非酒精性脂肪性肝病临床指南和共识的质量评价及推荐意见比较研究

Quality Assessment and Recommendations of Clinical Guidelines and Consensuses on Non-alcoholic Fatty Liver Disease:a Comparative Study

背景非酒精性脂肪性肝病(NAFLD)是消化系统的常见疾病。随着生活水平的提高和病毒性肝炎研究的不断突破,NAFLD已取代病毒性肝炎,成为常见的慢性肝病。指南性文件能够为临床工作人员提供标准可靠的诊疗方法,筛选和制定高质量的指南性文件对规范NAFLD的临床实践具有十分重要的意义。目的分析NAFLD指南性文件的方法学质量和报告质量,并对推荐意见进行总结和比较,为未来NAFLD指南的制订及报告提供参考依据。方法计算机检索PubMed、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据知识服务平台和维普网数据库,并补充检索WHO、国际指南协作网(GIN)、英国国家临床优化研究所(NICE)、美国国立指南文库(NGC)、苏格兰院际间协作网(SIGN)、医脉通数据库(Medlive)等数据库中有关NAFLD的临床实践指南和共识,检索时限为2012-01-01—2022-01-01。由2名肝病领域研究人员筛选文献、提取资料并分别独立使用AGREEⅡ和RIGHT对纳入指南性文件的方法学质量和报告质量进行评价,并对较高质量指南性文件的推荐意见进行整理和比较。结果共纳入19篇文献,其中12篇指南、7篇共识;中文6篇、英文13篇;使用循证方法制订10篇。AGREEⅡ各领域平均得分分别为:范围与目的(42.84%)、参与人员(31.43%)、严谨性(31.25%)、清晰性(60.67%)、应用性(32.68%)、独立性(37.50%)。RIGHT各领域平均得分分别为:基本信息(59.65%)、背景(66.12%)、证据(42.11%)、推荐意见(39.85%)、评审和质量保证(17.11%)、资金资助与利益冲突声明和管理(18.42%)、其他方面(47.37%)。基于循证方法制订的指南性文件在AGREEⅡ的平均得分及RIGHT中的报告质量均高于非循证指南性文件;国外指南性文件在AGREEⅡ的平均得分及RIGHT中的报告质量均高于国内指南性文件。主要推荐意见涉及筛查与诊断、评估、管理(非药物治疗和药物治疗)以及手术治疗。结论目前已发表的NAFLD指南性文件的方法学质量及报告质量仍有待提升,国内指南性文件较国际仍有差距,中医指南性文件的制订应遵循循证方法。在指南制订和报告过程中,应进一步参考AGREEⅡ和RIGHT等国际标准。临床应提高对NAFLD高危人群的筛查意识,建立完善的早期无创诊断和评估体系,并向NAFLD患者提供针对生活方式、肝脏功能、代谢障碍的多维度治疗方案。

Background Non-alcoholic fatty liver disease(NAFLD)is a common disease of the digestive system.With the improvements of living standards and breakthroughs in viral hepatitis research,NAFLD has replaced viral hepatitis as the most common chronic liver disease.Guidance documents can provide clinical staff with standard and reliable diagnosis and treatment approaches.The screening and development of high-quality guidance documents is of great importance to standardise the clinical practice of NAFLD.Objective To analyze the methodological quality and reporting quality of guidance documents for NAFLD,summarize and compare the recommendations,so as to provide a reference for the development and report of future guidelines for NAFLD.Methods PubMed,CNKI,CBM,Wanfang Data Knowledge Service Platform,VIP Database were searched for clinical guidelines and consensuses on NAFLD supplemented by WHO,GIN,NICE,SIGN and Medlive from 2012-01-01 to 2022-01-01.Two researchers in the field of liver disease screened the literature,extracted the data and independently evaluated the methodological quality and reporting quality of the included guideline documents using AGREEⅡand RIGHT,respectively.The recommendations of the higher quality guideline documents were collated and compared by the two researchers.Results A total of 19 publications were enrolled,including 12 guidelines and 7 consensuses;6 in Chinese and 13 in English;10 of which were developed using an evidence-based approach.The average scores for each domain of AGREEⅡwere 42.84%for scope and purpose,31.43%for participants,31.25%for rigour,60.67%for clarity,32.68%for application and 37.50%for independence.The average scores of RIGHT in each area were 59.65%for basic information,66.12%for background,42.11%for evidence,39.85%for recommendations,17.11%for review and quality assurance,18.42%for funding and conflict of interest statement and management,47.37%for other aspects.The average scores in AGREEⅡand reporting qualities in RIGHT of evidence-based guidance documents were both higher than non-evidence-based guidance documents.The average scores in AGREEⅡand reporting qualities in RIGHT of foreign guidance documents were higher than domestic guidance documents.The main recommendations relate to screening and diagnosis,assessment,management(non-pharmacologic and pharmacologic treatment)and surgical treatment.Conclusion The methodological quality and reporting quality of the published guidance documents for NAFLD still need to be improved,and there are still gaps between domestic guidance documents and international guidance documents.The development of TCM guidance documents should follow an evidence-based approach.Further reference should be made to international standards such as AGREEⅡand RIGHT in the development and reporting of guidelines.Clinical screening awareness for high-risk population of NAFLD and a comprehensive system for early non-invasive diagnosis and assessment should be established.Multidimensional treatment plans for lifestyle,liver function and metabolic disorders should be provided for patients with NAFLD.