田金徽, 何江鸿, 张盼, 娄丽丽, 梁莉, 葛龙, 甘雨虹, 何娟, 王小虎, 张红. 中文发表乳腺癌随机对照试验中不良反应报告质量评价[J]. 循证医学, 2016, 16(5): 289-293. DOI: 10.12019/j.issn.1671-5144.2016.05.011
    引用本文: 田金徽, 何江鸿, 张盼, 娄丽丽, 梁莉, 葛龙, 甘雨虹, 何娟, 王小虎, 张红. 中文发表乳腺癌随机对照试验中不良反应报告质量评价[J]. 循证医学, 2016, 16(5): 289-293. DOI: 10.12019/j.issn.1671-5144.2016.05.011
    TIAN Jin-hui, HE Jiang-hong, ZHANG Pan, LOU Li-li, LIANG Li, GE Long, GAN Yu-hong, HE Juan, WANG Xiao-hu, ZHANG Hong. Safety Reporting in Randomized Controlled Trial Related to Breast Cancer Published in China[J]. Journal of Evidence-Based Medicine, 2016, 16(5): 289-293. DOI: 10.12019/j.issn.1671-5144.2016.05.011
    Citation: TIAN Jin-hui, HE Jiang-hong, ZHANG Pan, LOU Li-li, LIANG Li, GE Long, GAN Yu-hong, HE Juan, WANG Xiao-hu, ZHANG Hong. Safety Reporting in Randomized Controlled Trial Related to Breast Cancer Published in China[J]. Journal of Evidence-Based Medicine, 2016, 16(5): 289-293. DOI: 10.12019/j.issn.1671-5144.2016.05.011

    中文发表乳腺癌随机对照试验中不良反应报告质量评价

    Safety Reporting in Randomized Controlled Trial Related to Breast Cancer Published in China

    • 摘要: 目的 使用Ioannidis量表和CONSORT声明扩展版全面评价中文发表的乳腺癌随机对照试验不良反应报告情况。 方法 计算机检索中国知网数据库、中国生物医学文献数据库、中文科技期刊数据库及万方数据资源,并严格按照纳入排除标准筛选获得中文发表的乳腺癌随机对照试验。采用CONSORT声明扩展版及Ioannidis量表评价和分析所有纳入文献,各条目符合程度由高到低分别评为“1分”、“0.5分”、“0分”。将所获数据录入Excel软件,并使用RevMan5.0软件进行统计分析。 结果 共纳入乳腺癌随机对照试验964篇,发表数量总体呈逐年上升之势。 812篇(84.2%)研究提及了不良反应或不良事件,CONSORT总评分为(2.94±1.68)分,中位数为3分;Ioannidis总评分为(0.94±1.00)分,中位数为1分,且所有条目的完整报告率均低于50%。分层分析结果显示: 仅Ioannidis评分在中国科学引文数据库期刊来源研究与非中国科学引文数据库期刊来源研究的差异具有统计学意义(P=0.03),其他方面的差异均无统计学意义。 结论 中文发表乳腺癌随机对照试验中不良反应的报告不够全面。作者和编辑需互相督促、学习,共同促进不良反应报告质量的提高。

       

      Abstract: Objective The aim of this report is to make judgment on the safety reporting in randomized controlled trial (RCT) related to breast cancer using Ioannidis checklist and the expanded version of CONSORT statement. Methods Search the China Knowledge Resource Integrated Database(CNKI), Chinese Biomedical Literature Database(CBM), Chinese Scientific Journals Database (VIP) and the Wanfang data resources, and activities in accordance with the inclusion and exclusion criteria to obtain the RCTs of breast cancer. The quality of included reviews was assessed in accordance with the Ioannidis checklist and the expanded version of CONSORT statement. Based on the degree of conformity with each criterion, the reviews were scored as “1”,“0.5” or “0” orderly. The data were put into Excel, and the RevMan5.0 software was used for statistical analysis. Results A total of 964 studies were included, and the number of publications was increasing annually. There were 812 (84.2%) studies mentioned adverse reactions or adverse events, the median of CONSORT score was 3 (2.94 ± 1.68); the median of Ioannidis score was 1 (0.94 ± 1.00), and all the entries were lower than 50%. The results of stratified analysis showed that: the difference of Ioannidis score between CSCD and non CSCD was statistical significance (P=0.03), other differences of other stratified factors didn’t have statistical significance(P>0.05). Conclusion The safety reporting in randomized controlled trial related to breast cancer published of Chinese is not comprehensive enough. That requires authors and editors to supervise and learn with each other, and work together to improve the quality of safety reporting.

       

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