CONTENT VALIDITY OF A PATIENT-REPORTED URINARY URGENCY RATING SCALE- RESULTS OF A COGNITIVE INTERVIEW STUDY
Author(s)
Chen WH1, Notte S1, Marshall TS2, Lee M2, Hakimi Z3, Revicki DA11United BioSource Corporation, Bethesda, MD, USA, 2Astellas Pharma Global Development - US, Deerfield, IL, USA, 3Astellas Pharma Global Development - EU, AC Leiderdorp, Netherlands
OBJECTIVES: The Patient Perception of Intensity of Urgency Scale (PPIUS) measures the urgency severity of urinary episodes, and was developed based on the definition of urgency presented by the International Continence Society (ICS) (Abrams et al. 2002) as well as recommendations from the Committee for Proprietary Medical Products (CPMP) (EMA 2002). The PPIUS is a single item scale with five levels of urgency severity, from “No urgency” to “Urge incontinence,” each with its definition provided. While the PPIUS has been used in previous trials, its content validity has not been established in overactive bladder (OAB) patients. The objective of this study was to determine comprehensibility and understanding of the scale through cognitive interviews with OAB patients. METHODS: Forty-one OAB patients participated in a non-interventional study assessing reproducibility of the PPIUS by completing a three-day micturition diary each week for three consecutive weeks. Following successful completion of the test-retest study, twelve participants were selected to participate in a 30-minute in-person interview discussing their experience with the PPIUS. Interviews were conducted by a trained interviewer and followed a semi-structured guide with think-aloud approach. RESULTS: N=12; mean (SD) age=61.6 (13.5) years; 66.7% Caucasian; 91.7% female; mean (SD) years with symptoms=5.8 (4.6); 83.3% reported medication use for treatment. Nine participants found it simple to choose a PPIUS rating for each of their daily micturition episodes. Most agreed with the definitions provided for the ratings of “No urgency” (n=9), “Mild urgency” (n=7), “Moderate urgency” (n=8), “Severe urgency” (n=9) and “Urge incontinence” (n=9). Three suggested distinction between daytime and nighttime episodes could be made clearer. CONCLUSIONS: Content validity of the PPIUS was supported by the results of the cognitive interviews. PPIUS was well understood and the urgency definitions were generally accepted. Participants found the diary easy to complete and did not have difficulty selecting their ratings.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PUK32
Disease
Urinary/Kidney Disorders