a layered guide to evaluation

Transcription

CONTEMPOR ARY OB/GYN
SEPTEMBER 2015
VOL. 60 NO. 09
SEPTEMBER 2015, Vol. 60, No. 09
Expert Advice for Today’s Ob/Gyn
For Doctors by Doctors
ContemporaryOBGYN.net
A LAYERED GUIDE TO EVALUATION
CHRONIC SE XUAL PAIN ◾ ULTR ASOUND UPDATE ◾ ACOG ON ENDOMETRIAL CANCER ◾ CHILDBIRTH COST VARIATIONS
PAINFUL
SEX
FIRST PERSON
Counseling
on shoulder
dystocia PAGE 30
GUEST EDITORIAL
How much does
a baby cost? PAGE 5
Christian Pettker, MD
PAGE 18
Deborah Coady, MD, FACOG
ACOG GUIDELINES
Endometrial
cancer PAGE 34
Ilana Cass, MD
DIGITAL OB/GYN
OB ultrasound
horizons PAGE 12
SEPTEMBER 2015
VOL. 60 NO. 09
SEPTEMBER 2015 , Vol. 60 , No. 09
For Doctors by Doctors
A LAYERED GUIDE TO EVALUATION
ContemporaryOBGYN.net
CHRONIC SE XUAL PAIN ◾ ULTR ASOUND UPDATE ◾ ACOG ON ENDOMETRIAL CANCER ◾ CHILDBIRTH COST VARIATIONS
PAINFUL
SEX
FIRST PERSON
Counseling
on shoulder
dystocia PAGE 30
are now recommended
PEG laxatives like MiraLAX®
as a first-line constipation therapy byGUEST
the
AGA
EDITORIAL
PAGE 18
Deborah Coady, MD, FACOG
One product. Two benefits.
MiraLAX® is the osmotic laxative
with dual benefits—it relieves
constipation and softens stool.
1
How much does
a baby cost? PAGE 5
Christian Pettker, MD
ACOG GUIDELINES
Endometrial
cancer PAGE 34
Ilana Cass, MD
DIGITAL OB/GYN
Recommend MiraLAX today and see why it is the
#1 GI recommended laxative.2
OB ultrasound
horizons PAGE 12
For more information, please visit
www.MiraLAXMD.com
Reference: 1. American Gastroenterological Association, Bharucha AE, Dorn SD, Lembo A, Pressman A.
American Gastroenterological Association medical position statement on constipation. Gastroenterology.
2013;144:211-217. 2. IMS data. IMS National Disease & Therapeutic Index. 2011.
Use as directed.
© 2015 Bayer
Rapid, Reliable, Non-Invasive Test for ROM
(Rupture Of [fetal] Membranes)
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© 2015 AmniSure® International LLC, all rights reserved.
EDITORIAL BOARD
HAVE A QUESTION FOR THE BOARD? SEND IT TO US AT
EDITOR IN CHIEF
drlockwood@advanstar.com
DEPUTY EDITOR
JON I EINARSSON, MD, PHD, MPH
CHARLES J LOCKWOOD, MD, MHCM
Senior Vice President, USF Health
Dean, Morsani College of Medicine
Associate Professor of Obstetrics and Gynecology
Harvard Medical School
University of South Florida
Director, Division of Minimally Invasive Gynecologic Surgery
Brigham and Women’s Hospital
TAMPA, FL
BOSTON, MA
YOUR EDITORIAL BOARD
PAULA J ADAMS HILLARD, MD
JOHN O DELANCEY, MD
CHRISTIAN PETTKER, MD
Professor, Department of Obstetrics
and Gynecology, Chief, Division of
Gynecologic Specialties
Norman F Miller Professor of
Gynecology, Director, Pelvic Floor
Research, Group Director, Fellowship
in Female Pelvic Medicine and
Reconstructive Surgery
Associate Professor, Maternal-Fetal
Medicine, Department of Obstetrics,
Gynecology and Reproductive
Sciences
University of Michigan
Medical School
NEW HAVEN, CT
Stanford University
School of Medicine
STANFORD, CA
ANN ARBOR, MI
SHARON T PHELAN, MD
HAYWOOD L BROWN, MD
Roy T. Parker Professor and Chair,
Division of Maternal Fetal Medicine
SARAH J KILPATRICK, MD, PHD
Helping Hand Endowed Chair,
Department of Obstetrics and
Gynecology
Duke University Medical Center
DURHAM, NC
Cedars-Sinai Medical Center
ALBUQUERQUE, NM
LAURIE J MCKENZIE, MD
Executive Associate Dean for
Academic Affairs, Professor of
Obstetrics and Gynecology, and
Human and Molecular Genetics
Houston Oncofertility Preservation
and Education (H.O.P.E.)
LOS ANGELES, CA
University of New Mexico
JOE LEIGH SIMPSON, MD
Director of Oncofertility,
Houston IVF, Director
Cedars-Sinai Medical Center
Professor, Department of
Obstetrics and Gynecology
LOS ANGELES, CA
ILANA CASS, MD
Vice Chair, Associate Clinical
Professor, Department of Obstetrics
and Gynecology
Yale School of Medicine
Florida International University
College of Medicine
MIAMI, FL
HOUSTON, TX
JOSHUA A COPEL, MD
Professor, Obstetrics, Gynecology,
and Reproductive Sciences, and
Pediatrics
FOUNDING JOHN T QUEENAN, MD
EDITOR Professor and Chair Emeritus, Department of Obstetrics and Gynecology
Yale School of Medicine
Georgetown University School of Medicine WASHINGTON, DC
NEW HAVEN, CT
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1
IN THIS ISSUE
september 2015
VOLUME 60 | NUMBER 09
PEER-REVIEWED
Hope for chronic
sexual pain
12
As the amount of information
revealed by prenatal ultrasound
technology continues to grow, so
does the need for better training
and interpretation.
The author’s “layer” technique
provides a systematic guide to
evaluating and treating chronic
pain with sexual activity.
FIRST PERSON
Our shoulder
dystocia policy
38
ARNOLD W COHEN, MD, AND
DAVID JASPAN, MD
The authors explain why they
have instituted a policy for
patients who have had previous
deliveries complicated by
shoulder dystocia.
5
GUEST EDITORIAL
44
CHRISTIAN PETTKER, MD
INTERACTIVE
56
This month: menopause news and
resources
34
ACOG GUIDELINES
Endometrial cancer
2005–2015
MARIANNE MONROY, JD
ILANA CASS, MD
Physicians have a legal
responsibility to help patients
with limited English to have
equal access to healthcare.
A commentary on ACOG
Practice Bulletin Number 149:
Endometrial Cancer.
WOMEN’S HEALTH UPDATE
LEGALLY SPEAKING
ANDREW I KAPLAN, ESQ
55
41
Patient language
barriers
A report on the 3rd annual GOHO
ultrasound course.
What does it really cost to give birth?
10
PRACTICE MATTERS
A womb with a view
BRIAN A LEVINE, MD, MS, FACOG
DEBORAH COADY, MD, FACOG
30
DIGITAL OB/GYN
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SEPTEMBER 2015
ILLUSTRATION BY ALEX BAKER, DNA ILLUSTRATIONS, INC
18
Rx only
Postmarketing Experience
delayed-release tablets, for oral use.
post-approval use of the combination of 10 mg doxylamine succinate and 10 mg
pyridoxine hydrochloride. Because these reactions are reported voluntarily from
a population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.
Cardiac disorders: dyspnea, palpitation, tachycardia
Ear and labyrinth disorders: vertigo
Eye disorders: vision blurred, visual disturbances
Gastrointestinal disorders: abdominal distension, abdominal pain, constipation,
diarrhea
General disorders and administration site conditions: chest discomfort, fatigue,
irritability, malaise
Immune system disorders: hypersensitivity
Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor
hyperactivity
Psychiatric disorders: anxiety, disorientation, insomnia, nightmares
Renal and urinary disorders: dysuria, urinary retention
Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculopapular
DICLEGIS® (doxylamine succinate and pyridoxine hydrochloride)
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION.
PLEASE SEE FULL PRESCRIBING INFORMATION.
INDICATIONS AND USAGE
DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in
women who do not respond to conservative management.
Limitations of Use
DICLEGIS has not been studied in women with hyperemesis gravidarum.
DOSAGE AND ADMINISTRATION
Initially, take two DICLEGIS delayed-release tablets orally at bedtime (Day 1). If this
dose adequately controls symptoms the next day, continue taking two tablets daily
at bedtime. However, if symptoms persist into the afternoon of Day 2, take the
usual dose of two tablets at bedtime that night then take three tablets starting
on Day 3 (one tablet in the morning and two tablets at bedtime). If these three
tablets adequately control symptoms on Day 4, continue taking three tablets daily.
Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet
mid-afternoon and two tablets at bedtime).
The maximum recommended dose is four tablets (one in the morning, one in the
mid-afternoon and two at bedtime) daily.
Take on an empty stomach with a glass of water. Swallow tablets whole. Do not
crush, chew, or split DICLEGIS tablets.
Take as a daily prescription and not on an as needed basis. Reassess the woman for
continued need for DICLEGIS as her pregnancy progresses.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category A
DICLEGIS is intended for use in pregnant women.
The combination of doxylamine succinate and pyridoxine hydrochloride has been
the subject of many epidemiological studies (cohort, case control and meta-analyses)
11 case-control studies published between 1963 and 1991 reported no increased
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg
pyridoxine hydrochloride.
CONTRAINDICATIONS
DICLEGIS is contraindicated in women with any of the following conditions:
antihistamines, pyridoxine hydrochloride or any inactive ingredient in the
formulation
(see Drug Interactions).
WARNINGS AND PRECAUTIONS
Activities Requiring Mental Alertness
DICLEGIS may cause somnolence due to the anticholinergic properties of doxylamine
succinate, an antihistamine. Women should avoid engaging in activities requiring
complete mental alertness, such as driving or operating heavy machinery, while using
DICLEGIS until cleared to do so by their healthcare provider.
DICLEGIS use is not recommended if a woman is concurrently using central nervous
system (CNS) depressants including alcohol. The combination may result in severe
drowsiness leading to falls or accidents (see Drug Interactions).
Concomitant Medical Conditions
DICLEGIS has anticholinergic properties and, therefore, should be used with caution
in women with: asthma, increased intraocular pressure, narrow angle glaucoma,
stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck
obstruction.
Drug Interactions
Use of DICLEGIS is contraindicated in women who are taking monoamine oxidase
of antihistamines. Concurrent use of alcohol and other CNS depressants (such as
hypnotic sedatives and tranquilizers) with DICLEGIS is not recommended.
Drug-Food Interactions
may be further delayed and a reduction in absorption may occur when tablets are
taken with food. Therefore, DICLEGIS should be taken on an empty stomach with a
glass of water (see Dosage and Administration).
ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere in labelling:
(see Warnings and Precautions)
DICLEGIS with CNS depressants including alcohol (see Warnings and Precautions)
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared to
hydrochloride with or without dicyclomine hydrochloride.
Nursing Mothers
Women should not breastfeed while using DICLEGIS.
The molecular weight of doxylamine succinate is low enough that passage into breast
milk can be expected. Excitement, irritability and sedation have been reported in
nursing infants presumably exposed to doxylamine succinate through breast milk.
Infants with apnea or other respiratory syndromes may be particularly vulnerable to
conditions.
Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of
adverse events in infants presumably exposed to pyridoxine hydrochloride through
breast milk.
Pediatric Use
been established.
cases have been characterized by coma, grand mal seizures and cardiorespiratory
died 18 hours after ingesting 1,000 mg doxylamine succinate. However, there is no
correlation between the amount of doxylamine ingested, the doxylamine plasma
level and clinical symptomatology.
OVERDOSAGE
Signs and Symptoms of Overdose
DICLEGIS is a delayed-release formulation, therefore, signs and symptoms of
intoxication may not be apparent immediately.
Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated
pupils, sleepiness, vertigo, mental confusion and tachycardia.
rhabdomyolysis, acute renal failure and death.
Management of Overdose
If treatment is needed, it consists of gastric lavage or activated charcoal, whole
overdose treatment, call a poison control center (1-800-222-1222).
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
clinical practice.
randomized, multi-center trial in 261 women with nausea and vomiting of pregnancy.
The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation
(see Clinical Studies)
than Placebo are shown)
Storage and Handling
DICLEGIS
(N = 133)
Somnolence
Somnolence and Severe Drowsiness
Inform women to avoid engaging in activities requiring complete mental alertness,
such as driving or operating heavy machinery, while using DICLEGIS until cleared to
do so.
Inform women of the importance of not taking DICLEGIS with alcohol or sedating
medications, including other antihistamines (present in some cough and cold
medications), opiates and sleep aids because somnolence could worsen leading to
falls or other accidents.
Placebo
(n = 128)
19 (14.3%)
or medicalinfo@duchesnayusa.com
medwatch.
and protect from moisture. Do not remove desiccant canister from bottle.
Distributed by:
www.fda.gov/
Duchesnay USA, Inc.
Bryn Mawr, PA, 19010
www.Diclegis.com
©2013, Duchesnay Inc. All rights reserved.
2013-0002-01 Apr 2013
GUEST EDITORIAL
by CHRISTIAN M. PETTKER, MD
How much does it cost to have
a baby in the United States?
L
ast year the US Department of Agriculture estimated that it would cost
a middle-income couple
just over $245,000 to
raise a child to the age of 18.1 Admittedly, these costs varied. For instance,
costs for low-income rural families
are about $145,000, while those for
high-income families in Northeast urban areas are estimated at $455,000.
These assessments don’t include
the cost of college, but they include
housing, food, childcare, education through high school, and other
expenses. When I read this information I was as surprised by the number
as I was by the fact that this has been
estimated annually since 1960!
However, as an obstetrician I found
it particularly interesting that these
expense estimates did not include
the cost of pregnancy and childbirth,
which certainly is an important part
of “raising a child.” The most obvious
reason for this oversight is that the
Department of Agriculture is trying to
account for the costs of raising a child
from birth, rather than from conception. However, looking deeper, it becomes clearer that the complexity of
our healthcare finance system makes
adding this estimate quite challenging. For instance, would the actuaries
use the cost of the insurance to cover
the pregnancy or the costs paid by
SEPTEMBER 2015
Evaluating patients with chronic sexual pain A detailed approach
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WRÀQGLQJDQGWUHDWLQJWKHVRXUFHVRISDLQZLWKVH[XDODFWLYLW\.
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those insurance companies for perinatal care? Furthermore, do we actually know the true costs of perinatal
care in the United States?
I became familiar with the difficulty in determining these costs when
a patient from overseas came to my
practice this year requesting an itemization of the costs she would be asked
to pay for her prenatal care and birth,
assuming a routine, uncomplicated
pregnancy. We went to our practice
and hospital administrators to determine the actual costs for ultrasounds,
prenatal visits, and hospitalization for
someone who was not indigent. We
arrived at an answer after a great deal
of investigation, but it was a bit shocking that such sophisticated businesses
could find it as challenging as it was. I
would encourage you to ask the question at your own center. For me, it was
a true-life demonstration of what I had
read in the popular press regarding the
enigmatic and highly variable process
for determining charges versus actual
cost estimates for common procedures such as hip replacements and
colonoscopies.2
Around the same time, coincidentally, a similar, larger-scale question
was being asked by a colleague of
mine at Yale University. Xiao Xu, PhD,
Assistant Professor of Obstetrics,
Gynecology and Reproductive Sciences and a member of the Institute
for Social Policy and Studies at Yale, is
a health economist who is interested
in how value, costs, and outcomes interact in women’s health. Her team’s
questions were simple: How much do
hospitals report it costs for an average, routine stay following childbirth
for a low-risk mother? Also, if there
is any variation in these costs, is the
variation due to any characteristics of
the patients or the hospitals, such as
volume, teaching status, quality outcomes, or other care practices?
As reported in the July issue of
Health Affairs, her team used the 2011
Nationwide Inpatient Sample database
that included 463 hospitals across
the country.3 (Editor’s note: this team
included Dr Pettker.) They limited their
analysis to low-risk pregnancies. Furthermore, they used reported hospital
“cost-to-charge” ratios to estimate
5
GUEST EDITORIAL
HEALTHCARE COSTS
ESTIMATED HOSPITAL COSTS FOR A LOW-RISK BIRTH RANGED FROM
A LOW OF
$1,189 TO A HIGH OF $11,986.
costs, as the dataset included only
hospital charges to payers, which are
known to not precisely indicate actual
expenditures. The cost estimates did
not include prenatal care or the fees
that obstetricians or anesthesiologists
may add. Vaginal deliveries averaged
$4192, whereas the mean cesarean
delivery estimate was $6945. These are
not unexpected numbers. What was
surprising was the variation. While the
overall average for low-risk births was
$4485, these estimated hospital costs
ranged from a low of $1189 to a high of
$11,986. Taking out the wide outliers,
there was still a 2.2-fold difference between the 10th and 90th percentiles.
Many hospital characteristics were
associated with this variability, some
of them quite counterintuitive. For
example, public hospitals were more
expensive than private ones, and
nonprofit hospitals were more expensive than for-profit hospitals. Care
was also more costly in rural locations, at facilities with lower volumes,
and at centers with low numbers
of Medicaid patients. Interestingly,
there was no difference between
geographic regions (eg, Northeast
vs South or Midwest) and teaching
hospitals did not seem to have higher
costs. Obstetric facilities with higher
cesarean delivery rates were indeed
associated with higher costs. Finally,
hospitals with longer lengths of stay
and with higher rates of serious maternal morbidity outcomes also had
higher facility costs.
