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Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia

University of Manchester, Department of Psychiatry

CAROLINE BRADLEY, MRCPsych, Wellcome Health Services Research Training Fellow

University of Oxford, Department of Psychiatry

CLIVE ADAMS, MRCPsych, CLAIRE JOY, BSc, Research Assistant and MARK FENTON, MA, Research Nurse

Cochrane Schizophrenia Group, Summertown Pavilion, Middleton Way, Oxford

Declaration of interest None. No funding.

Correspondence: Dr Max Marshall, University of Manchester, Department of Community Psychiatry, Guild Academic Centre, Royal Preston Hospital, Sharoe Green Lane, Preston PR2 9HT

Background A recent review suggested an association between using unpublished scales in clinical trials and finding significant results.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Results Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison (relative risk 1.37 (95% C11.12-1.68)). This effect increased when a ‘gold-standard’ definition of treatment superiority was applied (RR 1.94(95%C11.35-2.79)). 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Conclusions Unpublished scales are a source of bias in schizophrenia trials.

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