诊断试验中纳入、排除标准的报告质量评价

Quality evaluation of reports on inclusion and exclusion criteria in diagnostic tests

目的通过分析近5年北京大学图书馆“中文核心期刊”中诊断试验纳入、排除标准的报告质量,发现存在的问题,规范纳入、排除标准的报告方式。方法遴选北大核心目录下临床医学类期刊,检索2017年1月1日至2022年6月7日的诊断试验,提取纳入、排除标准,统计研究中缺失纳入、排除标准的篇数,分析纳入、排除标准的报告内容和书写位置,结合诊断准确性研究报告标准和诊断准确性研究的质量评价工具-2,发现存在的问题。结果共纳入226篇诊断试验,其中74篇既无纳入标准也无排除标准,97篇缺少纳入标准,91篇缺少排除标准;书写位置上,120篇将纳入、排除标准置于一般资料之前,33篇置于一般资料之后;有28篇将纳入标准的反面写入排除标准,形成“互补型”条件的情况。结论目前诊断试验中的纳入、排除标准存在内容欠完整、位置不统一、内容重复的问题。本研究提出规范纳入、排除标准的三点要求,并初步拟定纳入、排除标准书写范式。

Objective To analyze the quality of reports on inclusion and exclusion criteria from Chinese Core Journals of Peking University Library in the past five years,to find out the existing problems and to standardize the reports on inclusion and exclusion criteria.Methods We selected the clinical medical journals under the core catalog of Peking University,searched the diagnostic tests from January 1,2017 to June 7,2022,identified the inclusion and exclusion criteria,counted the number of articles missing inclusion and exclusion criteria,and analyzed the content and writing position of criteria.Standards of research reports on quality accuracy studies and quality evaluation tools of diagnostic accuracy studies 2 were also taken into consideration to identify the existing problems.Results A total of 226 diagnostic test reports were included in our study,in which there were neither inclusion nor exclusion criteria in 74 articles,no inclusion criteria in 97 and no exclusion criteria in 91.In terms of writing position,eligibility criteria reports were located before the general data in 120 articles,and after the general data in 33 articles.The exclusion criteria in 28 articles were the reverse side of inclusion criteria to form a"complementary"condition.Conclusion Incomplete reporting,inconsistent position,and duplicated contents are the three major problems in reports on inclusion and exclusion criteria.We thus proposed three requirements and drafted the writing from.