 86.6% of participants after 6 days (13 out of 15 people responding)
After the 2-week challenge:
• 95% of participants found that sweet foods and drinks tasted sweeter or too
sweet (18 out of 19 people responding)
• 75% found that other foods, such as baby carrots, apples, or crackers, tasted
sweeter (15 out of 20 people responding)
• 95% said moving forward, they would use less or even no sugar (19 out of 20
people responding)
• 35% said they lost weight (7 out of 20 people responding)
Eating out and social events were identified as problematic, so creating a plan of
action to deal with these situations, including bringing a healthy dessert such as
fresh fruit, was recommended.
Because many of the foods participants regularly ate contained more sugar than
they anticipated, taking a look at food items such as breakfast cereals, alternative
milk drinks, sauces, and drinks and finding lower- or no-sugar options before the
challenge was also recommended.
tea, oatmeal, and yogurt daily. Now
I enjoy the flavor of it without the
added sweetener.”
• “I enjoyed the challenge; it opened
my eyes to how many processed products add sugar. Thank you for helping
me move on to a healthier lifestyle.”
• “I rediscovered that I like my morning
espresso unsweetened—used to drink
it that way before getting hooked on
sweetener. Will not go back. Also
found that adding raisins to oatmeal
eliminated need to use a couple packets of Splenda.”
• “I realized I was emotionally dependent on these evening snacks and they
were not contributing to my goals
around weight loss/maintenance. It
was a good exercise.”
Many of us eat and drink too much
sugar and would benefit from consuming less of it. Although this was a small
survey, the results suggest that we can
make consuming less or no sugar easier
by cutting out sugar and artificial sweeteners for two weeks. We can also let
our patients know that cravings seem
to go away for most people after just
six days and that food and desserts will
taste sweeter for most people after the
challenge. Finding processed foods with
less added sugar, eating more real foods
instead of processed foods, choosing
fruit for dessert, and having some tasty
dessert recipes that do not add sugar,
can also help patients move forward
with a low- or no-sugar diet. Two of the
best recipes from a Kaiser Permanente
healthy dessert contest (banana cream
pie and watermelon and berry skewers)
follow this article and are worth trying.
CONCLUSION
Eating fewer processed foods and
choosing more real, whole, and plantbased foods make it easy to consume less
sugar. These changes will also improve
the overall quality of our diet, which is
important for optimal health.
In a very real sense, we are being set
up to desire and consume more and more
sugar. Using a two-week challenge to
reset our palates can help our patients—
and us—more easily transition to a
healthier diet with less sugar and alternative and artificial sweeteners. Physicians
should consider recommending a sugar
83
COMMENTARY
and artificial sweetener challenge to all
their patients to help them limit or avoid
added sugars, especially those with obesity, diabetes, or cardiovascular disease. v
5.
New York University Professor in the Department of
Nutrition, Food Studies, and Public Health, New York, NY.
6.
a
disclose.
7.
Acknowledgment
assistance.
References
1. Strom S. Food Scores, a new web service,
ranks grocery items on ingredients and nutrition
[Internet]. New York, NY: The New York Times;
2014 Oct 27 [cited 2015 Feb 6]. Available from:
www.nytimes.com/2014/10/28/business/foodscores-ranks-grocery-items-on-ingredients-andnutrition.html?_r=0.
2. EWG’s food scores [Internet]. Washington, DC:
Environmental Working Group; c2015 [cited 2015
Feb 6]. Available from: www.ewg.org/foodscores.
3. US Department of Agriculture; US Department
of Health and Human Services. Dietary
guidelines for Americans, 2010. 7th ed [Internet].
Washington, DC: US Government Printing Office;
2010 Dec [cited 2015 Feb 6]. Available from:
www.health.gov/dietaryguidelines/dga2010/
DietaryGuidelines2010.pdf.
4. Sugar and Sweeteners Yearbook Tables: US
Consumption of Caloric Sweeteners: Table 51-53
[Internet]. Washington, DC: US Department of
Agriculture Economic Research Service;
2015 Apr 2 [cited 2015 Apr 6]. Available from:
8.
9.
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11.
www.ers.usda.gov/data-products/sugar-andsweeteners-yearbook-tables.aspx#25512.
Vartanian LR, Schwartz MB, Brownell KD. Effects
of soft drink consumption on nutrition and health:
a systematic review and meta-analysis. Am J
Public Health 2007 Apr;97(4):667-75. DOI: http://
dx.doi.org/10.2105/AJPH.2005.083782.
Malik VS, Popkin BM, Bray GA, Després JP,
Willett WC, Hu FB. Sugar-sweetened beverages
and risk of metabolic syndrome and type 2
diabetes: a meta-analysis. Diabetes Care
2010 Nov;33(11):2477-83. DOI: http://dx.doi.
org/10.2337/dc10-1079.
Johnson RK, Appel LJ, Brands M, et al; American
Heart Association Nutrition Committee of the
Council on Nutrition, Physical Activity, and
Metabolism and the Council on Epidemiology
and Prevention. Dietary sugars intake and
cardiovascular health: a scientific statement
from the American Heart Association. Circulation
2009 Sep 15;120(11):1011-20. DOI: http://dx.doi.
org/10.1161/CIRCULATIONAHA.109.192627.
Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA
Intern Med 2014 Apr;174(4):516-24. DOI: http://
dx.doi.org/10.1001/jamainternmed.2013.13563.
Brown IJ, Stamler J, Van Horn L, et al; International Study of Macro/Micronutrients and Blood
Pressure Research Group. Sugar-sweetened
beverage, sugar intake of individuals, and their
blood pressure: international study of macro/
micronutrients and blood pressure. Hypertension 2011 Apr;57(4):695-701. DOI: http://dx.doi.
org/10.1161/HYPERTENSIONAHA.110.165456.
Welsh JA, Sharma A, Abramson JL, Vaccarino V,
Gillespie C, Vos MB. Caloric sweetener consumption and dyslipidemia among US adults. JAMA
2010 Apr 21;303(15):1490-7. DOI: http://dx.doi.
org/10.1001/jama.2010.449.
Fried SK, Rao SP. Sugars, hypertriglyceridemia,
and cardiovascular disease. Am J Clin Nutr 2003
Oct;78(4):873S-880S.
Banana Cream Pie (adapted with permission from Living on Live Food by Alissa Cohen)
Watermelon and Berry Skewers
Submitted by Ed Hernandez, Kaiser Permanente, Senior PC/LAN Analyst, Regional
Offices, Pasadena, CA
Submitted by Darin Kliem, Kaiser Permanente,
Senior Consultant, QRM/Quality Operations,
Regional Offices, Pasadena, CA
Ingredients
Crust
1 cup raw almonds
1 cup dates (soaked)
1 cup shredded coconut
Filling
6 small ripe bananas
1 cup shredded coconut
½ peeled apple
1 teaspoon pure vanilla
½ teaspoon carob powder (you can also use
unsweetened cocoa)
Instructions
1. Mix crust ingredients in a food processor and form into a pie plate.
2. Mash 2 bananas and place in a blender with the apple, 3/4 cup of
coconut, and vanilla. Blend until smooth.
3. Remove and place in bowl, slice the remaining bananas, and mix into
the filling.
4. Pour into pie crust and sprinkle with carob and the remaining coconut.
84
12. Aeberli I, Gerber PA, Hochuli M, et al. Low
to moderate sugar-sweetened beverage
consumption impairs glucose and lipid
metabolism and promotes inflammation in healthy
young men: a randomized controlled trial. Am
J Clin Nutr 2011 Aug;94(2):479-85. DOI: http://
dx.doi.org/10.3945/ajcn.111.013540.
13. Lennerz BS, Alsop DC, Holsen LM, et al. Effects
of dietary glycemic index on brain regions
related to reward and craving in men. Am J Clin
Nutr 2013 Sep;98(3):641-7. DOI: http://dx.doi.
org/10.3945/ajcn.113.064113.
14. Draft guideline: sugars intake for adults and
children [Internet]. Geneva, Switzerland: The
World Health Organization; c2015 [cited 2015
Feb 9]. Availabe from: www.who.int/nutrition/
sugars_public_consultation/en/.
15. Artificial sweeteners [Internet]. Boston, MA:
Harvard T.H. Chan School of Public Health;
c2015 [cited 2015 Feb 9]. Available from: www.
hsph.harvard.edu/nutritionsource/healthy-drinks/
artificial-sweeteners/.
16. Dhingra R, Sullivan L, Jacques PF. Soft
drink consumption and risk of developing
cardiometabolic risk factors and the metabolic
syndrome in middle-aged adults in the
community. Circulation 2007 Jul 31;
CIRCULATIONAHA.107.689935.
17. Lin J, Curhan GC. Associations of sugar and
artificially sweetened soda with albuminuria and
kidney function decline in women. Clin J Am Soc
Nephrol 2011 Jan;6(1):160-6. DOI: http://dx.doi.
org/10.2215/CJN.03260410.
18. Suez J, Korem T, Zeevi D, et al. Artificial
sweeteners induce glucose intolerance by
altering the gut microbiota. Nature 2014
Oct 9;514(7521):181-6. DOI: http://dx.doi.
org/10.1038/nature13793.
19. Beauchamp GK, Bertino M, Engelman K.
Modification of salt taste. Ann Intern Med
1983 May;98(5 Pt 2):763-9. DOI: http://dx.doi.
org/10.7326/0003-4819-98-5-763.
Ingredients
1 small bottle balsamic vinegar reduced
over low heat until it has reduced to
25% of its original volume. Let cool.
Mint leaves
Assorted berries (blueberries,
strawberries, and/or raspberries)
Watermelon cut into 1-inch cubes
Instructions
1. Skewer berries from smaller to larger,
then skewer 1 mint leaf, and lastly
the watermelon.
2. Drizzle a plate with the balsamic
vinegar and place the skewered fruit
over the balsamic vinegar.
COMMENTARY
Special Report
New Kid on the Block Turns Ten! The Brief, Remarkable History
of the National Physicians Alliance
Jean Silver-Isenstadt, MD, PhD
Perm J 2015 Summer;19(3):85-89
ABSTRACT
Founded in 2005 by General Surgeon Lydia J Vaias, MD, MPH, the National
Physicians Alliance is a 501c3 public charity with a mission to create research and
education programs that promote health and foster active engagement of physicians
with their communities to achieve high-quality, affordable health care for all. The
National Physicians Alliance offers a professional home to physicians across medical
specialties who share a commitment to professional integrity and health justice. As
the organization celebrates its tenth birthday, the history and scope of this missionaligned group are described.
INTRODUCTION
It is not a coincidence that the National Physicians Alliance (NPA)—a
nonpartisan, multispecialty organization of physicians and others committed to social justice and health care
reform—was founded by a surgeon from
Kaiser Permanente (KP). To hear Lydia
Vaias, MD, MPH talk about KP is to
hear the linkages laid bare:
“What’s great about [KP] is its alignment. [KP] allows me to practice in a
model where I can focus on the values
of medicine instead of on money. I get
paid to do the right thing for the patient.
Years ago, the [KP] system was mocked.
People were once embarrassed to say
they worked there. It wasn’t until very
recently that people have come to see
[KP] as a leading light, delivering health
care around a set of values.” (Lydia Vaias,
MD, MPH, personal communication;
2015 Jan 29.)a
National Physicians Alliance logo.
Ten years ago, Dr Vaias set out to organize physicians anew. “There are few
physicians in this country who practice
in settings that align the payors’, providers’, and hospitals’ incentives to keep
patients at the center of care. I feel so
lucky to be here at this time in history.”
(Lydia Vaias, MD, MPH; personal communication; 2015 Jan 29.)a
1993: THE CALL BEYOND CALL
Dr Vaias wasn’t looking for me when
she called my house back in 2005. She
was looking for her old medical school
buddy, my husband Ari Silver-Isenstadt,
MD, MSEd, with whom she and a few
others had organized 6 separate chapters of the American Medical Student
Association (AMSA) about a decade
earlier. In October 1993, student chapters from Hahnemann, Jefferson, the
Medical College of Pennsylvania, the
Philadelphia College of Osteopathic
Medicine, the University of Pennsylvania, and Temple University joined forces
as “Philadelphia AMSA” and delivered
an unprecedented regional conference
that laid the groundwork for generational change in medicine. They called
the conference “Physician Activism: The
Call Beyond Call.” Hugely ambitious,
the program offered 5 to 6 concurrent
tracks during 2 1/2 days and featured 75
Program from the October 1993 Philadelphia
American Medical Student Association
conference.
speakers, including M Joycelyn Elders,
MD, the US Surgeon General. Hoangmai Pham, then a 3rd-year student at
Temple University and now Director
of the Seamless Care Models Group at
the Center for Medicare and Medicaid
Innovation Center, served as Chair
of the Programming Committee. The
conference was a smash hit, drawing
more than 600 registrants—and it did
so without any pharmaceutical industry
sponsorship or staff support. AMSA’s
national president, David Evans, MD,
set the event’s tone in the printed program’s welcome letter: “It is activism that
rounds out our education … .”
Philadelphia AMSA was the twinkle
in the eye—the spark. Twelve years later,
Dr Vaias was on the phone, bringing the
band back together to launch the NPA.
I had helped with the conference
too, although in 1993 I was not yet a
medical student. At the University of
Jean Silver-Isenstadt, MD, PhD, is the Executive Director of the National Physicians
Alliance in Washington, DC. E-mail: jean@npalliance.org.
85
COMMENTARY
New Kid on the Block Turns Ten! The Brief, Remarkable History of the National Physicians Alliance
Pennsylvania, I was a doctoral student,
studying the history and sociology of
medicine, specifically 19th century
health reform movements. I explored
social change efforts led by utopian radicals and feminists—progressive troublemakers who challenged the use of corsets
and bloodletting, who touted exercise
and bathing, who fought for women’s
right to education and self-ownership.
Across campus, my husband and
his medical school classmates got to
know their cadavers, took countless
exams, and learned their way around
the wards. Their professors recycled
the old adage: Fifty percent of what
we will teach you is wrong; we just
don’t know which 50%. The lecturers
were playfully referring to the content
of their slide sets—acknowledging
dynamic scientific change—but they
may as well have been referring to the
curricular priorities themselves, the
physical plant and workflow of the
hospital, the food in the cafeteria, the
nature of clinical communication, the
financing of health care, the workforce
… or even the 50% estimate.
