Patient-reported outcome and experience measures in cardiovascular disease: a scoping review as part of iCARE4CVD

Abstract Background Patient-reported outcome and experience measures (PROMs and PREMs) are increasingly acknowledged as vital instruments for assessing the quality of care for cardiovascular diseases (CVD). These measures include validated and non-validated questionnaires, interview guides, and workshops, which differ in terms of their structure, reliability, and application. Currently, there is no overview of which patient-reported outcomes and experiences are measured in CVD research and care, and there is limited consensus on how PROMs and PREMs are selected and applied. Methods A scoping review was conducted in accordance with the PRISMA extension for scoping reviews, with the aim of systematically identifying and analysing studies that report on the use of PROMs and PREMs in CVD. Literature searches were performed in PubMed and ClinicalTrials.gov for studies published before April 2024. Studies assessing patients with heart diseases (ICD-10: I20–I25; I34–I37; I42; I46–I49; I50) using conventional or digital measures to evaluate care quality from the patient’s perspective were included. Studies focusing on CVDs stemming from neurological complications, rheumatic disease, birth defects, and peripheral artery disease were excluded. The same applies to studies using non-validated PROMs. Data analysis was conducted using qualitative content analysis. Results Of the 5,489 records identified, 390 publications were included for full-text analysis. More than a third of these were observational studies ( n = 168; 43%). PROMs were used more frequently than PREMs (309 vs. 159 studies). Quality of life was the most measured patient-reported outcome (211 of 309 studies; 68%), followed by health status ( n = 110; 36%) and depression ( n = 105; 34%). A total of 540 instances of PROM application were recorded across the 390 identified studies, representing 140 unique measurement instruments. More than half of these are disease-specific ( n = 443; 57%), particularly for heart failure, the condition most frequently studied. Of the 140 different PROMs identified, 26 were used in more than five studies, indicating that while many tools exist, only a small subset are in common use. Of the 166 PREMs identified, 57% ( n = 94) were self-developed questionnaires or interview guides, predominantly used in qualitative studies. Validated PREMs often do not focus on a specific disease. The most frequently assessed patient-reported experiences were self-care, treatment experiences, satisfaction, knowledge, and adherence. Both patient-reported outcomes and experiences were primarily assessed using paper-based measures. Conclusion This review highlights the lack of consensus in the use, validation status and reporting of PROMs and PREMs in CVD research and care. Although validated, disease-specific PROMs are widely used for key outcomes such as quality of life, there is a lack of standardised PREMs tailored to CVDs. To advance patient-centred care in CVDs, there is a need for more consistent use of validated instruments, transparent reporting of administration methods, and the development of robust PREMs. Furthermore, standardising the PROMs and PREMs used may help, particularly with regard to the comparability of findings in different studies.