Background The Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department (BUCKLED) trial is a multicentre, randomised, open-label, non-inferiority study comparing point-of-care ultrasound to x-ray as the initial imaging modality in children with clinically non-angulated distal forearm injuries. Objective The purpose of this document is to minimise bias by defining and making publicly available our analysis approach prior to completing the study and reviewing or analysing the trial data. Methods We developed a statistical analysis plan (SAP) for reporting and analysing the BUCKLED trial including our approach to expected protocol deviations, withdrawals, missing data, and loss to follow up. Study methods are described using a previously published study protocol. Broad statistical analysis principles are outlined. Primary and secondary trial outcomes are described, along with appropriate methods for statistical comparison. Results This report pre-specifies the SAP for the primary outcome of upper limb function at 4 weeks, using an intention-to-treat analysis with a hypothesis of non-inferiority. Results of a per-protocol analysis will also be reported. Subgroup analyses will include diagnostic category and age category and secondary outcomes will include cost, quality of life, satisfaction, pain, adverse events, rates of imaging, Emergency Department length of stay, treatment time and diagnostic accuracy. Methods of statistical comparison are outlined. Conclusion This report describes the SAP for the BUCKLED trial, to minimise analysis bias and ensure transparency and internal validity for the findings of this randomised controlled trial.

中文翻译：

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急诊科 (BUCKLED) 试验中上肢远端骨折儿童床边超声的统计分析计划

背景 在急诊科 (BUCKLED) 试验中对儿童上肢远端骨折进行床边超声检查是一项多中心、随机、开放标签、非劣效性研究，将床旁超声与 X 射线作为初始成像方式进行比较在临床上非成角的前臂远端损伤的儿童中。目标 本文件的目的是通过在完成研究和审查或分析试验数据之前定义和公开我们的分析方法来最大限度地减少偏差。方法 我们制定了一个统计分析计划 (SAP)，用于报告和分析 BUCKLED 试验，包括我们对预期方案偏差、退出、缺失数据和失访的方法。使用先前发布的研究方案描述了研究方法。概述了广泛的统计分析原则。描述了主要和次要试验结果，以及用于统计比较的适当方法。结果 本报告使用具有非劣效性假设的意向治疗分析预先指定了 4 周时上肢功能主要结果的 SAP。还将报告符合方案分析的结果。亚组分析将包括诊断类别和年龄类别，次要结果将包括成本、生活质量、满意度、疼痛、不良事件、成像率、急诊科住院时间、治疗时间和诊断准确性。概述了统计比较的方法。结论 本报告描述了用于 BUCKLED 试验的 SAP，