Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

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 12-Item Hypoglycemia Impact Profile (HIP12): psychometric validation of a brief measure of the impact of hypoglycemia on quality of life among adults with type 1 or type 2 diabetes.

INTRODUCTION: The aim of this study was to determine the psychometric properties of the 12-Item Hypoglycemia Impact Profile (HIP12), a brief measure of the impact of hypoglycemia on quality of life (QoL) among adults with type 1 (T1D) or type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Adults with T1D (n=1071) or T2D (n=194) participating in the multicountry, online study, 'Your SAY: Hypoglycemia', completed the HIP12. Psychometric analyses were undertaken to determine acceptability, structural validity, internal consistency, convergent/divergent validity, and known-groups validity. RESULTS: Most (98%) participants completed all items on the HIP12. The expected one-factor solution was supported for T1D, T2D, native English speaker, and non-native English speaker groups. Internal consistency was high across all groups (ω=0.91-0.93). Convergent and divergent validity were satisfactory. Known-groups validity was demonstrated for both diabetes types, by frequency of severe hypoglycemia (0 vs ≥1 episode in the past 12 months) and self-treated episodes (<2 vs 2-4 vs ≥5 per week). The measure also discriminated by awareness of hypoglycemia in those with T1D. CONCLUSIONS: The HIP12 is an acceptable, internally consistent, and valid tool for assessing the impact of hypoglycemia on QoL among adults with T1D. The findings in the relatively small sample with T2D are encouraging and warrant replication in a larger sample.

Feasibility and Acceptability of a Digital Patient-Reported Outcome Tool in Routine Outpatient Diabetes Care: Mixed Methods Formative Pilot Study.

BACKGROUND: Improvements in the digital capabilities of health systems provide new opportunities for the integration of patient-reported outcome (PRO) solutions in routine care, which can facilitate the delivery of person-centered diabetes care. We undertook this study as part of our development of a new digital PRO diabetes questionnaire and clinical dialog support tool for use by people with diabetes and their health care professionals (HCPs) to improve person-centered diabetes care quality and outcomes. OBJECTIVE: This study evaluates the feasibility, acceptability, and perceived benefits and impacts of using a digital PRO diabetes tool, DiaProfil, in routine outpatient diabetes care. METHODS: Overall, 12 people with diabetes scheduled for routine medical diabetes visits at the outpatient clinic were recruited. Purposive sampling was used to optimize heterogeneity regarding age, gender, duration, type of diabetes, treatment modality, and disease severity. Participants filled out a PRO diabetes questionnaire 2 to 5 days before their visit. During the visit, HCPs used a digital PRO tool to review PRO data with the person with diabetes for collaborative care planning. Participants completed evaluation forms before and after the visit and were interviewed for 30 to 45 minutes after the visit. HCPs completed the evaluation questionnaires after each visit. All visits were audio-recorded and transcribed for analysis. Data were analyzed using quantitative, qualitative, and mixed methods analyses. RESULTS: People with diabetes found the PRO diabetes questionnaire to be relevant, acceptable, and feasible to complete from home. People with diabetes and HCPs found the digital PRO tool to be feasible and acceptable for use during the diabetes visit and would like to continue using it. HCPs were able to use the tool in a person-centered manner, as intended. For several people with diabetes, completion of the questionnaire facilitated positive reflection and better preparation for the visit. The use of the PRO tool primarily improved the quality of the dialog by improving the identification and focus on the issues most important to the person with diabetes. People with diabetes did not report any negative aspects of the PRO tool, whereas HCPs highlighted that it was demanding when the person with diabetes had many PRO issues that required attention within the predefined time allocated for a visit. CONCLUSIONS: The Danish PRO diabetes questionnaire and the digital tool, DiaProfil, are feasible and acceptable solutions for routine diabetes visits, and this tool may generate important benefits related to advancement of person-centered care. Further research is now required to corroborate and expand these formative insights on a larger scale and in diverse health care settings. The results of this study are therefore being used to define research hypotheses and finalize real-world PRO evaluation tools for a forthcoming large-scale multisector implementation study in Denmark.

