TabsDetailsBasic DetailsDate: Sunday, November 17, 2019Type: PublicationDescription: Epidemiological study reporting is improving but is not transparent enough for easy evaluation or replication. One barrier is insufficient details about design elements in published studies. Using a previously conducted drug safety evaluation in claims as a test case, we investigated the impact of small changes in five key design elements on risk estimation. These elements are index day of incident exposure's determination of look-back or follow-up periods, exposure duration algorithms, heparin exposure exclusion, propensity score model variables, and Cox proportional hazard model stratification. We covaried these elements using a fractional factorial design, resulting in 24 risk estimates for one outcome. We repeated eight of these combinations for two additional outcomes. We measured design effects on cohort sizes, follow-up time, and risk estimates. Read More Materials: Pharmacoepidemiol Drug Saf. 2019 Nov 17. doi: 10.1002/pds.4892Additional InformationRelated Assessment(s): Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test CaseButterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal InferenceSmall Changes, Big Differences? Cohort Variation by Parameter Specifications in Claims-Based Drug Use EvaluationsContributorsAuthor(s): Rima Izem, Ting-Ying Huang, Laura Hou, Ella Pestine, Michael D. Nguyen, Judith C. MaroCorresponding Author: Rima Izem, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD and Division of Biostatistics and Study Methodology, The George Washington University, Children's National Research Institute, Silver Spring, MarylandEmail: rizem@childrensnational.org