The last issue is tricky. It is hard
6
to know if the lengths-of-stay and
morbidity differences reflect sicker
populations (ie, a higher case mix)
or a lower quality of care. However,
the authors attempted to reduce the
influence of case mix by selecting
mothers between 16 and 34 years of
age, and without major comorbidities
such as preeclampsia, hypertension,
diabetes, and obesity. The implication may be, then, that higher costs
VAGINAL DELIVERIES
AVERAGED
$4,192
WHEREAS CESAREAN
DELIVERIES AVERAGED
$6,945
might actually be due to worse quality, demonstrating that our national
goal of improving healthcare value by
lowering costs and improving quality
is not well adopted.
This report has important information for all of us. At the most basic
level, it is hard not to be surprised that
there could be a 10-fold difference in
estimated average costs for a low-risk,
uncomplicated birth. How the outliers
account for their extraordinarily low or
high costs would be an interesting, and
I suspect provocative, investigation.
Improving healthcare expenditures
begins with looking at variability, to
ascertain the secrets of best performers
and to begin to control waste and inefficiencies in the worst performers. But
from a policy standpoint the details
that might explain the variability also
provide insights into our next steps.
First, systematic approaches to lowering the cesarean delivery rate could be
very helpful in reducing obstetric care
costs, especially considering that some
of the centers in this study reported
primary cesarean rates as high as 39%
in their low-risk populations. Second,
resourceful solutions to reducing
lengths of stay (such as home nursing
visits, which are more common outside of the United States) may help.
Healthcare economists may ask
why it is important to study the costs
of childbirth, a seemingly small piece
of the healthcare puzzle. As pointed
out in the introduction of the article,
“In the United States, hospital care
is the most expensive component of
national health spending and childbirth is the leading cause of hospital
admission. In 2011 childbirth accounted for 3.8 million hospitalizations and more than $15.1 billion
in hospital facility costs. . . .” This
represents approximately 6.5% of total health expenditures ($2.3 trillion)
from that year and is not inconsequential.4 More than that, however,
our response to improving costs and
reducing variability in obstetrics may
help inform methods of doing this in
other medical specialties—such as
SEPTEMBER 2015
NUSWAB® VAGINITIS PORTFOLIO
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to laboratory testing.
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1. Willett LL, Centor RM. Evaluating vaginitis. The importance of patient factors. J Gen Intern Med.
2005 Sept;20(9): 871.
2. Centers for Disease Control and Prevention. Recommendations and Reports: Sexually
transmitted diseases treatment guidelines, 2010, MMWR. 2010;59(RR-12):1-114.
3. The American College of Obstetricians and Gynecologists. Vaginitis. ACOG Practice Bulletin No.
72. Obstet Gynecol. 2006;107:1195-1206.
4. Cartwright CP, Lembke BD, Ramachandran K, et al. Development and validation of a
semiquantitative multitarget PCR assay for diagnosis of bacterial vaginosis. J Clin Microbiol.
2012;50(7):2321-2329.
5. Richter SS, Galask RP, Messer SA, Hollis RJ, Diekema DJ, Pfaller MA. Antifungal susceptibilities of
Candida species causing vulvovaginitis and epidemiology of recurrent cases. J Clin Microbiol. 2005
May; 43(5):2155-2162.
6. APTIMA® Trichomonas vaginalis Assay [package insert]. San Diego, Calif: Gen-Probe
Incorporated; 2009-2011.
7. Chapin K, Andrea S. APTIMA Trichomonas vaginalis, a transcription-mediated amplification
assay for detection of Trichomonas vaginalis in urogenital specimens. Expert Rev Mol Diagn. 2011;
11(7):679-688.
8. Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcriptionmediated amplification to wet mount microscopy, culture, and polymerase chain reaction for the
diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol. 2009;200:188.e1-188.e7.9.
GUEST EDITORIAL
geriatrics or cardiology—that might
loom more prominently in the minds
of healthcare policy experts. This may
be an opportunity to use the example
of a rather straightforward condition
and hospitalization (labor and childbirth in healthy women) to suggest
strategies for more complicated hospitalizations (such as for myocardial
infarction or hip replacements).
What is most telling is that the variables studied (cesarean rate, length
of stay, hospital characteristics, and
maternal outcomes) accounted for only
13% of the variation in the mathematical model. Finding out what accounts
HEALTHCARE COSTS
for the rest of the variation is both a
daunting task and huge opportunity to
improve the value of maternity care. Dr Pettker is an Associate Professor of
Maternal-Fetal Medicine in the Department
of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New
Haven, Connecticut. He is also a member of
the Contemporary OB/GYN editorial board.
REFERENCES
1. United States Department of Agriculture. Parents projected to spend $245,340 to raise a child
born in 2013, according to USDA report. http://
www.usda.gov/wps/portal/usda/usdahome?c
ontentidonly=true&contentid=2014/08/0179.
xml. Accessed August 6, 2015.
2. The New York Times. The $2.7 trillion medical bill: colonoscopies explain why U.S. leads
the world in health expenditures. http://www.
nytimes.com/2013/06/02/health/colonoscopies-explain-why-us-leads-the-world-in-healthexpenditures.html. Accessed August 6, 2015.
3. Health Affairs. Wide variation found in hospital
facility costs for maternity stays involving low-risk
childbirth. http://content.healthaffairs.org/content/34/7/1212.full.html. Accessed August 6, 2015.
4. National Center for Health Statistics.
Health, United States, 2013: with special feature on prescription drugs. Hyattsville, MD.
2014; http://www.cdc.gov/nchs/data/hus/
hus13.pdf. Accessed August 6, 2015.
EDITORIAL
READERS REACT
[Regarding “What price
reassurance? The high cost of
routine mammography in younger
women,” May 2015 Contemporary
OB/GYN:] I read your article with a
great deal of interest and also some
amusement. It could have been scripted
by any insurance company with the
ultimate objective of saving money,
not saving lives. My patients are more
LPSRUWDQWWRPH(YHU\WLPH,ÀQGDQ
early breast cancer in a young women,
I am so thankful that I have encouraged
that individual to get a mammogram.
Perhaps we better look at other ways
to save money. Unless there is another
way to diagnose breast cancer early in
younger women, I will continue ordering
screening mammograms and follow
up appropriately. There are too many
40-year-old women diagnosed with breast
cancer to ignore.
To the best of my knowledge, there is
8
BY CHARLES J. LOCKWOOD
, MD, MHCM
What price reassurance?
The high cost of routine
mammography in younger
women
no other way to diagnose and treat early
breast cancer. I’m sure the insurance
companies and the government were
thrilled by your article. I promise you that
the patients whose lives were saved are
much less so. As a physician who treats
REAL patients, I am more concerned
with patients who are diagnosed early
rather than those who aren’t. Unless
you and those who really only look
at statistics rather than the individual
patients come up with another method
of detection, I will continue to practice
medicine that cares about the welfare of
the patient.
Steven Drosman, MD, FACOG
SAN DIEGO, CALIFORNIA
IN REPLY
Thank you for your comments. My intent
was to present the data in an entirely
empirical fashion and have our readers
make up their own minds as to how
T
he incidence of breast cancer
has
the relatively uncommon
(<1 per
been declining for more than
a
1000) occurrence of breast
cancer
decade, perhaps as a result
of
death among women aged
39 to 49
the dramatic reduction in
the
by around 15% (relative risk,
use of postmenopausal therapy
0.85
with
[95% credible interval, 0.75–0.96];
combined estrogen and progestin.
Far more significantly, breast
cancer
deaths have been declining
for the
past 25 years.1 This is likely
due to an
improved understand ing of
relevant
cancer biology, better therapies,
and
advances in screening technologie
s
and their utilization. However,
the
prevalence of breast cancer
rises with
8 trials), 3 such screening
is associage, making screening more
efficaated with substantial ly increased
cious in older women and
lowering
costs due to both false-positi
the positive predictive value
ve re(PPV) of
sults and overdiagnosis of
screening in younger women.
lesions
that would not necessarily
lead to
For example, routine mammomortality. But just how much
grams have a PPV of 1.6%
examong
pense does such screening
women aged 40 to 44 versus
add to
5.9%
the health system? A recent
for women aged 60 to 64 years.2
study
Consuggests far more than previously
versely, the higher rate of extremely
thought.
dense breasts in younger women
leads
to lower mammographic screening
The cost of false-positives
sensitivity (73.4% for women
aged
and over-diagnosis
40 to 44 vs 84.7% for those
aged 60
Ong and Mandl conducted
to 64 years).2 Thus, 1904 women
a
in
retrospective cohort study
their 40s would need to be
of
screened
702,154 women aged 40 to
to prevent one breast cancer
59
death,
years who underwent routine
while only 377 women in
their 60s
mammography during a 12-month
would need to be screened
to avoid
period. The researchers used
one such death.3
insurance data to calculate
Thus, while meta-analyses
sugthe expense of false-positi
ve
gest that mammogra phy
reduces
mammogra ms and breast
cancer
overdiagnoses. They included
beneficiaries from all 50 states
and the District of Columbia
undergoing such screening
in
2012 who were continuous
ly
4
Just how much expense does
such screening
add to the health system? It
may be far more
than previously thought.
10
CONTEMPOR ARYOBGYN.N
ET
enrolled in the insurance
plan
for the following 12 months.
They excluded high-risk women,
including those with a prior
diagnosis of breast cancer.
The authors defined a “false-positive mammogra m” as one
that led
to a further diagnostic workup
that
was not followed by a breast
cancer diagnosis. Women with
invasive
breast cancers were identified
by the
ICD-9 code for invasive breast
cancer (174.x) as well as by evidence
of
subsequent breast cancer treatment
(ie, surgery, radiation therapy,
or
chemotherapy). Women with
duc-
WE WANT TO
HEAR FROM YOU
Send your feedback to:
DrLockwood@advanstar.com.
MAY 2015
DID YOU MISS THIS?
READ IT AT
CONTEMPORARYOBGYN.NET/
WHAT-PRICE-REASSURANCE
to proceed, which you clearly have
done. I also recommend screening
mammography as per ACOG guidelines
but we should not be ignorant of the
FRQWURYHUV\WKHULVNVWKHEHQHÀWVDQG
the costs of our actions.
Charles J Lockwood, MD, MHCM
SEPTEMBER 2015
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INTERACTIVE
CLINICAL & PRACTICE MANAGEMENT RESOURCES FROM
contemporaryobgyn.net
Patients turn to unproven
treatments for menopause
According to The North American Menopause Society
(NAMS), about 53% of menopausal women use at least one
type of complementary and alternative medicine (CAM) for
the management of menopause-related symptoms such as hot
flashes, night sweats, anxiety, depression, stiff or painful joints,
vaginal discharge, and urine leakage. A study relesased in July
by Menopause, the NAMS journal, found that menopausal
women turning to CAM often do so without medical guidance.
ONLINE POLL
How much
FRQÀGHQFH
GR\RXKDYH
in alternative
therapies (such
as herbs) for
treating the
symptoms of
menopause?
medicines, aromatherapy oils, and/or Chinese medicines.
The study authors suggest that healthcare providers need to
be more aware of the various CAM therapies and take a more
active role in guiding patients through their options.
Fear of the potential risks of hormone therapy is cited as a
primary reason for the growing use of CAM, accoring to NAMS.
“ ... [J]ust because something appears natural does not necessarily mean it is without risk, especially for certain populations,” said NAMS Medical Director Wulf Utian, MD, PhD, DSc,
in a NAMS press release.
Menopause Society,
this talk by Dr Anna Fenton,
a consultant endocrinologist
with Christchurch Women’s
Hospital, New Zealand, covers complementary therapies
NAMS explains that the more popular self-prescribed CAM tresatments include vitamins/minerals, yoga/meditation, herbal
From the International
46
38%
16%
%
$JUHDWGHDO
for symptoms of menopause.
Dr Fenton discusses soybased estrogen, progesterone cream, Vitamin E, and
other treatments.
http://bit.ly/1IcWvsp
Some
None at all
Have your say! Visit
contemporaryobgyn.
net for next month’s
poll question.
FOR MORE OF
THE LATEST ON
MENOPAUSE
Are common chemicals
associated with earlier
onset of menopause?
contemporaryobgyn.net/
chemicals-menopause
Management of mood
and memory problems
during menopause
WHAT YOU’VE HAD TO SAY ON TWITTER LATELY
Be on top of the latest
osteoporosis recommendations and treatments
bit.ly/1Hm9pUN
@NAMSnews
10
More women turning to
CAM for menopause
without medical guidance bit.ly/1IyPTe4
@AllThingsGero
Alternative menopause
therapies not best
choice: study - ABC Online bit.ly/1DrTMAd
@apalachee
mood-memory-menopause
Ultrasound triage
of postmenopausal
bleeding
postmenopause-bleeding
SEPTEMBER 2015
Meet your
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THE DIGITAL OB/GYN
by BRIAN A LEVINE, MD, MS, FACOG
A womb with a view
How to prepare for tomorrow’s images
USED WITH PERMISSION OF GE HEALTHCARE
A
s obstetricians and
gynecologists we
must know not only
obstetrics and gynecology but also a
significant amount of internal medicine, general surgery, and radiology.
Knowing which radiologic test to
order is not enough; many of us routinely make clinical decisions and
perform procedures based solely on
our own ultrasonographic findings.
Ultrasound was first introduced to
ob/gyn in the late 1950s in an article
published by Dr Ian Donald in the
Lancet. In this sentinel paper, Donald
described how an image of a fetus
could be produced on a cathode ray
tube by rocking a transducer slowly
over a woman’s abdomen. This early
image was bistable (meaning that it
lacked any gray scale so it was completely black and white).1
It was Donald and his team who
first described the early diagnosis of
a hydatid mole, identification and assessment of early gestation, and presence of pelvic masses.2 In the years
that followed, these investigators also
made great advances in describing
the location of the placenta. That was
viewed as a paramount discovery
because hemorrhage from placenta
previa was then a significant cause
of maternal and fetal morbidity and
mortality.3
12
FIGURE 1 An image produced using the HDlive Silhouette feature of a Voluson E10.
It has been more than 55 years
since ultrasound was first described,
and today’s tools and techniques
barely resemble the initial construct.
Ultrasounds are now performed in
real time, transvaginal transducers allow for improved pelvic sonographic
studies, and 3D constructs are a common component of fetal anatomical
screening.
For example, GE Healthcare announced last year that it had released
a machine (the Voluson E10) that in
the company’s words has “4 times the
ultrasound pathways for improved
clarity with increased penetration, 10
times the data transfer rates for more
speed, higher resolution and very fast
frame rates, and 4 times the processing power for more flexibility with
advanced applications and efficient
workflow.”4
Do our patients really need all that
technological power? Most likely
not. Most patients who have 3D/4D
ultrasounds are having the scans as
“keepsake” mementos because they
are excited about the opportunity to
see a facial reconstruction of their
fetus. A glimpse of their baby smiling
or sucking his thumb while in utero
is a moment parents don’t forget.
SEPTEMBER 2015
Because Knowledge is a Powerful Tool.
BRCAssure® is a comprehensive suite of tests to identify patients
with BRCA mutations who are at increased risk for hereditary
breast, ovarian, and certain other cancers.
The overall prevalence of BRCA1 and BRCA2 mutations in the general population
is estimated at 1 in 400 1 and varies with ethnicity. Approximately 1 in 40 individuals
of Ashkenazi Jewish heritage carry one of three founder mutations.1
With the knowledge of your patient’s BRCA mutation status you have power to
help tailor prevention and treatment strategies speciﬁc to your patient, as well
as assist family members in understanding their risk.
Integrated Genetics is committed to providing comprehensive care to you and
your patients. Together, we offer:

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To learn more about our BRCAssure® test offerings,
please visit www.integratedgenetics.com or call
800-345-GENE (4363).
1. Genetics of Breast and Ovarian Cancer. National Cancer Institute. Available at: http://
www.cancer.gov/cancertopics/pdq/genetics/breast-and-ovarian/HealthProfessional/
page2#Section_113. Accessed November 1, 2013.
©2015 Laboratory Corporation of America ® Holdings. All rights reserved.
rep-963-v1-0815
However, the US Food and Drug
Administration (FDA) has recently
been vocal about avoiding such elective scans.
In an FDA statement released in
2014, Shahram Vaezy, PhD, an FDA
biomedical engineer, is quoted as
saying, “ultrasound can heat tissues
slightly, and in some cases, it can
also produce very small bubbles
(cavitation) in some tissues.” The
concern is that the long-term effects
of tissue heating and cavitation are
unknown. Therefore, the FDA recommends that ultrasound scans be
done only when there is a medical
need, based on a prescription, and
performed by appropriately trained
operators.5
This FDA opinion is focused
on protecting the population as a
whole—preventing patients from
being taken advantage of financially,
being reassured of normality from a
non-diagnostic “study,” and keeping
them from putting their unborn children at theoretical risk.
The Wall Street Journal reported
that in 2014 the most common fetalultrasound procedures were performed an average of 5.2 times per
pregnancy in the United States, up
ULTRASOUND
FIGURE 2 An image of a fetus with an omphalocele, produced using the HDlive
Silhouette feature of a Voluson E10.
stetricians that routine scans can help
stave off “surprises.” Such “defensive”
medical practices may be related the
fact that obstetricians pay among the
highest malpractice premiums of any
medical specialty.
