The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan
The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan
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DOI：
10.1186/1745-6215-14-234
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发表时间：
2013-07-24
期刊：
影响因子：
2.5
通讯作者：
Jago, Russell
中科院分区：
文献类型：
--
作者：
Lawlor, Debbie A.;Peters, Tim J.;Jago, Russell
背景：活性生命5年（AFLY5）随机对照试验方案于2011年发表在该杂志上。它提供了一个总结分析计划。本出版物是该协议的更新，并提供了详细的分析计划。更新：此更新提供了AFLY5干预措施的有效性和成本效益的详细分析计划。该计划包括如何对变量进行质量控制检查的细节，以及用于定义派生变量的标准。提供了四项主要分析的细节：(a)有效性分析1（在提供干预措施的学年结束时，AFLY5干预措施对小学和中学成绩的影响）；(b)中介分析（次要分析，检查干预的任何影响通过自我效能、父母支持和知识介导的程度，理论上认为干预是通过这些知识起作用的）；(c)有效性分析2（干预结束后12个月，AFLY5干预对主要和次要结果的影响）和(d)成本效益分析（AFLY5干预的成本效益）。细节包括如何定义治疗意图和每个协议分析，以及如何计划处理缺失数据的敏感性分析。附加文件1中提供了一组虚拟表。讨论：此详细的分析计划是在任何分析师访问任何数据之前编写的，并由AFLY5试验指导委员会批准。其发布将确保分析符合与试验目标相关的先验计划，而不受数据知识的驱动。
Background: The Active For Life Year 5 (AFLY5) randomised controlled trial protocol was published in this journal in 2011. It provided a summary analysis plan. This publication is an update of that protocol and provides a detailed analysis plan.Update: This update provides a detailed analysis plan of the effectiveness and cost-effectiveness of the AFLY5 intervention. The plan includes details of how variables will be quality control checked and the criteria used to define derived variables. Details of four key analyses are provided: (a) effectiveness analysis 1 (the effect of the AFLY5 intervention on primary and secondary outcomes at the end of the school year in which the intervention is delivered); (b) mediation analyses (secondary analyses examining the extent to which any effects of the intervention are mediated via self-efficacy, parental support and knowledge, through which the intervention is theoretically believed to act); (c) effectiveness analysis 2 (the effect of the AFLY5 intervention on primary and secondary outcomes 12 months after the end of the intervention) and (d) cost effectiveness analysis (the cost-effectiveness of the AFLY5 intervention). The details include how the intention to treat and per-protocol analyses were defined and planned sensitivity analyses for dealing with missing data. A set of dummy tables are provided in Additional file 1.Discussion: This detailed analysis plan was written prior to any analyst having access to any data and was approved by the AFLY5 Trial Steering Committee. Its publication will ensure that analyses are in accordance with an a priori plan related to the trial objectives and not driven by knowledge of the data.