摘要
目的对2008年至2011年《癌症进展》杂志发表的随机对照试验报告质量进行评价。方法全面收集《癌症进展》杂志2008年至2011年发表的随机对照试验文献,采用CONSORT(包括25项条目)对其报告质量进行评价。主要指标包括条目报告率和平均报告条目数。结果共获得23篇随机对照试验报告,平均报告条目数为11.3项(95%可信区间10.5～12.3项)。对研究背景与目标、试验设计、研究对象入选标准、干预内容、主要和次要结局指标、统计分析方法、研究对象征集的时间范围、基线特征、结果估计、危害效应、结果解释等条目的报告率达到了80%以上;而对样本量的确定、随机序列产生方法、分配隐藏、盲法、研究对象流程、ITT、研究局限性、结果可推广性和资助来源等条目的报告率较低。结论总体上该杂志2008年至2011年发表的随机对照试验报告质量不能令人满意,建议在投稿要求中采纳CONSORT,以改善随机对照试验的报告质量。
Objective To assess the quality of reporting of randomized controlled trials published in Oncolugy Pro- gress during 2008 -2011. Methods Alter a comprehensive search for randomized controlled trials articles published in this journal during 2008 -2011 , CONSORT statement （including 25 items） was used to assess the quality of reporting. The main outcome measures were reporting rates of items anti average number of items reported. Results 23 eligible arti- cles were identified, anti the average number of items reported was 11.3 （95% CI 10. 5 - 12. 3）. For such items as hack- ground and objectives, trial design, eligibility criteria for participants, interventions, primary and secondary outcome measures, statistical methods, recruitment, baseline data, outcomes estimation, harms and interpretation of resuhs, the reporting rates were higher than 80%. For the other items, including determination of sample size, method used to gener- ate the random allocation sequence, allocation concealment, blinding, participant flow, ITT, trial limitations, general- izability of the findings and funding sources, the reporting rates were low. Conclusion The overall quality of reporting of randomized controlled trials published in this journal during 2005 -2011 was unsatisfactory. We suggest that this journal should adopt CONSORT for manuscripts to improve the reporting of randomized controlled trials.
出处
《癌症进展》
2012年第5期525-529,共5页
Oncology Progress
