Higher levels of bodily pain in people with long-term type 1 diabetes: associations with quality of life, depressive symptoms, fatigue and glycaemic control - the Dialong study.

AIMS: To compare reported level of bodily pain, overall and health-related quality of life (QoL), depression and fatigue in people with long-term type 1 diabetes vs. a comparison group without diabetes. Further, to examine the associations of total bodily pain with QoL, depression, fatigue and glycaemic control in the diabetes group. METHODS: Cross-sectional study of 104 (76% of eligible) people with type 1 diabetes of ≥ 45 years' duration attending the Norwegian Diabetes Centre and 75 persons without diabetes who completed questionnaires measuring bodily pain (RAND-36 bodily pain domain), shoulder pain (Shoulder Pain and Disability Index), hand pain (Australian/Canadian Osteoarthritis Hand Index), overall QoL (World Health Organization Quality of Life - BREF), health-related QoL (RAND-36), diabetes-specific QoL (Audit of Diabetes-Dependent Quality of Life; only diabetes group), depression (Patient Health Questionnaire) and fatigue (Fatigue questionnaire). For people with type 1 diabetes, possible associations between the bodily pain domain (lower scores indicate higher levels of bodily pain) and other questionnaire scores, were measured with regression coefficients (B) per 10-unit increase in bodily pain score from linear regression. RESULTS: The diabetes group reported higher levels of bodily (P = 0.003), shoulder and hand pain (P < 0.001) than the comparison group. In the diabetes group, bodily pain was associated with lower overall and diabetes-specific QoL [B (95% confidence intervals)]: 0.2 (0.1, 0.2) and 0.2 (0.1, 0.3); higher levels of depression -1.0 (-1.3, -0.7) and total fatigue -1.5 (-1.9, -1.2); and worse glycaemic control HbA1c (mmol/mol; %) -0.8 (-1.5, -0.1); -0.1 (-0.1, -0.01). CONCLUSIONS: People with long-term type 1 diabetes experience a high level of bodily pain compared with a comparison group. Total bodily pain was associated with worse QoL and glycaemic control.

A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach.

AIMS: To select a core list of standard outcomes for diabetes to be routinely applied internationally, including patient-reported outcomes. METHODS: We conducted a structured systematic review of outcome measures, focusing on adults with either type 1 or type 2 diabetes. This process was followed by a consensus-driven modified Delphi panel, including a multidisciplinary group of academics, health professionals and people with diabetes. External feedback to validate the set of outcome measures was sought from people with diabetes and health professionals. RESULTS: The panel identified an essential set of clinical outcomes related to diabetes control, acute events, chronic complications, health service utilisation, and survival that can be measured using routine administrative data and/or clinical records. Three instruments were recommended for annual measurement of patient-reported outcome measures: the WHO Well-Being Index for psychological well-being; the depression module of the Patient Health Questionnaire for depression; and the Problem Areas in Diabetes scale for diabetes distress. A range of factors related to demographic, diagnostic profile, lifestyle, social support and treatment of diabetes were also identified for case-mix adjustment. CONCLUSIONS: We recommend the standard set identified in this study for use in routine practice to monitor, benchmark and improve diabetes care. The inclusion of patient-reported outcomes enables people living with diabetes to report directly on their condition in a structured way.

Motivation: key to a healthy lifestyle in people with diabetes? Current and emerging knowledge and applications.

AIM: Motivation to take up and maintain a healthy lifestyle is key to diabetes prevention and management. Motivations are driven by factors on the psychological, biological and environmental levels, which have each been studied extensively in various lines of research over the past 25 years. Here, we analyse and reflect on current and emerging knowledge on motivation in relation to lifestyle behaviours, with a focus on people with diabetes or obesity. Structured according to psychological, (neuro-)biological and broader environmental levels, we provide a scoping review of the literature and highlight frameworks used to structure motivational concepts. Results are then put in perspective of applicability in (clinical) practice. RESULTS: Over the past 25 years, research focusing on motivation has grown exponentially. Social-cognitive and self-determination theories have driven research on the key motivational concepts 'self-efficacy' and 'self-determination'. Neuro-cognitive research has provided insights in the processes that are involved across various layers of a complex cortical network of motivation, reward and cognitive control. On an environmental - more upstream - level, motivations are influenced by characteristics in the built, social, economic and policy environments at various scales, which have provided entry points for environmental approaches influencing behaviour. CONCLUSIONS: Current evidence shows that motivation is strongly related to a person's self-efficacy and capability to initiate and maintain healthy choices, and to a health climate that supports autonomous choices. Some approaches targeting motivations have been shown to be promising, but more research is warranted to sustainably reduce the burden of diabetes in individuals and populations.