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.

Examining Variations in Action Plan Quality Among Adults With Type 2 Diabetes in Primary Care.

INTRODUCTION: Collaborative goal setting and action-planning are key elements of self-management support for people with type 2 diabetes mellitus (T2DM), however little is known regarding action plan quality or correlation of quality in primary T2DM care. METHODS: T2DM patients from 12 primary care sites participated in either: Connection to Health (CTH; 6 practices), consisting of a health survey followed by collaborative action planning, or Enhanced Engagement CTH (EE-CTH; 6 practices), including additional training in relationship building promoting patient engagement. Action plan quality was rated using an adapted version of the Goal-Setting Evaluation Tool for Diabetes (GET-D) (dual coding of 20%, inter-rater reliability [IRR] >80%). Associations with patient characteristics were examined using generalized linear mixed models adjusting for clustering by clinic and intervention arm. RESULTS: With a mean score ± standard deviation (SD) of 14.62 ± 3.87 on a 0 to 20 scale (n = 725), overall action plan quality was moderate-high. Higher health literacy (ß = 1.184, 95% CI, 0.326-2.041; P = .007), and having no social risks (ß = 0.416; 95% CI, 0.062-0.770; P = .021) were associated with higher action plan quality, whereas sex, age, language, education level, depression, stress, and health distress were unrelated to quality (P value not significant). Higher quality was associated with greater patient confidence in the plan (ß = 0.050; 95% CI, 0.016-0.084, P = .004). CONCLUSIONS: Although there was a considerable difference in action plan quality ratings, ratings did not systematically differ based on most patient demographic or mental health measures. Results suggest that action planning should be tailored to health literacy and social risks. Further research should examine associations between quality and longer-term clinical outcomes.

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.

Can the Routine Use of Patient-Reported Outcome Measures Improve the Delivery of Person-Centered Diabetes Care? A Review of Recent Developments and a Case Study.

PURPOSE OF REVIEW: In recent years, the recommendation for and use of patient-reported outcome measures (PROMs) in routine diabetes care has significantly increased. We review recent evidence and highlight key opportunities and challenges related to the active clinical use of PROMs to support person-centered diabetes care and focus areas for future research in the area. RECENT FINDINGS: Recent pragmatic studies support that integration of multi-dimensional PROMs for diabetes in clinical care as part of a care improvement strategy can be acceptable for and valued by people with diabetes (PWD) and healthcare professionals (HCPs) and may improve multiple aspects of quality of care, including screening, medical care monitoring and decision support, individualization of self-management support and goal-setting, and broader benefits related to active patient participation and person-centred diabetes care. We identify multiple intervention, individual, and care setting characteristics, which influence acceptability, feasibility, implementation, and effectiveness of PROMs in routine care. Recent clinical PROM studies highlight the value of mixed methods research and systematic involvement of PWD, clinicians, and other stakeholders in the design and implementation of questionnaires for patient input in routine diabetes care. We identified a new significant trend towards participatory development of multi-dimensional PROMs with the aim of IT-enabled integration into routine diabetes care to facilitate multiple components of person-centered diabetes care and better clinical, quality of life, and cost outcomes. While results from large-scale randomized controlled studies are still limited, a growing number of pragmatic implementation studies support that user-centric PROM interventions have the potential to facilitate significant improvements in care for PWD.

Assessing the perceived impact of diabetes on quality of life: Psychometric validation of the DAWN2 Impact of Diabetes Profile in the second Diabetes MILES - Australia (MILES-2) survey.

