Reporting Quality of Literature Interpreting Clinical Practice Guidelines/Consensus: A Cross-sectional Study
-
摘要:
目的 调查中国临床实践指南/共识解读类文献报告质量现状。 方法 系统检索万方数据知识服务平台、维普中文期刊服务平台和中国知网3个中文数据库,对国内临床实践指南/共识解读类文献报告质量进行分析,从文献标题、摘要、背景、指南制订方法、指南推荐意见、优势与局限性、对当地指南制订与临床研究的意义、传播与实施8个方面分析解读类文献报告内容,检索时限从建库至2018年3月28日。 结果 共纳入临床实践指南/共识解读类文献1593篇,其中6篇(0.4%)文献报告了指南制订专家或循证医学方法学家参与解读,17篇(1.1%)报告了解读者的方法学背景,6篇(0.4%)联系了原指南/共识制订者辅助解读,13篇(0.8%)报告了原指南/共识的使用环境,在制订小组的组建(65篇,4.1%)、临床问题的确定(20篇,1.3%)、收集证据的方法(72篇,4.5%)、推荐意见达成共识的方法(53篇,3.3%)、资金资助来源(30篇,1.9%)、利益冲突(3篇,0.2%)等方面报告较少;在解读类文献研究意义方面,106篇(6.7%)报告了对未来研究的启示,296篇(16.9%)报告了对我国临床实践的意义。 结论 目前我国临床实践指南/共识解读类文献数量较多,但整体报告质量有待提高,主要表现为关键信息解读不全面、缺少方法学家的参与、对利益冲突的关注度不高等;建议未来研究者开发指南/共识解读类文献报告规范,提高其报告质量,促进指南/共识的传播与实施。 Abstract:Objective To investigate and analyze the status of the reporting quality of Chinese literature interpreting clinical practice guidelines/consensus. Methods Based on electronic databases of Wanfang Data Knowledge Service Platform, VIP Database for Chinese Technical Periodicals, and China National Knowledge Infrastructure from their inception to March 28, 2018, we analyzed the reporting quality of Chinese literature interpreting clinical practice guidelines/consensus including basic information, title, abstract, background, method of guideline development, recommendation, strengths, limitations, dissemination and implementation, and implications for local guideline development and clinical research. Results A total of 1593 articles interpreting clinical practice guidelines/consensuses were included in our study. Only 6 articles (0.4%) reported the participation of experts of guideline development or evidence-based methodology; 17 articles (1.1%) reported the methodological background of interpreters; 6 articles (0.4%) contacted with the authors of the guideline/consensus; 13 articles (0.8%) reported the background of the usage environment of the guideline/consensus. Fewer articles reported the establish of guideline development group (65, 4.1%), the identification of clinical questions (20, 1.3%), the method of collecting evidence (72, 4.5%), the method of reaching consensus (53, 3.3%), the resources of funding (30, 1.9%), and the conflict of interest (3, 0.2%). In terms of significance and value of interpreting literature, 106 articles (6.7%) reported implications for future research; 296 articles (16.9%) reported the significance for clinical practice in China. Conclusions At present, although there is a large volume of literature interpreting guidelines/consensus in China, the overall reporting situation is not optimistic, which is reflected from incomplete interpretation of key information, lack of methodologists, and insufficient attention to conflicts of interest. We suggest that future researchers should develop regulations on interpretation of guidelines/consensus to improve the reporting quality and promote the dissemination and implementation of guidelines. -
Key words:
- clinical practice guideline /
- consensus /
- interpretation /
- reporting quality
作者贡献:王子君负责数据提取、统计并撰写文章初稿;周奇、邢丹、杨楠、罗旭飞、张静怡负责数据提取;周奇、史乾灵、赵思雅、刘辉、刘萧、李沁原、杜亮、杨克虎负责初稿修改;陈耀龙负责文章审校。利益冲突: 无 -
表 1 1593篇临床实践指南/共识解读类文献基本信息[n(%)]
类别 文献数量 解读类文献的发表年份(年) 2000—2005 24(1.5) 2006—2010 340(21.3) 2011—2015 767(48.1) 2016—2018 462(29.0) 解读类文献的发表期刊* 《中国实用内科杂志》 93(5.8) 《中国实用妇科与产科杂志》 59(3.7) 《中国实用外科杂志》 47(3.0) 《中国循环杂志》 47(3.0) 《中国医学前沿杂志(电子版)》 46(2.9) 指南/共识的发表年份(年) 2000之前 2(0.1) 2000—2005 87(5.5) 2006—2010 382(24.0) 2011—2015 863(54.2) 2016—2018 250(15.7) 未报告 9(0.6) 指南/共识的制订国家或地区* 中国(包括中国台湾) 536(33.6) 美国 534(33.5) 多国合作 408(25.6) 英国 51(3.2) 日本 20(1.3) 方法学家参与指南/共识解读过程情况 是 6(0.4) 否 1587(99.6) *发表临床实践指南/共识解读类文献数量排名前五的期刊、国家或地区 表 2 1593篇临床实践指南/共识解读类文献报告情况[n(%)]
类别 文献数量 题目 包含"指南"字段 1402(88.0) 包含"共识"字段 191(12.0) 包含原指南/共识题目 1538(96.5) 摘要 报告指南/共识的发表期刊或来源 34(2.1) 报告指南/共识的发布机构 332(20.8) 报告指南/共识的发表年份 315(19.8) 报告解读部分的主要推荐意见 114(7.2) 报告主要推荐意见的数量 13(0.8) 报告主要推荐意见的强度和证据质量 5(0.3) 报告指南/共识对当地临床实践的意义 69(4.3) 报告指南/共识对当地指南制订的意义 3(0.2) 报告指南/共识对当地开展研究的意义 4(0.3) 报告指南/共识在制订方法方面的局限性 0(0) 报告指南/共识在临床实践方面的局限性 5(0.3) 指南/共识解读类文献背景 报告解读的原因 304(19.1) 报告解读者的临床背景 1113(69.9) 报告解读者的方法学背景 17(1.1) 联系指南/共识制订者进行辅助解读 6(0.4) 报告解读者与指南/共识相关的利益冲突 4(0.3) 指南/共识的制订背景 报告指南/共识的版本 610(38.3) 报告指南/共识的发表年份 1262(79.2) 报告指南/共识的更新情况 356(22.3) 报告指南/共识的发表期刊或来源 536(33.6) 报告指南/共识的制订机构 1082(67.9) 报告指南/共识的制订原因或理由 215(13.5) 报告指南/共识的目标使用人群 343(21.5) 报告指南/共识的目标应用人群 1132(71.1) 报告指南/共识的应用环境 13(0.8) 指南/共识的制订方法 报告制订小组的组建 65(4.1) 报告临床问题的确定过程 20(1.3) 报告收集证据的方法 72(4.5) 报告证据质量和推荐强度分级的方法及解释说明 162(10.2) 报告推荐意见达成共识的方法 53(3.3) 报告资助来源 3(0.2) 报告资助在指南/共识制订中的作用 0(0) 报告指南/共识可能存在的利益冲突 3(0.2) 报告指南/共识的有效时间 4(0.3) 报告指南/共识的更新计划 16(1.0) 报告指南/共识的更新方法 6(0.4) 指南/共识推荐意见相关内容 报告指南/共识推荐意见的总数 81(5.1) 报告指南/共识的推荐级别 447(28.1) 报告指南/共识的推荐意见 1286(80.7) 报告推荐意见对本土临床实践的意义 96(6.0) 报告构成和支持推荐意见的内容 66(4.1) 报告支撑推荐意见的重点参考文献信息(如期刊、发表年份、文献类型等) 113(7.1) 报告纳入分析或引用的中国重要文献情况 26(1.6) 报告其他重要内容(如附件所包含的检索策略、证据总结表和利益冲突声明表等) 20(1.3) 指南/共识的优势与局限性 报告指南/共识的优势 183(11.5) 报告指南/共识对未来研究的启示 106(6.7) 报告指南/共识在方法学方面的局限性 24(1.5) 报告指南/共识在内容上的局限性 95(6.0) 指南/共识对本土的意义 报告指南/共识对我国临床实践的意义 269(16.9) 报告指南/共识对我国制订同类或相关指南的指导意义 52(3.3) 报告指南/共识对我国未来开展临床研究的意义 79(5.0) 传播与实施 报告指南/共识传播与实施的方法或策略 9(0.6) 探讨指南/共识如何在我国更好地传播与实施 9(0.6) -
[1] Institute of Medicine. Clinical practice guidelines we can trust[M]. Washington DC: the National Academies Press, 2011. [2] Gundersen L. The effect of clinical practice guidelines on variations in care[J]. Ann Intern Med, 2000, 133: 317-318. doi: 10.7326/0003-4819-133-4-200008150-00102 [3] Chen YL, Wang C, Shang HC, et al. Clinical practice guidelines in China[J]. BMJ, 2018, 360: j5158. http://europepmc.org/abstract/MED/29412338 [4] Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement[J]. JAMA, 1999, 282: 1458-1465. doi: 10.1001/jama.282.15.1458 [5] Sheldon TA, Cullum N, Dawson D, et al. What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews[J]. BMJ, 2004, 329: 999. doi: 10.1136/bmj.329.7473.999 [6] Eisinger F, Geller G, Burke W, et al. Cultural