Indeed, the same WSJ article
also noted, “experts in the field
say it isn’t uncommon for lawsuits
against obstetricians to allege that
IN 2014 THE MOST COMMON FETAL-ULTRASOUND
PROCEDURES WERE PERFORMED AN AVERAGE OF
5.2 TIMES PER PREGNANCY IN THE UNITED STATES.
92% from 2004; some women report
getting scans at every doctor visit
during pregnancy.6 The article goes
on to say that the rising usage rates
may in part reflect a belief among ob-
14
more ultrasounds should have been
performed.”6
So if ultrasounds can legitimately
aid in prenatal diagnosis, more precisely diagnose gynecological disor-
ders and perhaps prevent litigation,
are all ob/gyn residents comfortable
using ultrasound to its full potential
upon completing training? A recent
evaluation of the quality of ultrasound education in Canadian ob/gyn
residency programs found that most
residents reported inadequate exposure to gynecologic ultrasound and
claimed that there was little standardization in training.7
One proposed solution is to introduce an accreditation training
process to standard ob/gyn training.
When facilitated feedback from a
board-certified ob/gyn sonography
expert is included, the quality of sonographic examinations performed
by ob/gyn residents reportedly improves markedly.8
Others have proposed simulation-based training, wherein
residents train on a virtual-reality
transvaginal simulator until they
SEPTEMBER 2015
USED WITH PERMISSION OF GE HEALTHCARE
THE DIGITAL OB/GYN
THE DIGITAL OB/GYN
attain an expert performance level
and progress to training using a pelvic mannequin.9 In a randomized
study of new ob/gyn residents with
no prior ultrasound experience,
researchers found that a rigorous
simulation-based ultrasound training program led to a substantial improvement in clinical performance
(as graded by the Objective Structured Assessment of Ultrasound
Skills [OSAUS] scale) that was sustained for months during clinical
training.9
In fact, a poster presented at this
year’s annual meeting of the American College of Obstetricians and Gynecologists demonstrated that when
medical students were tasked with
ULTRASOUND
teaching inexperienced rural healthcare workers to use the Rural Obstetrical Ultrasound Triage Exam—a
diagnostic algorithm using portable
ultrasound in rural areas to triage
patients for future risk of maternal or
fetal complications—there was a significant improvement in the quality
of the healthcare workers’ practical
sonographic skills.10
Technological advances are increasing at an exponential rate, and
as the tools improve, so do their
clinical and research applications.
Pregnancies can be identified earlier, complications can be detected
sooner and more accurately, and
some data are so robust that we don’t
have the tools to know how to inter-
SUBMIT YOUR PUZZLER!
Have a puzzling ob or gyn case that
you’d like to share with fellow readers?
We’re looking for stories about intriguing
diagnoses that have stumped the experts!
For submission guidelines, please contact
Content Channel Director Susan C. Olmstead
at solmstead@advanstar.com.
pret them.
For example, a recently published
study found that rates of mouth
movement and facial self-touch differ significantly between the fetuses
of smokers and those of nonsmokers.11 These authors openly admit
that interpretation and extrapolation
of these data are difficult and that
further research is needed to help understand why and how this all comes
together.
From a technological standpoint, ultrasound is the wave of the
future.
FOR REFERENCES VISIT
contemporaryobgyn.net/womb-view
Choose the best screening methodology.
Cervical cancer screening guidelines recommend Pap & HPV co-testing for women ages 30–65.1,2
Two tests, Pap & HPV co-testing, when ordered together for women 30–65 years of age, provide:
- "$'('#'(*$%($#$&("$'($"%!(&3
- "%&$*(($#$≥*&')'(&!$#$&%!$#3
- +&"''#&'*&')'(&!$#$&%!$#3
Visit GoWithCotesting.com to read the details of a landmark, real-world world analysis of cervical
cancer screening approaches and why co-testing provides the best screening protection in women
between the ages of 30 and 65.
Be one for 2 by co-testing with Pap & HPV. Learn more at QuestDiagnostics.com/CervicalCancer.
References
1. U.S. Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/uspstf/uspscerv.htm).
2. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the
prevention and early detection of cervical cancer. CA Cancer J Clin. 2012;62(3):147–172.
3. Blatt AJ, Kennedy R, Luff RD, et al. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathology. 2015;123(5):282–288.
© 2015 Quest Diagnostics Incorporated. All rights reserved.
PEER-REVIEWED
GYNECOLOGY
Chronic sexual pain
A layered guide to evaluation
by DEBORAH COADY, MD, FACOG
O
ne-third of women at
some point in their
lives experience painful sexual activity for
3 or more months.
Sexual pain may occur during arousal
or intimate contact or afterward and
may persist for days. Genital and vulvar pain may also exist steadily and
independently, with sex heightening
its severity. Sexual pain is a feature
of chronic pelvic pain (CPP), a condition affecting 30 million women in
North America at any one time.1-3 Most
women with various types of CPP experience painful sexual activity. For
example, 75% of women with interstitial cystitis/painful bladder syndrome
(IC/PBS) report sexual pain.4
Sexual intimacy is a fundamental
desire of most women. Women suffering from pain disorders consistently
report that lack of sexual activity or
enjoyment is their main reason for low
quality of life.5,6 Secondary depression,
anxiety, low libido, and relationship
difficulties are understandably com-
6H[XDOSDLQLVDSK\VLFDOSDLQFRQGLWLRQQRWDVH[XDOG\VIXQFWLRQRUD
QUICK
TAKE
SV\FKRORJLFDOGLVRUGHU
Most women can resume or begin satisfying sexual lives after
GLDJQRVLVDQGXSWRGDWHWUHDWPHQW
mon in these individuals.7
Compounding this decline in overall quality of life are feelings of shame,
guilt, confusion, and isolation. Despite increasing cultural openness
about sexuality, more than one-third
of women with sexual pain never seek
help from healthcare professionals.
When they do, many feel misunderstood or dismissed. Fifty percent are
dissatisfied with their encounters with
doctors.8,9 Women frequently report
being told after cursory pelvic exams
that their pain must be “in their head.”
Fortunately, women with sexual pain
are benefiting from social media, selfeducation, sharing experiences and
resources, and self-care.
Ob/gyns are on the front line of
care for women with sexual pain. But
because most of them have received
little formal training in or practical experience with this common problem,
they often feel ill-equipped to evaluate
patients who are distressed, skeptical,
or hopeless due to previous negative
experiences. Ob/gyns also may hold
preconceptions that the evaluation of
sexual pain is more complex and timeconsuming than it really is, and that
there are few effective treatments anyway. But many advances have been
made in understanding the multi-layered causes of sexual pain, and most
women can improve and resume or
begin satisfying sexual lives after diagnosis and up-to-date treatment. Postgraduate ob/gyn training on CPP is being updated, through the Committee
on Resident Education in Obstetrics
DR COADY is Clinical Assistant Professor of Obstetrics and Gynecology at NYU Langone Medical Center, New York.
6KHKDVQRFRQÁLFWVRILQWHUHVWWRUHSRUWZLWKUHVSHFWWRWKHFRQWHQWRIWKLVDUWLFOH
18
SEPTEMBER 2015
GYNECOLOGY
PEER-REVIEWED
MORE THAN
1/3
of women with sexual pain
never seek help from
healthcare professionals
and Gynecology’s (CREOG) expanded
core competencies, which will improve the future for women with these
conditions.10
Ob/gyns must accept and acknowledge that sexual pain is a physical pain
condition, not a sexual dysfunction or
a psychological disorder. Some patients
have wasted months or longer in sex
therapy, when in fact pain was the primary issue, and function could not be
helped until pain was recognized and
treated. Once this fact is established
and a patient is invited to become a
partner in caring for this upsetting
medical condition, healing can occur. A
mental health therapist who is knowledgeable about the physical causes of
painful sex may then join the team.
Couples counseling is valuable,
as the intimate partner often suffers along with the patient, and may
experience sexual dysfunction and
mood disorders. Stress reactions often accompany sexual pain, affecting
the immune and autonomic nervous
systems (ANS), which affects physical healing.11,12 Coping strategies and
mind-body therapies such as meditation and yoga mitigate the physical
consequences of stress.13-15
The layered approach
When I first began to care for women
with sexual pain, organized evaluation
methods were unavailable. Not wanting to miss any causes or triggers of
pain, I developed for my own benefit
a layered approach to evaluating the
pelvis that soon became a teaching
SEPTEMBER 2015
50%
THE LAYERED
APPROACH
MRVWVH[XDOSDLQLVPXOWLOD\HUHGDQG
intimately involves these structures.
1 Surface Layer
2 Nerve Layer
3 Myofascial Layer
4 Orthopedic Layer
5 Organ Layer
6 Body-wide Systems
tool for patients and students. At that
time, only 2 layers were recognized as
causing sexual pain: the surface (vulva and vagina) and the internal organs (eg, endometriosis). I knew that
the structures between those 2 layers
needed to be evaluated: the muscles,
nerves, connective tissues, bones,
and joints of the lumbopelvic region.
Working closely with pioneering pelvic physical therapists (PTs) who were
steadily gaining an understanding of
these “in between” layers, I realized
that most sexual pain intimately involved these structures.
The most revealing step in evaluation is obtaining a complete history,
which establishes rapport and validates a patient’s pain. Supplement
with forms such as the International
Pelvic Pain Society’s, which is available at www.pelvicpain.org. Include
baseline self-reported pain measures,
of women who do seek help
DUHGLVVDWLVÀHGZLWKWKHLU
encounters.
such as the Visual Analog Scale (VAS),
and the Vulvar Pain Functional Questionnaire (VQ).16 The patient should
be fully clothed, seated with you in a
private consult room, if possible, and
given time to detail her history, including childhood symptoms.
What sexual activities, positions,
menstrual cycle phase, and other triggers cause or worsen her pain? Is the
pain burning, raw, itching, cramping, sharp, or knife-like? Allow her to
use her own words. Did it begin after
starting combined hormonal contraception or other medications? Is her
pain provoked by simply touching the
vulvar surface, is it more intermediate
in location within the vaginal canal,
deeper with full penetration, or a combination of these? Give her a diagram
of the vulva to mark and include in her
chart for future comparisons.
What are the patient’s short and
long-term goals? Specific goals may
vary greatly among women. She may
want to be able to sit through a whole
movie with her partner without severe
pain, perform specific sexual activities
or positions, use a vibrator or tampon,
conceive naturally with intercourse,
or avoid days of pain after sex. Clarifying goals early, in writing, can be
enlightening to a patient, and periodically reviewing progress during treatment serves as an objective measure
of improvement.
Because of the time constraints of
most busy ob/gyns, this part of the
evaluation often takes up the entire
CONTINUED ON PAGE 25
19
PRACTICE MATTERS
HIPAA breach?
+HUH·VKRZWRVHFXUH\RXUGDWDDQGSUHYHQWÀQHV
by KEN TERRY
M
any private practices lack written policies and
procedures for
data security and
haven’t done a security risk assessment, health IT consultants say.
These omissions are a mistake for
several reasons, the observers note.
First, both the Health Insurance
Portability and Accountability Act
(HIPAA) security rule and the meaningful use criteria require periodic
security risk assessments, and HIPAA
mandates written policies and procedures. If you’re subjected to a HIPAA
audit and found to be in violation of
the rules, you could be facing a stiff
fine. If your meaningful use attestations are audited, you might have to
return your electronic health record
(EHR) incentive payments to the
government.
Security breaches can also open
you up to lawsuits from patients and
damage your reputation in the community. Moreover, if the breach is
large enough to require you to report
it immediately to the Office of Civil
Rights (OCR) in the U.S. Department
of Health and Human Services (HHS),
OCR may investigate your security
procedures.
Most physicians are at least vague-
20
ly aware of these perils. So why don’t
they pay more attention to data security? Some doctors are unaware of the
need for security risk assessments because they’re too busy to keep abreast
of compliance requirements, says David Zetter, a consultant in Mechanicsburg, Pennsylvania. Others know
the rules but figure there’s only a slim
chance they’ll be caught if they ignore
them, he adds.
staffs and can afford to hire security
consultants. Small and medium-sized
practices, in contrast, usually depend
on their EHR vendors and local computer service companies to implement
the security options they have chosen.
You need your IT vendors to establish data security, but you can’t rely on
them to protect you. While they must
all sign business associate agreements
under the latest iteration of the HIPAA
PROPERLY ENCRYPTED DATA ARE
NOT CONSIDERED PHI. IF I LOST A THUMB DRIVE
WITH ENCRYPTED INFORMATION ON IT, THAT WOULDN’T BE
CONSIDERED A BREACH.
While it is difficult to keep track of
all the government requirements, this
is an area that you don’t want to ignore
or be ignorant of. In either case, you’re
putting your practice, your patients, and
your own financial security at risk. Here
are some basics to consider as you evaluate your current security posture.
Practice setting
Security approaches differ by practice setting. Large medical groups and
healthcare systems have their own IT
rules, their liability is limited to the
security breaches they cause directly,
Zetter notes.
For example, if the EHR or network
vendor made a mistake in configuring
the system, and protected health information (PHI) was exposed as a result,
that vendor would be responsible. But
if a practice chose not to encrypt its
data or didn’t secure its mobile devices, the practice would be liable. Theoretically, an EHR developer would be
liable if a software design flaw led to
SEPTEMBER 2015
HIPAA
the unauthorized release of PHI; but
none of the experts we consulted had
heard of that happening.
Employed physicians must follow
the security policies and procedures of
their healthcare system or group. If an
employed doctor violates HIPAA rules,
the healthcare organization is responsible. But those physicians may face a
range of sanctions from their employer. In fact, HHS requires that organizations have a sanctions policy for employees who violate HIPAA, notes Ron
Sterling, CPA, a health IT consultant in
Silver Spring, Maryland.
The type of liability a physician has
may depend on the nature of his or
her relationship with a hospital, says
Mac McMillan, chief executive officer
of the security firm CynergisTek and
chair of the privacy and security policy
task force of the Healthcare Information and Management Systems Society
(HIMSS). “In some cases, they’re autonomous; in other cases, they’re almost like an employee; in other cases,
they manage their staff in their own
practice locations, but they get other
services from the hospital, and those
are governed by the hospital policies,”
McMillan says.
But regardless of their hospital relationship, he adds, non-employed physicians are responsible for complying
with HIPAA rules.
Security implications
of hosting
Most practices have an on-site clientserver system or use a cloud-based
EHR. If you have the latter, the EHR
vendor is responsible for the security
of the server that stores your application and data, as well as for data backup. If you have an on-premises server,
that’s your responsibility.
SEPTEMBER 2015
549
Number of referrals made by
OCR to the U.S. Department
of Justice for criminal
investigation tied to knowing
disclosure of obtaining
protected health information in
violation of HIPAA
23,580
Number of cases investigated
and resolved by OCR requiring
technical changes in privacy
practices and corrective actions,
or technical assistance to,
HIPAA covered entities and their
business associates, as of
May 31, 2015.
The physical security mandated
by HIPAA includes having a locked
room or closet where your server resides. In addition, off-site data backup
is required. You must have policies
governing the receipt and removal of
hardware and electronic media containing PHI to and from a facility, and
you must implement policies to protect PHI from improper alteration or
destruction.
McMillan strongly advises that
small and medium-sized practices
consider outsourcing their health IT
to remote hosting companies. “For
the physician, it’s like buying a service:
he’s buying an EHR, email, network
support, workstations, file servers and
data storage, and it’s all hosted in a vir-
PRACTICE MATTERS
tual environment. So he doesn’t have
the headaches of having to understand how to secure the system. He’s
buying it as a service.”
From a security standpoint, McMillan adds, “the only thing practices are
responsible for are their own employees and their physicians, and how they
interface with that system and what
they do with the information once
they have access to it. That’s much
easier for them to manage.”
Some of the larger EHR vendors,
including Epic, Cerner, McKesson,
Allscripts, and eClinicalWorks, offer
this kind of soup-to-nuts hosted solution, McMillan notes. Alternatively, he
says, a practice could use a third party
hosting firm that understands HIPAA
requirements. The total cost of ownership for running your own client-server network, he says, is probably greater than the fees you’d pay to a remote
hosting service.
David Boles, DO, who leads a
12-provider practice in Clarksville,
Tennessee, says his practice recently
decided to switch to remote hosting
“because keeping up with the security requirements got to be more than I
wanted to deal with.”
While it’s too soon to evaluate the
results, he notes that he made the
switch after a cloud-based EHR offered by his group’s longtime vendor
failed to work as promised. The group
went back to the EHR’s client-server
version; but rather than invest in new
servers, Boles decided to hire the remote hosting company.
The importance of
encryption
Regardless of how your system is set
up, there are certain security basics
that you need to be familiar with.
21
PRACTICE MATTERS
HIPAA
$21,906,500
To start with, the experts say, you
should encrypt all of your data. Encryption is a strong defense against
thieves and is considered nearly unbreakable, note McMillan and Sterling. It is possible that a “brute force
attack” could be used to obtain a user
password, which would sidestep the
encryption, Zetter says. Questioned
on that point, McMillan replies, “It’s
certainly possible, but encryption is
still a sound risk mitigation and liability manager response.”
Encryption is especially important
on laptops, smartphones, and computer tablets, because these devices
can easily be lost or stolen. In fact,
lost or stolen mobile devices account
for 39% of the security incidents in
healthcare, and for 78% of the records
compromised in security breaches,
according to one study.
