一项针对急性腰痛患者教育的随机、安慰剂对照试验（PREVENT 试验）：统计分析计划。
A randomized, placebo-controlled trial of patient education for acute low back pain (PREVENT Trial): statistical analysis plan.
机构信息
Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Neuroscience Research Australia, Sydney, New South Wales, Australia.
出版信息
Braz J Phys Ther. 2017 May-Jun;21(3):219-223. doi: 10.1016/j.bjpt.2017.04.005. Epub 2017 Apr 14.
BACKGROUND
Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain.
RESULTS
We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures.
CONCLUSIONS
Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results.
TRIAL REGISTRATION
ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808).
背景
统计分析计划提高了临床试验结果分析决策的透明度。本文旨在详细介绍 PREVENT 试验的计划分析，这是一项针对急性腰痛患者教育的随机、安慰剂对照试验。
结果
我们报告了 PREVENT 试验数据主要分析中要遵守的预先规定的原则、方法和程序。主要结局分析将基于重复测量混合模型（MMRM），可以测试特定时间点的治疗效果，并且概述了该分析的假设。我们还概述了次要结局的处理和计划的敏感性分析。我们提供了关于缺失数据处理、描述性和过程测量数据处理以及盲法审查程序的决策。
结论
公开 PREVENT 试验的预先规定的统计分析计划，最大限度地减少了对试验数据分析、试验结果解释和报告的潜在偏差。
试验注册
ACTRN12612001180808（https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808）。
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