中国临床指南循证制定的方法学现状分析

Analysis of Clinical Guidelines Developed Based on Evidence in China

目的了解我国当前临床实践指南循证制定的方法学现状。方法收集中华医学会2010～2012年公开发表的临床指南,以关键词"临床指南、实践指南"检索CNKI、VIP、WanFang Data及中国临床指南文库网站(www.cgc-chinaebm.org/index.aspx),同时补充检索临床常见大病指南,而后按照纳入与排除标准选择文献,并选取AGREE II量表中指南开发严谨性领域相关8个条目对纳入指南进行评分,符合评价指标者计1分,否则计0分。结果①共纳入22个国内循证制定的指南,其中13个是首版,9个是更新版,指南平均更新时间为3～5年。②纳入指南涵盖领域包括中风、糖尿病、慢性乙型肝炎、高血压和儿科营养等。③指南参考文献数在10～218篇不等,有9个指南共引用了24篇Cochrane系统评价,占总参考文献数的2.62%(24/916),引用Cochrane系统评价最多是急性缺血性脑卒中指南共7篇。④每个指南参与制定的专家人数在2～95人不等。⑤每个指南总页数在4～150页不等。⑥纳入指南评分在4～7分不等,推荐意见强度与证据质量相对应。但不少指南在检索方法、外部专家审阅和更新程序未清楚描述。结论循证制定临床实践指南是当前国内临床实践指南发展趋势,但指南开发方法的严谨性和报告规范等有待提高。Cochrane系统评价引用率较低。我们提倡指南推荐意见强度与证据质量水平相对应,同时应考虑国情、配套政策对实际操作性的影响。未来应注重对指南开发方法、报告规范、指南可及性及相关人员的规范化培训。

Objective To analyze the methodological quality of clinical practice guideline mentioned ＂evidence-based＂ in China.Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012,and meanwhile,we conducted additional search for guidelines on clinical major diseases.Then,we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation（AGREE II）.If the guidelines comply with the item,we recorded 1 point,otherwise 0 point.Results a） Among twenty-two included guidelines,13 were originated and 9 were updated once every 3 to 5 years.b） Diseases covered stroke,diabetes,chronic hepatitis B,hypertension,pediatric nutrition,etc.c） The number of guideline references were 10 to 218,of which,nine guidelines cited 24 Cochrane systematic reviews（CDSRs）,accounted for 2.62%（24/916）.Among them,the acute ischemic stroke guideline cited the most（7 CDSRs）.d） The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150.e） The guidelines＇ quality generally scored 4 to 7,most of which described the process of guidelines development.The grades of recommendation were consistent with the levels of evidence.But most of the included guidelines did not clearly described literature research methods,peer reviewer,and update procedures.Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China.However,the quality of reporting and the methodological rigor of guidelines need further improvement.The citation rates of Cochrane systematic reviews in these guidelines were relatively low.We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions,and relevant support policies for guideline implementation in practice.In future,attention should be paid to the aspects of guideline development methods,reporting standard,guideline accessibility,and standard training for relevant personnel.