part i: study design
Transcription
part i: study design
Utilizing Journal Club to Enhance an Understanding of Research Methodology Dr. Suporn Sukpraprut-Braaten, MSc, MA, PhD Dr. David Covey, MD, FACP Graduate Medical Education Unity Health Searcy, Arkansas INTRODUCTION Unity Health is the largest employer in an eight surrounding county area in with more than 2,000 associates located in Searcy, Newport, and Bradford, Arkansas. The facility has a combined total of 438 licensed beds and a medical staff of more than 150 physicians that specialize in various areas of healthcare. Location of White County, Arkansas Unity Health – White County Medical Center 2 Unity Health – Harris Medical Center UNITY HEALTH – WHITE COUNTY MEDICAL CENTER NYIT ARCOM 104 miles to Memphis 54 miles to Little Rock 3 INTRODUCTION Dr. Suporn Sukpraprut-Braaten Assistant Professor for Research, Unity Health – White County Medical Center Vice Chair on the Scholarly Activity & Faculty Development Committee of Kansas City University of Medicine and Biosciences (KCUMB) GME Consortium Adjunct Clinical Assistant Professor of Preventive Medicine, Department of Specialty Medicine, KCUMB Adjunct Clinical Assistant Professor in the Department of Academic Affairs, Arkansas College of Osteopathic Medicine (ARCOM), Fort Smith, AR Former Director of Preventive Medicine Research Center and Assistant Professor of Preventive Medicine and Public Health at Edward Via College of Osteopathic Medicine (VCOM) – Virginia Campus 4 KEY PERSONNEL Unity Health’s Osteopathic Residency Program Dr. Dewey McAfee Director of Medical Education Family Medicine Program Director Dr. David Covey Internal Medicine Program Director Arkansas’s White County Health Officer Dr. James S. Stanley Psychiatry Program Director Dr. John Henderson Chief Medical Officer Dr. Delaney Kinchen Institutional Education Officer Dr. Williams White GME Faculty Dennis Yecke, MBA Operations Director 5 RESIDENCY PROGRAM Unity Health’s Osteopathic Residency Program: Unity Health’s Residency Program is affiliated with Kansas City University of Medicine and Biosciences – Graduate Medical Education Consortium (KCU-GME Consortium). The program is the first osteopathic residency program in the state of Arkansas. The program is the second residency program in the state after a residency program at University of Arkansas Medical Center (UAMS). 6 RESIDENCY PROGRAM Unity Health’s Osteopathic Residency Program: The program was started in July, 2015 and approved for three specialty programs Family Medicine – 3 PGY1 and 1 PGY2 Internal Medicine – 5 PGY1 and 2 PGY2 Psychiatry – 3 PGY1 and 1 PGY2 7 Expectation for Graduation Condition 1: Every resident is required to: Provide a noon didactic lecture at least twice per year Conduct literature review for his/her case report or research project Provide a presentation to patients support group Present and attend journal clubs Attend a medical conference 8 Expectation for Graduation Condition 2: Every resident is required to accomplish one of the following four options of scholarly activity in order to graduate from Unity Health’s residency program Option 1: Two case reports for poster presentations (Level 3) Option 2: An original research project for a poster presentation or publication (Level 4†) Option 3: A grant application (Level 4†) or grant award (Level 5) Option 4: Accomplish a submission of a text book chapter (Level 5) †Level 4 is designed as a graduate target. 9 OBJECTIVES Journal club is an educational intervention that can improve reading habits and research skills, the use of medical literature in clinical practice for postgraduate physicians in training, and knowledge of clinical epidemiology and biostatistics. Learning Objectives: Conduct structured critical appraisal of research articles Gain an understanding about statistical analyses and interpretation of the results Recognize and understand different research study designs Improve the presentation skill Enhance the knowledge on how to practice evidence based medicine Distinguish strengths and limitations of different study designs and statistical analyses Provide transparent expectations from the GME faculty on how to appraise the resident’s performances 10 in a journal club meeting in order to help the residents to prepare for a journal club presentation. OBJECTIVES Our purpose is to explain how Unity Health utilizes a journal club to enhance the residents knowledge in evidence-based medicine practice. I. Journal club structure II. Knowledge Assessment Research Quality Evaluation Worksheet III. Transparent expectations from the residents and GME faculty on how to appraise the resident’s performances in a journal club meeting in order to help the