Sponsored by
AAGLAdvancing Minimally Invasive Gynecology Worldwide
Panel Session 1: Evidence-Based Medicine
PROGRAM CHAIR
Frank F. Tu, MD, MPH
Kristin Matteson, MD, MPH Michael P. Diamond, MD Togas Tulandi, MD, MHCM
Professional Education Information Target Audience This educational activity is developed to meet the needs of surgical gynecologists in practice and in training, as well as other healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.
Table of Contents
Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 The Fundamentals of Clinical Epidemiology and Research Design T. Tulandi ...................................................................................................................................................... 4 How to Conduct a Critical Appraisal of the Literature M.P. Diamond .............................................................................................................................................. 6 Proper Formulation of Relevant Clinical Research Questions K. Matteson .................................................................................................................................................. 8 Effective Communication of Individual Risk to the Public F.F. Tu ......................................................................................................................................................... 10 Cultural and Linguistics Competency ......................................................................................................... 12
Panel Session 1: Evidence-Based Medicine
Frank F. Tu, Chair Faculty: Kristin Matteson, Michael P. Diamond, Togas Tulandi
This session is suitable for all MIGS surgeons and trainees, where essential tools to enhance clinical
practice using principles of evidence-based medicine (EBM) will be presented. Combining the surgeon’s
clinical expertise, patient’s personal values, and the best available published research findings, EBM is an
essential concept in the execution of modern performance-based, outcomes-driven gynecological
surgery. Based on an extensive annotated bibliography of didactic resources identified from online sites,
specific, relevant, interactive cases will be discussed by an international panel of senior gynecological
surgeons.
Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Explain the
fundamentals of clinical epidemiology and research design; 2) properly formulate relevant clinical
research questions; 3) conduct a critical appraisal of the literature; and 4) recognize key strategies for
effectively communicating risk to the public.
Course Outline
11:00 Welcome, Introductions and Course Overview F.F. Tu
11:05 The Fundamentals of Clinical Epidemiology and Research Design T. Tulandi
11:10 How to Conduct a Critical Appraisal of the Literature M.P. Diamond
11:15 Proper Formulation of Relevant Clinical Research Questions K. Matteson
11:20 Effective Communication of Individual Risk to the Public F.F. Tu
11:25 Panel Discussion All Faculty
12:00 Adjourn
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PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* R. Edward Betcher* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Sarah L. Cohen Consultant: Olympus Erica Dun* Joseph (Jay) L. Hudgens Contracted Research: Gynesonics Frank D. Loffer, Medical Director, AAGL* Suketu Mansuria Speakers Bureau: Covidien Linda Michels, Executive Director, AAGL* Frank F. Tu Consultant: AbbVie Contracted Research: AbbVie Karen C. Wang* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Sawsan As-Sanie Consultant: Myriad Genetics Lab Jubilee Brown* Aarathi Cholkeri-Singh Consultant: Smith & Nephew Endoscopy Speakers Bureau: Bayer Healthcare Corp., DySIS Medical, Hologic Other: Advisory Board: Bayer Healthcare Corp., Hologic Jon I. Einarsson* Suketu Mansuria Speakers Bureau: Covidien Andrew I. Sokol* Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Stock Ownership: Titan Medical Karen C. Wang* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Michael P. Diamond Contracted Research: AbbVie, Bayer Healthcare Corp. Consultant: Seikagaku Corporation, Temple Pharmaceuticals, ZSX Medical Stock Ownership: Advanced Reproductive Care Kristen A. Matteson*
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Frank F. Tu Consultant: AbbVie Contracted Research: AbbVie Togas Tulandi* Content Reviewer has no relationships. Asterisk (*) denotes no financial relationships to disclose.
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The Fundamentals of Clinical Epidemiology and Research Design
Togas Tulandi MD, MHCM
Professor of Obstetrics and Gynecology and Milton Leong Chair in Reproductive Medicine
McGill University
Disclosures
• I have no financial relationships to disclose
Objective
Discuss fundamentals of research epidemiology and design including:
• Basic
• Clinical: medical or surgical research
• Retrospective or prospective study
• Randomized trial
Smoking marijuana and ectopic pregnancy
• Study 1 evaluated 100 women who had an ectopic pregnancy (EP) and
compare them with 100 others who have never had EP. They then conducted
interviews with all 200 women including questions about extended marijuana
use. Is this a case control study?
