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The Forearm Fracture Recovery in Children Evaluation (FORCE) trial : statistical and health economic analysis plan for an equivalence randomized controlled trial of treatment for torus fractures of the distal radius in children

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Knight, Ruth, Dritsaki, Melina, Mason, James, Perry, Daniel C. and Dutton, Susan J. (2020) The Forearm Fracture Recovery in Children Evaluation (FORCE) trial : statistical and health economic analysis plan for an equivalence randomized controlled trial of treatment for torus fractures of the distal radius in children. Bone & Joint Open, 1 (6). pp. 205-213. doi:10.1302/2046-3758.16.BJO-2020-0015.R1

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Official URL: https://doi.org/10.1302/2046-3758.16.BJO-2020-0015...

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Abstract

Aims
Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization.

Methods
FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.

Conclusion
This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results.

Item Type: Journal Article
Subjects: R Medicine > RD Surgery
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Radius (Anatomy) -- Fractures -- Treatment, Pediatric orthopedics
Journal or Publication Title: Bone & Joint Open
Publisher: British Editorial Society of Bone and Joint Surgery
ISSN: 2633-1462
Official Date: 9 June 2020
Dates:
DateEvent
9 June 2020Published
9 June 2020Accepted
Date of first compliant deposit: 8 September 2020
Volume: 1
Number: 6
Page Range: pp. 205-213
DOI: 10.1302/2046-3758.16.BJO-2020-0015.R1
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
17/23/02[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
CS-2014-14-012[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272

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