Living with diabetes: literature review and secondary analysis of qualitative data.

AIM: To review the published qualitative literature on the lived experience of people with diabetes, describe the emerging findings and research methods over the last 25 years, and make recommendations for future research. METHODS: We describe a 'Next-Generation' mixed-method approach to reporting qualitative data that combines the advantages of traditional qualitative analysis (assessing depth of meaning from participants themselves) with those of descriptive analysis (assessing breadth and representativeness). We used our Next-Generation approach to conduct a secondary analysis of qualitative data derived from a systematic search of PubMed. A formal coding scheme was developed and systematically applied to 2050 respondent quotations contained in the 74 selected articles; inter-rater agreement was high (κ = 0.90). Quotations were aggregated at the level of the article and reported to assess both narratives and numerical counts of the data. RESULTS: The rate of qualitative research on the lived experience of diabetes has increased over the last 25 years. Both positive and negative aspects of lived experience were reported, although the former was less common. Data from many different populations were reported, but most studies emphasized breadth of coverage over depth. Some findings are well established and there is little benefit to repeating these studies. Best practices of qualitative methodology were often not utilized. CONCLUSIONS: The amount of qualitative research in diabetes is substantial and increasing. We recommend that future research be focused on specific understudied topics rather than repeating existing research. We also provide recommendations for how qualitative study methodology can be improved by implementing the Next-Generation approach.

Longitudinal associations between depression and diabetes complications: a systematic review and meta-analysis.

To conduct a systematic review and meta-analysis of longitudinal studies assessing the bi-directional association between depression and diabetes macrovascular and microvascular complications. Embase, Medline and PsycINFO databases were searched from inception through 27 November 2017. A total of 4592 abstracts were screened for eligibility. Meta-analyses used multilevel random/mixed-effects models. Quality was assessed using the Newcastle-Ottawa scale. Twenty-two studies were included in the systematic review. Sixteen studies examined the relationship between baseline depression and incident diabetes complications, of which nine studies involving over one million participants were suitable for meta-analysis. Depression was associated with an increased risk of incident macrovascular (HR = 1.38; 95% CI: 1.30-1.47) and microvascular disease (HR = 1.33; 95% CI: 1.25-1.41). Six studies examined the association between baseline diabetes complications and subsequent depression, of which two studies involving over 230 000 participants were suitable for meta-analysis. The results showed that diabetes complications increased the risk of incident depressive disorder (HR = 1.14; 95% CI: 1.07-1.21). The quality analysis showed increased risk of bias notably in the representativeness of selected cohorts and ascertainment of exposure and outcome. Depression in people with diabetes is associated with an increased risk of incident macrovascular and microvascular complications. The relationship between depression and diabetes complications appears bi-directional. However, the risk of developing diabetes complications in depressed people is higher than the risk of developing depression in people with diabetes complications. The underlying mechanisms warrant further research.

Diabetes prevalence among older people receiving care at home: associations with symptoms, health status and psychological well-being.