basis for differences between US and French clinical recommendations for women at increased risk of breast and ovarian cancer[J]. Lancet, 1999, 353: 919-920. doi: 10.1016/S0140-6736(98)07516-3 [7] Elsadig H, Weiss M, Scott J, et al. Use of clinical guidelines in cardiology practice in Sudan[J]. J Eval Clin Pract, 2018, 24: 127-134. doi: 10.1111/jep.12746 [8] Halm EA, Atlas SJ, Borowsky LH, et al. Understanding Physician Adherence with a Pneumonia Practice Guideline: Effects of Patient, System, and Physician Factors[J]. Arch Intern Med, 2000, 160: 98-104. doi: 10.1001/archinte.160.1.98 [9] Fritz JM, Cleland JA, Brennan GP. Does adherence to the guideline recommendation for active treatments improve the quality of care for patients with acute low back pain delivered by physical therapists?[J]. Med Care, 2007, 45: 973-980. doi: 10.1097/MLR.0b013e318070c6cd [10] Brenner S, Oberaigner W, Stummer H. Should we care to adhere? Guideline adherence rates, glycemic control and physician perspective on adherence for type-2 diabetes[J]. J Public Health (Berl. ), 2020. https://doi.org/10.1007/s10389-019-01182-1. doi: 10.1007/s10389-019-01182-1 [11] Chen YL, Yang KH, Marušic A, et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement[J]. Ann Intern Med, 2017, 166: 128-132. doi: 10.7326/M16-1565 [12] Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines[J]. PLoS Med, 2010, 7: e1000217. doi: 10.1371/journal.pmed.1000217 [13] Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on[J]. Lancet, 2017, 390: 415-423. doi: 10.1016/S0140-6736(16)31592-6 [14] 陈耀龙, 王小琴, 王琪, 等. 遵循指南报告规范提升指南报告质量[J]. 中华内科杂志, 2018, 57: 168-170. Chen YL, Wang XQ, Wang Q, et al. Improve the reporting quality of guidelines by following the reporting guideline[J]. Zhonghua Nei Ke Za Zhi, 2018, 57: 168-170. [15] 王子君, 王玲, 玉炫, 等. 基于RIGHT康复临床实践指南报告质量研究[J]. 中国康复理论与实践, 2020, 26: 161-169. https://www.cnki.com.cn/Article/CJFDTOTAL-ZKLS202002007.htm Wang ZJ, Wang L, Yu X, et al. Report Quality of Clinical Practice Guidelines of Rehabilitation Based on RIGHT[J]. Zhongguo Kang Fu Li Lun Yu Shi Jian, 2020, 26: 161-169. https://www.cnki.com.cn/Article/CJFDTOTAL-ZKLS202002007.htm [16] 杨钦博, 周奇, 黄天相, 等. 2017年中国大陆期刊发表的临床实践指南的报告质量评价[J]. 中国循证医学杂志, 2019, 19: 1325-1332. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZXZ201911011.htm Yang QB, Zhou Q, Huang TX, et al. Reporting quality of clinical practice guidelines published in journals of mainland China in 2017[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2019, 19: 1325-1332. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZXZ201911011.htm [17] 段玉婷, 陈泽, 陈耀龙, 等. 针刺临床实践指南的质量评价[J]. 中国循证医学杂志, 2019, 19: 983-988. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZXZ201908016.htm Duan YT, Chen Z, Chen YL, et al. Quality assessment of clinical practice guidelines on acupuncture[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2019, 19: 983-988. https://www.cnki.com.cn/Article/CJFDTOTAL-ZZXZ201908016.htm [18] Xie RS, Xia Y, Chen YL, et al. The RIGHT Extension Statement for Traditional Chinese Medicine: Development, Recommendations, and Explanation[J]. Pharmacol Res, 2020, 160: 105178. doi: 10.1016/j.phrs.2020.105178 [19] 宋霄杨, 高玉婷, 王小琴, 等. 