Standardising personalised diabetes care across European health settings: a person-centred outcome set agreed in a multinational Delphi study

This is an updated preprint of our Delphi study to develop a person-centered outcome set for routine diabetes care in Europe. It corresponds to the same version that was published open-access by Diabetic Medicine (online ahead of print) on 28 November 2023 (Citation: Porth, A. K., Huberts, A. S., Rogge, A., Bénard, A. H. M., Forbes, A., Strootker, A., Del Pozo, C. H., Kownatka, D., Hopkins, D., Nathanson, D., Aanstoot, H. J., Soderberg, J., Eeg-Olofsson, K., Hamilton, K., Delbecque, L., Ninov, L., Due-Christensen, M., Leutner, M., Simó, R., . . . Kautzky-Willer, A. (2023). Standardising personalised diabetes care across European health settings: A person-centred outcome set agreed in a multinational Delphi study. Diabet Med, e15259. https://doi.org/10.1111/dme.15259).

Objective: Standardised patient-reported outcomes (PRO) data can contextualise clinical outcomes enabling precision diabetes monitoring and care. Comprehensive outcome sets can guide this process, but their implementation in routine diabetes care has remained challenging and has not been successful at the international level.

We aimed to address this with a person-centred outcome set for Type 1 and 2 diabetes that can be feasibly implemented and sustained in international healthcare settings.

Methods: A questionnaire-based Delphi study consisting of three consecutive survey rounds and based on previously identified outcomes was undertaken to reach consensus on the outcome set. Participants included patients (N=94), health professionals (N=65), representatives of industry (N=22) and health authorities (N=3). Subsequent consensus meetings were held to finalise the outcome set.

Results: The list of preliminary person-centred outcomes presented in the Delphi study included 64 outcomes and was shortlisted via the consensus process to 46 outcomes (27 clinical outcomes and 19 PROs). Two main collection times were recommended: 1) linked to a medical visit (e.g., diabetes-specific well-being, symptoms, and psychological health) and 2) annually (e.g., clinical data, general well-being, and diabetes self-management-related outcomes).

Conclusions: PROs are often considered in a non-standardised way in routine diabetes care. We propose a person-centred outcome set for diabetes, specifically considering psychosocial and behavioural aspects, which was agreed by four international key stakeholder groups. It guides standardised patient-important outcome collection at scale to support individual and population level healthcare decision-making. It will be implemented and tested in Europe as part of the H2O project.