AIMS: To investigate the validity and reliability of the 6-item DAWN2 Impact of Diabetes Profile (DIDP), and the modified 7-item DIDP, which includes assessment of dietary freedom. METHODS: The online, cross-sectional, Australian MILES-2 survey included the DIDP and other validated measures, to examine convergent, discriminant and known-groups validity. The DIDP was completed by 2207 adults with diabetes (Type 1: n = 1012; Type 2 insulin: n = 504; non-insulin: n = 691). Data were subjected to exploratory factor analysis, internal consistency reliability and univariate statistics, conducted separately by diabetes type/treatment. RESULTS: The DIDP was highly acceptable: 99% completion rate. One-factor solutions were supported for the 6-item and 7-item DIDP scales, in all diabetes type/treatment groups (variance explained range: 6-item: 59-67%, 7-item: 55-62%), with satisfactory internal consistency (α = 0.85-0.90). Known-groups validity was demonstrated, by diabetes type and complications presence/absence, as was satisfactory convergent and discriminant validity. CONCLUSIONS: The DIDP meets the need for a brief, contemporary, valid and reliable measure of the perceived impact of diabetes on quality of life, suitable for adults with Type 1 or Type 2 diabetes mellitus. The 6-item and 7-item scales have psychometric equivalence. Use of the seventh item can be informed by research questions.

The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream.

Benefit-risk assessment is the cornerstone of decision making in medical care, playing a critical role in bringing treatments to market by informing decisions regarding drug development, licensing and reimbursement, and informing treatment decisions made by health care professionals and patients in clinical practice. In regulatory approval decision making, benefit and risk attributes are identified and defined based on available, aggregated clinical data from registration trials. In the context of major developments in recent years for involvement of patients as partners in all phases of drug development and in health care improvement, decision makers increasingly recognize the importance of informing treatment decisions by patient needs, values, experiences, and preferences. Using this as a basis, a DIA workstream was convened to explore the potential of individual-level benefit-risk assessment as a supplement to traditional group-level benefit-risk assessment for evaluating treatment. Various approaches as to how this information could be collected, including via patient-reported outcome measures, open-ended questioning, and stated-preference methods are presented. The utility of this information for various stakeholders is discussed.

Targets and teamwork: Understanding differences in pediatric diabetes centers treatment outcomes.

OBJECTIVE: The reason for center differences in metabolic control of childhood diabetes is still unknown. We sought to determine to what extent the targets, expectations, and goals that diabetes care professionals have for their patients is a determinant of center differences in metabolic outcomes. RESEARCH DESIGN AND METHODS: Children, under the age of 11 with type 1 diabetes and their parents treated at the study centers participated. Clinical, medical, and demographic data were obtained, along with blood sample for centralized assay. Parents and all members of the diabetes care team completed questionnaires on treatment targets for hemoglobin A1c (HbA1c) and recommended frequency of blood glucose monitoring. RESULTS: Totally 1113 (53% male) children (mean age 8.0 ± 2.1 years) from 18 centers in 17 countries, along with parents and 113 health-care professionals, participated. There were substantial differences in mean HbA1c between centers ranging from 7.3 ± 0.8% (53 mmol/mol ± 8.7) to 8.9 ± 1.1% (74 mmol/mol ± 12.0). Centers with lower mean HbA1c had (1) parents who reported lower targets for their children, (2) health-care professionals that reported lower targets and more frequent testing, and (3) teams with less disagreement about recommended targets. Multiple regression analysis indicated that teams reporting higher HbA1c targets and more target disagreement had parents reporting higher treatment targets. This seemed to partially account for center differences in Hb1Ac. CONCLUSIONS: The diabetes care teams' cohesiveness and perspectives on treatment targets, expectations, and recommendations have an influence on parental targets, contributing to the differences in pediatric diabetes center outcomes.

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.

Household composition and psychological health: Results of the Second Diabetes Attitudes, Wishes and Needs (DAWN2) study.

AIMS: 1) To explore the effect of household composition on the psychological health of adults with diabetes by comparing those living with other adult(s) including a partner with those living with neither partner nor other adult(s); 2) to examine potential mediation of social support in the association between household composition and psychological health. METHODS: The study is part of the DAWN2 study conducted in 17 countries. The population comprised 8596 people with diabetes (PWD). Multiple regression models (linear and binary) were applied. RESULTS: People living with 'other adult(s) but no partner' experienced significantly lower well-being, higher diabetes distress and worried more frequently about hypoglycaemic events than those with a partner or those not co-habiting with another adult. However, participants living with 'other adult(s) but no partner' were more empowered compared to the other household composition groups. The association between household composition and psychological health was not mediated by diabetes-specific social support. CONCLUSIONS: The study indicates the psychological vulnerability of respondents living without a partner but with other adult(s). Appropriate support interventions must be developed and tested in order to enhance psychological health in people with diabetes living with other adults such as adult children, but with no partner.

