DEVELOPMENT AND VALIDATION OF A COMPREHENSIVE SYMPTOM CHECKLIST IN URINARY INCONTINENCE
Author(s)
Arnould B1, Benmedjahed K2, Amarenco G3, Coloby P4, Grise P5, Haab F6, Richard F71Mapi Values, Lyon, Rhone, France; 2 Mapi Values, Lyon, France; 3 Rothshild hospital, Paris, France; 4 René Dubos Hospital, Pontoise, France; 5 CHU Charles Nicolle, Rouen, France; 6 Ténon hospital, Paris, France; 7 Pitié Salpétrière Hospital, Paris, France
OBJECTIVES: To develop and validate a unique tool specific to urinary incontinence (UI) symptoms covering all types of incontinence among both men and women. METHODS: An Advisory Committee (AC) of 5 urologists was set up, involved at all stages of questionnaire development and validation. A test questionnaire was developed by AC with content validity being assessed simultaneously on 3 men, 4 women suffering from UI and 3 clinicians. Clinicians were asked to comment items' relevance and comprehensiveness; patients completed the scale and were asked to provide general comments regarding the scale and detailed comments regarding each element. The scale was redrafted and tested on 25 other patients. A longitudinal, multi-centre, anonymous, observational study was carried out to validate the scale. The scale was administrated by 21 urologists to 258 stable patients (206 UI sufferers and 52 not UI sufferers) until June 15th 2005. Patients filled in the scale, the ICIQ-SF and a diary twice at one-week interval and clinicians completed a medical form at baseline. RESULTS: The test scale contained 11 items covering urge, SUI, dysuria and pollakiuria. After initial cognitive debriefing and comments of patients and clinicians, 3 items were significantly modified. The pilot questionnaire still included 11 items. The validation study allowed to assess the internal consistency reliability, the test-retest reliability and the clinical validity of the scores. CONCLUSION: For the first time, psychometric properties were established for a simple-to-use, unique and UI specific symptom scale for men and women. This new instrument could be helpful for use in everyday medical practice and in clinical research.
Conference/Value in Health Info
2005-11, ISPOR Europe 2005, Florence, Italy
Value in Health, Vol. 8, No.6 (November/December 2005)
Code
PUK29
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Gastrointestinal Disorders, Urinary/Kidney Disorders