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遵守 CONSORT 声明和扩展用于肥胖手术随机对照试验中非药物治疗:系统调查。

Adherence to the CONSORT statement and extension for nonpharmacological treatments in randomized controlled trials of bariatric surgery: A systematic survey.

机构信息

Evidence-based Medicine Research Centre, Jiangxi University of Traditional Chinese Medicine, Nanchang, China.

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.

出版信息

Obes Rev. 2021 Aug;22(8):e13252. doi: 10.1111/obr.13252. Epub 2021 Apr 4.

DOI:10.1111/obr.13252
PMID:33817962
Abstract

Reporting is critical for establishing the value of randomized controlled trials (RCTs). This study evaluated the adherence of bariatric surgery RCT reporting to the CONsolidated Standards Of Reporting Trials (CONSORT) statement 2010 and its 2017 extension for non-pharmacologic treatments (NPT extension). We identified all RCTs comparing bariatric surgery with conservational therapy or alternative bariatric surgery up to June 30, 2020. Reporting quality was assessed using criteria developed from the CONSORT statement and the NPT extension and scored as a percentage. The factors associated with reporting quality were explored by univariate and multivariate analysis. In total, 102 RCTs of bariatric surgery were included. The median scores according to the CONSORT statement and NPT extension were 63.3 and 26.8 of a maximum possible 100, respectively. Two-thirds of NPT extension items were reported in less than 25% of the RCTs. The median score improved over time for the CONSORT statement but not the NPT extension. A higher CONSORT score was associated with publication in core clinical journals, protocol registration, and funding. No factors associated with the NPT extension score were identified. Substantial efforts are warranted from authors, journals, registration platforms, and funders to overcome the flaws in the reporting of bariatric surgery RCTs.

摘要

报告对于确定随机对照试验 (RCT) 的价值至关重要。本研究评估了减重手术 RCT 报告对 CONSORT 声明 2010 年及其 2017 年非药物治疗扩展版 (NPT 扩展版) 的依从性。我们确定了截至 2020 年 6 月 30 日比较减重手术与保守治疗或替代减重手术的所有 RCT。使用 CONSORT 声明和 NPT 扩展版制定的标准评估报告质量,并以百分比评分。通过单变量和多变量分析探讨了与报告质量相关的因素。总共纳入了 102 项减重手术 RCT。根据 CONSORT 声明和 NPT 扩展版,最高得分为 100 分,中位数评分为 63.3 分和 26.8 分。不到 25%的 RCT 报告了 NPT 扩展版的二分之一以上项目。CONSORT 声明的中位数评分随时间增加而提高,但 NPT 扩展版则不然。更高的 CONSORT 评分与在核心临床期刊上发表、方案注册和资助有关。未确定与 NPT 扩展评分相关的因素。作者、期刊、注册平台和资助者需要做出巨大努力,以克服减重手术 RCT 报告中的缺陷。

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