Aim: To develop a protocol and set of purpose-built psychometric PRO evaluation questionnaires for a national multi-sector study to evaluate feasibility, acceptability, validity, barriers, facilitators and perceived value of the National Danish PRO diabetes intervention (PRO diabetes questionnaire and dialogue tool) in Denmark.

Methods: The protocol was designed through a participatory process with People With Diabetes (PWD), multi-disciplinary representatives of diabetes centres and municipality diabetes rehabilitation centres from 3 regions of Denmark. Hypotheses and assessment tools were guided by formative qualitative research. The intervention involved that PWD fill out the PROM prior to their visit and the Health Care Professional (HCP) uses a PRO IT dialogue tool to collaboratively evaluate needs and plan care.

Results: The pragmatic mixed-methods study protocol involved hypothesis testing and exploratory research: 1) PRO-DIA-READY Scales for Clinic and HCP PRO-Diabetes Readiness (incl. structural/process indicators of person-centred care). 2) 6-item PRO-EVAL-P Scale completed by PWD after the PROM. 3) 8-item PROCON-EVAL-HCP and 13-item PROCON-EVAL-PWD scales completed by HCPs and PWD after the visit, 4) Clinician rating scales of PROM validity 5) Semi-structured interview/group workshop guides for PWD, Caregivers (CG), multi-disciplinary HCPs, and administrators based on RE-AIM: Reach, Effectiveness, Adoption, Implementation and Maintenance, 6) HCP/PWD Follow-Up Impact Questionnaires (incl. active participation, person-centred care, care utilisation and outcomes). Newly designed evaluation scales were analyzed psychometrically.

Conclusions: A protocol and new psychometric assessment tools for evaluation of validity, readiness, acceptability and impact of PRO in diabetes care were developed and successfully applied in large scale in Denmark. The new tools are available for comparative PRO research studies.


S.E. Skovlund: None. L. Boel: None. N.C. Balk-Møller: None. P.M. Højholt: None. D.B. Berthelsen: None. C. Glümer: None. H. Perrild: None. D.M. Hessler: Consultant; Self; Eli Lilly and Company. S.H. kaplan: None. P.O. Jakobsen: None. N. Ejskjaer: None.


Danish Health Data Board

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