A nine country study of the burden of non-severe nocturnal hypoglycaemic events on diabetes management and daily function.

AIMS: The purpose of this study was to explore the burden and impact of non-severe nocturnal hypoglycaemic events (NSNHEs) on diabetes management, patient functioning and well-being in order to better understand the role that NSNHEs play in caring for persons with diabetes and facilitate optimal diabetes treatment management strategies. METHODS: A 20-min survey assessing the impact of NSNHEs was administered to patients with self-reported diabetes age 18 or older via the Internet in nine countries (USA, UK, Germany, Canada, France, Italy, Spain, The Netherlands and Sweden) who experienced an NSNHE in the last month. Questions captured reasons for and length of the event, and impacts on diabetes management, daily function, sleep and well-being. RESULTS: A total of 20 212 persons with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) were screened of which 2108 respondents were eligible. Respondents initiated, on average, an additional 3.6 glucose monitoring tests, and did not resume usual functioning for an average of 3.4 hours after the NSNHE. Of the respondents using insulin, 15.8% decreased their insulin dose over an average of 3.6 days. NSNHEs also impacted sleep, with 10.4% not returning to sleep that night. Next day functioning was affected with 60.3% (n = 1273) feeling the need to take a nap and/or rest (with 65.5% of those actually taking a nap/rest) and 40.2% (n = 848) wanting to go to bed earlier than usual. A total of 21.4% were restricted in their driving the next day. These events also resulted in decreased well-being with 39.6% of respondents feeling 'emotional low' the following day. CONCLUSIONS: NSNHEs have serious consequences for patients. Greater attention to patient and physician education regarding the burden of NSNHEs and incorporation of corrective actions in treatment plans is needed to facilitate patients reaching optimal glycaemic control.

Comparison of 7-day and repeated 24-h recall of type 2 diabetes.

PURPOSE: Patient reporting of type 2 diabetes symptoms in a questionnaire with a 7-day recall period was expected to be different from symptom reports using a 7-day diary with repeated 24-h recall based on cognitive theory of memory processes and prior literature. This study compared these two types of recall in patients diagnosed with type 2 diabetes (T2D). METHODS: One hundred and forty adults with T2D completed a daily diary for 7 days containing 9 T2D-related symptom and impact items. On day 7, patients completed the same items with a 7-day recall period. We examined the concordance of 7-day recall with summary descriptors of the daily reports and compared the scores and the discriminant ability of 7-day recall and mean of daily reports. RESULTS: Seven-day recall was most concordant with the mean of daily reports. The average difference in scores was small (range 0.22-0.77 on 11-point scale) and less than 0.5 standard deviations. For some items, the difference was positively associated with the variation in daily reports. The discriminant ability was comparable. CONCLUSIONS: In this study population, a questionnaire with 7-day recall provided information consistent with a daily diary measure of the average week-long experience of T2D symptoms and impacts.

Electronic versus paper questionnaires: a further comparison in persons with asthma.

The use of electronic data capture (EDC) to assess health-related quality of life (HRQOL) using validated questionnaires is increasing; however, it must be determined how data collected electronically correlate with the original mode of administration used in validation. Our objective was to compare paper and electronic administration of the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S)), and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Using a crossover design, adults and children with asthma and caregivers of children with asthma were recruited from clinics. Subjects were asked to complete both forms of the appropriate HRQOL measures at enrollment and 24-48 hours later. In addition, 30 subjects from each group were asked to participate in a 1-week reproducibility assessment of the electronic versions of the three questionnaires. Psychometric properties were assessed for each of the EDC versions. Intraclass correlation coefficients (ICC) and Pearson correlations were calculated to compare EDC and paper versions. A total of 51 adults (mean age 37, 73% females), 52 children (mean age 13, 38% females), and 51 caregivers (mean age 43, 92% females) were evaluated. Internal consistency (Cronbach's alpha) for the overall score of each questionnaire was: 0.96 for the AQLQ(S) and the PAQLQ(S), and 0.92 for the PACQLQ. Overall ICCs comparing paper with EDC were: 0.96 for the AQLQ(S), 0.91 for the PAQLQ(S), and 0.82 for the PACQLQ. Pearson's correlations were identical. One-week reproducibility (ICC) of the EDC versions was: 0.88 for the AQLQ(S), 0.78 for the PAQLQ(S), and 0.85 for the PACQLQ. When asked which method subjects preferred, the electronic version was chosen by 69% of adults, 77% of children, and 73% of caregivers. Additionally, 14% of adults, 14% of children, and 18% of caregivers reported no difference in preference. As in previous studies comparing electronic with paper questionnaires, this study revealed statistical evidence to support the use of EDC of the AQLQ(S), PAQLQ(S), and PACQLQ for populations with asthma.

Validation of the United States' version of the World Health Organization Quality of Life (WHOQOL) instrument.

