Department of Digestive Surgery, Rouen University Hospital, Rouen, France.
UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.
Langenbecks Arch Surg. 2022 Dec;407(8):3793-3802. doi: 10.1007/s00423-022-02649-8. Epub 2022 Aug 27.
Randomized controlled trials (RCTs) are the gold standard tool used to evaluate therapeutic interventions. The published results showed that progress still needs to be made not only from a methodological point of view but also from an ethical point of view. The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in surgery over the last few years.
All of the articles chosen for review reported on randomized controlled surgical trials and were published in 10 international journals between 2016 and 2020. Eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. Methodological quality was evaluated using the Jadad scale, and ethical quality was evaluated using the Berdeu score.
The methodological quality score (Jadad scale) ranged from 5 to 13, with a mean of 10.0 ± 1.54. The methodological quality was insufficient (score ≤ 9) for 162 trials (31.2%). The ethical quality score ranged from 0.25 to 1, with a mean of 0.8 ± 0.11. Fifty-two articles (10%) did not state that informed consent was requested from the participants, and 21 articles (4%) did not report either research ethics committee or institutional committee protocol approval.
The randomized clinical surgical trials analyzed showed that they had satisfactory methods in only 70% of the cases and that they had respected the fundamental ethical principles in 90% of the cases. However, less than 8% of the studies reported planned interim analysis, prospectively defined stopping rules, and independent monitoring committee.
随机对照试验（RCT）是评估治疗干预措施的金标准工具。已发表的结果表明，不仅需要从方法学角度，还需要从伦理角度取得进展。本研究旨在评估过去几年外科领域随机临床试验的方法学和伦理质量。
所有纳入的综述文章均为随机对照外科试验，并于 2016 年至 2020 年在 10 种国际期刊上发表。根据一套广泛的预设标准，识别、选择和评估合格研究。使用 Jadad 量表评估方法学质量，使用 Berdeu 评分评估伦理质量。
方法学质量评分（Jadad 量表）范围为 5 至 13 分，平均为 10.0±1.54 分。162 项试验（31.2%）方法学质量不足（评分≤9 分）。伦理质量评分范围为 0.25 至 1 分，平均为 0.8±0.11 分。52 篇文章（10%）未说明已向参与者请求知情同意，21 篇文章（4%）未报告研究伦理委员会或机构委员会方案批准。
分析的随机临床外科试验表明，仅 70%的试验采用了令人满意的方法，90%的试验尊重了基本伦理原则。然而，不到 8%的研究报告了计划的中期分析、前瞻性定义的停止规则和独立监测委员会。
