Identification of Core Outcome Domains and Design of a Survey Questionnaire to Evaluate Impacts of Digital Health Solutions That Matter to People With Diabetes.

BACKGROUND: Digital health solutions (DHS) are increasingly used to support people with diabetes (PwD) to help manage their diabetes and to gather and manage health and treatment data. There is a need for scientifically reliable and valid methods to measure the value and impact of DHS on outcomes that matter to PwD. Here, we describe the development of a survey questionnaire designed to assess the perceptions of PwD toward DHS and their prioritized outcomes for DHS evaluation. METHOD: We applied a structured process for engagement of a total of nine PwD and representatives of diabetes advocacy organizations. Questionnaire development consisted of a scoping literature review, individual interviews, workshops, asynchronous virtual collaboration, and cognitive debriefing interviews. RESULTS: We identified three overarching categories of DHS, which were meaningful to PwD and crucial for the identification of relevant outcomes: (1) online/digital tools for information, education, support, motivation; (2) personal health monitoring to support self-management; (3) digital and telehealth solutions for engaging with health professionals. Overall outcome domains identified to be important were diabetes-related quality of life, distress, treatment burden, and confidence in self-management. Additional positive and negative outcomes specific to DHS were identified and corresponding questions were incorporated into the survey questionnaire. CONCLUSION: We identified the need for self-reporting of quality of life, diabetes distress, treatment burden, and confidence in self-management, as well as specific positive and negative impacts of DHS. We designed a survey questionnaire to further assess the perceptions and perspectives of people with type 1 and 2 diabetes on outcomes relevant for DHS evaluations.

The participatory development of a national core set of person-centred diabetes outcome constructs for use in routine diabetes care across healthcare sectors.

BACKGROUND: This study sought to utilise participatory research methods to identify the perspectives of people with diabetes regarding which diabetes outcomes were most important to them. These findings were then used to support an expert working group representing multiple health sectors and healthcare disciplines and people with diabetes to establish a core set of patient-important outcome constructs for use in routine diabetes care. METHODS: 26 people with diabetes and family members were recruited through purposive sampling to participate in interviews, focus groups, voting and plenary activities in order to be part of identifying outcome constructs. Content and qualitative analysis methods were used with literature reviews to inform a national multi-stakeholder consensus process for a core set of person-centred diabetes outcome constructs to be used in routine diabetes care across health care settings. RESULTS: 21 people with diabetes and 5 family members representing type 1 and 2 diabetes and a range of age groups, treatment regimens and disease burden identified the following patient-reported outcome constructs as an important supplement to clinical indicators for outcome assessment in routine diabetes care: self-rated health, psychological well-being, diabetes related emotional distress and quality of life, symptom distress, treatment burden, blood sugar regulation and hypoglycemia burden, confidence in self-management and confidence in access to person-centred care and support. Consensus was reached by a national multi-stakeholder expert group to adopt measures of these constructs as a national core diabetes outcome set for use in routine value-based diabetes care. CONCLUSIONS: We found that patient-reported outcome (PRO) constructs and clinical indicators are needed in core diabetes outcome sets to evaluate outcomes of diabetes care which reflect key needs and priorities of people with diabetes. The incorporation of patient-reported outcome constructs should be considered complementary to clinical indicators in multi-stakeholder value-based health care strategies. We found participatory research methods were useful in facilitating the identification of a core prioritised set of diabetes outcome constructs for routine value-based diabetes care. The use of our method for involving patients may be useful for similar efforts in other disease areas aimed at defining suitable outcomes of person-centred value-based care. Future research should focus on developing acceptable and psychometrically valid measurement instruments to evaluate these outcome constructs as part of routine diabetes care.

Outcome of diabetes care is mainly measured using clinical indicators such as long-term blood sugar (A1c), cholesterol, blood pressure, occurrence of diabetes complications and need for hospitalisation. Other factors such as quality of life, well-being, treatment burden and other psychosocial issues are of high importance to people with diabetes and their family members, but these factors are often not included in outcome evaluations and there is a lack of agreement about what to measure.This study set out to define how to measure outcomes of diabetes care that both adequately reflects priorities and needs of people with diabetes and contributes to ongoing improvement.Twenty-one people with diabetes and 5 family members were invited to take part in interview and workshop activities to identify their views and priority outcomes. Results were summarised and used to guide the establishment of a national core set of diabetes outcomes. In addition to clinical indicators, the following core outcomes were identified as important in order to adequately evaluate outcomes of diabetes care which matter to people with diabetes: self-reported health, psychological well-being, diabetes-related emotional distress, diabetes-related quality of life, symptom distress, treatment burden, impact of hypoglycemia, confidence in self-management and access to person-centred diabetes care and support. Involvement of people with diabetes helped fill important gaps in knowledge about how to measure outcomes of diabetes care that matter to people with diabetes. Future research is needed involving people with diabetes as partners in identifying how to best measure these outcomes as part of routine diabetes care.

