2019年期刊公开发表的中国临床实践指南文献调查与评价——研究空白

  目的  调查2019年期刊公开发表的中国临床实践指南中研究空白的报告情况, 并提出针对性建议, 以期促进指南研究空白报告的规范性和清晰性。  方法  系统检索并筛选2019年期刊公开发表的中国临床实践指南, 纳入报告研究空白的指南, 提取相关信息并进行整理和分析。  结果  2019年期刊公开发表的中国临床实践指南共226篇, 其中27篇(11.9%)报告了研究空白, 共报告78条研究空白, 中位报告条数为2条(范围: 1~10条)。报告研究空白的指南中, 11篇指南的研究空白出现在"待解决问题""未来研究的优先建议"和"对未来研究的建议"等独立部分, 16篇指南的研究空白融合在"总结""讨论"和"结语"等部分。具体内容方面, 主要涉及疗效(15.4%, 12/78)、安全性(12.8%, 10/78)、新方法/新方案/新技术/新产品(10.3%, 8/78)和生物标志物(9.0%, 7/78)。清晰性方面, 按照PICO (population, intervention, comparison, outcomes)原则解构后, 45条(57.7%, 45/78)研究空白包括其中2个或2个以上要素。  结论  2019年期刊公开发表的中国临床实践指南中, 研究空白的报告率和清晰性均有待提高, 研究空白出现的位置不固定, 建议指南制订者在指南中独立报告研究空白并力求做到规范、全面、清晰, 以期能够为未来研究指明方向。

Investigation and Evaluation of Chinese Clinical Practice Guidelines Published in Medical Journals in 2019:Research Gaps

  Objective  To investigate the reporting of research gaps in Chinese clinical practice guidelines published in medical journals in 2019 and to make targeted suggestions for standardising and clearly reporting research gaps.  Methods  We systematically reviewed Chinese clinical practice guidelines published in medical journals in 2019, extracted and analyzed information relevant to research gaps.  Results  Of the 226 guidelines published in 2019, 27 guidelines (11.9%) reported a total of 78 research gaps, and the median number of reports was 2(range: 1 to 10). Of these guidelines, 11 guidelines presented research gaps in separate sections such as "problems to be solved" "priority suggestions for future research "or" suggestions for future research ", while 16 guidelines integrated research gaps into other sections, such as" summary" "discussion" or "epilogue". In terms of content, the main focuses are on efficacy (15.4%, 12/78), safety (12.8%, 10/78), new methods/solutions/technologies/products (10.3%, 8/78) and biomarkers (9.0%, 7/78). In terms of clarity, only 45 research gaps (57.7%, 45/78) were deconstructed to include 2 or more of these elements according to the PICO (P, population; I, intervention; C, comparison; O, outcomes) principles.  Conclusions  The reporting rate and the clarity of research gaps in the 2019 Chinese guidelines need to be improved, and the location of research gaps is not fixed. It is recommended that guideline developers independently report on research gaps in the guideline and aim to make it standard, comprehensive and clear, so as to provide direction for future researches.