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.

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.

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.

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.

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.

Proceedings of the 5th International DAWN Summit 2014: Acting together to make person-centred diabetes care a reality.

Almost 250 stakeholders from across the world, representing all aspects of diabetes, attended the 5th International DAWN Summit. The summit focussed on the issues raised by the recently published DAWN2 study, placing particular emphasis on promoting the concept of person-centred diabetes care. Discussions between the delegates took place throughout a variety of sessions, with presentations, interactive exchanges and workshops providing a platform for clarification of common global priorities and opportunities for joint action. Following the summit, these ideas were developed further, leading to the creation of a Global Action Framework. The framework aims to support the ongoing local implementation of change in response to the DAWN2 results, while helping enable person-centred diabetes care to become a reality at all levels.

Personal accounts of the negative and adaptive psychosocial experiences of people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2) study.

OBJECTIVE: To identify the psychosocial experiences of diabetes, including negative accounts of diabetes and adaptive ways of coping from the perspective of the person with diabetes. RESEARCH DESIGN AND METHODS: Participants were 8,596 adults (1,368 with type 1 diabetes and 7,228 with type 2 diabetes) in the second Diabetes Attitudes, Wishes and Needs (DAWN2) study. Qualitative data were responses to open-ended survey questions about successes, challenges, and wishes for improvement in living with diabetes and about impactful experiences. Emergent coding developed with multinational collaborators identified thematic content about psychosocial aspects. The κ measure of interrater reliability was 0.72. RESULTS: Analysis identified two negative psychosocial themes: 1) anxiety/fear, worry about hypoglycemia and complications of diabetes, depression, and negative moods/hopelessness and 2) discrimination at work and public misunderstanding about diabetes. Two psychosocial themes demonstrated adaptive ways of coping with diabetes: 1) having a positive outlook and sense of resilience in the midst of having diabetes and 2) receiving psychosocial support through caring and compassionate family, friends, health care professionals, and other people with diabetes. CONCLUSIONS: The personal accounts give insight into the psychosocial experiences and coping strategies of people with diabetes and can inform efforts to meet those needs and capitalize on strengths.

Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

BACKGROUND: In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. METHODS/DESIGN: As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. DISCUSSION: In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

Diabetes Attitudes Wishes and Needs 2 (DAWN2): a multinational, multi-stakeholder study of psychosocial issues in diabetes and person-centred diabetes care.

AIMS: The Diabetes Attitudes Wishes and Needs 2 (DAWN2) study aims to provide a holistic assessment of diabetes care and management among people with diabetes (PWD), family members (FM), and healthcare professionals (HCPs) and explores potential drivers leading to active management. METHODS: DAWN2 survey over 16,000 individuals (∼9000 PWD, ∼2000 FM of PWD, and ∼5000 HCPs) in 17 countries across 4 continents. Respondents complete a group-specific questionnaire; items are designed to allow cross-group comparisons on common topics. The questionnaires comprise elements from the original DAWN study (2001), as well as psychometrically validated instruments and novel questions developed for this study to assess self-management, attitudes/beliefs, disease impact/burden, psychosocial distress, health-related quality of life, healthcare provision/receipt, social support and priorities for improvement in the future. The questionnaires are completed predominantly online or by telephone interview, supplemented by face-to-face interviews in countries with low internet access. In each country, recruitment ensures representation of the diabetes population in terms of geographical distribution, age, gender, education and disease status. DISCUSSION: DAWN2 aims to build on the original DAWN study to identify new avenues for improving diabetes care. This paper describes the study rationale, goals and methodology.

Monitoring of Individual Needs in Diabetes (MIND)-2: follow-up data from the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) MIND study.

