Comparison of important factors to patients recovering from pulmonary embolism and items covered in patient-reported outcome measures: A mixed-methods systematic review

Objective Up to 50 % of patients recovering from pulmonary embolism (PE) experience negative long-term outcomes. Patient-reported outcome measures (PROMs) are important in identifying what matters to patients. We aimed to identify PROMs used in clinical studies and recommended by the International Consortium of Health Outcomes (ICHOM) and compare individual items with factors considered important by patients recovering from PE. Methods This was a convergent mixed-methods systematic review, including quantitative studies, using PROMs and qualitative studies with non-cancer-related PE patients. Items from each PROM and qualitative findings were categorised using an International Classification of Function linking process to allow for integrated synthesis. Results A total of 68 studies using 34 different PROMs with 657 items and 13 qualitative studies with 408 findings were included. A total of 104 individual ICF codes were used, and subsequently sorted into 20 distinct categories representing patient concerns. Identified PROMs were found to adequately cover 17/20 categories, including anxiety, fear of bleeding, stress, depression, dizziness/nausea, sleep disturbance, pain, dyspnea, fatigue, activity levels, family and friends, socializing, outlook on life, and medical treatment. PROMs from the ICHOM core set covered the same categories, except for dizziness/nausea. Conclusions No single PROM covered all aspects assessed as important by the PE population. PROMs recommended in the ICHOM core set cover 16/20 aspects. However, worrisome thoughts, hypervigilance around symptoms, and uncertainty of illness were experienced by patients with PE but were not covered by PROMS.