Ruan Huanrong, Zhang Hailong, Feng Zhenzhen, Li Xuanlin, Han Weihong, Si Yimei, Li Jiansheng
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan, 450046, People's Republic of China.
Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, Henan, 450046, People's Republic of China.
Int J Gen Med. 2022 May 31;15:5335-5348. doi: 10.2147/IJGM.S356666. eCollection 2022.
To assess the completeness of reporting in randomized controlled trials (RCTs) of acupuncture therapy (AT) for chronic obstructive pulmonary disease (COPD).
We systematically searched PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), WANFANG Data, and China Biology Medicine (CBM) for studies published from their inception to May 8, 2021. The completeness of reporting was evaluated by CONSORT statement and STRICTA guidelines. Univariate and multivariate regression analyses were performed to preliminarily explore the factors related to completeness of reporting.
A total of 44 RCTs were included. The overall quality score (OQS) based on the CONSORT statement and STRICTA guidelines ranged from 3 to 26 and 7 to 14, with a median of 10 and 11, respectively. Among the 35 items of the CONSORT statement, 10 items were fully reported with reporting rate > 70%, and 11 items were poorly reported at a rate < 5%. Among the 17 items of the STRICTA guidelines, 10 items were adequately reported with > 70%, and only 3 items were incompletely reported at a rate < 20%. The agreement of most items was determined as "good", "substantial", or "moderate". By regression analysis, publication language (β coefficient: 6.432, 95% CI: 3.202 to 9.663, <0.001) and funding source (β coefficient: 3.159, 95% CI: 1.045 to 5.273, =0.004) acted as independent predictors of completeness of reporting according to the CONSORT statement. However, no variables associated with the STRICTA guidelines were identified.
The completeness of reporting of AT for COPD was inadequate. The condition relatively improved for trials with publication in the English language and funding source. By recommendation, reports should be strictly standardized in accordance with the CONSORT statement and STRICTA guidelines to improve the clinical research evidence of AT for COPD.
评估针刺疗法(AT)治疗慢性阻塞性肺疾病(COPD)的随机对照试验(RCT)报告的完整性。
我们系统检索了PubMed、Embase、Cochrane图书馆、科学网、中国知网(CNKI)、重庆维普(CQVIP)、万方数据和中国生物医学文献数据库(CBM),以查找从建库至2021年5月8日发表的研究。采用CONSORT声明和STRICTA指南评估报告的完整性。进行单因素和多因素回归分析,初步探讨与报告完整性相关的因素。
共纳入44项RCT。基于CONSORT声明和STRICTA指南的总体质量评分(OQS)范围分别为3至26分和7至14分,中位数分别为10分和11分。在CONSORT声明的35项中,10项报告完整,报告率>70%,11项报告较差,报告率<5%。在STRICTA指南的17项中,10项报告充分,报告率>70%,只有3项报告不完整,报告率<20%。大多数项目的一致性被判定为“良好”“高度一致”或“中等一致”。通过回归分析,根据CONSORT声明,发表语言(β系数:6.432,95%CI:3.202至9.663,P<0.001)和资金来源(β系数:3.159,95%CI:1.045至5.273,P =0.004)是报告完整性的独立预测因素。然而,未发现与STRICTA指南相关的变量。
COPD针刺疗法报告的完整性不足。英文发表和有资金来源的试验情况相对有所改善。建议严格按照CONSORT声明和STRICTA指南对报告进行标准化,以提高COPD针刺疗法的临床研究证据。