• Study 2 evaluated 300 women who smoked marijuana (study group) and 300
others did not smoke marijuana (control group) and evaluated the incidence of
ectopic pregnancy in 2 years (Study II). Is this a case control study?
Type of research
• Basic
• Clinical: medical or surgical research
• Retrospective or prospective study
• Randomized trial
Clinical Research
Exposure assigned?
Experimental
RCT Non-RCT
Observational
Analytical study
Cohort Case Control Cross Sectional
Descriptive study
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Analytical Study
Exposure and outcome
• Cross Sectional (Prevalence) study: Obesity and arthritis
• Myomectomy and pregnancy rate. Adhesion barrier vs. no adhesion barrier. Relative Risk.
• Ectopic Pregnancy after tubal anastomosis. Odds Ratio
Exposure assigned?
Experimental
RCT Non-RCT
Observational
Analytical study
Cohort Case Control Cross Sectional
Descriptive study References
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HOW TO CONDUCT A CRITICAL APPRAISAL OF THE
LITERATUREMichael P. Diamond, MD
Professor and Chair, Department of Obstetrics and Gynecology
William H. Brooks, MD, Distinguished Chair
Associate Dean for Research, Medical College of Georgia
Senior Vice President for Research
DISCLOSURES
• Contracted Research: AbbVie, Bayer Healthcare Corp.
• Consultant: Seikagaku Corporation, TemplePharmaceuticals, ZSX Medical
• Stock Ownership: Advanced Reproductive Care
OBJECTIVE
• Be able to identify key literature references
• Recognize relevant inclusion/exclusion criteria andconfounders
• Discuss inherent difficulties to establishingevidenced based surgical guidelines
IDENTIFYING RELEVANT LITERATURE (or equivalent)
1) Pubmed/Scopus/key word search
• Language to include
• Years to include
2) Pubmed/Scopus key individual search
3) Review of references in identified publications
“WHITTLING DOWN” MANUSCRIPTS TO INCLUDE:
1)Endpoints reported
2)Study Design
3)Inclusion/Exclusion criteria
4)Confounders reported
5)Availability of database for secondary analyses
DATA EXTRACTION
1) Standardized data collection forms
2) Conduct by multiple individuals with adjudicationof differences
3) Use of Standardized Guidelines
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CHALLENGES WITH SURGICAL RESEARCH‐IMPACT OF INTRAMURAL FIBROIDS
ON PREGNANCY OUTCOME‐
Oliveira et al, Fertility and Sterility, 81(3), 2004
CHALLENGES WITH SURGICAL RESEARCH
• Confounders to impact of intramural fibroids on pregnancy outcome include number, size, and location of fibroids; other infertility factors; female partner’s age.
• Even if accept that larger intramural fibroids impair pregnancy outcome, that does not mean that myomectomy in those women will improve pregnancy outcome.
CHALLENGES WITH SURGICAL RESEARCH‐VARICOCELECTOMY TO IMPROVE PREGNANCY OUTCOME‐
• NIH/NICHD Cooperative Reproductive Medicine Network (RMN) proposed a randomized, controlled study to assess whether varicocelectomy (as opposed to no varicocelectomy) would improve pregnancy outcome in couples with male factor infertility.Clinicaltrials.gov Trial #NCT00767338
• Only three couples able to be entered in to the trial
• Trial terminated because of inability to timely recruit couples into the trial.
