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, Ruth; Dritsaki, Melina; Mason, James; Perry, Daniel; Dutton, Susan

doi:10.1302/2633-1462.16.bjo-2020-0015.r1

Cited by 3 publications

(2 citation statements)

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“…the SaP has been reviewed and received input from the trial Steering Committee (tSC) and Data Safety monitoring Committee (DSmC). 28 any changes or deviations from the original SaP will be described and justified in the updated SaP, protocol, final report and/or publications, as appropriate. it is anticipated that all statistical analysis will be undertaken using Stata (StataCorp, College Station, texas, uSa) or other well-validated statistical packages.…”

Section: Discussionmentioning

confidence: 99%

“…a health economics analysis Plan (heaP), providing full details of the prospective economic analysis, has been published alongside this protocol. 28 the average staff time and time to deliver the rigid immobilization and soft bandage treatment will be recorded at each centre, as well as materials, and consumables involved. Data will be collected on the health service resources used in the treatment of each participant during the period between randomization and 6 weeks post-randomisation.…”

Section: Discussionmentioning

confidence: 99%

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A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

et al. 2020

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Aims Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

et al. 2020

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Publishing study protocols

Perry

Costa

2020

The Bone & Joint Journal

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Offer of a bandage versus rigid immobilisation in 4- to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT

Perry

Achten

Knight

et al. 2022

Health Technol Assess

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Background Torus (buckle) fractures of the wrist are the most common fractures in children involving the distal radius and/or ulna. It is unclear if children require rigid immobilisation and follow-up or would recover equally as well by being discharged without any immobilisation or a bandage. Given the large number of these injuries, identifying the optimal treatment strategy could have important effects on the child, the number of days of school absence and NHS costs. Objectives To establish whether or not treating children with a distal radius torus fracture with the offer of a soft bandage and immediate discharge (i.e. offer of a bandage) provides the same recovery, in terms of pain, function, complications, acceptability, school absence and resource use, as treatment with rigid immobilisation and follow-up as per usual practice (i.e. rigid immobilisation). Design A pragmatic, multicentre, randomised controlled equivalence trial. Setting Twenty-three UK emergency departments. Participants A total of 965 children (aged 4–15 years) with a distal radius torus fracture were randomised from January 2019 to July 2020 using a secure, centralised, online-encrypted randomisation service. Exclusion criteria included presentation > 36 hours after injury, multiple injuries and an inability to complete follow-up. Interventions A bandage was offered to 489 participants and applied to 458, and rigid immobilisation was carried out in 476 participants. Participants and clinicians were not blinded to the treatment allocation. Main outcome measures The pain at 3 days post randomisation was measured using the Wong–Baker FACES Pain Rating Scale. Secondary outcomes were the patient-reported outcomes measurement system upper extremity limb score for children, health-related quality of life, complications, school absence, analgesia use and resource use collected up to 6 weeks post randomisation. Results A total of 94% of participants provided primary outcome data. At 3 days, the primary outcome of pain was equivalent in both groups. With reference to the prespecified equivalence margin of 1.0, the adjusted difference in the intention-to-treat population was –0.10 (95% confidence interval –0.37 to 0.17) and the per-protocol population was –0.06 (95% confidence interval –0.34 to 0.21). There was equivalence of pain in both age subgroups (i.e. 4–7 years and 8–15 years). There was no difference in the rate of complications, with five complications (1.0%) in the offer of a bandage group and three complications (0.6%) in the rigid immobilisation group. There were no differences between treatment groups in functional recovery, quality of life or school absence at any point during the follow-up. Analgesia use was marginally higher at day 1 in the offer of a bandage group than it was in the rigid immobilisation group (83% vs. 78% of participants), but there was no difference at other time points. The offer of a bandage significantly reduced the cost of treatment and had a high probability of cost-effectiveness at a willingness-to-pay threshold of £30,000 per quality-adjusted life-year. Limitations Families had a strong pre-existing preference for the rigid immobilisation treatment. Given this, and the inability to blind families to the treatment allocation, observer bias was a concern. However, there was clear evidence of equivalence. Conclusions The study findings support the offer of a bandage in children with a distal radius torus fracture. Future work A clinical decision tool to determine which children require radiography is an important next step to prevent overtreatment of minor wrist fractures. There is also a need to rationalise interventions for other common childhood injuries (e.g. ‘toddler’s fractures’ of the tibia). Trial registration This trial is registered as ISRCTN13955395 and UKCRN Portfolio 39678. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 33. See the NIHR Journals Library website for further project information.

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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

Cited by 3 publications

References 37 publications

A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

Publishing study protocols

Offer of a bandage versus rigid immobilisation in 4- to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT

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