Dr Vaias went on to become a general
surgeon with a master’s degree in public
health. She moved to Long Beach, CA,
joined the KP system and, in 2005, was
just beginning a three-year term on the
Board of the Southern California Permanente Medical Group. My husband
became a Baltimore-based general pediatrician and I went to medical school
myself. It was organized medicine’s
muted response to the Terri Schiavo
case (a nationally debated legal struggle
involving prolonged life support)1 that
led Dr Vaias to start rounding up past
AMSA leaders. She was dismayed by the
political grandstanding but even more
so by the house of medicine, which
seemed less engaged in repairing its
own broken systems than in deepening
ties with industry. Like many others,
she saw the medical profession drifting
from its core values. Patients were not at
the heart of health care. I remember Ari
and I were chopping stir-fry ingredients
that spring evening ten years ago when
Dr Vaias called with a characteristically
modest proposal: “Let’s fix this.”
Make No Small Plans
The NPA’s first official organizing effort took place at AMSA’s 55th convention in Washington, DC, where many
past student leaders had gathered to
honor Paul R Wright, the organization’s
beloved Executive Director who was
retiring after 30 years in the position.
In a dedicated side room reserved for
the discussion, approximately thirty former leaders of the organization agreed
that the time had come to build a new
professional home for physicians across
specialties—an organization that would
Meeting with lawmakers on Capital Hill, National Physicians Alliance members: (left to right)
Charu Sawhney, MD; Lydia Vaias, MD, MPH; Judy Zerzan, MD; Bethany Picker, MD; Marc Dalton, MD;
Rupin Thakkar, MD; Stephen R Smith, MD, MPH; Jean Silver-Isenstadt, MD, PhD; Mara Merritt, MD;
and Lenny Lesser, MD.
86
not function as a trade association,
but rather as a community whose first
concern was patients. It was something
AMSA members had imagined building since their split from the American
Medical Association (AMA) 38 years
earlier. (AMSA had begun in 1950 as
a student branch of the AMA but split
off in 1967 after its parent organization
had opposed the creation of Medicare
and showed insufficient support for
the civil rights and community health
movements.)2
The group pledged $20,000 in immediate support of NPA’s launch and
scheduled a follow-up meeting at
AMSA’s headquarters in Reston, VA.
During the next year, an executive planning committee met for 2-hour phone
calls every Friday afternoon. It was a
monumental gift of volunteer energy
from practicing physicians, all inspired
by Dr Vaias’s mantra (with a hat-tip to
Joan Baez): “The antidote to despair is
action.”
It helped that the group included
longtime friends with a shared organizational history. It also helped that they
had taken different professional paths.
Stephen S Cha, MD, MHS—currently
the Chief Medical Officer for the Center on Medicaid and CHIP Services—
had recently completed his internal
medicine residency at Montefiore in
New York and was a Robert Wood
Johnson Foundation Clinical Scholar
at Yale. David V Evans, MD—now an
attending physician at the University
of Washington—had for the previous
decade practiced family medicine in the
small rural town of Madras, OR. David
Grande, MD, MPA—now an attending physician of internal medicine at
the University of Pennsylvania—was
a Robert Wood Johnson Foundation
Health and Society Scholar at the
University of Pennsylvania; his policy
research focused on the health of
vulnerable populations. Kavita Patel,
MD, MS—now Fellow and Managing
Director at the Brookings Institution
after two years at the White House and
time on Capitol Hill—was working on
health policy at the RAND Corporation. Alexa Oster, MD—now a Medical
Epidemiologist in the Centers for Disease Control and Prevention’s Division
COMMENTARY
of HIV/AIDS Prevention—was in the
midst of her residency in primary care
internal medicine at the University of
California, San Francisco/San Francisco
General Hospital. (I remember her often
biking between clinical sites during our
phone calls.) Stephen R Smith, MD,
MPH—now retired from academia and
practicing family medicine part-time
at a community health center in New
London, CT, was an Associate Dean at
the Warren Alpert Medical School of
Brown University when he joined the
NPA’s founding executive committee.
After my own years in the medical
archives studying the audacious work
of 19th-century health reformers, I
found myself unexpectedly surrounded
by health reformers focused on the 21st
century. But more than that, I found
myself surrounded by something crystalline and rare: a group of brilliant
people who were full of initiative but
not full of ego—collaborative, funny,
optimistic physicians who were singularly focused on making health care better for their patients. And they worked
like demons.
Logo for The Unbranded Doctor campaign.
Unbranded Doctors
Developing an organizational structure, finalizing a mission and bylaws,
building a Web site, formally incorporating, and myriad other details involved
lengthy discussion. But one decision was
easy: the NPA would not accept funding
from pharmaceutical or medical device
companies. Out of the gate, this made
NPA unique among medical organizations. Everywhere, financial conflict
of interest was compromising medical
research, education, and practice.3 It
was not only eroding patients’ trust in
their physicians, but also eroding trust
within the profession. Commitment to
conflict-free leadership was an undisputed core value of the NPA; because it
so clearly distinguished the organization
from others, the “Unbranded Doctor
Campaign” became our introductory
calling card.
Through this advocacy campaign—an
ally of the “No Free Lunch” movement
and AMSA’s “PharmFree” efforts—NPA
voiced loud concern over the scope and
influence of pharmaceutical marketing
tactics; supported full transparency regarding industry payments to physicians
and medical institutions; challenged the
AMA’s lucrative sale of personal Physician Masterfile records for industry
data mining and the legitimacy of data
mining itself; and called on physicians
to take the reins and simply stop accepting industry largesse. These efforts
all sought to ensure that medical education, research, and clinical decisions are
guided by scientific evidence and not by
marketing hype.
A different issue would have been an
easier lift and surely a more enticing
recruitment strategy—one that didn’t
ask physicians to give up the comforts
of free continuing medical education
dinners at posh restaurants; coffee and
donuts delivered right to the office by
cheerful, healthy drug reps; generous
speaking fees, etc—but the profession
had grown complacent about these entanglements and therefore complicit in
the marketing enterprise. This contamination of purpose had to be addressed.
Just as the AMA was launching a $60
million new ad campaign depicting
physicians as “everyday heroes,” the
NPA’s Unbranded Doctor Campaign
was pointing out the dirt under the rugs
and the mold in the bathroom tiles. We
were handing out buckets and mops by
way of recruitment: join the NPA—help
us clean our house. We knew the only
way to restore trust in medicine would
be to earn it.
Transparency about industry payments to physicians and hospitals is now
mandated by the Sunshine Act section
of the Affordable Care Act (ACA)4—a
component of the law that the NPA
fought hard to include and continues
to defend. This year, NPA President
William B Jordan, MD, MPH, was
featured on CSPAN commenting on
how far we’ve come but also on what
still goes unreported, for example free
medication samples that remain at the
heart of marketing but are unmentioned
in the ACA’s Sunshine Act provisions.
These provisions require manufacturers
of drugs, medical devices, and biologics
that participate in US federal health care
programs to report certain payments
and items of value given to physicians
and teaching hospitals for inclusion in
a content management system database
known as Open Payments.5 The Open
Payments Web site enables anyone to
search physicians and institutions by
name to learn the details of their financial relationships with industry. Thanks
in many ways to the work of the NPA, it
has become less comfortable for physicians to accept these payments, let alone
make light of them. For the first time,
researchers, journalists, policymakers,
physicians, and patients are gaining access to alarming data about the magnitude and direction of industry cash flow
in the system. It’s a necessary first step in
opening up space for substantive reform.
Trust in a Trustworthy System
This “pharma work” often set the
NPA apart from other physician organizations, testifying on panels and working with consumer advocacy groups
quite literally opposite our professional
siblings who were defending the status
quo. It was then that we could most
clearly see the void we were filling: patients needed physician allies.
From the outset, NPA’s founders were
determined to protect the organization
from ever becoming a doctors’ lounge.
The board of directors was structured
to include nonphysicians to ensure that
no discussions of patients’ best interests
would take place without patients. Very
naturally, the NPA found itself working
in regular coalition with groups ranging from Community Catalyst and the
National Center for Health Research
to the National Committee to Preserve
Social Security and Medicare and the
Law Center to Prevent Gun Violence.
The NPA board was proud to be the
first physician organization to join the
Health Care for America Now! coalition
in support of the ACA’s passage—a
coordinated effort of more than 1000
national and state-based groups dedicated to achieving federal health reform
and defending Medicare and Medicaid.
87
COMMENTARY
In 2014, the NPA was honored to have
Consumer Reports host our 9th annual
conference at their National Testing and
Research Center in Yonkers, NY.
Warm relationships with such allies
encouraged NPA members—who valued not only the organization’s bridgebuilding instincts, but also the NPA’s
willingness to step outside the profession’s usual comfort zones—to struggle
publicly with medicine’s problems and
to champion civic engagement.
I will never forget Gene Copello,
MSW, MDiv, PhD, late co-chair of
NPA’s Secure Health Care for All campaign, softly assuring other members
of the NPA’s board back in 2008: “The
NPA will succeed because it has to succeed. Patients need NPA to succeed.”
The room fell silent with the weight of
this charge. Dr Copello, whose doctorate had focused on medical ethics and
public policy, was then serving as the Executive Director of the AIDS Institute.
He died that year, unable
to see the passage of the
… physicians [taking]
ACA 4; the NPA’s Comore responsibility
pello Health Advocacy
Fellowship was named
for their role as
in his memory.
stewards of limited
It had become clear
clinical resources
that
if we wanted health
… quickly took
reporters to interview
shape as the NPA’s
physicians who voiced
Good Stewardship
a different perspective
Project, funded by
from that of traditional
the American Board
guilds, we would have
of Internal Medicine
to provide advocacy,
Foundation …[which]
media, and communihas since blossomed
cations training to physicians who viewed policy
under the American
through the lens of its
Board of Internal
potential impact on paMedicine Foundation’s
tients. Becky Martin,
direction into the
NPA’s Director of Projcelebrated Choosing
ect Management and
Wisely campaign.
a seasoned community
organizer, has for years
connected NPA Fellows and other members to local opportunity and opened up
relationships that fuel lasting change.
Advocacy, let alone “activism,” are
terms rarely associated with white-coat
professionalism. Yet our democratic
society grants enormous social capital
to the medical degree, and physicians
88
are coming to understand advocacy
skills as part of their responsibility to
patients. The white coat itself may have
more benefit for patients when worn
at a public podium than when worn in
the hospital.
The NPA’s immediate past president,
James Scott, MD, discovered the organization at a 2009 health reform rally in
Washington, DC, where NPA leaders
David Evans, MD, and Valerie Arkoosh,
MD, MPH, spoke boldly in support
of federal health reform. Dr Scott had
flown from Oregon to take part in the
growing movement for quality, affordable health care for all. As he described it
in a recent e-mail to me, “At a reception
after the rally, I found real soul-mates—
progressive doctors passionate about
improving the system for everyone. I
thought, after 40 years in medicine, I’ve
found my people!” (James Scott, MD;
personal communication; 2015 Jan 20)b
For many physicians, the opportunity
to meet with elected officials and to
speak to public audiences on behalf of a
like-minded cohort became a reason to
deepen involvement with the organization. For others, it was the opportunity
to focus on individual practice reform.
Dr Smith was only half kidding when
he first proposed the idea that NPA
generate “Top 5” lists–à la David Letterman—to highlight “things doctors
keep doing even though they know better.” The Board of Directors was having
lunch and brainstorming.
A longtime leader of NPA’s work to
reduce professional conflicts of interest,
Dr Smith wanted to see physicians take
more responsibility for their role as stewards of limited clinical resources. This
would require acknowledging overtreatment and waste—calling out bad habits.
What if NPA developed a “Top 5” list
of evidence-based, quality-improving,
resource-sparing activities that could be
incorporated into the routine practice of
primary care physicians in family medicine, internal medicine, and pediatrics?
Under Dr Smith’s leadership, the idea
quickly took shape as the NPA’s Good
Stewardship Project, funded by the
American Board of Internal Medicine
Foundation. A mouse that roared, this
modest initiative has since blossomed
under the American Board of Internal
Medicine Foundation’s direction into
the celebrated Choosing Wisely campaign. Conceiving and piloting this
culture-changing project has been one
of the NPA’s most significant contributions. More than 60 specialty societies
have since developed lists of “tests or
procedures commonly used in their
field, whose necessity should be questioned and discussed.”6 Similar efforts
are now happening abroad.
NPA’s Good Stewardship work challenged physicians to acknowledge and
address prescribers’ responsibility for
systemic waste and consequent patient
harm. Organized medicine has begun to
embrace stewardship as a core component of professionalism, and consumers
have welcomed this awakening.
It was no trivial thing to shift the
national conversation in this direction. The challenge now is to see these
values broadly translated to practice.
New and broad-ranging calls for price
transparency and fairness are providing wind at the back of this push for
high-value care. In short, as a nonprofit
organization without a great deal of
money, NPA has made a great deal
of difference. With little more than
stamina, purpose, and a value set that
aligns the incentives of physicians with
those of patients, the NPA has been
able to make important contributions
in a short period of time.
LOOKING AHEAD
At ten years old, the NPA continues
to attract physicians who understand
that the future of US health care will be
shaped by those who show up to shape
it—and that working with patients, we
now have a historic opportunity to put
health at the heart of medicine. There
are gains to be defended and new battles
to engage.
Relatively recent areas of NPA focus
also continue to build momentum, including the creation of NPA national
taskforces on gun violence prevention
and on the FDA’s drug and medical
device approval processes—two areas
brought to the fore during Cheryl Bettigole, MD, MPH’s, tenure as NPA
President. Although these issues may
COMMENTARY
at first seem to have little to do with
one another or with past NPA efforts
to expand access to high-quality health
care, they are united by the influence of
corporate lobbying.
