Principles and Methods of Comparative Effectiveness Research Spring 2015, Mondays, 2 PM – 4 PM Education Building, Room 3225A Class Session Date Topic/Assignments The textbooks for the course are as follows: Systematic Reviews to Support Evidence-based Medicine, 2nd edition [Paperback] Khalid Khan (Author), Regina Kunz (Author), Jos Kleijnen (Author), Gerd Antes (Author) Publication Date: July 29, 2011 | ISBN-10: 1853157945 | ISBN-13: 978-1853157943 | Edition: 2 A Concise Guide to Clinical Trials [Paperback] Allan Hackshaw (Author) Publication Date: April 27, 2009 | ISBN-10: 1405167742 | ISBN-13: 978-1405167741 | Edition: 1 (OPTIONAL) Meta-Analysis: An Updated Collection from the Stata Journal [Paperback] Jonathan Sterne Book Description Publication Date: March 18, 2009 | ISBN-10: 1597180491 | ISBN-13: 978-1597180498 | Edition: 1 Introduction and Systematic Reviews - Melnikow/Nishijima/Abbott Assignment for Session 1: Lesson 16: Systematic Review and Meta-analysis – Steps 1 through 4 - Slides 1-21 Lesson 17: Pub Med Search Demohttp://guides.lib.ucdavis.edu/print_content.php?pid=492203&sid=4040877&mode=g Reading: Khan , Systematic Reviews to Support Evidence-based Medicine, 2nd edition [Paperback] Pgs. 1-13 NEW DATES (1st Hour) Introduction to CER Course (Melnikow) March 30, 2015 (2nd Hour) Systematic Review Project (Melnikow/Nishijima) Defining the Research question Hierarchy of Evidence Searching PubMed and other resources (Abbott) Module 1: Randomized Clinical Trials (RCTs) – Kravitz/Tancredi Assignments for Session 2: Readings: Hackshaw, Allan K. A Concise Guide to Clinical Trials. Chichester, UK: Wiley-Blackwell/BMJ, 2009. Chapters 1 and 5. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009 May 12;180(10):E47-5 Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the women’s health initiative randomized controlled trial. JAMA. 2002 July 12; 288(3): 321-333. 2 On-Line Lessons 2 and 3 April 6, 2015 History and Basic Elements of RCTs and Explanatory/Pragmatic Distinction (Tancredi/Kravitz). Assignment for Session 3: Readings: Hackshaw, Allan K. A Concise Guide to Clinical Trials. Chichester, UK: Wiley-Blackwell/BMJ, 2009. Chapters 2, 6, 7 and 10 Kravitz RL, Duan N, Braslow J. Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages. Milbank Q. 2004;82(4):661-87. 3 On-Line Lessons 4, 5 and 6 April 13, 2015 Heterogeneity of Treatment Effects and Outcomes Assessment in Clinical Trials (Kravitz/Tancredi) COURSE HELD AT GRANGE Module 3: Systematic Review – Refining Research Questions – Melnikow/Nishijima Module 2: Observational Studies – Romano Assignment for Session 4a: Develop study question Complete Worksheet 1 (Formulating the Question) - email prior to session Reading: Khan: Framing questions for a review (pgs. 9-22) On-Line Lesson 16: slides 21-56 Assignment for Session 4b: On-Line Lesson 13 - Managing Dependent & Independent Variables in Observational CER Studies 76:50 (REQUIRED) Reading: Benson, Kjell, and Arthur J. Hartz. "A Comparison of Observational Studies and Randomized, Controlled Trials." New England Journal of Medicine 342.25 (2000): 1878-886. Concato, John, Nirav Shah, and Ralph I. Horwitz. "Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs." New England Journal of Medicine 342.25 (2000): 1887-892. Lawler, Debbie A., George D. Smith, K. R. Bruckdorfer, Devi Kundu, and Shah Ebrahim. "Those Confounded Vitamins: What Can We Learn from the Differences between Observational versus Randomised Trial Evidence? Debbie A Lawlor, George Davey Smith, K Richard Bruckdorfer, Devi Kundu, Shah Ebrahim." www.thelancet.com. The Lancet, 22 May 2004. Web.Vol 363 Meehan, John P. "A Population-Based Comparison of the Incidence of Adverse Outcomes After Simultaneous-Bilateral and Staged-Bilateral Total Knee Arthroplasty." The Journal of Bone and Joint Surgery 93.23 (2011): 2203 4a (1st Hour) April 20, 2015 Systematic Review: Refining Research Questions (Melnikow/Nishijima) nd 4b (2 Hour) April 20, 2015 Management of Dependent and Independent Variables in Observational Studies: Approaches to Dealing