Evidence map›Paper›PMID 32787892›Full record

ArticleTrials2020

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

Sheila Sprague, Taryn Scott, Shannon Dodds, David Pogorzelski, Paula McKay, Anthony D Harris, Amber Wood, Lehana Thabane, Mohit Bhandari, Samir Mehta and 8 more

Erratum issued 3 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03385304 phase4completednot on this map

Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2018 to 2022Enrolled1,638ConditionsSurgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular FractureArms10% povidone-iodine (1% free iodine) in purified water, 4% chlorhexidine gluconate (CHG) in purified water
NCT03523962 phase4completednot on this map

PREPARE: A Pragmatic Randomized Trial Evaluating Pre-operative Alcohol Skin Solutions in FRactured Extremites

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2018 to 2024Enrolled8,485ConditionsSurgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular Fracture, Closed Lower Extremity FractureArmsDuraPrep, ChloraPrep
NCT05974384 narecruitingnot on this mapstarted 2023, after this paper: background citation

Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial

TypeinterventionalSponsorCorporacion Parc TauliRan2023 to 2025Enrolled100ConditionsDistal Radius Fracture ReductionArmsNo Music, Music
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 3 countries.

Sheila SpragueDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada. sprags@mcmaster.ca.ORCID http://orcid.org/0000-0003-1466-8063
Taryn ScottDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Shannon DoddsDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.
David PogorzelskiDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Paula McKayDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Anthony D HarrisDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Amber WoodAssociation of periOperative Registered Nurses, Denver, CO, USA.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, L8L 8E7, Canada.
Mohit BhandariDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Samir MehtaDepartment of Orthopaedic Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Greg GaskiDepartment of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
Christina BoultonDepartment of Orthopaedics, Banner Health and the University of Arizona-Tucson, Tucson, AZ, USA.
Francesc Marcano-FernándezOrthopedic Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain.
Ernesto Guerra-FarfánDepartment of Orthopaedic Surgery and Traumatology, University Hospital Vall d'Hebron, Barcelona, Spain.
Joan HebdenDepartment of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Lyndsay M O'HaraDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Gerard P SlobogeanDepartment of Orthopaedics, University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.
PREP-IT Investigators
McMaster University · CAUniversity of Maryland, Baltimore · USImpact · CAAssociation of Perioperative Registered Nurses · USIndiana University School of MedicineUniversitat Autònoma de Barcelona · ESUniversity of Arizona · USUniversity of Pennsylvania · USVall d'Hebron Hospital Universitari · ES

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167Patient-Centered Outcomes Research Institute PCS-1609-36512Physicians' Services Incorporated Foundation N/AU.S. Department of Defense W81XWH-17-1-070
6 · The paper itself

Abstract

backgroundIn 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.

methodsThe 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.

resultsWe 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.

conclusionsThe 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 registrationBoth trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

Indexed as

Fractures, BonePragmatic Clinical Trials as TopicChlorhexidineCross-Over StudiesHumansIodophorsReoperationSurgical Wound InfectionChlorhexidineIodophorsClusterCluster characteristicsOrthopedicPragmaticRandomized crossoverSurgical site infection

Identifiers

PMID32787892
PMCPMC7425374
OpenAlexW3048708312

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.