1Charité - Universitätsmedizin Berlin CC12: Med. Klinik m. S. Psychosomatik Berlin, Deutschland; 2Charité - Universitätsmedizin Berlin CC11: Med. Klinik m.S. Kardiologie Berlin, Deutschland; 3Charité - Universitätsmedizin Berlin CC11: Med. Klinik m. S. Kardiologie und Angiologie Berlin, Deutschland; 4Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CBF Berlin, Deutschland; 5Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CVK Berlin, Deutschland
Backgrounud Our prospective, randomized clinical trial strives to establish an unique Patient-reported Outcome Measurement (PROM) Alert System for atrial fibrillation patients, actively integrating their perspective into healthcare. PROMs, measuring Health-related Quality of Life (HRQoL), serve as a treatment effectiveness indicator, enabling timely treatment adjustments in case of significant deterioration in patients’ HRQoL or lack of substantial improvement. We believe consistent HRQoL measurement will provide further evidence for targeted treatment choice; i.e., catheter ablation vs. medical treatment. The goal of this systematic review is to provide an overview on PROM integration in patient management in clinical trials to highlight the novelty of patient-centric management strategies.
Methods A systematic literature search in the scientific database Medline through PubMed was conducted to identify studies from 2015 to November 2023 that assessed PROMs as intervention in different diseases in comparison to a control group receiving the standard check-up in symptom management. The search was carried out in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Non-randomized and randomized controlled trials were included in the analysis. We included studies with a study population of individuals aged 19 years or older, controlled study designs, and the presence of an alert and intervention system associated with PROMs.
Results From 204 initially identified studies, 76 studies were selected after the first screening. Of these, 11 studies met our inclusion criteria. These 11 eligible studies spanned various medical specialties, with one study in heart failure treatment while the remainder investigated patients from other specialties including eight studies in the field of cancer therapy, one study in joint replacement therapy, and one study in gynecological surgery. All studies reported a positive effect of PROM interventions compared to the standard of care. The primary and secondary outcomes varied due to different pathologies but included symptom threshold events, patient satisfaction, physical function, symptom control, HRQOL, emergency department visits, and the reduction of fatigue and depressive symptoms.
Conclusion Only one trial was conducted in the field of cardiology (PROMs intervention in heart failure), implying our upcoming trial will be the first PROM-based intervention study in arrhythmia management. The consistently positive results across these diverse medical areas suggest that the application of PROM interventions is a promising strategy to enhance symptom control and patients' HRQoL. The results of the previous studies indicate that PROM integration in patient management optimizes patient care across different subjects. The obvious evidence gap in the treatment of cardiovascular patients need to be addressed. Our trial beginning in 2024 aims to start with patients with atrial fibrillation.