Type 1 diabetes (T1D) treatment focuses on achieving normoglycemia to prevent acute and long-term complications. This relies on intensive self-management, including but not limited to frequent insulin administration and glucose monitoring (1). Continuous diabetes self-management is very time consuming, taking on average 4 to 5 hours a day for persons with T1D (PWDs) and/or their care partners (2) and impacts PWDs’ quality of life (QoL) and regular aspects of daily life (e.g. school, work, relations) (1, 3). Recent technological advancements such as automated insulin delivery (AID) can partially automate glucose management, decreasing time spent (4, 5), but access to AID systems is still limited in many countries (6). Despite technological developments, outcome data show that only 30-50% of PWDs reach recommended glucose levels (3, 7). Furthermore, PWDs still report diabetes-specific worries such as fear of hypoglycemia or long-term complications, as well as lack of understanding and limited support from parents, partners, friends and healthcare professionals (HCPs) (8, 9). PWDs also experience more general stress, anxiety, and depression than people from the general population (8, 10, 11). These psychosocial issues negatively affect self-management and daily life issues (12). In daily diabetes care, self-management has largely been based on a one-size-fits-all concept (13) with focus on biomedical outcomes and continuous education (14, 15). Recently, the focus has shifted to individualized care beyond biomedical metrics, including increased awareness of the psychosocial impact of T1D and the need for psychological screening and support (16–20). Therefore, guidelines recommend the assessment of emotional health and QoL in regular daily care (21).

Person-Reported Outcomes (PROs) are outcomes, self-reported by the person concerned, regarding their health, well-being, experiences and effects of their medical condition and treatment. They can be assessed using PRO measures (PROMs), usually questionnaires. PROMs are often used for research purposes (22, 23), population analyses, policy and advocacy (23–25). Applying PROMs in clinical practice can add significant value and information to the individual healthcare process, thereby helping to identify issues and problems hindering optimal glucometrics and quality of life. Several studies show that during implementation of PROMs they were assessed positively by the PWDs, improving communication about their diabetes during consultations. PWDs felt that they and their HCPs were more involved in their treatment and that their needs were more easily discussed (26–30). PROs represent ‘outcomes that matter to people’, an essential part of value-based healthcare (VBHC) systems (31). Therefore, various stakeholders are increasingly requiring HCPs to include PROMs in the assessment of routine care, to monitor and improve care and QoL. The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) state that HCPs should individualize therapy based on, amongst others, psychosocial factors like emotional well-being and treatment burden (21). PROMs are a suitable tool for this (19), but few PROM initiatives have made it to a broad and firm implementation in daily clinical practice. While there are efforts for standardization of PROs in both research and clinical practice (17, 23), the latter often demands sensitivity to disease-specific and contextual variables like socio-demographic and organizational factors (16, 17, 32). For example, while generic PROMs applicable across conditions enable comparing research findings and population analyses (24), they may be of limited value to T1D care and outcomes. In contrast, diabetes-specific PROMs are better suited to providing detailed insights, needed to improve individual outcomes and QoL, and to personalize care processes (33–35). Furthermore, PROs developed for research often include many items per domain, limiting the number of domains that can be covered, while clinical practice benefits from covering a broad scope of domains with a concise item set. To integrate PROM systems into the consulting room in a feasible way and to ensure their value for both PWDs and HCPs, we need to ensure that all relevant domains are evaluated, the total number of questions is not overwhelming, and each domain is discussed in a shared consultation shortly after completing the questionnaires. Repeating the process yearly would bring PROM use/psychosocial assessment into the real world of clinical care (36).

Table 1 lists the characteristics of existing diabetes-specific PROM sets. As most of these systems are not T1D-specific, limited in covered domains, too time-consuming or do not follow up on identified issues (15, 37–39), our overarching goal is the development and implementation of a PRO system that can be used in routine clinical T1D care in our clinic. This will strengthen shared decision making (SDM) discussions between PWDs and their HCPs as part of our care program.

The PRO system should be sustainable, easy to use in daily diabetes care by PWDs and HCP teams and add value to care. For use in our clinical setting, this system needs to be T1D specific with short questionnaires for multiple domains, that can be filled in online during or shortly before a visit, with immediate transfer of calculated results in the electronic health record of the PWD. Here we describe the design and methodology of the ‘Diabeter-PROM study’, the first stage in the overall project. This study aims to determine a set of index questions that best predict increased scores on in-depth questionnaires for every included domain. An index question is a newly designed domain-specific question that indicates whether further (in-depth) questions are needed to evaluate the domain. The PWD only needs to fill in the in-depth questions when the answer to the index question warrants further investigation. If this is not necessary, the index question for the next domain is presented. Additionally, we will explore the viability of limiting the number of in-depth questions by determining the most informative in-depth item set. In short, the goal is to optimize the feasibility of a PROM system in routine type1 diabetes care.