In 1991, the World Health Organization initiated a project to simultaneously develop a quality of life (QOL) instrument in 15 countries: The World Health Organization Quality of Life (WHOQOL) instrument. This was intended as a generic QOL tool for use with patients across varying disease types, severities of illness, and cultural subgroups. The objective of the current study was to evaluate the WHOQOL-100 in the U.S., one of the original 15 participating countries. The WHOQOL is a 100-item self-report instrument consisting of 24 subscales within six domains: Physical, Psychological, Independence, Social, Environment, and Spiritual. Four additional items pertain to overall QOL/health. We tested the WHOQOL-100 (U.S. version) in a sample of 443 adults (n = 251 chronically ill, n = 128 healthy, and n = 64 childbearing) in the U.S. to test its reliability (internal consistency, test-retest), construct validity (convergent, discriminant), responsiveness, and factor structure. The WHOQOL-100 (U.S. version) has acceptable internal consistency (alpha range: 0.82-0.95 across domains) and reproducibility (ICC range: 0.83-0.96 at 2-week retest interval). It is responsive to change in clinical conditions, as evidenced by predicted score change (effect size) in women after childbirth. Construct validity was demonstrated by (1) its correlation with the Short Form-36 and Subjective Quality of Life Profile, and (2) its ability to discriminate between the diverse samples in this study. The conceptual structure was confirmed exactly with the exception of four facets that did not correlate most highly with the domains to which they were originally assigned, but these differences were minor. The WHOQOL measurement system is suitable for evaluating the QOL of adults in the U.S. The psychometric properties will be continually evaluated as more data become available in the U.S.

Cultural adaptation of a quality-of-life measure for urinary incontinence.

OBJECTIVES: To translate and validate a urinary incontinence-specific measure of quality of life (I-QOL) in French, Spanish, Swedish, and German and provide translations only into seven other languages and variants of these languages. METHODS: Quality of life and linguistic experts prepared two forward translations from American English to their native languages and helped to harmonize these translations at a meeting. In the four European countries, the adapted versions of the I-QOL were administered to 259 women with stress, urge, and mixed incontinence. Principal component analyses were used to confirm the proposed measurement model suggested by patient interviews. Psychometric testing was conducted using standardized procedures. RESULTS: Translation procedures resulted in a change in the original instrument's Likert response scale from 4 to 5 points. Principal component analyses confirmed three patient-derived subscales and higher-order factor analysis confirmed a total summary score. In all countries, the internal consistency (alpha) and reproducibility (ICC) were high (alpha ranged between 0.87 and 0.93); (ICC ranged between 0.92 and 0.95). In all countries, I-QOL scores were significantly worse (p < 0.001) as perceived severity of incontinence, use of services, and number of incontinent episodes increased. CONCLUSIONS: The I-QOL has been adapted successfully into eleven languages and six variants of these languages. The cross-sectional psychometric properties of the US version were confirmed in four European countries. The I-QOL fills the need for a valid, international quality-of-life instrument for incorporation in clinical trials covering patients with varying types and severity of urinary incontinence.

Quality of life and Parkinson's disease: translation and validation of the US Parkinson's Disease Questionnaire (PDQ-39).

Parkinson's disease is a common progressive neurodegenerative disorder affecting an estimated 4 million people worldwide. A number of general health status measures exist but few fully capture the subjective evaluation of life quality associated with Parkinson's disease. We report here the results of: (1) translating the British PDQ-39 into a US version, (2) validity and reliability of the new US PDQ-39 questionnaire, and (3) parallel validation analyses following the method published in the development of the British version of the PDQ-39. Data were collected by postal survey on 150 patients recruited from neurology clinics in the Seattle area. A short, generic health status measure (SF-36) was used to test convergent validity, and a three-day test-retest assessed the reliability of the PDQ-39. The US version of the PDQ-39 demonstrated acceptable internal consistency (alpha = 0.51 to 0.96) and proved to be reproducible (0.86 to 0.96). Subscales of the PDQ-39 showed convergence with like scales of the SF-36 and was able to discriminate between levels of symptom severity.

Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL)

OBJECTIVES: To report on the further development of the Incontinence Quality of Life Instrument (I-QOL), a self-report quality of life measure specific to urinary incontinence (UI), including its measurement model, responsiveness, and effect size. METHODS: Incontinent female patients (141 with stress, 147 with mixed UI) completed the I-QOL and comparative measures at screening, pretreatment, and four subsequent follow-up visits during participation in a multicenter, double-blind, placebo-controlled, randomized trial assessing the efficacy of duloxetine. Psychometric testing followed standardized procedures. RESULTS: Factor analysis confirmed an overall score and three subscale scores (avoidance and limiting behaviors, psychosocial impacts, and social embarrassment). All scores were internally consistent (alpha = 0.87 to 0.93) and reproducible (ICC = 0.87 to 0.91). The pattern of previously reported correlations with the Short-Form 36-item Health Survey and Psychological Well-Being Schedule were confirmed. Responsiveness statistics using changes in the independent measures of stress test pad weight, number of incontinent episodes, and patient global impression of improvement ranged from 0.4 to 0.8. Minimally important changes ranged from 2% to 5% in association with these measures and effect sizes. CONCLUSIONS: In a clinical trial, the I-QOL proved to be valid, reproducible, and responsive to treatment for UI in women.