Author(s)
Karin S. Coyne, MPH, PhD, Doctor of Research1, Chris Sexton, PhD, Senior Project Manager1, Zoe Kopp, Mph, Director2, Tara Symonds, PhD, Director, GU WWOR TA Lead3, Lalitha Aiyer, MD;, MS;, PMBA, Global Medical4, Steve Kaplan, MD, Professor of Urology5, Christopher Chapple, BSc, MD, FRCS, Consultant Urologist6, Alan J Wein, MD, Professor & Chr of Urology71United BioSource Corporation Center for Health Outcomes Research, Bethesda, MD, USA; 2 Pfizer, Inc, New York, NY, USA; 3 Pfizer Global Research & Development, Sandwich, Kent, United Kingdom; 4 Pfizer Inc, New York, NY, USA; 5 Weill Cornell Medical College, Cornell University, New York, NY, USA; 6 The Royal Hallamshire Hospital, Sheffield, United Kingdom; 7 University of Pennsylvania, Philadelphia, PA, USA
OBJECTIVE: Although various instruments have been used to assess the prevalence of LUTS, the interpretability of questions from a patient perspective has not been assessed. There is a need for qualitative research to inform the development of a patient reported outcome (PRO) tool that assesses all LUTS. METHODS: A series of eight focus groups and 66 cognitive debriefing interviews were conducted to elicit patient descriptions of urinary symptoms and to assess treatment-seeking behavior and treatment outcomes. Participants with a range of LUTS were recruited from urology clinics and community settings in different USA geographic regions. Trained interviewers conducted each session following semi-structured interview guides. Content and descriptive analyses were performed. RESULTS: A total of 129 people (66 men, 63 women) participated. Mean age was 54 (26-80 y); 71% were white. Mean symptom duration was 7 years for men; 15 years for women. A wide range of LUTS were reported with participants generally understanding and agreeing on the words used to describe most LUTS. There were no differences in terminology used by clinical and community participants. Some difficulty describing bladder area pain, split stream, terminal dribble and post-micturition dribble was noted. Most participants identified with the word “bother” and thought it was important to assess both the frequency and bother of each symptom. Reasons for seeking care included symptom bother and fears about cancer and bladder infections. When asked to describe a positive treatment outcome, 64% of participants responded that a 50% improvement in at least one LUTS would be meaningful. A draft LUTS tool was developed based on patient feedback. CONCLUSION: There is a need for a new PRO tool to assess the frequency and bother of all LUTS in terms understood by patients. A new LUTS PRO tool was developed to include the patient perspective and is undergoing validation.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PUK22
Disease
Urinary/Kidney Disorders