1965-2023年间中国诊断标准的特点、制定方法、报告质量和证据基础：一项横断面研究。

IF 3.6 2区医学 Q1 MEDICINE, GENERAL & INTERNAL

Journal of Evidence‐Based Medicine Pub Date : 2024-06-21 DOI:10.1111/jebm.12624

Qi Zhou, Hongfeng He, Qinyuan Li, Janne Estill, Zhengxiu Luo, Kehu Yang, Jinling Tang, Yaolong Chen

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引用次数: 0

摘要

目的：作为一个人口众多的大国，中国发布了大量的诊断标准。然而，目前尚未对已发布的诊断标准进行系统分析。因此，本研究旨在调查中国发布的诊断标准的特点、制定方法、报告质量和证据基础：方法：我们检索了五个数据库中自始至 2023 年 7 月 31 日的诊断标准。通过摘要和全文阅读对所有诊断标准进行筛选，如果符合预设标准则纳入。两名研究人员独立提取了诊断标准的特征、制定方法、报告质量和证据基础等方面的数据：结果：共纳入了 143 项诊断标准。在制定方法方面，涉及系统文献检索（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%）的诊断标准比例相对较低。在报告质量方面，ACCORD 检查表的平均符合率为 5.1%；没有一项诊断标准报告了注册、专家纳入标准、专家招募过程或共识结果。大多数标准（58.7%；95% CI，50.6% 至 66.5%）没有引用任何研究，只有一项标准（0.7%；95% CI，0.1% 至 3.9%）来自系统综述。此外，只有 16.1%（95% CI，11.0% 至 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，尤其是在证据检索、专家小组的组建、共识方法和验证方面。此外，只有少数诊断标准使用了系统的证据综合或来自中国的证据。制定诊断标准的方法亟待改进。

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The characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria in China between 1965 and 2023: A cross-sectional study

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.

Conclusion

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.

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来源期刊

Journal of Evidence‐Based Medicine MEDICINE, GENERAL & INTERNAL-

CiteScore

11.20

自引率

1.40%

发文量

期刊介绍： The Journal of Evidence-Based Medicine (EMB) is an esteemed international healthcare and medical decision-making journal, dedicated to publishing groundbreaking research outcomes in evidence-based decision-making, research, practice, and education. Serving as the official English-language journal of the Cochrane China Centre and West China Hospital of Sichuan University, we eagerly welcome editorials, commentaries, and systematic reviews encompassing various topics such as clinical trials, policy, drug and patient safety, education, and knowledge translation.