The National Rifle Association’s lobbyists have choked off research funding for gun violence prevention7,8 and
have successfully backed state laws that
forbid physicians from asking standard
screening questions about gun ownership and storage.9 Fracking companies
have successfully backed the passage
of state laws that require physicians to
sign confidentiality agreements before
learning what chemicals a sick patient
may have been exposed to.10,11 Drug
companies continue to press the FDA
to approve applications on the basis of
surrogate endpoint data and mathematical modeling rather than requiring full
clinical trials.12 And far too many medical devices continue to reach the market
without any clinical trials at all.13 These
are areas that cry out for more attention from organized medicine to ensure
patient safety.
For our federal watchdog agencies,
our clinical guidelines, our pharmacopeia, our educational resources, our
state laws, and our individual clinical
relationships to be grounded in trust
and science, physicians and patients
will have to claim more power in these
debates.
It is fair to say that with my background in medicine and medical history,
I never expected to become the Executive Director of a nonprofit organization. But I have always been drawn to
visionaries. I had the good fortune to
help unite this multispecialty band of
serious idealists, this growing force for
good. NPA’s presidents have included a
surgeon, Dr Vaias; four family practice
physicians—Drs Evans, Bettigole, Scott,
and Jordan; and an obstetric anesthesiologist, Dr Arkoosh. Around the NPA
conference table, consensus has always
emerged quickly among family physicians, surgeons, pediatricians, internists,
cardiologists, anesthesiologists, patient
advocates, and more. We have found
there is no fighting for turf when the
fight is for patients. As Dr Vaias says,
“The NPA reminds me why I got into
medicine in the first place.”(Lydia Vaias,
MD, MPH; personal communication;
2015 Apr 27)a
We have a vision for the next ten
years: sparking a transformation of the
medical profession that returns us to the
core value of serving patients. We have
seen this vision made real at places like
KP, but we will continue to press on
until it is the default setting for health
care in our country. Join us in October
in Washington, DC, as we launch our
second decade at our annual meeting,
themed Truth to Power: Alliance for the
Public Good.
You may learn more about the NPA’s past
and future work at www.npalliance.org. v
a
General Surgeon and Founder, the National
Physicians Alliance; Washington, DC.
b
Immediate Past President of the National Physicians
Alliance; Washington, DC.
4.
5.
6.
7.
8.
9.
10.
11.
12.
References
1. Racine E, Amaram R, Seidler M, Karczewska M,
Illes J. Media coverage of the persistent vegetative state and end-of-life decision-making. Neurology 2008 Sep 23;17(13):1027-32. DOI: http://
dx.doi.org/10.1212/01.wnl.0000320507.64683.ee.
2. History of the American Medical Student
Association [Internet]. Sterling, VA; 2014 [cited
2015 Apr 28]. Available from: www.amsa.org/
amsa/homepage/About/History.aspx.
3. Wazana A. Physicians and the pharmaceutical
industry: is a gift ever just a gift. JAMA 2000 Jan
13.
19;283(3): 373-80. DOI: http://dx.doi.org/10.1001/
jama.283.3.373.
The Patient Protection and Affordable Care Act of
2010. Public Law 111-148, 111th Congress, 124
Stat 119, HR 3590, enacted 2010 Mar 23.
openpaymentsdata.CMS.gov [Internet].
Washington, DC: US Department of Health and
Human Services; 2015 [cited 2015 Apr 28].
Available from: https://openpaymentsdata.cms.gov.
Choosing wisely: about us [Internet]. Philadelphia,
PA: ABIM Foundation; 2015 [cited 2015 Apr 28].
Available from: www.choosingwisely.org/about-us/.
Jamieson C. Gun violence research: history of the
federal funding freeze: Newton tragedy may lead
to lifting of freeze in place since 1996 [Internet].
Washington, DC: American Psychological
Association; 2013 Feb [cited 2015 Apr 28].
Available from: www.apa.org/science/about/
psa/2013/02/gun-violence.aspx.
Frankel TC. Why the CDC still isn’t researching
gun violence, despite the ban being lifted two
years ago [Internet]. Washington, DC: The
Washington Post; 2015 Jan 14 [cited 2015 Apr
28]. Available from: www.washingtonpost.com/
news/storyline/wp/2015/01/14/why-the-cdc-stillisnt-researching-gun-violence-despite-the-banbeing-lifted-two-years-ago/.
Federal court upholds Fla’s docs vs glocks law
[Internet]. Arlington, VA: Politico.com; 2014 Jul 26
[cited 2015 Apr 28]. Available from: www.politico.
com/story/2014/07/federal-court-upholds-floridadocs-vs-glocks-law-109403.html
Pennsylvania’s disclosure rules: what the frack’s
in the ground? [Internet]. Harrisburg, PA: WITF—
StateImpact; 2015 [cited 2015 Apr 28]. Available
from: http://stateimpact.npr.org/pennsylvania/tag/
fracking-disclosure/.
Wilkinson KD, Cawley MJ. Client Alert: In nonprecendential case, Third Circuit affirms fracking
trade secrets trump physician’s right to know,
absent actual harm [Internet]. White Plains, NY:
Wilson-Elser; 2015 Apr 13 [cited 2015 Apr 28].
Available from: www.wilsonelser.com/news_and_
insights/client_alerts/2256-in_non-precedential_
case_third_circuit_affirms.
Doshi P. Speeding new antibiotics to market:
a fake fix? BMJ 2015 Mar 25;350:h1453. DOI:
http://dx.doi.org/10.1136/bmj.h1453.
Medical devices and the public’s health: the FDA
510(k) clearance process at 35 years [Internet].
Washington, DC: Institute of Medicine; 2011 Jul
[cited 2015 Apr 28]. Available from: www.iom.
edu/~/media/Files/Report%20Files/2011/MedicalDevices-and-the-Publics-Health-The-FDA510k-Clearance-Process-at-35-Years/510k%20
Clearance%20Process%202011%20Report%20
Brief.pdf.
The True Physician
The true physician cannot remain outside the manifold of the events he observes.
— Alan Gregg, MD, 1890-1957, Associate Director of the Medical Education Division,
Director of Medical Sciences Division and Vice President of the Rockefeller Foundation
89
NARRATIVE MEDICINE
Suicide is a Baobab Tree: A Narrative Medicine Case Study
Adriano Machado Facioli, PhD; Fábio Ferreira Amorim, MD, PhD;
Karlo Jozefo Quadros de Almeida, MD; Eliana Mendonça Vilar Trindade, PhD
Perm J 2015 Summer;19(3):90-94
“A baobab is something you will never, never
be able to get rid of if you attend to it too late.”1
— Antoine de Saint-Exupéry
ABSTRACT
This case study is an example of applying narrative medicine
as a useful tool for health professionals to manage an existential
and complex scenario such as the suicide of a sibling. Some suicides are like baobab trees—these large and resilient trees grow
deep roots for many years, only spreading their limbs above
ground once they are firmly established. Like the baobab, when
suicide or a suicide attempt occurs, suicidal ideations are well
cultivated and have often already been repeatedly planted.
Consequently, suicide is often difficult to prevent: once the
death seed is planted, it is difficult to recreate life.
Every year, more than 800,000 people die by suicide
worldwide (1.4% of all deaths), which is approximately 1
person every 40 seconds. These unexpected deaths, predominantly occuring among young and middle-aged adults, have
a continuing ripple effect and result in a huge economic,
social, and psychological burden for individuals, families,
communities, and countries. The complexity of suffering and
pain experienced by suicidal individuals and their families,
regardless of the success or failure of the suicidal act, is intensified by strong stigmas attached to traditional concepts of
sin and eternal damnation. This unfortunate reality emerges
in the narrative as a tragic family drama, which is permeated
by deep feelings of helplessness.
But suicide is preventable. Prevention requires 3 important
factors: knowledge, public support, and creation of strategies
to enact social change. Now is the time to act and make
suicide prevention an imperative goal.
CASE STUDY
Some suicides are like baobab trees—these trees are large
and almost indestructible once established. They grow deep
roots for many years, only spreading their limbs to the sky
when they are firmly entrenched. Like the baobab, when
suicide or a suicide attempt occurs, suicidal ideations are well
cultivated and have often already been repeatedly planted.
Consequently, suicide is often difficult to prevent. How can
one prevent something that has become part of an individual’s
identity and constitution?
Many suicidal individuals have planned their own death
for years in the form of impulses and constant thoughts of
how they will end their lives. Personally and professionally,
I have witnessed the life course of individuals who showed,
many years before they actually committed suicide, clear signs
that one day they would kill themselves. I remember quite
well my older brother, Edu, at age 18 saying life was often
not worth it, because it was very unfair and full of suffering.
My mother disagreed with him.
At that time she said, “I think it [suicide] is an act of extreme selfishness. One kills himself and doesn’t think about
the suffering of those who are left behind.”
Edu replied, “Selfishness is when people think they are the
owners of the life of the one who is killing himself. Whose
life is it anyway?”
This conversation took place in 1988, ten years before my
brother died.
Five years before his death, in 1993, Edu also reportedly
told a few friends, as they sat at the banks of the university
lake, that it was “a beautiful place to die.” His death took
place nearby in 1998.
I also remember Edu occasionally joking about other
people’s suicide threats. “Do you really want to commit suicide?” he would ask mockingly. “So hang yourself with a steel
wire coated with grease. If you do that, there is no turning
back.” Edu spoke as someone who believed most people who
threatened suicide would not really do it, and that they used
their threats only as a means to manipulate others. And he
never threatened to kill himself.
For the ten years before Edu’s death, I dealt with an extremely unpleasant fear that he would one day kill himself,
but this dread was not enough to rid me of the devastating
surprise of the reality of his suicide. Although we had clearly
talked about suicide, I was not spared the shock of dealing
with this kind of misfortune.
Five years before his death, Edu and I had a conversation
in which he expressed concern about the possibility of me
being suicidal. I was 21, and he was 23 years old. I said to
him, “Brother, let’s make it clear, the suicidal individual here
is you and not me.”
Adriano Machado Facioli, PhD, is a Psychologist and Professor of Medicine in the Department of Research and Scientific Communication
at Escola Superior de Ciências da Saúde in Brasília, Distrito Federal, Brazil. E-mail: facioli@gmail.com. Fábio Ferreira Amorim, MD, PhD,
is a Professor of Medicine in the Department of Research and Scientific Communication at Escola Superior de Ciências da Saúde in
Brasília, Distrito Federal, Brazil. E-mail: ffamorim@gmail.com. Karlo Jozefo Quadros de Almeida, MD, is a Professor of Medicine in
the Department of Research and Scientific Communication at Escola Superior de Ciências da Saúde in Brasília, Distrito Federal, Brazil.
E-mail: karlo.escs@gmail.com. Eliana Mendonça Vilar Trindade, PhD, is a Psychologist and Professor of Medicine in the Department
of Research and Scientific Communication at Escola Superior de Ciências da Saúde in Brasília, Distrito Federal, Brazil. E-mail:
elianavilar@yahoo.com.br.
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NARRATIVE MEDICINE
“And does that disturb you, do you worry too much about
it?” he asked.
“Yes, it is very distressing. It is very, very unpleasant to imagine
one day I will come home and find you hanged yourself, man.”
Our conversation continued and he tried to fix it, tried to
show me he would take my distress seriously. He demonstrated
empathy and realized the whole situation was painful for me.
I thought to myself that this conversation had produced some
benefits, that his concern for me would be enough to keep
him alive. Unfortunately I was wrong. His baobab missed
being watered only on that day or on the few days like that
one. His baobab had already grown big, very big, and I had
no idea of its hugeness in my brother’s life.
SINCE EDU’S DEATH
I have often said, “Suicide is a little plant. But do not
plant it. If you have planted it, do not cultivate it and do
not water it because it is a little plant that grows and turns
into a baobab. Then it can become quite difficult to remove
from your life.” Edu gave birth to his end of everything by
hanging himself from a rope tied around his neck and fastened to a branch of a tree at the banks of the lake near the
university where he had studied a few years before.
My brother somehow anticipated where and how he would
die. It was only a matter of time, because he had been planting
and cultivating his suicide for several years. A letter addressed
to me, but never sent, was found in his drawer just after his
death—he had hidden it there for more than nine months
before his suicide. In the letter, Edu made it clear he was already very close to death. The letter began like this: “Yes, my
brother, I have been talking to death closely and quite often.
It whispers in my ear and pulls me by my feet.”
He left many other writings in his drawer. They were kept
there so no one would mess them up and to keep Edu’s privacy, which was well respected by the entire family. Several
of these writings are part of a more complex picture about
his motives and his history. In a letter written a few months
before his death, he said, “I rode my bike, at night through
deserted streets, and pedaled as fast as I could so that my
heart would burst.”
I never stop thinking and imagining how his last day went
by. He was living with some friends, very close to the university. He took his bicycle and went to the university. Inside his
backpack there were his documents, a small notebook, and a
pair of handcuffs. I figured that, in case of losing his will, he
would handcuff himself so there would be no return. I know
nothing else about that day: if he was crying; if he was calm;
if he had ever visited that tree beside the lake before, to think
or plan about ending his life. I do not know whether he stood
there for hours, mustering his courage; whether he took the
time to appreciate the landscape in an absurd and lonely farewell; or if there was despair and distress until the last moment.
He left farewell letters with justifications and apologies, one
for me and one for my parents and my brother. “Mother, it is
not your fault”; “I know a black shroud of pain will cover all
of you, but I cannot bear my suffering any longer”; “It’s nobody’s fault.” Why did he leave a personal letter to me? Why?
The only thing I can guess is he really cared about me, as the
loving older brother he was, and because he worried about
how much suffering his suicide would bring me.
PREVENTING A SUICIDE
Years later I learned, through his death and in my professional practice, the basics of preventing a suicide. Suicide is a
very lonely act. Suicidal people are, in general, socially isolated
and radically lonely in their pain. In the Sidebar: Years Later,
I have included my attempt to further explore Edu’s world
of loneliness and pain.
Edu loved being with me and our youngest brother, but
he was alone in his town, far from us and with no easy communication available. In Brazil in 1998, our family had no
cell phones or personal computers or wireless Internet that
allowed us to reach anyone at any time. We were separated
by hundreds of miles, by several days without talking to each
other, by our ignorance about suicide and the danger that was
haunting Edu’s life. He suffered with all these distances. During a phone call some days before his death, he said, probably
knowing our recent visit was the last time he would see us,
“It was very hard for me to see you leaving …”
Now I know that in these moments it is crucial to have
loved ones close by and part of our lives. Social gratifications
are possibly the most relevant ones in a human being’s life.
