DEVELOPMENT AND PILOT TESTING OF A NEW SCALE SPECIFICALLY MEASURING THE IMPACT OF STRESS URINARY INCONTINENCE (SUI) ON COMMON PHYSICAL ACTIVITIES OF DAILY LIFE
Author(s)
Arnould B1, Costa P2, Dard S3, Heurtebize N4, Droumaguet C4, Bosio-Le Goux B41Mapi Values, Lyon, Rhone, France; 2 Caremeau Hospital, Nîmes, France; 3 Mapi Values, Lyon, France; 4 Lilly France, Suresnes, France
OBJECTIVES:Since stress incontinence episodes frequency is highly related to maintenance or avoidance of activities causing leakages, the additional benefit of therapeutic options might be difficult to capture. Our objective was to develop a new specific and sensitive endpoint to evaluate treatment effects in Stress Urinary Incontinence (SUI) in clinical trials METHODS: A comprehensive list of efforts provoking leakages was established from a systematic literature review and 30 clinician interviews. The list was updated according to comments collected during 8 semi-structured clinicians interviews. Clinicians were asked about the relevance, comprehensiveness, and ability of the listed activities to capture changes. They also reported how their patients managed to control the risk of leakage. Twenty SUI women were asked to assess the relevance, importance, and applicability of each effort, to reword the list and to describe with their own words how they control the risk of leakage. The scale was finalised according to their comments. RESULTS: A list of 72 daily life efforts provoking leakage was set from 15 UI specific scales and 21 studies selected from the literature. The clinician interviews allowed to group similar concepts and to establish a shortlist containing the 15 most relevant efforts. Answer choices covered the occurrence of leakage, and various behaviour adaptation such as seeking help, taking precautions, muscular control, and avoiding situations. After validation of format, items, wording, and answer choices, by the patients, the pilot scale was produced. CONCLUSION: This self-reported scale allows SUI patients to accurately describe their control on leakage risk in daily life efforts. This highly specific instrument will allow clinicians to better assess the true impact of therapeutics on patients' life, in both clinical research and clinical practice. The scoring procedure and its properties will be assessed in a specific validation study.
Conference/Value in Health Info
2005-11, ISPOR Europe 2005, Florence, Italy
Value in Health, Vol. 8, No.6 (November/December 2005)
Code
PUK31
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Gastrointestinal Disorders, Urinary/Kidney Disorders