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

Author:

Porth Ann‐Kristin1ORCID,Huberts Anouk Sjoukje2,Rogge Alizé3,Bénard Angèle Helene Marie4,Forbes Angus5ORCID,Strootker Anja6,Del Pozo Carmen Hurtado7,Kownatka Dagmar8,Hopkins David910ORCID,Nathanson David11,Aanstoot Henk‐Jan12,Soderberg Jeanette7,Eeg‐Olofsson Katarina1314,Hamilton Kathryn5,Delbecque Laure15,Ninov Lyudmil16,Due‐Christensen Mette5ORCID,Leutner Michael1,Simó Rafael4171819,Vikstrom‐Greve Sara11,Rössner Sophia11,Flores Vanesa418,Seidler Yuki20,Hasler Yvonne6,Stamm Tanja2021ORCID,Kautzky‐Willer Alexandra1ORCID

Affiliation:

1. Department of Internal Medicine III Divison of Endocrinology and Metabolism Medical University Vienna Vienna Austria

2. Department of Quality and Patientcare Erasmus University Medical Center Rotterdam The Netherlands

3. Charité Center for Patient‐Centered Outcomes Research Department of Psychosomatic Medicine Center for Internal Medicine and Dermatology Charité ‐ Universitätsmedizin Berlin Berlin Germany

4. Vall d'Hebron Institute of Research (VHIR) Vall d'Hebron Barcelona Hospital Campus Barcelona Spain

5. Florence Nightingale Faculty of Nursing Midwifery and Palliative Care Kings College London London UK

6. Medtronic International Trading Sàrl Tolochenaz Switzerland

7. JDRF International New York New York USA

8. Roche Diabetes Care GmbH Mannheim Germany

9. Department of Diabetes King's College London London UK

10. Institute for Diabetes Endocrinology and Obesity King's Health Partners London UK

11. Department of Medicine Karolinska Institutet Karolinska University Hospital Huddinge Huddinge Sweden

12. Diabeter, Center for Focussed Diabetes Care and Research Rotterdam The Netherlands

13. Department of Molecular and Clinical Medicine Institute of Medicine University of Gothenburg Göteborg Sweden

14. National Diabetes Register Göteborg Sweden

15. Eli Lilly and Company Indianapolis Indiana USA

16. European Patients' Forum (EPF) Brussels Belgium

17. Centro de Investigación Biomédica en Red Instituto de Salud Carlos III (CIBERDEM (ISCIII)) Madrid Spain

18. Vall d'Hebron University Hospital Barcelona Spain

19. Autonomous University of Barcelona Barcelona Spain

20. Section for Outcomes Research Center for Medical Statistics Informatics and Intelligent Systems Medical University of Vienna Vienna Austria

21. Ludwig Boltzmann Institute for Arthritis and Rehabilitation Vienna Austria

Abstract

AbstractObjectiveStandardised person‐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 unsuccessful at international level. We aimed to address this by developing a person‐centred outcome set for Type 1 and Type 2 diabetes, using a methodology with prospects for increased implementability and sustainability in international health settings.MethodsWe used a three‐round questionnaire‐based Delphi study to reach consensus on the outcome set. We invited key stakeholders from 19 countries via purposive snowball sampling, namely people with diabetes (N = 94), healthcare professionals (N = 65), industry (N = 22) and health authorities (N = 3), to vote on the relevance and measurement frequency of 64 previously identified clinical and person‐reported outcomes. Subsequent consensus meetings concluded the study.ResultsThe list of preliminary outcomes 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).ConclusionsPROs 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 collection of meaningful outcomes at scale, supporting individual and population level healthcare decision making. It will be implemented and tested in Europe as part of the H2O project.

Funder

European Federation of Pharmaceutical Industries and Associations

Innovative Medicines Initiative

Juvenile Diabetes Research Foundation United States of America

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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