Factors Influencing the Participation of Patients, Caregivers, and Healthcare Professionals in the Development of Digital Health Technologies: A Scoping Review and Field Study (Preprint)

<sec> <title>BACKGROUND</title> Digital health technologies are changing the way patient care is delivered by enabling more personalized, efficient, and accessible healthcare solutions. These technologies facilitate real-time monitoring, data-driven insights, and remote consultations, aimed at enhancing the quality of care. There is evidence that involving patients, caregivers, and healthcare professionals in the development of digital health technologies may support better care outcomes, increased patient satisfaction, and higher adoption rates. When these groups contribute both early on and throughout the development process, the resulting technologies may better reflect their needs, values, and experiences. However, the factors influencing the participation of these stakeholders remain poorly understood. </sec> <sec> <title>OBJECTIVE</title> To identify and summarize the factors that influence the participation of patients, caregivers, and healthcare professionals in the development of digital health technologies. </sec> <sec> <title>METHODS</title> The first step of our research methodology was a scoping review of published studies involving participatory approaches for the development of digital health technologies. This method was chosen to map the heterogeneity of existing evidence in this emerging field, rather than to evaluate a narrowly defined research question. A scoping review was particularly suitable as it can be used to identify knowledge gaps, scope a body of literature, and clarify concepts. The second step consisted of an empirical field study with sixteen participants recruited at Miguel Servet University Hospital, a tertiary care hospital in Spain, aimed at confirming and expanding the knowledge gained in the first step. The field study focused on the development of a specific type of digital health technology in a specific context, namely, prognostic tools for shared decision-making in breast cancer and melanoma treatment. </sec> <sec> <title>RESULTS</title> The scoping review included 25 studies for analysis. Based on the results of both the scoping review and the field study, four factors were identified as influencing the participation of patients, caregivers, and healthcare professionals in the development of digital health technologies: communication, empowerment, trust, and context. Communication played a role, particularly when tailored to participants’ needs, when expectations were clarified, and when cultural or linguistic differences were considered. Empowerment was supported when participants were offered flexibility in how and when to contribute, and when they were involved early enough to influence the direction of digital health technology development. Trust appeared to develop through transparency, familiarity with the technology development process, and sustained relationships between participants and those involved in such development. Finally, the context, such as the perceived relevance of the technology and participants’ awareness of institutional or infrastructural boundaries to participation, influenced how meaningful and feasible participation felt for them. </sec> <sec> <title>CONCLUSIONS</title> The findings of this study demonstrate that stakeholder participation in the development of digital health technologies is shaped by the interrelated factors of communication, empowerment, trust, and context. Ensuring clear, tailored communication, fostering early and flexible engagement, building trust through transparency and sustained relationships, and acknowledging contextual constraints and relevance are essential to enabling meaningful involvement. When these factors are systematically addressed, digital health initiatives may achieve greater alignment with stakeholder needs, thereby enhancing both the quality and adoption of the resulting technologies. </sec>