AIMS: To determine the prevalence of diabetes among older people receiving care at home, and to explore differences in sociodemographic and clinical characteristics, symptoms, health status, quality of life and psychological well-being between diabetes categories defined as HbA1c ≥ 48 mmol/mol (6.5%) and/or self-report. METHODS: A community-based sample of 377 people receiving care at home in Western Norway participated in a cross-sectional survey. Instruments included the MMSE-NR, Symptom Check-List, WHO Quality of Life-BREF (WHOQOL-BREF, global items), EuroQol EQ-5D-5L/EQ-5D-VAS and WHO-Five Well-Being Index (WHO-5). Participants were grouped into four categories: no diabetes, self-report only, HbA1c ≥ 48 mmol/mol (6.5%) and self-report, and HbA1c ≥ 48 mmol/mol (6.5%) only. RESULTS: Median age (IQR) was 86 (81-91) years and 34% of the sample were men. We identified 92 people (24%) with diabetes. Diabetes was more prevalent in men than women (34% vs. 20%, age-adjusted P = 0.005). Among people with diabetes, 14% were unaware of their diagnosis. There were significant differences in symptoms between the diabetes categories, with more symptoms (abnormal thirst, polyuria, genital itching, nausea, excessive hunger, perspiring, cold hands/feet, daytime sleepiness) among the groups with elevated HbA1c . Significant differences in WHO-5, WHOQOL-BREF and EQ-5D-5L between diabetes categories were identified, with the poorest scores in the group with undiagnosed diabetes. CONCLUSIONS: A high percentage of people with diabetes receiving care at home are unaware of their diagnosis. Diabetes deserves increased case-finding efforts and allocation of resources towards those receiving care at home to alleviate symptoms and the burden of inadequate diabetes care.

Deficiencies in postgraduate training for healthcare professionals who provide diabetes education and support: results from the Diabetes Attitudes, Wishes and Needs (DAWN2) study.

AIMS: To consider the global provision of self-management diabetes education and training for healthcare professionals using data from the second Diabetes Attitudes, Wishes and Needs (DAWN2) study. METHODS: A total of 4785 healthcare professionals caring for people with diabetes were surveyed in 17 countries to assess diabetes healthcare provision, self-management support and training. RESULTS: Of the healthcare professionals surveyed, 33.5% received formal postgraduate training in self-management (19.3-51.4% across countries) and 62.9% received training for medical management of diabetes (47.6-70.6% variation). Training in psychological management was low (19.1%), ranging from 3.6 to 36.5%, while 20.4% (a range of 3.6-36.4% across countries) had received no postgraduate training. Overall, the greatest training need was in the management of psychological aspects of diabetes (59.5%). For some, training in a domain was positively associated with a perceived need for further training. Communication skills, for example, listening (76.9%) and encouraging questions (76.1%), were the skills most widely used. Discussion of emotional issues was limited; 31-60% of healthcare professionals across the different countries reported that this only occurred if initiated by patients. Approximately two-thirds of participants reported a need for major improvements in emotional/psychological support, but few had received training in this area, with consistent findings across professional affiliations. CONCLUSIONS: The present study shows that healthcare professionals report being insufficiently equipped to provide diabetes self-management education, including emotional and psychological aspects of diabetes, and many are not receiving postgraduate training in any part (including medical care) of the management of diabetes. It is paramount that those responsible for the continuing professional development of healthcare professionals address this skills gap.

Correlates of psychological outcomes in people with diabetes: results from the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To assess country- and individual-level correlates of psychological outcomes, and differences among countries in the associations of individual characteristics with psychological outcomes among adults with diabetes. METHODS: The second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study assessed self-reported characteristics of people with diabetes in 17 countries, including 1368 adults with Type 1 diabetes and 7228 with Type 2 diabetes. In each country, a sample of 500 adults, stratified by diabetes type and treatment, completed a questionnaire incorporating the validated WHO-5 wellbeing index, the WHOQOL-BREF, and the five-item Problem Areas in Diabetes Scale, as well as the newly developed Diabetes Impact on Life Dimensions that assessed impact ranging from very positive to very negative, with no impact as the midpoint. Multilevel regression analyses identified significant (P < 0.05) independent correlates of psychological outcomes. RESULTS: There were significant variations in all outcomes across countries before adjustment for individual-level factors; adjustment reduced between-country disparities. Worse psychological outcomes were associated with more complications, incidence of hypoglycaemia, hypoglycaemic medication, perceived burden of diabetes, family conflict and experience of discrimination. Better psychological outcomes were associated with higher self-rated health, greater access to diabetes education and healthcare, and more psychosocial support from others. The associations of many factors with the outcomes were mediated by modifiable factors. The association of all factors with the outcomes varied across (interacted with) countries, highlighting the need for country-specific analyses. CONCLUSIONS: Improvements in modifiable risk factors (reductions in burden and increases in support) may lead to better psychological outcomes in adults with diabetes.

