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

Abstract

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. Disclosure S.E. Skovlund: None. L. Troelsen: None. M. Dømgaard: None. P.O. Jakobsen: None. N. Ejskjaer: None.

The use of systematic approaches to patient involvement in the development and evaluation of a patient reported outcomes tool for use in routine diabetes care

“…To improve outcomes for PWD, care services are required which provide individualized 23 , collaborative, person-centered 5,24,25 and psychosocial 5,7,[26][27][28] diabetes care as feasible with the available healthcare resources 29,30 . Many PWD do not receive the level of individualized care and self-management and psychosocial support they need to achieve optimal care outcomes 7,31 .…”

“…There is general consensus that involvement of PWD should be prioritized at all levels: individuals, families, health care, community and civil society, and policy 5 . The author of this thesis has previously designed patient involvement as part of participatory multi-stakeholder person-centered diabetes research 5,29,30,135,187 . Despite a trend towards more focus on patient involvement in diabetes research and care, methodological approaches and reporting are not standardized in the literature and further methodological and theoretical research is warranted 176 .…”

“…The ambition of the project was to explore scalable models for implementation of principles of value-based health care 48 in Denmark. The aim was to create value for PWD in the healthcare system by aligning efforts across the care system towards measuring and improving a shared set of outcomes which matter to PWD 30 . While several aspects of the value-based care framework was found to not be easily applicable to either diabetes or the Danish health system, the value-based ambition to "Improve outcomes by focusing care on what creates the most value for each person with diabetes" which was established in the early phase of the project was found to be an appealing and unifying goal for both PWD and other diabetes stakeholders in Denmark.…”

“…As described in detail in study I, it was concluded that supplementing clinical outcome indicators with measurement of multiple PRO constructs 197 which reflect the priorities of PWD was a shared priority (Appendix I).…”