期刊
VALUE IN HEALTH
卷 12, 期 6, 页码 1004-1010出版社
ELSEVIER SCIENCE INC
DOI: 10.1111/j.1524-4733.2009.00533.x
关键词
chronic constipation; instrument development; irritable bowel syndrome; treatment satisfaction
资金
- Takeda Pharmaceuticals North America, Inc., Deerfield, Illinois 60015 USA
Objectives: To develop and validate the constipation treatment satisfaction questionnaire (CTSAT-Q) for use in patients with chronic constipation and irritable bowel syndrome with constipation (IBS-c). Methods: Questionnaire development included item representation from the reviewed literature, focus groups, and pretesting. Dimensions related to treatment satisfaction were identified with exploratory factor analysis, verified with confirmatory factor analysis (CFA), and tested with structural equation modeling. Results: A total of 31,988 email invitations were disseminated to obtain 311 qualified respondents with diagnoses for chronic constipation and IBS-c using ROME II criteria, which required that two of the following symptoms: fewer than 3 bowel movements per week, hard or lumpy stools, straining with defecation, and a sensation of incomplete evacuation, a sensation of anorectal obstruction, and the use of manual maneuvers to assist defecation be present 25% of the time during the last year. Approximately 84% of the sample was female. Item-to-total correlations were 0.66 for activities, ranged from 0.60 to 0.67 for expectations, from 0.59 to 0.69 for value, from 0.56 to 0.60 for effectiveness, and 0.68 to 0.79 for treatment satisfaction. All standardized parameter estimates from CFA were significant (P < 0.01). The chi-square was 46.98, df = 41, P = 0.241, comparative fit index = 0.996, Tucker-Lewis Index = 0.994, root mean square error of approximation = 0.022, indicating an excellent fit between the sample data and proposed model. Treatment satisfaction was a strong and significant predictor of effectiveness, activities, and value (P < 0.001). Conclusions: The CTSAT-Q was demonstrated to be reliable and valid, and appears to assess treatment satisfaction for patients with chronic constipation and patients with IBS-c.
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