Correlates of psychological outcomes among family members of people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To conduct a second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study, examining the experiences of family members caring for adults with diabetes in order to identify correlates of family member psychological outcomes (generic psychological well-being, perceived quality of life, and diabetes-related burden, impact and distress). METHODS: A total of 2057 family members living with a person with diabetes and involved in their care participated in an online, telephone or in-person survey. Samples of 120 respondents were recruited in each of 17 countries. Significant (P < 0.05) correlates of psychological outcomes were identified by multi-level multiple regression. RESULTS: Outcomes were worse for family members not working because of diabetes or those who had other competing obligations. Outcomes were worse if the person with diabetes was not a partner or parent, used injected diabetes medication, or had more frequent hypoglycaemia. Outcomes were worse for family members who believed that diabetes was more severe, were more involved in diabetes care, had more conflict over diabetes care or were frustrated about not knowing how to help the person with diabetes. Outcomes were better for those who had greater support from others and felt they found good ways to help the person with diabetes. There were significant differences in outcomes among countries before and after adjustment for individual characteristics, and correlates of outcomes varied by country. CONCLUSIONS: Several modifiable risk and protective factors for family member psychological outcomes were identified in this study. Diabetes education and social support were associated with improved outcomes, especially if they were helpful in supporting people with diabetes.

Correlates of psychological care strategies for people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To assess the ways in which healthcare professionals address psychological problems of adults with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study. METHODS: Approximately 120 primary care physicians, 80 diabetes specialists and 80 nurses and dietitians providing diabetes care participated in each of 17 countries (N=4785). Multiple regression analyses were used to evaluate independent statistically significant associations of respondent attributes concerning psychological care strategies, including assessment of diabetes impact on the patient's life, assessment of depression, provision of psychological assessment and support, and coordination with mental health professionals. RESULTS: Psychological care strategies were positively associated with each other but differed by healthcare practice site and discipline; nurses and dietitians were less likely to assess depression than other healthcare professionals, while primary care physicians were less likely to coordinate with mental health specialists or ask patients how diabetes affects their lives. Psychological care was positively associated with healthcare professionals' beliefs that patients need help dealing with emotional issues and that clinical success depends on doing so, and also with level of psychological care training, multidisciplinary team membership and availability of resources for psychological care. There were significant between-country variations in psychological care strategies, before and after adjustment for individual-level factors, and significant country-by-covariate interactions for almost all individual-level factors investigated. CONCLUSIONS: Improvements in training and resources, recognition and assessment of psychological problems, and increased belief in the efficacy of psychological support may enhance healthcare professionals' efforts to address psychological problems in adults with diabetes.

Self-reported diabetes self-management competence and support from healthcare providers in achieving autonomy are negatively associated with diabetes distress in adults with Type 1 diabetes.

AIM: To investigate the associations of self-perceived competence in diabetes management and autonomy support from healthcare providers with diabetes distress in adults with Type 1 diabetes mellitus that is not optimally controlled [HbA(1c) ≥ 64 mmol/mol (8.0%)]. METHODS: This cross-sectional study comprised blood sampling and three self-report questionnaires, the Problem Areas in Diabetes scale, the Perceived Competence in Diabetes Scale and a measure of autonomy support by healthcare providers, the Health Care Climate Questionnaire. We fitted blockwise linear regression models to assess the associations between Problem Areas in Diabetes score and the variables of interest (autonomy support and perceived diabetes competence), controlling for clinical and sociodemographic variables. RESULTS: Of the study sample [n = 178; mean age 36.7 (±10.7) years], 31.5% had long-term complications and 43.2% reported elevated (≥40) Problem Areas in Diabetes scores. A significant negative association was found between autonomy support and Problem Areas in Diabetes score (B = -3.61, P = 0.001), indicating that lower autonomy support was associated with greater diabetes distress. When perceived competence was controlled, it mediated the association of autonomy support with diabetes distress, reducing it to non-significance. There was a significant negative association between perceived competence and Problem Areas in Diabetes score (B = -8.89, P < 0.001), indicating that lower perceived competence was associated with greater perceived distress. CONCLUSIONS: There was an indirect (fully mediated) relationship between autonomy support and diabetes distress; autonomy support was associated with increased perceived competence, which, in turn, was associated with reduced distress. Healthcare providers' communication styles enhancing perceived competence through autonomy support may contribute to effective treatment for people with Type 1 diabetes and suboptimum glycaemic control.

