Primary Care Health Sciences, University of Oxford, Oxford, UK
Primary Care Health Sciences, University of Oxford, Oxford, UK.
BMJ Evid Based Med. 2022 Apr;27(2):120-124. doi: 10.1136/bmjebm-2020-111489. Epub 2021 Feb 1.
Clinicians and lay people tend to overestimate the effectiveness of a treatment when only the relative effect is presented, particularly if the relative effect is large, but the absolute effect is small. In recognition of this problem, item 17b of The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement stipulates authors present both absolute and relative effects for binary outcomes in randomised controlled trials (RCTs). Adherence to item 17b and the effect of differing levels of CONSORT endorsement by journals on adherence is not well known. We assessed the extent to which item 17b is adhered to in 258 RCTs published in five leading medical journals (, , , and ) between January and December 2019 that all endorsed the CONSORT statement to varying degrees. Only 53 of 258 (20.5%; 95% CI 15.8% to 26.0%) included studies adhered fully to item 17b. Proportional adherence was higher in journals that endorsed the statement more strictly ( and , 47.4% [34.0% to 61.0%]) compared with journals less strict in their endorsement ( and , 12.2% [7.0% to 19.3%]; , 14.1% [7.3% to 23.8%]). Journals that only recommend author adherence to CONSORT had a greater proportion of studies reporting only relative effects in the main results section (62.6%) and abstract (64.2%) compared with journals that require authors to submit a completed checklist (24.6% and 29.8%, respectively). The majority of RCTs (79.5%) with binary primary outcomes published in five leading medical journals during 2019 do not report both absolute and relative effect estimates as per item 17b of the CONSORT guideline despite its universal endorsement. Differences in adherence were observed between journals that endorsed the CONSORT statement to differing extents.
临床医生和非专业人士往往会高估治疗效果，尤其是当只呈现相对效果时，尤其是当相对效果较大而绝对效果较小时。为了认识到这个问题，2010 年 CONSORT 报告标准（CONSORT）声明的第 17b 项规定，作者应在随机对照试验（RCT）中报告二分类结局的绝对和相对效果。不同程度地遵守第 17b 项和期刊对 CONSORT 认可的影响尚不清楚。我们评估了在 2019 年 1 月至 12 月期间在五家主要医学期刊（、、、和）上发表的 258 项 RCT 中，第 17b 项的遵守程度，这些期刊均在不同程度上认可了 CONSORT 声明。只有 258 项中的 53 项（20.5%；95%置信区间 15.8%至 26.0%）包含完全遵守第 17b 项的研究。在更严格地认可该声明的期刊中（和，47.4%[34.0%至 61.0%]），比例性遵守率高于认可程度较低的期刊（和，12.2%[7.0%至 19.3%]；，14.1%[7.3%至 23.8%]）。仅建议作者遵守 CONSORT 的期刊，在主要结果部分（62.6%）和摘要（64.2%）中报告相对效果的研究比例高于要求作者提交完整清单的期刊（分别为 24.6%和 29.8%）。尽管 CONSORT 指南的第 17b 项得到普遍认可，但在 2019 年期间，五家主要医学期刊发表的二分类主要结局 RCT 中，大多数（79.5%）未报告绝对和相对效果估计值。在对 CONSORT 声明的认可程度不同的期刊之间观察到了遵守情况的差异。
