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METHODOLOGY

Open Access

Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials Sheila Sprague1,2* , Taryn Scott1, Shannon Dodds1, David Pogorzelski1, Paula McKay1, Anthony D. Harris3, Amber Wood4, Lehana Thabane2, Mohit Bhandari1,2, Samir Mehta5, Greg Gaski6, Christina Boulton7, Francesc Marcano-Fernández8, Ernesto Guerra-Farfán9, Joan Hebden10, Lyndsay M. O’Hara3, Gerard P. Slobogean11, on behalf of the PREP-IT Investigators

Abstract Background: In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. Methods: The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (AqueousPREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. (Continued on next page)

* Correspondence: [email protected] 1 Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada 2 Department of Health Research Methods, Evidence, and Impact, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON L8L 8E7, Canada Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative