Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments
Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments
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DOI：
10.7326/0003-4819-148-4-200802190-00008-w1
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发表时间：
2008-02-19
影响因子：
39.2
通讯作者：
Ravaud, Philippe
中科院分区：
文献类型：
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作者：
Boutron, Isabelle;Moher, David;Ravaud, Philippe
背景：对非药物治疗的随机对照试验的进行提出了在试验报告中没有充分解决的具体挑战。目的：为非药物治疗试验制定CONSORT（综合试验报告标准）声明的扩展。设计：组织了一次共识会议，以制定CONSORT声明的扩展，解决非药物治疗的随机试验。为了筹备会议，进行了一项调查，以确定要讨论的具体问题。地点：在法国巴黎举行协商一致会议。参加人员：共有33名专家参加了会议。专家为方法学家（n = 17）；外科医生（n = 6）；编辑（n = 5）；参与康复（n = 1）、心理治疗（n = 2）、教育（n = 1）和植入式装置（n = 1）的临床医生。测量：专家指出CONSORT清单上的22个项目中哪些需要修改，哪些额外的项目应该专门为非药物治疗增加。在为期3天的共识会议中，讨论了所有项目，并确定了与非药物研究相关的其他方法学问题。结果：共识是CONSORT清单上的11个项目需要对非药物试验进行一些修改：项目1（标题和摘要）、项目3（参与者）、项目4（干预措施）、项目7（样本量）、项目8（随机化）、项目11（盲法）、项目12（统计方法）、项目13（参与者流）、项目15（基线数据）、项目20（讨论：解释）和项目21（概括性）。此外，与会者还增加了1个与实施干预措施有关的项目。局限性：并不总是有证据支持每个清单项目的纳入。结论：该扩展所采用的方法和流程可用于其他报告指南。CONSORT声明的这一扩展应用将提高评估非药物治疗的随机对照试验报告的质量。
Background: The conduct of randomized, controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports.Objective: To develop an extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement for trials of nonpharmacologic treatments.Design: A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses randomized trials of nonpharmacologic treatments. To prepare for the meeting, a survey was conducted to identify the specific issues for discussion.Setting: Consensus meeting in Paris, France.Participants: A total of 33 experts attended the meeting. The experts were methodologists (n = 17); surgeons (n = 6); editors (n = 5); and clinicians involved in rehabilitation (n = 1), psychotherapy (n = 2), education (n = 1), and implantable devices (n = 1).Measurements: Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments. During a 3-day consensus meeting, all items were discussed and additional methodological issues related to nonpharmacologic research were identified.Results: The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials: item 1 (title and abstract), item 3 (participants), item 4 (interventions), item 7 (sample size), item 8 (randomization), item 11 (blinding), item 12 (statistical methods), item 13 (participant flow), item 15 (baseline data), item 20 (discussion: interpretation), and item 21 (generalizability). In addition, the meeting participants added 1 item related to implementation of the intervention.Limitation: Evidence was not always available to support the inclusion of each checklist item.Conclusion: The methods and processes used to develop this extension could be used for other reporting guidelines. The use of this extension to the CONSORT Statement should improve the quality of reporting randomized, controlled trials assessing nonpharmacologic treatments.