• Cameron J Gettel, YiadomMaame Yaa A BMYABDepartment of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA., Steven L Bernstein, Corita R Grudzen, Bidisha Nath, Fan Li, Ula Hwang, Erik P Hess, and Edward R Melnick.
• Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
• Acad Emerg Med. 2022 Oct 1; 29 (10): 124712571247-1257.

AbstractPragmatic clinical trials (PCTs) focus on correlation between treatment and outcomes in real-world clinical practice, yet a guide highlighting key study considerations and design types for emergency medicine investigators pursuing this important study type is not available. Investigators conducting emergency department (ED)-based PCTs face multiple decisions within the planning phase to ensure robust and meaningful study findings. The PRagmatic Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool allows trialists to consider both pragmatic and explanatory components across nine domains, shaping the trial design to the purpose intended by the investigators. Aside from the PRECIS-2 tool domains, ED-based investigators conducting PCTs should also consider randomization techniques, human subjects concerns, and integration of trial components within the electronic health record. The authors additionally highlight the advantages, disadvantages, and rationale for the use of four common randomized study design types to be considered in PCTs: parallel, crossover, factorial, and stepped-wedge. With increasing emphasis on the conduct of PCTs, emergency medicine investigators will benefit from a rigorous approach to clinical trial design.© 2022 The Authors. Academic Emergency Medicine published by Wiley Periodicals LLC on behalf of Society for Academic Emergency Medicine.

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