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Medical Care Supplements
Executive Summary – May 25, 2010
Symposium on Research Methods for Clinical and Comparative Effectiveness Studies – Part II
Medical Care Supplement
In June 2009, the Agency for Healthcare Research and Quality convened an invitational symposium on research methods for clinical and comparative effectiveness studies. The project is a direct followup to the 2006 conference on Emerging Methods in Comparative Effectiveness and Safety. The major themes for the symposium were developed with substantial input from external stakeholders, researchers, and federal officials who have expertise in comparative effectiveness research. With this input, a Planning Committee of experts from academia, the private sector, and government determined that the symposium would emphasize (a) ways to enhance the inclusion of clinically heterogeneous populations in clinical and comparative effectiveness studies; and (b) methods to implement longitudinal investigations that capture longer term health outcomes, including patient-reported outcomes. Cutting across these themes were four major content areas for which abstracts were solicited from scientists across the United States: (1) study design, (2) data collection, (3) statistics and analytic methods, and (4) policy issues and applications.
The symposium proceedings are published in a supplement to the June 2010 issue of the journal Medical Care. A printed copy of the supplement is available free of charge through the AHRQ Publications Clearinghouse. To order the supplement call toll free 800-358-9295 or send an email to AHRQpubs@ahrq.hhs.gov. The AHRQ publication number is OM10-0067.
Medical Care Supplement
Table of Contents
Advancing Methods for Comparative Effectiveness Research
Scott R. Smith, M.S.P.H., Ph.D.
Comparative Effectiveness Research Methods: Symposium Overview and Summary
Kathleen N. Lohr, Ph.D.
Defining Comparative Effectiveness Research: The Importance of Getting It Right
Harold C. Sox, M.D., M.A.C.P.
Who Can Respond to Treatment? Identifying Patient Characteristics Related to Heterogeneity of Treatment Effects
Sherrie H. Kaplan, Ph.D., M.P.H., John Billimek, Ph.D., Dara H. Sorkin, Ph.D., Quyen Ngo-Metzger, M.D., M.P.H., and Sheldon Greenfield, M.D.
Practice-Based Evidence: Incorporating Clinical Heterogeneity and Patient-Reported Outcomes for Comparative Effectiveness Research
Susan D. Horn, Ph.D., and Julie Gassaway, M.S., R.N.
Assessing Medication Exposures and Outcomes in the Frail Elderly: Assessing Research Challenges in Nursing Home Pharmacotherapy
Stephen Crystal, Ph.D., Dorothy Gaboda, Ph.D., Judith Lucas, Ed.D., Tobias Gerhard, Ph.D., and Sujoy Chakravarty, Ph.D.
Electronic Patient-Reported Data Capture as a Foundation of Rapid Learning Cancer Care
Amy P. Abernethy, M.D., Asif Ahmad, M.S., M.B.A., S. Yousuf Zafar, M.D., M.H.S., Jane L. Wheeler, M.S.P.H., Jennifer Barsky Reese, Ph.D., and H. Kim Lyerly, MD
Comparative Effectiveness Research in DARTNet Primary Care Practices: Point of Care Data Collection on Hypoglycemia and Over-the-Counter and Herbal Use Among Patients Diagnosed With Diabetes
Anne M. Libby, Ph.D., Wilson Pace, M.D., Cathy Bryan, M.H.A., B.S.N., R.N., Heather Orton Anderson, Ph.D., Samuel L. Ellis, Pharm.D., Richard Read Allen, M.S., Elias Brandt, B.S., Amy G. Huebschmann, M.D., David West, Ph.D., and Robert J. Valuck, Ph.D., R.Ph.
Distributed Health Data Networks: A Practical and Preferred Approach to Multi-Institutional Evaluations of Comparative Effectiveness, Safety, and Quality of Care
Jeffrey S. Brown, Ph.D., John H. Holmes, Ph.D., Kiran Shah, B.A., Ken Hall, M.D., IV, Ross Lazarus, M.B.B.S., M.P.H., and Richard Platt, M.D., M.Sc.
