Urology
Volume 68, Issue 2, Supplement , Pages 3-8 , August 2006

Patient-reported outcomes in overactive bladder: Importance for determining clinical effectiveness of treatment

  • Linda Brubaker

      Affiliations

    • Departments of Obstetrics, Gynecology, and Urology, Loyola University Medical Center, Maywood, Illinois, USA
    • Corresponding Author InformationReprint requests: Linda Brubaker, MD, MS, Departments of Obstetrics, Gynecology, and Urology, Loyola University Medical Center, 2160 South First Avenue, Building 103, Room 1004D, Maywood, Illinois 60153.
    • Linda Brubaker receives research funding from Q-Med, Pfizer Inc, and Allergan and receives consultant/speaker honoraria from Q-Med, Novartis, Pfizer Inc, and Astellas.
    • ,
  • Christopher Chapple

      Affiliations

    • Department of Urology Research, Royal Hallamshire Hospital, Sheffield, United Kingdom
    • Christopher Chapple is a scientific consultant to Pfizer Inc, Astellas, Novartis, Schwarz, Q-Med, Tanabe, and Allergan; and receives funding from Pfizer, and Allergan.
    • ,
  • Karin S. Coyne

      Affiliations

    • Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland, USA
    • Karin S. Coyne is a consultant to Pfizer Inc.
    • ,
  • Zoe Kopp

      Affiliations

    • Pfizer Inc, New York, New York, USA
    • Zoe Kopp is an employee of Pfizer Inc.

