针刺治疗卒中后吞咽障碍随机对照试验的方法学及报告质量评价

Methodological and Reporting Quality Evaluation of RCTs on Acupuncture for Post-Stroke Dysphagia

目的:分析国际上中医针刺治疗卒中如吞咽障碍(PSD)的RCT方法学和报告质量,以期为今后研究设计和报告提供改进依据。方法:检索式检索Pubmed、Cochrane Library与Embase数据库。年限为各数据库建库至2021年9月30日,文种限制为英文。由2位评价者根据纳排标准独立进行文献筛选,并采用RoB2.0、CONSORT-NPTs与STRICTA分别进行方法学及报告质量。结果:最终纳入13篇文献。RoB2.0结果显示文献整体方法学质量较低,高风险偏倚主要发生在随机化过程和结局测量两个领域;CONSORT-NPTs与STRICTA结果显示文献在基本问题(文题表述、目的与假设)、方法学(样本量确定、随机序列产生及限定细节、分配隐藏机制、盲法实施细节、比较主次要指标的统计方法、针刺类型、针灸师资历及选择对照依据)、结果(流程图、效应估计值及其精确性、危害)、讨论以及其他信息(研究注册、方案发表与资助信息)方面报告不够充分。结论:目前国际上发表的中医针刺治疗PSD的RCT方法学及报告质量评价均不高,今后研究应进行更加科学严谨的方案设计,减少文献偏倚,并遵循CONSORT-NRTs和STRICTA形成透明、完整的研究报告。

Objective:To analyze the methodology and report quality of randomized controlled trials(RCTs)published internationally in terms of acupuncture treatment for post-stroke dysphagia(PSD),aiming to provide evidences for future research design and reports.Methods:Databases of Pubmed,Cochrane Library and Embase were searched from the establishment of the database to September 30,2021.The language requirement was English.Two reviewers independently screened the studies according to the inclusion and exclusion criteria,RoB2.0,CONSORT-NPTs and STRICTA were used to evaluate the methodology and report quality.Results:13 RCTs were included finally.RoB2.0 results showed that the overall methodological quality of the RCTs was low,and high-risk bias mainly occurred in the two areas of the randomization process and outcome measurement.CONSORT-NPTs and STRICTA results showed that the RCTs did not adequately report the following items,including basic questions(title,objectives or hypotheses),methodology(sample size calculation,randomized sequence generation and defined details,allocation concealment mechanism,blind method implementation details,statistical methods for comparing primary and secondary outcomes,types of acupuncture,experience of acupuncturist and basis for the establishment of the control group),results(flow charts,the estimated effect and its precision,harms),discussions and other information(registration,protocol,funding).Conclusion:Currently,the methodology and report quality of RCTs published internationally,in terms of TCM acupuncture treatment for PSD,are not high.Future research should carry out more scientific and rigorous program design,reduce the risk bias,and follow CONSORT-NRTs and STRICTA to form a transparent and complete research report.