肝硬化指南方法学和报告质量评价

The Methodology and Reporting Quality Assessment of the Clinical Practice Guidelines for Liver Cirrhosis

目的:运用指南研究与评价Ⅱ(AGREEⅡ)工具及RIGHT清单评价和分析肝硬化临床实践指南的方法学和报告质量,为未来肝硬化指南的制定与报告提供参考和借鉴。方法:系统检索PubMed、EMBASE、CBM、CNKI和Wanfang 5个数据库,以及GIN、SIGN、NGC、NICE 4个指南数据库,并补充检索医脉通网站。两名研究人员独立筛选文献、提取数据,遇到分歧讨论解决或咨询第三方。运用AGREEⅡ工具和RIGHT清单评价纳入指南的方法学和报告质量,并计算组内相关系数(ICC)值评价两名研究人员运用AGREEⅡ工具评价指南的一致性。结果:共纳入9篇指南。纳入指南发表于2012—2016年,主要来自6个国家,其中日本最多(3篇,33.3%)。8篇(88.9%)指南发表于期刊,1篇(11.1%)来自NICE指南数据库。ICC值为0.895[95%CI(0.872,0.923),P=0.013]。纳入指南6个领域得分依次为范围和目的(34.9%,SD=14.0%)、参与人员(26.5%,SD=18.4%)、制定严谨性(44.4%,SD=12.1%)、表达明晰性(59.9%,SD=13.6%)、应用性(18.8%,SD=8.9%)和编辑独立性(51.9%,SD=16.0%)。纳入指南的平均得分为12.9(SD=2.5),范围为9.5～17.5分。报告充分比例大于50%的条目共7条。结论:超过75%的肝硬化指南于近两年发表,大部分指南来自于亚洲。与国际平均水平相比,肝硬化指南在"表达明晰性"、"制定严谨性"和"编辑独立性"领域的AGREE评分相近或更高,但其余领域的得分均较低。肝硬化指南RIGHT的平均得分较低,且超过一半的条目上未报告的比例大于50%。

Objective:To evaluate and analyze the methodology and reporting quality of the clinical practice guidelines for liver cirrhosis by the AGREE Ⅱinstrument and RIGHT checklist,in order to give reference for the formulation and report of guidelines for liver cirrhosis in the future. Methods:We systematically searched five general databases,including PubMed,EMBASE, Chinese Biomedical Literature Database(CBM),Wanfang database,and China National Knowledge Infrastructure(CNKI),and four guidelines databases,namely,Guidelines International Network(GIN),Scottish Intercollegiate Guidelines Network(SIGN),National Guideline Clearinghouse(NGC)and National Institute for Health and Clinical Excellence(NICE).Additionally,we also searched the website of Yimaitong.Two independent reviewers screened and extracted data.When meeting the disagreement, we solved it by discussion or consultation with a third reviewer.Two reviewers evaluated methodology and reporting quality of the included guidelines by AGREE Ⅱ instrument and RIGHT checklist.The consistency was assessed by the ICC value. Results: Nine guidelines were included. These guidelines were published from 2012 to 2016, and mainly from six countries, particularly Japan(three guidelines,33.3%). Eight guidelines(88.9%) were from journals,and one guideline(11.1%) was from the NICE.The consistency between two assessors was high,ICC value was 0.895(95%CI(0.872,0.923),P=0.013)The scores of six domains were scope and purpose(34.9%,SD=14.0%),stakeholder and involvement(26.5%,SD=18.4%),rigor of development(44.4%,SD=12.1%),clarity of presentation(59.9%,SD=13.6%),applicability(18.8%,SD=8.9%)and editorial independence( 51.9%,SD=16.0%), respectively.The average score of reporting quality of guidelines was 12.9(SD=2.5), which the total score of each guideline ranged from 9.5 to 17.5. There were seven items in which more than 50% guidelines were evaluated as adequately reporting. Conclusion: More than 75% guidelines for liver cirrhosis are published in recent years, and from Asia. By comparing with the average scores of the guidelines worldwide,the scores of guidelines are similar and apparently higher in three domains(rigor of development,clarity of presentation and editorial independence),the other domains are lower. Meahwhile, the RIGHT scores are relative low. Particularly, there are more than 50% guidelines reported nothing in more than 50% items.