with Confounding (Romano) Assignment for Session 5: On-Line Lesson 14: Observational Studies for CER. How can they be made as good as RCTs? (53:07) REQUIRED Lesson 15: Instrumental Variables and Propensity Scores (45:08) REQUIRED OPTIONAL but Recommended Lessons 8-12 provide background information and some very interesting examples of the principles that we will discuss, so they can be viewed at your convenience. o o o o o Lesson 8: Using the UC Davis Cohort Discovery Tool (powered by i2b2) to Facilitate Comparative Effectiveness Research (23:02) Lesson 9: Use of Observational Data in CER Use of OSHPD Administrative Data (39:36) Lesson 10: Computer-Aided Detection and Screening Mammography (21:07) Lesson 11: Off-Pump vs. On-Pump Bypass Surgery (20:40) Lesson 12: Using National HCUP Data to Evaluate CE of Pediatric Empyema Treatments (18:19) Reading: Austin, P. C. "The Relative Ability of Different Propensity Score Methods to Balance Measured Covariates Between Treated and Untreated Subjects in Observational Studies." Medical Decision Making 29.6 (2009): 661-77. Lu-Yao, G. L., P. C. Albertsen, D. F. Moore, W. Shih, Y. Lin, R. S. Dipaola, and S.-L. Yao. "Survival Following Primary Androgen Deprivation Therapy Among Men With Localized Prostate Cancer." JAMA: The Journal of the American Medical Association 300.2 (2008): 173-81. Mehrotra, R., Y.-W. Chiu, K. Kalantar-Zadeh, J. Bargman, and E. Vonesh. "Similar Outcomes With Hemodialysis and Peritoneal Dialysis in Patients With End-Stage Renal Disease." Archives of Internal Medicine 171.2 (2011): 110-18. 5 April 27, 2015 How Can Observational Studies be Made as Good as RCTs? (Romano) COURSE HELD AT GRANGE Module 3: Systematic Reviews (continued) – Melnikow/Holmes/Nishijima Assignment for Session 6: 6 Complete Worksheet 2 (Selection of studies to be included) and Worksheet 3 (Synthesizing the data)email prior to session Reading: Khan: Identifying relevant literature (pgs. 23-37) and Assessing the quality of the literature (pgs. 39-50) and Summarizing the evidence (pgs. 51-84) STATA Journal PDFs: Metan, metaregression, and funnel plots On-Line Lesson 18: Analyzing, Interpreting, and Presenting the Results May 4, 2015 Systematic Reviews (Holmes/Nishijima) Selecting studies - defining criteria - study selection - data abstraction Meta-analysis (Jim Holmes) (Note: Dr. Melnikow Unavailable) Module 4: Health Economics and Modeling – Leigh/Nishijima Assignment for Session 7: Reading: The lifetime distribution of the incremental societal costs of autism. by ML Ganz - 2007 Cited by 249 – 1. 7 JAMA. 1994 Feb 2; 271(5):375-81. Cost-effectiveness of a routine varicella vaccination program for US children. Lieu TA1, Cochi SL, Black SB, et al Read abstract only. Routine childhood varicella vaccination. Lebel RR. JAMA. 1994 Jun 22-29; 271(24):1906. May 11, 2015 Health Economics – (Leigh) “Cost of Illness: Methods and Examples” Systematic Review: Refining Research Questions (Nishijima) (30 minutes following session 3:30 – 4:00 PM ) Assignment for Session 8: Reading: Meltzer, Introduction to health economics for physicians. Health economics quintet, THE LANCET • Vol 358 • September 22, 2001, pgs. 993-998 8 May 18, 2015 Cost Effectiveness Analysis (Melnikow) Introduction to cost effectiveness analysis 9 May 25, 2015 HOLIDAY – NO SCHEDULED CLASSES Systematic Reviews – Melnikow/Holmes/Nishijima/Other faculty Assignment for Session 10: Teams come prepared to present overview of their systematic reviews 10 June 1, 2015 Systematic Review Project Presentations Presentations of projects (10 min, 5 min discussion) Online Lessons http://ctsa-cermethodscourse.org/ Course Assignments and Discussion https://mycourses.ucdmc.ucdavis.edu/portal) Instructor Office Hours and Contact Information Melnikow Kravitz Tancredi Romano Nishijima Mondays, 1-2 and 4-5, 2020 Ellison; 734-1000 jamelnikow@ucdavis.edu [INSERT OFFICE HOURS] rlkravitz@ucdavis.edu [INSERT OFFICE HOURS] djtancredi@ucdavis.edu [INSERT OFFICE HOURS] psromano@ucdavis.edu [INSERT OFFICE HOURS] daniel.nishijima@ucdmc.ucdavis.edu