We are social animals, fed by social interactions—healthy
social interactions. We need to love and be loved. We need
real love, which at its root involves proximity, being close and
together, being present, interacting, and pushing the ghosts
of unhealthy loneliness away.
When suffering comes, life takes a sudden stop and
everything starts moving slowly. Time takes too long to
pass and weighs on us unbearably. There, at this time, you
are, fully and without escape, feeling all the pain you can
experience. When this most extreme part of suffering goes
away, another wave comes, although less intense: it is the
echo of that past suffering. This is when the blanket of
love that others weave for us plays a decisive role. If this
blanket is effective, real, and supportive, we will feel that
life is worthwhile despite all the pain and injustice in the
world. This love is not a crumb of pleasure immersed in
the suffering soup of existence deluding us. It is actually
the base, often subtle, of a happy life.
It seems to me that this structure of a happy life remains
primarily a history of comfortable and supportive relationships, largely provided by parents (or our first caregivers), that
teach us how to love and be loved. Edu felt so safe when in
contact with me and our youngest brother. We two seemed
to offer a family structure that could support an important
part of Edu’s psychological well-being.
Long-gestated suicides, thought out and planned numerous
times, often for years, grow like a baobab tree, acquiring and
building size along with the person’s identity. I think these
deep-rooted intentions are the most difficult to prevent. They
come from a long daily routine that feeds them for years.
For those of us left behind, what remains are the ashes, our
feelings of helplessness and guilt, and, in my case, a lot of good
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NARRATIVE MEDICINE
memories. Edu was an inexhaustible source of ideas, beauty,
creativity, art, and surprise. Despite all his faults, he was a rare,
beautiful, explosive, surprising, and all-too-brief event that
passed through our lives and helped form who I am.
DISCUSSION
We make sense of the world and the things that happen to
us by constructing narratives to explain and interpret events
both to ourselves and to other people. Furthermore, narratives also play an important role in touching readers. As a
literary genre, the narrative is an important field of arts. A
fundamental function of arts in our lives is awakening and
vivifying our slumbering feelings, inclinations, and passions
of every kind.2 In this context, narrative medicine emerges
as a medical practice model based on narrative competence:
the capacity of human beings to acknowledge, to absorb,
to interpret, and to react to stories that provide resources
for the understanding of stories’ meanings, leading to solutions and indicating a way to provide better holistic care.3-6
Moreover, narrative medicine uses patient stories as a diagnostic, therapeutic, and educational tool. Our narrative is
an example of applying narrative medicine as a useful tool
to manage an existential and complex scenario such as the
suicide of a sibling.
Some suicidal thoughts grow slowly from recurrent unconscious conflicts that do not arise from nothing.7-8 Freud
proposed inevitable intrapsychic conflicts from Eros (life
drive) and Thanatos (death drive).9 The complexity of suffering and pain experienced by suicidal individuals and their
families, regardless of the success or failure of the suicidal act,
is intensified by the strong stigmas attached to traditional
concepts of sin and eternal damnation.10-12 This unfortunate
reality emerges in our narrative as a tragic family drama
permeated by profound feelings of helplessness.
A GROWING BAOBAB TREE
In our narrative, this suicide construction was compared to
a growing baobab tree. The baobab is one of nature’s oldest
trees, native to Madagascar, mainland Africa, and Australia.
Capable of living for thousands of years, this tree grows to 40
to 75 feet tall with a trunk diameter of 35 to 60 feet. Baobabs
are hardy and seemingly indestructible—they are renowned
for being difficult to kill and will even regrow bark if stripped
of it or burnt. In one chapter of The Little Prince,1 the classic
novel by Antoine de Saint-Exupéry, the Little Prince and the
author have a very important conversation about baobab trees.
The Little Prince talks about how they are a constant threat to
his tiny planet, and he has to pull up the little baobab saplings
every morning. The Little Prince points out that these trees
start out as tiny seedlings, but if not uprooted and discarded
when they are small, they firmly take root and can even cause
a planet to split apart. Saint-Exupéry states that the lesson to
be learned from the story of the baobabs is so important that
he has drawn them more carefully than any other drawing
in the book.1 On a metaphorical level, the baobabs stand for
unpleasant things in our human nature—if we don’t spot these
unpleasant elements and weed them out early, they will take
firm root and distort our personality. Edu’s suicide grew and
became like a baobab tree. His suicidal ideation was left to
grow stronger and stronger, and it took root in his personality.
His ideation grew for ten years or more in silence, in his and
his family’s silence. When his suicide happened, his ideation
had been repeatedly planted long before. Some members of
our family only realized its enormity when it happened.
PUBLIC HEALTH PROBLEM
Suicide is an important public health problem that causes
immeasurable pain, suffering, and loss to individuals, families,
friends, and communities in the world.13,14 Every year, more
YEARS LATER
By Adriano Machado Facioli, PhD
Almost 15 years after my brother’s
death, I wrote a poetic text, in first person, in which I play the role of a suicide,
attempting to further explore my feelings
about the world of Edu and others who
lived something similar to his existential
dilemmas.
I am 28 years old and have long been
carrying, in the empty space of my dark
existence, the constant and raw idea that
it makes no difference being dead or alive.
Since my adolescence I have been
unable to navigate my thoughts otherwise
away from the turbid basement of ideologies
upon which I have been building the edifice
92
of my soul. Existentially, nothing puts me at
a point beyond my morbid desires.
The infinity of the universe, its sparkling,
dark, and deaf mysteries, or the absurdity
of any inconceivable reality, only feed
my desire of not existing, of returning the
universe to as it once was before my birth.
The immensity of everything swallows my
soul into the mouth of the most savage
impulses of killing myself or launching my
existence to unpredictable and uncontrollable heights.
I am a man (though I have never felt
like a man) who carries on my shoulders
the weight of an insignificant history. I
carry also envy of the poorest I meet in
the sad corners of the world, knowing the
reality of life is unfair and that suffering is
the first experience of our brutal collision
with existence.
We exist so little in the scope of the
existence of everything, and too much for
ourselves. I cannot bear myself. I cannot
handle this voracious struggle exploding
inside me, yearning to invade the plagued
field of my rationality.
Loneliness—this has always been my
name, my identity from never having met
any loving reflection of the starving people
on my face in the mirror of life. v
NARRATIVE MEDICINE
than 800,000 people die by suicide worldwide (1.4% of all
deaths), approximately one person every 40 seconds.11 It is
one of the top 10 causes of death in the US.14 Globally, suicide is the 15th leading cause of death and the 2nd leading
cause of death between the ages of 15 and 29 years; and it
accounts for 50% of all violent deaths among men and 71%
among women.11 Death by suicide is only a small part of the
problem—for every person who dies from suicide, there are
more than 30 others who attempt it.14 The heavy burden of
long-lasting physical and emotional problems associated with
suicidal behaviors affects countless individuals: family members of the person with suicidal behaviors, friends, coworkers,
and others in the community. There is also a large economic
impact, related to medical care costs and productivity loss.11,14
In Canada, it has been estimated that direct and indirect
costs due to suicide are over $2.4 billion ($850,000 for each
suicide).13 Another concerning fact is that almost 75% of
suicides occur in low- and middle-income countries, where
health services and resources for identification, treatment,
and support are often scarce and limited. Indeed, suicide has
a great impact on the most vulnerable populations, especially
because of its high prevalence in minority, marginalized, and
discriminated-against society groups, such as indigenous
peoples, displaced persons, and individuals who are lesbian,
gay, bisexual, transgender, or questioning their sexual identity (LGBTQ).10,11 For instance, LGBTQ youths have a 3- to
4-fold higher suicide risk, and those who have been rejected
by their families are 8 times more likely to commit suicide.10
These striking facts make suicide a global health problem that
must be considered a priority.10,11
“SUICIDE”
In 1642, Sir Thomas Browne, a physician and philosopher,
coined the term “suicide” in his famous work, Religio Medici.8
People have worked to understand suicide throughout history
and across disciplines of knowledge, such as philosophy, sociology, psychoanalysis, and psychiatry. Social representations
regarding suicide have also changed with time: a constituent
element of tradition or acceptable option in certain cultures
such as Rome, a sin in the Middle Ages, and a sign of mental
illness in the 19th century.15-17 Currently, the idea that suicide
is a legitimate option has permeated individual human rights
and dying-with-dignity debates in certain circumstances.18-20
Durkheim,21 the late 19th-century sociologist who classified
suicide types as egoistic, altruistic, or anomic, correlated
suicide to the degree of social cohesion in a person’s life. He
said family, church, and the state ceased to function as social
integration factors after the social revolution, and nothing
has replaced them to date. This analysis is a modern one in a
world filled with conflicts.8,17,21
Although it is imperative to address suicidal behaviors as
soon as possible, they are often met with silence and shame.
Social reactions related to the stigma and taboo surrounding
suicide are often a huge obstacle to those who need help when
going through a crisis, which means many at suicide risk are
left alone. Furthermore, a large segment of health services
are not prepared to provide timely and effective help to those
who do seek help.10,11,14 Between 2% and 7% of primary care
patients have thought about committing suicide; 45% to 76%
of individuals who commit suicide visited their primary care
clinician in the preceding month.10 Most primary care clinicians know there are suicidal patients in their practice, but
they are not prepared to identify and to provide care for these
patients.10 This is an alarming situation. Indeed, physicians
may avoid the topic of suicide with patients because they
feel ill prepared to care for a patient going through a crisis.10
SUICIDES ARE PREVENTABLE
Because suicide was historically associated with mental
illness, suicide prevention was largely viewed as a mental
health service competence. However, mental health is just
one factor that can influence suicide risk. It is important to
note that the vast majority of individuals with mental disorders do not have suicidal behaviors.11,14 No single factor
is sufficient to fully explain why a person commits suicide.
Several risk factors frequently act cumulatively to increase
vulnerability to suicidal behavior. Suicidal behavior is a
complex phenomenon that is determined by the interplay
between personal, social, psychological, cultural, biologic,
and environmental factors. At the individual level, risk factors include previous suicide attempts, mental disorders,
financial loss, chronic pain, family history of suicide, and
alcohol and/or drug abuse. Some risk factors linked to community and human relations include wartime and natural
disasters; acculturation stresses, such as those found among
indigenous peoples or displaced individuals; discrimination;
feelings of social isolation; abuse; violence; and conflicting
relationships.
Suicide prevention requires coordination and collaboration
among multiple society sectors, such as education, labor, business, agriculture, justice, law, politics, and the media. These
efforts must be comprehensive, synergistic, and integrated
because no single approach can address so complex an issue
as suicide. All have a role to play in helping make suicide
prevention more widely available.11,12,14
The foundation of any effective preventive response lies
in the identification of suicide risk factors and the relief of
these risk factors by implementing appropriate interventions.
Strategies to counter risk factors are of three types: 1) universal prevention strategies, which are designed to reach an
entire population; 2) selective prevention strategies, which
target vulnerable individuals; and 3) indicated prevention
strategies, which target specific vulnerable individuals with
community support.11
Among all risk factors for suicide, a prior suicide attempt is
the single most important in the general population. In these
cases, follow-up care by health caregivers through regular
contact, including by phone or home visits, together with
community support, is essential. Decreasing access to suicide
means is another way to reduce suicide rates. Context is imperative to understanding suicide risk. Many suicides occur
impulsively in moments of crisis, and ready access to suicide
means (such as pesticides, firearms, and certain medications)
can determine whether a person lives or dies.11 Other effective
93
NARRATIVE MEDICINE
measures include responsible suicide reporting in the media,
avoiding language that sensationalizes suicide and avoiding
explicit descriptions of methods used.11,12,22-25
In a recent report, the World Health Organization recommended that countries get a range of government departments
involved in the development of a comprehensive coordinated
response to prevent suicide.11 Furthermore, high-level commitment is needed, not just in the health care sector but also
within the education, social welfare, employment, and judicial
sectors.11 One recommended milestone is to place suicide prevention under national strategy, and to develop standards and
guidelines with a multidisciplinary approach that addresses
suicide in a comprehensive manner. Implementing timely
and effective suicide prevention strategies can considerably
reduce suicides rates.11 It is necessary to respond rapidly
when a person in crisis is identified. Youth-focused efforts to
reduce suicide have reported up to a 40% decrease in deaths
by suicide. Among the elderly, these strategies have decreased
suicide rates by 33%.10,11,13 In the World Health Organization
Mental Health Action Plan 2013-2020,26 World Health Organization member states have pledged to implement actions
to reduce the suicide rate by 10% by 2020.
CONCLUSION
Every suicide is a tragedy. These unexpected deaths, occuring predominantly among young and middle-aged adults,
have a continuing ripple effect and result in a huge economic,
social, and psychological burden for individuals, families,
communities, and countries. Suicide is preventable, and prevention requires social change. To create social change, three
important factors are required: knowledge (both scientific
and informed by practice), public support (political will), and
a social strategy (such as a national response to accomplish
suicide prevention goals). Every life lost to suicide is one too
many. The time to act and to make suicide prevention an
imperative goal is now.10,11,14 If we attend to suicide when it
is already too late, a baobab forest will have grown and we
may never be able to get rid of it. v
References
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New York, NY: Oxford University Press Inc; 1998.
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4. Charon R. The patient-physician relationship. Narrative medicine: a model for
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& Huber Publishers; 2004 Oct. p 3-4.
9. Lind L. Thanatos: the drive without a name. The development of the concept
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9789241564779_eng.pdf?ua=1.
12. Fitzpatrick SJ, Kerridge IH. Challenges to a more open discussion of suicide.
Med J Aust 2013 May 20;198(9):470-1. DOI: http://dx.doi.org/10.5694/
mja12.11540.
13. Spiwak R, Elias B, Bolton JM, Martens PJ, Sareen J. Suicide policy in Canada:
lessons from history. Can J Public Health 2012 Jul 18;103(5):e338-41.
14. 2012 national strategy for suicide prevention: goals and objectives for action. A
report of the US Surgeon General and of the National Action Alliance for Suicide
Prevention [Internet]. Washington, DC: US Department of Health and Human
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gov/library/reports/national-strategy-suicide-prevention/full_report-rev.pdf.
