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dc.contributor.authorSprague, Sheila
dc.contributor.authorScott, Taryn
dc.contributor.authorDodds, Shannon
dc.contributor.authorPogorzelski, David
dc.contributor.authorMcKay, Paula
dc.contributor.authorHarris, Anthony D
dc.contributor.authorWood, Amber
dc.contributor.authorThabane, Lehana
dc.contributor.authorBhandari, Mohit
dc.contributor.authorMehta, Samir
dc.contributor.authorGaski, Greg
dc.contributor.authorBoulton, Christina
dc.contributor.authorMarcano-Fernández, Francesc
dc.contributor.authorGuerra-Farfán, Ernesto
dc.contributor.authorHebden, Joan
dc.contributor.authorO'Hara, Lyndsay M
dc.contributor.authorSlobogean, Gerard P
dc.date.accessioned2020-09-08T16:55:21Z
dc.date.available2020-09-08T16:55:21Z
dc.date.issued2020-08-12
dc.identifier.urihttp://hdl.handle.net/10713/13647
dc.descriptionErratum 10.1186/s13063-020-04767-4: PREP-IT Investigators are now added in Supplementary file 1 linked to this erratum.
dc.description.abstractBACKGROUND: 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 (Aqueous-PREP 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. RESULTS: We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. CONCLUSIONS: The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. TRIAL REGISTRATION: Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).en_US
dc.description.urihttps://doi.org/10.1186/s13063-020-04611-9en_US
dc.description.urihttps://doi.org/10.1186/s13063-020-04767-4
dc.language.isoen_USen_US
dc.publisherSpringer Natureen_US
dc.relation.ispartofTrialsen_US
dc.subjectClusteren_US
dc.subjectCluster characteristicsen_US
dc.subjectOrthopedicen_US
dc.subjectPragmaticen_US
dc.subjectRandomized crossoveren_US
dc.subjectSurgical site infectionen_US
dc.titleCluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trialsen_US
dc.typeArticleen_US
dc.identifier.doi10.1186/s13063-020-04611-9
dc.identifier.pmid32787892
dc.source.volume21
dc.source.issue1
dc.source.beginpage712
dc.source.endpage
dc.source.countryUnited States
dc.source.countryEngland


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