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Can We Rely on Patients' Reports of Adverse Events?

Zhu, Junya MS, MA*,†; Stuver, Sherri O. ScD*; Epstein, Arnold M. MD, MA‡,§; Schneider, Eric C. MD, MS‡,§,∥; Weissman, Joel S. PhD‡,¶,♯; Weingart, Saul N. MD, PhD*

doi: 10.1097/MLR.0b013e31822047a8
Original Articles

Background Evidence suggests that patients can report a variety of adverse events (AEs) not captured by traditional methods such as a chart review. Little is known, however, about whether patient reports are useful for measuring patient safety.

Objectives To examine the degree to which physician reviewers agreed that patient reports of “negative effects” constituted AEs, and to identify questionnaire items that affected reviewers' judgments.

Methods We surveyed patients discharged from Massachusetts hospitals in 2003 to elicit information about negative effects associated with hospitalization. Physician reviewers judged whether patient-reported negative effects represented AEs, and classified the severity of the event. Likelihood ratios were calculated to assess whether patient responses to questionnaire items affected reviewers' judgments.

Results Of the 2582 patients surveyed, 753 patients reported 1170 negative effects, and 71.2% of these effects were classified as AEs by physician reviewers. Negative effects most likely to be classified as AEs involved newly prescribed medications and changes to previously prescribed medications. Additional information elicited from follow-up survey questions modestly affected reviewers' classification of serious AEs. Negative effects reported by women, younger patients, those reporting better health status, and those not admitted through the emergency department were more likely to be classified as AEs.

Conclusions Many patients were able to identify care-related AEs. Patient responses to questions about the sequelae of the events provided limited additional information for physicians to use in gauging the presence and severity of the event. Patient reports complement other incident-detection methods by providing information that is credible and unavailable from other sources.

*Center for Patient Safety, Dana-Farber Cancer Institute

The Heller School for Social Policy and Management, Brandeis University

Department of Health Policy and Management, Harvard School of Public Health

§Division of General Medicine and Primary Care, Brigham and Women's Hospital

RAND Boston

Institute for Health Policy, Massachusetts General Hospital

Department of Health Care Policy, Harvard Medical School

Supported by a Cooperative Agreement from the Agency for Healthcare Research and Quality to the Massachusetts Department of Public Health [U18 HS11928], and the Center for Patient Safety at Dana-Farber Cancer Institute.

The authors thank the anonymous reviewers for their insightful and constructive comments.

The authors declare no conflicts of interest.

Reprints: Junya Zhu, MS, MA, Center for Patient Safety, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215-5450. e-mail:

© 2011 Lippincott Williams & Wilkins, Inc.