Remote measurement based care (RMBC) interventions for mental health-Protocol of a systematic review and meta-analysis.

BACKGROUND: Poor management of mental illnesses is associated with lower treatment adherence, chronification, avoidable re-hospitalisations, and high costs. Remote measurement based care (RMBC) interventions have gained increasing relevance due to its potential in providing a comprehensive and patient-centric approach to mental health management. OBJECTIVES: The systematic review and meta-analysis aims to provide a comprehensive overview and analysis of existing evidence on the use of RMBC for patients with mental illness and to examine the effectiveness of RMBC interventions in alleviating disorder-specific symptoms, reducing relapse and improving recovery-oriented outcomes, global functioning, and quality of life. METHODS AND ANALYSIS: Our multidisciplinary research team will develop a comprehensive search strategy, adapted to each electronic database (PubMed, Medline, Embase, and PsychINFO) to be examined systematically. Studies with patients formally diagnosed by the International Classification of Diseases or the Diagnostic and Statistical Manual of Mental Disorders which include assessment of self-reported psychiatric symptoms will be included. Publications will be reviewed by teams of independent researchers. Quality of studies will be assessed using the Cochrane Collaboration's tool for assessing risk of bias. Outcomes cover symptom-focused or disease-specific outcomes, relapse, recovery-focused outcomes, global functioning, quality of life and acceptability of the intervention. Further data that will be extracted includes study characteristics, target population, intervention, and tracking characteristics. Data will be synthesised qualitatively, summarising findings of the systematic review. Randomised controlled trials (RCTs) will be considered for meta-analysis if data is found comparable in terms of mental illness, study design and outcomes. Cumulative evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation framework. TRIAL REGISTRATION: Trial registration number: PROSPERO CRD42022356176.

A digital patient-reported outcome (electronic patient-reported outcome) system for patients with severe psychiatric disorders: User-centered development study and study protocol of a multicenter-controlled trial.

Background: The effective treatment of patients with severe psychiatric disorders primarily relies on subjective reporting of symptoms and side-effects. This information is crucial for a clinician's decision regarding medication adjustment. Treatment adjustment usually happens at a low frequency (∼4-8 weeks). In between points of care, patients are left alone with their symptoms and side-effects. This leads to uncertainty regarding the treatment, non-adherence, possible relapse, and rehospitalization. Objectives: We aim to design a flexible electronic patient-reported outcome (ePRO) system, which allows patients with severe psychiatric disorders to: (a) record their symptoms using an app; (b) share the data with the clinical team at points of care; and (c) utilize the data to support therapy decisions. Methods: In this article, we describe the development process which included the following steps: (a) formation of a co-design team; (b) stakeholder interviews with patients, practitioners, and digital health experts to access needs, requirements, and barriers; (c) prototype conceptualization and design; (d) user acceptance testing and refinement; and (e) finalization of the system for testing in a pilottrial. Results: We included input from patients with lived experience of psychiatric disorders, clinical team members, software engineers, and researchers. A prototype system was refined, and iterative changes were made before finalization during a series of operational meetings. The system allows patients to digitally self-report their symptoms and provides longitudinal ePRO symptom data for export into the electronic health record. Conclusions: Routine ePRO collection has the potential to improve outcomes and hereby also reduce health service costs. We have successfully developed a trial-ready ePRO system for severe psychiatric disorders. The findings were incorporated in the planning of a feasibility pilot trial. Assuming feasibility will be established, the system might be subjected to a certification process evaluation of safety and efficacy including a randomized controlled trial.