Hosana Cristina Morales Ornelas

EHealth systems, such as digital care applications or remote monitoring devices, can improve health outcomes using user-centered design principles to create medical devices that adapt to users’ needs and contexts. Data-enabled design (DED) builds on these principles by leveraging user-generated data to iteratively refine systems based on real-world use, enabling adaptive and context-sensitive solutions. However, its exploratory and iterative nature conflicts with the rigid protocols required in clinical trials to evaluate safety and effectiveness. This study revises DED in alignment with clinical trial requirements, identifying four key challenges and proposing a four-phase Clinical Data-Enabled Design (C-DED) framework. This framework reconciles exploratory design with trial methodological demands, supporting the development of safe, effective, and user-centered eHealth medical devices.

Background: Patient and staff experience is a vital factor to consider in the evaluation of remote patient monitoring (RPM) interventions. However, no comprehensive overview of available RPM patient and staff experience–measuring methods and tools exists. Objective: This review aimed at obtaining a comprehensive set of experience constructs and corresponding measuring instruments used in contemporary RPM research and at proposing an initial set of guidelines for improving methodological standardization in this domain. Methods: Full-text papers reporting on instances of patient or staff experience measuring in RPM interventions, written in English, and published after January 1, 2011, were considered for eligibility. By “RPM interventions,” we referred to interventions including sensor-based patient monitoring used for clinical decision-making; papers reporting on other kinds of interventions were therefore excluded. Papers describing primary care interventions, involving participants under 18 years of age, or focusing on attitudes or technologies rather than specific interventions were also excluded. We searched 2 electronic databases, Medline (PubMed) and EMBASE, on February 12, 2021.We explored and structured the obtained corpus of data through correspondence analysis, a multivariate statistical technique. Results: In total, 158 papers were included, covering RPM interventions in a variety of domains. From these studies, we reported 546 experience-measuring instances in RPM, covering the use of 160 unique experience-measuring instruments to measure 120 unique experience constructs. We found that the research landscape has seen a sizeable growth in the past decade, that it is affected by a relative lack of focus on the experience of staff, and that the overall corpus of collected experience measures can be organized in 4 main categories (service system related, care related, usage and adherence related, and health outcome related). In the light of the collected findings, we provided a set of 6 actionable recommendations to RPM patient and staff experience evaluators, in terms of both what to measure and how to measure it. Overall, we suggested that RPM researchers and practitioners include experience measuring as part of integrated, interdisciplinary data strategies for continuous RPM evaluation. Conclusions: At present, there is a lack of consensus and standardization in the methods used to measure patient and staff experience in RPM, leading to a critical knowledge gap in our understanding of the impact of RPM interventions. This review offers targeted support for RPM experience evaluators by providing a structured, comprehensive overview of contemporary patient and staff experience measures and a set of practical guidelines for improving research quality and standardization in this domain.

BACKGROUND Patient and staff experience is a vital factor to consider in the evaluation of remote patient monitoring (RPM) interventions. However, no comprehensive overview of available RPM patient and staff experience–measuring methods and tools exists. OBJECTIVE This review aimed at obtaining a comprehensive set of experience constructs and corresponding measuring instruments used in contemporary RPM research and at proposing an initial set of guidelines for improving methodological standardization in this domain. METHODS Full-text papers reporting on instances of patient or staff experience measuring in RPM interventions, written in English, and published after January 1, 2011, were considered for eligibility. By “RPM interventions,” we referred to interventions including sensor-based patient monitoring used for clinical decision-making; papers reporting on other kinds of interventions were therefore excluded. Papers describing primary care interventions, involving participants under 18 years of age, or focusing on attitudes or technologies rather than specific interventions were also excluded. We searched 2 electronic databases, Medline (PubMed) and EMBASE, on February 12, 2021.We explored and structured the obtained corpus of data through correspondence analysis, a multivariate statistical technique. RESULTS In total, 158 papers were included, covering RPM interventions in a variety of domains. From these studies, we reported 546 experience-measuring instances in RPM, covering the use of 160 unique experience-measuring instruments to measure 120 unique experience constructs. We found that the research landscape has seen a sizeable growth in the past decade, that it is affected by a relative lack of focus on the experience of staff, and that the overall corpus of collected experience measures can be organized in 4 main categories (service system related, care related, usage and adherence related, and health outcome related). In the light of the collected findings, we provided a set of 6 actionable recommendations to RPM patient and staff experience evaluators, in terms of both what to measure and how to measure it. Overall, we suggested that RPM researchers and practitioners include experience measuring as part of integrated, interdisciplinary data strategies for continuous RPM evaluation. CONCLUSIONS At present, there is a lack of consensus and standardization in the methods used to measure patient and staff experience in RPM, leading to a critical knowledge gap in our understanding of the impact of RPM interventions. This review offers targeted support for RPM experience evaluators by providing a structured, comprehensive overview of contemporary patient and staff experience measures and a set of practical guidelines for improving research quality and standardization in this domain.