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.

Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire.

OBJECTIVE: The objective of this study was to develop a valid and reliable health-related quality of life (HRQOL) questionnaire for use in multinational clinical trials of patients with type I and type II diabetes. METHODS: Through patient focus groups and expert clinician panels in the United States (US) and France, relevant HRQOL domains for patients with type I and type II diabetes were identified. A draft questionnaire was developed by including validated, widely used generic and diabetes-specific domains and by developing original questions as required. A pilot study (n = 123) was conducted to evaluate the psychometric properties of the draft questionnaire with revisions being subsequently made. Data collected from two multinational clinical trials of patients with type I and type II diabetes were used to further validate and enhance the questionnaire (DQLCTQ). RESULTS: A total of 942 patients were recruited in the clinical trials from Canada, France, Germany, and the United States. The mean age was 33.8 years for patients with type I diabetes (n = 468) and 58.2 years for patients with type II diabetes (n = 474). The mean HbAlc level at baseline was 8.6. The revised version of the questionnaire (DQLCTQ-R) contains a total of 57 questions comprising 8 generic and disease-specific domains, as follows: Physical Function; Energy/Fatigue; Health Distress; Mental Health; Satisfaction; Treatment Satisfaction; Treatment Flexibility; and Frequency of Symptoms. Intraclass correlation coefficients range from 0.74 to 0.90 and Cronbach's alphas range from 0.77 to 0.90. With very few exceptions, all eight domains were able to discriminate between type I and type II diabetes, tight and poor metabolic control, male and female, and good and poor self perceived control of diabetes. Four domains (Treatment Satisfaction, Health/Distress, Mental Health, and Satisfaction) were responsive to clinical change in metabolic control. CONCLUSION: The DQLCTQ-R is a reliable, valid, and comprehensive HRQOL instrument. It is suitable in multinational clinical trials to evaluate new or alternative treatments for patients with type I and type II diabetes.