Ooms Alexander Gert, Png May Ee, Cook Jonathan A, Dritsaki Melina, Dakin Helen A, Costa Matthew L
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Bone Jt Open. 2020 Jun 11;1(6):245-252. doi: 10.1302/2633-1462.16.BJO-2020-0044.R1. eCollection 2020 Jun.
Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.
DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.
This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously.
The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses.Cite this article: 2020;1-6:245-252.
描述桡骨远端急性骨折固定试验2（DRAFFT2）随机对照试验的统计和经济分析计划。
DRAFFT2是一项多中心、平行、双臂随机对照试验。它比较了在桡骨远端背侧移位骨折的成年患者中，克氏针手术固定与石膏固定的效果。主要结局指标是随机分组后12个月时的患者自评腕关节评估（PRWE，一种经过验证的腕关节功能和疼痛评估方法）。次要结局指标在随机分组后的3个月、6个月和12个月进行测量，包括PWRE、欧洲五维度健康量表EQ-5D-5L指数和EQ-视觉模拟量表（VAS）、并发症发生率以及治疗的成本效益。
本文描述了计划分析方法和描述性统计的全部详细信息。DRAFFT2研究方案此前已发表。
所描述的计划分析策略记录了我们进行统计分析和试验内成本效用分析的意图。引用本文：2020；1 - 6：245 - 252。
