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Cluster Randomized Stepped Wedge Blinded Controlled Trials (CRSWBCT) In Comparative Effectiveness Research (CER) - Part I: Toward a Revision of CONSORT

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

The current state of translational science and comparative effectiveness research (CER) faces inherent barriers to accuracy, which can compromise the integrity of the study. Design flaws such as information bias, inferential bias, selection bias, and reporting quality of trials require careful assessment in order to appropriately compare and contrast evidence in pursuit of the best evidence base (BEB). Here, we describe a novel research design, the Cluster Randomized Stepped Wedge Blinded Controlled Trials (CRSWBCT), which consists of a type of pragmatic trial that attempts to minimize these biases by implicating a system in which each unit of study acts as both the experimental group and control group. The CRSWBCT design has an inherent ability to enhance statistical stringency by minimizing risk of bias, and, in contrast to the traditional parallel, run-in, or cross -over trials, preserves ethical equipoise. In the CRSWBCT, all the clusters begin the study in the placebo-control, and roll-out into the experimental treatment group in a systematic, sequential fashion that retains the stringency of random double- blind protocol. CRSWBCT, while more complex in terms of power and statistical inference, has greater validity and is the preferred design with respect to ethical, logistical, and financial considerations over traditional simpler trials for the modern and contemporary pursuit of patient-centered outcomes research and individual patient data collection and analysis. In the context of CER, the adoption of CRSWBCT requires a revision of the CONSORT10 checklist (e.g., CONSORT10-R) to evaluate the evidence base obtained by the CRSWBCT design.