Original Investigation |March 19, 2019

Levels of Evidence Supporting American College of Cardiology/American Heart Association and European Society of Cardiology Guidelines, 2008-2018

Alexander C. Fanaroff, Robert M. Califf, Stephan Windecker, et al

JAMA. 2019;321(11):1069-1080. doi:10.1001/jama.2019.1122

Importance  背景

Clinical decisions are ideally based on evidence generated from multiple randomized controlled trials (RCTs) evaluating clinical outcomes, but historically, few clinical guideline recommendations have been based entirely on this type of evidence.

理想情况下，应根据评估临床预后的多中心随机对照试验(RCTs)的证据进行临床决策，但从历史上看，只有少数临床指南的推荐意见完全基于这种证据。

Objective  目的

To determine the class and level of evidence (LOE) supporting current major cardiovascular society guideline recommendations, and changes in LOE over time.

确定支持主要心血管学会现行指南推荐意见的证据种类与证据级别(LOE)，以及LOE随时间的变化。

Data Sources  数据来源

Current American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) clinical guideline documents (2008-2018), as identified on cardiovascular society websites, and immediate predecessors to these guideline documents (1999-2014), as referenced in current guideline documents.

通过心血管学会网站查询的美国心脏病学院/美国心脏协会(ACC/AHA)与欧洲心脏病学会(ESC)现行临床指南文件(2008-2018)，以及目前指南文件中列举的现行指南的前一版本(1999-2014)。

Study Selection  研究选择

Comprehensive guideline documents including recommendations organized by class and LOE.

所有指南文件，包括根据证据种类及LOE分类的推荐意见

Data Extraction and Synthesis  数据提取及整合

The number of recommendations and the distribution of LOE (A [supported by data from multiple RCTs or a single, large RCT], B [supported by data from observational studies or a single RCT], and C [supported by expert opinion only]) were determined for each guideline document.

根据每个指南文件确定的推荐意见数目及LOE分布（A[多个RCTs或一项大样本RCT支持]，B[观察性研究或一项RCT支持]及C[仅有专家意见支持]）。

Main Outcomes and Measures  主要结局指标

The proportion of guideline recommendations supported by evidence from multiple RCTs (LOE A).

多个RCTs证据支持(LOE A)的指南推荐意见比例。

Results 结果

Across 26 current ACC/AHA guidelines (2930 recommendations; median, 121 recommendations per guideline [25th-75th percentiles, 76-155]), 248 recommendations (8.5%) were classified as LOE A, 1465 (50.0%) as LOE B, and 1217 (41.5%) as LOE C. The median proportion of LOE A recommendations was 7.9% (25th-75th percentiles, 0.9%-15.2%). Across 25 current ESC guideline documents (3399 recommendations; median, 130 recommendations per guideline [25th-75th percentiles, 111-154]), 484 recommendations (14.2%) were classified as LOE A, 1053 (31.0%) as LOE B, and 1862 (54.8%) as LOE C. When comparing current guidelines with prior versions, the proportion of recommendations that were LOE A did not increase in either ACC/AHA (median, 9.0% [current] vs 11.7% [prior]) or ESC guidelines (median, 15.1% [current] vs 17.6% [prior]).

在26项ACC/AHA现行指南中（2930项推荐意见；中位数，每个指南121项推荐意见[25-75百分位数，76-155]），248项推荐意见(8.5%)为LOE A，1465项(50.0%)为LOE B，1217项(41.5%)为LOE C。LOE A推荐意见的中位比例为7.9%（25-75百分位数，0.9%-15.2%）。在25项ESC现行指南中（3399项推荐意见；中位数，每个指南130项推荐意见[25-75百分位数，111-154]），484项推荐意见(14.2%)为LOE A，1053项(31.0%)为LOE B，1862项(54.8%)为LOE C。LOE A推荐意见的中位比例为7.9%（25-75百分位数，0.9%-15.2%）。将现行指南与既往版本进行比较，ACC/AHA（中位数9.0% [现行] vs 11.7% [既往]）或ESC（中位数15.1% [现行] vs 17.6% [既往]）的LOE A推荐意见并未增加。

Conclusions and Relevance  结论与意义

Among recommendations in major cardiovascular society guidelines, only a small percentage were supported by evidence from multiple RCTs or a single, large RCT. This pattern does not appear to have meaningfully improved from 2008 to 2018.

在主要心血管学会指南的推荐意见中，仅有少数得到多项RCTs或一项大样本RCT的证据支持。从2008年到2018年这种情况并未显著改善。