摘要
目的分析评价《中华健康管理学杂志》已刊发的随机对照试验的报告质量及研究特征。方法在万方数据库检索《中华健康管理学杂志》自创刊至2019年7月刊发的所有随机对照试验,两位研究者严格按照纳入排除标准筛选检索文献,根据临床试验报告的统一标准(CONSORT)声明2010提取、汇总各个文献的报告质量和研究特征(含研究对象类型、招募地点、干预措施、指标评价类别等),分三个时间段(2008-2011年、2012-2015年、2016-2019年)进行评价分析。结果经过检索、筛选最终得到57篇符合要求的文献,CONSORT声明中有13/25个条目全部文献均达标,有8/25个条目部分文献达标,4/25个条目全部文献均不达标。随着时间的推移,三个时间段描述随机方法(16.7%、47.6%、66.7%)、项目获得基金项目资助(25.0%、33.3%、75.0%)与知情同意(50.0%、76.2%、100.0%)的比例有增长趋势,在三个时间段构成比差异均有统计学意义(均P<0.05)。而三个时间段文献中,研究对象均以慢性病人群为主,占比分别为58.3%、85.7%和66.7%,描述研究病例的筛选过程(41.7%、33.3%、75.0%)以及基线(83.3%、95.2%、100.0%)的构成差异均无统计学意义;但是病例的筛选过程和基线情况的描述随着时间发展有所改善。结论《中华健康管理学杂志》的研究报告质量尚待提高,尤其在随机分配方案隐藏、试验注册等方面。
Objective To evaluate the report quality and study characteristics of randomized controlled trials(RCT)published in the Chinese Journal of Health Management.Methods All studies published in the Chinese Journal of Health Management from January 2007 to July 2019 were retrieved via Wanfang data.Two researchers screened the articles strictly according to the inclusion and exclusion criteria independently.Based on the Consolidated Standards of Reporting Trials(CONSORT)statement 2010,the report quality and characteristics of the articles(including the type of participants,recruiting site,interventions,outcome measure,etc.)were extracted and summarized.Then the report quality,study characteristics were analysed among three periods based on the publishing date(2008—2011,2012—2015,2016—2019).Results Titles,abstracts,and full text manuscripts were screened against inclusion criteria by two independent reviewers and 57 studies were included.There were 13/25 items of the CONSORT statement were fulfilled completely,the other 8/25 items were partly fulfilled,and the else 4/25 items were not met the standards in these studies.There was statistically significant difference in the description ratio of‘randomization sequence generation’(16.7%vs.47.6%vs.66.7%),foundation(25.0%vs.33.3%vs.75.0%)and informed consent(50.0%vs.76.2%vs.100.0%)during the three periods(all P<0.05).There was no statistically significant difference in the proportion of chronic diseases(58.3%vs.85.7%vs.66.7%),the description ratio of participant flow(41.7%vs.33.3%vs.75.0%)and baseline data(83.3%vs.95.2%vs.100.0%)in the studies from different periods,however,the description situation of participant flow and baseline data has been improved along the time.Conclusion According to the CONSORT statement,it is found that the quality of research in health management still needs to be improved,especially in the concealment of randomization and trial registration.
作者
聂燕丽
阳洁
石展英
曾琳
Nie Yanli;Yang Jie;Shi Zhanying;Zeng Lin(The Department of Science and Technology of the Fourth Affiliated Hospital of Guangxi Medical University,Liuzhou 545005,China;The Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing 100191,China)
出处
《中华健康管理学杂志》
CAS
CSCD
2020年第4期339-344,共6页
Chinese Journal of Health Management
基金
首都卫生发展科研专项(2018-2-4098)
广西卫计委自筹项目(Z2015165)
柳州市科协资助项目(20150108)。