15. De Leo D, Burgis S, Bertolote JM, Kerkhof A, Bille-Brahe U. Definitions of
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Suicidal behaviour: theories and research findings. 1st ed. Göttingen, Germany:
Hogrefe & Huber Publishers; 2004 Oct. p 17-39.
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1477-7525-1-65.
18. Nuland SB. Physician-assisted suicide and euthanasia in practice.
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NEJM200002243420811.
19. Sullivan AD, Hedberg K, Fleming DW. Legalized physician-assisted suicide in
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http://dx.doi.org/10.1056/NEJM200002243420822.
20. Willems DL, Daniels ER, van der Wal G, van der Maas PJ, Emanuel EJ.
Attitudes and practices concerning the end of life: a comparison between
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2000 Jan 10;160(1):63-8. DOI: http://dx.doi.org/10.1001/archinte.160.1.63.
21. Pickering WSF, Walford G, editors. Durkheim’s suicide: a century of research
and debate. 1st ed. London, United Kingdom: Routledge; 2000.
22. Niederkrotenthaler T, Fu KW, Yip PS, et al. Changes in suicide rates following
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23. Sisask M, Värnik A. Media roles in suicide prevention: a systematic review. Int J
Environ Res Public Health 2012 Jan;9(1):123-38. DOI: http://dx.doi.org/10.3390/
ijerph9010123. 24. Daine K, Hawton K, Singaravelu V, Stewart A, Simkin S, Montgomery P. The
power of the Web: a systematic review of studies of the influence of the Internet
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DOI: http://dx.doi.org/10.1371/journal.pone.0077555.
25. Westerlund M, Hadlaczky G, Wasserman D. The representation of suicide on
the Internet: implications for clinicians. J Med Internet Res 2012 Sep 26;
14(5):e122. DOI: http://dx.doi.org/10.2196/jmir.1979.
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A66_R8-en.pdf.
NARRATIVE MEDICINE
Why a Hanging Man Dances
Gurpreet Kaur Padam, MD
Perm J 2015 Summer;19(3):95
“Do you know why a hanging man His eyes opened wide. Through the
dances?” asked Mr B. He was once an glossy haze of the sclera, his baby blue
intensely independent man, now 80 pupils dilated and held my gaze as he
years old and afflicted with end-stage expressed great fear of eternal suffering
lung disease. At first observation, he ap- if he chose to shorten his life. He manpeared tired, repositioning himself with aged to gather together the energy to
great effort from lying down and then reveal that he lived alone at home and
reclining in his bed. He then shifted to did not think he could return there,
sitting at the edge of the bed, tightly as this was the beginning of the end.
holding onto the bed sheets as if clenchWe discussed symptom management
ing to a life that was slowly escaping options for dyspnea. He let out a sigh
him. He positioned his right hand on of relief that there were alternatives to
his chest, gasping for air, and appeared suicide but was disappointed that we
frighteningly distressed. I picked up the had not figured out a way to circumnasal cannula and the tubing connected vent the dying process.“That is why a
to the oxygen tank sitting
hanging man dances, he is
beside him. He thrust his
looking for something to
… he is
outstretched palm towards
step on,” he said.
looking for
me and said, “No. I don’t
In his agony, Mr B knew
something to
want anything that will make
there wasn’t much time left
step on …
me live longer.” Despite the
and when “see you later”
explanation that the flowing
slipped from my tongue as
air would help him with the sensation I bid farewell, he responded swiftly
of air hunger, he still refused the readily that he would not be here the next day
available oxygen.
but perhaps we may meet in another
He had a furrowed brow. He was lifetime. The next day at the hospital,
clearly trying to catch his breath with I visited Mr B’s empty bed. I bid goodhis mouth open and mentioned that he bye to the unoccupied and neatly made
was also in pain from a sacral decubitus bed where I imagined his last moments.
ulcer. Working through his anguish,
While I hoped that our meeting was
he muttered a few bitter words and re- as meaningful to him as it was to me,
quested a “magic injection” to end it all. I prayed for him to be at peace. This
While gasping for air between words, encounter left me with more questions
his pauses for rest seemed like minutes. than answers. Did he appear frightened
Mr B debated out loud as if answering and distressed to me because I was? He
his own questions, his predicament seemed so comfortable with the notion
that his spiritual belief prohibited him of death and knowing that it hovered
from taking his own life and risking nearby. Perhaps I perceived him to be
reincarnation. To him, rebirth meant clenching to life not because he was
inevitably reliving his current situation. scared to die but because I was afraid
That would not be tolerable for him. to let him down? Perhaps the one
clenching to life was me, while he had
resolved to let go.
I am humbled with gratitude that
Mr B unknowingly assisted in making
me a better person and a more compassionate physician. When I find myself
sitting at the edge of the bed in the early
morning, I often think of him and what
he must have felt. An asthmatic yearns
for air as the chest becomes tighter with
each cough; most of us experience transitional dyspnea or discomfort when we
are afflicted with the flu or a cold. This
heightened sense of awareness used to
cause anxiety, but now I can channel it
as motivation to improve the delivery
of my care and our system for those
who need it the most.
Mr B left a mark on my soul as if
through the looking glass he gave me
another vital glimpse of my own mortality. After all, I will be at the receiving
end one day. v
Gurpreet Kaur Padam, MD, is a Hospice and Family Medicine Physician at
the Redwood City Medical Center in CA. E-mail: gurpreet.k.padam@kp.org.
95
ONLINE ONLY
BOOK REVIEW
The Body Keeps the Score: Brain, Mind, and Body in the Healing of Trauma
by Bessel van der Kolk, MD
Review by Albert Ray, MD Perm J 2015 Summer;19(3):e118-e119
This valuable book is an informative primer about the ways traumatic
life events affect us as human beings.
The impact of physical and emotional
trauma on brain, mind, and body is examined thoroughly by the author, Bessel
van der Kolk, MD, through numerous
real life examples that arouse our clinical
interest. In our modern age, when we so
often hear the term “posttraumatic stress
disorder,” this book takes us back in time
to its historic origins and the past efforts
of some of the icons of psychiatry who
attempted to explain and treat trauma
in dealing with their patients. What
becomes clear very quickly is that individuals can be forever branded with a
historic score that travels with them for
the remainder of life. The body indeed
keeps that score as a permanent record
unless something is done to address its
tattoo. Although we all deal with the
results in our practices, the origins are
rarely recognized.
As a result, treatment of such traumaaffected patients today is mostly based
on the use of powerful medications to
lower the score pharmacologically rather
than by exploring underlying causality and thereby creating an individual
who feels understood. On the surface,
it would appear to be easier to deliver
treatment as a “medicating practitioner”
rather than as a “talking practitioner.”
But unless one gets down into the action
through discovering and understanding
the patient’s experience, one cannot
truly help the healing process begin in
a successful manner.
On the basis of this foundation,
this book explores the ways that both
patients and healers can develop the
skills to appropriately evaluate historic
traumatic events and how to successfully
begin treating them. For the scientifically oriented physician, the biochemical, physiologic, and anatomic effects of
trauma on the body are well explored
in this detailed exposé. What is more
importantly emphasized, though, is
the invisible mark that is embedded
permanently on mind and body by
past traumatic events. Through its case
examples, this book helps us appreciate
this over and over again. It is only with
this understanding of the toll on the human being that the score can be altered,
resulting in victory. Van der Kolk methodically reviews how our body keeps
as a permanent record the history of
any “adverse experiences” in a locked
account. It is imperative for the clinician to find the key to unlocking that
safe, so the individual can remember
and emote an experience of past trauma,
and deal with it in a healing fashion that
is permanent and nonthreatening. It is
only in this way that the brain, mind,
and body can begin to heal and restart
the game with no remnant of points
left on the scoreboard. Trauma victims
are often unable to recover fully on
their own without causal understanding and guidance because our minds
and bodies have not been trained to
open up new pathways to lead us out
of the maze. Instead, patients are often
numbed with medications to help them
live with the stress of trauma, while numerous unsuccessful visits to health care
professionals take place for a myriad of
somatic complaints. This has had a major effect on the cost of providing health
care. The techniques in this book teach
New York, NY: Viking Press; 2014.
ISBN: 978-0-670-78593-3.
Hardcover: 464 pages.
$27.95
helpful methods that should instead be
considered, including mediation, yoga,
eye-movement desensitization and reprocessing, neurofeedback, and play,
to return the patient to a healthy state
of wellness. It is never too late to learn
to help a person tap into their inner
strength through teaching the use of
breathing, movement, and touch as an
art for healing. Ultimately, the goal of this book is to
learn how to help traumatized patients,
and to guide their healers to bring a
feeling of safety, calm, and acceptance to
their patients as we assist them with remembering memories of horrible events
that they have experienced. Whether
that patient is a child, a war veteran, an
abused spouse, a sexually traumatized
Albert Ray, MD, is a Partner Emeritus of the Southern California Permanente Medical Group and is the
Bariatric Surgery Physician Champion, Positive Choice Wellness Center, San Diego, CA. He is a Clinical
Professor at the University of California School of Medicine, a former elected Director of the Southern
California Permanente Medical Group, and 2008 President of the San Diego County Medical Society.
E-mail: albert.x.ray@kp.org.
e118
BOOK REVIEW
The Body Keeps the Score: Brain, Mind, and Body in the Healing of Trauma
individual, or a victim of poverty, the
roadmap for discovery and healing are
much the same and can be achieved
without the often ineffectiveness of
resorting to multiple courses of potent
medications or repeated outpatient visits, which avoid the underlying pathology. Those who use this book and who
would find its content useful include not
only traumatized individuals and their
loved ones, but physicians, health care
workers, mental health professionals,
policy makers, law enforcement, educators, and military personnel. We are all
shocked to hear on the daily news, horrific events involving murder and suicide
that have past trauma as their underlying
etiology. We need a new paradigm to
effectively deal with this horror, and
this book begins to provide that for us.
The world has advanced and retreated
throughout its history as a result of
monumental events, many of which
have been quite traumatic. Success and
defeat, agony and ecstasy are familiar to
all of us, collectively or individually. A
thorough reading of The Body Keeps the
Score offers us a new window to help
recognize, interpret, and better comprehend how a traumatic event in the past,
based not on genetics but rather caused
by life experiences, can be explored and
successfully overcome so that the individual is no longer a victim but a hero.
I encourage you to become an active
player in the game, and not an observer,
by employing the teachings that this
enjoyable, easy-to-read book has to offer. I congratulate the author on taking
such a complex subject, making it easy
to understand and practical at the same
time, so that in the end the brain, mind,
and body are healed and no longer have
to keep the score. v
e119
ONLINE ONLY
CLINICAL MEDICINE
Image Diagnosis: Inferior Mesenteric Vein Thrombosis
Avin Aggarwal, MBBS; Shashank Garg, MBBS
Perm J 2015 Summer;19(3):e120-e121
CASE STUDY
gastroenterology clinic with 2 weeks
of worsening lower back pain. There
was associated poor appetite, fatigue,
night sweats, and chills. The patient’s
medical history was significant for
well-controlled hypertension and
sigmoid diverticulosis. He had been
smoking half a pack of cigarettes per
day for 30 years. Physical examination
was remarkable for fever (100.7°F),
periumbilical tenderness, and a soft
epigastric bruit. Laboratory evaluation, including complete blood count,
lipase, liver and renal function, electrolytes, and lactate, were within normal
limits. Ultrasound of the abdomen
with venous duplex was performed
to evaluate the epigastric bruit. The
ultrasound revealed a nonocclusive
thrombus in the splenic vein (Figure 1).
A computed tomography (CT) scan
with intravenous contrast confirmed
a thrombus in the inferior mesenteric
vein (IMV) (Figure 2) extending to
the confluence of the IMV with the
splenic vein (Figure 3). Inflammatory
changes around the sigmoid colon with
a hyperdense diverticulum were also
noted on CT scan (Figure 4), suggestive of diverticulitis. No evidence of
intestinal obstruction or infarction was
seen on imaging, which indicated only
partial vein occlusion and/or early IMV
thrombosis. The thrombosis probably
resulted from inflammation in the adjacent diverticulum. The patient was
given ciprofloxacin and metronidazole
for 10 days and was started on warfarin
therapy, initially bridged with heparin.
A CT scan of the patient’s abdomen
was performed 15 weeks after his initial visit and treatment. The CT scan
Figure 2. Coronal view computed tomography
scan of the abdomen, with the white arrows
indicating the thrombus in the inferior mesenteric
vein.
Figure 3. Axial view computed tomography scan
of the abdomen, with the white arrow indicating
the inferior mesenteric vein thrombus extending
up to its confluence with the splenic vein.
Figure 1. Ultrasound of the abdomen with the white arrow indicating a nonocclusive thrombus in the
splenic vein. The distance between the crosshairs is 0.726 cm.
Avin Aggarwal, MBBS, is a Resident in the Department of Medicine at Hennepin County Medical
Center in Minneapolis, MN. E-mail: avin.ucms@gmail.com. Shashank Garg, MBBS, is a Fellow in
the Division of Digestive Diseases and Nutrition in the Department of Medicine at the University of
Kentucky in Lexington. Email: shashank.garg@uky.edu.
e120
CLINICAL MEDICINE
Image Diagnosis: Inferior Mesenteric Vein Thrombosis
IMV thrombosis is an uncommon
but potentially life-threatening complication of sigmoid diverticulitis. Prompt
diagnosis and management of IMV
thrombosis can prevent mesenteric
infarction or surgical intervention. v
The authors have no conflict of interest to
disclose.
References
Figure 4. Coronal view computed tomography scan Figure 5. Coronal view computed tomography
of the abdomen. Arrow 1 indicates a hyperdense
scan of the abdomen 15 weeks after initial
diverticulum, arrow 2 indicates edema of the sigmoid treatment. The white arrow indicates a smaller
colon wall, and arrow 3 indicates pericolonic fat
inferior mesenteric vein, compared with the time of
stranding.
diagnosis, without thrombus or collaterals.
showed a smaller IMV without any
collateral vein formation, indicating
resolution of the thrombus (Figure 5).
