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Background: The Impact of Weight on Self-Perceptions Questionnaire (IW-SP) assesses an individual's self-perception related to his or her weight. The primary objective of this study was to provide evidence of the reliability, validity, and responsiveness of the IW-SP., Materials and Methods: Study participants were individuals with type 2 diabetes mellitus (T2DM) and obesity enrolled in clinical weight-loss programs in the United States. Data were obtained for clinical measures, IW-SP, and other patient-reported outcome measures. An intraclass correlation coefficient (ICC) and Cronbach's α were calculated for test-retest reliability and internal consistency, respectively. For validity, correlations and t tests were performed. For responsiveness, baseline and 6-month data for a subgroup of patients were analyzed using the paired t test and calculation of effect size (ES)., Results: Reliability data for 106 study participants (mean age, 52 years; 69% female; 31% white; mean body mass index, 38 kg/m(2)) yielded an ICC of 0.85 and Cronbach's α values of >0.89. IW-SP scores were associated with obesity-related quality of life, mental health, and vitality (r>0.50, P<0.001). In the subgroup (n=40) used to estimate responsiveness, weight was significantly less at end point than at baseline (mean, baseline=231.9 vs. end point=222.0 pounds; P<0.001; ES=0.23), and IW-SP scores were significantly better than at baseline (mean, baseline=61.0 vs. end point=72.1 [on a scale of 0-100]; P=0.01; ES=0.34). Mean IW-SP change scores significantly discriminated between those achieving >5% body weight loss and those who achieved <5% (mean change, 23.6 vs. 5.7; P=0.03)., Conclusions: The IW-SP has demonstrated reliability, validity, and responsiveness in individuals with T2DM and obesity, thereby making it a potentially valuable tool in the evaluation of weight-loss interventions targeted toward patients with T2DM.

Background: The Ability to Perform Physical Activities of Daily Living Questionnaire (APPADL) measures the self-reported ability of individuals with type 2 diabetes mellitus (T2DM) and obesity to perform daily physical activities. The primary objective of this study was to estimate APPADL test-retest reliability, responsiveness, and minimal important change (MIC)., Subjects and Methods: Study participants were individuals with T2DM and body mass index ≥30 kg/m(2) enrolled in clinical weight loss programs in the United States. Data were obtained for clinical measures, APPADL, and other patient-reported instruments. APPADL test-retest reliability was estimated with intraclass correlation coefficient. To estimate responsiveness in a subgroup of participants, baseline and 6-month data were analyzed using paired t test and calculation of responsiveness indices (e.g., effect size [ES]). To estimate MIC, both distribution-based and anchor-based methods were used., Results: Test-retest data for 106 study participants (mean age, 52 years; 69% female; 31% white; mean body mass index, 38 kg/m(2)) yielded an intraclass correlation coefficient of 0.91. In the subgroup (n = 40) used to estimate responsiveness, weight was significantly less at end point than at baseline (mean, 222.0 vs. 231.9 pounds; P < 0.001, ES = 0.24), and APPADL scores were significantly better than at baseline (mean, 77.0 vs. 70.8; P = 0.01, ES = 0.32). Results of distribution- and anchor-based methods to establish MIC suggest values of 6-14 points (0-100 scale)., Conclusions: The APPADL has demonstrated reliability and validity. In addition, it has demonstrated responsiveness to weight loss in individuals with T2DM and obesity, thereby making it a potentially valuable tool in the evaluation of weight loss interventions (e.g., antihyperglycemic medications that produce weight loss) targeted toward patients with T2DM.

Background: The aims of this study were (1) to demonstrate the reliability and validity of the Impact of Weight on Activities of Daily Living Questionnaire (IWADL), a measure of ability to perform daily physical activities, in individuals with type 2 diabetes who are moderately obese and (2) to characterize those individuals with low self-reported ability., Methods: Data from a web-based survey of individuals with type 2 diabetes and body mass index (BMI) of 30-40 k/mg(2) were used to calculate Cronbach's α and demonstrate both IWADL factorial and construct validity. These data were entered into a multivariable multinomial logistic regression model with survey variables (demographics, health status, weight- and diabetes-related) as the independent variables and three IWADL scoring groups (Low, Medium, and High) as the dependent variables., Results: Study participants were 349 individuals with type 2 diabetes (mean age = 59 years, 44% male, 91% white, mean BMI = 35 k/mg(2)). Factor analysis indicated a one-factor solution for a seven-item IWADL with Cronbach's α = 0.94. Significant (P < 0.05) relationships were identified between IWADL and variables previously shown to be related to level of physical activity. Ten variables remained independently (P < 0.05) related to IWADL scores, including age, gender, health status, current exercise, using exercise programs or hypnosis as a step to lose weight, and self-reported weight history., Conclusions: The IWADL is a reliable and valid measure of the ability of individuals with type 2 diabetes and moderate obesity to perform daily physical activities. This ability may be an important patient-reported end point to include in clinical trials of antihyperglycemic medications that produce weight loss.