Longitudinal relationship between diabetes-specific emotional distress and follow-up HbA1c in adults with Type 1 diabetes mellitus.

AIM: To examine whether diabetes-specific emotional distress was related to follow-up glycaemic control in adults with Type 1 diabetes mellitus. METHODS: Adults with Type 1 diabetes mellitus completed the Diabetes Distress Scale and reported sociodemographic information when attending a clinical consultation at a university endocrinology unit. Blood samples to determine baseline HbA1c were taken during consultations. All respondents' HbA1c measurements registered from January 2009 to December 2011 were collected from medical records. The relationship between baseline diabetes-specific emotional distress and HbA1c was examined with linear mixed-effects models in 175 patients with complete data. RESULTS: After controlling for confounders, baseline diabetes-specific emotional distress and glycaemic control were significantly associated (fixed-effect coefficient 0.40, P < 0.001) and the regimen-related distress subscale had the strongest association with glycaemic control (fixed-effect coefficient 0.47, P < 0.001). The two-item measure of diabetes-specific distress had a weaker but still significant association with glycaemic control (fixed-effect coefficient 0.31, P < 0.001). None of these relationships was significant after adjusting for the baseline HbA1c . CONCLUSIONS: People with elevated baseline diabetes-specific emotional distress are at risk of prolonged suboptimum glycaemic control; therefore, elevated diabetes-specific emotional distress, especially regimen-related distress, might be an important marker for prolonged suboptimum glycaemic control, and might indicate a need for special attention regarding patient self-management.

Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form.

