How well are randomized controlled trials reported in the dermatology literature?
How well are randomized controlled trials reported in the dermatology literature?
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DOI：
10.1001/archderm.136.3.381
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发表时间：
2000-03-01
影响因子：
--
通讯作者：
Williams, H
中科院分区：
文献类型：
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作者：
Adetugbo, K;Williams, H
目的：为了评估在一个主要的皮肤病学专业期刊上发表的随机对照试验的设计和报告的方法学质量，设计和数据来源：在对所有已发表的平行组随机对照试验的调查中，我们发现从1976年到1997年，从临床和实验皮肤病学的所有问题中随机分配73份报告。直接和间接措施的充分性随机化，试验样本量，基线比较，和意向治疗analysis.Results：手搜索确定了73随机对照试验，但只有31这些被发现通过搜索MEDLINE的出版物类型的临床试验。在73项随机对照试验中，68项包含足够的信息，可纳入分析。只有1项研究（1%）报告了随机序列生成方法，只有5项研究（7%）报告了分配的充分隐藏。在38项使用简单随机化的试验中，对照组的样本量在22种情况下相同，这增加了简单随机化可能没有充分产生或隐藏的可能性。大多数试验（88%）从分析中排除了一些随机参与者。每项试验的中位样本量为23。只有1个试验报告的样本量和统计能力的考虑，并有一个先验的主要hypothes.Conclusions：手搜索是重要的定位所有相关的试验。皮肤病学期刊临床试验报告需要更高的方法学质量。采用CONSORT（报告试验的统一标准）声明和检查表报告试验应提高有效性和加强临床试验报告的证据。
Objective: To assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal.Design and Data Sources: In a survey of all published parallel group randomized controlled trials, we found 73 reports with allocation described as randomized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997.Main Outcome Measures: Direct and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis.Results: Hand searching identified 73 randomized controlled trials, but only 31 of these were found by searching MEDLINE for the publication type clinical trials. Of the 73 randomized controlled trials, 68 contained sufficient information to include in the analysis. Only 1 study (1%) reported the method of random sequence generation, and only 5 studies (7%) reported adequate concealment of allocation. Among 38 trials that used simple randomization, the sample sizes in the comparison groups were identical in 22 occasions, raising the possibility that simple randomization might not have been adequately generated or concealed. Most trials (88%) excluded some randomized participants from their analysis. The median sample size was 23 per trial. Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis.Conclusions: Hand searching is important for locating all relevant trials. There is the need for higher methodological quality in clinical trial reporting in dermatology journals. The adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.