One way to prevent theft of mobile
devices is to prohibit providers and
staff from taking them out of the office
or facility, Zetter notes. If a physician
goes to the hospital, he points out, that
doctor can use a hospital laptop and
connect to the office network from
that device.
If a laptop or other mobile device
is lost, and PHI is on it, the incident
should be reported, Zetter says, even if
the data is encrypted. “Because if you
fail to and the government finds out,
you’re going to be in bigger trouble,”
Zetter says.
Sterling takes a different view. “If
data is properly encrypted, it’s not
considered PHI,” he says. “If I lost a
thumb drive with all kinds of encrypted information on it, that wouldn’t be
considered a breach.”
What constitutes a security breach
under HIPAA is discussed later in this
article. At this point, it’s just impor-
Monetary settlements, as of
June 19, 2015, involving HIPAA
Privacy, Security and Breach
1RWLÀFDWLRQ5XOHV
$4.3 MILLION
The lone civil money penalty
issued by OCR for violations of
HIPAA Privacy Rule
(http://www.hhs.gov/ocr/privacy/hipaa/
news/cignetnews.html)
115,929
Number of complaints received
by OCR since compliance date
of HIPAA Privacy Rule in April
2003, as of May 31, 2015
1,216
Compliance reviews initiated over
that same time period
15
Resolutions of cases involving
WKH+,3$$%UHDFK1RWLÀFDWLRQ
Rule, as of May 31, 2015
$15,581,000
Monetary settlements tied to
those resolution agreements
22
tant to understand that encryption
greatly reduces the possibility of such
a breach.
END-user devices and PHI
Another strategy that many practices
have adopted is to set up their computer systems in such a way that PHI is
stored only on their servers or in their
cloud-based EHRs. Desktops, laptops,
and other mobile devices that doctors
and staff members use are not allowed
to store PHI.
Some practices have “thin-client”
networks, where the desktops in the
office are dumb terminals that cannot
store programs or data. Other practices can’t use that approach because the
physicians have to carry their laptops
with them when they travel to other
practice settings. They keep the EHR
applications on their laptops but don’t
store any data on them.
For example, Jeffrey Kagan, MD,
an internist in Newington, Connecticut and a Medical Economics editorial consultant, and his partner use
laptops when they visit patients in
nursing homes and when they travel. Several years ago, they stored all
of their patient records on their laptops, syncing with the office server
every day.
Then, because their laptops didn’t
have enough disk space, they stopped
storing PHI on them and began using
remote access to the network when
they needed to see their records.
Boles’ practice discourages providers from taking laptops out of the office, but allows remote access to the
system from home computers. “We’d
never get through with the paperwork
if we didn’t let people work at home,
too,” he says.
Security experts advise caution
SEPTEMBER 2015
PRACTICE MATTERS
HIPAA
when using personal computers, because they can be infected with malware or used as conduits to break into
a network. If you do use a personal
computer, McMillan says, remote access should include a proxy server or
a virtual private network to ensure you
don’t store any PHI on the personal
computer and to shield the network
from unauthorized intrusions.
Two-factor authentication
Good access controls are critical,
McMillan notes, because thieves impersonating users can gain access to
EHRs. Besides having strong passwords, practices should deploy “twofactor authentication,” he says. Under
this approach, which he says is very
affordable, the practice can use a biometric tool, such as thumbprint au-
thentication, or a proximity badge to
confirm the user’s identity. Alternatively, users might be asked a personal
question when they log on.
To make two-factor authentication
less onerous, he adds, you can set up the
system so that the password has to be
entered only once a day. “You use some
second factor associated with the person so they only have to put their user-
HIPAA 4 THINGS TO AVOID
by AUBREY WESTGATE
secure e-mail application. If
your practice would rather
prohibit the use of e-mail
altogether, an alternative might
be a patient portal that enables
secure messaging.
protected health information
(ePHI).
Though the security risk
analysis requirement has been
in place since the security rule
was formally adopted in 2003,
it’s been pretty widely ignored
by practices. Since conducting
a security risk analysis is now
an attestation requirement in
the EHR incentive program,
auditors are increasingly
noting whether practices are in
compliance.
2|
3|
You may think you know HIPAA inside and out, but experts say
many practices and physicians are making mistakes regarding
protected health information (PHI) that could get them into big
trouble with the law. Here are four of the most common compliance
missteps they say practices and physicians are making.
1|
Texting or
E-mailing
Unencrypted PHI
For most physicians, texting
is an easy, convenient, and
HIÀFLHQWZD\WRFRPPXQLFDWH
with patients and colleagues.
But if a text contains
unencrypted PHI, it could raise
serious HIPAA problems.
That’s not to say that texting
PHI is never appropriate, it just
means that physicians must
ÀQGDZD\WRGRVRVHFXUHO\
Most likely, the answer will be a
secure messaging service with
encryption.
Similar to text messaging,
many physicians are e-mailing
unencrypted PHI to patients
and colleagues. If your
providers are e-mailing PHI,
consider implementing a
SEPTEMBER 2015
Failing To
Conduct A
Risk Analysis
If your practice has not
conducted a security risk
analysis, it is violating HIPAA.
The security rule requires
any covered entity creating
or storing PHI electronically
to perform one. Essentially,
this means practices must
go through a series of steps
to assess potential risks
and vulnerabilities to the
FRQÀGHQWLDOLW\LQWHJULW\DQG
availability of their electronic
Failing To
Update The NPP
If your practice has not
updated its Notice of Privacy
Practices (NPP) recently, it
could be in violation of HIPAA.
The HIPAA Omnibus Rule
requires practices to update
these policies and take
additional steps to ensure
patients are aware of them.
In addition to updating the
NPP, a practice must post it
prominently in its facility and
on the website, and have new
patients sign it and offer a copy
to them.
Some of the required
updates to the NPP include
information regarding:
uses and disclosures that
require authorization; an
individual’s right to restrict
certain disclosures of PHI to
a health plan; and an affected
LQGLYLGXDO·VULJKWWREHQRWLÀHG
following a privacy or security
breach.
4|
Not Providing
6XIÀFLHQW
Training
The privacy and security
rules require formal HIPAA
education and training of
staff. Though the rules don’t
provide detailed guidance
regarding what training is
required, experts recommends
training all the members of
your workforce on policies
and procedures that address
privacy and security at the
time of hire, and at least
annually thereafter. Be sure to
document any HIPAA training
provided to staff.
23
PRACTICE MATTERS
name and password in once. Then the
system might time out, but I can touch
it with my badge or my fingerprint and
it comes right back up,” McMillan says.
Two-factor authentication also can
be used for remote access, he says.
iPhone users, for example, can download a free app that enables this kind
of identity access, while Google Mail
provides options for encryption and
two-factor authentication.
HIPAA
The extent to which the risk to the
PHI has been mitigated.
“If there’s a low probability that the PHI
was compromised, you don’t have to
report it,” Sterling maintains. “But you
have to maintain the documentation.”
If the records of 500 or more patients
are breached, you are required to notify
the patients and HHS within 60 days. If
fewer than 500 patients are involved,
THERE’S A WHOLE GROUP OF SECURITY VENDORS
NOW THAT CATER TO THE SMALL PRACTICE.
AND THERE ARE SOME GOOD ONES.
risk assessment tools online, McMillan
notes. Sterling specifically cites ONC’s
Security Risk Assessment Tool.
Sterling admits that the first time
a practice does such an assessment,
“it’s complicated.” But subsequent annual updates are much easier. A group
that’s never done it before might want
to get some advice from a security
consultant, he says.
If a practice can’t afford to hire a
consultant, there are vendors who
can walk you through the process using online software. “There’s a whole
group of security vendors now that cater to the small practice. And there are
some good ones.” McMillan says.
Summary
Reporting breaches
What should you do if you have a security incident? That depends on whether it’s regarded as a security breach
and how many patients are involved.
As noted earlier, experts disagree
over whether the loss of encrypted
data constitutes a breach. The HIPAA
security rule says that an impermissible use or disclosure of PHI is presumed to be a breach unless the
HIPAA-covered entity or business associate shows there is a low probability
that the PHI has been compromised,
based on a risk assessment of these
factors:
The nature and extent of the PHI
involved, including the types of
identifiers and the likelihood of
re-identification;
The unauthorized person who used
the PHI or to whom the disclosure
was made;
Whether the PHI was actually acquired or viewed; and
24
you don’t have to tell the government
right away, but you must notify the patients. If 10 or more patients can’t be
reached, you have to make a public
announcement that a breach has occurred, Sterling says. You must document all security breaches, regardless of
size, and report them to HHS annually.
If a laptop is stolen in a practice
where PHI can be accessed only
through the network, Zetter advises
consulting an attorney. Tell him or her
what you think is on the laptop and
when it was taken. Then ask the lawyer whether you need to notify HHS or
the patients immediately.
Establishing policies and
procedures
Templates for security policies and security risk assessments are available for
free from a variety of sources, but must
be adapted to the specifics of the practice situation, consultants say. HIMSS
and the Office of the National Coordinator for Health IT (ONC) have security
Safeguarding your PHI takes some dedicated effort. That could prove challenging. Boles and some of his colleagues, for
example, did their own security risk assessment this year, having laid off the inhouse IT technician who used to do it.
“We go through it the best we can,” he
says, “but it’s like the IRS code.” Hiring
a consultant, however, would be too expensive, he adds.
Kagan says he’s concerned about
security risks, “but I’ve got so many
concerns going on simultaneously.
I’m more worried about the quality
of patient care, malpractice suits, and
my reputation in the community. Cybersecurity and HIPAA issues just get a
lower priority for most doctors.”
That’s all true, until the HIPAA police
come knocking at the door. Then you’ll
be glad you did your due diligence on
data security. FROM THE
PAGES OF
SEPTEMBER 2015
GYNECOLOGY
CONTINUED FROM PAGE 19
first visit. Prepare the patient for this
and reassure her that your full understanding of her pain and previous
treatments promotes effective care.
Because the physical exam is detailed
and cannot be rushed, schedule a
second visit in the very near future to
perform it. If a patient brings up her
chronic sexual pain during a scheduled routine checkup, it may be best to
postpone the exam; devote the rest of
the allotted time to obtaining the allimportant history. Provide the patient
with written or online educational materials for self-care between visits.
At the second visit (or the first, if
time allows) perform a layer-by-layer
exam as described below, and formulate working diagnoses. Schedule
testing as needed and formulate a
preliminary treatment plan. Be open
at all visits for an intimate partner or
other support person to be present,
take notes, add overlooked items to
the history, and help the patient to
feel safe, which is especially important
for women who have had demoralizing experiences with other healthcare
providers. You may be the first person
to whom the patient has revealed her
pain, and she may be nervous.
1 SURFACE LAYER
The vulvar surface requires a comprehensive magnified inspection from
above the mons pubis to behind to
the anus. Lithotomy stirrups that support the patient’s knees are comfortable and less tiring for a patient. Use
a handheld magnifier or colposcope
and a light source without a bulb that
heats up during a long exam, as burns
can occur.
The patient can be your best assistant: have her hold a magnifying mir-
SEPTEMBER 2015
ror in one hand and prop herself up
by leaning on her opposite elbow so
she can view her vulva in the mirror.
She can point out her painful areas
and feel in control as she participates
in and observes your exam. Have her
open her labia and retract her clitoral
hood herself, as she can more easily
tolerate her own touch. All skin and
mucosa should be inspected for red,
white, or dark lesions, erosions, ulcers,
PEER-REVIEWED
erythema, even if tiny and subtle. To
identify LPV’s diagnostic feature, allodynia, the Q-tip (swab) test is key.
Begin checking for provoked pain
systematically at the outer labial skin,
an area unlikely to startle the patient.
Gently press the cotton tip enough to
dent the surface just 1 mm, and note
her pain level, as well as superficial
muscle responses. Repeat, gradually
moving inward to the smooth vesti-
THE VAST MAJORITY OF WOMEN WHO HAVE BEEN TOLD
THEY HAVE ‘VAGINISMUS’ ACTUALLY SUFFER FROM
LOCALIZED PROVOKED VESTIBULODYNIA AND
SEVERE PELVIC FLOOR DYSFUNCTION.
nodules, edema, architectural changes, and fissures. Ask the patient to rate
on a scale of 0 to 5 the pain she may
feel with touch. Use vulvar diagrams
to record findings; documenting with
digital photography helps assess the
benefits of therapy later.
Do not perform a typical bimanual
exam until the very end of the evaluation of all layers, after deciding if it will
add information. In cases of chronic
sexual pain it usually will not, and often
triggers surface pain or muscle spasms
that hinder the rest of the exam.
By far the most common cause of
sexual pain in premenopausal women is localized provoked vestibulodynia (LPV). Research is leading to a
better understanding of this mucosal
disorder.17,18 It is crucial that LPV not
be missed. After your general inspection, give specific attention to the
vestibule, at first without touching it,
using your patient-assistant for exposure. Note and document all areas of
bule mucosa between Hart’s line and
the hymenal ring, to delineate tender
areas. Repeat this testing “around the
clock” with the midpoint of the introitus the clock’s center. Be sure to assess
the vestibule around the urethra, and
the urethra itself, as its mucosa is contiguous and often involved in LPV.
Chronic or recurrent fissures in the
posterior fourchette are another cause
of introital dyspareunia. Inspect for
midline scars in this area, because it
may tear, heal, remain weak, then retear with the next penetration, so fissures may only be seen soon after sex.
Complete your surface evaluation by
assessing for vulvovaginal infections
or inflammation, such as desquamative inflammatory vaginitis, with the
use of a warmed, lubricated, very narrow speculum, or obtain wet smears
and cultures with just a swab. Patients
with LPV and pelvic floor (PF) disorders often cannot tolerate a speculum,
and in these conditions it is usually not
25
PEER-REVIEWED
necessary, at least at initial exam. Use
of dilute acetic acid may also cause
significant pain and is rarely needed.
Vulvar biopsies are best avoided unless a lesion is suspicious for neoplasia, because results rarely affect management. A biopsy of the vestibule is
not needed. Biopsies of specific lesions to diagnose vulvar dermatoses
can be delayed until a follow-up visit,
after potential causes of pain in other
layers have been assessed. Many patients attribute worsening pain to previous biopsies, so if one is needed, take
as small a piece of tissue as possible
and use a pathologist experienced in
vulvar dermatology.
2 NERVE LAYER
Disorders of pelvic nerves may cause
chronic sexual pain in women and
men.19,20 These long nerves are subject
to the same injuries and diseases as peripheral nerves that run through other
parts of the body. Nerve compression,
injuries resulting in formation of neuromata, and peripheral sensitization
all can occur in the pelvis.
During your vulvar exam, work with
the patient to localize the area that is
GYNECOLOGY
painful (eg, clitoris, anus, posterior left
vestibule), and if surface conditions do
not explain her pain, determine which
nerve likely innervates that sensory
area. Patients with generalized vulvodynia (GV) may have trouble isolating
specific areas of pain, as burning and
itching nerve pain may be felt broadly. Patients may sense unilateral conditions as involving the entire vulva,
due to global PF responses. Your careful history and neuroanatomy-based
exam will clarify which pelvic nerves
may be pain generators.
Because the pudendal nerve (PN) is
the main sensory nerve of the external
genitalia, mentally visualize the course
of its 3 main branches through the PF
while palpating. Inspect for scarring
from surgery or childbirth that may
have lacerated a nerve branch, creating a neuroma. Neuromata are only
occasionally large enough to be palpable and may present as small areas of exquisite tenderness. Consider
whether pain is localized to a single
PN branch or if the whole nerve itself
is involved, deeper in the PF proximal
to its division into branches. The landmark of the ischial spine, under which
FOR YOUR PATIENTS Chronic Sexual Pain Resources
ACOG: When sex is painful
DFRJRUJ3DWLHQWV)$4V:KHQ6H[,V3DLQIXO
National Vulvodynia Association: Patient tutorial 3DLGPHPEHUVKLSUHTXLUHG
QYDRUJOHDUQSDWLHQW
The North American Menopause Society: Pain with penetration
PHQRSDXVHRUJIRUZRPHQVH[XDOKHDOWKPHQRSDXVHRQOLQHVH[XDO
SUREOHPVDWPLGOLIHSDLQZLWKSHQHWUDWLRQ
Endometriosis.org: Painful intercourse
HQGRPHWULRVLVRUJUHVRXUFHVDUWLFOHVSDLQIXOLQWHUFRXUVH
26
the pudendal neurovascular bundle
passes, is quite easy to locate by singledigit vaginal exam; specific pain elicited at this point by light touch is suggestive of PN involvement. If the PN is
compressed here or proximally in its
path from the sacral nerve roots, all
its branches will be affected, including the rectal branch, generating pain
that includes the anal area.
Digitally guided transvaginal, or
transperineal, perineural pudendal
nerve injections (PNPI) at the ischial
spine avoid expense, sedation, and xray exposure for a patient. Such injections are simple for ob/gyns to perform
in-office, and many gained experience
using them for childbirth analgesia. If
a PNPI alleviates a patient’s pain temporarily, the PN is a component that
needs to be addressed. An image-guided PNPI from the posterior approach
can be planned with an interventional
radiologist if clinical suspicion for PN
pain remains high despite a negative
(ineffective) injection, or if a patient
needs sedation for the procedure.
