摘要
目的评价《中国新药与临床杂志》刊出的有关脑血管疾病的随机对照试验(RCT)的质量。方法计算机联合手工检索《中国新药与临床杂志》1989年1月―2012年12月刊载的脑血管疾病RCT,按照CONSORT 2010声明对照检查清单的25个条目制定评价表,对纳入的每篇文献进行分配,每一条目根据作者是否报告,给出"是"或"否"判断,分别计算每个条目报告百分比,对1989―1999年和2000―2012年12月发表的RCT报告质量进行对比,使用SPSS19.0软件进行统计分析。结果纳入51篇RCT,2000―2012年12月与1989―1999年发表的脑梗死RCT相比,其在文题摘要(1a)、受试者(4b)、样本量(7b)、随机序列产生(8a、8b)、分配隐藏(9)、随机方法的实施(10)、盲法(11a、11b)、受试者流程(13b)、招募受试者(14a)、基线资料(15)、局限性(20)、资助(25)等条目的报告质量有一定改善,4b、(8a、8b)、10、13b的报告率有明显的增长(P<0.05)。虽然RCT的关键条目-方法学部分的8b、9、10、(11a、11b)较之前实现了0的突破,仍然存在报告不充分或不准确的问题。结论《中国新药与临床杂志》1989―2012年发表的脑血管疾病的RCT在方法学的报告方面存在一些不足,影响了脑血管疾病治疗的真实评价。建议今后撰稿人报告RCT与审稿人接受RCT论文时均应参考CONSORT声明。
AIM To investigate the quality of randomized controlled trials （RCTs） related to cerebrovas- cular disease published in the ＂Chinese Journal of New Drugs and Clinical Remedies＂ by CONSORT 2010 statement. METHODS The RCTs published from 1989 to 2012 about cerebrovascular disease were searched. The methodological quality of the literatures was evaluated according to the 25 items in the checklist of Cochrane statement, the findings were judged as ＂Yes＂ or ＂No＂ according to the authors report or not and each item report percentage was calculated. To compare the reporting quality of RCTs which were published during 1989- 1999 with 2000-2012. SPSS 19.0 software was used to analyze the data statistically. RESULTS A total of 51 RCTs were included. Even though the reporting quality of RCTs published in the ＂Chinese Journal of New Drugs and Clinical Remedies＂ improved in some aspects such as title and abstract （1a）, participants （4b）, sample size （7b） , randomisation sequence generation （8a, 8b） , allocation concealment mechanism （9） , randomisation implementation （10） , blinding （ 11a, 11b） , participants flow （13b） , recruitment （14a） , baseline data （15）, limitations （20）, funding （25）, the report rate of 4b, （8a, 8b）, 10, 13b had increased significantly （P 〈 0.05）. Moreover, some important methodological components have achieved a new breakthrough, but still incompletely reported. CONCLUSION The quality of RCTs about cerebral infarction is still low in methodological, which has influences on the real evaluation of the effect of cerebral infarction. It is suggested that the future RCTs on cerebral disease should be conducted with references of CONSORT statement.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2014年第5期338-344,共7页
Chinese Journal of New Drugs and Clinical Remedies
关键词
CONSORT
2010声明
中国新药与临床杂志
脑血管损伤
随机对照试验
质量评价
CONSORT 2010 statement
Chinese journal of new drugs and clinical remedies
cerebrovas-cular injure
randomized controlled trial
quality assessment of literature
