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

Knight, R ORCID: 0000-0001-6810-2845, Dritsaki, M, Mason, J, Perry, DC ORCID: 0000-0001-8420-8252 and Dutton, SJ (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. ISSN 2633-1462, 2633-1462

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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:	Article
Uncontrolled Keywords:	Statistical analysis plan, Economic analysis plan, Randomised controlled trial, Paediatrics, Trauma, Distal radius
Divisions:	Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Population Health
Depositing User:	Symplectic Admin
Date Deposited:	23 Jul 2021 10:09
Last Modified:	23 May 2026 05:27
DOI:	10.1302/2633-1462.16.BJO-2020-0015.R1
Open Access URL:	https://doi.org/10.1302/2046-3758.16.BJO-2020-0015...
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3131036
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