Boutron Isabelle, Moher David, Altman Douglas G, Schulz Kenneth F, Ravaud Philippe
INSERM U738, AP-HP, Hôpital Bichat-Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France.
Ann Intern Med. 2008 Feb 19;148(4):W60-6. doi: 10.7326/0003-4819-148-4-200802190-00008-w1.
The conduct of randomized, controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports.
To develop an extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement for trials of nonpharmacologic treatments.
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.
Consensus meeting in Paris, France.
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).
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.
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.
Evidence was not always available to support the inclusion of each checklist item.
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.
非药物治疗的随机对照试验面临着一些特殊挑战，而试验报告中并未充分解决这些问题。
为非药物治疗试验制定《CONSORT（试验报告统一标准）声明》的扩展版。
组织了一次共识会议，以制定《CONSORT声明》的扩展版，该扩展版适用于非药物治疗的随机试验。为筹备此次会议，开展了一项调查，以确定需要讨论的具体问题。
法国巴黎的共识会议。
共有33名专家参加了会议。专家包括方法学家（n = 17）；外科医生（n = 6）；编辑（n = 5）；以及从事康复（n = 1）、心理治疗（n = 2）、教育（n = 1）和植入式设备（n = 1）的临床医生。
专家指出《CONSORT清单》中的22项内容中哪些应修改，或哪些应专门针对非药物治疗添加额外项目。在为期3天的共识会议期间，对所有项目进行了讨论，并确定了与非药物研究相关的其他方法学问题。
达成的共识是，《CONSORT清单》中的11项内容在非药物试验中需要一些修改：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（参与者流程）、项目15（基线数据）、项目20（讨论：解释）和项目21（普遍性）。此外，会议参与者添加了1项与干预措施实施相关的内容。
并非总能获得支持纳入每个清单项目的证据。
用于制定此扩展版的方法和流程可用于其他报告指南。使用此《CONSORT声明》扩展版应能提高评估非药物治疗的随机对照试验的报告质量。