residents to prepare for a journal club presentation IV. AOA/ACGME Requirements V. ACGME Milestones 11 I. Journal Club Structure Journal Club Structure: Every resident must attend the monthly journal club Program director selects the main research article and assigns the journal club presenter Journal club presenter is expected to: Provide background information about the main article Seek for other evidence to support the main article Explain about the study design, methods, and statistical analyses Translate the evidence to patient care The GME faculty evaluate the presenting resident Other residents must systematically evaluate the main article using the Research Quality Evaluation Worksheet 12 I. JOURNAL CLUB STRUCTURE 13 Research Quality Evaluation Worksheet 14 Research Quality Evaluation Worksheet 15 Journal Club Expectation Journal club presenter is expected to: Provide background information about the main article Seek for other evidence to support the main article Explain about the study design, methods, and statistical analyses Translate the evidence to patient care Other residents are expected to: Systematically evaluate the main article using the Research Quality Evaluation Worksheet Summarize the main article Explain how to utilize the information from the article to improve patient care GME faculty are expected to: Evaluate the presenting residents Provide comments and recommendations 16 17 Common Program AOA Requirements AOA Basic Documents for Postdoctoral Training: IX.D Research and Scholarly Activity 9.1 Each OPTI shall require each member institution to establish policies and guidelines that govern scientific research activities in accordance with local, state and federal guidelines. 9.2 Each OPTI shall facilitate and provide research education, assistance and resources directly to trainees and institutions to encourage research and to meeting the Specialty College requirements. 9.3 Each OPTI shall provide in collaboration with its member COM(S), hospitals and other teaching institutions access to basic science and/or clinical research mentorship. ACGME Requirements ACGME Common Program Requirements – Residents’ Scholarly Activities: IV.B Residents’ Scholarly Activities IV.B.1 The curriculum must advance residents’ knowledge of the basic principles of research, including how research is conducted, evaluated, explained to patients, and applied to patient care. IV.B.2 Residents should participated in scholarly activity. IV.B.3 The sponsoring institution and program shall allocate adequate educational resources to facilitate resident involvement in scholarly activities. 9.4 The OPTI shall support and provide a mechanism to recognize trainees who conduct research activities. 9.5 The OPTI shall provide budgeted funding for OPTI-wide or program specific research for its trainees. 9.6 The OPTI shall demonstrate its support of trainee scholarly activity. 18 Family Medicine Program: Residents should complete two scholarly activities, at least one of which should be a quality improvement project. (IV.B.2.a) Internal Medicine Program: Residents should participate in scholarly activity. (IV.B.2) Psychiatry Program: All residents must be educated in research literacy and in the concepts and process of evidence-based clinical practice to develop skills in question formulation, information searching, critical appraisal, and medical decision-making. (IV.B.2.c) 19 Family Medicine ACGME – Milestones PBLI-1: Locates, appraises, and assimilates evidence from scientific studies related to the patients’ health problems 20 PBLI = Practice-Based Learning and Improvement †Level 4 is designed as the graduation target Family Medicine ACGME – Milestones PBLI-1: (Continue) 21 PBLI = Practice-Based Learning and Improvement †Level 4 is designed as the graduation target Family Medicine ACGME – Milestones PBLI-2: Demonstrates Self-Directed Learning PBLI = Practice-Based Learning and Improvement †Level 4 is designed as the graduation target 22 Internal Medicine ACGME – Milestones PBLI-4: Learns and Improves at the Point of Care PBLI = Practice-Based Learning and Improvement †Ready for Unsupervised Practice: This level is designed as the graduation target 23 Psychiatry ACGME – Milestones PBLI-1: Development and execution of lifelong learning through constant self-evaluation, of research and clinical evidence A: Self-Assessment and self-improvement B: Evidence in the clinical workflow 24 PBLI = Practice-Based Learning and Improvement Psychiatry ACGME – Milestones PBLI-3: Teaching A: Development as a teacher B: Observable teaching skills 25 PBLI = Practice-Based Learning and Improvement Research Quality Evaluation Worksheet 26 Research Quality Evaluation Worksheet 27 PART I: STUDY DESIGN 15 Clinical Trial Part I: Study Design Study Intervention Part I: Study Design Study Endpoints Meta-Analysis Researh Articles 0 5 10 Journal Quality Score 15 Researh Articles 15 Clinical Trial Meta-Analysis Researh Articles 0 0 5 10 Journal Quality Score 15 Part I: Study Design Sample size and Power Analysis Meta-Analysis 10 Researh Articles 10 0 Clinical Trial 5 Meta-Analysis Part 1: Study Design All residents accurately identify the study types. 