Gewandter Jennifer S, Eisenach James C, Gross Robert A, Jensen Mark P, Keefe Francis J, Lee David A, Turk Dennis C
Department of Anesthesiology, University of Rochester, Rochester, NY.
Departments of Anesthesiology and Physiology & Pharmacology, Wake Forest, Winston-Salem, NC.
Pain Rep. 2019 May-Jun;4(3):e621. doi: 10.1097/PR9.0000000000000621. Epub 2017 Sep 13.
Randomized clinical trials (RCTs) are considered the gold standard when assessing the efficacy of interventions because randomization of treatment assignment minimizes bias in treatment effect estimates. However, if RCTs are not performed with methodological rigor, many opportunities for bias in treatment effect estimates remain. Clear and transparent reporting of RCTs is essential to allow the reader to consider the opportunities for bias when critically evaluating the results. To promote such transparent reporting, the Consolidated Standards of Reporting Trials (CONSORT) group has published a series of recommendations starting in 1996. However, a decade after the publication of the first CONSORT guidelines, systematic reviews of clinical trials in the pain field identified a number of common deficiencies in reporting (e.g., failure to identify primary outcome measures and analyses, indicate clearly the numbers of participants who completed the trial and were included in the analyses, or report harms adequately).
Qualitative review of a diverse set of published recommendations and systematic reviews that addressed the reporting of clinical trials, including those related to all therapeutic indications (e.g., CONSORT) and those specific to pain clinical trials.
A checklist designed to supplement the content covered in the CONSORT checklist with added details relating to challenges specific to pain trials or found to be poorly reported in recent pain trials was developed.
Authors and reviewers of analgesic RCTs should consult the CONSORT guidelines and this checklist to ensure that the issues most pertinent to pain RCTs are reported with transparency.
在评估干预措施的疗效时，随机临床试验（RCT）被视为金标准，因为治疗分配的随机化可将治疗效果估计中的偏差降至最低。然而，如果随机临床试验的实施缺乏方法学严谨性，治疗效果估计中仍存在许多偏差机会。清晰、透明地报告随机临床试验对于读者在批判性评估结果时考虑偏差机会至关重要。为促进这种透明报告，报告试验的统一标准（CONSORT）小组自1996年起发布了一系列建议。然而，在首版CONSORT指南发布十年后，对疼痛领域临床试验的系统评价发现了报告中的一些常见缺陷（例如，未确定主要结局指标和分析方法，未明确指出完成试验并纳入分析的参与者数量，或对危害的报告不充分）。
对一系列已发表的关于临床试验报告的建议和系统评价进行定性综述，包括与所有治疗适应症相关的建议（如CONSORT）以及疼痛临床试验特有的建议。
制定了一份清单，旨在补充CONSORT清单所涵盖的内容，并增加与疼痛试验特有的挑战或近期疼痛试验中报告不足的方面相关的详细信息。
镇痛随机临床试验的作者和审稿人应参考CONSORT指南和本清单，以确保透明地报告与疼痛随机临床试验最相关的问题。
