Cluster identification, selection, and description in cluster randomized crossover trials : the PREP-IT trials
Sprague, Sheila (McMaster University. Department of Health Research Methods, Evidence, and Impact)
Scott, Taryn (McMaster University (Canadà))
Dodds, Shannon (McMaster University (Canadà))
Pogorzelski, David (McMaster University (Canadà))
McKay, Paula (McMaster University (Canadà))
Harris, Anthony D. (University of Maryland School of Medicine)
Wood, Amber (Association of periOperative Registered Nurses)
Thabane, Lehana (McMaster University (Canadà))
Bhandari, Mohit (McMaster University (Canadà))
Mehta, Samir (University of Pennsylvania Perelman School of Medicine)
Gaski, Greg (Indiana University School of Medicine)
Boulton, Christina (Banner Health and the University of Arizona-Tucson)
Marcano-Fernández, Francesc (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Guerra-Farfán, Ernesto (Hospital Universitari Vall d'Hebron)
Hebden, Joan (University of Maryland School of Medicine)
O'Hara, Lyndsay M. (University of Maryland School of Medicine)
Slobogean, Gerard P. (University of Maryland)
Universitat Autònoma de Barcelona

Data:	2020
Resum:	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. 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. 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. 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. Both trials are registered at ClinicalTrials. gov (A-PREP: December 28, 2017, and PREPARE: May 14, 2018).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Cluster ; Randomized crossover ; Pragmatic ; Cluster characteristics ; Orthopedic ; Surgical site infection
Publicat a:	Trials, Vol. 21 (august 2020) , ISSN 1745-6215

DOI: 10.1186/s13063-020-04611-9
PMID: 32787892

12 p, 1.8 MB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d’Investigació i Innovació Parc Taulí (I3PT)
Articles > Articles de recerca
Articles > Articles publicats