TYPES OF RETROSPECTIVE STUDIES HOW TO
When carefully designed and properly executed, a retrospective pharmacoepidemiological analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial. A detailed supplement presents a practical how-to guide for following each rule. Here we summarize these contributions as 10 rules that serve as an end-to-end introduction to retrospective pharmacoepidemiological analyses of observational health care data using a running example of a hypothetical COVID-19 study. A proper analysis of observational health care data thus requires contributions from experts in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. An observational study can provide this evidence, but the lack of randomized exposure and the researcher’s inability to control treatment administration and data collection introduce significant challenges. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial.
TYPES OF RETROSPECTIVE STUDIES TRIAL
A randomized controlled trial generally provides the most credible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. Since the beginning of the COVID-19 pandemic, pharmaceutical treatment hypotheses have abounded, each requiring careful evaluation. 14Department of Mental Health, Johns Hopkins Bloomberg School of Public Health at Johns Hopkins University, Baltimore, MD, United States.13Department of Health Policy and Management, Columbia University Mailman School of Public Health, New York, NY, United States.12Department of Biomedical Data Science, Stanford University, Stanford, CA, United States.
11VA Health Economics Resource Center, Palo Alto VA, Menlo Park, CA, United States.10Department of Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, MD, United States.9Datavant Inc., San Francisco, CA, United States.8Health Catalyst Inc., Salt Lake City, UT, United States.7Graduate School of Business, Stanford University, Stanford, CA, United States.6Division of Rheumatology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, United States.5Ludwig Center, Lustgarten Laboratory, Howard Hughes Medical Institute, The Johns Hopkins University School of Medicine, Baltimore, MD, United States.4Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health at Johns Hopkins University, Baltimore, MD, United States.3Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, United States.2Institute for Computational & Mathematical Engineering, Stanford University, Stanford, CA, United States.1Department of Biomedical Engineering, Institute for Computational Medicine, The Johns Hopkins University, Baltimore, MD, United States.Konig 5,6, Ruoxuan Xiong 7, Sadiqa Mahmood 8, Vera Mucaj 9, Chetan Bettegowda 5,10, Liam Rose 11, Suzanne Tamang 12, Adam Sacarny 13, Brian Caffo 4, Susan Athey 7, Elizabeth A. Michael Powell 1*, Allison Koenecke 2, James Brian Byrd 3, Akihiko Nishimura 4, Maximilian F.
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