Content and quality of 2000 controlled trials in schizophrenia over 50 years

BMJ 1998;317:1181-1184 ( 31 October )

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Content and quality of 2000 controlled trials in schizophrenia over 50 years

Ben Thornley, research assistant, Clive Adams, coordinating editor.

Cochrane Schizophrenia Group, Summertown Pavilion, Oxford OX2 7LG

Correspondence to: Dr Adams clive.adams{at}psych.ox.ac.uk

Objective To provide a comprehensive survey of the content and quality of intervention studies relevant to the treatmentofschizophrenia.
Design Data were extracted from 2000 trials on the Cochrane Schizophrenia Group'sregister.
Main outcome measures Type and date of publication, country of origin, language, size of study, treatment setting,participant group, interventions, outcomes, and quality ofstudy.
Results Hospital based drug trials undertaken in the United States were dominant in the sample (54%). Generally, studieswere short (54%<6 weeks), small (mean number of patients 65),and poorly reported (64% had a quality score of $=<$ 2 (maximum score5)). Over 600 different interventions were studied in these trials,and 640 different rating scales were used to measureoutcome.
Conclusions Half a century of studies of limited quality, duration, and clinical utility leave much scope for wellplanned, conducted, and reported trials. The drug regulatory authoritiesshould stipulate that the results of both explanatory and pragmatictrials are necessary before a compound is given a licence foreverydayuse.

Key messages

The advent of randomised controlled trials coincided with many new drug treatments for schizophrenia
This survey of 2000 randomised controlled trials of treatment for schizophrenia found that the reporting of key aspects of trial methods could easily be improved
The consistently poor quality of reporting is likely to have resulted in an overoptimistic estimation of the effects of treatments
Large studies, of long duration, investigating outcomes of importance to clinicians and patients are needed

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Rapid Responses:

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Practical Problems in Recruiting Patients with Schizophrenia into RCTs: Helen Lester
bmj.com, 10 Nov 1998 [Full text]
Re: Practical Problems in Recruiting Patients with Schizophrenia into RCTs: Ben Thornley, et al.
bmj.com, 9 Dec 1998 [Full text]