Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.
Department of Medical Ethics and Health Law, Leiden University Medical Center, The Netherlands.
Eur J Prev Cardiol. 2019 Dec;26(18):1944-1952. doi: 10.1177/2047487319868540. Epub 2019 Aug 14.
Reviews of clinical practice guidelines have repeatedly concluded that only a minority of guideline recommendations are supported by high-quality evidence from randomised controlled trials. The aim of this study is to evaluate whether these findings apply to the whole cardiovascular evidence base or specific recommendation types and actions.
All recommendations from current European Society of Cardiology guidelines were extracted with their class (I, treatment is beneficial; II, treatment is possibly beneficial; III, treatment is harmful) and level of evidence (A, multiple randomised controlled trials/meta-analyses; B, single randomised controlled trials/large observational studies; C, expert opinion/small studies). Recommendations were categorised by type (therapeutic, diagnostic, other) and actions (e.g. pharmaceutical intervention/non-invasive imaging/test).
In total, 3531 recommendations (median 128, interquartile range 108-150) were extracted from 27 guidelines. Therapeutic recommendations comprised 2545 (72.1%) recommendations, 411 (16.1%) were supported by level of evidence A, 833 (32.7%) by B and 1301 (51.1%) by C. Class I/III (should/should not) recommendations on minimally invasive interventions were most supported by level of evidence A (55/183, 30.1%) (B [70/183, 38.3%], C [58/183, 31.7%]), while class I/III recommendations on open surgical interventions were least supported by level of evidence A (15/164, 9.1%) (B [34/164, 20.7%], C [115/164, 70.1%]). Of all (831, 23.5%) diagnostic recommendations, just 44/503 (8.7%) class I/III recommendations were supported by level of evidence A (B (125/503, 24.9%), C (334/503, 66.4%)).
Evidence levels supporting European Society of Cardiology guideline recommendations differ widely between recommendation types and actions. Attributing to this variability are different evidence requirements, therapeutic/diagnostic recommendations, different feasibility levels for trials (e.g. open surgical/pharmacological) and many off-topic/policy recommendations based on expert opinion.
临床实践指南的综述反复得出结论,只有少数指南推荐意见得到了来自随机对照试验的高质量证据的支持。本研究旨在评估这些发现是否适用于整个心血管证据基础或特定的推荐类型和措施。
提取当前欧洲心脏病学会指南的所有建议,根据其类别(I,治疗有益;II,治疗可能有益;III,治疗有害)和证据水平(A,多项随机对照试验/荟萃分析;B,单随机对照试验/大型观察性研究;C,专家意见/小型研究)。建议按类型(治疗、诊断、其他)和措施(如药物干预/非侵入性成像/测试)进行分类。
共从 27 项指南中提取了 3531 项建议(中位数 128,四分位间距 108-150)。治疗建议包括 2545 项(72.1%),411 项(16.1%)得到 A 级证据支持,833 项(32.7%)得到 B 级证据支持,1301 项(51.1%)得到 C 级证据支持。在微创介入方面,I/III 类(应/不应)推荐意见得到 A 级证据的支持最为有力(55/183,30.1%)(B [70/183,38.3%],C [58/183,31.7%]),而在开放性手术干预方面,I/III 类推荐意见得到 A 级证据的支持最少(15/164,9.1%)(B [34/164,20.7%],C [115/164,70.1%])。在所有(831,23.5%)诊断建议中,只有 44/503(8.7%)I/III 类建议得到 A 级证据支持(B [125/503,24.9%],C [334/503,66.4%])。
欧洲心脏病学会指南推荐意见所依据的证据水平在推荐类型和措施之间差异很大。造成这种差异的原因是不同的证据要求、治疗/诊断建议、试验的不同可行性水平(如开放性手术/药物治疗)以及基于专家意见的许多非主题/政策建议。