5 Journal Quality Score 10 0 5 Journal Quality Score 10 5 0 Journal Quality Score Clinical Trial Journal Quality Score Part I: Study Design Study Population 15 Part I: Study Design Study Aims 15 Part I: Study Design Literature Review Clinical Trial Meta-Analysis Researh Articles Clinical Trial Meta-Analysis Researh Articles The residents recognizes the potential bias in the clinical trial due to the source of funding from a pharmaceutical company. Study population is unclear to the residents when evaluating metaanalysis. The endpoints are stated clearer for the residents to recognize in the clinical trial than the metaanalysis study. PART II: RESEARCH METHOD Meta-Analysis 15 Meta-Analysis Part II: Research Methodology Blinding 10 5 0 0 5 10 Journal Quality Score 15 Part II: Research Methodology Source of Data 15 Researh Articles Meta-Analysis Researh Articles 10 0 Clinical Trial Researh Articles Clinical Trial Part 2: Research Method The residents learned about the difference in enrollment process between a clinical trial vs. metaanalysis study. 5 Journal Quality Score 10 0 5 Journal Quality Score 10 5 0 Journal Quality Score Clinical Trial Journal Quality Score Part II: Research Methodology Timeline 15 Part II: Research Methodology Randomization Process 15 Part II: Research Methodology Enrollment Process Clinical Trial Meta-Analysis Researh Articles Clinical Trial Meta-Analysis Researh Articles The residents recognize the benefit of blinding process in clinical trial. The residents recognize metaanalysis is ranked as a higher level of research evidence. PART 3: RESULTS AND CONCLUSION 10 Descriptive statistics Statistical analyses 0 Clinical Trial Meta-Analysis Clinical Trial Meta-Analysis Researh Articles Part III: Results and Conclusion Results Part III: Results and Conclusion Conclusion 5 10 15 Clinical Trial Meta-Analysis Researh Articles Interpretation of the results Conclusion The residents are more comfortable in interpreting clinical trial than meta-analysis studies. 0 5 10 Journal Quality Score 15 Researh Articles 0 Journal Quality Score Part 3: Results and Conclusion The residents evaluated the meta-analysis study with lower quality scores in: 5 Journal Quality Score 10 5 0 Journal Quality Score 15 Part III: Results and Conclusion Statistical Analysis 15 Part III: Results and Conclusion Descriptive Statistics Clinical Trial Meta-Analysis Researh Articles STUDY COMPARISON: OVERALL Meta-Analysis Researh Articles 60 50 40 30 10 Clinical Trial 0 0 Clinical Trial Meta-Analysis Clinical Trial 20 Journal Quality Score (0-150 points) 50 40 30 10 20 Journal Quality Score (0-150 points) 50 40 30 20 10 Clinical Trial 0 Journal Quality Score (0-150 points) Quality of Research Study Comparison Part III: Conclusion 60 Quality of Research Study Comparison Part II: Research Methodology 60 Quality of Research Study Comparison Part I: Study Design Meta-Analysis Clinical Trial Meta-Analysis Researh Articles Meta-Analysis Clinical Trial Meta-Analysis Researh Articles STUDY COMPARISON: OVERALL Quality of Research Study Comparison Total Evaluation Score 100 50 Clinical trial study is evaluated as: to have an “Above Average” quality Score average is 114 ± 19 points Clinical Trial 0 Journal Quality Score (0-150 points) 150 Quality of Research Score: 0-30 Poor 31-60 Below average 31-90 Average 91-120 Above Average 120-150 Excellent P-value = 0.15 Meta-Analysis Clinical Trial Meta-Analysis Researh Articles Meta-Analysis study is evaluated as: an “Average” quality Score average is 88 ± 35 points STUDY COMPARISON: INDIVIDUAL RESIDENT Total Quality of Research Score Evaluated by the Residents Ray Montgomery, FACHE – Unity Health’s President and CEO John Henderson, M.D., FACC – Chief Medical Officer Dewey McAfee, D.O., FACOFP, PharmD – Director of Medical Education/Family Program Director James S. Stanley, M.D., FANP – Psychiatry Program Director Delaney Kinchen, D.O., FAEP – Institutional Education Officer Dennis Yecke, MBA – Operations Director, Graduate Medical Education Program Rachael Sowers, MBA – Program Coordinator , Graduate Medical Education Program Leslie Provence, MBA – Program Coordinator , Graduate Medical Education Program Kelly Bopp – Administrative Assistant , Graduate Medical Education Program 34 THANK YOU 35