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Data quality in a distributed data processing system: the SHEP Pilot Study.

A Bagniewska, D Black, K Molvig

    Controlled Clinical Trials
    |March 1, 1986
    PubMed
    Summary
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    The Systolic Hypertension in the Elderly Program (SHEP) Pilot trial demonstrated that distributing data processing tasks to clinics enhanced data quality. This approach ensured accuracy, completeness, and timeliness, involving clinic staff actively in quality control.

    Area of Science:

    • Clinical Trials
    • Health Informatics
    • Data Management

    Background:

    • The Systolic Hypertension in the Elderly Program (SHEP) Pilot was a collaborative clinical trial.
    • Distributed data processing models were explored for clinical trials.

    Purpose of the Study:

    • To evaluate the effectiveness and quality control measures of a distributed data processing model in a clinical trial setting.
    • To assess the advantages and disadvantages of distributing data processing tasks to participating clinics.

    Main Methods:

    • Clinics handled data entry, verification, and local file maintenance using customized programs.
    • Data was transmitted electronically to a central Coordinating Center.
    • Quality control was measured using centralized and distributed criteria, including error rates and re-entry verification.

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    Main Results:

    • The error rate for baseline forms was 0.5 per 1000 items.
    • Ninety-eight percent of forms were query-free.
    • A central re-entry of a 5% data sample showed a miskey rate of 2 per 1000 items.

    Conclusions:

    • Distributed data processing in clinical trials can achieve high levels of data accuracy, completeness, and timeliness.
    • Active involvement of clinic staff in quality control and functional accessibility to the Coordinating Center are key advantages.
    • Potential challenges include local master file vulnerability and programmer time demands for system maintenance.