1. In 50 patient-reported outcome measures evaluated, only a small minority reported the validation of all Food and Drug Administration (FDA)-recommended psychometric properties.
2. Patient-reported outcome measures (PROMs) rarely had psychometric properties rated as sufficient by consensus-based standards.
Evidence Rating Level: 1 (Excellent)
Study Rundown: PROs are reported directly by patients and evaluated by clinicians to measure standards of health status, health behaviors, and the patient experience of care in clinical and research environments. PROMs are tools or instruments used to measure PROs and are generally administered to patients via self-reported questionnaires. Recently, PROMs have gained increased recognition in clinical and research settings, though continue to be underused in cardiovascular disease trials. Additionally, there is a gap in knowledge as to understanding generic and disease-specific PROMs that measure health status or health-related quality of life for cardiovascular disease (CVD) populations, as well as their psychometric properties. Overall, this study found that of 50 PROMs validated in CVD populations, a small fraction adhered to all FDA recommendations and had psychometric properties rated as sufficient by COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). This study was limited by factors such as content validity and missing commonly used PROMs without published validation studies in CVD populations, such as a generic PROM like the Health Utilities Index. Nevertheless, these study’s findings are significant, as they demonstrate that only a handful of PROMs validated in CVD populations adhere to FDA recommendations and have sufficient psychometric properties.
In-Depth [systematic review]: This systematic review searched MEDLINE, EMBASE, CINAHL, and the Allied and Complementary Medicine Database and applied the COSMIN method for systematic reviews of PROMs. Studies that recruited patients with CVDs and described the development and validation process of instruments that assessed health status and/or health-related quality of life were eligible for the study. Letters, editorials, commentaries, practice guidelines, reviews, and discussion papers were excluded from the study. The primary studies included were those that developed and/or validated health status PROMs in CVD populations and their psychometric properties. Outcomes in the primary analysis were assessed via narrative synthesis and descriptive analysis. Based on the primary analysis, 50 health status PROMs were identified, and 45 of them were disease-specific while five were generic. In total, 22% of the 50 PROMs validated in CVDs had minimally important differences established. Further, 16% reported the validation of all psychometric properties recommended by the FDA. Based on COSMIN standards for evaluating PROMs, only 4% had all their psychometric properties rated as sufficient in quality. Only 64% of PROMs had less than 50% of psychometric properties rated as sufficient. Overall, this study demonstrates that of the 50 PROMs validated in CVDs, only a small fraction of them had validation of all FDA-recommended psychometric properties or had psychometric properties rated as sufficient by COSMIN, suggesting a need for better adherence to quality standards in PROM validation for future CVD specific PROM.
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