AIMS: To develop and validate a short form of the 54-item Diabetes Medication System Rating Questionnaire that maintains the domains and performance characteristics of the long-form questionnaire. METHODS: Data from the Diabetes Medication System Rating Questionnaire validation study were analysed to select items representing the nine scales (convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference). The resulting 20-item Diabetes Medication System Rating Questionnaire Short-Form was administered online, with validated criterion measures of treatment satisfaction and medication adherence, with a retest within 2 weeks. Participants were US adults (N = 413) with Type 2 diabetes using oral agents alone; insulin by syringe and/or pen with or without oral agents; or glucagon-like peptide-1 agents. Most participants (82%) completed the retest. RESULTS: The median inter-item agreement of scales was 0.76 and the total composite (mean of all items except treatment preference) was 0.88. The median test-retest reliability of scales was 0.86, and of the total composite was 0.95. All statistically significant correlations between Diabetes Medication System Rating Questionnaire Short-Form scales and criterion measures of treatment satisfaction and adherence were in the expected direction. The median correlation of the Diabetes Medication System Rating Questionnaire Short-Form with corresponding criterion measures of treatment satisfaction was 0.59; the mean correlation of the same Diabetes Medication System Rating Questionnaire Short-Form measures with adherence was 0.42. The Diabetes Medication System Rating Questionnaire Short-Form scales were more powerful predictors of adherence than were the criterion measures of treatment satisfaction. The Diabetes Medication System Rating Questionnaire Short-Form scales differentiated between those taking different medications and between those using different insulin delivery devices. CONCLUSIONS: This study suggests that the Diabetes Medication System Rating Questionnaire Short-Form provides a comprehensive set of measures with acceptable reliability and validity and a reduced burden of administration.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national comparisons on barriers and resources for optimal care--healthcare professional perspective.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study sought cross-national comparisons of perceptions on healthcare provision for benchmarking and sharing of clinical practices to improve diabetes care. METHODS: In total, 4785 healthcare professionals caring for people with diabetes across 17 countries participated in an online survey designed to assess diabetes healthcare provision, self-management and training. RESULTS: Between 61.4 and 92.9% of healthcare professionals felt that people with diabetes needed to improve various self-management activities; glucose monitoring (range, 29.3-92.1%) had the biggest country difference, with a between-country variance of 20%. The need for a major improvement in diabetes self-management education was reported by 60% (26.4-81.4%) of healthcare professionals, with a 12% between-country variance. Provision of diabetes services differed among countries, with many healthcare professionals indicating that major improvements were needed across a range of areas, including healthcare organization [30.6% (7.4-67.1%)], resources for diabetes prevention [78.8% (60.4-90.5%)], earlier diagnosis and treatment [67.9% (45.0-85.5%)], communication between team members and people with diabetes [56.1% (22.3-85.4%)], specialist nurse availability [63.8% (27.9-90.7%)] and psychological support [62.7% (40.6-79.6%)]. In some countries, up to one third of healthcare professionals reported not having received any formal diabetes training. Societal discrimination against people with diabetes was reported by 32.8% (11.4-79.6%) of participants. CONCLUSIONS: This survey has highlighted concerns of healthcare professionals relating to diabetes healthcare provision, self-management and training. Identifying between-country differences in several areas will allow benchmarking and sharing of clinical practices.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking indicators for family members living with people with diabetes.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study examined the experiences of family members of people with diabetes for benchmarking and identifying unmet needs or areas for improvement to assist family members and those with diabetes to effectively self-manage. METHODS: In total, 2057 family members of people with diabetes participated in an online, telephone or in-person survey designed to assess the impact of diabetes on family life, family support for people with diabetes and educational and community support. RESULTS: Supporting a relative with diabetes was perceived as a burden by 35.3% (range across countries 10.6-61.7%) of respondents. Over half of respondents [51.4% (22.5-76.0%)] rated their quality of life as 'good' or 'very good'. However, distress about the person with diabetes was high, with 61.3% (31.5-86.4%) worried about hypoglycaemia. The impact of diabetes on aspects of life was felt by 51.8% (46.9-58.6%). The greatest negative effect was on emotional well-being [44.6% (31.8-63.0%)], although depression was less common [11.6% (4.2-20.0%)]. Many respondents did not know how to help the person with diabetes [37.1% (17.5-53.0%)] and wanted to be more involved in their care [39.4% (15.5-61.7%)]. Participation in diabetes educational programmes was low [23.1% (9.4-43.3%)], although most of those who participated found them helpful [72.1% (42.1-90.3%)]. CONCLUSIONS: Diabetes has a negative impact on family members of people with diabetes. DAWN2 provides benchmarking indicators of family members' psychosocial needs that will help identify the support required for, and from, them to improve the lives of people with diabetes and their families.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study aimed to assess psychosocial outcomes in people with diabetes across countries for benchmarking. METHODS: Surveys included new and adapted questions from validated questionnaires that assess health-related quality of life, self-management, attitudes/beliefs, social support and priorities for improving diabetes care. Questionnaires were conducted online, by telephone or in person. RESULTS: Participants were 8596 adults with diabetes across 17 countries. There were significant between-country differences for all benchmarking indicators; no one country's outcomes were consistently better or worse than others. The proportion with likely depression [WHO-5 Well-Being Index (WHO-5) score ≤ 28] was 13.8% (country range 6.5-24.1%). Diabetes-related distress [Problem Areas in Diabetes Scale 5 (PAID-5) score ≥ 40] was reported by 44.6% of participants (17.2-67.6%). Overall quality of life was rated 'poor' or 'very poor' by 12.2% of participants (7.6-26.1%). Diabetes had a negative impact on all aspects investigated, ranging from 20.5% on relationship with family/friends to 62.2% on physical health. Approximately 40% of participants (18.6-64.9%) reported that their medication interfered with their ability to live a normal life. The availability of person-centred chronic illness care and support for active involvement was rated as low. Following self-care advice for medication and diet was most common, and least common for glucose monitoring and foot examination, with marked country variation. Only 48.8% of respondents had participated in diabetes educational programmes/activities to help manage their diabetes. CONCLUSIONS: Cross-national benchmarking using psychometrically validated indicators can help identify areas for improvement and best practices to drive changes that improve outcomes for people with diabetes.

Treatment satisfaction in the sensor-augmented pump therapy for A1C reduction 3 (STAR 3) trial.

