■临床实践以循证医学时代的指南为指导,以改善医疗保健。临床指南中建议的强度与证据的潜在质量之间的一致性及其演变动态地反映了医学实践在重要方面的地位。这项研究旨在评估2003年至2021年间中国心血管疾病(CVD)指南中支持不同类别建议(CORs)的证据水平(LOEs),以及随时间的变化。
■由领先专业组织发布的心血管主题的临床指南文件从成立至2021年6月在SinoMed和WanfangMedOnline的数据库中检索。所有指南都是通过摘要和全文阅读进行筛选的,如果满足预先指定的标准,则包括在内。79份关于12个子专题的中国准则文件,包括总共5195项建议和指定的CORs/LOE,是抽象的。Ⅰ类推荐数量,Ⅱ类,Ⅲ类,LOEA,LOEB,并为每个指南文件确定LOEC。CORs的比例,LOEs,指南中的COR-LOE组合以及≥2个版本之间的变化。
■共79条指南被纳入分析。在检查当前准则的状态时,在2011-2021年从59份文件中得出的3325项建议中,735项建议(22.1%)被归类为LOEA,1280(38.5%)作为LOEB,和1310(39.4%)作为LOEC。596个建议(17.9%)被表征为Ⅰ类-LOEA,占LOEA建议的大部分,但只占I类建议的三分之一。证据水平在不同的子主题和个人指南中差异很大。关于5个子主题的9个指南有≥2个版本。当分析随时间的变化时,尽管建议总数有所增加,指定为Ⅰ类-LOEA的建议比例没有显着改善(19.1%[当前]对19.0%[先前],p=0.97)。
■在当前的中国CVD指南中,缺乏高水平的证据,它与强有力的建议的一致性不足。尽管它在某些主要主题上显示出适度的改进(例如,冠状动脉疾病,介入治疗,手术)在过去的二十年里,I-LOEA类建议的总体比例仍然很小,表明传导,尤其是翻译,高质量的研究,如RCT解决心血管疾病相关的问题仍然是必不可少的和需要的,尤其是关注较少的地区。
■本研究得到了北京市科学技术委员会北京新星计划(Z211100002121063,Z201100006820002);中央高校基础研究基金(3332022023);国家重点研发计划(2020YFC2004705);CAMS医学创新基金(国家自然科学基金)(2021-I92M-5-8220076);
UNASSIGNED: Clinical practice is guided by
guidelines in the era of
evidence-based medicine to improve healthcare. The consistency between the strength of recommendations and the underlying quality of evidence in clinical guidelines and its evolution dynamically reflects the status of medical practice in important aspects. This study aimed to evaluate the levels of evidence (LOEs) supporting different classes of recommendations (CORs) in Chinese cardiovascular disease (CVD) guidelines between 2003 and 2021, and changes over time.
UNASSIGNED: Clinical
guideline documents on cardiovascular topics issued by leading professional organizations were retrieved in the Databases of SinoMed and Wanfang Med Online from inception to June 2021. All guidelines were screened through abstract and full-text reading, and included if satisfying the pre-specified criteria. 79 Chinese
guideline documents on 12 sub-topics including a total of 5195 recommendations and the designated CORs/LOEs, were abstracted. The number of recommendations of Class Ⅰ, Class Ⅱ, Class Ⅲ, LOE A, LOE B, and LOE C were identified for each guideline document. The proportion of CORs, LOEs, and COR-LOE combinations in guidelines and the changes among those with ≥2 versions.
UNASSIGNED: A total of 79 guidelines were included in the analysis. When examining the status of current guidelines, among the 3325 recommendations derived from 59 documents during 2011-2021, 735 recommendations (22.1%) were classified as LOE A, 1280 (38.5%) as LOE B, and 1310 (39.4%) as LOE C. 596 recommendations (17.9%) were characterized as Class Ⅰ-LOE A, accounting for the majority of LOE A recommendations but only one-third of Class I recommendations.
Evidence levels varied greatly across different sub-topics and individual
guidelines. There are 9 guidelines on 5 sub-topics having ≥2 versions. When analyzing the changes over time, although an increase was observed in the total number of recommendations, the proportion of recommendations designated as Class Ⅰ-LOE A did not significantly improve (19.1% [current] vs 19.0% [prior], p = 0.97).
UNASSIGNED: In current Chinese CVD
guidelines, the high level of
evidence lacks, and its alignment with strong recommendations is deficient. Although it shows moderate improvements in certain major topics (e.g., coronary artery disease, interventional therapy, surgery) in the past two decades, the overall proportion of Class I-LOE A recommendations remains small, suggesting that conduction, and particularly translation, of high-quality studies like RCTs addressing CVDs-related questions are still essential and demanded, especially for areas with less attention.
UNASSIGNED: This study was supported by Beijing Nova Program from Beijing Municipal Science & Technology Commission (Z211100002121063, Z201100006820002); Fundamental Research Funds for the Central Universities (3332022023); National Key R&D Program of China (2020YFC2004705); CAMS Innovation Fund for Medical Sciences (2021-I2M-5-003); National Natural Science Foundation of China (81825003, 91957123, 82270376).