Background: Involvement of People With Diabetes (PWD) is important for diabetes research and care, yet there is a lack of evidence-based and systematic methodologies.

Aim: To evaluate the quality and value of a novel User Involvement (UI) process for people with diabetes (PWD) and caregivers in a national project to develop a new Patient Reported Outcomes (PRO) questionnaire for routine diabetes care.

Methodology: 56 PWD (type 1 and 2) and 9 caregivers were recruited for individual and group UI activities with consideration of age, gender, diabetes type, duration, complications, treatment, geographic region and patient advocacy experience. Analyses were done on qualitative data from interviews, focus groups and workshops over 1 year. 7 UI quality criteria were used for planning and evaluation: 1) Shared purpose, 2) Respect and Accessibility, 3) Representativeness, 4) Roles, 5) Capacity and Capability, 6) Transparency and Documentation, 7) Continuity.

Results: UI generated multiple insights which impacted A) Aims and focus for PRO, B) PRO content and C) PRO implementation. Key insights included: A) PWD priority aims for use of PRO: To enable PWD to take more active role (incl. vulnerable groups), ensure all priority topics (incl e.g., sexual dysfunction) are covered consistently in visits, focus on what matters most to each PWD (use care resources where they add most value). B) PWD preferences for items: Simple, brief, relevant (individualized), supportive of autonomy, non-stigmatizing, non-paternalistic and not overly negative, C) PWD insights for implementation: PWD and care providers to be able to act on all PRO outputs (e.g., web tool and training). Stakeholders found the 7 quality criteria relevant for UI planning and evaluation.

Conclusions: Systematic UI led to major new insights that impacted outcomes of a national PRO diabetes program. The systematic diabetes UI process is recommended for further use in diabetes research and care improvement.


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.


National Health Data Authority Region, Northern Denmark

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