PH6062 Research Synthesis and Meta-analysis PHC 6062 Research Synthesis and Meta-analysis GENERAL INFORMATION DESCRIPTION A. Course Overview: This course is designed to train students in the conduct of a systematic literature review and developing the skills critical for evidence-based clinical and public health practice. This course will provide a detailed description of systematic review process and will combine didactic sessions with in-class laboratory sessions where students will be taught how to perform each step in a review. Students will be provided step-by-step guidance on how to perform a systematic review and will be expected to apply all the tools taught in the class to a topic of their choosing. The final deliverable for the course will be a systematic literature review with/without meta-analysis. OBJECTIVES B. Course Objectives: By the completion of the course, the students will be able to: 1. Formulate key questions for a review. 2. Organize a literature search; identify which literature bases to search. 3. Abstract relevant information from appropriate studies in a systematic manner. 4. Rate the scientific quality of each study and the level of evidence for each question. 5. Create evidence tables and summary tables. 6. Summarize the studies’ findings. 7. Interpret the pattern of evidence in terms of strength and consistency. 8. Describe the elements of a meta-analysis and when such a step is appropriate. MPH CONCENTRATION-SPECIFIC COMPETENCIES The following competency will be reinforced in this course: Competency Critically evaluate reports of epidemiologic Course Syllabus Version 5.0 Updated January 17, 2012 Course Objectives 1-8 1 PH6062 Research Synthesis and Meta-analysis studies CLASS POLICIES AND PROCEDURES C. Prerequisites: Students must have completed both an introductory epidemiology and biostatistics course (PHC 6000 Introduction to Public Health Epidemiology, PHC 6065 Health Statistics) D. Course Format: This course will combine a modest amount of didactic material presented in lectures and readings with a substantial amount of hands-on experience. Each student, or group of students, will be expected to choose a topic for review. They will work individually or in small groups to carry out each phase of a systematic literature review. Those whose work is more promising will be encouraged to develop their reports into publishable papers. E. Course Assignments: - Course readings, in-class discussion. - Homework on protocol of systematic literature review. - Final paper with detailed outlines of the systematic review. - Presentation of the review. Course Readings: Students are expected to read all recommended materials before the class. All recommended readings will be listed on moodle website. Class Discussion: All students are required to participate in all discussions. Informal writings followed by the discussion are encouraged and will be reviewed by the instructor. Homework is essential to achieve the course outcome: Systematic reviews of the literature based on concepts and research questions of the thesis, dissertations, or grant proposals will be encouraged. F. Course Evaluation: Evaluation will be based on: Classroom Discussion Activities: 20% Homework & Exercises: 25% Final Presentation & Critique: 25% Final Literature Review Report: 30% Students’ grades will be based on articulation in-class and in each stage of their project work. The grade for the course will be based primarily on the quality of the final paper and/or presentation. A paper is required for the final grade. Higher levels of performance will be expected from group projects. Power point Presentation: Each student must provide 1 copy of the power point handout for each student colleague and the instructor at the time of the student final presentation. The student must also submit the power point electronic file by email, 24 hours before his/her presentation is due. Power point Critique: Using the rubric provided, each student must critically assess every student power point presentation and provide the assessments at the end of each presentation session Course Syllabus Version 5.0 Updated January 17, 2012 2 PH6062 Research Synthesis and Meta-analysis (this is an assessment of how well you can critique your colleague’s work – so be critical in a constructive manner and be fair. Your critique will not impact the grade of your colleague. EVALUATION AND GRADING The approximate guidelines for the transformation of percentages into grade points for this course are: A AB+ B BC+ 92.6-100 89.6-92.5 86.6-89.5 82.6-86.5 79.6-82.5 76.6-79.6 C CD+ D DF 72.6-76.5 69.6-72.5 66.6-69.5 62.6-66.5 59.6-62.5 < 59.5 Late Submission Policy: