Unpublished rating scales: A major source of bias in randomised controlled trials of treatments for schizophrenia
Unpublished rating scales: A major source of bias in randomised controlled trials of treatments for schizophrenia
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DOI：
10.1192/bjp.176.3.249
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发表时间：
2000-03-01
影响因子：
10.5
通讯作者：
Fenton, M
中科院分区：
文献类型：
--
作者：
Marshall, M;Lockwood, A;Fenton, M
背景最近的一篇综述表明，在临床试验中使用未发表的量表与发现显著的结果之间存在关联。目的确定在精神分裂症试验中是否存在这种关联。方法从Cochrane精神分裂症组的登记中随机选择300个试验。治疗组和对照组之间使用评分表进行的所有比较均已确定。结果当使用未发表的量表进行比较时，试验更有可能报告治疗优于对照(相对危险度1.37(95%可信区间1.12~1.68))。当采用治疗优势的“金标准”定义时，这种效果会增加(RR 1.94(95%CI 1.35-2.79))。在非药理学试验中，如果使用已发表的量表，则不会有三分之一的治疗优势的“金标准”声明。结论未发表的量表是精神分裂症试验中偏倚的来源。
Background A recent review suggested an association between using unpublished scales in clinical trials and finding significant results.Aims To determine whether such an association existed in schizophrenia trials.Method Three hundred trials were randomly selected from the Cochrane Schizophrenia Group's Register. All comparisons between treatment groups and control groups using rating scales were identified. The publication status of each scale was determined and claims of a significant treatment effect were recorded.Results Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison (relative risk 1.37 (95% CI 1.12-1.68)). This effect increased when a 'gold-standard' definition of treatment superiority was applied (RR 1.94 (95% CI 1.35-2.79)). In non-pharmacological trials, one-third of 'gold-standard' claims of treatment superiority would not have been made if published scales had been used.Conclusions Unpublished scales area source of bias in schizophrenia trials.