Development of a National Minimal Set of Patient-Important Outcome Domains for Value-Based Diabetes Care in Denmark

Aim: To identify a minimal set of patient-reported (PRO) domains for use in value-based diabetes care in Denmark.

Methodology: A structured mixed-methods research protocol was applied to ensure an evidence-based approach to involvement of people with diabetes in the identification of patient-centered outcome domains. 20 people with diabetes and 4 caregivers of people with diabetes selected for representativeness in age, gender, type of therapy, duration of diabetes, type of diabetes, and disease burden were recruited for qualitative research and co-creation to examine 1) psychological, physical and social impacts of diabetes and desired outcomes of treatment, 2) dis-utilities of therapy and 3) factors enabling sustainability in line with the value based care model. Qualitative research based on interviews, structured focus group and co-creation workshop sessions together with desk research on patient, clinical, health economic, and societal relevance of identified domains informed the final identification of domains by a multi-disciplinary and multi-sector working group using strict criteria of patient importance, clinical relevance and applicability, measurability and mutability.

Results: The following PRO domains were selected to complement the clinical outcome domains: Self-reported health, psychological well-being, symptom burden (e.g., sleep, sexual dysfunction, complications), multi-faceted impact of diabetes on life including diabetes distress, treatment burden and impacts of hypoglycemia, and specific indicators of care confidence, quality and diabetes self-care ability.

Conclusions: The assessment of patient-important outcomes for value based diabetes care in Denmark require the implementation of PRO questionnaires in standard diabetes care.