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[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。
[Objective] To evaluate the ethical quality of randomized controlled trials of breast cancer and analyze its influencing factors. [Methods] CBM, Wanfang database, CNKI, VIP database were searched by computer, and the randomized controlled trials of breast cancer were searched. The ethical quality was evaluated by Berdeu scale. [Results] The final RCTs included 965 breast cancer patients, with an average of 3.31 ± 2.10 authors, 33.16% of published journal titles for CSCD journals and an average of 2.43 ± 1.24 for collaborating institutions, and only 0.41 for methodological personnel %. The ethical quality evaluation showed that the average score of Berdeu scale was 1.11 ± 0.87, and the items 2, 5, 6, 8 and 10 could fully report less than 1% of the research. Literature published journals rank (MD = 0.12, 95% CI: 0.02-0.22, P = 0.02) and methodological participation (MD = 0.74,95% CI: 0.13-1.35, P = 0.02) may improve the ethics of the literature Quality score (P <0.05). [Conclusion] Ethical quality reports of randomized controlled trials for breast cancer need to be further improved.