| 田金徽,马继春,谢 吻.中文发表乳腺癌随机对照试验伦理学质量评价[J].中国肿瘤,2016,25(2):155-160. |
| 中文发表乳腺癌随机对照试验伦理学质量评价 |
| Assessment of Ethical Quality of Randomized Controlled Clinical Trials in Breast Cancer Published in China |
| 投稿时间：2015-06-17 |
| DOI：10.11735/j.issn.1004-0242.2016.02.A015 |
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| 中文关键词: 随机对照试验 伦理学质量 乳腺癌 Berdeu量表 |
| 英文关键词:randomized controlled trials ethical quality breast cancer Berdeu scale |
| 基金项目:甘肃省技术研究与开发专项计划（1004TCYA006）， |
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| 摘要点击次数: 2529 |
| 全文下载次数: 688 |
| 中文摘要: |
| 摘 要：［目的］ 评价乳腺癌随机对照试验伦理学质量，分析其影响因素。［方法］ 计算机检索CBM、万方数据库、CNKI、维普数据库，查找乳腺癌随机对照试验，采用Berdeu量表评价伦理学质量。［结果］ 最终纳入965个乳腺癌RCT，作者数量平均为3.31±2.10，发表的杂志等级为CSCD期刊论文的占33.16%，合作机构数量平均为2.43±1.24；有方法学人员参与的仅占0.41%。伦理学质量评价显示：Berdeu量表平均得分为1.11±0.87，条目2、5、6、8、10能够充分报告的研究不足1%。文献发表期刊等级（MD=0.12，95%CI：0.02~0.22，P=0.02）和有方法学人员参与（MD=0.74，95%CI：0.13~1.35，P=0.02）可能会提高文献伦理学质量评分（P<0.05）。［结论］ 乳腺癌随机对照试验伦理学质量报告还需进一步提高。 |
| 英文摘要: |
| Abstract：［Purpose］ To evaluate the ethical quality of randomized controlled clinical trials (RCTs) in breast cancer published in China，and to analyze its influencing factors. ［Methods］ All RCTs of breast cancer indexed in CNKI，CBM and Wanfang database were retrieved. The ethical quality of RCTs was evaluated by using the Berdeu 10-item scale. ［Results］ All of 965 RCTs were included，33.16% of included RCTs were indexed in CSCD，the mean number of authors were 3.31±2.10，the average number of affiliations were 2.43±1.24，0.41% of RCTs were performed by methodologist. The results of ethical quality showed that the mean score of Berdeu scale was 1.11±0.87. Almost 1% of included RCTs completed reported item 2，5，6，8，10. The results of stratified analysis showed that，both statistician/ epidemiologist/evidence-based medicine involvement（MD=0.74，95%CI：0.13~1.35，P=0.02），the type of publication（MD=0.12，95%CI：0.02~0.22，P=0.02） could improve the ethical quality，with a significant difference(P<0.05). ［Conclusion］ The overall ethical quality of randomized controlled clinical trials in breast cancer published in China must be improved in the future. |
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