A 5% penalty for every 24-hour period an item is submitted late. For example, if an item worth 25% is submitted late, but within 24 hours of the stated deadline, the item’s maximum value is reduced to 20%. If it is submitted after 24 hours but within 48 hours, its value is reduced to 15%. Incomplete Grade: An incomplete grade is permitted only in cases of exceptional circumstances and following consultation with the instructor. In such cases an “I” grade will require a specific written agreement between the instructor and the student specifying the time and manner in which the student will complete the course requirements. Extension for completion of the work will not exceed one year. G. Attendance: Attendance in the class is extremely important. Anytime a student is absent (or late) from a class, it is the student’s responsibility to know the class materials/ announcements. Know at least one of your classmate’s contact info. READINGS H. Textbooks: Course materials will be selected from a variety of reference material and textbooks. All students will be required to use the following course text book: Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Cochrane Collaboration, 2011. http://www.cochrane-handbook.org/ Supplementary Reading Publications of the AHRQ Methods Reference Guide for Comparative Effectiveness Reviews. http://www.effectivehealthcare.ahrq.gov/repFiles/2007_10DraftMethodsGuide.pdf Course Syllabus Version 5.0 Updated January 17, 2012 3 PH6062 Research Synthesis and Meta-analysis COURSE SCHEDULE AND ASSIGNMENTS Session 1. Title Content Course objectives & performance expectations What are systematic reviews, how can they be useful, and how can I conduct my own systematic review? The difference between systematic reviews and other reviews. Definitions of evidence. Level of evidence. Reporting the evidence. Formulating a well-formed study question. Population, intervention, comparators, outcomes, setting and timing (PICOTS). Readings: Framing questions that can be answered. Conceptual model and refined hypotheses. Introduction to evidence based analysis and systematic reviews of literature. Readings: Taubes, G. Do we really know what makes us healthy? NY Times Sept 16, 2007. Helfand M, Balshem H. AHRQ Series Paper 2: Principles for developing guidance: AHRQ and the effective health-care program. J Clin Epidemiol. 2010 May; 63(5): 484-90. Slutsky J, Atkins D, Chang S, Collins Sharp BA. Comparing medical interventions: AHRQ and the effective health-care program. J Clin Epidemiol. 2010; 63(5): 481-3. No Class 2. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 5: Defining the review question and developing criteria for including studies. Whitlock EP, Lopez SA, Chang S, Helfand M et al. AHRQ Series Paper 3: Identifying, selecting, and refining topics for comparative effectiveness systematic reviews: AHRQ and the effective healthcare program. J Clin Epidemiol. 2010 May; 63(5):491-501. In class exercise: Developing key questions on a common topic. Homework: Students will choose a topic and identify three to four key questions and a logic model. Assignment is due January 28 at 1200 hrs. Upload slides for in-class presentation with a topic, research questions, and a logic model. Upload a Word or PDF document with introduction, key questions, and a logic model. Course Syllabus Version 5.0 Updated January 17, 2012 4 PH6062 Research Synthesis and Meta-analysis 3. Developing a protocol for a systematic review. Planning analysis and major threats to consistency. Readings: Level of detail. Clinical, methodological heterogeneity. Identifying salient variables. Identifying eligibility criteria for the studies. Discussion of MeSH headings. Search strategies and databases. Readings: Cochrane Handbook for Systematic Reviews of Interventions, Chapter 6: Searching for studies. What literature to review and the role of gray literature. What types of studies to include in a review Developing search strategies according to PICOTS Steps in search strategy: preliminary screen and actual review. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 2: Preparing a Cochrane review and Chapter 4: Guide to the contents of a Cochrane protocol and review. Norris S, Atkins D, Bruening W, et al. Selecting observational studies for comparing medical interventions. In: Agency for Healthcare Research and Quality. Methods Guide for Comparative Effectiveness Reviews [posted June 2010]. Rockville, MD. 4. Searching the literature and identifying studies. Chou R, Aronson N, Atkins D, Ismaila AS, Santaguida P, Smith DH, Whitlock E, Wilt TJ, Moher D. AHRQ Series Paper 4: Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program. J Clin Epidemiol. 