Integrating Patient Perspectives Into the Digital Health Technology Readiness Framework: Delphi Study.

Area of Science:

• Digital Health
• Health Technology Assessment
• Patient-Centered Care

Background:

• Digital health technologies are transforming healthcare delivery, improving access, personalization, and efficiency.
• Traditional technology readiness levels (TRLs) lack explicit consideration of patient involvement, crucial for real-world effectiveness.
• Patient engagement is essential for the usability and acceptance of digital health innovations.

Purpose of the Study:

• To integrate patient perspectives into the TRLs framework for digital health innovations.
• To develop a patient-centered dimension for assessing digital health technologies.
• To enhance the usability, acceptance, and real-world effectiveness of digital health solutions.

Main Methods:

• A Delphi methodology involving 24 Spanish-speaking experts from diverse fields was employed.
• Experts evaluated patient involvement across 10 TRL stages using a 6-point Likert scale.
• Two iterative rounds were conducted to refine statements and achieve consensus (≥75% agreement, mean score ≥4.5).

Main Results:

• Consensus was achieved in round 1 for all 10 TRL statements, with mean scores ranging from 4.70 to 5.25.
• A second round refined statements, increasing agreement and incorporating precise patient roles in development and evaluation.
• The framework integrates patient-reported measures into TRLs 5, 7, and 8, with high agreement on key refinements.

Conclusions:

• The PULSO-Tech-Clinic Model is the first framework to systematically embed patient perspectives within TRLs.
• This validated, patient-centered model enhances the design, evaluation, and adoption of digital health technologies.
• Further research is needed to evaluate the model's adaptability across diverse healthcare systems.