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报告质量和偏倚风险:职业健康随机试验综述。

Quality of reporting and risk of bias: a review of randomised trials in occupational health.

机构信息

Department of Public and Occupational Health, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC Location AMC, Amsterdam, The Netherlands

Occupational health department, Finnish Institute of Occupational Health (FIOH), Kuopio Regional Office, Kuopio, Finland.

出版信息

Occup Environ Med. 2021 Sep;78(9):691-696. doi: 10.1136/oemed-2020-107038. Epub 2021 Jun 23.

Abstract

OBJECTIVES

To assess the reporting quality of randomisation and allocation methods in occupational health and safety (OHS) trials in relation to Consolidated Standards of Reporting Trials (CONSORT) requirements of journals, risk of bias (RoB) and publication year.

METHODS

We systematically searched for randomised controlled trials (RCTs) in PubMed between 2010 and May 2019 in 18 OHS journals. We measured reporting quality as percentage compliance with the CONSORT 2010 checklist (items 8-10) and RoB with the ROB V.2.0 tool (first domain). We tested the mean difference (MD) in % in reporting quality between CONSORT-requiring and non-requiring journals, trials with low, some concern and high RoB and publications before and after 2015.

RESULTS

In 135 articles reporting on 129 RCTs, average reporting quality was at 37.4% compliance (95% CI 31.9% to 43.0%), with 10% of articles reaching 100% compliance. Reporting quality was significantly better in CONSORT-requiring journals than non-requiring journals (MD 31.0% (95% CI 21.4% to 40.7%)), for studies at low RoB than high RoB (MD 33.1% (95% CI 16.1% to 50.2%)) and with RoB of some concern (MD 39.8% (95% CI 30.0% to 49.7%)). Reporting quality did not improve over time (MD -5.7% (95% CI -16.8% to 5.4%).

CONCLUSIONS

Articles in CONSORT-requiring journals and of low RoB studies show better reporting quality. Low reporting quality is linked to unclear RoB judgements (some concern). Reporting quality did not improve over the last 10 years and CONSORT is insufficiently implemented. Concerted efforts by editors and authors are needed to improve CONSORT implementation.

摘要

目的

评估职业健康与安全(OHS)试验中随机化和分配方法的报告质量与期刊 CONSORT 要求、偏倚风险(RoB)和出版年份的关系。

方法

我们系统地在 PubMed 中检索了 2010 年至 2019 年 5 月期间的 18 种 OHS 期刊中的随机对照试验(RCT)。我们通过 CONSORT 2010 清单(项目 8-10)的百分比符合率和 ROB V.2.0 工具(第一域)来衡量报告质量。我们测试了 CONSORT 要求期刊和非要求期刊、低、中度和高度 RoB 试验以及 2015 年前后发表的文献之间报告质量的差异(MD)。

结果

在 135 篇报告 129 项 RCT 的文章中,平均报告质量为 37.4%的符合率(95%置信区间 31.9%至 43.0%),其中 10%的文章达到了 100%的符合率。在 CONSORT 要求期刊和非要求期刊、低 RoB 研究和高 RoB 研究以及中度 RoB 研究之间(MD 31.0%(95%置信区间 21.4%至 40.7%)),报告质量有显著差异。报告质量随着 RoB 的降低而提高(MD 33.1%(95%置信区间 16.1%至 50.2%))和 RoB 的中度关注(MD 39.8%(95%置信区间 30.0%至 49.7%))。报告质量没有随着时间的推移而改善(MD-5.7%(95%置信区间-16.8%至 5.4%))。

结论

CONSORT 要求期刊和低 RoB 研究的文章显示出更好的报告质量。低报告质量与不明确的 RoB 评估(中度关注)有关。在过去的 10 年中,报告质量没有得到改善,CONSORT 的实施也不够充分。编辑和作者需要共同努力,提高 CONSORT 的实施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5a5/8380877/4a2235d53411/oemed-2020-107038f01.jpg

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