OBJECTIVE: To test the effects of implementing computer-assisted Monitoring of Individual Needs in Diabetes (MIND) in routine diabetes care on psychological status and glycemic control, identify predictors of poor psychological outcomes, and evaluate care providers' experiences. RESEARCH DESIGN AND METHODS: The MIND procedure was implemented as part of the annual review in diabetes clinics across eight countries in a prospective observational study with a 1-year follow-up. MIND encompasses well-being (World Health Organization Five Well-Being Index [WHO-5]), diabetes-related distress (Problem Areas in Diabetes [PAID]), a Life Event Inventory, and the patient's agenda for their consultation. Medical data and agreed case-management actions were retrieved from the charts. RESULTS: Of the total 1,567 patients, 891 patients (57%) were monitored at a 1-year follow-up. Twenty-eight percent of the patients screened positive for depression and/or diabetes distress at baseline and considered cases, 17% of whom were receiving psychological care. Cases were significantly more often female and had type 2 diabetes and worse glycemic control compared with noncases. Clinically relevant improvements in WHO-5 and PAID were observed over time in cases, irrespective of referral (effects sizes 0.59 and 0.48, respectively; P < 0.0001). Glycemic control did not change. Female sex, life events, and concomitant chronic diseases were predictors of poor psychological outcomes. MIND was well received by patients and staff. CONCLUSIONS: MIND appears suitable for screening and discussion of emotional distress as part of the annual review. Broader dissemination in diabetes care is recommendable, but sustainability will depend on reimbursement and availability of support services.

Monitoring of Individual Needs in Diabetes (MIND): baseline data from the Cross-National Diabetes Attitudes, Wishes, and Needs (DAWN) MIND study.

OBJECTIVE: To test the feasibility and impact of implementing the computer-assisted Monitoring of Individual Needs in Diabetes (MIND) procedure, which is aimed at improving recognition and management of the psychological needs of diabetic patients in routine care. RESEARCH DESIGN AND METHODS: The MIND study was implemented in diabetes clinics across eight countries as part of the annual review. The computerized assessment covered emotional well-being (World Health Organization 5 Well-Being Index), diabetes-related distress (Problem Areas in Diabetes), life events, and the patient's agenda. Medical data were retrieved from the charts, and agreed-upon actions were recorded. RESULTS: Of 1,567 patients monitored using the MIND, 24.9% had either likely depression or high diabetes-related distress; 5.4% had both. Over 80% of these patients were newly identified cases, and 41% of patients with depression were referred to a mental health professional. CONCLUSIONS: Monitoring of well-being and diabetes-related distress as part of routine diabetes care is feasible and helps to identify and discuss unmet psychosocial needs.

Barriers towards insulin therapy in type 2 diabetic patients: results of an observational longitudinal study.

BACKGROUND: The course of barriers towards insulin therapy was analysed in three different groups of type 2 diabetic patients. This observational longitudinal study surveyed a three-month follow-up. METHODS: Participants in this study totalled 130 type 2 diabetic patients. The first subgroup was on insulin therapy at baseline (group 1: n = 57, age 55.6 ± 8.7 yrs, disease duration 12.7 ± 7.2 yrs, HbA1c 8.5 ± 1.6%) and remained on insulin at follow-up. Of an initial 73 insulin-naïve patients, 44 were switched to insulin therapy (group 2: age 58.1 ± 6.8 yrs, disease duration 7.7 ± 5.0 yrs, HbA1c 9.1 ± 1.7%) and 29 patients remained on an oral regimen (group 3: age 52.7 ± 10.7 yrs, disease duration 5.3 ± 4.6 yrs, HbA1c 8.3 ± 1.4%). Barriers towards insulin therapy were measured using the Insulin Treatment Appraisal Scale (ITAS). As generic instruments of health related quality of life patients completed also the Problem Areas of Diabetes Questionnaire (PAID), the WHO-5 Well-Being Scale (WHO-5), the Centre for Epidemiologic Studies Depression Scale (CES-D) and the Trait Version of the State Trait Anxiety Inventory (STAI) at baseline and at three-month follow-up. RESULTS: At the three-month follow-up, HbA1c had improved in all three groups (7.7 ± 1.2% vs. 7.1 ± 1.1% vs. 6.7 ± 0.8%). The course of negative appraisal of insulin therapy was significantly different in the three groups (p > .003): the ITAS score increased in patients remained on oral antidiabetic drugs (51.2 ± 12.2 to 53.6 ± 12.3), whereas it decreased in patients switched to insulin therapy (49.2 ± 9.8 to 46.2 ± 9.9) or remained on insulin treatment (45.8 ± 8.3 to 44.5 ± 8.0). Diabetes-related distress, trait anxiety, and well-being, showed a similar course in all three groups. The depression score improved significantly in patients switched to insulin treatment compared with patients remaining on insulin therapy. CONCLUSIONS: In summary, this study suggests that a negative appraisal of insulin treatment is modifiable by the initiation of insulin therapy. This finding indicates that barriers to insulin are a rather temporary than a stable phenomenon.