2010 May;63(5):502-12. Homework: Students will develop a study protocol, a search strategy and conduct a search on their topic. Assignment is due on February 4 at 1200 hrs. Upload slides for in-class presentation with definitions of PICOT, and the inclusion and exclusion criteria of the studies, search strategies, strings, and the search results. Upload a Word or PDF document with a study protocol and complete documented literature searches. 5. Capturing how the variables are reported as well as actual results. Describe evidence table formats. Readings: Cochrane Handbook for Systematic Reviews of Interventions, Chapter 7: Selecting studies and collecting data, and Chapter 8: Assessing risk of bias in included studies. Reorganize evidence table data requirements as a coding sheet. Develop coding sheet dictionary/instructions. Overview of the software used for systematic reviews. Developing data extraction forms - separate forms for RCTs and observational studies. In-class exercise: Developing an abstraction form for a research question. In-class presentations: Students will present the results of their key questions, logic model & study protocol. Course Syllabus Version 5.0 Updated January 17, 2012 5 PH6062 Research Synthesis and Meta-analysis Homework: Students will create an abstract form for their own key question. Pilot testing of the form by abstracting one to two articles. Assignment is due on February 11 at 1200 hrs. Upload slides for in-class presentation with abstraction forms and abstracted articles. 6. Extracting data from a randomized controlled trial and from an observational study. Analysis of different types of the outcomes. Creating evidence tables. Identify different effect size metrics. Choose appropriate effect size metric for review question. Identify data requirements for different effect size metrics. Adapt evidence tables and coding sheets to incorporate effect size data. Criteria of internal and external validity of RCTs with different exposures. In-class presentations: Students will present their abstraction forms and the abstracted articles. Homework: Students will revise the abstraction forms and abstract ~ 5 articles. Students will develop a study protocol. Assignment is due on February 18 at 1200 hrs. Upload a completed Excel template with abstracted articles. 7. Quantitative synthesis of evidence Code studies using coding sheet provided in class. Readings: Identify coding errors. Examine coding reliability. Pooling criteria. Publication bias. Fixed and random effects model. Calculating effect sizes Identify & explain formula for calculating effect sizes: Readings: Identify & explain effect size metric conversion formulas. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 7: Selecting studies and collecting data, and Chapter 9: Analyzing data and undertaking meta-analyses. 8. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 9: Analyzing data and undertaking meta-analyses. In-Class exercise: Effect size calculation practical exercise Course Syllabus Version 5.0 Updated January 17, 2012 6 PH6062 Research Synthesis and Meta-analysis 9. Introduction to Meta-analysis Explain homogeneity/ heterogeneity with respect to meta-analysis Readings: Cochrane Handbook for Systematic Reviews of Interventions, Chapter 9: Analyzing data and undertaking meta-analyses. o Conceptual o Statistical Identify and explain formula for weighted average effect size: o Fixed effect model o Random effects model Interpret a weighted average effect size produced using REVMAN for various effect size metrics Compare and contrast fixed effect and random effects meta-analytic results produced using REVMAN SPRING BREAK 10. Assessing the quality of studies: Criteria for RCTs and observational studies. Definitions of quality. Methodological and reporting quality. Readings: RCTs and CONSORT. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 8: Assessing risk of bias in included Studies; and Chapter 10: Addressing reporting biases. Quasi-experimental designs including MOOSE. Available tools for assessing quality of individual studies and what key issues standard instruments may fail to recognize. Biases in quality, including: Moher D, Schulz KF, Altman DG. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials. The Lancet. 2001;357:1191-1194. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000 Apr 19;283(15):2008-12. o Selection o Attrition o Performance o Detection In-class exercise: Students will conduct meta-analysis calculations and will assess quality of RCT with the Cochrane tool. Homework: Students will evaluate quality of included studies in their abstraction forms. Assignment is due on March 24 at 1200 hrs. Upload completed abstraction forms with quality evaluation of the abstracted studies. 