Perceived Benefits, Barriers, and Facilitators of a Digital Patient-Reported Outcomes Tool for Routine Diabetes Care: Protocol for a National, Multicenter, Mixed Methods Implementation Study.

BACKGROUND: There is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO tools in routine care. Furthermore, limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings. OBJECTIVE: This study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different health care settings in Denmark and to determine the factors affecting its implementation. Furthermore, the study evaluates the psychometric characteristics of the Danish PRO Diabetes Questionnaire and the validity of the scoring algorithms for dialogue support. The objective of this study is to guide the ongoing optimization of the PRO diabetes tool, its implementation, and the design of future randomized controlled effectiveness studies. METHODS: We designed a multicenter, mixed methods, single-arm acceptability-feasibility implementation study protocol to contribute to the real-world pilot test of a new digital PRO diabetes tool in routine diabetes care. The use of the tool involves two main steps. First, the people with diabetes will complete a digital PRO Diabetes Questionnaire in the days before a routine diabetes visit. Second, the health care professional (HCP) will use a digital PRO tool to review the PRO results together with the people with diabetes during the visit. The PRO diabetes tool is designed to encourage and support people to take an active role for the people with diabetes in their own care and to expedite the delivery of person-centered, collaborative, and coordinated care. RESULTS: A multicenter pilot study protocol and psychometrically designed digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention. A total of 598 people with diabetes and 34 HCPs completed the study protocol by April 1, 2021. CONCLUSIONS: A large-scale, mixed methods, multicenter study for evaluating the use of the nationally developed PRO Diabetes Questionnaire in routine care across all health care sectors in Denmark by using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) model as a framework has been designed and is ongoing. This study is expected to provide new important and detailed information about the real-world acceptability, perceived relevance, and benefits of the PRO diabetes tool among a large heterogeneous population of people with diabetes in Denmark and HCPs in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies, and design future controlled effectiveness studies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28391.

Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative.

INTRODUCTION: Meaningful patient engagement (PE) can enhance medicines' development. However, the current PE landscape is fragmentary and lacking comprehensive guidance. METHODS: We systematically searched for PE initiatives (SYNaPsE database/publications). Multistakeholder groups integrated these with their own PE expertise to co-create draft PE Quality Guidance which was evaluated by public consultation. Projects exemplifying good PE practice were identified and assessed against PE Quality Criteria to create a Book of Good Practices (BOGP). RESULTS: Seventy-six participants from 51 organisations participated in nine multistakeholder meetings (2016-2018). A shortlist of 20relevant PE initiatives (from 170 screened) were identified. The co-created INVOLVE guidelines provided the main framework for PE Quality Guidance and was enriched with the analysis of the PE initiatives and the PE expertise of stakeholders. Seven key PE Quality Criteria were identified. Public consultation yielded 67 responses from diverse backgrounds. The PE Quality Guidance was agreed to be useful for achieving quality PE in practice, understandable, easy to use, and comprehensive. Overall, eight initiatives from the shortlist and from meeting participants were selected for inclusion in the BOGP based on demonstration of PE Quality Criteria and willingness of initiative owners to collaborate. DISCUSSION: The PE Quality Guidance and BOGP are practical resources which will be continually updated in response to user feedback. They are not prescriptive, but rather based on core principles, which can be applied according to the unique needs of each interaction and initiative. Implementation of the guidance will facilitate improved and systematic PE across the medicines' development lifecycle.

The complex interplay between clinical and person-centered diabetes outcomes in the two genders.