Epidemiology and correlates of weight worry in the multinational Diabetes Attitudes, Wishes and Needs study.

OBJECTIVE: This study examined the epidemiology of worry about weight among adults with diabetes and whether this weight worry was associated with worse quality of life and diabetes self-management. RESEARCH DESIGN AND METHODS: Participants were 5088 adults with type 1 or type 2 diabetes from the multi-national DAWN study. Random samples of approximately 500 were obtained from each of 11 countries/regions in Asia, Australia, Europe, and North America. All measures were self-reported data obtained during structured interviews. High weight worry was represented by the highest level of agreement with the statement 'I feel very anxious about my weight.' RESULTS: One-quarter (25.1%) of respondents reported high weight worry. Using multivariate logistic regression to assess independent relationships, high weight worry was significantly (p < 0.05) more common among respondents who were women, less educated, had type 2 diabetes and more comorbidities, were diagnosed more recently and reported weight gain with diabetes. Using multivariate logistic regression to control for confounding factors, high weight worry was significantly (p < 0.05) associated with most of the adverse outcomes examined, including lower self-rated health, poorer reported regimen adherence and diabetes control, more diabetes-related distress, poorer psychological well-being, and more psychological treatment. LIMITATIONS: The cross-sectional, correlational analysis could not assess causal relationships among patient reported outcomes, and the study did not include objective outcome measures. CONCLUSIONS: High weight worry was common among adults with diabetes and associated with several adverse outcomes, including multiple indicators of diabetes-related distress, poor physical and psychological well-being, and regimen non-adherence. These findings suggest that healthcare providers should assess and address weight worry among their patients with diabetes.

Where is the patient in diabetes performance measures? The case for including patient-centered and self-management measures.

OBJECTIVE: Health policies are important determinants of clinician and patient behavior, and an important policy issue is what items are included in healthcare quality and performance measures. There is consensus that patient-centered care and self-management support are essential evidence-based components of good diabetes care. However, most major diabetes performance measures such as the National Committee for Quality Assurance (NCQA)/American Diabetes Association (ADA) Provider Recognition Program indexes have not included self-management or psychosocial items. RESEARCH DESIGN AND METHODS AND RESULTS: We review the case for and propose a set of patient-centered, self-management indicators to be included as a standard part of diabetes quality indicators. The proposed indicators include: patient self-management goal(s), measures of health behaviors (e.g., healthy eating, medication taking, physical activity, and smoking status), quality of life, and patient-centered collaborative care. We discuss the evidence and the concerns about patient-report measures and summarize successful incorporation of such patient-centered measures in other countries and by the American Association of Diabetes Educators (AADE). CONCLUSIONS: The adage that "what gets measured, gets done" applies to diabetes management and many other areas of healthcare. Inclusion of the proposed indicators in national diabetes performance measures would be consistent with Institute of Medicine (IOM), ADA, Centers for Disease Control (CDC), Diabetes Attitudes, Wishes, and Needs (DAWN), AADE, and Society of Behavioral Medicine (SBM) recommendations. Such action would enhance both the priority and delivery of quality, patient-centered care, and diabetes self-management support.