制订卫生研究报告指南的方法学指导[J]. 中国循证儿科杂志, 2017, 12: 204-208. https://www.cnki.com.cn/Article/CJFDTOTAL-XZEK201703014.htm Song XY, Gao YT, Wang XQ, et al. Methodological guidance for the development of reporting items for practice guidelines in health care[J]. Zhongguo Xun Zheng Er Ke Za Zhi, 2017, 12: 204-208. https://www.cnki.com.cn/Article/CJFDTOTAL-XZEK201703014.htm [20] 靳英辉, 张林, 黄笛, 等. 临床实践指南制定方法——指南制定参与人员及组成分配[J]. 中国循证心血管医学杂志, 2018, 10: 385-391. https://www.cnki.com.cn/Article/CJFDTOTAL-PZXX201804001.htm Jin YH, Zhang L, Huang D, et al. Methodology for clinical practice guidelines- members, groups or committee of guideline development[J]. Zhongguo Xun Zheng Xin Xue Guan Yi Xue Za Zhi, 2018, 10: 385-391. https://www.cnki.com.cn/Article/CJFDTOTAL-PZXX201804001.htm [21] 陈耀龙, 马艳芳, 周奇, 等. 谁应该参与临床实践指南的制订?[J]. 协和医学杂志, 2019, 10: 524-530. doi: 10.3969/j.issn.1674-9081.2019.05.017 Chen YL, Ma YF, Zhou Q, et al. Who Should Participate in the Development of Clinical Practice Guidelines?[J]. Xie He Yi Xue Za Zhi, 2019, 10: 524-530. doi: 10.3969/j.issn.1674-9081.2019.05.017 [22] World Health Organization. WHO handbook for guideline development. 2nd edition[M/OL].[2020-09-21].https://apps.who.int/iris/handle/10665/145714. [23] Wang XQ, Chen YL, Yao L, et al. Reporting of declarations and conflicts of interest in WHO guidelines can be further improved[J]. J Clin Epidemiol, 2018, 98: 1-8. http://www.sciencedirect.com/science/article/pii/S0895435617303888 [24] 陈耀龙, 王健健, 詹思延, 等. 如何应对指南制订中的利益冲突[J]. 协和医学杂志, 2019, 10: 685-691. doi: 10.3969/j.issn.1674-9081.2019.06.023 Chen YL, Wang JJ, Zhan SY, et al. How to Address Conflicts of Interest in Clinical Practice Guidelines[J]. Xie He Yi Xue Za Zhi, 2019, 10: 685-691. doi: 10.3969/j.issn.1674-9081.2019.06.023 [25] National Institute for Health and Care Excellence (Great Britain). Developing NICE guidelines: the manual[M/OL].[2020-09-21]. https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-nice-guidelines-the-manual.pdf. [26] Scottish Intercollegiate Guidelines Network (SIGN). SIGN 50: a guideline developer's handbook[M/OL].[2020-09-21].https://www.sign.ac.uk/assets/sign50_2019.pdf. [27] 蒋朱明, 詹思延, 贾晓巍, 等. 制订/修订《临床诊疗指南》的基本方法及程序[J]. 中华医学杂志, 2016, 96: 250-253. Jiang ZM, Zhan SY, Jia XW, et al. The basic methods and procedures of development/revision of the clinical guidelines[J]. Zhonghua Yi Xue Za Zhi, 2016, 96: 250-253. [28] 杨克虎. 循证社会科学的产生、发展与未来[J]. 图书与情报, 2018: 1-10. https://www.cnki.com.cn/Article/CJFDTOTAL-BOOK201803001.htm Yang KH. Evidence-based Social Science: The Origin, Development and Prospects[J]. Tu Shu Yu Qing Bao, 2018: 1-10. https://www.cnki.com.cn/Article/CJFDTOTAL-BOOK201803001.htm [29] 杨克虎, 李秀霞, 拜争刚. 循证社会科学研究方法[M]. 兰州: 兰州大学出版社, 2018.