H.C. Morales Ornelas
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Integrating evidence generation in eHealth development
Bridging design and healthcare practices
eHealth solutions promise more efficient and patient-centred healthcare, yet their development is challenged by differing approaches to evidence generation. In practice, designers tend to favour dynamic, context-sensitive evidence generated through iterative engagement with users, while healthcare professionals often incline towards static, predefined evidence to ensure clinical safety and regulatory compliance. Although these preferences are not absolute, insufficient integration between them can hinder the development of clinically robust and meaningful eHealth solutions. This thesis investigates how static and dynamic approaches to evidence generation can be integrated to support user-centred, standard-compliant eHealth development. Through systematic literature review, qualitative interviews, case study research, and theory adaptation, the thesis identifies shared evidence practices across design and healthcare, clarifies how patient-centred outcomes can guide dynamic evidence generation, and examines how integration can be structured within existing eHealth standards. Based on these findings, the thesis develops the Clinical Data-Enabled Design (C-DED) framework, which structures evidence generation through iterative development phases and evidence reflections. The thesis concludes that tensions in eHealth evidence generation stem from insufficient integration rather than incompatible practices.
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eHealth solutions promise more efficient and patient-centred healthcare, yet their development is challenged by differing approaches to evidence generation. In practice, designers tend to favour dynamic, context-sensitive evidence generated through iterative engagement with users, while healthcare professionals often incline towards static, predefined evidence to ensure clinical safety and regulatory compliance. Although these preferences are not absolute, insufficient integration between them can hinder the development of clinically robust and meaningful eHealth solutions. This thesis investigates how static and dynamic approaches to evidence generation can be integrated to support user-centred, standard-compliant eHealth development. Through systematic literature review, qualitative interviews, case study research, and theory adaptation, the thesis identifies shared evidence practices across design and healthcare, clarifies how patient-centred outcomes can guide dynamic evidence generation, and examines how integration can be structured within existing eHealth standards. Based on these findings, the thesis develops the Clinical Data-Enabled Design (C-DED) framework, which structures evidence generation through iterative development phases and evidence reflections. The thesis concludes that tensions in eHealth evidence generation stem from insufficient integration rather than incompatible practices.
Surrendering to Powerlesness
Governing Personal Data Flows in Generative AI
Personal data flows across digital technologies integrated into people’s lives and relationships. Increasingly, these technologies include Generative AI. (How) should personal data flow into and out of GenAI models? We investigate how people experience personal data collection in GenAI ecosystems and unpack the enablers and barriers to governing their data. We focus on personal data collection by Meta, specifically Instagram, in line with their recent policy update on processing user data to train GenAI models. We conducted semi-structured interviews with 20 Latin American Instagram users, based in Europe and Latin America. We discussed the acceptability of their data flowing in and out of GenAI models through different scenarios. Our results interrogate power dynamics in data collection, the (inter)personal nature of data, and the multiple unknowns concerning data and their algorithmic derivatives. We pose provocations around feelings of powerlessness, reframing (inter)personal data, and encountering unknown data and algorithms through design.
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Personal data flows across digital technologies integrated into people’s lives and relationships. Increasingly, these technologies include Generative AI. (How) should personal data flow into and out of GenAI models? We investigate how people experience personal data collection in GenAI ecosystems and unpack the enablers and barriers to governing their data. We focus on personal data collection by Meta, specifically Instagram, in line with their recent policy update on processing user data to train GenAI models. We conducted semi-structured interviews with 20 Latin American Instagram users, based in Europe and Latin America. We discussed the acceptability of their data flowing in and out of GenAI models through different scenarios. Our results interrogate power dynamics in data collection, the (inter)personal nature of data, and the multiple unknowns concerning data and their algorithmic derivatives. We pose provocations around feelings of powerlessness, reframing (inter)personal data, and encountering unknown data and algorithms through design.
Journal article
(2025)
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Hosana Cristina Morales Ornelas, Maaike Kleinsmann, Gerd Kortuem, Arend W. van Deutekom
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.
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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.
Towards designing for health outcomes
Implications for designers in eHealth design
eHealth development faces the challenge of generating evidence about health effectiveness in real-world settings. Designers can potentially support this challenge but must understand health approaches to evidence generation about health outcomes. This case study investigates how health and care professionals conceptualise health outcomes and their evidence generation in eHealth. Our results identify three key conceptual dimensions: effect, meaning, and collection. We discuss how these inform future design competencies to support evidence generation about health outcomes in eHealth design.
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eHealth development faces the challenge of generating evidence about health effectiveness in real-world settings. Designers can potentially support this challenge but must understand health approaches to evidence generation about health outcomes. This case study investigates how health and care professionals conceptualise health outcomes and their evidence generation in eHealth. Our results identify three key conceptual dimensions: effect, meaning, and collection. We discuss how these inform future design competencies to support evidence generation about health outcomes in eHealth design.
Journal article
(2024)
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Valeria Pannunzio, Hosana Morales Ornelas, Pema Gurung, Robert van Kooten, Dirk Snelders, Hendrikus van Os, Michel Wouters, Rob Tollenaar, Douwe Atsma, Maaike Kleinsmann
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. ...
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.
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.
Evidence-based practices play an essential role in the development of eHealth systems. Prior research has investigated the challenge of shared understanding between professionals from the fields of health sciences and design and has highlighted the need for effective alignment of development and research practices in eHealth. However, there is a limited understanding of epistemological differences between these fields and how professionals conceptualise evidence. In this paper, we investigate how healthcare and design professionals think about evidence and how they implement evidence practices in their work. We interviewed eight professionals and used reflexive thematic analysis to identify the challenges and strategies associated with their evidence practices. Our results identify five shared evidence practices between healthcare and design professionals: stakeholder-driven, process-driven, problem-driven, effect-driven, and solution-driven. These five evidence practices indicate opportunities for closer alignment of development and research practices among healthcare and design professionals and offer a basis to create a shared understanding of evidence between both fields.
...
Evidence-based practices play an essential role in the development of eHealth systems. Prior research has investigated the challenge of shared understanding between professionals from the fields of health sciences and design and has highlighted the need for effective alignment of development and research practices in eHealth. However, there is a limited understanding of epistemological differences between these fields and how professionals conceptualise evidence. In this paper, we investigate how healthcare and design professionals think about evidence and how they implement evidence practices in their work. We interviewed eight professionals and used reflexive thematic analysis to identify the challenges and strategies associated with their evidence practices. Our results identify five shared evidence practices between healthcare and design professionals: stakeholder-driven, process-driven, problem-driven, effect-driven, and solution-driven. These five evidence practices indicate opportunities for closer alignment of development and research practices among healthcare and design professionals and offer a basis to create a shared understanding of evidence between both fields.