REFERENCES
• Oliveira et al, Fertility and Sterility, 81(3), 2004
• Abuzeid et al, Facts Views Vis OBGYN, 6(4):194‐202,2014
CONCLUSION
• Decisions regarding when to perform surgery andwhich procedures to perform would benefit fromevidence based medicine
• There are unique challenges related to applicationof evidence based medicine to surgical questionsand procedures
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Evidence‐based Medicine Panel Discussion:
Proper Formulation of Relevant Clinical Research Questions
Kristen A. Matteson, MD, MPH
Associate Professor of Obstetrics and GynecologyResearch Director, WIH/Brown WRHR Program
Director of Resident ResearchWomen and Infants Hospital
Warren Alpert Medical School of Brown University
Disclosures
I have no financial relationships to disclose
Objectives
• Discuss how to formulate evidence based clinical research questions
Why do we do research?
Advancement of evidence based medical care
Where do research questions come from?
Clinical questions
Talking with colleagues
Literature review
“Standard practice”
“New technologies”
Criteria for a Good Research Question
• FINER–Feasible
–Interesting
–Novel
–Ethical
–Relevant
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Generating a research question
• Components:
– Predictor (treatment/intervention)
– Outcome of interest
– Target population
• If there is more than one question ‐ develop one primary and several secondary questions
• Specific and unambiguous– Clear operational definitions of all variables
Developing your hypothesis
• Components of hypothesis statement
– Predictor (treatment/intervention) of interest
– Outcome of interest
– Target population
– Direction of the association
• One‐tailed : specifies direction of association (ex.”increased risk”)
• Two‐tailed : no direction specified (ex. different frequency)
New to research? Find a mentor!
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Communicating Risk
Frank F. Tu, MD, MPH
Disclosures
• Consultant: AbbVie
• Contracted Research: AbbVie
Objective
• Utilize evidence based approaches to communicating risk accounting for health literacy
Risk communication
• Principle: individuals should receive needed information in a timely, concise, comprehensible way, building warranted trust in their own decision‐making abilities and in the institutions that support them
Meeting the duty to inform
• Communication is adequate when– it contains the information needed for effective decision making
• Materiality standard (will it affect a substantial fraction of users’ choices)
– users can access that information • Proximity standard – should put most users within X degrees of separation from this guidance
• Account for heterogeneity of target populations
– users can comprehend what they access• Comprehensibility standard – should be clear enough for consumers to extract information
Numeracy
• How many Americans can calculate a tip?
• What % of college educated adults cannot pick the highest risk from 1, 5, and 10%
• 34% to 55% of U.S. adults have limited literacy skills. – older, less educated, belonging to racial or ethnic minority groups, socioeconomically disadvantaged, and from rural areas
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Solutions
• 1) Fewer options generally better (Zikmund‐Fisher et al) for knowledge and speed of processing
• 2) gain and loss framing – Survival > mortality for choice– Gain framing better for prevention (certain outcomes)– Loss framing better with uncertainty (MMG)
• 3) AR, RR, NNT• 4) Natural freq > vs. %, more emotional imagery for less literate.
Incremental risk formats
References
• Fischhoff B, Brewer NT, Downs JS, Eds. Communicating Risks and Benefits: An Evidence‐Based User's Guide [Internet]. US Department of Health and Human Services, Food and Drug Administration; 2011 [cited 2016 Oct 6]. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/ default.htm
• Kutner M, Greenberg E, Jin Y, Paulsen C, White S. The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy: National Center for Education Statistics: US Department of Education; 2006.
• Zikmund‐Fisher B, Fagerlin A, Ubel P. Improving understanding of adjuvant therapy options via simpler risk graphics. Cancer. 2008;113(12):3382‐3390.
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CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as
the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians
(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which
recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).
California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws
identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org
Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from
discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national
origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the
program, the importance of the services, and the resources available to the recipient, including the mix of oral
and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.
Executive Order 13166,”Improving Access to Services for Persons with Limited English
Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,
including those which provide federal financial assistance, to examine the services they provide, identify any
need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.
Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every
California state agency which either provides information to, or has contact with, the public to provide bilingual
interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.
~
If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.
A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.
US Population
Language Spoken at Home
English
Spanish
AsianOther
Indo-Euro
California
Language Spoken at Home
Spanish
English
OtherAsian
Indo-Euro
19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%
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