背景:实用针灸试验(PAT)是在现实世界中评估针灸治疗有效性的研究工具。本研究旨在使用PRECIS-2(PRagmatic解释性连续指标摘要2)工具对PAT进行全面的方法学分析,以确定其实用主义。
方法:MEDLINE,EMBASE,Cochrane中央控制试验登记册,CINAHL,联合和补充医学数据库,中国国家知识基础设施,VIP,万方,台湾期刊文献数据库,KoreaMed,KMbase,研究信息服务系统,东方医学高级搜索集成系统,搜索了CINii和ClinicalTrials.gov。搜索包括随机对照试验(RCT)和RCT方案,这些试验研究了所有类型的针灸并使用了自我宣称的语用设计。两位作者独立收集了研究的基本信息和特征,并使用9个PRECIS-2域和其他控制域评估了他们的实用主义。
结果:共纳入93项研究。资格的手段,招募,organization,主要结果,初步分析,和控制域在统计学上大于三个,并显示为实用。设置的手段,灵活性:交付,后续领域不超过3个,并显示为不实用。对于灵活性:由于研究中的信息不足,依从性域不适合评估。
结论:PAT在资格领域是务实的,招募,organization,主要结果,初步分析,和控制,在设置领域并不务实,灵活性:交付,和后续行动。未来的PAT需要在设置中加强实用主义,灵活性:交付,和后续领域,并更详细地描述灵活性:坚持领域。
背景:CRD42021236975。
BACKGROUND: Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a comprehensive methodological analysis of PATs using the PRECIS-2(PRagmatic Explanatory Continuum Indicator Summary-2) tool to determine their pragmatism.
METHODS: The MEDLINE, EMBASE, Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov were searched. The search included randomised controlled trials (RCTs) and protocols of RCTs that investigated all types of acupuncture and used self-declared pragmatic design. Two authors independently collected the basic information and characteristics of the studies and assessed their pragmatism using the nine PRECIS-2 domains and the additional domain of control.
RESULTS: A total of 93 studies were included. The means of eligibility, recruitment, organisation, primary outcome, primary analysis, and control domains were statistically larger than three and were shown to be pragmatic. The means of setting, flexibility:delivery, and follow-up domains were not greater than three and were shown to be non-pragmatic. For flexibility:adherence domain was inappropriate for assessment owing to insufficient information in the studies.
CONCLUSIONS: PATs were pragmatic in the domain of eligibility, recruitment, organisation, primary outcome, primary analysis, and control and were not pragmatic in the domain of setting, flexibility:delivery, and follow-up. Future PATs need to strengthen the pragmatism in the setting, flexibility:delivery, and follow-up domains and to describe the flexibility:adherence domain in more detail.
BACKGROUND: CRD42021236975.