Patient-reported outcome measures for depression or anxiety symptoms in patients with cardiovascular disease: A COSMIN systematic review.
BACKGROUND: Depression and anxiety are common in patients with cardiovascular disease (CVD), but the measurement quality of patient-reported outcome measures (PROMs) used in this population remains unclear. This review aimed to evaluate the methodological quality, measurement properties, and certainty of evidence for depression and anxiety PROMs in adults with CVD and to inform instrument selection. METHODS: Following COSMIN and PRISMA guidance, four databases were searched from inception to February 2026. Studies assessing measurement properties of PROMs in adults with CVD were included. Methodological quality was evaluated using the COSMIN Risk of Bias checklist, and certainty of evidence was graded using an adapted GRADE approach. RESULTS: Sixty-six studies assessing 38 PROMs were included, comprising 29 generic and 9 CVD-specific instruments. Six PROMs met COSMIN Category A criteria: Cardiac Depression Scale-Short Form, Patient Health Questionnaire-9, Beck Depression Inventory-II, Hospital Anxiety and Depression Scale, Generalized Anxiety Disorder-7, and Major Depression Inventory. Four instruments were classified as Category C because of insufficient structural validity. Content-validity evidence was largely indeterminate or of limited certainty. Only 24 studies used confirmatory factor analysis or Rasch analysis, and no study assessed measurement error or responsiveness. Cross-cultural validity evidence was scarce. CONCLUSIONS: Six PROMs met Category A criteria, but selection should remain purpose- and context-specific. Particular attention should be given to somatic symptom overlap and intended clinical use. Further validation should prioritize content validity, measurement invariance, responsiveness, measurement error, and clinimetric performance.