At 30 weeks, ultrasound of the patient’s
abdomen showed a patent splenic vein
with normal flow (Figure 6). The patient had a comprehensive workup for
thrombophilia, which was unremarkable. Warfarin therapy was stopped
after resolution of the thrombus.
DISCUSSION
Acute mesenteric vein thrombosis is
responsible for 6% to 9% of cases of acute
mesenteric ischemia.1 IMV thrombosis is
relatively uncommon and constitutes 4%
to 11% of cases of acute mesenteric vein
thrombosis.2,3 However, IMV thrombosis
carries a 15% to 23% risk of mortality.4-6
It is usually seen in the setting of thrombophilia or local inflammation, and
IMV thrombosis on abdominal imaging
should prompt workup for these conditions.7 Initial management involves
bowel rest, pain control, intravenous
hydration, and therapeutic anticoagulation with bridging from heparin to
warfarin.7 Surgical resection is reserved
for patients with progressive intestinal
dilatation or peritoneal signs.
1. Harnik IG, Brandt LJ. Mesenteric venous thrombosis. Vasc Med 2010 Oct;15(5):407-18. DOI:
http://dx.doi.org/10.1177/1358863X10379673.
2. Grisham A, Lohr J, Guenther JM, Engel AM.
Deciphering mesenteric venous thrombosis:
imaging and treatment. Vasc Endovascular Surg
2005 Nov-Dec;39(6):473-9. DOI: http://dx.doi.
org/10.1177/153857440503900603.
3. Alvi AR, Khan S, Niazi SK, Ghulam M, Bibi S.
Acute mesenteric venous thrombosis: improved
outcome with early diagnosis and prompt
anticoagulation therapy. Int J Surg 2009
Jun;7(3):210-3. DOI: http://dx.doi.org/10.1016/j.
ijsu.2009.03.002.
4. Acosta S, Alhadad A, Svensson P, Ekberg O.
Epidemiology, risk and prognostic factors in
mesenteric venous thrombosis. Br J Surg
org/10.1002/bjs.6319.
5. Morasch MD, Ebaugh JL, Chiou AC,
Matsumura JS, Pearce WH, Yao JS. Mesenteric
venous thrombosis: a changing clinical entity.
J Vasc Surg 2001 Oct;34(4):680-4. DOI: http://
dx.doi.org/10.1067/mva.2001.116965.
6. Dentali F, Ageno W, Witt D, et al; WARPED
consortium. Natural history of mesenteric venous
thrombosis in patients treated with vitamin K
antagonists: a multi-centre, retrospective cohort
study. Thromb Haemost 2009 Sep;102(3):501-4.
DOI: http://dx.doi.org/10.1160/TH08-12-0842.
7. Singal AK, Kamath PS, Tefferi A. Mesenteric
venous thrombosis. Mayo Clin Proc 2013
Mar;88(3):285-94. DOI: http://dx.doi.org/10.1016/j.
mayocp.2013.01.012.
Figure 6. Ultrasound of the abdomen 30 weeks after initial treatment. The white arrow indicates the
patent splenic vein without any thrombus.
e121
ONLINE ONLY
CASE REPORTS
Pneumomediastinum Diagnosed on Ultrasound
in the Emergency Department: A Case Report
Hilary FH Beason, MD; Joshua E Markowitz, MD, RDMS, FACEP
Perm J 2015 Summer;19(3):e122-e124
ABSTRACT
An emergency ultrasound performed at bedside helped to confirm
and expedite the diagnosis of esophageal perforation in a 23-year-old
man. Early diagnosis was essential
for prompt treatment and consultation because the patient’s underlying
pathology created the potential for him
to become critically ill. By serving as
a quick, bedside tool for the diagnosis
and evaluation of patients in the Emergency Department, bedside ultrasound
allows emergency physicians to care
for critically ill patients without delays
or the need to send patients out of
the department for imaging studies.
Although the use of ultrasound in
diagnosing soft-tissue pathologies is
a core competency, the diagnosis of
pneumomediastinum by ultrasound
has been reported in the literature in
only a few case reports. To our knowledge, this is the first published report
of using ultrasound as an aid in the
diagnosis of Boerhaave syndrome by
diagnosing pneumomediastinum in
an adult male.
INTRODUCTION
Ultrasound is an essential tool for
emergency physicians because of its use
for diagnosis, resuscitation, monitoring,
and adjunct treatment in core areas of
practice, including trauma, deep vein
thrombosis, and thoracic, abdominal,
and soft-tissue pathologies.1,2 This article presents a case in which the use of
bedside ultrasound aided in a prompt
diagnosis of pneumomediastinum,
which led to a diagnosis of postemesis
esophageal rupture. Cases of esophageal
rupture have a high risk of morbidity
Figure 1. Ultrasound of the neck. The white arrow indicates free air with posterior acoustic shadowing in the soft tissue of the neck. Free air is identified by the hyperechoic white spots. The white “M”
indicates sternohyoid and sternothyroid muscles. The white “Thy” indicates the thyroid. The white “Tr”
indicates the trachea.
and mortality, and early, definitive diagnosis leading to definitive management
improves outcomes. Definitive diagnosis is most often made with imaging,
including x-ray and computed tomography scans. These modalities may lead
to delays in diagnosis or, in many cases,
may require the potentially unstable
patient to leave the Emergency Department (ED). This case demonstrates that
with a high degree of clinical suspicion
and utilization of bedside ultrasound,
the emergency physician may 1) more
confidently provide earlier interventions
including antibiotics and surgical consult, and 2) limit time out away from the
department (for imaging) in a patient
who may be critically ill.
CASE REPORT
A 23-year-old man with a history
of asthma and alcohol and marijuana
use presented to the ED with 2 hours
of severe, sharp right-sided chest pain.
The pain started suddenly after the patient choked on a large piece of steak and
subsequently coughed once and vomited
forcefully. On physical examination, the
patient appeared uncomfortable and was
noted to have reproducible tenderness
over the right anterior chest wall and
anterior neck. Initially, no other findings
on physical exam were noted, but on repeat evaluation after an echocardiogram
was performed, the patient had crepitus
over his anterior neck. No other positive
physical findings were noted. His echocardiogram showed normal sinus rhythm.
Using a SonoSite MicroMaxx (SonoSite, Inc, Bothell, WA) machine and a
P38 probe, a bedside ultrasound of the
soft tissue of the neck was performed
26 minutes later to confirm the physical examination finding of crepitus over
the anterior neck. Examination of the
anterior neck revealed subcutaneous
hyperechoic white foci suggestive of
air bubbles in the soft tissue (Figure 1).
After confirmation of free air in his
anterior neck, the patient was given a
diagnosis of subcutaneous air from a
presumed pneumomediastinum and a
diagnosis of likely esophageal rupture
consistent with Boerhaave syndrome.
The patient was started on piperacillin/tazobactam. Portable x-ray was not
Hilary FH Beason, MD, is an Emergency Physician at the DCH Health System Medical Center in Tuscaloosa, AL.
E-mail: sheofdg@aol.com. Joshua E Markowitz, MD, RDMS, FACEP, is an Emergency Physician at the Santa Clara
Medical Center in CA. E-mail: joshuamarkowitzmd@gmail.com.
e122
CASE REPORTS
Pneumomediastinum Diagnosed on Ultrasound in the Emergency Department: A Case Report
Figure 2. Radiograph of the chest. The white arrow indicates free air in the soft tissues of the neck.
initially available; a chest radiograph
was obtained 2 hours and 13 minutes
after presentation to the ED (Figure 2).
The on-call surgeon was notified of the
radiograph findings and the patient was
admitted to the Surgical Intensive Care
Unit. The diagnosis of pneumomediastinum was further evaluated using a
computed tomography scan with contrast (Figure 3), and eventually with an
esophagram from the Surgical Intensive
Care Unit. These images demonstrated a
right pleural effusion, mild emphysema
and pneumomediastinum in the chest,
and subcutaneous emphysema, in the
neck. On the day after admission to
the ED, a repeat esophagram was performed that showed that the patient’s
perforation had spontaneously closed.
The patient was managed medically and
was discharged home on hospital day 2.
DISCUSSION
Boerhaave syndrome is defined as
spontaneous transmural rupture and
perforation of the esophagus or postemesis esophageal rupture.3,4 The most
common causes of esophageal rupture
include chest trauma (blunt or penetrating), local trauma from swallowed
foreign bodies or caustic agents, spontaneous rupture, anastamotic breakdown,
and iatrogenesis.3 Boerhaave syndrome
has a high rate of morbidity and mortality due to mediastinal contamination,
with 20% to 50% of cases resulting in
death even when properly treated.3,5 If
a significant esophageal tear occurs, the
definitive management is surgical.3,4
In our case, the patient reported forceful vomiting, which probably caused the
esophageal perforation. Our patient had
only a small perforation, which closed
spontaneously and required no surgical
intervention. However, prompt diagnosis was aided by bedside ultrasound,
allowing for the early initiation of
antibiotic therapy. These were critical
steps in this patient’s hospital course.
The physical examination finding of
crepitus raised our suspicion for free
air; ultrasound confirmed this finding,
which, in conjunction with the patient’s
presenting history, led to a presumptive
diagnosis of pneumomediastinum.
The diagnosis of Boerhaave syndrome
requires a high clinical suspicion and can
often be overlooked. Patients typically
present with severe chest or abdominal
pain that can mirror other pathologies,
thus causing early examination findings
to be nonspecific. The classic physical
findings associated with Boerhaave syndrome often present late and include a
systolic crunch (Hamman sign) and
crepitus that is palpable in the neck or
along the chest wall.3 Common chest
x-ray findings include widening of the
mediastinum, pneumothorax, pneumomediastinum, and/or pleural effusions
(usually left-sided).3,4
Emergency ultrasound is an accepted
practice for the primary assessment of
ED patients. 6 Although ultrasound
may not be able to definitively diagnose
Boerhaave syndrome, sonography has
been used to identify some of its common features. Using sonography in the
diagnosis of pneumothorax and pleural
effusion is common practice. Ultrasound has also been used to identify
subcutaneous air bubbles in necrotizing
fasciitis and subcutaneous air caused
by surgical procedures.7,8 However, the
ability to diagnose pneumomediastinum
with ultrasound has only been reported
in a few case reports and is more often
associated with children.9-13
The diagnosis of pneumomediastinum can be challenging with bedside
ultrasound and is operator dependent.
Thoracic ultrasound poses its own challenges because of limitations caused by
bone and by air in the lungs. However,
the ability to visualize free air in the soft
tissue of the neck is often more straight
forward. Differential diagnoses to consider for free air in the neck include
Figure 3. Computed tomography scan of the
neck with contrast. The white arrow indicates
free air in the prevertebral space.
e123
CASE REPORTS
Pneumomediastinum Diagnosed on Ultrasound in the Emergency Department: A Case Report
direct local extension (such as from a
line placement), infection from a gasproducing bacteria, pneumothorax, or
pneumomediastinum. In our case, use
of ultrasound led to early treatment and
allowed for close patient monitoring
before the patient left the department
for further imaging. In an unstable
patient, transportation to the Radiology Department would increase risk to
the patient, and the use of ultrasound
could make an even greater difference
in patient mortality.
Our patient was young and of appropriate body mass index, which allowed
for the thorough physical examination
that identified crepitus in his neck. In
patients with severely elevated body
mass indexes and those considered
morbidly obese, findings such as subcutaneous emphysema may be equivocal or even absent on palpation, thus
making it more difficult to properly
diagnose this condition. In these cases,
ultrasound is an even greater tool for
identifying subcutaneous air because it
can have greater sensitivity than physical
examination alone.
Many facilities have access to portable
x-ray machines, a useful tool in diagnosing free air in the soft tissues. However,
there are occasions when this modality
may be unavailable. Some EDs may not
have access to portable x-ray machines
at all. In either of these cases, the ability to use ultrasound becomes crucial
in helping to identify and to diagnose
e124
emergent conditions. Although it may
not be the only imaging modality that
can diagnose free air, ultrasound may
compliment current available technology because there are times when it is
the most accessible imaging modality.
Early intervention reduces morbidity
and mortality in cases of Boerhaave syndrome. The use of ultrasound at bedside
can help lead to early diagnosis of certain
aspects of the syndrome, such as pneumomediastinum. Although definitive
imaging such as computed tomography
and barium esophagram may still be
required, particularly before surgical
intervention, bedside diagnosis with
ultrasound allows for prompt initiation
of antibiotics, critical in the treatment
of Boerhaave syndrome. v
The author(s) have no conflict of interest to
disclose.
References
1. American College of Emergency Physicians policy statement: emergency ultrasound guidelines
[Internet]. Dallas, TX: American College of Emergency Physicians; 2008 Oct [cited 2015 May 8].
Available from: www.acep.org/WorkArea/linkit.asp
x?LinkIdentifier=ID&ItemID=32878.
2. Burgher SW, Tandy TK, Dawdy MR. Transvaginal ultrasonography by emergency physicians
decreases patient time in the emergency department. Acad Emerg Med 1998 Aug;5(8):802-7.
DOI: http://dx.doi.org/10.1111/j.1553-2712.1998.
tb02507.x.
3. Eckstein M, Henderson SO. Thoracic trauma.
In: Marx J, Hockberger R, Walls R, et al, editors.
Rosen’s emergency medicine: concepts and
clinical practice. 7th ed. Vol 1. Philadelphia, PA:
Mosby; 2010. p 387-413.
4. Park DR, Vallières E. Tumors and cysts of the
mediastinum. In: Mason RJ, Broaddus VC,
Martin T, et al, editors. Murray and Nadel’s
textbook of respiratory medicine. 5th ed. Vol 2.
Philadelphia, PA: Saunders; 2010. p 1836-58.
5. Zun LS, Singh A. Nausea and vomiting. In: Marx
J, Hockberger R, Walls R, et al, editors. Rosen’s
emergency medicine: concepts and clinical practice. 7th ed. Vol 1. Philadelphia, PA: Mosby; 2010.
p 149-58.
6. American College of Emergency Physicians. Use
of ultrasound imaging by emergency physicians.
Ann Emerg Med 2001 Oct;38(4):469-70.
7. Castleberg E, Jenson N, Dinh VA. Diagnosis
of necrotizing fasciitis with bedside ultrasound:
the STAFF exam. West J Emerg Med 2014
westjem.2013.8.18303.
