Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.
Department of Evidence-Based Medicine and Clinical Epidemiology, The Second Clinical College, Wuhan University, Wuhan, China.
BMC Med Res Methodol. 2020 Jun 17;20(1):160. doi: 10.1186/s12874-020-01041-8.
Clinical practice guidelines have become increasingly widely used to guide quality improvement of clinical practice. Qualitative research may be a useful way to improve the quality and implementation of guidelines. The methodology for qualitative evidence used in guidelines development is worthy of further research.
A comprehensive search was made of WHO, NICE, SIGN, NGC, RNAO, PubMed, Embase, Web of Science, CNKI, Wanfang, CBM, and VIP from January 1, 2011 to February 25, 2020. Guidelines which met IOM criteria and were focused on clinical questions using qualitative research or qualitative evidence, were included. Four authors extracted significant information and entered this onto data extraction forms. The Appraisal of Guidelines for Research and Evaluation (AGREE II) tool was used to evaluate the guidelines' quality. The data were analyzed using SPSS version 17.0 and R version 3.3.2.
Sixty four guidelines were identified. The overall quality of the guidelines was high (almost over 60%). Domain 1 (Scope and Purpose) was ranked the highest with a median score of 83% (IQ 78-83). Domain 2 (Stakeholder involvement) and Domain 5 (Applicability) were ranked the lowest with median scores of 67% (IQ 67-78) and 67% (IQ 63-73) respectively. 20% guidelines used qualitative research to identify clinical questions. 86% guidelines used qualitative evidence to support recommendations (mainly based on primary studies, a few on qualitative evidence synthesis). 19% guidelines applied qualitative evidence when considering facilitators and barriers to recommendations' implementation. 52% guideline developers evaluated the quality of the primary qualitative research study using the CASP tool or NICE checklist for qualitative studies. No guidelines evaluated the quality of qualitative evidence synthesis to formulate recommendations. 17% guidelines presented the level of qualitative research using the grade criteria of evidence and recommendation in different forms such as I, III, IV, very low. 28% guidelines described the grades of the recommendations supported by qualitative and quantitative evidence. No guidelines described the grade of recommendations only supported by qualitative evidence.
The majority of the included guidelines were high-quality. Qualitative evidence was mainly used to identify clinical questions, support recommendations, and consider facilitators and barriers to implementation of recommendations'. However, more attention needs to be paid to the methodology. For example, no experts proficient in qualitative research were involved in guideline development groups, no assessment of the quality of qualitative evidence synthesis was included and there was lack of details reported on the level of qualitative evidence or grade of recommendations.
临床实践指南已被广泛用于指导临床实践质量的改进。定性研究可能是提高指南质量和实施的一种有用方法。指南制定中定性证据的方法学值得进一步研究。
从 2011 年 1 月 1 日至 2020 年 2 月 25 日，全面检索了世界卫生组织、英国国家卫生与临床优化研究所、苏格兰院际指南网、加拿大安大略注册护士协会、中国国家卫生健康委员会、PubMed、Embase、Web of Science、中国知网、万方数据知识服务平台、中国生物医学文献数据库和维普网。纳入符合 IOM 标准、使用定性研究或定性证据的、以临床问题为重点的指南。四位作者提取重要信息并将其输入数据提取表中。使用 AGREE II 工具评估指南的质量。使用 SPSS 版本 17.0 和 R 版本 3.3.2 分析数据。
共确定了 64 条指南。指南的总体质量较高（几乎超过 60%）。领域 1（范围和目的）得分最高，中位数为 83%（IQ 78-83）。领域 2（利益相关者参与）和领域 5（适用性）得分最低，中位数分别为 67%（IQ 67-78）和 67%（IQ 63-73）。20%的指南使用定性研究来确定临床问题。86%的指南使用定性证据支持建议（主要基于原始研究，少数基于定性证据综合）。19%的指南在考虑建议实施的促进因素和障碍时应用了定性证据。52%的指南开发人员使用 CASP 工具或 NICE 定性研究检查表评估原始定性研究的质量。没有指南评估定性证据综合的质量以制定建议。17%的指南使用不同形式的证据和推荐等级标准，如 I、III、IV、极低，报告了定性研究的质量。28%的指南描述了定性和定量证据支持的推荐等级。没有指南描述仅由定性证据支持的推荐等级。
大多数纳入的指南质量较高。定性证据主要用于确定临床问题、支持建议以及考虑建议实施的促进因素和障碍。然而，需要更加关注方法学。例如，指南制定小组中没有精通定性研究的专家，没有纳入对定性证据综合质量的评估，也缺乏关于定性证据水平或推荐等级的详细报告。
