Patient-reported outcome measures for adverse events: A systematic review and COSMIN evaluation study

Abstract

ABSTRACT Background: Health care requires constant improvement. Harms in health care are becoming a priority, as is incorporating the patient’s voice in both clinical research and clinical care. Patients have been found to provide a more subjective, detailed perspective of their treatment experiences compared with health care providers; this is especially true of potential harms they have experienced. Measurement instruments must be valid and reliable; a new field of Patient Reported Outcome Measures (PROM) has emerged to capture the patient’s perspective and experience. Methods: A systematic review was conducted to identify all patient-reported outcome measures for adverse events (PROM-AE) currently published in the health literature databases. These measures were compared to establish similarities and differences, and to determine if any core characteristics existed. Results: The most commonly used PROM AE in clinical research and clinical practice were evaluated further with regards to their measurement properties. Conclusion: Important gaps, such as minimal harms reporting in clinical research and practice, were identified that could help advance the field of PROM AE and thereby enhance patient safety in both research and clinical settings.