Pain located in the field of one branch
of the PN, or of the perineal branch of
the posterior femoral cutaneous nerve,
can be evaluated by performing specific small-volume anesthetic injections
directed to a convenient point along
a branch’s usual course, or where you
think a neuroma may be. Nerve branch
injections that relieve pain indicate involvement of that branch primarily, or
secondarily from myofascial abnormalities as discussed below.
Clitoral pain (clitorodynia) and the
related pain disorder persistent genital
arousal may result from multiple etiologies, but irritation or compression of the
dorsal branch of the PN usually plays a
role. Some cases of clitoral pain result
from surgical injury to the nerves above
SEPTEMBER 2015
GYNECOLOGY
the clitoris (the ilioinguinal, iliohypogastric, and genitofemoral) so check for suprapubic and groin scarring. Diagnostic
blocks of these, and of the dorsal branch,
performed along their course well away
from the clitoris, will clarify their involvement and direct therapy.
3 MYOFASCIAL LAYER –
THE PELVIC FLOOR
Just under the surface of the vulva
lies the invisible layer of the PF, made
up of muscles and the fascia covering and attaching them to each other,
and forming their origins and insertions into bone and cartilage. Whether sexual pain begins in this layer or
not, the PF almost always contributes
to its intensity and chronicity. Muscle
spasms, muscle shortening, myofascial trigger points, and secondary dystrophic changes add to nerve irritation
and compression. Patients often sense
both PF and PN pain as a foreign object in the vaginal canal, which corresponds to the bulkiness of muscles
remaining in an abnormal contracted
state. Dysfunction of the PF is a common component of all types of CPP
and is “the missing link” in making a
complete diagnosis.21 In women with
sexual pain, it is crucial that the PF be
systematically evaluated.
The vast majority of women who
have been told they have “vaginismus”
actually suffer from LPV and severe PF
dysfunction. Painful experiences from
touching, sexual activity, and medical exams understandably result in
avoidance of vulvar contact, which is
often misinterpreted as a psychological problem. For these patients, perform exams under anesthesia only
as a last resort, because with muscle
relaxation, important PF and nerve
findings may disappear. Oral or intra-
SEPTEMBER 2015
vaginal diazepam is an option an hour
before an exam, but you may underappreciate the severity of myofacial abnormalities with this premedication.
PF evaluation needs to attend both
vaginally and rectally to superficial and
deep myofascial structures. Palpate
the bulbocavernosus, ischiocavernosus, transverse perineal, levator ani
PEER-REVIEWED
4 MUSCULOSKELETAL
LAYER
The musculoskeletal structures of the
lumbopelvic area intimately affect the
PF and may cause pain with sexual
activity. Intra-articular hip disorders
such as femoroacetabular impingement are common in women and hip
evaluation via history and exam is
MENOPAUSE, WHETHER IT OCCURS NATURALLY OR IS
MEDICALLY OR SURGICALLY INDUCED, AFFECTS ALL
LAYERS IN MOST WOMEN TO SOME DEGREE.
(puborectalis, pubococcygeus, iliococcygeus), obturator internus, piriformis,
and anal sphincter for tenderness, high
tension, tight bands, trigger points, bilateral symmetry, and hypertrophy or
atrophy, and the connective tissue for
string-like restrictions. Constrictions
around the courses of nerves hinder
normal stretching and gliding in the
tissues during sexual activity, causing
burning pain. Dry-needling tight bands
and trigger points, or injecting them
with 0.5 cc lidocaine, then palpating
to confirm their release and effect on
pain, is a useful diagnostic tool.
Note findings of vaginal relaxation,
pelvic organ prolapse, and Bartholin’s
cysts, but keep in mind that these are
usually not sexual pain generators.
Many patients with unappreciated
LPV have had small Bartholin’s cysts
surgically excised without benefit. If
they are present, be sure to continue
to evaluate all layers for more likely
causes of sexual pain.
PTs who specialize in PF dysfunction
have taken up the challenge of caring
for women with sexual pain, and can
help us improve our PF exam skills.22
needed.23 Observe gait and routinely
perform a provocative test for hip impingement, such as the FABER (flexion, abduction, external rotation) test.
The obturator internus, part of the PF
along which the PN runs, is a main hip
rotator; pain on palpation of this muscle, and at the greater trochanter of the
hip, is suggestive of hip dysfunction
contributing to painful sex. Also assess
for tenderness at the pubic symphysis,
coccyx, and sacroiliac joint. Lumbar
disc disease and osteoarthritis are
common with age, and older women
may report pain during sexual activity
in positions that stress these conditions. Further evaluation by an orthopedist and PT may be needed.
5 ORGAN LAYER
It has been recognized for years that
deep dyspareunia suggests endometriosis, but clinicians should remember to
evaluate for painful PF responses that
usually coexist, adding to sexual pain.
After endometriosis surgeries, ongoing painful sex is an often-overlooked
concern, and hormonal therapies routinely used postoperatively may cause
27
PEER-REVIEWED
the additional painful consequence of
atrophy of genital tissues.
We now appreciate that sexual pain
is a usual component of the 3 main
CPP disorders that are often comorbid: endometriosis, interstitial cystitis/painful bladder syndrome (IC/
PBS), and irritable bowel syndrome
(IBS). IC/PBS causes significant introital pain, as LPV often coexists, as well
as urethrodynia. Penetration may also
induce severe long-lasting pain flares,
GYNECOLOGY
where in the body. Consider the possibility of autoimmune disorders, which
are common in women, when inflammatory surface changes do not respond
quickly to treatment. Conditions such
as Sjogren’s, lupus, and connective tissue disorders may affect mucosa, fascia,
and small nerve fibers.
Menopause, whether it occurs
naturally or is medically or surgically induced, affects all layers in most
women to some degree. We now un-
P.T.S WHO SPECIALIZE IN PELVIC FLOOR DYSFUNCTION HAVE
TAKEN UP THE CHALLENGE OF CARING FOR WOMEN WITH
SEXUAL PAIN, AND CAN HELP US IMPROVE OUR
PELVIC FLOOR EXAM SKILLS.
as the base of the bladder and the often hypertonic PF are compressed.
Include gentle specific assessment for
tenderness of the urethra and bladder
base in your single digit exam. Similarly, IBS sufferers frequently have PF
hypertonicity, as well as defecatory
dysfunction and anal fissures.
A complete evaluation must attend
to the possibility of one or more of these
overlapping disorders. Further evaluation of complicated pain in several layers includes imaging of the pelvic organs, PF, and lumbopelvic region.
6 SYSTEMIC CAUSES
Body-wide disorders may underlie the
development of sexual pain. Three interconnected systems control tissue
healing: the endocrine system, the immune system, and the nervous system.
Even borderline diabetes can affect sensory nerves in the vulva, just as it causes
burning pain in peripheral nerves else-
28
derstand more about how declines in
estrogen and androgen may disrupt
vulvar and pelvic tissues, due to sex
hormone receptors in mucosa, myofascia, and sensory neurons. In some
women, menopause triggers LPV, resulting in severe sexual pain and vestibular exam findings similar to those in
younger patients.24,25 Topical hormone
therapy usually benefits menopausal
dyspareunia, and testing baseline and
follow-up blood hormone levels is not
necessary. But for women who do not
respond quickly, re-evaluation for LPV
and disorders in other layers is key to a
complete diagnosis in menopause, too.
Centralized pain may occasionally be
present as a component of chronic sexual pain.26 Findings suggesting this condition include systemic allodynia, hyperesthesia, and lowered pain thresholds,
and comorbidities such as fibromyalgia
and chronic headaches. Assembling
a team of specialists in neurology and
rheumatology for further evaluation of
systemic conditions is crucial. Research
and experience continue to show the
benefits of integrating complementary
mind-body therapies into care of complex and systemic pain disorders.27
Overall treatment principles
Share with patients a written individualized treatment plan addressing each
layer. The vulvar surface must be protected and strengthened, abnormal
peripheral and central nerve activity
suppressed, and the PF normalized
with PT. Musculoskeletal abnormalities and pelvic organ pain require
focused therapies, and underlying
systemic conditions must be appreciated and treated. Depression, anxiety,
and hopelessness are improved by
supportive and cognitive behavioral
therapy. Develop a relationship with a
therapist who is knowledgeable about
chronic pain and mind-body practices, which calm the ANS and physical
consequences of pain and stress.
Anticipate pain flares and have a plan
in place before they occur. Re-evaluate
persistent or recurrent pain often, layer by layer. Address the side effects of
medications preemptively and quickly. Avoid opioid pain relievers, which
do not relieve chronic pain, but may
cause bowel and bladder symptoms,
endocrinopathies, sexual dysfunction,
and mood and cognitive disturbances
that may lead to overdose.28
Patients trust ob/gyns with the care
of chronic sexual pain. Our committed
partnership with patients will improve
their quality of life and provide an essential component of healing: hope for
the real possibility of cure. FOR REFERENCES VISIT
contemporaryobgyn.net/sexual-pain
SEPTEMBER 2015
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Sample to Insight
FIRST PERSON
HOW IT’S DONE
IN MY PRACTICE
Counseling patients with
prior shoulder dystocia
This hospital uses a counseling form to educate their patients about the risk
of recurrence of a shoulder dystocia and to choose whether they want to have
another vaginal delivery.
by ARNOLD W COHEN, MD, AND DAVID JASPAN, MD
I
n obstetrics there is nothing that
produces more anxiety than a
shoulder dystocia. We fear the
fetal outcome, the potential maternal complication, and being sued.
Imagine you are in the labor room
with your patient, an anxious and excited 28-year-old G2P1 with no medical problems. You delivered her first
baby, and she is thrilled to have you in
the room for baby number two. After
all, you were able to deliver her first
baby using all your skill, knowledge,
and maneuvers to overcome a serious
shoulder dystocia. The current fetal
heart rate tracing is a picture-perfect
Category One, you have previously accessed the maternal pelvis for adequacy, and you have adeptly performed
your best obstetric estimate of the fetal weight, 3300 g. She is progressing
beautifully along Zhang’s new labor
30
curve.1 The baby’s head is delivered;
excitement fills the air … then a shoulder dystocia occurs followed by a brachial plexus injury and the baby is left
with an Erb’s palsy.
Obstetricians manage risk. We are
trained to consider the risk and benefit of all medical and obstetric procedures performed during pregnancy as
well as any medications prescribed or
recommended during pregnancy. We
use data to enable us to make rational
decisions and/or counsel patients fairly. For example, the risk of uterine rupture after more than one cesarean delivery ranges from 0.9% to 3.7%, so we
counsel our patients and inform them
about this potentially catastrophic
outcome. We also use risk-benefit data
to determine when to recommend an
invasive prenatal diagnostic procedure, such as an amniocentesis.
Why is it, then, that we have not
routinely used such data to make decisions about recommended optimal
delivery routes when a patient has a
history of a prior delivery complicated
by a shoulder dystocia?
One of the greatest fears of every
physician and midwife who provide
obstetrical services is the unpredictability of shoulder dystocia and the
risk of being sued for this “unpredictable” outcome.
We at the Einstein Healthcare Network in Philadelphia have chosen not
to allow women to undergo a trial of
labor after 3 cesarean deliveries due to
the increased risk of uterine rupture.
We have chosen not to use misoprostol
when inducing a woman after a prior
cesarean delivery due to the elevated
risk of uterine rupture. We have been
asked not perform laparoscopic power
DR COHEN is Chairman Emeritus, Einstein
DR JASPAN is Chairman of the Department of
Healthcare Network, Philadelphia, Pennsylvania,
Obstetrics and Gynecology, Einstein Health Care Network,
and Professor of Ob/Gyn, Sidney Kimmel Medical
Philadelphia, Pennsylvania, and Associate Professor, Sidney
College, Thomas Jefferson University, Philadelphia,
Kimmel Medical College, Thomas Jefferson University,
Pennsylvania.
Philadelphia, Pennsylvania.
SEPTEMBER 2015
FIRST PERSON
1% TO 16.7%
The risk of recurrence of shoulder dystocia
after a previous shoulder dystocia
morcellation of fibroids due to a 1-in350 risk of undiagnosed sarcoma So
why is it that many of us are willing to allow women to assume the risk of recurrent shoulder dystocia when delivering
a term infant of comparable size? Data
are not available to indicate the risk of
permanent injury if the prior shoulder
dystocia was relieved by one maneuver
or more, nor on the recurrence rate of
persistent brachial plexus injury if the
previous shoulder dystocia was associated with a permanent injury.
We understand that the first shoulder dystocia is usually unpredictable.
American College of Obstetricians and
Gynecologists (ACOG) Practice Bulletin Number 40 states that the risk of
recurrence of shoulder dystocia after
a previous shoulder dystocia ranges
from 1% to 16.7%.2 ACOG’s Neonatal
Brachial Plexus Palsy document states
that the incidence of neonatal brachial plexus palsy occurring with shoulder dystocia ranges between 4% and
23%.3 Therefore, we ask, “Is the second shoulder dystocia really that unpredictable? If we allow someone to
deliver vaginally at term who has had
a previous shoulder dystocia, aren’t
we taking a chance with the baby, the
mother, and the legal system?”
In order to provide the safest care
and limit our medicolegal risk, we have
developed a prenatal counseling form
to educate our patients about the risk of
recurrence of a shoulder dystocia and
the potential unpredictable and catastrophic events that may come from
SEPTEMBER 2015
4% TO 23%
The incidence of neonatal brachial plexus
palsy occurring with shoulder dystocia
a vaginal delivery after a prior shoulder dystocia. We allow our patients to
choose whether they want to have another vaginal delivery after a previous
shoulder dystocia or to have an elective
cesarean delivery to minimize risks to
mother, baby, and obstetrician.
If the patient elects to attempt a vaginal delivery knowing the increased
risk and the unpredictability of the
outcome, we encourage the patient to
seek care at another institution. If she
chooses not to go to another institution
and she and her provider are willing to
take the risk of proceeding with a trial
of labor after a prior shoulder dystocia
(TOLAPS), the provider must agree to
be present for the labor and delivery
and not transfer this risk to others.
We feel that this policy benefits the
patient, the newborn, and the delivering physician. It is a “win-win-win”
policy for all involved. It decreases the
provider’s fear and significantly decreases the malpractice risk for the obstetrician and the hospital, and most
importantly limits the risk to the baby.
REFERENCES
1. Zhang J, Landy HJ et al. Contemporary
patterns of spontaneous labor with normal neonatal outcomes: Obstet Gynecol.
2010;116:1281–1287.
2. Sokol RJ, Blackwell SC; American College
of Obstetricians and Gynecologists, Committee on Practice Bulletins-Gynecology. ACOG
practice bulletin, Shoulder dystocia, Number
40, November 2002. (Replaces practice pattern number 7, October 1997). Int J Gynaecol
Obstet. 2003 Jan;80(1):87-92.
3. Executive Summary: Neonatal Brachial
Plexus Palsy Report of the American College
of Obstetricians and Gynecologists’ Task
Force on Neonatal Brachial Plexus Palsy.
Obstet Gynecol. 2014;123(4).
ONLINE ARTICLES Shoulder Dystocia
Neonatal brachial plexus palsy: Is prevention possible?: An ACOG
WDVNIRUFHUHSRUWFRQÀUPVWKDW1%33LVGLIÀFXOWWRSUHGLFWDQGSUHYHQW
contemporaryobgyn.net/brachial-plexus-palsy-prevention
Plaintiff settles Erb’s palsy case 28 years after delivery: /LWLJDWLRQ
GRHVQ·WXVXDOO\WDNHGHFDGHVEXWWKLVFDVHZHQWWKURXJKPXOWLSOHSODLQWLIIV·
DWWRUQH\VDQGVDWTXLHWO\RQWKHFRXUW·VGRFNHWXQWLOWKHFRXUWUHH[DPLQHGLW
contemporaryobgyn.net/erb’s-palsy-28-years
Shoulder dystocia results in severe brain damage: $ZRPDQVXHV
WKH8QLWHG6WDWHVIRUSUHQDWDOFDUHSURYLGHGE\DKHDOWKFHQWHUIXQGHGE\WKH
IHGHUDOJRYHUQPHQW
contemporaryobgyn.net/shoulder-dystocia-brain-damage
31
SAMPLE
PRIOR SHOULDER DYSTOCIA PATIENT FORM
Shoulder dystocia (“stuck shoulder”) occurs when the baby’s
head delivers and the shoulder gets stuck on the mother’s pelvic bone (pubic bones). This is a true obstetric/birth emergency
that happens in approximately 1-2 out of 100 deliveries. If this
happens, your doctor or midwife will try to help free the baby’s
shoulders. Following shoulder dystocia deliveries, some babies
may suffer some sort of injury, either temporary or permanent.
For example, shoulder dystocia may cause a bone (the clavicle)
to be broken or a nerve to be injured in the baby’s arm. Most
often these problems heal quickly. However, sometimes the
nerve(s) to the arm and hand do not heal and the baby can be
left with weakness or inability to move the arm or hand (Erb’s
Palsy). There are also cases when the baby could suffer brain
injury due to lack of oxygen during the time that the baby is
stuck. This could result in cerebral palsy or death. Additionally,
for the mother, shoulder dystocia may cause tears around the
vaginal opening and bleeding after birth.
Shoulder dystocia is usually not something we can predict
or prevent, but is common when the baby is over 9 ½ lb, the
mother is overweight or has diabetes. We also know that a
major risk factor for shoulder dystocia is when a mother has
had a previous delivery with shoulder dystocia. It has been
reported that the risk of a shoulder dystocia happening again
increases to as high as 15 out of 100 deliveries. There is no
guarantee that another shoulder dystocia will not result in
permanent neurologic injury or death this time, even if your
baby has no problems from a prior shoulder dystocia.
