Patient-reported outcome measures in carotid artery revascularization: systematic review and psychometric analysis

Objective: Patient-reported outcome measures (PROMs) provide a way to measure the impact of a disease and its associated treatments on the quality of life from the patients’ perspective. The aim of this review was to identify PROMs that have been developed and/or validated in patients with carotid artery stenosis (CAS) undergoing revascularisation and to assess their psychometric properties and examine suitability for research and clinical use. Methods: Eight electronic databases including MEDLINE and CINAHL were searched using a two-stage search approach to identify studies reporting the development and/or validation of relevant PROMs in patients with CAS undergoing revascularisation. Supplementary citation searching and hand-searching reference lists of included studies were also undertaken. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and Oxford criteria were used to assess the methodological quality of the included studies and the psychometric properties of the PROMs were evaluated using established assessment criteria. Results: Five studies reporting on six PROMs were included: 36-Item Short Form Health Survey (SF-36), Euro-QoL-5-Dimension Scale (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Dizziness Handicap Inventory (DHI), Quality of life for carotid artery disease scale and a disease-specific PROM for CAS. The rigour of the psychometric assessment of the PROMs was variable with most only attempting to assess a single psychometric criterion. No study reported evidence on construct validity and test-retest reliability. Evidence for acceptability for the use of SF-36, EQ-5D and the disease-specific PROM were rated good in most studies. Only one study reported a Cronbach alpha score >0.70 as evidence of internal consistency. Overall, the psychometric evaluation of all included PROMs was rated as poor within the CAS population undergoing revascularisation. Conclusions: This review highlighted a lack of evidence in validated PROMs used for patients undergoing carotid artery revascularisation. As a result, the development and validation of a new PROM for this patient population is warranted in order to provide data which can supplement traditional clinical outcomes (stroke<30 days post-procedural, myocardial infarction and death) and capture changes in health status and quality of life to help inform treatment decisions.