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Characterization of Health Related Quality of Life (HRQOL) for Patients With Functional Bowel Disorder (FBD) and Its Response to Treatment

Drossman, Douglas, M.D.1; Morris, Carolyn B., Ph.D.1; Hu, Yuming, Ph.D.1; Toner, Brenda B., Ph.D.2; Diamant, Nicholas, M.D.2; Whitehead, William E., Ph.D.1; Dalton, Christine B., Ph.D.1; Leserman, Jane, Ph.D.1; Patrick, Donald L., Ph.D.3; Bangdiwala, Shrikant I., Ph.D.1

American Journal of Gastroenterology: July 2007 - Volume 102 - Issue 7 - p 1442–1453

BACKGROUND AND AIMS Assessing health related quality of life (HRQOL) is becoming more important in research and clinical care. However, little information is available on the performance of HRQOL questionnaires for the functional bowel disorders (FBD). The aims of this study were to (a) understand the performance of the Sickness Impact Profile (SIP) and IBS-QOL for the functional bowel disorders at baseline and after treatment, (b) determine which HRQOL subscales best improve with treatment, (c) determine clinically meaningful improvement, and (d) determine the predictors of HRQOL at baseline and in response to treatment.

METHODS Women with moderate to severe FBD were evaluated using both medical (desipramine vs placebo) and psychological (cognitive-behavioral therapy vs education) treatments. Clinical and psychosocial questionnaires along with the SIP and IBS-QOL were given at baseline and after 12-wk treatment.

RESULTS (a) Patients with FBD experience functional limitations in social interactions, home management, and recreational activities, respond emotionally to the pain, feel helpless, out of control, depressed, and irritable, and perceive restrictions in lifestyle relating to toilet accessibility, and eating; (b) HRQOL is not different among the FBD diagnoses or IBS subgroups; (c) the IBS-QOL is more responsive to treatment than the SIP; (d) meaningful clinical improvement is 2.8 points for SIP and 14 for IBS-QOL; and (e) improvement is demonstrated primarily in psychosocial rather than physical domains. In addition, we found that expectation of benefit is greater for taking a pill over a psychological intervention, and the predictive effects of abuse history and pain on outcome is mediated by psychosocial factors.

CONCLUSIONS The data support the value of the IBS-QOL over the SIP, and provide new information on the profile of impairment in FBD, and the ways in which medical and psychological treatments produce improvement in HRQOL.

1The UNC Center for Functional GI and Motility Disorders, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina; 2Centre for Addiction and Mental Health, University of Toronto, Toronto, Canada; and 3University of Washington, Seattle, Washington

Reprint requests and correspondence: Douglas A. Drossman, M.D., 4150 Bioinformatics Bldg, CB 7080, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599.

Received November 10, 2006; accepted March 12, 2007.

© The American College of Gastroenterology 2007. All Rights Reserved.
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