炎症性肠病随机对照试验的报告质量:系统综述

IF 3.3 Q2 GASTROENTEROLOGY & HEPATOLOGY
Morris Gordon, Jamal Khudr, Vassiliki Sinopoulou, Svetlana Lakunina, Aditi Rane, Anthony Akobeng
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引用次数: 0

摘要

目标 我们的目的是对已发表的有关炎症性肠病(IBD)的随机对照试验(RCT)报告的偏倚风险进行系统评估。设计 我们使用 Cochrane 工具评估了偏倚风险,将其作为方法不当或随后报告不当的指标。我们通过双重独立判断,系统地选择了所有已发表的无时间限制的 IBD 研究,并再次通过独立的双重评分对纳入研究的方法学质量进行了评估。结果 经过筛选和审查,共纳入 563 篇全文。没有一篇摘要出版物不存在任何偏见。全文出版物的表现仍然不佳,因为在排除盲法的情况下,只有 103 篇全文论文在所有报告领域的偏倚风险都较低。在影响因子(IF)较高的期刊上发表的 RCT 论文总体上降低了高风险率。然而,在过去 5 年中,在影响因子大于 10 的期刊上发表的 RCT 论文中,只有 6% 不存在偏倚。随着时间的推移,所有领域的报告都有改进的趋势。作者团队规模较大、以全文形式发表的试验以及获得行业和公共赞助的试验与较低的偏倚风险呈正相关。随着时间的推移,只有分配隐藏在统计学上有显著改善(p=0.037)。结论 这些发现与其他专业的文献一致。虽然这种不明确的偏倚风险可能是方法报告不完善而不是方法质量不高,但它给读者和未来的二次研究人员留下了有关这些关键问题的重大疑问。数据可在合理要求下提供。所有与研究相关的数据都包含在文章中或作为补充信息上传。综述协议已上传至资料库(资料库 ID:33117)。更多的方法论内容和结果载于附录。其他数据可应合理要求提供。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quality of reporting inflammatory bowel disease randomised controlled trials: a systematic review
Objective Our objective was to perform a systemic evaluation of the risk of bias in randomised controlled trial (RCT) reports published on inflammatory bowel disease (IBD). Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher impact factor (IF) were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialties in the literature. While this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues. Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The protocol for the review has been uploaded to a repository (Repository ID: 33117). Further methodological components and results are included in the appendix. Other data are available upon reasonable request.
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来源期刊
BMJ Open Gastroenterology
BMJ Open Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
5.90
自引率
3.20%
发文量
68
审稿时长
2 weeks
期刊介绍: BMJ Open Gastroenterology is an online-only, peer-reviewed, open access gastroenterology journal, dedicated to publishing high-quality medical research from all disciplines and therapeutic areas of gastroenterology. It is the open access companion journal of Gut and is co-owned by the British Society of Gastroenterology. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around continuous publication, publishing research online as soon as the article is ready.
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