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Reporting on methods in clinical trials

R DerSimonian, L J Charette, B McPeek

    The New England Journal of Medicine
    |June 3, 1982
    PubMed
    Summary
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    Reporting of clinical trial methods is often inadequate. A survey of 67 trials found only 56% of key design and analysis aspects were clearly reported, highlighting a need for improved standards in medical research publication.

    Area of Science:

    • Clinical Trials Methodology
    • Medical Research Publication Standards

    Background:

    • Adequate interpretation of clinical trials necessitates comprehensive reporting of study design and analysis methods.
    • A significant gap exists in the transparent disclosure of crucial trial elements.

    Purpose of the Study:

    • To assess the frequency of reporting 11 essential design and analysis aspects in major medical journals.
    • To identify deficiencies in clinical trial reporting to inform recommendations for improvement.

    Main Methods:

    • A systematic survey of 67 clinical trials published between July 1979 and June 1980 across four leading medical journals.
    • Evaluation of the reporting completeness for 11 predefined critical items related to study design and data analysis.

    Main Results:

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    • Overall, only 56% of the 11 important items were clearly reported across the surveyed clinical trials.
    • While statistical analyses (80%) and random allocation (80%) were frequently mentioned, specific randomization methods (19%) and blinding of outcome assessment (30%) were poorly reported.
    • Significant variation in reporting quality was observed across journals, with The New England Journal of Medicine performing best (71%) and The Lancet performing worst (46%).

    Conclusions:

    • Clinical trial reporting frequently lacks essential details, hindering proper interpretation and replication.
    • Journal editors should implement guidelines to ensure comprehensive reporting of clinical trial design and analysis.
    • Improving reporting standards is crucial for enhancing the reliability and validity of medical research findings.