CONTENT VALIDITY OF THE SUBJECT'S ASSESSMENT OF CONDITION, SUBJECT'S ASSESSMENT OF TREATMENT SATISFACTION, KING'S HEALTH QUESTIONNAIRE, AND INTERNATIONAL CONSULTATION ON INCONTINENCE QUESTIONNAIRE – SHORT FORM IN PATIENTS WITH OAB

Author(s)

Vasudha Vats, MPH, Research Associate1, Mary Kay Margolis, MHA, MPH, Senior Project Manager2, Karin S. Coyne, MPH, PhD, Doctor of Research21Pfizer, Inc, New York, NY, USA; 2 United BioSource Corporation, Bethesda, MD, USA

OBJECTIVES: Evaluate the content validity of the Subject’s Assessment of Condition (SAC), Subject’s Assessment of Treatment Satisfaction (SATS), King’s Health Questionnaire (KHQ) and International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF) in overactive bladder (OAB) patients. METHODS: Cognitive interviews were conducted with adult OAB patients. Patients provided consent, completed the SAC, SATS, KHQ and ICIQ-SF and one-on-one interviews to provide feedback about each questionnaire. The SAC and SATS are single item questions related to bladder problems and treatment satisfaction. The KHQ is a 21-item disease-specific instrument assessing health-related quality of life and incontinence severity. The ICIQ-SF is a 3-item, incontinence-specific questionnaire. Content and descriptive analyses were performed. RESULTS: Twenty-four patients (18 women, 6 men), mean age 59.0±10.8 years, completed the study; 100% Caucasian. All questionnaires were acceptable and understood by participants. In general, the KHQ covered the key aspects of how OAB impacts patients’ daily lives. A few minor inconsistencies were noted: 1) “Shopping” was not considered by some to be a “household task”; “cleaning” did not resonate with men; 2) “Limiting social life” and “limit ability to visit friends” and “depressed” and “feel bad about yourself” were perceived as redundant while “depressed” and “anxious or nervous” were perceived by some to be too strong; and 3) Some women were unsure if the intended meaning of the item “change your underclothes when they get wet” was about changing wet underwear or frequency of incontinence. A few inconsistencies were also noted for the ICIQ-SF: The amount of urine leaked item was problematic for women as “amount” frequently varies, and while lifting heavy objects” and “during sexual relations” were suggested as questions to ask when leakage occurs.CONCLUSIONS: The SAC, SATS, KHQ, and ICIQ-SF were understood by patients with OAB.  Minor suggestions for improvement were made for the KHQ and ICIQ-SF.

Conference/Value in Health Info

2008-11, ISPOR Europe 2008, Athens, Greece

Value in Health, Vol. 11, No. 6 (November 2008)

Code

PUK21

Disease

Urinary/Kidney Disorders

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