Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire in Diarrheal-Predominant Irritable Bowel Syndrome Patients
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2013/12/13
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Details
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Personal Author:Andrae DA ; Covington PS ; Drossman DA ; Patrick DL ; Andrae DA ; Covington PS ; Drossman DA ; Patrick DL
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Description:Background: Diarrhea-predominant irritable bowel syndrome (IBS-d) significantly diminishes the health-related quality of life (HRQOL) of patients. Psychological and social impacts are common with many IBS-d patients reporting comorbid depression, anxiety, decreased intimacy, and lost working days. The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire is a 34-item instrument developed and validated for measurement of HRQOL in non-subtyped IBS patients. The current paper assesses this previously-validated instrument employing data collected from 754 patients who participated in a randomized clinical trial of a novel treatment, eluxadoline, for IBS-d. Methods: Psychometric methods common to HRQOL research were employed to evaluate the IBS-QOL. Many of the historical analyses of the IBS-QOL validations were used. Other techniques that extended the original methods were applied where more appropriate for the current dataset. In IBS-d patients, we analyzed the items and substructure of the IBS-QOL via item reduction, factor structure, internal consistency, reproducibility, construct validity, and ability to detect change. Results: This study supports the IBS-QOL as a psychometrically valid measure. Factor analyses suggested that IBS-specific QOL as measured by the IBS-QOL is a unidimensional construct. Construct validity was further buttressed by significant correlations between IBS-QOL total scores and related measures of IBS-d severity including the historically-relevant Irritable Bowel Syndrome Adequate Relief (IBS-AR) item and the FDA's Clinical Responder definition. The IBS-QOL also showed a significant ability to detect change as evidenced by analysis of treatment effects. A minority of the items, unrelated to the IBS-d, performed less well by the standards set by the original authors. Conclusions: We established that the IBS-QOL total score is a psychometrically valid measure of HRQOL in IBS-d patients enrolled in this study. Our analyses suggest that the IBS-QOL items demonstrate very good construct validity and ability to detect changes due to treatment effects. Furthermore, our analyses suggest that the IBS-QOL items measure a univariate construct and we believe further modeling of the IBS-QOL from an item response theory (IRT) approach under both non-treatment and treatment conditions would greatly further our understanding as item-based methods could be used to develop a short form. [Description provided by NIOSH]
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ISSN:1477-7525
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Volume:11
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NIOSHTIC Number:nn:20055414
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Citation:Health Qual Life Outcomes 2013 Dec; 11:208
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Contact Point Address:David A. Andrae, Furiex Pharmaceuticals, Inc., 3900 Paramount Parkway, Suite 150, Morrisville, NC 27560, USA
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Email:David.Andrae@furiex.com
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Federal Fiscal Year:2014
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Performing Organization:University of Washington
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Peer Reviewed:True
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Start Date:20050701
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Source Full Name:Health and Quality of Life Outcomes
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End Date:20250630
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Main Document Checksum:urn:sha-512:2d7d4985066411dc6a945480e58a5d512cb2461fd0c694562221b182f8237d3809d9ec8ba19346ad2a2925b1b197b4da9fbf833cc5fc014799527c183f907a1b
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