Development and validation of the insulin treatment appraisal scale (ITAS) in patients with type 2 diabetes.

BACKGROUND: Timely initiation of insulin therapy in type 2 diabetes is important to achieve metabolic control but can be hindered by negative perceptions of patients regarding insulin treatment. To assess the appraisal of insulin therapy of persons with type 2 diabetes, we developed the insulin treatment appraisal scale (ITAS) and tested its reliability and validity in insulin treated type 2 diabetes patients. METHODS: A sample of 282 patients with type 2 diabetes form the United States (US) completed the ITAS, the WHO-5 Well-being index (WHO-5) and the Problem Areas in Diabetes (PAID) Survey. Exploratory factor analysis (EFA), internal consistency (Cronbach's alpha) and item-total correlations were determined to test the reliability of the instrument. Concurrent validity was examined by calculating Pearson correlation coefficients between the different measures. Discriminant validity was examined by comparing ITAS scores of insulin naive and insulin using patients. RESULTS: EFA suggested a two-factor structure, separating positively worded and negatively worded items. Cronbach's alpha was 0.90 for the negative appraisal scale and 0.68 for the positive appraisal scale. Yet, Cronbach's alpha of the total 20-item scale was 0.89, suggesting high homogeneity and allowing for calculation of an overall score. Item-total correlations were in the range of 0.46-0.74 for the negative and 0.34 - 0.53 for the positive appraisal scale. The item pertaining to weight gain, as part of the negative appraisal subscale, showed low communality and deserves further testing. Concurrent validity was confirmed with low to moderate correlations in the expected direction between ITAS and WHO-5 and PAID. Discriminant validity was confirmed by the fact that patients using insulin had significantly less negative appraisals than insulin naive patients. CONCLUSION: The ITAS is a brief, psychometrically sound instrument that can be used in insulin naive and insulin-treated patients to assess positive and negative perceptions regarding insulin treatment and changes therein.

Parent and health professional perspectives in the management of adolescents with diabetes: development of assessment instruments for international studies.

OBJECTIVE: Assessment of quality of life (QOL) in adolescents with diabetes requires patient, parent and health professional input. Psychometrically robust instruments to assess parent and professional perspectives are required. RESEARCH DESIGN AND METHODS: Questionnaires concerning adolescent QOL were developed for completion by parents and health professionals. In an international study assessing QOL in 2,101 adolescents with diabetes (median age 14 years, range 10-18; from 17 countries including Europe, Japan and North America), parents and health professionals completed their respective questionnaires between March and August 1998. RESULTS: Feasibility and acceptability of the new questionnaires were indicated by high questionnaire completion rates (adolescents 92%; parents 89%; health professionals 94%). Internal consistency was confirmed (Cronbach's alpha coefficients 0.80 parent; 0.86 health professional). Correlations of Diabetes Quality of Life Questionnaire for Youths (DQOLY) scores with parent and health professional global QOL ratings were generally low (r ranging from 0.12 to 0.36). Parent-rated burden decreased incrementally across adolescence, particularly for girls. Professional-rated burden followed a similar profile but only after age 15 years. Until then, burden was rated as uniformly high. Clinically relevant discrepancies in parent and professional burden scores were noted for one-parent families and families where adolescents had been referred for psychological help. In both cases, health professionals but not one-parent families perceived these as high burden situations. The clinical significance of this relates to the significantly poorer metabolic control recorded for adolescents in both situations. CONCLUSIONS: Parent and health professional questionnaires were found to have adequate internal consistency, and convergent and discriminant validity in relation to key clinical and QOL outcomes. The questionnaires are brief, easy to administer and score. They may also enable comparisons across countries and languages to facilitate development of international health outcome parameters. The inclusion of the parent and health professional perspectives completes a comprehensive assessment of adolescent QOL relevant to diabetes.