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Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials

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 parall...

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Autores principales: Sprague, Sheila, Scott, Taryn, Dodds, Shannon, Pogorzelski, David, McKay, Paula, Harris, Anthony D., Wood, Amber, Thabane, Lehana, Bhandari, Mohit, Mehta, Samir, Gaski, Greg, Boulton, Christina, Marcano-Fernández, Francesc, Guerra-Farfán, Ernesto, Hebden, Joan, O’Hara, Lyndsay M., Slobogean, Gerard P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425374/
https://www.ncbi.nlm.nih.gov/pubmed/32787892
http://dx.doi.org/10.1186/s13063-020-04611-9
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author Sprague, Sheila
Scott, Taryn
Dodds, Shannon
Pogorzelski, David
McKay, Paula
Harris, Anthony D.
Wood, Amber
Thabane, Lehana
Bhandari, Mohit
Mehta, Samir
Gaski, Greg
Boulton, Christina
Marcano-Fernández, Francesc
Guerra-Farfán, Ernesto
Hebden, Joan
O’Hara, Lyndsay M.
Slobogean, Gerard P.
author_facet Sprague, Sheila
Scott, Taryn
Dodds, Shannon
Pogorzelski, David
McKay, Paula
Harris, Anthony D.
Wood, Amber
Thabane, Lehana
Bhandari, Mohit
Mehta, Samir
Gaski, Greg
Boulton, Christina
Marcano-Fernández, Francesc
Guerra-Farfán, Ernesto
Hebden, Joan
O’Hara, Lyndsay M.
Slobogean, Gerard P.
author_sort Sprague, Sheila
collection PubMed
description 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 (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).
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spelling pubmed-74253742020-08-16 Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials Sprague, Sheila Scott, Taryn Dodds, Shannon Pogorzelski, David McKay, Paula Harris, Anthony D. Wood, Amber Thabane, Lehana Bhandari, Mohit Mehta, Samir Gaski, Greg Boulton, Christina Marcano-Fernández, Francesc Guerra-Farfán, Ernesto Hebden, Joan O’Hara, Lyndsay M. Slobogean, Gerard P. Trials Methodology 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 (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). BioMed Central 2020-08-12 /pmc/articles/PMC7425374/ /pubmed/32787892 http://dx.doi.org/10.1186/s13063-020-04611-9 Text en © The Author(s) 2020 Open AccessThis 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 Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Methodology
Sprague, Sheila
Scott, Taryn
Dodds, Shannon
Pogorzelski, David
McKay, Paula
Harris, Anthony D.
Wood, Amber
Thabane, Lehana
Bhandari, Mohit
Mehta, Samir
Gaski, Greg
Boulton, Christina
Marcano-Fernández, Francesc
Guerra-Farfán, Ernesto
Hebden, Joan
O’Hara, Lyndsay M.
Slobogean, Gerard P.
Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
title Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
title_full Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
title_fullStr Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
title_full_unstemmed Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
title_short Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
title_sort cluster identification, selection, and description in cluster randomized crossover trials: the prep-it trials
topic Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425374/
https://www.ncbi.nlm.nih.gov/pubmed/32787892
http://dx.doi.org/10.1186/s13063-020-04611-9
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