8. Butcher CH, Dooley RW, Levitov AB. Detection
of subcutaneous and intramuscular air with
sonography: a sensitive and specific modality.
J Ultrasound Med 2011 Jun;30(6);791-5.
9. Dulchavsky SA, Henry SE, Moed BR, et al.
Advanced ultrasonic diagnosis of extremity
trauma: the FASTER examination. J Trauma
org/10.1097/00005373-200207000-00006.
10. Anantham D, Ernst A. Ultrasonography. In:
Mason RJ, Broaddus VC, Martin T, et al, editors.
Murray and Nadel’s textbook of respiratory
medicine. 5th ed. Vol 2. Philadelphia, PA:
Saunders; 2010. p 445-60.
11. Testa A, Candelli M, Pignataro G, Costantini AM,
Pirronti T, Silveri NG. Sonographic detection of
spontaneous pneumomediastinum. J Ultrasound
Med 2008 Oct;27(10):1507-9.
12. Jung AY, Yang I, Go HS, et al. Imaging neonatal
spontaneous pneumomediastinum using ultrasound. J Med Ultrason (2001) 2014;41:45-9. DOI:
http://dx.doi.org/10.1007/s10396-013-0454-3.
13. Van Gelderen WF. Ultrasound diagnosis of an
atypical pneumomediastinum. Pediatr Radiol
1992;22(6):469. DOI: http://dx.doi.org/10.1007/
BF02013517.
ONLINE ONLY
CASE REPORTS
Case Report: Pulmonary Papillomatosis
in a Patient Presenting with Cough and Hemoptysis
Zhou Zhang, MD; Melisa Chang, MD; Luis M Moreta-Sainz, MD
Perm J 2015 Summer;19(3):e125-e127
ABSTRACT
A previously healthy patient was seen in the Emergency Department for evaluation
of a one-month history of cough and one-day history of hemoptysis. A computed
tomography scan of the thorax found a mass on the right lower pulmonary lobe
and a mass on the left upper lobe. A biopsy specimen of the right lobe lung mass,
obtained during bronchoscopy, demonstrated papilloma. This case report, from
a pulmonologist’s perspective, includes a comprehensive review of the patient’s
clinical presentation and outcome, as well as a discussion of recurrent respiratory
papillomatosis.
INTRODUCTION
Recurrent respiratory papillomatosis (RRP) is an uncommon clinical
entity. The incidence rate is 1.8 cases
per 100,000 adults and 4.3 cases per
100,000 children. Recurrent respiratory papillomatosis is caused by human
papillomavirus (HPV) serotypes 6 and
11 (the same serotypes responsible for
more than 90% of genital condylomata) and serotypes 16, 18, 31, and 33
(the serotypes associated with genital
and aerodigestive tract malignancies).
A double-stranded DNA virus in the
Papovaviridae family, HPV infects the
mucosal basal layer and induces cellular proliferations via activation of host
Figure 1. Computed tomography scan of chest
showing masses in right lower and left upper
pulmonary nodes.
replication genes through the epidermal
growth factor receptor pathway.1 This
results in thickening of the basal layer.
Papilloma appears grossly as velvety or
exophytic “cauliflower.”
Figure 2. Bronchoscopy demonstrating polypoid
lesion on right vocal cord.
CASE REPORT
Emergency Department with a 1-day
history of dark burgundy-colored sputum and a cough. The patient had the
cough as well as a 2.7-kg (6-pound)
weight loss in the month before admission. He denied fever, night sweats, or
change in the tone of his voice. He had
no remarkable medical history and no
prior surgery. He was not taking any
medications. He did not know his family
history because he is adopted. His social
history included substantial secondhand
smoking exposure. He had multiple drug
use in the past that included marijuana,
cocaine, lysergic acid diethylamide, and
amphetamine. He had multiple female
sexual partners.
A chest x-ray film obtained on admission showed a right-sided lung mass.
Computed tomography scan of the
chest was subsequently performed for
better visualization. Chest computed
tomography (Figure 1) demonstrated
a right lung mass measuring 5.4 cm ×
5.2 cm × 6.1 cm at the superior segment
Figure 3. Bronchoscopy showing view of endobronchial mass at right lower lobe.
of the right lower lobe with associated
“tree-in-bud” nodularity, as well as a lesion in the left upper lobe measuring 1.7
cm in diameter. The inpatient pulmonary team was consulted for assistance
with the diagnosis. The patient underwent bronchoscopy, which identified a
polypoid lesion on the right vocal cord
(Figure 2) and an endobronchial mass
at the right lower lobe (Figure 3). The
right lung mass was biopsied. Pathologic findings revealed squamous cell
papillomatosis.
Zhou Zhang, MD, is a Third-Year Resident in Internal Medicine at the Los Angeles Medical Center in CA.
E-mail: zhou.x.zhang@kp.org. Melisa Chang, MD, is a Second-Year Fellow in Pulmonary and Critical Care at
Cedars-Sinai Medical Center in Los Angeles, CA. E-mail: melisa.chang@cshs.org. Luis M Moreta-Sainz, MD, is an
Attending Physician in the Department of Pulmonary and Critical Care at the Los Angeles Medical Center in CA.
E-mail: luis.m.moreta-sainz@kp.org
e125
CASE REPORTS
Case Report: Pulmonary Papillomatosis in a Patient Presenting with Cough and Hemoptysis
Figure 4. Gross specimen from right lobectomy demonstrating squamous cell carcinoma.
The patient had 4 hospitalizations for
treatment of recurrent pneumonia in the
next 6 months, with 19 inpatient days
accounted for by this complication. A
thoracic surgeon was consulted, and
the decision was made to perform a
right-sided lobectomy via video-assisted
thoracoscopic surgery. A biopsy was
performed from the gross specimen
obtained at the lobectomy (Figure 4).
Results demonstrated squamous cell carcinoma. The patient was subsequently
referred to an oncologist for a discussion
of treatment options for squamous cell
carcinoma of the lung.
Human papillomavirus has a predilection for the junction between squamous and ciliated epithelium. RRP
affects, from the most common site to
the least common site, the true vocal
cord, oral cavity, trachea, bronchi, and
esophagus. Therefore, patients present
most commonly with hoarseness followed by stridor, cough, and dyspnea.
Pediatric patients may present with
failure to thrive as well. Talierco et al4
reported 100% of patients with adultonset RRP had concurrent HPV infection of the oral cavity; however, our
patient had no evidence of oral cavity
HPV infection on physical examination
or bronchoscopy findings.
The diagnosis of lesions typically
is first made through visualization by
imaging modalities such as computed
tomography of the chest, followed by
biopsy of suspicious lesions through laryngoscopy, nasopharyngolaryngoscopy,
or bronchoscopy. The gross appearance
of papilloma is exophytic, with white or
pink lesions with frondlike projections.
Histologically, papilloma is described as
projections of nonkeratinized stratified
squamous epithelium over a fibrovascular core (Figure 5).
The primary treatment of RRP is surgical removal of the papilloma to reduce
the tumor burden. Surgical techniques
include cold steel excision, carbon dioxide or argon laser, endoscopic microdebrider, and pulsed dye laser.5 Potential
side effects of carbon dioxide or argon
laser include active viral DNA in the laser
smoke, which potentially can expose the
practitioner performing the procedure
and the staff to HPV and spread HPV
to the patient’s previously unaffected
body parts. Other side effects of laser
therapy include damage to surrounding
tissue causing vocal glottis edema or vocal cord scarring, as well as the potential
for the laser to cause an explosion when
mixed with oxygen-rich supply from the
DISCUSSION
The incidence of RRP is bimodal,
with the juvenile-onset form typically
first occurring in children aged 2 to
4 years and adult-onset RRP typically occurring in adults aged 20 to 40
years. Juvenile-onset RRP is thought to
be caused from peripartum exposure
through an infected birth canal. Cesarean delivery appears to lower the risk of
RRP in newborns but does not eliminate
the risk. Risk factors for juvenile-onset
RRP include being firstborn, being born
via normal spontaneous vaginal delivery,
and being born to a teenage mother.2
Risk factors for adult-onset RRP include
multiple lifetime sexual partners as well
as a high frequency of oral sex. There was
no statistically significant difference in
illicit drug use between patients with
adult-onset RRP vs a control group in
a study by Ruiz et al.3
e126
Figure 5. Pathologic specimen from right lower lobe lesion demonstrating squamous cell papillomatosis. Immunostaining was positive for tumor suppressor protein p16. Fingerlike projections of
nonkeratinized stratified squamous epithelium appear with fibrovascular core.
CASE REPORTS
Case Report: Pulmonary Papillomatosis in a Patient Presenting with Cough and Hemoptysis
Table 1. Comparison of our case report to case reports from the literature
Author, year
Martina et al, 201410
Azadarmaki et al, 201311
Hasegawa et al, 201312
Lin et al, 201013
Comparison
Their patient had a history of laryngeal papillomatosis since
childhood. Our patient did not have a history of papillomatosis
from childhood.
Both our patient and theirs had malignant transformation of
respiratory papillomatosis. However, their case report featured a
transplant recipient.
Both patients had malignant transformation of respiratory
papillomatosis to squamous cell carcinoma. However, their
patient had tracheal papilloma diagnosed ten years before
transformation. Our patient was diagnosed with respiratory
papillomatosis about six months before evidence of malignant
transformation.
Both patients had malignant transformation of respiratory
papillomatosis to squamous cell carcinoma. However, their
patient had human papillomavirus infection of the larynx and
trachea since childhood, years before malignant transformation.
Our patient was diagnosed with respiratory papillomatosis about
six months before evidence of malignant transformation.
endotracheal tube. Tracheostomy might
be needed for patients with airway obstruction. However, tracheostomy is to be
avoided if at all possible because of a risk
of activating or contributing to the spread
of RRP because tracheostomy creates a
squamocolumnar junction.
Medical therapy is considered adjuvant to surgical therapy. The criteria
for medical therapy include more than
4 surgeries performed per year, spread
of the disease to a distant site, or rapid
growth of lesions. Medical therapy includes interferon, ribavirin, acyclovir,
and intralesional injection of cidofovir.6 Additional new adjuvant medical
therapy under investigation includes
bevacizumab and HPV vaccine. Injection of bevacizumab to vocal cord RRP
lesions enhanced photoangiolytic laser
treatment of RRP and was found to be
safe without additional complications
related to laser treatment.7,8 For patients
who had rapidly growing laryngeal papilloma, adjuvant therapy with 3 doses of
quadrivalent prophylactic HPV vaccine
(Silgard, Merck, Sharp & Dohme Corp,
Merck Co, New York, NY) prolonged
the interval between surgical procedures,
from a mean interval of 272.1 days
before vaccination to 537.4 days after
vaccination (p = 0.034) in a study by
Hočevar-Boltežar et al.9
There is no cure for RRP, and in
3% to 5% of patients with RRP, it will
undergo malignant transformation to
squamous cell carcinoma. A quadrivalent
HPV vaccine (Gardasil, Merck Co, New
York, NY) was approved in the US for
prevention of cervical cancer caused by
HPV infection. Gardasil theoretically
should prevent RRP, and future studies
should focus on the role of vaccination
to prevent RRP.
A literature review of RRP case reports10-13 (Table 1) revealed that patients
usually have the diagnosis of RRP many
years before evidence of malignant
transformation. In contrast, our patient
had evidence of malignant transformation about six months after diagnosis of
respiratory papillomatosis. Our patient
received primary therapy for RRP, which
was surgical removal of papilloma that
was causing infectious complications.
However, once malignant transformation
to squamous cell carcinoma was diagnosed in the surgical specimen, adjuvant
therapy for RRP would have been inappropriate, and the focus was therefore
shifted toward treatment of squamous
cell carcinoma. v
disclose.
Acknowledgment
The authors would like to thank the Kaiser
Permanente Los Angeles Medical Center
Department of Pulmonary and Critical Care for
supporting its resident and fellow writing this
case report.
References
1. Derkay CS, Wiatrak B. Recurrent respiratory
papillomatosis: a review. Laryngoscope
org/10.1097/MLG.0b013e31816a7135.
2. Kashima HK, Shah F, Lyles A, et al. A comparison
of risk factors in juvenile-onset and adultonset recurrent respiratory papillomatosis.
Laryngoscope 1992 Jan;102(1):9-13. DOI: http://
dx.doi.org/10.1288/00005537-199201000-00002.
3. Ruiz R, Achlatis S, Verma A, et al. Risk factors for
adult-onset recurrent respiratory papillomatosis.
Laryngoscope 2014 Oct;124(10):2338-44. DOI:
http://dx.doi.org/10.1002/lary.24730.
4. Taliercio S, Cespedes M, Born H, et al. Adultonset recurrent respiratory papillomatosis: a
review of disease pathogenesis and implications
for patient counseling. JAMA Otolaryngol Head
Neck Surg 2015 Jan 1;141(1):78-83. DOI: http://
dx.doi.org/10.1001/jamaoto.2014.2826.
5. Andrus JG, Shapshay SM. Contemporary
management of laryngeal papilloma in adults
and children. Otolaryngol Clin North Am
org/10.1016/j.otc.2005.10.009.
6. Chadha NK, James AL. Antiviral agents for the
treatment of recurrent respiratory papillomatosis:
a systemic review of the English-language
literature. Otolaryngol Head Neck Surg 2007
Jun;136(6):863-9. DOI: http://dx.doi.org/10.1016/j.
otohns.2006.09.007.
7. Zeitels SM, Barbu AM, Landau-Zemer T, et al.
Local injection of bevacizumab (Avastin) and
angiolytic KTP laser treatment of recurrent
respiratory papillomatosis of the vocal cords: a
prospective study. Ann Otol Rhinol Laryngol 2011
Oct;120(10):627-34.
8. Best SR, Friedman AD, Landau-Zemer T, et al.
Safety and dosing of bevacizumab (avastin)
for the treatment of recurrent respiratory
papillomatosis. Ann Otol Rhinol Laryngol
2012 Sep;121(9):587-93. DOI: http://dx.doi.
org/10.1177/000348941212100905.