Because the doctors and midwives who deliver at XXX hospital desire to minimize the risk to your baby, we are asking you to agree to a cesarean section (c-section) delivery for
your baby. There are risks to a cesarean section that include,
but are not limited to, infection, blot clots, injury to other organs, and bleeding. If you agree to a c-section, your doctor
signing below and his/her partners will continue to provide
you with prenatal care and you can deliver at XXX hospital.
If you do not want a c-section, we are asking you to obtain
your prenatal care and deliver your baby at another hospital
unless your doctor and the other doctors in his/her practice
agree to guarantee that one of them will be there while you
are laboring and during your delivery at XXX hospital. If your
doctor is unable to guarantee to be there for the labor and delivery, you understand you will need to find another obstetrical provider to care for you during your pregnancy. If you
experience an emergency regarding your pregnancy during
any time you are locating another obstetrician, you should go
to the nearest emergency department.
By signing my name below, I agree to have a cesarean section (c-section).
Patient Name (print)
Clinician Name (print)
Patient Signature
Clinician Signature
Date:
Date:
By signing below, I agree to be present or agree that one of my partners will be present during this patient’s entire
labor and delivery at XXX Hospital.
Clinician Signature
Date:
I understand the information on this counseling document that I have received. I have had an opportunity to ask questions
which have been answered to my satisfaction, and I do not want to have a cesarean section for this pregnancy. By signing
my name below, I do not agree to a cesarean section (c-section).
Patient Name (print)
Patient Signature
Clinician Signature
Date:
Date:
32
SEPTEMBER 2015
ACOG GUIDELINES AT A GLANCE
EXPERT PERSPECTIVES ON PRACTICE BULLETINS
COMMITTEE ON PRACTICE BULLETINS—GYNECOLOGY AND THE SOCIETY OF GYNECOLOGIC
ONCOLOGY.
ACOG Practice Bulletin Number 149: Endometrial Cancer. April 2015. Obstet Gynecol 2015;125:1006-26. Full text of ACOG
Practice Bulletins is available to ACOG members at www.acog.org/Resources-And-Publications/Practice-Bulletins/Committee-onPractice-Bulletins-Gynecology/Endometrial-Cancer
ENDOMETRIAL CANCER Endometrial carcinoma is the
tribute toward risk reduction, and facilitate early diagnosis. The
most commonly diagnosed gynecologic malignancy: almost
purpose of this document is to review the current understand-
every gynecologist will encounter it. A thorough understand-
ing of endometrial cancer and to provide guidelines for man-
ing of the epidemiology, pathophysiology and diagnostic and
agement that have been validated by appropriately conducted
management strategies for this type of cancer allows the obste-
outcome-based research when available. Additional guidelines
trician-gynecologist to identify women at increased risk, con-
on the basis of consensus and expert opinion also are presented.
Used with permission. Copyright the American College of Obstetricians and Gynecologists.
COMMENTARY
Endometrial cancer 2005-2015
by ILANA CASS, MD
Dr. Cass is Vice Chair and Associate Clinical
Professor, Department of Obstetrics and
Gynecology, Cedars-Sinai Medical Center, Los
Angeles, California. She is also a member of
the Contemporary OB/GYN editorial board.
Practice Bulletin 149, published in
April, 2015, replaces Practice Bulletin
65, published in 2005. This commentary broadly discusses endometrial
cancer using Practice Bulletin 149 as a
source. The new guidelines reflect current understanding of genetic causes
of and risk factors for endometrial cancer. The new Practice Bulletin expands
upon contemporary management to
include level “A” recommendations
regarding the appropriate evaluation
of abnormal uterine bleeding to optimize detection and describes appro-
34
priate preoperative evaluation.
A new surgical staging system was
adopted in 2009 to better reflect the
behavior of endometrial cancer and
align treatment planning. The Practice
Bulletin endorses the use of minimally
invasive surgery to stage and treat endometrial cancer, which has now been
validated in large, prospective trials to
dramatically reduce the morbidity of
surgery. The Practice Bulletin reflects
the ongoing controversy about adjuvant therapy and offers important
consensus opinions regarding the appropriate surveillance of endometrial
cancer patients after treatment to improve quality of life.
Expanded risk factors
The epidemic of obesity in the United
States has resulted in an increased in-
cidence of endometrial cancer. A recent meta-analysis of more than 40
studies involving 32 million women
found that body mass index (BMI) was
strongly associated with risk of endometrial cancer. Overweight women
(BMI 25–29.9 kg/m2) and obese women (BMI > 30 kg/m2) had an estimated
odds ratio (OR) of developing endometrial cancer of 1.43 (95% CI: 1.30–
1.56) and 3.33 (95% CI: 2.87–3.79)
respectively, compared to normalweight women.1
Estrogen, whether derived from endogenous sources like excess adipose
tissue or from exogenous sources including unopposed estrogen therapy,
is associated with type I endometrial
cancer in a dose-dependent relationship. While this risk is offset by
concomitant progestins, the optimal
SEPTEMBER 2015
ACOG GUIDELINES
dose and length of progestin therapy
remains unclear. Intermittent dosing of oral progestins (< 10 days per
month) or the variable absorption
seen with topical progestin creams increases the risk of endometrial cancer,
whereas continuous regimens including that obtained from the intrauterine
levonorgestrel-releasing intrauterine
system (IUS) decrease the risk.2 Based
upon this compelling data, the use of
prophylactic progestins in women at
the highest risk of developing endometrial cancer has been advocated. 3
Genetic predisposition
Increased awareness of the strong association between personal and family history and inherited predisposition to gynecologic cancers has led to
more frequent genetic testing. Lynch
syndrome (formerly known as hereditary non-polyposis colorectal cancer)
is the most common hereditary cause
of endometrial cancer, responsible for
2% to 3% of all cases and up to 10%
of endometrial cancer diagnoses in
women younger than age 50.4
Endometrial cancer is the sentinel
cancer among women with Lynch
syndrome, an autosomal-dominant
condition that results from germline
mutations in DNA mismatch repair
genes including MLH1, MSH2, MSH6,
and PMS2, which are responsible for
recognizing and repairing errors in
DNA replication.5 Mutations in DNA
mismatch repair genes result in accumulated somatic mutations, which increase the risk of many cancers including those of the endometrium, ovary,
colon, hepatobiliary system, brain/
central nervous system, small bowel,
and urinary tract, as well as sebaceous
tumors.
Cowden’s syndrome, a rare autoso-
SEPTEMBER 2015
mal-dominant condition caused by
PTEN mutations, is also associated
with an increased risk of endometrial
cancer. Recent consensus guidelines
have proposed more liberal genetic
testing of women with endometrial cancer, even in the absence of a
strong family history, to reduce the
morbidity and mortality from other
endometrial cancer found that African-American women had a 30% decreased incidence of being diagnosed
with endometrial carcinoma compared with Caucasian women, but
a two-and-a-half-fold higher risk of
death from their cancer. The authors
suggest that aggressive histology and
socioeconomic factors largely drive
OVERWEIGHT WOMEN AND OBESE WOMEN
HAD ESTIMATED ODDS RATIOS OF DEVELOPING ENDOMETRIAL
CANCER OF 1.43 AND 3.33 RESPECTIVELY, COMPARED TO
NORMAL-WEIGHT WOMEN.
cancers related to this syndrome.4,6
Increased access to genetic testing
using available next-generation sequencing techniques, which study
multiple genes simultaneously, may
potentially reveal gynecologic cancer
risks associated with other genetic
mutations.7
A concomitant increase in the
number of deaths from endometrial
cancer has been reported that is not
entirely attributable to the increase
in obesity-related type I endometrial
cancers, which generally carry a better prognosis. Emerging data suggest
that significant healthcare disparities
are largely responsible for the poorer
prognosis observed in some women
despite similar disease characteristics. African-American women, older
women, and those from rural demographic settings have worse outcomes,
even when adjusted for the frequency
of the more aggressive, type II endometrial cancers.
A recent systematic review of 24
studies of more than 366,000 cases of
these differences.8 To date, no clear
hormonal or reproductive risk factors
have been linked to type II endometrial cancers. Healthcare disparities
remain an area of active research in order to improve outcome for the treatment of endometrial cancer.
Diagnosing endometrial
cancer
The Practice Bulletin endorses transvaginal sonography (TVS) or outpatient histologic evaluation of the endometrium with a disposable device
as equally acceptable methods for initial assessment of women with postmenopausal bleeding. An endometrial
thickness >5 mm seen on TVS in postmenopausal women with bleeding has
shown high rates of sensitivity in the
detection of endometrial cancer and
mandates histologic evaluation.
Level A recommendations support
the addition of hysteroscopy at the
time of dilation and curettage (D&C)
to fully evaluate the endometrial lining
and exclude a premalignant or benign
35
ACOG GUIDELINES
lesion as the cause of bleeding or endometrial cancer.
TABLE 1
Updates in surgical staging
Staging of endometrial cancer was
updated in 2009, 2 decades after the
system was initially described. The
mainstay of treatment for endometrial cancer is surgical removal of the
uterus, cervix, ovaries, and fallopian tubes. The update in 2009 better
aligns histopathologic findings with
prognosis. Review of data from more
than 42,000 women with endometrial
cancer by FIGO allowed for analysis of
specific prognostic factors in surgicopathologic staging. The FIGO committee simplified the 1988 staging classification by combining some substages
that had a similar prognosis and segregating others that were believed to
have a distinct prognosis 9,10 (Table 1).
Randomized clinical trials have established that minimally invasive surgery is appropriate and the preferred
staging approach for endometrial cancer. Minimally invasive surgery has
been associated with improved recovery times and decreased length of stay
and postoperative complications.11
Newer studies have described other
minimally invasive techniques, including use of the robot and single-incision
ports, in addition to standard laparoscopy, with promising results. The differences in patient selection, operator
experience, and increased cost of these
techniques limit any definitive conclusions. These technologies may expand
the number of patients with endometrial cancer who would be candidates
for minimally invasive surgery.
The role of routine lymphadenectomy in women with endometrial
cancer remains controversial, as no
randomized trial has shown a sur-
36
Summary of 2009 endometrial cancer staging
6WDJH,VLPSOLÀHGWRGHVFULEHLQYDVLRQRIOHVVWKDQ,$RUPRUHWKDQKDOIWKHP\RPHWULXP,%
Stage II disease now limited to cervical stromal invasion by classifying endocervical
involvement of the cervix as part of stage I disease
(OLPLQDWHGWKHVHSDUDWHFODVVLÀFDWLRQRISRVLWLYHSHULWRQHDOF\WRORJ\DV6WDJH,,,$
which is now limited to disease involving the serosa of the uterus or adnexa
6HSDUDWHG6WDJH,,,&LQWRPHWDVWDVHVLQYROYLQJWKHSHOYLFO\PSKQRGHV,,,&YHUVXV
SDUDDRUWLFO\PSKQRGHV,,,&
vival benefit from lymphadenectomy
that may relate to the preponderance
of early-stage disease confined to the
uterus.12 Although women with lowgrade, minimally invasive disease
do not appear to benefit from rou-
30
%
THE DECREASED INCIDENCE OF
AFRICAN-AMERICAN WOMEN BEING
DIAGNOSED WITH ENDOMETRIAL
CARCINOMA COMPARED WITH
CAUCASIAN WOMEN
BUT THEY HAVE A
TWO-AND-A-HALF-FOLD
HIGHER RISK OF DEATH
FROM THEIR CANCER
tine lymphadenectomy, no definitive
pre- or intraoperative predictors exist
that can reliably identify them. Consequently, preoperative consultation
with a gynecologic oncologist is recommended, especially in the context
of preoperative high-risk features or
limited intraoperative ability to either
assess the extent of uterine disease or
adequately stage the patient’s disease.
Endometrial cancer is considered
high-risk if it is grade 2 or 3 disease,
there is evidence of clear cell or papillary serous histology, or any clinical
or radiologic suspicion of cervical or
extrauterine disease, and when it is
diagnosed in a woman with a family
history of the disease. Comprehensive
staging of women with high-risk disease improves the diagnostic accuracy
of surgery and prognosis, and allows
for better tailoring of treatment recommendations. Comprehensive staging reduces unnecessary treatment
and its related morbidity.
A study of 714 women with early-stage uterine cancer found that
women treated with pelvic radiation
had higher rates of urinary and bowel
symptoms resulting in lower physical
function up to 15 years after completion of treatment.13 A subsequent prospective trial of 560 women with early-stage endometrial cancer showed
that treatment with a combination of
vaginal and pelvic radiation was associated with higher rates of secondary
malignancies than was treatment with
vaginal radiation alone.14
A recent pooled study of more than
SEPTEMBER 2015
ACOG GUIDELINES
1,200 women with endometrial cancer
did not find an increased risk of developing a second cancer among those
treated with pelvic radiation after a
median of 13 years.15 The authors concluded that adjuvant therapy should
be reserved for patients with the highest-risk endometrial cancer.
Surveillance of women with
endometrial cancer
Consensus guidelines from both the
Society of Gynecologic Oncologists
and the National Comprehensive Cancer Network for post-treatment surveillance of women with endometrial
cancer emphasize improving healthcare delivery and outcomes by limiting
unnecessary imaging in asymptomatic
cancer patients. Routine vaginal cytology and annual chest radiography are
not recommended in the low-risk patient, given the limited ability to detect
asymptomatic recurrences.
Provocative data suggest that cardiovascular disease is associated with
the greatest risk of mortality in women
with the most common endometrial
cancer, type 1 disease. Therefore, gynecologists who care for obese women with endometrial cancer are in a
unique position to use the diagnosis
and treatment of endometrial cancer
as an opportunity to modify healthcare behaviors.
A small randomized, controlled trial provides level I evidence that diet
and exercise programs may improve
the overall survival and quality of life
for women following treatment of endometrial cancer.16 Interventions designed to reduce non-cancer health
risks for women successfully treated
for endometrial cancer may be the
best way to affect their survival. REFERENCES
1. Jenabi E , Poorolajal J. The effect of body
mass index on endometrial cancer: a metaanalysis. Public Health. 2015; doi:10.1016.
[Epub ahead of print].
2. Jaakkola S, Lyytinen HK, Dyba T, Yikorkala
O, Pukkala E. Endometrial cancer associated with various forms of postmenopausal
hormone replacement therapy. Int J Cancer.
2011;128:1644–1651.
THE CONSENSUS AMONG
THE AUTHORS OF A
RECENT STUDY IS THAT
ADJUVANT THERAPY
SHOULD BE RESERVED
FOR PATIENTS WITH
THE HIGHEST-RISK
ENDOMETRIAL CANCER.
8. Long B, Liu FW, Bristow RE. Disparities in uterine cancer epidemiology, treatment, and survival among African Americans in the United States. Gynecol Oncol.
²
9. Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium.
Int J Gynaecol Obstet
10. Creasman W Revised FIGO staging for
carcinoma of the endometrium. Gynecol Oncol. 2009;105:109.
11. Walker JL, Piedmonte MR, Spirtos NM, et
al. Recurrence and survival after random assignment to laparoscopy versus laparotomy
for comprehensive surgical staging of uterine
cancer: Gynecologic Oncology Group Lap2
Study. J Clin Oncol
12. Benedetti-Panici P, Basile S, Maneschi F,
et al. Systematic pelvic lymphadenectomy vs.
no lmphadenetcomy in early stage endometrial cancer:randomized clinical trial. J Natl
Cancer Inst. 2008;100:1707-1716.
3. Lu KH, Loose DS, Yates MS, et al. Prospective multicenter randomized biomarker study
of oral contraceptive versus depo-provera for
prevention of endometrial cancer in women
with . Lynch syndrome. Cancer Prev Res.
2013;6:774–781.
13. Nout RA, van de Poll-Franse LV, Lybeert
ML, et al. Long-term outcome and quality of
life of patients with endometrial carcinoma
treated with or without pelvic radiotherapy in
the post-operative radiation therapy in endoPHWULDOFDUFLQRPD3257(&WULDOJ Clin
Oncol²
4. SGO Clinical Practice Statement: Screening for Lynch Syndrome in Endometrial
&DQFHU 6*2 KWWSVZZZVJRRUJ
clinical-practice/guidelines/screening-forlynch-syndrome-in-endometrial-cancer/.
14. Onsrud M, Cvancarova M, Hellebust TP,
et al: Long-term outcomes after pelvic radiation for early-stage endometrial cancer. J Clin
Oncol. 2013;31:3951–3956.
5. Lu KH, Dinh M, Kohlmann W, et al. Gynecologic cancer as a “sentinel cancer”
for women with hereditary nonpolyposis
colorectal cancer syndrome. Gynecol Oncol.
2005;105:569–574.
15. Wiltink LM, Nout RA, Fiocco M, et al. No
increased risk of second cancer after radiotherapy in patients treated for rectal or endometrial cancer in the randomized TME,
PORTEC-1, and PORTEC-2 trials. J Clin Oncol. 2015;33:1640–1646.
6. Batte BA, Bruegl AS, Daniels MS, et al. Consequences of universal MSI/IHC in screening
endometrial cancer patients for Lynch syndrome. Gynecol Oncol²
7. Walsh T, Casadei S, Lee MK, et al. Muta-
SEPTEMBER 2015
tions in 12 genes for inherited ovarian, falloSLDQWXEHDQGSHULWRQHDOFDUFLQRPDLGHQWLÀHG
by massively parallel sequencing. Proc Natl
Acad Sci. 2011;108:18032–18037.
