五行音乐疗法改善肿瘤病人生存质量及负性情绪研究的方法学及报告质量评价

Quality evaluation on methodology and reporting of five elements music therapy of traditional Chinese medicine for improving life quality and negative emotions of tumor patients

[目的]对五行音乐疗法改善肿瘤病人生存质量及负性情绪的随机对照试验(RCT)的方法学质量及报告质量进行评价。[方法]计算机检索CBM、CNKI、VIP、Wanfang Data和MEDLINE,检索时间均从建库至2016年12月。收集所有五行音乐疗法改善肿瘤病人生存质量及负性情绪的RCT,分别参考Cochrane手册5.1.0版的偏倚风险评估工具、CONSORT声明2010版及9项中医药特色指标评价所纳入RCT的方法学质量和报告质量。[结果]最终纳入文献28篇。Cochrane偏倚风险评估工具评价结果显示:35.7%的RCT采用了较为合理的随机分配方法,均未采用分配隐藏和盲法;10.7%的RCT报告了失访情况;17.8%的RCT采用了意向性分析;研究均不清楚是否存在选择性报告。CONSORT声明2010版评价结果显示:3.6%的文献能从文题识别是随机临床试验;样本含量计算、随机化实施细节、分配隐藏、盲法、流程图的使用、随访、结果分析类型、不良反应、试验注册及方案等的报告率均为0。中医药特色指标补充评价结果显示:3.6%采用中医证候诊断;无RCT报告干预措施的质控措施;1项RCT报告为多中心研究。[结论]五行音乐疗法改善肿瘤病人生存质量及负性情绪研究报告质量不高,研究存在不同程度的方法学问题,今后在设计和报告RCT时可参考Cochrane手册中的偏倚风险评估工具和CONSORT声明,以提高研究质量,增强五行音乐疗法改善肿瘤病人生活质量及负性情绪疗效证据的强度,推进五行音乐疗法的科学和规范化发展。

Objective：To evaluate the methodological and reporting quality therapy of five elements music therapy of tra- ditional Chinese medicine to improve quality of life and negative emotions for patients with cancer by randomized con- trolled trial （RTC）. Methods. Database including CBM, CNKI, VIP, Wanfang Data and MEDLINE were electronically searched from inception to December 2016 to collect the randomized controlled trials（RCTs ） about five elements music therapy of traditional Chinese medicine for improving quality of life and negative emotions of tumor patients. The methodological and reporting quality of included RCTs was respectively evaluated according to the assessment tool of risk of bias of the Cochrane Handbook 5. 1. 0, the CONSORT 2010 statement, and the 9 traditional Chinese medicine characteristic indexes, the quality of the methodology and reporting quality of RCTs were included. Resuits： 125 articles were first detected and a total of 28 literatures were finally included. As Cochrane bias risk assessment tool evaluation results showed,35.7% of the RCTs performed proper random method,and no allocation concealment and blinding were conducted;only 10.7% of the RCT reported the loss of follow-up; 17.8% selected intention-to-treat analysis;and all of the studies were not clear about whether existed selective report. The CONSORT 2010 statement indicated that 3. 6% of the literatures could be identified from a randomized clinical trial. The reporting rate of sample size, randomization implementation details, allocation concealment, blindness, flow chart usage, follow-up, result analysis type, adverse reactions, test registration and scheme were all 0. The result of supplementary evaluation of Chinese medicine characteristic index showed that only 3.6% of TCM adopt syndrome diagnosis;no RCT took intervention measures for quality control;and only one RCT report was a multicenter study. Conclusion：The quality of five elements music therapy of traditional Chinese medicine for improving quality of life and negative emotions of tumor patients was still low in methodological and reporting aspects. It is suggested that the future design and report should be conducted with references of CONSORT statement and the assessment tool of risk of bias of the Cochrane Handbook,in order to improve the quality of research, enhance the intensity of five elements music of TCM to improve the quality of life and the intensity of evidence of negative emotions oftumor patients, and promote the scientific and standardized development of therapy of five elements music of TCM.