肺癌筛查领域指南方法学质量的系统评价

Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines

背景与目的早期筛查可降低肺癌的死亡率,依据高质量的筛查指南进行实践工作是十分重要和必要的。本研究旨在了解国内外肺癌筛查指南研究的方法学质量,为我国的肺癌筛查权威指南的制定工作提供借鉴。方法检索Pub Med、Embase、Cochrane图书馆(Cochrane Library,CL)、Web of Science数据库、中国期刊全文数据库(China National Knowledge Infrastructure,CNKI)、中国生物医学文献数据库(China Bio-Medicine database,CBM)和万方等中英文共7个数据库(截至2016年2月)和相关网站有关肺癌筛查指南的所有中英文文献,按既定的纳入与排除标准,筛选文献、纳入国内外公开发布的国内外独立报告的具备方法学描述的肺癌筛查指南,采用欧洲指南研究与评估工具(Appraisal of Guidelines Research and Evaluation in Europe,AGREE II)对质量进行评价。结果 (1)共纳入11篇报告研究方法的肺癌筛查指南。(2)纳入指南主要由美国(81%)发布,中国和加拿大各发布1篇具备方法学描述的指南。(3)政府发布指南1篇,肿瘤/胸科等专业机构发布指南数9篇,未指明发布机构的指南1篇。(4)方法学质量评估结果:"范围和目的"领域总体评价结果平均80分,"参与人员"领域总体评价结果平均52分,"严谨性"领域总体评价结果平均50分,"清晰性"领域总体评价结果平均76分,"应用性"领域总体评价结果平均43分和"独立性"领域总体评价结果平均59分。2013年和2015年发布的指南在各领域评分较高。加拿大的指南在6个领域得分均最高。7篇指南为A推荐等级,其余4篇指南为B推荐等级。结论 (1)指南发布数量呈上升趋势,主要集中在肺癌疾病负担较重的国家。(2)指南的制定或更新有不断打破国家和地区界限的趋势。(3)循证实践指南制定方法已经逐渐成为各国研究制定临床指南的趋势。(4)我国发布了1篇原创和独立呈现的肺癌筛查指南,质量较好。

Background and objective Lung cancer is the most common malignancy and screening can decrease the mortality. High quality screening guideline is necessary and important for effective work. Our study is to review and evaluate the basic characteristics and methodology quality of the current global lung cancer screening guidelines so as to provide useful information for domestic study in the future. Methods Electronic searches were done in English and Chinese databases including Pub Med, the Cochrane Library, Web of Science, Embase, CNKI, CBM, Wanfang, and some cancer official websites. Articles were screened according to the predefined inclusion and exclusion criteria by two researchers. The quality of guidelines was assessed by AGREE II. Results At last, a total of 11 guidelines with methodology were included. The guidelines were issued mainly by USA（81%）. Canada and China developed one, respectively. As for quality, the average score in the ＂Scale and objective＂ of all guidelines was 80, the average score in the ＂Participants＂ was 52, the average score in the ＂rigorism＂ was 50, the average score in the ＂clarity＂ was 76, the average score in the ＂application＂ was 43 and the average score in the ＂independence＂ was 59. The highest average score was found in 2013 and 2015. Canada guideline had higher quality in six domains. 7 guidelines were evaluated as A level. Conclusion The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries with heavy burden. Multi-country contribution to one guideline was another trend. Evidencebased methodology was accepted globally in the guideline development.