摘要
目的:运用临床试验报告统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明2010及偏倚风险评估工具评价推拿治疗小儿肌性斜颈随机对照试验(Randomized Controlled Trial,RCT)的报告质量。方法:利用系统检索中国知网、万方数据知识服务平台、维普中文科技期刊全文数据库、中国生物医学文献服务系统、美国国立医学图书馆、OVID数据库中有关推拿治疗小儿肌性斜颈的相关RCT,并佐以手工检索,将检索时间段设置为2011年1月1日-2021年12月31日。文献筛选由两位评价人员根据本研究的纳、排标准独立进行,筛选工作完成后采用CONSORT声明2010对文献进行报告质量评估,文献的偏倚风险评价采用偏倚风险评估工具进行评价。结果:通过筛选后最终纳入22篇文献。偏倚风险评估工具显示偏倚风险评为低风险、不确定风险及高风险的百分比分别是20.13%、64.93%及14.94%。从评估报告中可得出,完全报告及未报告条目数占全部条目的百分比分别为16.22%和37.84%。文献整体质量不高,尤其是在随机化、盲法、样本量估算等方面存在较大的不足,其报告率分别为45.45%、0.00%及9.09%。结论:目前推拿治疗小儿肌性斜颈的RCT研究报告质量有待进一步提高,建议今后研究者严格参照CONSORT声明条目对推拿治疗小儿肌性斜颈的RCT进行规范报告,以期使推拿疗法更好地指导临床并推广。
Objective: To evaluate the reporting quality of randomized controlled trials on massage treatment for muscular torticollis in children based on the CONSORT Statement 2010 and Risk of Bias Assessment Tool. Methods: The studies included in China National Knowledge Network, Wanfang data knowledge service platform, VIP Chinese Science and Technology Journal Full-text Database, China Biomedical Literature Service System, US National Library of Medicine, OVID database related to massage treatment of pediatric muscular torticolis were searched, which was combined with manual retrieval. The retrieval period was set from January 1, 2011 to December 31, 2021. The literature was screened independently by two evaluators according to the inclusion and ranking criteria of this study. After the screening, CONSORT Statement 2010 was used to evaluate the report quality of the literature, and the bias risk assessment tool was used to evaluate the literature. Results: After screening, twenty-two papers were finally included. The risk of bias assessment tool showed that the percentages of low risk, uncertain risk and high risk were 20.13%, 64.93% and 14.94%, respectively. The percentage of fully reported and unreported items were 16.22% and 37.84% in the evaluation report. But the overall quality is not good, especially in the aspects of randomization, blind method, sample size estimation and other aspects, there were great shortcomings, the reporting rates were 45.45%, 0.00% and 9.09%, respectively. Conclusion: At present, the reporting quality of randomized controlled trial on massage treatment for muscular torticollis in children needs to be further improved. It is suggested that researchers should strictly refer to the CONSORT Statement items to normalize the report of the randomized controlled trials on massage treatment for muscular torticollis in children in the future, and make massage therapy better guide clinical application and promotion.
作者
王晓增
王洪博
高玉奇
占茂林
张宇
吕子萌
WANG Xiaozeng;WANG Hongbo;GAO Yuqi;ZHAN Maolin;ZHANG Yu;LYU Zimeng
出处
《中医临床研究》
2022年第33期1-6,共6页
Clinical Journal Of Chinese Medicine
基金
安徽省卫生健康软科学研究项目(2020WR04006)
安徽省2020年度中医药传承创新项目(2020 ccyb06)
2021年度安徽省卫生健康委科研项目(AHWJ2021b047)
安徽中医药大学第一附属医院临床科研基金(2020yfyzc30)
国家中医药管理局国医大师工作室建设项目(2018-474)。
关键词
推拿
肌性斜颈
随机对照试验
CONSORT声明
报告质量
Massage
Muscular torticollis
Randomized controlled trial
CONSORT statement
Reporting quality