Background: This study explored relationships among pretreatment expectations, treatment perceptions, expectation-perception difference, change in diabetes treatment satisfaction, and end point diabetes treatment satisfaction in individuals with type 2 diabetes., Methods: Multivariate models were used to evaluate clinical and patient-reported outcomes (PRO) data from a randomized clinical trial comparing treatment algorithms for an inhaled insulin. PRO measures--Diabetes Symptom Checklist-Revised subscales, Well-Being Questionnaire 12, Diabetes Treatment Satisfaction Questionnaire, and Self-Efficacy Scale--were administered at baseline and end point. Expectations about Insulin Therapy (EITQ) and Perceptions of Insulin Therapy Questionnaires (PITQ) were administered at baseline and end point, respectively. Change scores for hemoglobin A1C (A1C), PRO (i.e., during-trial effects), and expectation-perception change were calculated. Perceptions, expectation-perception difference, and change in and end point treatment satisfaction served as dependent variables for statistical models., Results: Complete EITQ and PITQ data were available for 240 insulin-naive individuals with type 2 diabetes (mean age, 58 years; 61% male; 78% white; mean baseline A1C, 8.4%). Treatment perceptions were significantly (P < 0.01) more positive than expectations. After controlling for baseline patient assessments and during-trial effects, regression analyses showed that pretreatment expectations independently contributed to perceptions (beta = 0.18, P = 0.001) and expectation-perception change (beta = -0.71, P < 0.001). Acting as a suppressor variable, pretreatment expectations enhanced the ability of expectation-perception difference to predict both change in (beta = 0.39, P < 0.001) and end point (beta = 0.57, P < 0.001) diabetes treatment satisfaction., Conclusions: Pretreatment expectations and expectation-perception difference play an important role in the amount of change that occurs in satisfaction with new treatment as compared to that of previous treatment, as well as satisfaction with new treatment.

Background: Patients with type 2 diabetes often initiate insulin with once-daily basal insulin. Over time, many patients intensify their insulin regimens in an attempt to attain and sustain glycemic targets. This study compares three intensification approaches: changing insulin glargine to preprandial AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.), intensifying glargine via validated titration algorithms (IG), or adding AIR insulin while intensifying glargine (AIR + IG)., Methods: Five hundred sixty patients with hemoglobin A(1c) (A1C) of 7.5-10.5%, on one or more antihyperglycemic medications, and on once-daily insulin glargine for > or =4 months were randomly allocated to one of the three treatments lasting 52 weeks. The primary objective assessed between-group differences in A1C mean change from baseline to 24 weeks using last-observation-carried-forward (LOCF) in the intent-to-treat population., Results: At 24 weeks, A1C was reduced from a mean baseline of 8.5% to 7.7%, 7.9%, and 7.5% for the AIR, IG, and AIR + IG groups, respectively. AIR produced 0.20% greater A1C decrease than IG (least-squares mean difference = -0.20%; 95% confidence interval [CI], -0.39, -0.02). AIR + IG had a 0.35% greater A1C decrease versus IG (95% CI, -0.57, -0.13). The -0.15% difference between AIR + IG versus AIR was not significant (P < 0.198). More hypoglycemia categorized as severe occurred with AIR alone versus IG alone at LOCF end points. More nocturnal hypoglycemia occurred with IG alone versus AIR alone and AIR + IG., Conclusions: Preprandial inhaled insulin provides an alternative for patients not optimized on insulin glargine alone. Glycemic control, hypoglycemic risk, delivery preference, and regimen complexity must be considered when selecting insulin initiation and optimization regimens.

Background: In the concordance model, physician and patient discuss treatment options, explore the impact of treatment decisions from the patient's perspective, and make treatment choices together. We tested, in a concordance setting, whether the availability of AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.), as compared with existing treatment options alone, leads to greater initiation and maintenance of insulin therapy and improves glycemic control in patients with type 2 diabetes., Methods: This was a 9-month, multicenter, parallel, open-label study in adult, nonsmoking patients with diabetes not optimally controlled by two or more oral antihyperglycemic medications. Patients were randomized to the Standard Options group (n = 516), in which patients chose a regimen from drugs in each major treatment class excluding inhaled insulin, or the Standard Options + AIR insulin group (n = 505), in which patients had the same choices plus AIR insulin. The primary end points were the proportion of patients in each group using insulin at end point and change in hemoglobin A1C (A1C) from baseline to end point., Results: At end point, 53% of patients in the Standard Options group and 59% in the Standard Options + AIR insulin group were using insulin (P = 0.07). Both groups reduced A1C by about 1.2% and reported increased well-being and treatment satisfaction. The most common adverse event with AIR insulin was transient cough., Conclusions: The opportunity to choose AIR insulin did not affect overall use of insulin at end point or A1C outcomes. Regardless of group assignment, utilizing a shared decision-making approach to treatment choices (concordance model), resulted in improved treatment satisfaction and A1C values at end point. Therefore, increasing patient involvement in treatment decisions may improve outcomes.

