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Objective: Nonsevere hypoglycemic events are common and may occur in one-third of persons with diabetes as often as several times a week. This study’s objective was to examine the economic burden of nonsevere nocturnal hypoglycemic events (NSNHEs). Methods: A 20minute Web-based survey, with items derived from the literature, expert input, and patient interviews, assessing the impact of NSNHEs was administered in nine countries to 18 years and older patients with self-reported diabetes having an NSNHE in the past month. Results: A total of 20,212 persons were screened, with 2,108 respondents meeting criteria and included in the analysis sample. The cost of lost work productivity per NSNHE was estimated to be between $10.21 (Germany) and $28.13 (the United Kingdom), representing 3.3 to 7.5 hours of lost work time per event. A reduction in work productivity (presenteeism) was also reported. Compared with respondents’ usual blood sugar monitoring practice, on average, 3.6 6.6 extra tests were conducted in the week following the event at a cost of approximately $87.1 per year. Additional costs were also incurred for doctor visits as well as medical care required because of falls or injuries incurred during the NSNHE for an annual cost of $2,111.3 per person per year. When taking into consideration the multiple impacts of NSNHEs for the total sample and the frequency that these events occur, the resulting total annual economic burden was $288,000 or $127 per person per event. Conclusions: NSNHEs have serious consequences for patients. Greater attention to treatments that reduce NSNHEs can have a major impact on reducing the economic burden of diabetes.

ObjectivesTo test the psychometric properties of the EUROHIS-QOL 8-item index, a shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version (WHOQOL-BREF).MethodsThe sample consisted of 2359 subjects identified from primary care settings, with 1193 having a confirmed diagnosis of depression. Data came from six countries (Australia, Brazil, Israel, Russia, Spain, and the United States) involved in a large international study, the Longitudinal Investigation of Depression Outcomes. The structure of the EUROHIS-QOL 8-item index follows that of the WHOQOL-BREF assessment. Internal consistency was measured by using Cronbach's alpha. Convergent validity was assessed by using correlations with different measures for mental health (Symptom Checklist 90), physical health (self-evaluation), and quality of life (WHOQOL-BREF and short form 36 health survey). Discriminant group validity was assessed between diagnosed depressed and nondepressed patients. Differential item functioning and unidimensionality were analyzed by using Rasch analysis. Factor structure was assessed with structural equation modeling analyses.ResultsInternal consistency was acceptable (ranged between 0.72 and 0.81 across countries), and the index discriminated well between depression (t = 6.31–20.33; P < 0.001) across all countries. Correlations between the EUROHIS-QOL 8-item index and different measures—Symptom Checklist 90 (r = −0.42), physical health (r = −0.42), WHOQOL-BREF domains (r = 0.61–0.77), and short form 36 health survey (r = 0.58)—were all significant (P < 0.001). The index is unidimensional with desired item fit statistics. Two items (“daily living activities” and “enough money to meet your needs”) had residuals exceeding 4. Differential item functioning was observed with general quality of life, general health, relationships, and home items for age. A common one-factor structure with acceptable fit was identified in three out of six countries (comparative fit index = 0.85, root mean square error of approximation = 0.11).ConclusionsThe EUROHIS-QOL 8-item index showed acceptable cross-cultural performance and a satisfactory discriminant validity and would be a useful measure to include in studies to assess treatment effectiveness.

Objectives To assess the comparability, reliability, and subject acceptability of electronic data capture (EDC) versions of Irritable Bowel Syndrome—Quality of Life (IBS-QOL), EuroQoL (EQ-5D) and Work Productivity and Activity Impairment (WPAI:IBS) instruments. Methods Comparability of EDC and paper questionnaires was evaluated in 72 subjects with IBS who completed a baseline EDC or paper questionnaire, a crossover questionnaire 24 hours later, and a retest of the crossover version at 1 week. The EDC version was presented on a hand-held device. Comparability was assessed using paired t -test statistics, intraclass correlation coefficients (ICC) and tests for internal consistency (Cronbach's alpha). Results No significant differences were found between scores obtained by paper questionnaire and EDC at the baseline and crossover assessments. ICCs between baseline and crossover assessments ranged from 0.83 to 0.96 for the IBS-QOL scores, 0.82 to 0.96 for the WPAI:IBS scores, and 0.77 to 0.82 for the EQ-5D. Internal consistency was comparable for the two data collection methods for the IBS-QOL overall score (0.96) and subscales and the EQ-5D Index (0.70 vs. 0.74). Retest statistics (ICC) were generally comparable between the EDC and paper versions for all scores. Ease of use was comparable for the two modes of administration, but more patients preferred EDC (47.2%) than the paper questionnaire (23.6%). Conclusions EDC versions of the IBS-QOL, EQ-5D, and WPAI:IBS are comparable to paper questionnaires in internal consistency and test–retest reliability, and have greater patient acceptability.

