国内外肺癌临床指南循证评价

Evidence-Based Evaluation of Global Clinical Guideline for Lung Cancer

目的了解国内外肺癌临床指南的发布现状,为我国的研究工作提供借鉴。方法检索PubMed等6个数据库(截至2008年6月)和相关网站有关肺癌临床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肺癌临床指南,而后采用自拟的方法对其数量分布、内容质量进行评价。结果①共检出相关文献208篇,其中符合纳入和排除标准的133篇,后者按原创与更新分类分别是78篇和55篇;按是否提供研究方法分类,分别是86篇和47篇。②现有指南主要由美国(39.85%)、加拿大(24.81%)和法国(8.27%)等14个国家和地区发布,最早的指南1984年由美国发布。③肿瘤/胸科等专业机构发布指南数125篇,未指明或非专业协会发布指南8篇。④133篇指南关注的临床问题包括综合类(24篇)、多项类(21篇)和专项类(88篇)三方面内容。⑤质量评价结果:总体平均分72.09分,1996年最高(83.50分),1997最低(66.80分);法国平均分最高(79.80分),日本最低(48.00分);非小细胞肺癌、肺癌、小细胞肺癌、支气管肺癌指南平均分分别是73.54、65.74、74.72、76.00分。结论①指南发布数量呈上升趋势,主要集中在发达国家。②综合指南关注的临床问题日趋广泛,包括了从预防到临终关怀20个方面的条目。③指南的制定或更新有不断打破国家地区界限的趋势,在分型分期研究上也呈现不断细化的趋势。④循证方法已经逐渐成为各国研究制定临床指南的趋势,但目前尚未查询到应用卫生技术评估方法的指南。⑤我国仅发布了两部原创指南,研究方法分别是综述和专家意见。⑥受文献语言和获取全文内容及缺乏权威性、特异性评价技术方案的限制,本研究评价结果仅供参考。

Objective To review and evaluate the basic contents and development of the current global cnnlcal guidelines for lung cancer practice so as to provide useful information for domestic study. Methods Six databases including PubMed （to June 2008） and relevant websites （both in Chinese and English） were searched. Articles were screened according to the predefined inclusion and exclusion criteria. The number of clinical guidelines was counted and the quality of guidelines was also assessed. Results A total of 208 articles were found to be clinical guideline-related and 133 were finally included. Of those, 78 were original versions and 55 were updated versions. And 86 articles mentioned guideline development methodology. The guidelines were issued by 14 countries/regions, mainly by USA （39.85%）, Canada （24.81%） and France （8.27%）. The earliest one was published by USA in 1984. 125 guidelines were issued by oncological or thoracic institutions, and the other 8 were not issued by specialized institutions or not specified. The 133 articles were classified into 3 major clinical categories： synthesis （24）, multi-subject （21） and single-subject （88）. As for quality evaluation, the average score of all guidelines was 72.09 （full score 100）. The highest average score was found in 1996 which was 83.50, and the lowest in 1997 （66.80）. The guidelines issued by France had the highest average score （79.80）, and Japan, with the lowest average score （48.00）. The average score of 4 categories of lung cancer were 73.54 （non-smallcell lung cancer）, 65.74 （lung cancer）, 74.72 （small-cell lung cancer）, and 76.00 （bronchogenic lung cancer）, respectively. Conclusion The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries. The subjects included in the synthetic guidelines showed an expanding trend covering about 20 subjects from prevention to palliative care. A trend of multi-country contribution to the guidelines development and revision was noted.Researches became more focused on different types and stages. Evidence-based methodology was accepted globally in the clinical guideline development, but unfortunately very few applied the method of health technology assessment. China issued only 2 original guidelines, which were based on literature review and expert opinions, respectively. Due to the limitation of language restriction, inaccessibility of full-text articles and unavailability of authorized and specific quality evaluation protocols, the conclusions of this study should be interpreted with caution.