Aim: To develop a multi-dimensional Patient Reported Outcomes (PRO) questionnaire to improve person-centered care for type 1 and 2 diabetes across sectors in Denmark.
Methodology: A stepwise cross-regional multi-stakeholder multi-disciplinary co-development process was undertaken: 1) Patient-important PRO domains for value based diabetes care defined (ADA 2018), 2) Multi-sector strategy for active use of PRO to benefit People With Diabetes (PWD) and care quality 3) Conceptual measurement model and psychometric methodological foundation, 4) Literature review and mapping of PRO items/scales 5) Iterative item selection/testing and design of PRO dialogue tool 7) Qualitative, clinical and psychometric evaluation.
Results: The final e-PRO questionnaire (53-78 items) consisted of pre-existing/adapted items (from e.g., WHO-5, PROMIS-10, MDI, DSC-R) and newly developed global essence domain and single items covering: General health, social support, life stress, psychological well-being, symptom distress (neuropathic pain, heart, gastro-intestinal, sexual, sleep, fatigue, foot problems), diabetes well-being, worries, limitations and support, self-care, lifestyle and technology confidence, wishes for support, confidence in care access, medicine burden and satisfaction, blood sugar regulation (stability, moderate/severe hypoglycemia), preferred topics for next visit. Workshops and selective item testing (n=85) supported item acceptability and content coverage. A novel web dialogue tool with algorithms/resources to enable PWD and providers to interpret and follow-up on each PRO output was designed as part of the project.
Conclusions: A systematic collaborative process led to a new PRO questionnaire and dialogue tool for use in routine diabetes care. Research is now ongoing to validate scoring and evaluate benefits of real-world use of intervention for PWD, clinicians and payers.
S.E. Skovlund: Stock/Shareholder; Self; Novo Nordisk A/S. L. Nørgaard: None. S. Stefansen: None. T. Honnens de Lichtenberg: None. L. Troelsen: None. A. Pietraszek: None. P.H. Kjær: None. H. Ravn Larsen: None. P.O. Jakobsen: None. N. Ejskjaer: None.
Danish Health Care System