DEVELOPMENT AND TESTING OF A COMPOSITE SCALE TO ASSESS THERAPEUTIC RESPONSE IN STRESS URINARY INCONTINENCE
Author(s)
Arnould B1, Bosio-Le Goux B2, Cadi-Soussi N3, Dard S3, Droumaguet C2, Heurtebize N2, Costa P41Mapi Values, Lyon, Rhone, France; 2 Lilly France, Suresnes, France; 3 Mapi Values, Lyon, France; 4 Caremeau Hospital, Nîmes, France
OBJECTIVES: Clinicians in charge of Stress Urinary Incontinence (SUI) patients miss specific tools taking into account patients' perspective to support treatment decision. Our aim was to develop a global medical judgement scale to assess therapeutic response METHODS: The concepts useful to assess SUI treatment outcomes were identified from a literature review and 30 clinician interviews. A test version of the pragmatic assessment form (PAF) was developed. Eight clinicians involved in the care of SUI were interviewed to assess concept relevance, comprehensiveness, validity, accessibility to source information, clarity, applicability to various situations in real life, usefulness in clinical practice to form global medical judgement. The PAF was updated accordingly. Ten SUI patients reviewed the PAF for concept relevance, reliability and applicability in clinical practice. RESULTS: Eight broad concepts covering symptom and functional status, impact on daily life activities, well-being, coping, satisfaction and expectations were included in the test PAF. Seven of 8 clinicians found the PAF complete, relevant, specific to SUI, clear and valid to support medical judgement. The clinicians were happy to have an assessment guide to support judgement, but did not request a formal scoring procedure to support decision. Satisfaction was divided into treatment benefit, undesirable effects and constraints. Patient's intention was added. After validation by 10 SUI patients, the pilot version of the PAF was finalised in double A4 format including instructions. Concept elicitation can be pragmatic for clinical practice, or standardized for clinical research. CONCLUSION: This short, simple and pragmatic composite tool will help the clinicians to easily manage the complexity of patients' perspective by comprehensively covering the relevant outcomes to assess therapeutics and support medical decision making in SUI. Its properties in clinical practice and clinical research will be assessed in specific validation studies
Conference/Value in Health Info
2005-11, ISPOR Europe 2005, Florence, Italy
Value in Health, Vol. 8, No.6 (November/December 2005)
Code
PUK33
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Gastrointestinal Disorders, Urinary/Kidney Disorders