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应对持续性疼痛，自我管理的有效性研究（COPERS）：一项随机对照试验的统计分析计划。

Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial.

机构信息

Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, London E1 2AB, UK.

出版信息

Trials. 2014 Feb 15;15:59. doi: 10.1186/1745-6215-15-59.

DOI:10.1186/1745-6215-15-59
PMID:24528484
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3930300/
Abstract

BACKGROUND

The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain. This article describes the statistical analysis plan for the COPERS trial.

METHODS AND DESIGN

COPERS was a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial. This article describes (a) the overall analysis principles (including which participants will be included in each analysis, how results will be presented, which covariates will be adjusted for, and how we will account for clustering in the intervention group); (b) the primary and secondary outcomes, and how each outcome will be analysed; (c) sensitivity analyses; (d) subgroup analyses; and (e) adherence-adjusted analyses.

TRIAL REGISTRATION

ISRCTN24426731.

摘要

背景

应对持续性疼痛、自我管理有效性研究（COPERS）试验评估了基于小组的自我管理课程是否能有效减少患有慢性肌肉骨骼疼痛的参与者的疼痛相关残疾。本文介绍了 COPERS 试验的统计分析计划。

方法和设计

COPERS 是一项实用的、多中心的、非盲的、平行组、随机对照试验。本文介绍了（a）总体分析原则（包括将哪些参与者纳入每项分析，如何呈现结果，将调整哪些协变量，以及我们将如何考虑干预组中的聚类）；（b）主要和次要结局，以及如何分析每个结局；（c）敏感性分析；（d）亚组分析；和（e）依从性调整分析。

试验注册

ISRCTN24426731。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3309/3930300/4206353cabf8/1745-6215-15-59-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3309/3930300/4206353cabf8/1745-6215-15-59-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3309/3930300/4206353cabf8/1745-6215-15-59-1.jpg

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Choosing sensitivity analyses for randomised trials: principles.随机试验敏感性分析的选择：原则。
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Analytic methods for individually randomized group treatment trials and group-randomized trials when subjects belong to multiple groups.
运用干预映射法来开发一种基于理论的、以小组为基础的复杂干预措施，以支持骨关节炎和腰痛的自我管理（SOLAS）。
Implement Sci. 2016 Apr 26;11:56. doi: 10.1186/s13012-016-0418-2.
个体随机分组治疗试验和当受试者属于多个组时的整群随机试验的分析方法。
Stat Med. 2014 Jun 15;33(13):2178-90. doi: 10.1002/sim.6083. Epub 2014 Jan 8.
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