11. Rating the body of evidence. Readings: Course Syllabus Version 5.0 Updated January 17, 2012 The risk of bias. The need for consistency, directness, and precision. 7 PH6062 Research Synthesis and Meta-analysis Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann HJ; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 Apr 26;336(7650):924-6. Atkins D, Briss PA, Eccles M, Flottorp S, Guyatt GH, Harbour RT, Hill S, Jaeschke R, Liberati A, Magrini N, Mason J, O'Connell D, Oxman AD, Phillips B, Schünemann H, Edejer TT, Vist GE, Williams JW Jr; GRADE Working Group. Systems for grading the quality of evidence and the strength of recommendations II: pilot study of a new system. BMC Health Serv Res. 2005 Mar 23;5(1):25. Dose-response association. Plausible confounding that would decrease the observed effect. Strength of association and the magnitude of effect. Bias in publication. Strength of evidence grades and definitions of same. Class exercise: Students will present the results from quantitative and qualitative synthesis of evidence Homework: Students will rate a body of evidence for their key questions. Assignment is due on March 31 at 1200 hrs. Upload analytical plans, including quantitative data, qualitative synthesis of evidence, pooling criteria and pooling data. 12. Summarizing the findings. Creating summary tables corresponding to research hypotheses. Readings: Plotting results from the studies. Cochrane Handbook for Systematic Reviews of Interventions, Chapter 12: Interpreting results and drawing conclusions. Strength of evidence. Heterogeneity and consistency of evidence: Forest plots Reconciling differences: Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group. What is "quality of evidence" and why is it important to clinicians? BMJ. 2008 May 3;336(7651): 995-8. Review. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009 Aug 18;151(4):264-9, W64. o Measures o Samples o Methods and design Publication bias. Summarizing evidence when meta-analysis is not feasible. Generalizability. Class exercise: Students will rectify contrasting findings from two articles on the same topic. Homework: Students will develop summary tables, key messages. Assignment is due on April 7 at 1200 hrs. Upload slides for in-class presentation with summary tables and key messages. Upload a Word or PDF document with evidence tables and summary tables. 13. Writing the report or paper, including templates, outlines, and storyline. Readings: Discussion of Transparency. Presenting major findings. Strength and consistency of the evidence and explanation of Cochrane Handbook for Systematic Reviews of Course Syllabus Version 5.0 Updated January 17, 2012 8 PH6062 Research Synthesis and Meta-analysis Interventions, Chapter 12: Interpreting results and drawing conclusions. Shojania KG, Sampson M, Ansari MT, Ji J, Doucette S, Moher D. How quickly do systematic reviews go out of date? A survival analysis. Ann Intern Med. 2007; 147:224-233. inconsistencies. Implications for practice and policy. Affecting limitations. Tabulation of research needs. Class exercise: Students will present summary tables and conclusions. Homework: Upload your slides and drafts of the systematic review on April 12 by 1200 hrs to receive comments and recommendations from instructors. 14 Presentations: Each student or student group will give a Power Point presentation. Student reviewers of the presentations will write critiques. Presentations should include key questions, conceptual model, search strategy, data analysis, and interpretation. Final Assignment due on April 20, 2012 by 1200 hrs – Upload a systematic review that includes an introduction, key questions, a conceptual model, search strategy, data analysis and interpretation. 15. Final Paper Due. NOTE: “All written work must be submitted through www.turnitin.com where it will be checked for plagiarism. Work that is found to be plagiarized will receive a failing grade and the student may be subject to charges of academic misconduct.” All students are required to complete this online tutorial and turn in the certificate in the next class. http://www.cte.usf.edu/plagiarism/plagindex.html FIU HONOR CODE Students are urged to be careful that they properly attribute and cite others' work in their own writing. In addition, original work is expected in this course. It is unacceptable to hand in assignments for this course for which you receive credit in another course unless by prior agreement with the instructor. Building on a line of work begun in another course or leading to a thesis, dissertation, or final project is