JMIR Publications

ABSTRACT

Background:

Digital health technologies, such as mHealth applications, telemedicine platforms, and eHealth solutions, have revolutionized healthcare delivery by improving access, efficiency, and personalization. However, the successful adoption and implementation of these innovations rely heavily on patient acceptance and usability, factors that are often overlooked in traditional Technology Readiness Levels (TRLs) frameworks.

Objective:

This study aimed to integrate patient perspectives into the Technology Readiness Levels (TRLs) framework by developing a patient-centered dimension. Using a Delphi methodology, the study sought to establish consensus on practical approaches for incorporating patient insights, enhancing usability, acceptance, and addressing real-world challenges in digital health technology development and evaluation.

Methods:

This study utilized a Delphi methodology, employing iterative rounds of expert surveys to gather and refine consensus on patient inclusion within TRLs. The study engaged a geographically diverse panel of Spanish-speaking experts, representing diverse profiles across healthcare, technology, public health, ethics, and patient advocacy. Participants included patient advocates, clinicians, public health professionals, technology specialists, and ethicists. Selection criteria emphasized expertise in patient-centered approaches and healthcare innovation. Primary outcome measures focused on achieving consensus on a set of recommendations for a Patient TRL framework, integrating patient perspectives into each stage of the TRLs framework. Consensus was defined as 75% agreement, operationalized as a mean score of ≥4.75 on a 6-point Likert scale. Secondary outcomes included the development of a new dimension within the TRLs, providing specific recommendations for enhancing patient participation in healthcare innovation technologies.

Results:

Twenty-four experts were invited to participate in the study, with 20 experts completing both rounds of the Delphi process, resulting in an 83.33% participation rate. Delphi process involved two iterative rounds, which progressively refined consensus on patient-related TRL statements. Each round allowed for detailed feedback and adjustments, improving clarity, precision, and achieving the targeted level of consensus across all TRL stages. The final framework incorporated significant refinements that enhanced both clarity and inclusiveness. Key improvements included defining explicit roles for patients in usability testing, co-creation, and clinical validation processes. Furthermore, mechanisms for ongoing feedback and monitoring were integrated into later TRLs, ensuring continuous engagement and real-world adaptability. These refinements collectively solidify the PULSO framework as a comprehensive, patient-centered adaptation of the TRL model, designed to address real-world challenges in healthcare technology development.

Conclusions:

To the best of our knowledge, PULSO is the first framework to incorporate patient perspectives into the TRLs framework, highlighting their critical role in ensuring the usability, acceptance, and success of healthcare technologies. The proposed patient-centered TRLs provide a structured pathway for integrating patient insights across all stages of technology development, fostering engagement and improving real-world outcomes. Future research should focus on expanding the framework to diverse geographic and cultural contexts to validate and generalize its applicability. Clinical Trial: The study did not undergo formal registration.