AIM: To identify insulin delivery system perceptions that contributed to improvements in overall satisfaction with insulin therapy (treatment satisfaction) that were larger in those using sensor-augmented pump therapy than those using multiple daily injections with self monitoring of blood glucose. METHODS: The Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3), a randomized 12-month clinical trial, compared sensor-augmented pump therapy to multiple daily injections + self monitoring of blood glucose in adult and paediatric patients. The Insulin Delivery System Rating Questionnaire measured perceptions of convenience, problems, interference with daily activities, blood glucose monitoring burden, social burden, clinical efficacy, diabetes worries and psychological well-being, as well as treatment satisfaction. We conducted separate multiple regression analyses for the 334 adult patients and 147 paediatric patients and their caregivers to assess the independent associations (P < 0.05) between change from baseline to follow-up in user perceptions and treatment satisfaction. RESULTS: Increased convenience was associated with improved treatment satisfaction in all user groups. Reduced interference with daily activities (caregivers), reduced social burden (adults) and increased efficacy (both) also were associated with improved treatment satisfaction. CONCLUSIONS: Treatment satisfaction among children was primarily a function of convenience, while perceived clinical efficacy was also a primary determinant among adults, reflecting different emphases on the treatment process itself vs. treatment consequences. Among adult patients and caregivers, improved treatment satisfaction was also a function of reductions in social burden and interference with daily activities (respectively), reflecting concern with the broader psychosocial impact of sensor-augmented pump therapy on their lives.

Patient-reported outcomes in the practice-based opportunities for weight reduction (POWER) trial.

PURPOSE: To evaluate effects of two behavioral weight-loss interventions (in-person, remote) on health-related quality of life (HRQOL) compared to a control intervention. METHODS: Four hundred and fifty-one obese US adults with at least one cardiovascular risk factor completed five measures of HRQOL and depression: MOS SF-12 physical component summary (PCS) and mental component summary; EuroQoL-5 dimensions single index and visual analog scale; PHQ-8 depression symptoms; and PSQI sleep quality scores at baseline and 6 and 24 months after randomization. Change in each outcome was analyzed using outcome-specific mixed-effects models controlling for participant demographic characteristics. RESULTS: PCS-12 scores over 24 months improved more among participants in the in-person active intervention arm than among control arm participants (P < 0.05, ES = 0.21); there were no other statistically significant treatment arm differences in HRQOL change. Greater weight loss was associated with improvements in most outcomes (P < 0.05 to < 0.0001). CONCLUSIONS: Participants in the in-person active intervention improved more in physical function HRQOL than participants in the control arm did. Greater weight loss during the study was associated with greater improvement in all PRO except for sleep quality, suggesting that weight loss is a key factor in improving HRQOL.

Factors associated with injection omission/non-adherence in the Global Attitudes of Patients and Physicians in Insulin Therapy study.

AIM: To examine factors associated with insulin injection omission/non-adherence on a global basis. METHODS: Telephone survey of 1530 insulin-treated adults with self-reported diabetes (110 type 1 and 1420 type 2) in China, France, Japan, Germany, Spain, Turkey, UK or USA. Participants had a mean age of ∼60 years, ∼15 years duration of diabetes and ∼9 years duration of insulin treatment. Regression analysis assessed the independent associations (p < 0.05) of country, participant characteristics and treatment-related beliefs/perceptions with number of days in the past month that an insulin injection was missed or not taken as prescribed. RESULTS: One third (35%) of respondents reported one or more days (mean: ∼3 days) of insulin omission/non-adherence. Insulin omission/non-adherence differed widely across countries (range = 20-44%); differences in days of insulin omission/non-adherence were maintained after adjustment for other risk factors. Most risk factors had similar relationships with insulin omission/non-adherence across countries (few interactions with country). Insulin omission/non-adherence was more frequent among respondents who were male, younger, had type 2 diabetes or more frequent hypoglycaemia, were less successful with other treatment tasks, regarded insulin adherence as less important, had more practical/logistical barriers and difficulties with insulin adherence, were concerned that insulin treatment required lifestyle changes or were dissatisfied with the flexibility of injection timing. CONCLUSIONS: The results of this large-scale study suggest that insulin omission/non-adherence is common and associated with several modifiable risk factors (including practical barriers, injection difficulties, lifestyle burden and regimen inflexibility). Additional efforts to address these risk factors might reduce the frequency of insulin omission/non-adherence and lead to improved clinical outcomes.