Cluster Randomized Trials in Comparative Effectiveness Research: Randomizing Hospitals to Test Methods for Prevention of Healthcare-Associated Infections
Richard Platt, M.D., M.S., Samuel U. Takvorian, A.B., Edward Septimus, M.D., Jason Hickok, M.B.A., R.N., Julia Moody, M.S., Jonathan Perlin, M.D., Ph.D., John A. Jernigan, M.D., M.S., Ken Kleinman, Sc.D., and Susan S. Huang, M.D., M.P.H.
Rethinking Analytical Strategies for Surveillance of Medical Devices: The Case of Hip Arthroplasty
Sharon-Lise Normand, Ph.D., Danica Marinac-Dabic, M.D., Ph.D., Art Sedrakyan, M.D., Ph.D. and Ronald Kaczmarek, M.D., M.P.H.
Literacy-Fair Measurement of Health-Related Quality of Life Will Facilitate
Comparative Effectiveness Research in Spanish-Speaking Cancer Outpatients
Elizabeth A. Hahn, M.A., Hongyan Du, M.S., Sofia F. Garcia, Ph.D., Seung W. Choi, Ph.D., Jin-Shei Lai, Ph.D., David Victorson, Ph.D., and David Cella, Ph.D.
Privacy-Maintaining Propensity Score-Based Pooling of Multiple Databases Applied to a Study of Biologics
Jeremy A. Rassen, Sc.D., Daniel H. Solomon, M.D., M.P.H., Jeffrey R. Curtis, M.D., M.P.H., Lisa Herrinton, Ph.D., and Sebastian Schneeweiss, M.D., Sc.D.
Using Mechanistic Models to Simulate Comparative Effectiveness Trials of Therapy and to Estimate Long-term Outcomes in HIV Care
Mark S. Roberts, M.D., M.P.P., Kimberly A. Nucifora, M.S., and R. Scott Braithwaite, M.D., M.S.
Evaluating Health Outcomes in the Presence of Competing Risks: A Review of Statistical Methods and Clinical Applications
Ravi Varadhan, Ph.D., Carlos O. Weiss, M.D., M.H.S., Jodi B. Segal, M.D., M.P.H., Albert W. Wu, M.D., M.P.H., Daniel Scharfstein, Sc.D., and Cynthia Boyd, M.D., M.P.H.
Prediction Modeling Using EHR Data: Challenges, Strategies, and a Comparison of Machine Learning Approaches
Jionglin Wu, M.S., Jason Roy, Ph.D., and Walter F. Stewart, Ph.D., M.P.H.
Confounding Control in Healthcare Databases Research: Challenges and Potential Approaches
M. Alan Brookhart, Ph.D., Til Stu¨rmer, M.D., M.P.H., Robert J. Glynn, Ph.D., Sc.D., Jeremy Rassen, Sc.D., and Sebastian Schneeweiss, M.D., Sc.D.
A Framework for Evidence Evaluation and Methodological Issues in Implantable Device Studies
Art Sedrakyan, M.D., Ph.D., Danica Marinac-Dabic, M.D., Ph.D., Sharon-Lise T. Normand, Ph.D., Alvin Mushlin, M.D., Sc.M., and Tom Gross, M.D., M.P.H.
Comparative Effectiveness Research and Policy: Experiences Conducting a Coverage With Evidence Development Study of a Therapeutic Device
Judith A. Turner, Ph.D., William Hollingworth, Ph.D., Bryan Comstock, M.S., and Richard A. Deyo, M.D., M.P.H.
Bayesian Meta-Analyses for Comparative Effectiveness and Informing Coverage Decisions
Scott M. Berry, Ph.D., K. Jack Ishak, Ph.D., Bryan R. Luce, Ph.D., and Donald A. Berry, Ph.D.
An Integrated Evidence Rating to Frame Comparative Effectiveness Assessments for Decision Makers
Daniel A. Ollendorf, M.P.H., and Steven D. Pearson, M.D., M.Sc.
Translating Comparative Effectiveness Into Practice: The Case of Diabetes Medications
Nilay D. Shah, Ph.D., Rebecca J. Mullan, M.Sc., Maggie Breslin, M.Des., Barbara P. Yawn, M.D., M.Sc., M.P.H., Henry H. Ting, M.D., M.B.A., and Victor M. Montori, M.D., M.Sc.