作者
Shirley V Wang, Sebastian Schneeweiss, Jessica M Franklin, Rishi J Desai, William Feldman, Elizabeth M Garry, Robert J Glynn, Kueiyu Joshua Lin, Julie Paik, Elisabetta Patorno, Samy Suissa, Elvira D’Andrea, Dureshahwar Jawaid, Hemin Lee, Ajinkya Pawar, Sushama Kattinakere Sreedhara, Helen Tesfaye, Lily G Bessette, Luke Zabotka, Su Been Lee, Nileesa Gautam, Cassie York, Heidi Zakoul, John Concato, David Martin, Dianne Paraoan, Kenneth Quinto, RCT-DUPLICATE Initiative
发表日期
2023/4/25
期刊
Jama
卷号
329
期号
16
页码范围
1376-1385
出版商
American Medical Association
简介
Importance
Nonrandomized studies using insurance claims databases can be analyzed to produce real-world evidence on the effectiveness of medical products. Given the lack of baseline randomization and measurement issues, concerns exist about whether such studies produce unbiased treatment effect estimates.
Objective
To emulate the design of 30 completed and 2 ongoing randomized clinical trials (RCTs) of medications with database studies using observational analogues of the RCT design parameters (population, intervention, comparator, outcome, time [PICOT]) and to quantify agreement in RCT-database study pairs.
Design, Setting, and Participants
New-user cohort studies with propensity score matching using 3 US claims databases (Optum Clinformatics, MarketScan, and Medicare). Inclusion-exclusion criteria for each database study were prespecified to emulate the corresponding RCT. RCTs were …
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SV Wang, S Schneeweiss, JM Franklin, RJ Desai… - Jama, 2023