• Login
    View Item 
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2020
    • View Item
    •   UMB Digital Archive
    • UMB Open Access Articles
    • UMB Open Access Articles 2020
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UMB Digital ArchiveCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

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

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    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
    Show allShow less

    Date
    2020-08-12
    Journal
    Trials
    Publisher
    Springer Nature
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1186/s13063-020-04611-9
    https://doi.org/10.1186/s13063-020-04767-4
    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 (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).
    Description
    Erratum 10.1186/s13063-020-04767-4: PREP-IT Investigators are now added in Supplementary file 1 linked to this erratum.
    Keyword
    Cluster
    Cluster characteristics
    Orthopedic
    Pragmatic
    Randomized crossover
    Surgical site infection
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/13647
    ae974a485f413a2113503eed53cd6c53
    10.1186/s13063-020-04611-9
    Scopus Count
    Collections
    UMB Open Access Articles 2020

    entitlement

    Related articles

    • Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.
    • Authors: Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators., Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U
    • Issue date: 2020 Apr 1
    • The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality.
    • Authors: Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE
    • Issue date: 2016 Dec 6
    • Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial.
    • Authors: Arnup SJ, McKenzie JE, Hemming K, Pilcher D, Forbes AB
    • Issue date: 2017 Aug 15
    • The use of the cluster randomized crossover design in clinical trials: protocol for a systematic review.
    • Authors: Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McDonald S, McKenzie JE
    • Issue date: 2014 Aug 12
    • Appropriate statistical methods were infrequently used in cluster-randomized crossover trials.
    • Authors: Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE
    • Issue date: 2016 Jun
    DSpace software (copyright © 2002 - 2021)  DuraSpace
    Quick Guide | Policies | Contact Us | UMB Health Sciences & Human Services Library
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.