Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
复制标题
DOI：
10.1136/bmj.328.7430.22
复制
发表时间：
2004-01-03
影响因子：
--
通讯作者：
Djulbegovic, B
中科院分区：
文献类型：
--
作者：
Soares, HP;Daniels, S;Djulbegovic, B
目的探讨随机对照试验中方法报告不完善是否反映了方法不完善。设计观察性研究。放射治疗肿瘤学组自1968年成立以来进行的随机对照试验报告。参与者：放射治疗肿瘤学组。结果测量报告内容与所有随机对照试验方案中描述的设计特征进行比较。结果56项随机对照试验的方法学质量优于文献报道。在所有试验中都实现了适当的分配隐藏，但只有42%的论文报道了这一点。83%的试验进行了意向治疗分析，但只有69%的论文报道了意向治疗分析。76%的研究进行了样本量计算，但只有16%的论文进行了报道。在76%和74%的试验中，终点是明确定义的，cc和beta误差是预先指定的，但只有10%的论文报告了这些误差。唯一的例外是对退出的描述，报告的频率与放射治疗肿瘤组的原始统计文件中所包含的频率相似。结论：随机对照试验方法学方面的报告不一定反映试验的实施情况。审查研究方案和联系试验人员以获取更多信息可能会改善质量评估。
Objective To determine whether poor reporting of, methods in randomised controlled trials reflects on poor methods.Design Observational study.Setting Reports of randomised controlled trials conducted by the Radiation Therapy Oncology Group since its establishment in 1968.Participants The Radiation Therapy Oncology Group.Outcome measures Content of reports compared with the design features described in the protocols for all randomised controlled trials.Results The methodological quality of 56 randomised controlled trials was better than reported. Adequate allocation concealment was achieved in all trials but reported in only 42% of papers. An intention to treat analysis was done in 83% of trials but reported in only 69% of papers. The sample size calculation was performed in 76% of the studies, but reported in only 16% of papers. End points were clearly defined and cc and beta errors were prespecified in 76% and 74% of the trials, respectively, but only reported in 10% of the papers. The one exception was the description of drop outs, where the frequency of reporting was similar to that contained in the original statistical files of the Radiation Therapy Oncology Group.Conclusions The reporting of methodological aspects of randomised controlled trials does not necessarily reflect the conduct of the trial. Reviewing research protocols and contacting trialists for more information may improve quality assessment.