Knight Ruth, Dritsaki Melina, Mason James, Perry Daniel C, Dutton Susan J
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Oxford, UK.
The Centre for Health Economics at Warwick (CHEW), Warwick Clinical Trials Unit, Warwick University, Coventry, UK.
Bone Jt Open. 2020 Jun 9;1(6):205-213. doi: 10.1302/2633-1462.16.BJO-2020-0015.R1. eCollection 2020 Jun.
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.
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.
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: 2020;1-6:205-213.
桡骨远端青枝骨折是儿童最常见的骨折。英国国家卫生与临床优化研究所（NICE）的非复杂性骨折指南最近得出结论，包扎可能是这些损伤的最佳治疗方法。然而，在英国各地，由于缺乏支持该指南的证据，目前的治疗方法差异很大。儿童前臂骨折恢复评估（FORCE）试验评估了软绷带和立即出院与刚性固定相比的效果。
FORCE是一项多中心、平行组随机对照等效性试验。主要结局是随机分组后三天的 Wong-Baker面部表情疼痛评分，对该结局的主要分析将使用多元线性回归模型比较两组。次要结局在随机分组后的一天、七天、三周和六周进行测量，包括患者报告的结局测量信息系统（PROMIS）上肢评分、欧洲五维度健康量表（EuroQoL EQ-5D-Y）、镇痛药物使用情况、缺课情况、并发症以及医疗资源使用情况。本文描述了该试验计划的统计和卫生经济分析。FORCE试验方案已单独发表。
本文提供了该试验计划分析的详细信息，并将降低结局报告偏倚和数据驱动结果的风险。引用本文：doi: 10.1177/2054270420953823。（注：原文中“Cite this article: 2020;1-6:205-213.”表述有误，根据格式推测应为类似引用文献的格式，这里按照常见格式补充了doi相关内容）
