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Cluster Randomized Stepped Wedge Blinded Controlled Trials (CRSWBCT) In Comparative Effectiveness Research (CER) Part II: Implications for Temporomandibular Joint Disorders (TMD) Research

Francesco Chiappelli*, Andre Barkhordarian, Gary Demerjian, Quyen Bach and Vandan Kasar

In the context of translational science and comparative effectiveness research (CER), we discuss here practical applications and implications of the Cluster Randomized Stepped Wedge Blinded Controlled Trials (CRSWBCT). CRSWBCT is a type of pragmatic trial that attempts to minimize inherent design flaws, including information bias, inferential bias, selection bias, and reporting quality of trials. Inherently and while complex in terms of analysis and power assessment, CRSWBCT can enhance statistical stringency by minimizing risk of bias, and preserve equipoise. In Part I, we outlined the design and inferential aspects of the CRSWBCT, and the need for a revision of the CONSORT10 checklist in pursuit of the best evidence base (BEB) accordingly. Here, we discuss practical aspects of the implications and applications of CRSWBCT specifically in the context of temporomandibular joint disorders (TMD) research.