acceptable. If you have any questions, consult the instructor. Students are responsible for knowing and complying with all FIU Policies and Regulations listed in the Student Handbook and also at the following link: http://policies.fiu.edu/files/740.pdf. The following are excerpts: Reason for Policy: “Graduate students at Florida International University are expected to adhere to the highest standards of integrity in every aspect of their lives. Honesty in academic matters is part of this obligation. Academic integrity is adherence to those special values regarding life and work in an Course Syllabus Version 5.0 Updated January 17, 2012 9 PH6062 Research Synthesis and Meta-analysis academic community. Any act or omission by a graduate student which violates this concept of academic integrity and undermines the academic mission of the University shall be defined as academic misconduct and shall be subject to the procedures and penalties that follow.” Definition of Academic Misconduct: Academic misconduct is defined as the following intentional acts or omissions committed by any FIU graduate student: “Cheating: The unauthorized use of books, notes, aids, electronic sources; or unauthorized use of on-line exams, library materials or assistance from another person with respect to examinations, course assignments, field service reports, class recitations; or the unauthorized possession of examination papers (or on-line examinations) or course materials, whether originally authorized or not. Any student helping another cheat may be found guilty of academic misconduct” Plagiarism: The deliberate use and appropriation of another's work without any indication of the source and the representation of such work as the student's own. Any student, who fails to give credit for ideas, expressions or materials taken from another source, including internet sources, is guilty of plagiarism. Any student helping another to plagiarize may be found guilty of academic misconduct. Misrepresentation: Intentionally lying to a member of the faculty, staff, administration, or an outside agency to gain academic advantage for oneself or another, or to misrepresent or in other ways interfere with the investigation of a charge of academic misconduct. Misuse of Computer Services: The unauthorized use of any computer, computer resource or computer project number, or the alteration or destruction of computerized information or files or unauthorized appropriation of another's program(s). Bribery: The offering of money or any item or service to a member of the faculty, staff, administration or any other person in order to commit academic misconduct. Conspiracy and Collusion: The planning or acting with one or more fellow students, any member of the faculty, staff or administration, or any other person to commit any form of academic misconduct together. Falsification of Records: The tampering with or altering in any way of any academic record used or maintained by the University.” Disability Statement It is University policy to provide, on a flexible and individualized basis, reasonable accommodations to students who have a documented disability (e.g., physical, learning, psychiatric, vision, hearing, or systemic) that may affect their ability to participate in course activities or to meet course requirements. Students with disabilities are encouraged to contact Disability Services to have a confidential discussion of their individual needs for accommodations. Course Syllabus Version 5.0 Updated January 17, 2012 10 PH6062 Research Synthesis and Meta-analysis Statement of Understanding Late Submission Policy: A 5% penalty for every 24-hour period an item is submitted late. For example, if an item worth 25% is submitted late, but within 24 hours of the stated deadline, the item’s maximum value is reduced to 20%. If it is submitted after 24 hours but within 48 hours, its value is reduced to 15%. If any of the above occurs due to an emergency, you must submit verifiable, written documentation of the emergency. This does not, however, guarantee avoidance of penalty. I understand the penalty for not meeting specified class deadlines. _________________________ ___________________________________ Printed Name and Date Signature Student Contact Information: Name:________________________________________ PID:__________________________________________ FIU Email:_____________________________________ Cell Phone:____________________________________ Alternate Email:________________________________ Alternate Phone:________________________________ Remove this page from your syllabus and turn in before leaving class today. Course Syllabus Version 5.0 Updated January 17, 2012 11