Exploring feasible ways of person-reported outcome measurement in routine type 1 diabetes care: a protocol for the Diabeter-PROM study

Background: Psychosocial person-reported outcome measurements (PROMs) may assist monitoring, screening and support in routine care for people with type 1 diabetes (PWDs). However, recommended PROM sets are either too limited in covered domains, too time-consuming, or too general to fit type 1 diabetes (T1D) clinical practice. We propose an alternative approach to PROM assessment in routine daily T1D care (Diabeter-PROM study) that is maximally relevant and minimally burdensome for PWDs and healthcare professionals (HCPs). We identify single index questions indicating the need for more in-depth assessment, thereby aligning total assessment length more closely with individual needs. Methods: Scientist-practitioners identified twelve key psychosocial domains based on literature review, clinical experience and discussion with PWDs: general quality of life, mood, anxiety, diabetes-specific worries, impact, disturbed eating behaviour, self-efficacy, self-esteem, social support/interaction, resiliency, stigma and satisfaction with care. These domains will be divided over three observational mixed-method sub-studies. Through purposive-sampled interviews and panels, HCPs and PWDs (> 10 per sub study) co-determine candidate index questions for each domain. These are then included in three separate cross sectional questionnaire batteries with existing PROMs. Each will be completed by ≥200 PWDs from our clinic. Per domain, the optimal index question and most informative in-depth item set are determined using statistics (test characteristics, item response) and clinical interpretation. Discussion: We describe the exploration of an alternative way of PROM assessments, adapted to use in regular T1D care. After determining the most suitable index questions, we will apply this system in our daily diabetes practice, taking end-user needs into account and facilitating sustainable PROM implementation in routine care.