Background: This study identifies factors that influence satisfaction with an insulin delivery system (IDS). Knowledge of such factors could help identify individuals who would benefit from innovative IDS., Methods: Individuals with type 2 diabetes who use insulin, recruited from a general and chronic illness panel, participated in a web-based survey that included questions about demographics, self-reported diagnoses and hemoglobin A1c (HbA1c), current IDS used, insulin therapy attitudes, current IDS features, and satisfaction with IDS. Univariate analyses identified variables associated with IDS satisfaction (P < 0.05); those variables were entered into stepwise linear regression analyses with IDS satisfaction as the dependent variable., Results: Six hundred sixty-seven individuals with type 2 diabetes participated (mean age, 57 years; 52% female; 88% Caucasian; 73% vial/syringe users, 27% insulin pen users). IDS satisfaction was associated (P < 0.05) with gender, health status, HbA1c, self-reported comorbidity, insulin therapy attitudes, IDS type, and evaluation of IDS features. Among individuals who reported their HbA1c (n = 438), the best predictors of IDS satisfaction were perceived effectiveness and value of insulin therapy, evaluation of IDS activity interference, and commitment to insulin therapy (R2 = 0.49, P < 0.001). Among all participants (n = 667), a second regression analysis that employed a variable representing report of HbA1c found the best predictors of IDS satisfaction included those in the first analysis with the addition of gender, report of HbA1c, and evaluation of IDS ease of use. These variables provided additional variance (R2 = 0.56, P < 0.001)., Conclusions: In people with type 2 diabetes, positive perceptions and attitudes about insulin therapy have greater influence than the type of IDS used on IDS satisfaction.

Background: Inhaled insulin may provide patients with diabetes a safe, efficacious method of insulin delivery without the burden of injection, but complexity of and time required for training in proper use of delivery systems have not been evaluated., Methods: This 4-week, multicenter, single-blind, randomized parallel-group study compared the effect of self-directed [written text-graphic directions for use (DFU) with patient-assistance phone number] or intensive (same DFU, personal training by study personnel, inspiratory flow rate coaching) training for the Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system on patient-reported outcomes (PROs). Patients with type 2 diabetes poorly controlled on oral therapy (n = 102, mean hemoglobin A1C = 9.3%) were administered measures of vitality, diabetes-associated symptoms, fear of hypoglycemia, insulin-delivery system satisfaction, and a delivery system-specific evaluation questionnaire. Analysis of covariance models were used to compare the effect on PROs of treatment of diabetes for 1 month following the two training methods. Paired t tests were used to determine change in PROs after treatment with HIIP., Results: PROs did not differ significantly between training groups. Patients in both groups positively evaluated the delivery system, but the intensive group agreed significantly (P < 0.05) more strongly that the DFU was easy to follow. Improvements in vitality and symptoms of fatigue and increases in fear of hypoglycemia were detected among all patients after using HIIP (P < 0.05)., Conclusion: Training for this HIIP delivery system can be self-directed without detrimental effects on PROs, making it potentially a more patient-friendly insulin-delivery method that should appeal to both clinicians and patients.

Background: This study was designed to develop and validate a patient-reported outcomes measure, sensitive to the different features of diabetic neuropathy (DN)-small fiber, large fiber, and autonomic nerve function., Methods: The review of 1,000 structured patient interviews guided the development of 28 items pertaining specifically to the symptoms and impact of large fiber, small fiber, and autonomic nerve function. These items, in addition to 14 generic health status items and five general information items formed the 47-item Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (QOL-DN). Items were grouped according to small fiber, large fiber, and autonomic nerve function, symptoms, and activities of daily living (ADL). Scores in individual domains were aggregated to provide a total score. Item groupings were tested for their ability to distinguish between the effects of specific nerve fiber deficits in 262 subjects-81 healthy controls (C), 86 controls with diabetes (DC), and 95 patients with DN-using one-way analysis of variance (ANOVA). Internal consistency was estimated using Cronbach's alpha coefficient. Test-retest reliability over a 4-6-week period was estimated by intra-class correlation coefficients and ANOVA on data of a subset of patients and controls., Results: Differences between DN subjects and both DC and C subjects were significant (P < 0.05) for all item groupings. Total quality of life (QOL) scores correlated with total neuropathy scores. The ADL, total QOL, and autonomic scores were greater in DC than C subjects (P < 0.05). Intra-class correlation coefficients were > 0.9 for most domains. Internal consistency of the fiberspecific domains using Cronbach's alpha was > 0.6 and up to 0.8., Conclusions: The fiber-specific domains of the QOL-DN demonstrated acceptable reliability and ability to discriminate between subjects with and without neuropathy. Not surprisingly, the DN group scored significantly (P < 0.05) higher than either of the two control groups (i.e., greater impairment). The positive scores for the DC group in the ADL and autonomic domains suggest that diabetes per se impacts these aspects of QOL.