Toward the complexities of the development and validation process of digital health interventions for the symptom management for patients with Chronic Kidney Disease: A scoping review based on the UK Medical Research Council Framework

Abstract

Background: Chronic Kidney Disease (CKD) presents a growing global health issue with a complex symptom phenotype, negatively impacting patients' health-related quality of life and increasing healthcare utilization. While digital health interventions offer promising avenues for improving symptom management in CKD, understanding their development, validation, and effectiveness is crucial for clinical application. Objective: To comprehensively map the existing literature on the development and validation processes of digital health interventions aimed at managing symptoms in patients with Chronic Kidney Disease (CKD), using the UK Medical Research Council's complex intervention framework as a guiding lens. This scoping review aims to identify gaps, challenges, and prospects in this domain, thereby informing future research endeavours and clinical practice guidelines for developing and implementing effective digital health interventions for CKD symptom management. Methods: A scoping review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Databases searched included PubMed, Scopus, Embase, and others, covering literature up to December 2023. Studies were selected based on predefined eligibility criteria focusing on digital health interventions for CKD symptom management. Results: The search yielded 31 studies, with a mix of development and validation studies, predominantly from developed countries. The review highlights the potential of digital interventions in enhancing symptom management, quality of life, and patient engagement in CKD care. However, gaps were identified as follows: 1) Iterative refinement cycles involving multidisciplinary stakeholders enhanced intervention acceptability and usability should be guaranteed, 2) Theory-driven and evidence-based approaches were underutilized in current intervention development, 3) Long-term implementation outcomes and process evaluations were rarely assessed. This review maps an evolving landscape where digital health interventions offer patient-centric solutions for CKD symptom management while highlighting opportunities for methodological advancements. Conclusion: Digital health interventions hold promise for improving symptom management in CKD, yet more research is needed to overcome current limitations and fully realize their potential. Future studies should focus on patient-centred designs, comprehensive validation processes, exploring the underlying mechanism using process evaluation and the integration of these technologies into routine clinical practice.