目标:作为一个人口大国,中国发布了大量的诊断标准。然而,尚未对已发表的诊断标准进行系统分析.因此,这项研究的目的是调查这些特征,开发方法,报告质量,以及中国公布的诊断标准的证据基础。
方法:从开始到2023年7月31日,我们搜索了五个数据库的诊断标准。通过摘要全文阅读筛选所有诊断标准,如果满足预定标准,则包括在内。两名研究人员独立提取了特征数据,开发方法,报告质量,和诊断标准的证据基础。
结果:共纳入143项诊断标准。在开发方法方面,涉及系统文献检索的诊断标准比例(n=2;1.4%;95%置信区间(CI),0.4%至5.0%),采用正式共识方法(n=4;2.8%;95%CI,1.1%至7.0%),和标准验证(n=9;6.3%;95%CI,3.3%至11.5%)相对较低。关于报告质量,对ACCORD检查表的平均依从性为5.1%;没有任何诊断标准在注册时报告,专家入选标准,专家招聘流程,或共识结果。大多数标准(58.7%;95%CI,50.6%至66.5%)没有引用任何研究,只有一项(0.7%;95%CI,0.1%~3.9%)标准来自系统评价.此外,只有16.1%(95%CI,11.0%~23.0%)的诊断标准使用了来自中国人群的证据.
结论:中国制定的诊断标准存在严重缺陷,特别是在证据检索中,组建专家小组,共识方法,和验证。此外,只有少数诊断标准使用了来自中国的证据或证据的系统综合。迫切需要加强制定诊断标准的方法。
OBJECTIVE: As a large and populous country, China releases a high number of diagnostic criteria. However, the published diagnostic criteria have not yet been systematically analyzed. Therefore, the aim of this
study is to investigate the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria published in China.
METHODS: We searched five databases for diagnostic criteria from their inception until July 31, 2023. All diagnostic criteria were screened through abstract and full-text reading, and included if satisfying the prespecified criteria. Two researchers independently extracted data on the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria.
RESULTS: A total of 143 diagnostic criteria were included. In terms of development methods, the proportions of diagnostic criteria that involved a systematic literature search (n = 2; 1.4%; 95% confidence interval (CI), 0.4% to 5.0%), adoption of formal consensus methods (n = 4; 2.8%; 95% CI, 1.1% to 7.0%), and criteria validation (n = 9; 6.3%; 95% CI, 3.3% to 11.5%) were relatively low. Regarding reporting quality, the average compliance with the ACCORD checklist was 5.1%; none of the diagnostic criteria reported on registration, expert inclusion criteria, expert recruitment process, or consensus results. A majority (58.7%; 95% CI, 50.6% to 66.5%) of criteria did not cite any research, and only one (0.7%; 95% CI, 0.1% to 3.9%) criterion was derived from a systematic review. Moreover, only 16.1% (95% CI, 11.0% to 23.0%) of diagnostic criteria used evidence from the Chinese population.
CONCLUSIONS: The diagnostic criteria developed in China exhibit serious flaws, particularly in evidence retrieval, formation of expert panels, consensus methods, and validation. Additionally, only few diagnostic criteria used a systematic synthesis of the evidence or evidence from the China. There is an urgent need to enhance the methodology for developing diagnostic criteria.