Understanding the Economic Burden of Nonsevere Nocturnal Hypoglycemic Events: Impact on Work Productivity, Disease Management, and Resource Utilization

AbstractObjectiveNonsevere 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).MethodsA 20-minute 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.ResultsA 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.ConclusionsNSNHEs have serious consequences for patients. Greater attention to treatments that reduce NSNHEs can have a major impact on reducing the economic burden of diabetes

Further Validation of an Individualized Migraine Treatment Satisfaction Measure

AbstractObjectiveTo 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

Development and validation of the Treatment Related Impact Measure of Weight (TRIM-Weight)

<p>Abstract</p> <p>Background</p> <p>The use of prescription anti-obesity medication (AOM) is becoming increasingly common as treatment options grow and become more accessible. However, AOM may not be without a wide range of potentially negative impacts on patient functioning and well being. The Treatment Related Impact Measure (TRIM-Weight) is an obesity treatment-specific patient reported outcomes (PRO) measure designed to assess the key impacts of prescription anti-obesity medication. This paper will present the validation findings for the TRIM-Weight.</p> <p>Methods</p> <p>The online validation battery survey was administered in four countries (the U.S., U.K., Australia, and Canada). Eligible subjects were over age eighteen, currently taking a prescription AOM and were currently or had been obese during their life. Validation analyses were conducted according to an <it>a priori </it>statistical analysis plan. Item level psychometric and conceptual criteria were used to refine and reduce the preliminary item pool and factor analysis to identify structural domains was performed. Reliability and validity testing was then performed and the minimally importance difference (MID) explored.</p> <p>Results</p> <p>Two hundred and eight subjects completed the survey. Twenty-one of the 43 items were dropped and a five-factor structure was achieved: Daily Life, Weight Management, Treatment Burden, Experience of Side Effects, and Psychological Health. <it>A-priori </it>criteria for internal consistency and test-retest coefficients for the total score and all five subscales were met. All pre-specified hypotheses for convergent and known group validity were also met with the exception of the domain of Daily Life (proven in an ad hoc analysis) as well as the 1/2 standard deviation threshold for the MID.</p> <p>Conclusion</p> <p>The development and validation of the TRIM-Weight has been conducted according to well-defined principles for the creation of a PRO measure. Based on the evidence to date, the TRIM-Weight can be considered a brief, conceptually sound, valid and reliable PRO measure.</p

Performance of the EQ-5D in Patients with Irritable Bowel Syndrome

ABSTRACTObjectiveThe EQ-5D is a standardized, nondisease-specific instrument for evaluating patients' preference-based valuations of health-related quality of life (HRQoL). This study's purpose was to determine the psychometric properties of EQ-5D in patients with irritable bowel syndrome (IBS).MethodsData from four European IBS studies were assessed: UK (n = 161 and n = 297), Spain (n = 503), and Germany (n = 100). The EQ-5D is a five-item health state descriptive system used to develop health states (EQ-5DINDEX) and a visual analog scale (VAS) (0–100 from worst to best imaginable health state, EQ-5DVAS). Measures used with the EQ-5D included the SF-36, Irritable Bowel Syndrome—Quality of Life (IBS-QOL), and both subjective and clinical global assessments of IBS. Convergent validity was assessed using SF-36 and IBS-QOL data, discriminant validity using global ratings of IBS severity, and responsiveness by subjective and physician assessment of condition.ResultsModerate-to-high associations (r ≥ 0.33) were seen between the EQ-5DVAS and the SF-36 and IBS-QOL subscales. Mean response scores to EQ-5DINDEX dimensions and the EQ-5DVAS score were significantly better for control patients than for patients with IBS (all P < 0.01). The EQ-5DVAS was able to discriminate between levels of pain severity (quartiles, P < 0.001; mild/moderate/severe, P < 0.05) and general health severity (mild/moderate/severe, P < 0.001). The EQ-5DVAS and the EQ-5DINDEX were responsive in patients using both a self-perceived (Subject's Global Assessment) and physician-rated (Clinic Global Assessment) improvement.ConclusionsThe EQ-5D performs well in comparison to general and disease-specific outcomes. It is a valid and responsive measure that can be used to generate preference-based valuations of HRQoL in patients with IBS and useful for comparisons in clinical and cost-effectiveness studies

The EUROHIS-QOL 8-Item Index: Comparative Psychometric Properties to Its Parent WHOQOL-BREF

AbstractObjectivesTo 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

Validation of Electronic Data Capture of the Irritable Bowel Syndrome—Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol

ABSTRACTObjectivesTo 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.MethodsComparability 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).ResultsNo 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%).ConclusionsEDC 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

Understanding and assessing the impact of treatment in diabetes: the Treatment-Related Impact Measures for Diabetes and Devices (TRIM-Diabetes and TRIM-Diabetes Device)

<p>Abstract</p> <p>Purpose</p> <p>Diabetes is a debilitating illness requiring lifelong management. Treatments can be varied in terms of mode of administration as well as type of agent. Unfortunately, most patient reported outcome measures currently available to assess the impact of treatment are specific to diabetes type, treatment modality or delivery systems and are designed to be either a HRQoL or treatment satisfaction measure. To address these gaps, the Treatment Related Impact Measure-Diabetes and Device measures were developed. This paper presents the item development and validation of the TRIM Diabetes/Device.</p> <p>Methods</p> <p>Patient interviews were conducted to collect the patient perspective and ensure high content validity. Interviews were hand coded and qualitatively analyzed to identify common themes. A conceptual model of the impact of diabetes medication was developed and preliminary items for the TRIM-Diabetes/Device were generated and cognitively debriefed. Validation data was collected via an on-line survey and analyzed according to an a priori statistical analysis plan to validate the overall score as well as each domain. Item level criteria were used to reduce the preliminary item pool. Next, factor analysis to identify structural domains was performed. Reliability and validity testing was then performed.</p> <p>Results</p> <p>One hundred and five patients were interviewed in focus groups, individual interviews and for cognitive debriefing. Five hundred seven patients participated in the validation study. Factor analysis identified seven domains: Treatment Burden, Daily Life; Diabetes Management; Psychological Health; Compliance and Device Function and Bother. Internal consistency reliability coefficients of the TRIM-Diabetes/Device ranged from 0.80 and 0.94. Test-retest reliability of the TRIM-Diabetes/Device ranged from 0.71 to 0.89. All convergent and known groups validity hypotheses were met for the TRIM-Diabetes/Device total scores and sub-scales.</p> <p>Conclusion</p> <p>Validation is an ongoing and iterative process. These findings are the first step in that process and have shown that both the TRIM-Diabetes and the TRIM-Diabetes Device have acceptable psychometric properties. Future research is needed to continue the validation process and examine responsiveness and the validity of the TRIM-Diabetes/Device in a clinical trial population.</p