基于CONSORT拓展声明和STRICTA清单评价推拿治疗小儿腹泻的随机对照试验方法学质量与报告质量

Evaluation on Methodological and Reporting Quality of Randomized Controlled Trials of Tuina Therapy for Childhood Diarrhea Using CONSORT and STRICTA Standards

目的评价推拿治疗小儿腹泻随机对照试验(RCTs)的方法学质量与报告质量现况。方法系统检索中国知网(CNKI)、中国科技期刊数据库(VIP)、万方数据库、Sino Med、Pub Med、Cochrane图书馆、Embase等数据库中推拿治疗小儿腹泻的随机对照试验,由两名研究者独立进行文献筛选和资料提取,基于Cochrane系统评价手册、CONSORT拓展声明评价RCTs的方法学质量及报告质量,参考STRICTA清单和相关研究拟定的条目评价RCTs干预措施报告质量,对结局指标进行计数统计。结果最终纳入45项RCTs,报告质量较低。随机序列产生方法、分配隐藏、盲法、基线完整性、样本量估算及研究方案注册报告率分别为48.9%、4.4%、4.4%、68.9%、0、0。干预措施报告中推拿理论依据、推拿施加其他干预措施的细节、推拿师背景报告率分别为53.3%、13.3%、20.0%。结局指标的腹泻持续时间、腹泻次数、大便量变化、腹泻伴随症状消退时间报告率依次为17.7%、11.1%、0、4.4%,报告安全性结局的有5篇(11.1%)。结论目前推拿治疗小儿腹泻的RCTs方法学质量与报告质量均较低,今后的RCT研究应遵循CONSORT声明、STRICTA清单条目进行方案设计、方案注册和研究报告,同时应注重客观结局指标的设定与报告。

Objective To evaluate the methodological quality and reporting quality of randomized controlled tri-als （RCTs） of tuina therapy for childhood diarrhea, and provide a reference for methodology in the future clinical re-search and therapeutic evaluation. Methods We identified RCTs by electronic searches of the Chinese Network Knowledge Information （CNKI）, Chinese Science Journal Database （VIP） , China biomedical literature database, Wanfang Data, SinoMed, PubMed database, The Cochrane library, EMBASE. We included the literature on tuina therapy for childhood diarrhea. Two researchers independently screened and extracted data. Based on the Cochrane handbook for systematic reviews and the CONSORT statement of progress, the methodological quality and reporting quality of RCTs were evaluated, and the items prepared according to the STRICTA were used to evaluate the quality of RCTs intervention reports and count the outcome measures. Results 45 RCTs were included, and the methodologi-cal quality and reporting quality of RCTs of tuina in treating childhood diarrhea was low. The rate of random methods, allocation concealment, blinding, baseline integrity, sample size estimation and registration of research protocols were reported 48.8% , 4. 4% , 4.4% , 68.9% , 0% , 0% respectively. In intervention measures reports, the rate of theo-retical basis, the details of intervention, and the qualifications of tuina operators were 53.3% , 13.3% , 20. 0% re-spectively. The outcome measurement of diarrhea such as the duration of diarrhea, frequency of diarrhea, changes of stool volume, and disappearance time of diarrhea accompanying symptoms were reported 17.7% , 11.1% , 0% and 4. 4% respectively. Conclusion The methodological quality and reporting quality of RCTs of tuina in treating childhood diarrhea was low. In the future, RCTs should be designed, registered and reported based on the CONSORT statement and standards of STRICTA reference list, and pay attention to the setting and reporting of objective outcome indicators.