Gagne critically appraising example SC studies following reporting and methodological recommendations. Hallas will review persistent user issues and introduce a worksheet for the design of SC studies. Tadrous will discuss pooling of SC study results. Delaney will then focus on issues related to the selection of observation windows. Whitaker) will be presented each including example hand calculations for effect estimates. Next, a brief review of the history, strengths and limitations of the CCO (Dr. Cadarette will chair the workshop and set the stage by summarizing the application of SC study designs in the field of pharmacoepidemiology. By the end of the symposium, audience members should understand the following: (1) the relative strengths and limitations of SC study designs (2) issues to consider when selecting the optimal SC design given a specific question, dataset, exposure, and outcome (3) how to calculate effect measures for each design (4) issues with pooling results across SC studies and 5) approaches to critically appraise SC studies.ĭescription: Dr. The symposium will be of interest to those keen to understand the design, application, reporting, combination, and replication of SC studies. Objectives: To introduce and receive feedback on guidance documents for the application and reporting of SC study designs in pharmacoepidemiology. We received ISPE manuscript proposal funding to develop guidance documents for the application and reporting of SC study designs: case-crossover (CCO), case-time control (CTC), case-case-time control (CCTC), and self-controlled case-series (SCCS). Michael's Hospital, Toronto, ON, Canada 3 University of Washington, Seattle, WA 4 Brigham and Women's Hospital, Harvard Medical School, Boston, MA 5 The Open University, Buckinghamshire, United Kingdom 6 University of Southern Denmark, Odense, Denmark 7 University of Victoria, Victoria, BC, Canadaīackground: Self-controlled (SC) study designs are “trigger designs” that control for time-invariant confounding factors and target the association between transient exposures and sudden-onset outcomes. Wang 4, Heather Whitaker 5, Jesper Hallas 6 and Malcolm Maclure 7ġ University of Toronto, Toronto, ON, Canada 2 St. Control Yourself: Guidance for the Application and Reporting of Self-Controlled Study Designs in Pharmacoepidemiology
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