Author’s response to reviews Title: Stepped wedge cluster randomised trials: a review of the statistical methodology used and available Authors: Daniel Barker ([email protected]) Patrick McElduff ([email protected]) Catherine D'Este ([email protected]) Michael Campbell ([email protected]) Version: 1 Date: 11 Mar 2016 Author’s response to reviews: Dear Editors, Please accept a revised version of the manuscript “Stepped wedge cluster randomised trials: a review of the statistical methodology used and available” for consideration for publication in your journal. Neither this manuscript nor a version of it have been published or are currently being considered for publication elsewhere. The revision has placed more emphasis on the strengths of our review, not the least of which is the inclusion of far more examples of stepped wedge trials in practice. We point out that the next largest review had approximately one third of the number of trials that are in this manuscript which has resulted in an overestimate of the number of clusters typically randomised in stepped wedge trials. This is an important distinction because the options for statistical analysis are heavily dependent on the number of clusters available. Another feature of our review which is not found in the earlier reviews is the comparison between the types of stepped wedge trials and the statistical methodology built up around them. We highlight that in the case of the cohort stepped wedge design the theory lags behind the practice. As part of this process we had regular discussions with Professor Michael Campbell who is an expert in cluster randomised trials and therefore he has been added as an author. Yours sincerely, Mr Daniel Barker School of Medicine and Public Health University of Newcastle
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