Correlates and outcomes of worries about hypoglycemia in family members of adults with diabetes: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study.

OBJECTIVE: We examined (a) the demographic and clinical correlates of worries about hypoglycemia in adult family members of adults with diabetes, and (b) the association of these worries with measures of diabetes support. METHODS: The second multinational Diabetes Attitudes, Wishes and Needs (DAWN2) study cross-sectionally surveyed 2057 family members from 17 countries. Participants completed questions about demographics, diabetes, and psychosocial functioning, including worry about overall and nocturnal hypoglycemia. Analyses included hierarchical ordinal and linear regression. RESULTS: Eighty-five percent of family members (n=1661) were at least occasionally very worried about the risk of hypoglycemic events overall. Correlates of worries about hypoglycemia included female gender, higher age and lower education in the family member, younger age of the person with diabetes and this person being a parent or another adult (versus spouse or partner), insulin or non-insulin injectable treatment, severe or non-severe hypoglycemia in the past 12months, and family member recognition of hypoglycemia. Elevated worries about hypoglycemia had a significant independent association with increased odds of diabetes-related family arguments and family member frustration in providing helpful support (OR range 1.60-3.72). High levels of worries about hypoglycemia were associated with increased odds of attending diabetes-related health-care visits. Worries about hypoglycemia were not associated with family member involvement in diabetes care. Similar results were found for worries about nocturnal events. CONCLUSION: Worries about hypoglycemia were common in family members and were associated with suboptimal diabetes support. This issue therefore deserves increased clinician attention.

Living with an adult who has diabetes: Qualitative insights from the second Diabetes Attitudes, Wishes and Needs (DAWN2) study.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study identified the experiences of family members who support adults living with diabetes. METHODS: Participants were 2057 adult family members living with the person with diabetes from 17 countries. Qualitative data were responses to open-ended survey questions about how living with a person with diabetes has impacted family members and the ways they choose to be involved in the diabetes care for the person with whom they live. Emergent coding with input from multinational collaborators identified thematic content about psychosocial aspects. RESULTS: Family members wanted to do what was best for the person with diabetes and help in whatever way possible. Four themes branched from that principle: (1) family members worry about day-to-day struggles of the person with diabetes, such as hypoglycemia and employment stability; (2) diabetes negatively affects the person with diabetes-family member relationship, creating an emotional strain and shift in relationship; (3) family members have some support resources to deal with the burdens and lifestyle changes of diabetes, but would like more; and (4) the person with diabetes has provided inspiration to the family member, and helped the family member make positive life changes in eating healthier. CONCLUSIONS: These data provide insight into the ways that family members experience living with diabetes, including their challenges, motivations and intentions in supporting their person with diabetes. Family members speak eloquently and with emotion about their role in a family with diabetes.

Treatment beliefs, health behaviors and their association with treatment outcome in type 2 diabetes.

OBJECTIVE: While the prevalence of type 2 diabetes is growing, it is increasingly well recognized that treatment outcomes in primary care practice are often suboptimal. The aim of this study is to examine the extent to which treatment beliefs and health behaviors predict diabetes health outcome as measured by glycated hemoglobin (HbA1c) level, blood pressure, and lipid profile. RESEARCH DESIGN AND METHODS: This was a large-scale cross-sectional, registry-based study involving a well-defined type 2 diabetes population, in the county of Funen, Denmark. Registry data were combined with a 27-item self-reported survey administered to all insulin-treated people in the registry (n=3160). The survey was constructed to operationalize key concepts of diabetes management, diabetes treatment beliefs, and health behaviors. RESULTS: In total, 1033 respondents answered the survey. The majority of treatment beliefs and health behaviors examined were predictors of glycemic control and, to a large extent, lipid profile. Absence from, or a low frequency of, self-measured blood glucose, non-adherence to general medical advice and the prescribed treatment, a low primary care utilization, and perceived low treatment efficacy were factors positively associated with HbA1c levels, s-cholesterol, and low-density lipoprotein. Conversely, infrequent self-measured blood glucose was associated with a significantly higher likelihood of having a blood pressure below 130/80 mm Hg. Perceived low treatment efficacy was the only health belief associated with poorer levels of health outcome other than HbA1c. CONCLUSIONS: Health behaviors were stronger predictors for health outcomes than treatment beliefs. Self-reported adherence to either the treatment regimen or general medical advice most consistently predicted both glycemic control and cardiovascular risk factors.