Use of PROMs in routine clinical practice will contribute to the urgent need for (1) delivering individualized T1D care beyond biomedical metrics (2), increased psychological screening and support and (3) and improvement of diabetes care and QoL of PWDs (16–19). Currently, most existing diabetes PROM systems are not T1D-specific, limited in domains covered, time-consuming and often do not incorporate actions or referrals towards solving the identified issues. However, there are initiatives to develop questionnaire sets for use in routine T1D care and clinical practice (e.g. the DiaFlex Care PROM (28), the DiaPROM pilot trial (15, 44), the digital Diabetes Questionnaire (29), the DiaProfil PROM (19) and the H2O initiative (45) (Table 1). We describe the development of an alternative approach to PRO measurement (Diabeter-PROM study), aimed specifically or use in routine T1D care, with the aim to be maximally relevant for PWDs, HCPs and the organisation alike and minimally burdensome for PWDs and HCPs. Part of this study is exploring to what extent existing questionnaires fit this aim. Many existing questionnaires (used for the in-depth assessments in this study) comprise too many questions to be practical for use in daily routine diabetes care. Our suggested strategy of index questions signalling the need for in-depth assessment of a certain domain—validated against elevated scores on existing questionnaires—is designed to help in preventing question overload and questionnaire fatigue, while still covering multiple psychosocial domains. Furthermore, we will also assess if the number of in-depth questions can be limited for each domain, by determining the most informative items per domain (46). If questionnaire copyright holders do not consent to use the resulting abbreviated sets in our clinical practice, alternative (though not preferred) options include using the short-form (SF) versions of existing questionnaires or custom-made question(naire)s for each domain. This approach is similar to the Danish initiative (PRO Diabetes Questionnaire, embedded in the stand-alone PRO diabetes digital tool DiaProfil (40)) which uses introduction questions for each domain. The type of introduction questions used there (“Do you want to discuss this item with your HCP?”) could lead to misinterpreting the results however, because not filling in a domain could mean the PWD has no problem with this domain or does have a problem but does not want to discuss the domain. The Diabeter-PROM system enables us to cover practically all psychosocial domains that have an impact on diabetes outcome and that can be or need to be improved. With the index questions we are sure all domains are checked. Domains that need attention will be investigated further with the in-depth domain questionnaires, focusing on the problems that need attention. All PROM results will be discussed during a yearly shared decision making (SDM) consultation with the PWD individually and follow up treatment will be initiated when needed if desired.

Key strengths of our proposed approach include the extensive combined statistical and clinical assessment of the questions/items included in the system, closely involving the end users throughout the process (9, 27–30). Second, we aim to include more domains than covered by the International Consortium for Health Outcomes Measurement (ICHOM) standard set (17) in the Diabeter PROM-system. The inclusion of more domains, providing optimal coverage of physical and psychological health, has recently been recommended in a consensus statement for diabetes research and in a systematic review of the European Health Outcomes Observatory (22, 45, 47). The third strength is the two-step approach, using index questions to determine whether in depth evaluation is necessary, which decreases workload and supports acceptance by both PWDs and HCPs.

The approach also has potential limitations. First, the exclusion of questionnaires taht are not free and publicly available may affect the optimal sets of in-depth questions. Second, this study currently focuses on psychosocial PROMs without including social structure, educational level and information about the involvement of other HCPs, including mental health or social care. These factors are already integrated in our clinic SDM process, and the PROMs will eventually be added to this process. Third, this study only includes PWDs aged ≥16 years. For younger PWDs an adapted PRO system will need to be developed and tested, covering relevant domains for children and their caregivers. Fourth, although the rigorous scientific evaluation of the PROM system strengthens its credibility for clinical use, the time-intensive nature of this process means that newly developed instruments, such as the T1DDAS (48), cannot always be included in the PRO set immediately. Consequently, the set will require periodic updates to reflect the evolving landscape of available instruments.

Future plans: Implementation & training

Organizations will have to make managerial decisions to initiate development of PROM structures. In addition, implementation in clinical workflows can be challenging and varies significantly between organizations (9, 49). It requires a well-developed strategy and preparation. We identify five areas essential for successful implementation of our PRO system.

First, one of the most important facilitating factors in PROM implementation is training of both HCPs and PWDs to explain the purpose of the PROM system, to clarify its value (also addressing attitudes relating to the need to include psychosocial aspects and have a more holistic approach to care) and to use it in their discussions and communication (15, 50) (33). Results of PROMs and interventions always need to be discussed and aligned with the wishes and needs of the PWD. The second requirement for successful implementation of PROMs into routine care is the need for adequate ICT technology, including data flow (19, 32, 51). Results of PROMs must be easily collected and be accessible to both PWDs and HCPs in electronic health records systems and apps, in a sustainable manner, with minimal burden and maximal benefit (32). A comprehensive online display of the PROM data, with information on various interventions and peer reported experiences will not only improve the SDM discussion but can help PWDs and HCPs to choose the optimal personal treatment option. Modern digital platforms allow identification and discussion of a multitude of factors, personalizing PROM results (26).

Third, a care system able to act on identified issues needs to be in place. This includes training team-members in discussing and first responding to issues. To ensure that psychosocial issues are addressed appropriately, referrals to HCPs with other expertise (e.g. psychologist, social worker) or online psychoeducation, need to be part of the standard care system.

Fourth, diabetes care needs to develop from a glucose-centric and education-centred care to personalized medicine that includes individual needs of PWDs (16–19). This will not only involve measurement and support at the level of the individual, but also at the policy level, e.g. improvement of access to care through modifications in legislation and reimbursements. Fifth, being an important part of our VBHC approach, the assessment of the long-term impact of the PROM system will be an essential part of our implementation strategy, not in the least from the PWD point of view (9, 32). To our knowledge, no studies have assessed if PROM systems and subsequent referrals actually improve quality of life and solve issues for PWD. Published data was mainly collected in academic medical settings with different facilitating factors and barriers compared with other settings (32).

There is a need to develop a PROM system that is sustainable, minimally burdensome and maximally benefitting in routine T1D care (32). Before such a system can be implemented it should be rigorously aligned with routine care needs based on scientific foundation. Once implemented, issues identified by the PROM system can be discussed and addressed by the PWD and the HCP team during a consultation or as part of shared decision-making discussion. Our Diabeter-PROM study is designed to result in a feasible and efficient PROM system aimed specifically at PWDs to primarily identify if, what and to what extent PWDs are experiencing psychosocial issues or barriers in their lives with T1D that warrant further discussion and potential support.