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Related Experiment Videos

Single vs. double data entry in CAST.

R A Reynolds-Haertle1, R McBride

  • 1University of Washington, Seattle 98105.

Controlled Clinical Trials
|December 1, 1992
PubMed
Summary
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Double data entry (DE) showed a trend toward reducing data keying errors compared to single entry (SE) in clinical trials. However, DE increased data entry time by 37%.

Area of Science:

  • Clinical research methodology
  • Health informatics
  • Data management

Background:

  • Accurate data collection is crucial for clinical trial integrity.
  • Traditional single data entry (SE) methods may be prone to keying errors.
  • Evaluating advanced data entry techniques like double data entry (DE) is essential.

Purpose of the Study:

  • To compare the data keying error rates between single entry (SE) and double data entry (DE) in a clinical trial setting.
  • To assess the efficiency and time implications of implementing DE versus SE.

Main Methods:

  • A randomized crossover design was employed across clinical centers of the Cardiac Arrhythmia Suppression Trial (CAST).
  • A total of 42,278 data fields were compared between paper forms and the computer database.

Related Experiment Videos

  • Error rates for SE and DE were calculated and compared using Poisson regression.

    • Main Results:

    • The overall error rate across both methods was 19 per 10,000 fields.
    • Single entry (SE) had an error rate of 22 per 10,000 fields.
    • Double data entry (DE) demonstrated a lower error rate of 15 per 10,000 fields (P = .09).
    • DE required 37% more time than SE, adding approximately 90 minutes of work per clinic monthly.

    Conclusions:

    • Double data entry (DE) may reduce data entry errors in clinical trials, though the current study did not reach statistical significance (P = .09).
    • The implementation of DE incurs a notable time cost, increasing operational workload for clinical centers.
    • Further research may be warranted to explore the cost-effectiveness and optimal implementation strategies for DE in large-scale clinical research.