The Reliability of Medical Record Review for Estimating Adverse Event Rates

  1. Eric J. Thomas, MD, MPH;
  2. Stuart R. Lipsitz, PhD;
  3. David M. Studdert, LLB, ScD, MPH; and
  4. Troyen A. Brennan, MD, JD, MPH
  1. From Brigham and Women's Hospital and Harvard School of Public Health, Harvard University, Boston, Massachusetts; Medical University of South Carolina, Charleston, South Carolina; and University of Texas-Houston Medical School, Houston, Texas.

    Abstract

    Background: The data used by the U.S. Institute of Medicine to estimate deaths from medical errors come from a study that relied on nurse and physician reviews of medical records to detect the errors.

    Objective: To measure the reliability of medical record review for detecting adverse events and negligent adverse events.

    Design: Medical record review.

    Setting: Hospitalizations in Utah and Colorado in 1992.

    Measurements: After three independent reviews of 500 medical records, the following were measured: reliability and the effect of varying criteria for reviewer confidence in and reviewer agreement about the presence of adverse events.

    Results: For agreements in judgments of adverse events among the three sets of reviews, the κ statistics ranged from 0.40 to 0.41 (95% CIs ranged from 0.30 to 0.51) for adverse events and from 0.19 to 0.23 (CIs, 0.05 to 0.37) for negligent adverse events. Rates for adverse events and for negligent adverse events varied substantially depending on the degree of agreement and the level of confidence that was required among reviewers.

    Conclusion: Estimates of adverse event rates from medical record review, including those reported by the Institute of Medicine in its 2000 report on medical errors, are highly sensitive to the degree of consensus and confidence among reviewers.

    Article and Author Information

    • Grant Support: By the Robert Wood Johnson Foundation.

    • Requests for Single Reprints: Eric J. Thomas, MD, MPH, University of Texas-Houston Medical School, 6431 Fannin MSB 1.122, Houston, TX 77030.

    • Current Author Addresses: Dr. Thomas: University of Texas–Houston Medical School, 6431 Fannin MSB 1.122, Houston, TX 77030.

    • Dr. Brennan: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115.

    • Dr. Studdert: Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115.

    • Dr. Lipsitz: Department of Biometry and Epidemiology, Medical University of South Carolina, 135 Rutledge Avenue, Box 250551, Charleston, SC 29425.

    • Author Contributions: Conception and design: E.J. Thomas, S.R. Lipsitz, D.M. Studdert, T.A. Brennan.

    • Analysis and interpretation of the data: E.J. Thomas, S.R. Lipsitz, D.M. Studdert, T.A. Brennan.

    • Drafting of the article: E.J. Thomas, D.M. Studdert.

    • Critical revision of the article for important intellectual content: E.J. Thomas, T.A. Brennan.

    • Final approval of the article: E.J. Thomas.

    • Provision of study materials or patients: E.J. Thomas, T.A. Brennan.

    • Statistical expertise: S.R. Lipsitz.

    • Obtaining of funding: E.J. Thomas, T.A. Brennan.

    • Administrative, technical, or logistic support: E.J. Thomas.

    • Collection and assembly of data: E.J. Thomas, T.A. Brennan.

    Summary for Patients

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