BACKGROUND: New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2DM) are needed; gender influences the complex interplay between clinical and non-clinical factors. We used data from the BENCH-D study to assess gender-differences in terms of clinical and person-centered measures in T2DM. METHODS: Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records. Ten self-administered validated questionnaires (SF-12 Health Survey; WHO-5 well-being index; Problem Areas in Diabetes (PAID) 5, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Diabetes Empowerment Scale, Diabetes Self-care Activities, Global Satisfaction for Diabetes Treatment, Barriers to Taking Medications, Perceived Social Support) were adopted as person-centered outcomes indicators. RESULTS: Overall, 26 diabetes clinics enrolled 2,335 people (men: 59.7%; women: 40.3%). Lower percentages of women reached HbA1c levels < =7.0% (23.2% vs. 27.8%; p = 0.03), LDL-cholesterol < 100 mg/dl (48.3 vs. 57.8%; p = 0.0005), and BMI <27 Kg/m2 (27.2 vs. 31.6%; p = 0.04) than men. Women had statistically significant poorer scores for physical functioning, psychological well-being, self-care activities dedicated to physical activities, empowerment, diabetes-related distress, satisfaction with treatment, barriers to medication taking, satisfaction with access to chronic care and healthcare communication, and perceived social support than men; 24.8% of women and 8.8% of men had WHO-5 < =28 (likely depression) (p < 0.0001); 67.7% of women and 55.1% of men had PAID-5 > 40 (high levels of diabetes-related distress) (p < 0.0001). At multivariate analysis, factors associated with an increased likelihood of having elevated HbA1c levels (≥8.0%) were different in men and women, e.g. having PAID-5 levels >40 was associated with a higher likelihood of HbA1c ≥8.0% in women (OR = 1.15; 95%CI 1.05-1.25) but not in men (OR = 1.00; 95%CI 0.93-1.08). CONCLUSIONS: In T2DM, women show poorer clinical and person-centered outcomes indicators than men. Diabetes-related distress plays a role as a correlate of metabolic control in women but not in men. The study provides new information about the interplay between clinical and person-centered indicators in men and women which may guide further improvements in diabetes education and support programs.

Interplay among patient empowerment and clinical and person-centered outcomes in type 2 diabetes. The BENCH-D study.

OBJECTIVE: We evaluated empowerment in T2DM and identified its correlates. METHODS: A sample of individuals self-administered the Diabetes Empowerment Scale-Short Form (DES-SF) and other 9 validated instruments (person-centered outcomes). Correlates of DES-SF were identified through univariate and multivariate analyses. For person-centered outcomes, ORs express the likelihood of being in upper quartile of DES-SF (Q4) by 5 units of the scale. RESULTS: Overall, 2390 individuals were involved. Individuals in Q4 were younger, more often males, had higher levels of school education, lower HbA1c levels and prevalence of complications as compared to individuals in the other quartiles. The likelihood of being in Q4 was directly associated with higher selfreported self-monitoring of blood glucose (SDSCA6-SMBG) (OR=1.09; 95% CI: 1.03-1.15), higher satisfaction with diabetes treatment (GSDT) (OR=1.15; 95% CI: 1.07-1.25), perceived quality of chronic illness care and patient support (PACIC-SF) (OR=1.23; 95% CI: 1.16-1.31), and better person-centered communication (HCC-SF) (OR=1.10; 95% CI: 1.01-1.19) and inversely associated with diabetes-related distress (PAID-5) (OR=0.95; 95% CI: 0.92-0.98). Adjusted DES-SF mean scores ranged between centers from 69.8 to 93.6 (intra-class correlation=0.10; p<0.0001). CONCLUSIONS: Empowerment was associated with better glycemic control, psychosocial functioning and perceived access to person-centered chronic illness care. Practice of diabetes center plays a specific role. PRACTICE IMPLICATIONS: DES-SF represents a process and outcome indicator in the practice of diabetes centers.

Good practice recommendations on paediatric training programmes for health care professionals in the EU.

Part of the SWEET Project: EU (European Union), Better Control in Paediatric and Adolescent Diabetes: Working to Create Centres of Reference, was specifically to examine the training of health care professionals (HCPs) across the EU. Several types of information were collected during 2009, and these included a literature search, workshops of the SWEET members, examination of the data collected by the Hvidøre Study Group and the Diabetes Attitudes, Wishes, and Needs (DAWN) Youth initiative, and a questionnaire distributed to SWEET members and professional colleagues who cared for children and young people (CYP) with diabetes. It was clear from the information collected that there was no European or global consensus either on a curriculum for the training of the paediatric diabetes multidisciplinary team (MDT) or individual professions in paediatric diabetes. A minority of countries had well-established training but, for the majority, there was little standardisation or accreditation. Moreover, most countries did not have available courses for training the diabetes MDT and training was not mandatory. Of the courses that were available more were accredited for doctors and nurses but fewer for the other professions. As a consequence, the majority of HCP posts in paediatric diabetes do not demand prior experience in the specialty. Standardised accredited training and continuous professional development (CPD) opportunities are severely limited. The SWEET Project supports a standardised, accredited approach to training and CPD of the MDT and for individual professions. As a consequence, a curriculum for the training of the MDT was developed, and this is now ready for implementation.