16. von Gruenigen VE, Frasure HE, Kavanagh MB, et al. Survivors of uterine cancer
empowered by exercise and healthy diet
68&&(('DUDQGRPL]HGFRQWUROOHGWULDO
Gynecol Oncol. 2012;125:699–704.
37
PRACTICE MATTERS
Patient language
services: Your
responsibilities
Why your practice needs to develop protocols and procedures
by MARIANNE MONROY, JD
L
anguage barriers may
undermine a patient’s
“meaningful access” to
federally funded healthcare services, because
these barriers may prevent patients
from understanding medical treatment and advice received from providers. Therefore, HHS mandates that
providers take reasonable steps to
overcome language barriers and ensure that limited-English-proficient
(LEP) patients have timely and meaningful access to healthcare.
The HHS Office for Civil Rights
(OCR) is responsible for enforcing
this mandate. A patient who feels that
a provider has discriminated by denying access to language services may
file a civil rights complaint with OCR,
which has the authority to investigate
complaints and to conduct “compliance reviews” to determine if providers’ policies, procedures, and actions
are consistent with the law.
Providers should arrange for oral
and/or written language assistance
services to communicate effectively
with LEP patients. HHS allows a provider some flexibility in determining
the appropriate mix of language assistance services to facilitate communications depending upon:
the percentage of LEP individuals
served;
the frequency of services provided to
LEP individuals;
whether the services provided are
important or emergent; and
the resources available to the
provider.
However, while a provider has a
range of choices regarding language
assistance services, the services the
provider chooses must actually work
to ensure effective communication.
Below are best practices.
Determine language preferences
Ask the patient about her primary
oral language and preferred written
language. Consider language identification cards that help the patient
inform staff of language needs (ie,
“I speak Spanish”).
Ensure understanding
Determine if the patient requires an
interpreter. It is important for providers not to assume that a multilingual
patient understands them. Though it is
not required by law, as a best practice
MS MONROY is a partner at Garfunkel Wild, PC, in Great Neck, New York.
38
SEPTEMBER 2015
M
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Hysteroscopic
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True Fact 4:
This scope’s small size creates a big advantage:
see-and-treat capability.
The truth is clear.
TRUCLEAR™.
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The pioneering design of the TRUCLEAR 5.0 Operative Hysteroscope enables you
to treat intrauterine abnormalities at the same time you diagnose them, eliminating
the need for two separate scopes. Use with the TRUCLEAR System allows for the
efficient removal of targeted pathology as well as the complete capture of resected
tissue for histological confirmation.
Get the true facts. Make the clear choice. Visit www.sntruclear.com/TRU.
Smith & Nephew, Inc.
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PRACTICE MATTERS
PATIENT LANGUAGE SERVICES
a provider may check for a patient’s
understanding by requesting her to repeat treatment and discharge instructions in her own words.
maintain confidentiality and impartiality throughout exams. Be sure to
research community agencies that
provide interpretation services.
Inform patients of their
rights
Use caution with staff and
family
Inform the patient of her right to a
competent interpreter free of charge.
Providers may provide notice regarding how to access language assistance
services by posting signs, translated
into the most common languages
encountered, in intake areas. The Social Security Administration provides
such notices at www.ssa.gov/multilanguage/langlist1.htm.
While it may be appropriate to rely on
bilingual staff in certain situations, be
aware that if the information is highly technical, this is risky unless the
staff member has a strong command
of healthcare vocabulary and terms
across languages.
Be wary of using family members
as interpreters, because often they are
not skilled in interpreting medical terminology and may have interests that
conflict with the best interests of the
patient. Moreover, using family members and friends as interpreters can
lead to problems with confidentiality.
8VHTXDOLÀHGLQWHUSUHWHUV
Use a qualified interpreter during exams to obtain a patient’s history and
informed consent, and when giving treatment or hospital discharge
instructions.
According to federal rules, a qualified interpreter is one who can interpret effectively, accurately, and impartially, using any necessary specialized
vocabulary. All interpreters must adhere to their roles as interpreters and
DO YOU NEED
TO HIRE AN
INTERPRETER?
by TRACY D. HUBBEL, JD
40
Don’t forget written documents
Provide translated written documents
in the patient’s preferred written
language. Vital documents must be
translated; a document is considered
vital depending on the importance of
the information. Examples are consent and complaint forms and intake
forms with the potential for important
consequences.
Consider culture
Language and culture are not identical. Providers and interpreters should
be aware that culture affects not
only communication methods, but
also health-related knowledge and
behavior.
Use video if appropriate
Though face-to-face interpreters are
generally preferred, HHS is aware that
telephonic or video interpreting may
be necessary, especially for providers
with small practices. When using telephonic or video interpreting, consider
Consider your prior experience
with LEP encounters and
demographic data for your eligible
population to determine what
languages are spoken by LEP
persons in your service area.
Assess the frequency with which
you will have contact with LEP
patients. The more frequent the
contact with a particular language
group, the more likely language
services in that language will be
needed.
Physicians who encounter LEP
patients on a daily basis have
the nature and quality of the technology used (passing a headset back and
forth is not ideal, for example).
Never refuse
Above all, providers never should refuse to provide language access services, charge LEP patients for language
access services, or delay important or
emergency treatment. greater duties than physicians
who serve LEP patients on an
unpredictable or infrequent basis.
Physicians who encounter LEP
patients on an infrequent or
unpredictable basis might use
one of the commercially available
telephonic interpretation services
to obtain real-time interpreter
services to ensure that LEP
patients have access to their
services.
Also take into account whether
services are important and
urgent, to determine if immediate
language services are necessary.
Physician services are important,
but not always urgent.
Last, consider the resources
and costs it will take to provide
language services.
Costs may seem unreasonable
LIWKH\H[FHHGWKHEHQHÀWVRI
providing the language services
but costs may be reduced
by using technology, sharing
resources, using bilingual staff
or volunteers, and standardizing
documents.
SEPTEMBER 2015
TOOLS TEST DRIVE
by JAMES GREENBERG, MD
CryoPen
This sleek cryosurgery device won me over with its convenience and usability.
COMPANY H&O Equipments (Ghislenghien, Belgium)
WEBSITE www.ho-equipments.com
DESIGN/FUNCTIONALITY
IMAGE COURTESY OF H&O EQUIPMENTS
Background
LIST PRICE $2,695 (Cryoprobe M Starter Kit)
OVERALL SCORE
INNOVATION
after treatment, further contributing
Condylomata acuminata (genital
to destruction of the lesion through
warts) result from infection with huimmunologically mediated mechaman papillomavirus (HPV), which
nisms.
is the most common viral sexuSlow thaw times and repeat
ally transmitted disease in the
freeze-thaw cycles produce
United States. Treatment
more tissue injury than a
options include chemical
single freeze and thaw.
THE
DEVICE
IS
or physical destruction,
As compared with other
LIGHT, EASY TO
immunotherapy, and surdestructive treatments,
OPERATE, AND
gical removal. Although
cryosurgery offers the
INTUITIVE.
there is no evidence that
further benefit of preservany one treatment option
ing the surrounding tissue
is significantly better than
matrix, which is relatively coldanother, cryocautery is a popular
resistant, thereby decreasing scarmodality with which these lesions are
ring. After dead tissue is sloughed
addressed.
off, re-epithelization occurs.
With cryosurgery, extreme cold
In clinical practice, liquid nitemperatures are used to crystalize a
trogen, which boils at −196°C
cell’s cystoplasm, destroying it. Mild
(−320.8°F), is an effective cryogen
freezing also leads to separation
for clinical use and has been a staple
of the dermal-epidermal junction,
of treatment for close to 100 years.
which is useful in treating epidermal
Temperatures of −25°C to −50°C
lesions because the more sensitive
(−13°F to −58°F) can be achieved
cells in the epidermis are destroyed
quickly if a sufficient amount
while the dermis is left intact. The
of liquid nitrogen is applied
degree of damage depends on the
to tissue. Generally though,
rate of cooling and the minimum
destruction of most lesions
temperature achieved. Inflammarequires temperatures of
tion develops during the 24 hours
only −20°C to −30°C (−4°F
SEPTEMBER 2015
to −22°F) and for that, nitrous oxide
(N20) has proven ideal.
Much as with the telephone,
which took more than a century to
evolve from its introduction by
Alexander Graham Bell in 1876
to the availability of its more
convenient and portable
offspring, the iPhone
(introduced in 2007),
41
TOOLS TEST DRIVE
OptiSpec Gynecology Light
This single-use clip-on brings light to wherever you need it.
COMPANY Utah Medical Products, Inc (Midvale, Utah)
WEBSITE www.utahmed.com
LIST PRICE $75 (box of 25)
DESIGN/FUNCTIONALITY
INNOVATION
OVERALL SCORE
Background
Consistent, proper illumination
of the vagina and cervix can be a
challenge. Fortunately, over time,
this challenge has been met with a
variety of technologies. Single-use
plastic speculums with built-in LED
lights have lately emerged as popular choices for clinical situations in
which fixed external lighting is not
readily available.
Now, a new twist on the disposable light idea comes to us from Utah
Medical in the form of OptiSpec.
Rather than a completely disposable, single-use lighted speculum,
OptiSpec is a small, ultra-bright,
pure white-light-spectrum LED light
source that can clip onto any speculum to provide immediate illumination of the upper vagina and cervix.
The device is intended as a singleuse product and comes in an individual sterile packet with 25 devices
per box. It is simple, lightweight, and
intuitive.
In clinical use, OptiSpec provided
outstanding light—better than my
current halogen goose-necks. It fit
easily onto every speculum I tried
and was never in my way. My only
42
objection came from my inner
“green” soul that generally prefers
reusables to disposables but, compared with completely disposable
plastic speculums, this is a nobrainer.
DESIGN/FUNCTIONALITY SCORE:
Innovation
Today, LED is everywhere. It lights
up our homes, turns our phones into
flashlights, and now helps illuminate
the deeper recesses of the vagina
and cervix. Where OptiSpec makes a
difference is in its empowering abil-
ity to allow pelvic exam providers
to use the speculum of their choice
rather than succumb to a “one-sizefits-all because that is the only way
to get light in there” mentality.
OptiSpec is more clever than innovative but I do think it is a better
choice than most disposable lighted
speculums that are currently in this
space.
INNOVATION SCALE:
SEPTEMBER 2015
IMAGE COURTESY OF UTAH MEDICAL PRODUCTS
Design/Functionality
TOOLS TEST DRIVE
CryoPen
cryocautery delivery systems have
taken a while to mature. Now from
our Belgian friends comes the newest
and coolest cryosurgery device yet:
CryoPen.
Design/Functionality
When I first saw CryoPen at the 2015
ACOG Annual Clinical Meeting, I
was drawn immediately to its sleek,
ultramodern design and space-age
brushed aluminum casing. With an
appearance closer to one of those
high-end writing utensils that are
given as gifts to people who already
have everything, CryoPen is ergonomically proportioned to fit into the
hand comfortably. The device is light,
the spray trigger mechanism is easy to
operate, and use of the whole product
is intuitive. It comes with a variety of
tip configurations to address different
clinical situations.
The device uses nitrous oxide as
its cryogen and is available in models that accommodate either 8-g or
16-g cartridges. Eight-g cartridges
provide 100 seconds of constant gas
flow while the 16-g cartridges provide 200 seconds. As a general rule,
lesions require about 5 seconds of
treatment for every 1 mm of tissue
penetration.
In clinical use, CryoPen worked like
a dream. In the past I have used both
large gas tanks connected to pistolgripped probe tips and HistoFreezer.
CryoPen blew away both of these in
terms of convenience, usability, and
accuracy of application. Instead of
touching a probe to the lesion, CryoPen is a spray application and simple
enough for any clinician to use.
DESIGN/FUNCTIONALITY SCORE:
Innovation
I suspect little about this technology is
too novel or complex but, as the end
user, I was impressed. CryoPen’s design, functionality, and packaging are
all relatively innovative in this space
and I would be surprised if other similar products did not appear soon (if
they are not already there).
I see this as the new standard by
which other products for condyloma
destruction will be judged.
INNOVATION SCALE:
Summary
I love CryoPen. I love the way it works;
I love its convenience; I love its look.
When it comes to treating condyloma,
this is a great product that I highly
recommend.
OVERALL SCORE:
OptiSpec Gynecology Light
Summary
landfill space.
OptiSpec is a really good
If you currently have
OPTISPEC
product. It provides betgood lights in every
ALLOWS PELVIC EXAM
ter light to the upper
room in which you perPROVIDERS TO USE
vagina and cervix than
form speculum exams,
THE SPECULUM OF
anything else I have
perhaps this is not for
THEIR
CHOICE.
ever used. However, it
you. If you need to bring
is a single-use product
a light into the room for
meant to replace a reusable
speculum exams then this
light source, so each provider will
is definitely better than whatever
need to decide whether his or her
you are currently using. clinical situation justifies the cost and
OVERALL SCORE:
SEPTEMBER 2015
The views of the author are personal
opinions and do not necessarily represent
the views of Contemporary Ob/Gyn.
Dr Greenberg personally tests all the
SURGXFWVKHUHYLHZV+HKDVQRFRQÁLFWV
of interest with these products or the
companies that produce them.
43
3rd annual ‘GOHO’ ultrasound
course educates capacity crowd
by KIM ABRUZESE, RDMS
PHOTOS BY KIM ABRUZESE, RDMS
F
or the third year in a row,
the GOHO course returned
to the Icahn School of Medicine at Mount Sinai in New
York City this summer, bringing learning from ultrasound’s leaders to a capacity crowd of enthusiastic ob/gyn
residents. The free program is hosted
by The Gottesfeld-Hohler (GOHO)
Memorial Foundation, a nonprofit
organization dedicated to improving
education and research in ultrasound
for ob/gyns.
Headlining the course, which attracted 60 second-year residents, were
Contemporary OB/GYN editorial board
member Joshua A Copel, MD, and Lawrence Platt, MD. They were joined by
Joanne Stone, MD, John Hobbins, MD,
Ilan Timor, MD, and Brian Wagner,
MD, as physician-lecturers.
Spanning a full weekend, the 2-day
course afforded the students, who
came from New England, New Jersey,
Pennsylvania, Ohio, and Michigan, the
opportunity for 6 hours of hands-on
scanning. Representatives from GE,
Samsung, and Philips were present and
26 live pregnant models were recruited
for attendees to scan. Ob/gyn residents
enjoyed their time with the transducer
and rotated through different rooms to
learn from the physicians. Lesson plans
for hands-on scanning included biom-
44
etry, organ anatomy in
areas such as the heart
and brain, and umbilical artery Doppler.
Brian Wagner, MD,
Katherine Kohari, MD,
and Anna Monteagudo, MD, all helped with
hands-on learning.
Medaphor brought
their ScanTrainer Ultrasound simulator, providing attendees with hands-on experience in transvaginal scanning. During lectures and
in hands-on training, ob/gyn residents
were exposed to pathology images on
Trice Imaging’s ScanTrainer, which
sends HIPAA-compliant medical images to physicians and patients via cell
phones and email.
Dr Copel ended the event with an
interactive quiz, to which ob/gyns resi-
dents were asked to text in their answers. The responses—a jump from
60% correct on the pretest to 80% correct on the post-test—clearly demonstrated the knowledge gained by the
attendees during the weekend. Said Dr
Copel of the course, “We (GOHO) are
confident that attendees will take the
ideas and skills learned in this course
and apply them to everyday clinical
SEPTEMBER 2015
Coming in October
Surgical Technology:
From Promise to Practice
Look for a special section on gynecologic surgery advances and
innovations in next month’s edition of Contemporary OB/GYN.
Edited by Jon I Einarsson, MD, PhD, MPH, it features authoritative,
peer-reviewed information on procedures, techniques, tools, and
controversies including:
t
t
t
t
t
Practical tips for turning a bright idea into a real medical device
Pros/cons of microlaparoscopy instrument design
Radical technical innovations in laparoscopic/robotic surgery
New tool for objective evaluation of surgical skills
Surgical management of endometriosis
Only Contemporary OB/GYN brings you so much practical
advice on gynecologic surgery in a single focus issue.
GOHO ULTRASOUND COURSE
GOHO Tweets
PHOTOS BY KIM ABRUZESE, RDMS
Yalda Afshar
@yafshar
$VHOÀHZLWKWKHVWDUVRI0)0
#MDFRSHO#&WU)HWDO0HG
#<DOH0)0*R+R&RXUVH
care. Ultrasound is
a driving modality in
women’s health and
we believe increasing exposure to ultrasound will help
with patient care and accuracy within
our field. It is our hope to grow this program in upcoming years to strengthen
ultrasound knowledge within the ob/
gyn community.”
The GOHO faculty extend special
thanks to course sponsors GE Healthcare, Philips, Samsung, Medaphor, and
Trice Imaging and to Joanne Stone,
MD, Director of Maternal-Fetal Medicine at Mount Sinai, for hosting the
GOHO event in her facility for the third
consecutive year.
