RISK OF LEAKAGES IN DAILY ACTIVITIES, RE-WORKING THE CONCEPTUAL FRAMEWORK

Author(s)

Benoit Arnould, MSc, MA, Director, Patient Scales for Clinical Practice1, Brigitte Bosio-Legoux, MD, Gynaecologist - Senior Physician2, Sylvie Dard, BA, Senior Research Associate1, Sophie Bresson, MSc, Clinical Research Associate - Coordinator3, Pierre Costa, MD, Professor41Mapi Values France, Lyon, France; 2 Lilly France, Suresnes, France; 3 Contractor for Lilly France, Suresnes, France; 4 Carémeau University Hospital, Nîmes, France

OBJECTIVES: Since the frequency of stress urinary incontinence (SUI) episodes is closely linked to continuing or avoiding activities causing leakages, evaluating therapeutic benefit can be rendered difficult. Our aim was to develop a sensitive instrument to evaluate how SUI patients cope with their handicap in everyday-life. METHODS: A list of potential efforts provoking stress urinary leakages was established from a systematic literature review and 30 clinician interviews. Eight clinician interviews allowed the listed efforts' relevance, common occurrence and ability to capture changes to be assessed. Clinicians also reported how patients control the risk of leakage in daily life. A questionnaire was developed and further tested by 20 SUI women for relevance, importance and applicability. The patients were invited to reword items and describe how they control the risk of leakage. The scale was subsequently finalised. RESULTS: Seventy-two efforts provoking leakages were listed from 15 SUI-specific scales and 21 studies from the literature review. Clinician interviews allowed a shortlist containing the most relevant efforts to be established. Answer choices covered leakage occurrence, and various behaviour adaptations (taking precautions, muscular control, avoiding situations). The questionnaire was revised 3 times: after the 6th, the 13th and the 20th patient interviews. The pilot questionnaire contains 13 efforts of daily life and 4 items on coping with the risk of leakage. CONCLUSION: This iterative approach enabled the necessary modifications to be made to produce an understandable and complete self-reported questionnaire accepted by patients. It measures three complementary criteria related to SUI severity: leakage occurrence in daily activities, avoidance of activities provoking leakages and control of leakage risk. This highly specific instrument will allow clinicians to better assess the real impact of SUI and therapeutics on patients' lives in both clinical research and practice. Scoring procedures and psychometric properties will be established after a validation study.

Conference/Value in Health Info

2006-10, ISPOR Europe 2006, Copenhagen, Denmark

Value in Health, Vol. 9, No.6 (November/December 2006)

Code

PUK27

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Urinary/Kidney Disorders

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