Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, NSW, Australia.
South Western Sydney Clinical School, UNSW, Sydney, NSW, Australia.
Trials. 2020 Jul 15;21(1):651. doi: 10.1186/s13063-020-4228-0.
We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan.
METHODS/DESIGN: A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance.
This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients.
CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.
我们正在进行一项联合随机和观察性研究，比较内固定与非手术治疗老年常见腕部骨折。本文描述了统计分析计划。
方法/设计：一项针对老年人桡骨远端骨折的手术与非手术治疗的联合随机和观察性研究（CROSSFIRE）是一项比较两种常规治疗方法治疗老年腕部骨折的随机对照试验，一种是使用掌侧锁定板的手术内固定，另一种是使用闭合复位和石膏固定的非手术治疗。这项比较有效性研究的主要目的是确定手术是否优于非手术治疗，在治疗后 12 个月时，患者报告的腕关节功能是否更好。次要结局包括影像学结局、并发症发生率和患者报告的结局，包括生活质量、疼痛、治疗成功率和美容效果。主要分析将使用两样本 t 检验和意向治疗分析，使用研究的随机臂。统计分析将采用双尾检验，显著性由 p<0.05 确定。将进行敏感性分析，以评估意向治疗、方案治疗和实际治疗分析的差异。还将进行敏感性分析，以评估随机和观察性研究臂之间参与者的差异、任何缺失数据的选择偏差以及与任何缺失数据相关的偏倚。如果手术显示提供优于临床显著水平的结果，则将单独进行经济分析。
本统计分析计划描述了 CROSSFIRE 研究的分析，旨在为老年患者桡骨远端骨折的治疗提供决策依据。
CROSSFIRE 已获得新南威尔士亨特地区人类研究伦理委员会（HNEHREC 参考号：16/02/17/3.04）批准。于 2016 年 7 月 22 日在澳大利亚和新西兰临床试验注册中心（ANZCTR 编号；ACTRN12616000969460）注册。本文基于第 11 版统计分析计划。第 11 版由首席研究员和高级统计学家签署，保存在管理机构。
