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.

Access the full-text of this item by clicking on the Open Access link.

Abstract

<h4>Aims</h4>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.<h4>Methods</h4>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.<h4>Conclusion</h4>This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results.Cite this article: <i>Bone Joint Open</i> 2020;1-6:205-213.

Item Type:	Article
Uncontrolled Keywords:	Statistical analysis plan, Economic analysis plan, Randomised controlled trial, Paediatrics, Trauma, Distal radius
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health
Depositing User:	Symplectic Admin
Date Deposited:	23 Jul 2021 10:09
Last Modified:	27 Feb 2024 23:41
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 URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3131036