13.) I like to lean on my doctor when I feel sick 1 2 3 4 5 • After providing informed consent, participants were randomized to complete the PDHCO on either paper or computerized format at their first study visit. The alternate format was completed at the second study visit (24 hours later) and the one-week retest was completed from home (Figure 2). VALIDATION AND PSYCHOMETRIC EVALUATION OF A HEALTH CARE ORIENTATION ASSESSMENT

OBJECTIVES: Previous researchers (Ren, 1999) have used a 5-item shortened version of the Medical Outcomes Study Social Support Scale (MOS-SSS; Sherborne, 1991), but the measurement properties of this brief measure have not been established. We filled this gap by evaluating the psychometric properties of a 5-item perceived social support instrument (the SS-5) and testing equivalence between paper and web-based administration modes. METHODS: The SS-5 and other questionnaire measures were administered to a sample of adults recruited through newspaper and web-based advertisements in 8 U.S. cities. Participants were randomized to complete the SS-5 on either paper or computerized format followed by a one-week retest. The intraclass correlation coefficient (ICC) was calculated to assess reproducibility of the SS-5 and equivalence between administration modes. Cronbach’s alpha was calculated to assess internal consistency. To assess known groups’ validity, differences in SS-5 scores between marital status/living arrangement groups and (separately), trichotomous groupings of a validated measure of dispositional optimism, the Life Orientation Test (LOT-R), were assessed with analysis of variance (ANOVA) models. RESULTS: Of the 258 participants that completed the baseline assessment, 251 (97%) completed the retest. Mean age of participants was 48.6 years, 61% were female, and 71% were Caucasian. Participants included 44% married or living with a partner; 24% had never been married. The mean SS-5 score was 17.3 4.9, and the ICC between paper and webbased was 0.89. Reproducibility was strong (ICC=0.92), and the instrument was internally consistent (alpha=0.88). The SS-5 significantly discriminated between participants living with a partner and those living alone (means: 19.1 vs. 15.9; p

ObjectiveTo assess individualized satisfaction with migraine treatment, patient expectations, importance rankings, treatment outcomes, and overall satisfaction were combined using a four-part conceptual model. This article describes the measurement properties of the Migraine Treatment Satisfaction Measure (MTSM) using participants from a randomized controlled trial evaluating a Headache Management Program (HMP).MethodsParticipants completed the first two parts of the MTSM upon enrollment and the final two parts at 6 months. Internal consistency reliability was computed within each of the four modules. Discriminant validity was ascertained using Migraine Disability Assessment Survey (MIDAS), Patient Health Questionnaire-9, and MSFB scores. Convergent validity was established by hypothesized positive correlations between MTSM scores, Medical Outcomes Study Short-Form (SF-36), MIDAS, and Migraine Symptom Frequency Bother (MSFB).ResultsIn total, 124 participants (mean age 45.4 years, 75% women, 59.7% Caucasian) enrolled. Internal consistency for expectations, importance rankings, outcomes, and satisfaction measures was 0.83, 0.95, 0.86, and 0.95, respectively. As the severity of depression increased, MTSM scores decreased significantly. ANOVA between MTSM scores and symptom bothersomeness and symptom frequency tertiles showed a significant decrease in satisfaction in the moderate-to-severe groups. MTSM scores showed expected associations with MSFB scores (−0.301; P < 0.01), MIDAS (−0.267; P < 0.01), general health (0.253; P < 0.05), mental health (0.217; P < 0.05), and vitality subscales of SF-36 (0.214; P < 0.05). Patients in the HMP reported significantly higher MTSM scores (43.2 vs. 31.4; P < 0.001). Patients on triptans reported a significantly higher satisfaction compared to patients on analgesics (39.5 vs. 32.9; P < 0.05).ConclusionThe MTSM is a valid and reliable patient-reported outcome that can be used to evaluate differences in treatment satisfaction associated with migraine therapies.

Objectives Hypoglycemia is a common complication of treatment with certain diabetes drugs. Non-severe hypoglycemic events (NSHEs) occur more frequently than severe events and account for the majority of total events. The objective of this multi-country study was to identify how NSHEs in a working population affect productivity, costs, and self-management behaviors. Methods A 20-minute survey assessing the impact of NSHEs was administered via the Internet to individuals (≥ 18 years of age) with self-reported diabetes in the United States, United Kingdom, Germany, and France. The analysis sample consisted of all respondents who reported an NSHE in the past month. Topics included: reasons for, duration of, and impact of NSHE(s) on productivity and diabetes self-management. Results A total of 1404 respondents were included in this analysis. Lost productivity was estimated to range from $15.26 to $93.47 (USD) per NSHE, representing 8.3 to 15.9 hours of lost work time per month. Among individuals reporting an NSHE at work (n = 972), 18.3% missed work for an average of 9.9 hours (SD 8.4). Among respondents experiencing an NSHE outside working hours (including nocturnal), 22.7% arrived late for work or missed a full day. Productivity loss was highest for NSHEs occurring during sleep, with an average of 14.7 (SD 11.6) working hours lost. In the week following the NSHE, respondents required an average of 5.6 extra blood glucose test strips. Among respondents using insulin, 25% decreased their insulin dose following the NSHE. Conclusions NSHEs are associated with substantial economic consequences for employers and patients. Greater attention to treatments that reduce NSHEs could have a major, positive impact on lost work productivity and overall diabetes management.