Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia2Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia.
Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
JAMA. 2014 May;311(20):2092-100. doi: 10.1001/jama.2014.4949.
Little is known regarding the durability of clinical practice guideline recommendations over time.
To characterize variations in the durability of class I ("procedure/treatment should be performed/administered") American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations.
DESIGN, SETTING, AND PARTICIPANTS: Textual analysis by 4 independent reviewers of 11 guidelines published between 1998 and 2007 and revised between 2006 and 2013.
We abstracted all class I recommendations from the first of the 2 most recent versions of each guideline and identified corresponding recommendations in the subsequent version. We classified recommendations replaced by less determinate or contrary recommendations as having been downgraded or reversed; we classified recommendations for which no corresponding item could be identified as having been omitted. We tested for differences in the durability of recommendations according to guideline topic and underlying level of evidence using bivariable hypothesis tests and conditional logistic regression.
Of 619 index recommendations, 495 (80.0%; 95% CI, 76.6%-83.1%) were retained in the subsequent guideline version, 57 (9.2%; 95% CI, 7.0%-11.8%) were downgraded or reversed, and 67 (10.8%; 95% CI, 8.4%-13.3%) were omitted. The percentage of recommendations retained varied across guidelines from 15.4% (95% CI, 1.9%-45.4%) to 94.1% (95% CI, 80.3%-99.3%; P < .001). Among recommendations with available information on level of evidence, 90.5% (95% CI, 83.2%-95.3%) of recommendations supported by multiple randomized studies were retained, vs 81.0% (95% CI, 74.8%-86.3%) of recommendations supported by 1 randomized trial or observational data and 73.7% (95% CI, 65.8%-80.5%) of recommendations supported by opinion (P = .001). After accounting for guideline-level factors, the probability of being downgraded, reversed, or omitted was greater for recommendations based on opinion (odds ratio, 3.14; 95% CI, 1.69-5.85; P < .001) or on 1 trial or observational data (odds ratio, 3.49; 95% CI, 1.45-8.41; P = .005) vs recommendations based on multiple trials.
The durability of class I cardiology guideline recommendations for procedures and treatments promulgated by the ACC/AHA varied across individual guidelines and levels of evidence. Downgrades, reversals, and omissions were most common among recommendations not supported by multiple randomized studies.
对于临床实践指南建议随时间推移的耐久性,人们知之甚少。
描述美国心脏病学会/美国心脏协会(ACC/AHA)I 级(“应进行/实施的程序/治疗”)指南建议耐久性的变化。
设计、环境和参与者:4 位独立审查员对 1998 年至 2007 年间发表的 11 项指南和 2006 年至 2013 年修订的指南进行了文本分析。
我们从每本指南的最近 2 个版本中的第 1 个版本中提取了所有 I 级建议,并在随后的版本中确定了相应的建议。我们将被不太确定或相反的建议取代的建议归类为降级或反转;我们将没有相应项目可识别的建议归类为遗漏。我们使用双变量假设检验和条件逻辑回归测试了指南主题和潜在证据水平对建议耐久性的影响。
在 619 项索引建议中,495 项(80.0%;95%CI,76.6%-83.1%)保留在随后的指南版本中,57 项(9.2%;95%CI,7.0%-11.8%)降级或反转,67 项(10.8%;95%CI,8.4%-13.3%)被遗漏。指南之间保留建议的百分比差异很大,从 15.4%(95%CI,1.9%-45.4%)到 94.1%(95%CI,80.3%-99.3%;P < .001)。在有证据水平信息的建议中,90.5%(95%CI,83.2%-95.3%)的建议得到了多项随机研究的支持,而 81.0%(95%CI,74.8%-86.3%)的建议得到了 1 项随机试验或观察性数据的支持,73.7%(95%CI,65.8%-80.5%)的建议得到了意见的支持(P = .001)。在考虑了指南水平因素后,基于意见(优势比,3.14;95%CI,1.69-5.85;P < .001)或基于 1 项试验或观察性数据(优势比,3.49;95%CI,1.45-8.41;P = .005)的建议降级、反转或遗漏的可能性大于基于多项试验的建议。
ACC/AHA 颁布的心脏病学 I 级指南建议的程序和治疗的耐久性因个别指南和证据水平而异。降级、反转和遗漏最常见于未得到多项随机研究支持的建议。