Correlates of diabetes-related distress in type 2 diabetes: Findings from the benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study.

OBJECTIVE: To evaluate correlates of high diabetes-related distress (HD) among individuals with type 2 diabetes mellitus (T2DM). METHODS: The study involved a sample of patients with T2DM who filled in the Problem Areas in Diabetes questionnaire (PAID-5); a score ≥ 40 indicates HD. Additional instruments included: SF12 health survey (SF12), Well-Being Index (WHO-5), Diabetes Empowerment Scale-Short Form (DES-SF), Patient Assessment of Chronic Illness Care-Short Form (PACIC-SF), Health Care Climate-Short Form (HCC-SF), Global Satisfaction with Diabetes Treatment (GSDT), Summary of Diabetes Self-Care Activities (SDSCA-6); Barriers to Medications (BM), Perceived Social Support (PSS). Clinical data were extracted from computerized medical records. Multivariable logistic regression analyses were performed to identify correlates of HD. RESULTS: Of 2374 patients (mean age 65.0±10.2 years, diabetes duration 14.0±15.3 years, 59.9% males), 1429 (60.2%) had HD. Compared to patients with a PAID-5 score<40 those with HD were more often female, living alone, had a lower level of education, higher HbA1c levels, a greater perceived impact of hyperglycemic and hypoglycemic symptoms, a greater number of diabetes-related complications, lower scores of WHO-5, DES-SF, PSS, GSDT, SF-12 PCS, SDSCA-healthy diet and physical activity subscales, higher scores of BM and SDSCA-SMBG component. Multivariable analyses confirmed the relationship between HD and symptoms of hyperglycemia, levels of empowerment, global satisfaction with treatment, perception of barriers to medication, and psychological well-being. Conclusion HD is extremely common among people with T2DM, affecting almost two-thirds of patients. High levels of distress are associated with worse clinical and psychosocial outcomes and should be considered as a key patient-centered indicator.

"I Do My Best To Listen to Patients": Qualitative Insights Into DAWN2 (Diabetes Psychosocial Care From the Perspective of Health Care Professionals in the Second Diabetes Attitudes, Wishes and Needs Study).

PURPOSE: The aim of this study was to describe the perspectives of diabetes care professionals regarding the roles and responsibilities of people with diabetes (PWD), health care professionals (HCPs), and the larger society to improve the provision of person-centered diabetes care. METHODS: The survey contained open-ended items about challenges of, successes of, and wishes for improvements in treating adults with diabetes. All responses were systematically coded using a schema developed and validated through multinational collaboration. FINDINGS: Participants were 4785 diabetes care professionals (physicians, nurses, and dietitians) from 17 countries. The data contained 2 distinct themes. One theme reflected the fact that the roles and responsibilities of HCPs are transitioning from those of one who "tells" to one who "listens" to PWD. Some ways that HCPs can "listen" to PWD and family members is to involve them in goals and to encourage self-management for the improvement of treatment. The second theme identified barriers to successful diabetes care, which include a lack of time and collaboration from HCPs, a lack of availability of resources for treatment, and a lack of psychosocial support. IMPLICATIONS: The views of diabetes care professionals are in transition from a conventional hierarchic approach to a PCC approach. Further adoption of this approach would be facilitated by additional psychosocial training and educational/psychological resources, increased teamwork, and societal changes that would make it easier for people to live successfully with diabetes.

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.