口腔医学随机对照试验报告的质量研究
Reporting quality of randomized control trials in dentistry
作者：李星1 张舒2 苏乃川2 李琳华1 王璟3
Author：Li Xing1, Zhang Shu2, Su Naichuan2, Li Linhua1, Wang Jing3.
收稿日期：2013-03-28 年卷（期）页码：2014,41(2):156-161
期刊名称：国际口腔医学杂志
Journal Name：International Journal of Stomatology
关键字：随机对照试验,口腔医学,报告临床试验的强化标准声明,
Key words：randomized controlled trial,dentistry,consolidated standards of reporting trials statement,
基金项目：
2012年度同济大学青年优秀人才培养计划资助项目（1501- 219-058）
中文摘要
目的 对中文核心期刊上发表的有关口腔医学研究的随机对照试验（RCT）研究报告质量进行评价，了解影响报告质量的因素。方法 将2011年1月—2012年8月在5种口腔医学中文核心期刊发表的RCT纳入研究，使用改良报告临床试验的强化标准（CONSORT）评分量表评价纳入文献报告质量，对影响报告质量的因素进行单因素分析和多因素分析。结果 符合纳入标准的68篇文献的平均改良CONSORT评分为50.38±1.83，经伦理委员会批准、签署知情同意书、Jadad评分较高与改良CONSORT评分有正向相关性。结论 目前国内口腔医学RCT研究的报告质量有待提高。
英文摘要
Objective This study aimed to assess the quality of reporting randomized controlled trials(RCT) published in Chinese coredental journals. Methods Published RCTs in five Chinese core dental journals between January 2011 and August 2012 were included. The quality of the RCT reports was assessed through modified consolidated standards of reporting trials(CONSORT) statement checklist. The data was analyzed by using descriptive statistics and univariate and multivariate regression analysis to identify important factors affecting the quality at α=0.05 level. Results A total of 68 articles met the inclusion criteria. The mean CONSORT score is 50.38±1.83. The quality score has a positive association with the approval of the ethics committee, whether the informed consent form was signed, and high Jadad scores. Conclusion The quality scores of RCTs in the Chinese core dental journals are considered suboptimal. The reporting quality of RCTs needs to be improved.
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