The Gottesfeld-Hohler Memorial Foundation honors the memory
of Kenneth Gottesfeld and Charles
Hohler, 2 early pioneers of ob/gyn
ultrasound. The organization has
co-sponsored a research award with
46
Joshua Copel
@jacopel
7KDQNV#\DIVKDU*UHDWFRXUVH
WKLVZHHNHQG#&RQWHPS2%
*<1#.LP$EUX]WZLWWHUFRP
\DIVKDUVWDWXV«
ACOG, run “think tanks,” and provided
grants for other ultrasound education
activities. Faculty for the GOHO program receive only expense reimbursements and no honoraria.
Dr Copel, who is the group’s treasurer, reports that more than 98% of the
money the organization raises goes to
support scholarly activities. The ultrasound program is the organization’s
way of leveraging its limited assets to
support its educational goals.
Money is also raised through a continuing education ultrasound course
the Foundation offers every year in
December.
Kim
@KimAbruz
#MDFRSHOTXL]]LQJ2E*\Q
PHGLFDOUHVLGHQWV6HHLQJZKDW
WKH\·YHOHDUQHGDVWKH\WH[WLQ
WKHLUDQVZHUV
Yalda Afshar
@yafshar
$EGRPLQDOYVYDJLQDO
XOWUDVRXQGNH\GLIIHUHQFHV
#MDFRSHO#<DOH0)0
*R+R&RXUVHPRXQWVLQDLQ\F
,QIRUPDWLRQRQWKDWFRXUVHLV
DYDLODEOHDWcmebyplaza.com
SEPTEMBER 2015
OB/GYN VERDICTS AND SETTLEMENTS
LEGALLY SPEAKING
Was it an infection? A jury decides
reflected that the codefendant ob/
gyn was made aware of all findings
overnight and directed continued
observation.
At 8:30 am, the chief resident ob/
gyn saw the patient and suspected
“likely bowel perforation with abdominal ascites secondary to mannitol solution.” The codefendant ob/gyn was
contacted about the need for exploratory surgery and the on-call attending obstetrician also was contacted
because the codefendant ob/gyn did
not have privileges for “major GYN
surgery.” The chief resident ob/gyn
contacted general surgery for consultation for possible bowel perforation
and a plan for reoperation with exploration. The on-call attending obstetrician wrote a note at 9:15 am on May
15 that stated: “Called by resident to
surgically manage patient’s status-post
D&C hysteroscopy resectoscope with
perforation and mannitol fluid deficit
of approximately 950 ccs. Patient with
increased abdominal distension and
decreased urine output. Blood pressure 97/60, pulse 120, hematocrit 36,
white blood count 5.7, afebrile. Called
[codefendant ob/gyn] and informed
him to meet me at hospital to evaluate this patient. Also contact surgical
consult for possible surgical/bowel
exploration. Operating room notified
of case.”
A general surgery consultation
was performed by the codefendant
general surgeon. The brief note documented that the patient’s abdomen
was “distended, tender and silent.”
His impression was peritonitis and
his plan was to perform exploratory
SEPTEMBER 2015
laparotomy and possible colostomy.
That was discussed in detail with
the patient, who agreed with the
plan. At 11:30 am the on-call attending obstetrician wrote another note
stating that the codefendant ob/gyn
and the codefendant general surgeon
agreed on the need for exploratory
laparotomy, possible total abdominal
hysterectomy (TAH)/BSO, possible
mesenteric border was found. He
performed a primary anastomosis
and was able to avoid an ileostomy.
The peritoneum was irrigated with
saline solution.
The on-call attending obstetrician stated in her operative note that
upon exploration of the abdomen
and pelvis, a uterine perforation was
noted in the midline posterior aspect
THE CODEFENDANT SURGEON DID NOT PLACE THE
PATIENT ON ANTIBIOTICS POSTOPERATIVELY.
bowel resection, and colostomy. The
surgery started at 12:25 pm and was
completed at 2:23 pm.
The intraoperative nursing record
described the procedure as exploratory laparotomy with small bowel
resection and primary anastomosis
and lyses of adhesion. The anesthesia
record described the procedure as
exploratory laparotomy and repair
of small bowel perforation. The anesthesia record indicated that 1 g of
the antibiotic Cefotetan was administered IV 7 minutes before the skin
incision. Exploration of the small
bowel by the codefendant general
surgeon revealed a 1000-cc hemoperitoneum and a mesenteric injury
at one site of the small bowel that did
not compromise the small bowel, and
a separate small bowel perforation
(approximately 1 cm) exuding greenish bilious material. The codefendant
general surgeon resected the small
bowel where the perforation of the
of the uterus. The perforated site was
sealed with a hematoma that was not
actively bleeding. Palpation in the
cul-de-sac area revealed some free
green bilious material. At that point,
the codefendant surgeon stepped in
and took over the case. The on-call
attending obstetrician did not see
the patient postoperatively and did
not write any further notes in the
patient’s chart. The on-call attending obstetrician and the codefendant
general surgeon agreed that surgery
should follow the patient post-op.
The codefendant ob/gyn rounded on
the patient almost every day for the
remainder of her admission. The codefendant surgeon did not place the
patient on antibiotics postoperatively.
On May 19, the patient was transferred to the Pulmonary Care Unit
because of shortness of breath, low
urine output, abdominal pain, and
distension. An echocardiogram ruled
out any possible cardiac etiology for
47
LEGALLY SPEAKING
the pleural effusion. The woman’s
condition was stabilized and she was
transferred back to the floor on May
21. On May 27, a computed tomography (CT) scan of the abdomen demonstrated worsening ascites and “new
increased enhancement of peritoneal
reflections representing peritonitis,
likely infectious in origin.” The report
also stated that there were “no wellformed fluid collections to suggest
addendum note documenting a conversation with Interventional Radiology regarding the collection seen on
the CT scan. According to Interventional Radiology, the collections were
“smaller than previous aspiration of
150 ccs” with negative culture x 48
hours. The patient was afebrile with
no elevation of WBC and Interventional Radiology recommended no
drainage at that time.
A CT SCAN OF THE ABDOMEN AND PELVIS SHOWED A PELVIC
FLUID COLLECTION CONSISTENT WITH AN ABSCESS
AND LOCULATED PLEURAL EFFUSIONS.
abscess formation.” On May 28, the
plaintiff underwent CT-guided drainage of approximately 120 cc of pelvic
fluid. Microbiology determined that
the fluid was sterile with no growth
documented. Antibiotics were never
ordered and Infectious Diseases was
never consulted. The plaintiff was
discharged home on May 29 by the
codefendant general surgeon. The
patient did not spike a fever or have
an elevated WBC.
The plaintiff was readmitted to
the codefendant general surgeon’s
service at defendant hospital on May
31 with a chief complaint of back and
abdominal pain. The admitting diagnosis was “rule out pelvic abscess,”
and if possible, interventional radiology drainage. A CT of the abdomen
with contrast was performed. The impression was an interval development
of 2 discrete abscesses in the right
lower quadrant and cul de sac with
increased moderate bilateral pleural
effusions. Surgery A team wrote an
48
Medications included IV Zosyn
(started this admission) for 4 days,
Effexor, heparin, and Dilaudid PRN.
The assessment and plan by Pulmonology was: “bilateral pleural effusions
likely sympathetic effusion from pelvic abscesses. Continue IV Zosyn and
suspect pleural effusion will resolve/
improve with treatment of pelvic
process. Recommend periodic chest
x-ray follow up.” The findings, assessment, and plan were discussed with
the codefendant general surgeon. On
June 5 the plaintiff was discharged
home by the codefendant general
surgeon. Throughout that admission,
the patient remained afebrile.
On June 6 the plaintiff presented
to a nonparty hospital’s emergency
room and reported continued pain
in her abdominal area and fever. The
patient was admitted with a diagnosis of abdominal pain and intraabdominal abscess. She had no fever.
A CT scan was recommended. A chest
CT showed bilateral effusions, more
on the right side than on the left. A
CT scan of the abdomen and pelvis showed a pelvic fluid collection
consistent with an abscess and loculated pleural effusions. A Pulmonology consult stated that the pleural
effusions were likely reactive to the
intra-abdominal abscess. On June 7
the plaintiff agreed to have a thoracentesis. Infectious Disease was consulted and indicated that “the patient
is without fever, possible infection,
pelvic collection on CT, collection not
easily accessible to drainage. Before
we initiate antibiotics, will await impact of thoracentesis.” Thoracentesis
was performed and was negative for
any malignancy, fungus, or bacteria.
Over the next few days, the amount
of the patient’s pelvic collection decreased, as did the right pleural effusion, and the left pleural effusion was
documented as persistently small. On
June 9 a consultation with Pulmonary
indicated that the exudate from the
right thoracentesis was likely not an
infection, but secondary to possible
inflammation. It was noted that the
patient was stable, off antibiotics, and
likely would not need intervention for
the pelvic collection.
On June 10 an Infectious Disease
consult stated “no evidence to suggest
infection, has been afebrile also for 6
days and the CT shows improvement.
No need for antibiotics at present.”
A consult the next day indicated “no
indication for antibiotics. Shortness
of breath has improved. Patient is still
without fever.” The patient was discharged home on June 12.
Allegations
The plaintiffs alleged that the defendant ob/gyn was negligent in the
performance of the May 15, 2010
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LEGALLY SPEAKING
surgery, causing uterine and bowel
perforation, and failed to recognize
and repair the perforations intraoperatively. They alleged that the defendant ob/gyn delayed in obtaining
surgical consultation overnight and
that led to pain, suffering, infection,
and adhesion formation. They alleged that the codefendant surgeon
failed to intraoperatively irrigate with
antibiotic solution; failed to culture
the green bilious peritoneal contents;
failed to place the patient on antibiotics post-op; failed to consult with
an infectious disease specialist, and
failed to earlier arrange for drainage
of the patient’s pelvic collections. As
a result, it was alleged that the patient
suffered from an undiagnosed infection that led to abscess formation,
pleural effusions, shortness of breath,
and pain and suffering while hospitalized and afterward.
Discovery
The plaintiff testified at her deposition that as a result of the failure to
diagnose her infections, she suffered
unrelenting pelvic pain, fatigue, adhesion formation, deconditioning,
asthma, and an inability to adequately run her home-based physical therapy practice. Her income tax returns,
however, suggested that she had her
most profitable year subsequent to
the surgery and that her business
was adversely affected by Hurricane
Sandy and an auto accident in 2011.
The codefendant ob/gyn testified that
the uterine perforation was caused by
current from the resectoscope, and
that the bowel perforation was likely
caused by adherence of the small
bowel to the uterus.
He felt that, in the absence of
continued bleeding, he did not want
50
to subject the patient to laparotomy
(which would have been required,
given her surgical history) because
most small uterine perforations heal
without repair. He felt that the management overnight was appropriate,
because he did not have reason to
suspect bowel perforation until the
patient became “shocky” the following morning. The codefendant surgeon felt there was no indication for
post-op antibiotics, as there is always
contamination after a bowel perforation, even one this small, and he
expected it and followed the patient
carefully. He stated that the absence
of elevated WBC, elevated temperature, and culture-proven bacteria in
her pelvic or chest fluids confirmed
his opinion that the patient never suffered from infection.
We represented the hospital, the
chief obstetric resident, and the oncall obstetric attending in this case,
and because the 2 codefendant attendings took full responsibility for
the surgeries and the complications
and the management of the patient
thereafter, we moved for dismissal on
their behalf. Dismissal was granted to
the resident and the on-call attending, but the court felt that while there
was no direct allegation of negligence against the hospital, there was
a question of whether the hospital
was vicariously responsible for the
codefendant surgical consultant (ie,
whether the patient had reason to
believe that he was a hospital representative as opposed to a private
attending when they first met).
Our expert obstetrician felt that the
care was reasonable and appropriate,
and that observation overnight was
within the standard of care because
the complication of uterine perfora-
tion was a known risk of the procedure and there was no way to know
whether there was a bowel perforation
without first performing laparotomy.
The trial
The codefendant ob/gyn settled
on the morning of the trial in 2015.
The case proceeded to trial against
the hospital and the codefendant
surgeon. We obtained testimony
from the codefendant surgeon confirming that he was consulted as a
private attending by the codefendant
private ob/gyn, and that he did not
hold himself out to the patient as an
employee of the hospital, but rather
would have told her he was brought
in by her private obstetrician as a
surgical consultant. Because the
patient had already testified that she
did not recall meeting the surgeon
until after the operation, we were
let out of the case at the close of the
plaintiff’s evidence.
The verdict
The codefendant surgeon
took the case to verdict and
the jury returned a verdict in
KLVIDYRUÀQGLQJWKDWKHGLG
not depart from the standard of care in treating the
patient and indicating that
they did not believe, based
on the evidence, that the patient ever had an infection.
Andrew I Kaplan, Esq, is a partner at
Aaronson, Rappaport, Feinstein & Deutsch,
LLP in New York City, specializing in medical
malpractice defense and healthcare
litigation.
SEPTEMBER 2015
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NATIONAL
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¾Urgent need for BC/BE physician in solo, single specialty practice;
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Additional opportunities in Utah and Louisiana
Love OB/GYN Medicine Again...
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Please e-mail CV: along@iasishealthcare.com
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CONTEMPORARY OB/GYN
53
CAREERS
CALIFORNIA
MASSACHUSETTS
OBSTETRICS/GYNECOLOGY PHYSICIAN
A well-established, full-scope community Ob/Gyn practice is seeking a
full-time BC/BE physician to join their busy and growing practice.
Olive View-UCLA Medical Center, a Los Angeles County facility and
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gynecologist.
We are seeking individuals who will contribute to an academic,
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include direct patient care with strong emphasis on mentoring and
training residents in the UCLA Ob/Gyn Residency Program, as well
as the teaching of medical students. Opportunities in clinical and
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includes an academic appointment at the David Geffen School of
Medicine at UCLA. Competitive salary and benefits provided.
Applicants at the level of Assistant or Associate Professor will be
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for licensure in California. EOE
This practice includes MD’s, CNM’s and NP’s with a large experienced
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Please submit letter of intent, CV, and three references to:
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14445 Olive View Drive, 6D-116
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Fax: (818) 364-3255
Email: cholschneider@dhs.lacounty.gov
Please email rgiordano@emersonhosp.org
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54
ContemporaryObgyn.net
SEPTEMBER 2015
CAREERS
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New York Hospital Queens has employment opportunities
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Companies featured in this issue
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SEPTEMBER 2015
CONTEMPORARY OB/GYN
55
LEGALLY SPEAKING
by ANDREW I KAPLAN, ESQ
Was it an infection?
A jury decides
A case hinges on whether a surgical complication was properly managed.
Facts
On May 14, 2010, a 41-year-old
woman was admitted to a hospital’s
ambulatory care center by a private
attending gynecologist for a D&C,
saline hysteroscopy, and resection
of a submucosal myoma. The patient
had a history of 2 cesarean deliveries, a right ovarian cystectomy, and
ventral hernia repair. The gynecologist was assisted by an ob/gyn chief
resident who had discovered the
patient’s 1.4-cm endometrial lesion during a recent evaluation for
menometrorrhagia.
The patient was taken to the operating room and placed under general
anesthesia via LMA. Mannitol solution was infused to dilate the uterus.
After the hysteroscope was inserted, a
probable fundal submucosal myoma
was visualized. The patient was
dilated to allow for insertion of the
resectoscope into the uterine cavity.
A 1.5 x 1-cm myoma was resected in
2 parts and retrieved for pathology.
A mannitol deficiency of 950 ccs was
noted with potential uterine perforation as the suspected cause.
Upon reinserting the resectoscope,
a small 1- to 2-mm fundal perforation was identified. There was no
active bleeding from the site. All
instrumentation was removed and
the codefendant ob/gyn observed the
56
patient intraoperatively for approximately 10 minutes to make sure there
was no excess vaginal bleeding. The
procedure was then terminated. The
defendant ob/gyn decided to admit
the patient for observation overnight rather than repair the uterine
At 8 pm on the day of surgery, a
nursing note documented guarding and pain on movement, which
was consistent with local peritonitis.
The patient’s white blood cell (WBC)
count spiked to 16.90 (nl: 4.0–10.6).
The plaintiff was receiving IV fluids at
THE DEFENDANT OB/GYN DECIDED TO ADMIT THE
PATIENT FOR OBSERVATION OVERNIGHT RATHER THAN
REPAIR THE UTERINE PERFORATION INTRAOPERATIVELY OR
OBTAIN SURGICAL CONSULTATION.
perforation intraoperatively or obtain
surgical consultation.
In his dictated operative note, the
codefendant ob/gyn wrote: “… patient
was being admitted for observation
with Foley catheter that was inserted.
Strict I’s and O’s, CBC and electrolytes
to be monitored closely throughout
the night and decision about further
procedures will be determined based
on clinical findings. Because of the
patient’s previous surgical history,
laparotomy as opposed to laparoscopy will be required if clinically
necessary.” A mannitol deficiency of
950 ccs was noted. Intravenous (IV)
Kefzol was infused intraoperatively.
Pathology confirmed a submucosal
leiomyoma with underlying muscle.
a rate of 150 ccs per hour and her urinary output was decreasing. At 12:30
am on May 15 the patient reported
pain of 10 out of 10 and repeat complete blood counts (CBCs) were done
at 12:09 am, 3:08 am, and 6:42 am;
the WBC counts were 5.69, 3.01, and
3.54, respectively. In the early morning hours the plaintiff was described
as tachypneic and her urine output
was still decreasing. Her abdomen
was described as “hard.” She was prescribed toradol for abdominal pain
and given fluid boluses.
By 6 am the patient was suffering
tachycardia and hypotension. Notes
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