小儿推拿治疗厌食症随机对照试验的方法学和干预措施报告质量评价

Randomized Controlled Trials of Pediatric Tuina for Anorexia: Quality Assessment of Methodological and Intervention Reports

目的评价目前已公开发表的小儿推拿治疗厌食症随机对照试验(randomized controlled trials,RCTs)的方法学质量和干预措施报告质量,为今后小儿推拿RCTs的临床设计和干预措施报告提供一些建议,以提升关于小儿推拿临床研究证据结果的真实性、可靠性及临床推广应用价值。方法系统检索中国知网、维普、万方3个中文数据库和PubMed、EMBASE 2个英文数据库。检索日期均从建库至2018年11月。纳入所有小儿推拿治疗厌食症的双臂RCTs文献。由两名研究者根据纳入/排除标准独立筛选文献及提取资料,并采用Cochrane偏倚风险评估标准和基于STRICTA清单对纳入文献中的研究方法学质量及干预措施报告质量进行评价。结果最终纳入63篇RCTs。随机序列生成、分配方法隐匿、盲法、不完整结局数据、基金资助、基线资料可比的报告率分别为34.92%(22/63)、3.17%(2/63)、4.76%(3/63)、79.37%(50/63)、7.94%(5/63)、100%,所有文献均未对选择性结局报告、样本量估算、临床注册及试验方案相关信息进行报告。对方法学质量进行评价,63个RCTs存在不同程度的方法学质量问题,缺乏高质量的研究。对干预措施小儿推拿疗法的报告质量评价发现,阐述小儿推拿疗法及对照设置合理性的报告率分别为63.49%(40/63)、23.81%(15/63),对小儿推拿师资历、治疗场所和相关信息的报告率均为1.59%(1/63),对小儿推拿疗法的个体化/非个体化选择、小儿推拿部位单/双侧、小儿推拿所引发机体的反应以及小儿推拿是否同期施加其它干预措施的报告率分别为34.92%(22/63)、39.68%(25/63)、6.35%(4/63)、47.62%(30/63)。结论目前,缺乏高质量方法学的关于小儿推拿治疗厌食症的RCTs,相关文献对试验方法学和干预措施小儿推拿疗法的报告质量较低。未来,开展小儿推拿相关临床RCT时,应严格按照Cochrane偏倚评估标准中提出的条目对试验进行设计和报告,参考STRITCA清单[8]并结合小儿推拿特点对干预措施进行报告。同时,应尽快制定针对小儿推拿疗法报告的规范清单。

Objective To evaluate the methodological quality and intervention reporting quality of published randomized controlled trials(RCTs)on pediatric Tuina(PT)for anorexia and provide suggestions for clinical trial design and reporting of PT.Methods Five electronic databases were searched from inception to November 2018.The literature that met the inclusion criteria was included.Two authors used the Cochrane bias risk assessment criteria and modified the STRICTA reporting guideline for PT to evaluate the methodological and intervention reporting quality of the included RCTs.Results A total of 63 RCTs were included.The reporting rates of random sequence generation,allocation concealment,blind method,incomplete outcome data,funding and baseline data were 34.92%(22/63),3.17%(2/63),4.76%(3/63),79.37%(50/63),7.94%(5/63)and 100%,respectively.Selective outcome reports,sample size estimates,trial protocol registration and information were not reported in any of the included publications.Methodological quality assessment showed that 63 RCTs had methodological problems of varying degrees and lacked high-quality.The quality evaluation of PT reports found that the reporting rate of providing the rationale for using PT and the control setting were 63.49%(40/63)and 23.81%(15/63),respectively.The reporting rate of the qualifications of clinician providing the PT treatment setting were the same,both were 1.59%(1/63).The reported rates of individualized/non-individualized selection of PT,single/bilateral manipulation of the massage site,the body reaction induced by the massage were 34.92%(22/63),39.68%(25/63)and 6.35%(4/63)respectively and that of the RCTs about whether other interventions were applied in the same period was 47.62%(30/63).Conclusion Currently,there is a lack of RCTs with high-quality methodology for the treatment of anorexia by PT.The quality of methodological and intervention reporting in the literature was low.Future RCTs for PT should be designed and reported in strict accordance with the Cochrane Bias Evaluation Criteria.A specific reporting guideline for PT which could be achieved by adapting STRICTA is required in order to develop standards for reporting this intervention.