妊娠期高血压疾病指南循证评价

Evidence-based evaluation of guidelines for hypertensive disorders of pregnancy

目的对国内外妊娠期高血压疾病(hypertensive disorders of pregnancy, HDP)相关指南进行量化评分, 为未来HDP管理指南的发布提供参考意见。方法通过医学主题词和关键字"妊娠期高血压疾病""子痫前期""子痫""指南""hypertension in pregnancy""hypertensive disorders of pregnancy""pre-eclampsia""eclampsia""guidelines"在中国知网、万方数据库、中华医学期刊全文数据库、维普中文期刊、PubMed、Embase和Web of Science等数据库中检索2018年1月1日至2022年12月31日发表的HDP相关指南。按照指南评价工具临床指南研究与评估系统Ⅱ(The Appraisal of Guidelines for Research and Evaluation Ⅱ, AGREE Ⅱ), 以及科学性(Scientific)、透明性(Transparent)和适用性(Applicable)的评级(Rankings)(以下简称STAR)指南评价工具分别对纳入指南进行评价。AGREE Ⅱ指南评价工具评价相关指南时, 通过2名研究人员根据AGREE Ⅱ使用手册中的评价表对每个条目进行评分, 最终得出范围和目的、参与人员、严谨性、清晰性、应用性及独立性6个领域平均标准化评分及总体评价得分。STAR指南评价工具评价相关指南时, 按照评价工具手册建议, 通过2名研究人员及1名方法学人员根据STAR评价工具手册进行评分, 对每个条目进行赋值, 最终得出注册、计划书、资助、工作组、利益冲突、临床问题、证据、共识方法、推荐意见、可及性及其他方面11个领域的领域得分率及总分。结果共纳入HDP相关指南19篇, 覆盖3个洲6个国家。AGREE Ⅱ评价系统结果显示, 纳入文献的范围和目的、参与人员、严谨性、清晰性、应用性和独立性6个领域平均标准化评分分别为73.98%、63.16%、59.98%、66.37%、56.36%及71.93%。STAR评价工具结果显示, 注册、计划书、资助、工作组、利益冲突、临床问题、证据, 共识方法、推荐意见、可及性和其他方面11个领域得分率分别为0.00%、0.00%、76.15%、39.87%、58.92%、65.19%、60.80%、49.78%、78.95%、30.89%及42.11%。12篇为强烈推荐, 7篇为建议修改。多数指南在阿司匹林预防子痫前期、重度高血压患者药物治疗方式以及子痫前期患者终止妊娠时机三方面达成一致推荐, 其推荐一致率分别为10/13、9/13、9/13, 且有较为充足的证据作为支撑。结论国内外HDP相关指南整体质量较高, 仍有改进空间。在未来制订相关指南过程中应注意指南撰写成员中除了相关专业领域专家, 也可包括统计学专家和指南方法学专家以提高指南循证质量, 同时应注意利益冲突的披露。在计划发布指南时进行注册并撰写计划书。开发不同用户版本可以更好地提高HDP的管理效果。

Objective To quantitatively evaluate the guidelines for hypertensive disorders of pregnancy(HDP)at home and abroad,and to provide a reference for the development of related guidelines in the future.Methods Guidelines related to HDP published at home and abroad from 1 January 2018 to 31 December 2022 were retrieved from several databases,including CNKI,Wanfang Database,Yiigle,VIP Database,PubMed,Embase,and Web of Science with the terms of"hypertension in pregnancy","hypertensive disorders of pregnancy","pre-eclampsia","eclampsia",and"guidelines".The retrieved guidelines were evaluated with the Appraisal of Guidelines for Research and EvaluationⅡ(AGREEⅡ)and Scientific,Transparent and Applicable Rankings(STAR)tool.According to the manual of AGREEⅡtwo researchers graded the retrieved guidelines from six domains:scope and purpose,participants,rigor,clarity,applicability,and independence.Mean standardized score of each domain and the overall score were obtained.STAR tool was used to grade the guidelines by two researchers and one methodologist from 11 domains:registration,protocol,funding,working groups,conflicts of interest,clinical issues,evidence,consensus methods,recommendations,accessibility,and others.Results A total of 19 related guidelines were included,covering six countries on three continents.The mean standardized scores of the 19 guidelines in the six domains of scope and purpose,participants,rigor,clarity,applicability,and independence using the AGREE II instrument were 73.98%,63.16%,59.98%,66.37%,56.36%,and 71.93%,respectively.Scores in the 11 domains of registration,protocol,funding,working groups,conflicts of interest,clinical issues,evidence,consensus methods,recommendations,accessibility,and others using the STAR tool were 0.00%,0.00%,76.15%,39.87%,58.92%,65.19%,60.80%,49.78%,78.95%,30.89%,and 42.11%,respectively.According to the overall evaluation results,12 guidelines were recommended and seven needed further modifications.It was found that most guidelines were unanimous in their recommendations on the prevention of preeclampsia with aspirin,medications for patients with severe hypertension,and the timing of pregnancy termination in preeclampsia patients,with the consensus rates of 10/13,9/13,and 9/13,respectively.Besides,these recommendations were supported by substantial evidence.Conclusions The overall quality of guidelines related to HDP at home and abroad is high,but there is still room for improvement.When developing relevant guidelines in the future,statisticians and methodologists should be included in the working groups to improve the evidence-based quality,and much attention should be paid to the disclosure of conflicts of interest guidelines.Registration and protocol are needed before publishing a guideline.The development of multiple versions for different users will conduce to improving the management of HDP.