9. Hočevar-Boltežar I, Matičič M, Sereg-Bahar M,
et al. Human papilloma virus vaccination in
patients with an aggressive course of recurrent
respiratory papillomatosis. Eur Arch Otorhinolaryngol 2014 Dec;271(12):3255-62. DOI:
http://dx.doi.org/10.1007/s00405-014-3143-y.
10. Martina D, Kurniawan A, Pitoyo CW. Pulmonary
papillomatosis: a rare case of recurrent
respiratory papillomatosis presenting with multiple
nodular and cavitary lesions. Acta Med Indones
2014 Jul:46(3):238-43.
11. Azadarmaki R, Lango MN. Malignant transformation of respiratory papillomatosis in a solid-organ
transplant patient: case report and literature review.
Ann Otol Rhinol Laryngol 2013 Jul;122(7):457-60.
12. Hasegawa Y, Sato N, Niikawa H, et al. Lung
squamous cell carcinoma arising in a patient with
adult-onset recurrent respiratory papillomatosis.
Jpn J Clin Oncol 2013 Jan;43(1):78-82. DOI:
http://dx.doi.org/10.1093/jjco/hys179.
13. Lin HW, Richmon JD, Emerick KS, et al.
Malignant transformation of a highly aggressive
human papillomavirus type 11-associated
recurrent respiratory papillomatosis. Am J
Otolaryngol 2010 Jul-Aug;31(4):291-6. DOI:
http://dx.doi.org/10.1016/j.amjoto.2009.02.019.
e127
Physicians may earn up to 1 AMA PRA Category 1 CreditTM per article for reading and analyzing the designated CME
articles published in each edition of TPJ. Each edition has four articles available for review. Other clinicians for whom
CME is acceptable in meeting educational requirements may report up to four hours of participation. The CME evaluation
form may be completed online or via mobile Web at www.tpjcme.org. The Certification of Credit form will be e-mailed
immediately upon successful completion. Alternatively, this paper form may be completed and returned via fax or mail to
the address listed below. All Sections must be completed to receive credit. Certification of Credit will be mailed within two
months of receipt of the paper form. Completed forms will be accepted until November 2016.
To earn CME for reading each article designated for AMA PRA Category 1 Credit, you must:
• Score at least 50% in the posttest
• Complete the evaluation and provide your contact information
This form is also available online: www.thepermanentejournal.org
Summer 2015
CME Evaluation Program
Section A.
Article 1. (page 21) “Getting off the Bus Closer to Your Destination”: Patients’ Views
about Pharmacogenetic Testing
Article 3. (page 54) Relationship between Participation in Patient- and Family-Centered Care Training
and Communication Adaptability among Medical Students: Changing Hearts, Changing Minds
Which of the following was not a main finding of this article?
a.participants saw the potential value of pharmacogenetic testing but expressed concerns
about privacy and discrimination based on genetic information
b.participants worried that physicians might overvalue pharmacogenetic test results and
dismiss patients’ reports about how a medication is working
c. participants did not believe that pharmacogenetic testing should be implemented
d.participants wanted to know whether the results of pharmacogenetic testing could be used
for purposes other than guiding prescribing decisions
According to this study, Families as Faculty education:
a.increases medical students’ awareness of best practices for clinical communication techniques
b.improves medical students’ awareness of how much information about themselves is necessary
for meaningful communication exchanges with patients
c. increases anxiety in patients
d.compromises HIPAA standards
Which of the following did participants not identify as potential risks of pharmacogenetic testing?
a.employment discrimination
b.breach of confidentiality
c. inability to obtain disability or long-term care insurance
d.misuse of genetic information by law enforcement
e.cloning
Article 2. (page 29) A Community-Based Hip Fracture Registry: Population, Methods, and Outcomes
What are the most common surgical procedures used to treat fractures of the femoral neck
subtrochanteric region?
a.internal fixation and hemiarthroplasty
b.total hip arthroplasty and hemiarthroplasty
c. hip resurfacing and internal fixation
d.internal fixation and total hip arthroplasty
The Hip Fracture Registry monitors primary hip fractures treated surgically and subsequent
revisions for what period of time?
a.for 1 year
b.for 2 years after surgery
c. for 5 years after surgery
d.for the patient’s lifetime
The author of this study uses a theoretical foundation that supposes:
a.patients need to be protected from information
b.successful communication between cultures depends on deep understanding of other cultures
c. patients and physicians do not represent different cultures
d.communication adaptability is comprised of factors that include social composure, wit,
appropriate disclosure, articulation, social experience, and social confirmation
Article 4. (page 64) 2014 Hypertension Guideline: Recommendation for a Change in Goal Systolic
Blood Pressure
Strong supportive evidence for the 8th Joint National Committee recommendation favoring goal
systolic blood pressure < 150 mmHg in the general elderly population beginning at age 60, exclusive
of patients with chronic kidney disease and diabetes, comes from which 2 trials?
a.Systolic Hypertension in the Elderly Program (SHEP) and Systolic Hypertension in Europe (Syst-Eur)
b.HYpertension in the Very Elderly Trial (HYVET) and Systolic Hypertension in Europe (Syst-Eur)
c. JApanese Trial to Assess Optimal Systolic Blood Pressure (JATOS) and HYpertension in the
Very Elderly Trial (HYVET)
d.Systolic Hypertension in the Elderly Program (SHEP) and Valsartan in Elderly Isolated
Hypertension Study (VALISH)
In confirmatory hypertension treatment trials supportive of goal systolic blood pressure < 150 mmHg
in the general elderly beginning at age 60, exclusive of patients with chronic kidney disease and
diabetes, which of the following highly significant endpoint reductions occurred?
a.stroke was reduced by 25% to 30% and major cardiovascular events were reduced by 20%
b.stroke was reduced by 15% to 20% and major cardiovascular events were reduced by 30%
c. stroke was reduced by 35% to 40% and major cardiovascular events were reduced by 30%
d.stroke was reduced by 20% to 25% and major cardiovascular events were reduced by 25%
Section C.
Section B.
Referring to the CME articles, how likely is it that you will implement this learning to improve your practice
within the next 3 months?
Objective 1
Objective 2
Objective 3
What other changes, if any, do you plan to make in your practice as
a result of reading these articles?
Integrate learned
knowledge and
increase competence/
confidence to support
improvement and
change in specific
practices, behaviors,
and performance.
Lead in further developing “PatientCentered Care” activities by acquiring
new skills and methods to overcome
barriers, improve physician/patient
relationships, better identify diagnosis
and treatment of clinical conditions,
as well as, efficiently stratify health
needs of varying patient populations.
Implement changes and
apply updates in services and
practice/policy guidelines,
incorporate systems and
quality improvements, and
effectively utilize evidencebased medicine to produce
better patient outcomes.
______________________________________________________
Article 1
210
543
5 4 3 2 1 0
5 4 3 2 1 0
Name _____________________________________________
Article 2
210
543
5 4 3 2 1 0
5 4 3 2 1 0
Article 3
210
543
5 4 3 2 1 0
5 4 3 2 1 0
Article 4
210
543
5 4 3 2 1 0
5 4 3 2 1 0
Key
5 = highly likely
4 = likely
3 = unsure
2 = unlikely
1 = highly unlikely
0 = I already did this
______________________________________________________
______________________________________________________
Section D. (Please
print)
Physician
Non-Physician Title _____________________________________________
E-mail _____________________________________________
Address _____________________________________________
The Kaiser Permanente National CME Program is accredited by the
Accreditation Council for Continuing Medical Education (ACCME) to provide
continuing medical education for physicians.
The Kaiser Permanente National CME Program designates this journal-based
CME activity for 4 AMA PRA Category 1 Credits™. Physicians should claim
only the credit commensurate with the extent of their participation in the activity.
96
Mail or fax completed form to:
Phone: 503-813-3286
Fax: 503-813-2348
_____________________________________________
Signature _____________________________________________
Date _____________________________________________
BOOKS PUBLISHED BY
PERMANENTE AUTHORS:
Summer 2015/ Volume 19 No. 3
PermanenteJournal
The
Mission: The Permanente Journal advances
knowledge in scientific research, clinical
medicine, and innovative health care delivery.
Circulation: 25,000 print readers per
quarter, 6900 eTOC readers, and in
2014, TPJ content had 1 million page
views—760,000 of those on TPJ articles
on PubMed. Viewers visited from
187 countries/territories.
ON THE COVER:
Rocky Perspective
by David L Shenson, MD
This photograph was
taken at Ruby Beach, on
the Olympic Peninsula in
Washington. The contrast
in depth of field creates an
interesting perspective of
these stones ground smooth
by the elements and the
passage of time.
Dr Shenson is an Internist at the Mt Scott
Medical Office in Clackamas, OR. More
of his photography may be viewed at:
www.davidshenson.com.
ORIGINAL RESEARCH
& CONTRIBUTIONS
4 Characteristics of Newly Enrolled
Members of an Integrated
Delivery System after the Affordable
Care Act.
Elizabeth A Bayliss, MD, MSPH;
Jennifer L Ellis, MSPH; Mary Jo Strobel,
RN, MBA; Deanna B McQuillan, MA;
Irena B Petsche, PhD; Jennifer C
Barrow, MSPH; Arne Beck, PhD
Of 89,289 newly enrolled non-Medicare
members, 25.3% completed the Brief Health
Questionnaire between 1/1/2014, and
8/31/2014. Of these, 3593 respondents
were insured through Medicaid, 9434
through the individual health exchange,
and 9521 through primarily commercial
plans. Of Medicaid, exchange, and
commercial members, 19.5%, 7.1%,
and 5.3%, respectively, self-reported fair
or poor health; 12.9%, 2.0%, and 3.3%
of each group self-reported 2 or more
Emergency Department visits during the
previous year; and 8.1%, 4.3%, and 4.4%
self-reported an inpatient admission during
the previous year.
11 A Metrics Taxonomy and Reporting
Strategy for Rule-Based Alerts.
Michael Krall, MD, MS; Alexander
Gerace
An action-oriented alerts taxonomy
according to structure, actions, and
implicit intended process outcomes
using a set of 333 rule-based alerts at
Kaiser Permanente Northwest (KPNW)
was developed. The authors identified 9
major and 17 overall classes of alerts and
developed a specific metric approach for
5 of these classes, including the 3 most
numerous ones in KPNW, accounting for
224 (67%) of the alerts.
21 “Getting off the Bus Closer to Your
Destination”: Patients’ Views about
Pharmacogenetic Testing.
James Ralston, MD, MPH; Gail P Jarvik,
MD, PhD; Eric B Larson, MD, MPH
96
CME EVALUATION FORM
The authors conducted focus groups with
patients prescribed antidepressants (pilot
session plus 2 focus groups, n = 27);
patients prescribed carbamazepine
(2 focus groups, n = 17); and healthy
patients (2 focus groups, n = 17). Although
advantages of pharmacogenetic testing,
many felt that the risks (discrimination,
stigmatization, physician overreliance on
genomic results, and denial of certain
medications) may outweigh the benefits.
These concerns were shared across
groups but were more strongly expressed
among participants with chronic mental
health diagnoses.
29 A Community-Based Hip Fracture
Registry: Population, Methods,
and Outcomes.
Maria C S Inacio, PhD; Jennifer M
Weiss, MD; Alex Miric, MD; Jessica J
Hunt, MA; Gary L Zohman, MD;
Elizabeth W Paxton, MA
Cases of hip fracture recorded from
1/2009 to 12/2011 were ascertained using
the Kaiser Permanente Hip Fracture
Registry. The registry collects information
on patient, procedure, surgeon, facility,
and surgical outcomes. The population
(N = 12,562) was predominantly white,
women, and older (≥ 75 years), and
32% had at least 5 comorbidities. The
average length of follow-up was 1.1 years.
Hemiarthroplasty was the most common
procedure (33.1%). Most fractures were
treated by medium-volume surgeons
at high-volume facilities. The 90-day
readmission rate was 22.1%, and the
mortality rate was 12.3%.
37 Utility of the Multinational Association
for Supportive Care in Cancer (MASCC)
Risk Index Score as a Criterion for
Nonadmission in Febrile Neutropenic
Patients with Solid Tumors.
Febrile neutropenic episodes in patients
with solid tumors were identified
electronically from 10/1/2008 to
11/15/2010. Inclusion criteria were met
in 198 episodes. Sensitivity, specificity,
and positive and negative predictive
values of the MASCC risk index score vs
complications were, respectively, 94%,
29.6%, 57.7%, and 82.9%. An MASCC risk
index score of 21 or greater could not be
used as a criterion for “no complication/
do not admit.” Inability to eat should be an
admission criterion.
48 Evidence-Based Referral: Effects of the
Revised “Youth Fit 4 Life” Protocol
on Physical Activity Outputs: A
Randomized Controlled Trial.
James J Annesi, PhD, FAAHB, FTOS,
FAPA; Linda L Vaughn, MS, MBA
The authors contrasted 2 physical activity/
nutrition treatments on the basis of social
cognitive and self-efficacy theory, and a
comparison condition, on time in moderateto-vigorous physical activity (MVPA) during
the 45-min/day physical activity segment
of elementary after-school care. The Revised Youth Fit 4 Life protocol that sought
to maximize participants’ cardiovascular
physical activity appeared to improve upon
the Original Youth Fit For Life treatment on
time in MVPA. Thus, pediatricians might
have confidence in referring their patients
to such evidence-based approaches.
Instant Work-Ups: A Clinical Guide
to Obstetric and Gynecologic Care
Theodore X O’Connell, Kathleen Dor
ISBN-10: 1416054618
ISBN-13: 978-1416054610
Philadelphia, PA; Saunders: 2008
$31.95
Glimpses in Time
Nicholas Morell
ISBN-10: 1483690202
ISBN-13: 978-1483690209
Bloomington, IN: Xlibris; 2013
$19.99
If you are a Permanente author and would like your book cited here,
send an e-mail to max.l.mcmillen@kp.org.
NOW AVAILABLE!
The new Web mobile CME application
from The Permanente Journal.
- Read articles.
- Take quizzes.
- Earn credit.
- Get your
CME certificate
immediately.
www.tpjcme.org
ISSN 1552-5767
Follow @PermanenteJ
For information and/or rates for placing an
announcement here, please contact amy.r.eakin@kp.org.

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