References 

  1. Fairclough DL . Patient reported outcomes as endpoints in medical research . Stat Methods Med Res . 2004;13:115–138
  2. Kelleher C . Quality of life and urinary incontinence . Baillieres Best Pract Res Clin Obstet Gynaecol . 2000;14:363–379
  3. Abrams P , Arbitani W , Gajewski JB , et al.   Assessment of treatment outcomes in patients with overactive bladder (importance of objective and subjective measures) . Urology . 2006;68(suppl 2A):17–28
  4. Willke RJ , Burke LB , Erickson P . Measuring treatment impact (a review of patient-reported outcomes and other efficacy endpoints in approved product labels) . Control Clin Trials . 2004;25:535–552
  5. Fitzpatrick R , Davey C , Buxton MJ , et al.   Evaluating patient-based outcome measures for use in clinical trials . Health Technol Assess . 1998;2:1–73
  6. Coyne K , Revicki D , Hunt T , et al.   Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire (the OAB-q) . Qual Life Res . 2002;11:563–574
  7. Abrams P , Kelleher C , Lerr L , et al.   Overactive bladder significantly affects quality of life . Am J Manag Care . 2000;6:S580–S590
  8. Chapple CR , Wein AJ . The urgency of the problem and the problem of urgency in the overactive bladder . BJU Int . 2005;95:274–275
  9. Abrams P , Cardozo L , Fall M , et al.   The standardisation of terminology in lower urinary tract function (report from the standardisation sub-committee of the International Continence Society) . Urology . 2003;61:37–49
  10. Ricci JA , Baggish JS , Hunt TL , et al.   Coping strategies and health care-seeking behavior in a US national sample of adults with symptoms suggestive of overactive bladder . Clin Ther . 2001;23:1245–1259
  11. Irwin DE , Milsom I , Kopp Z , et al.   Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries . BJU Int . 2006;97:96–100
  12. Coyne K , Payne C , Bhattacharyya S , et al.   The impact of urinary urgency and frequency on health-related quality of life in overactive bladder (results from a national community survey) . Value Health . 2004;7:451–459
  13. Liberman JN , Hunt TL , Stewart WF , et al.   Health-related quality of life among adults with symptoms of overactive bladder (results from a U.S. community-based survey) . Urology . 2001;57:1044–1050
  14. Coyne KS , Zhou Z , Thompson C , et al.   The impact on health-related quality of life of stress, urge and mixed urinary incontinence . BJU Int . 2003;92:731–735
  15. Wyman JF , Harkins SW , Choi SC , et al.   Psychosocial impact of urinary incontinence in women . Obstet Gynecol . 1987;70:378–381
  16. Weber AM , Abrams P , Brubaker L , et al.   The standardization of terminology for researchers in female pelvic floor disorders . Int Urogynecol J Pelvic Floor Dysfunct . 2001;12:178–186
  17. Homma Y , Kawabe K . Health-related quality of life of Japanese patients with overactive bladder treated with extended-release tolterodine or immediate-release oxybutynin (a randomized, placebo-controlled trial) . World J Urol . 2004;22:251–256
  18. Kelleher CJ , Kreder KJ , Pleil AM , et al.   Long-term health-related quality of life of patients receiving extended-release tolterodine for overactive bladder . Am J Manag Care . 2002;8:S616–S630
  19. Kelleher CJ , Reese PR , Pleil AM , et al.   Health-related quality of life of patients receiving extended-release tolterodine for overactive bladder . Am J Manag Care . 2002;8:S608–S615
  20. Kelleher CJ , Cardozo L , Chapple CR , et al.   Improved quality of life in patients with overactive bladder symptoms treated with solifenacin . BJU Int . 2005;95:81–85
  21. Kelleher CJ , Cardozo LD , Khullar V , et al.   A new questionnaire to assess the quality of life of urinary incontinent women . Br J Obstet Gynaecol . 1997;104:1374–1379
  22. Brubaker L . Urgency (the cornerstone symptom of overactive bladder) . Urology . 2004;64:12–16
  23. Chapple CR , Artibani W , Cardozo LD , et al.   The role of urinary urgency and its measurement in the overactive bladder symptom syndrome (current concepts and future prospects) . BJU Int . 2005;95:335–340
  24. Dmochowski R , Heit M , Sand P . The effect of anticholinergic therapy on urgency severity in patients with overactive bladder (clinical assessment of a newly validated tool) . [abstract] Neurourol Urodyn . 2003;22:411–412
  25. Cardozo L , Coyne KS , Versi E . Validation of the Urgency Perception Scale . BJU Int . 2005;95:591–596
  26. Brubaker L , Shull B . EGGS for patient-centered outcomes . Int Urogynecol J Pelvic Floor Dysfunct . 2005;16:171–173
  27. Wiklund I . Assessment of patient-reported outcomes in clinical trials (the example of health-related quality of life) . Fundam Clin Pharmacol . 2004;18:351–363
  28. Pleil AM , Coyne KS , Reese PR , et al.   The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue—the BSW . Value Health . 2005;8(suppl 1):S25–S34
  29. Piault E, Evans C, Marcucci G, et al: Patient satisfaction: international development, translatability assessment and linguistic validation of the OAB-S, an overactive bladder treatment satisfaction questionnaire: ISPOR 8th Annual European Congress. Florence, Italy. Value in Health 8(6):A88(PUK36), 2005.
  30. Conway K , Acquadro C , Uzun V , et al.   Linguistic validation of the overactive bladder questionnaire (OAB-q), OAB-q SF and the overactive bladder-validated 8 (OAB V8) screening questionnaire for this condition in Europe, Asia, North America, and South America . Int Urogynecol J . 2005;16(suppl 2):S103–S104
  31. Carlberg A . Patient satisfaction and design of treatment (results from a study of two different ways of treating hypertension) . Scand J Prim Health Care . 1993;11:105–110
  32. Cleary PD , McNeil BJ . Patient satisfaction as an indicator of quality care . Inquiry . 1988;25:25–36
  33. Ware JE . How to survey patient satisfaction . Drug Intell Clin Pharm . 1978;15:892–899
  34. Acquadro C , Berzon R , Dubois D , et al.   Incorporating the patient’s perspective into drug development and communication (an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001) . Value Health . 2003;6:522–531
  35. Chassany O , Sagnier P , Marquis P , et al.   Patient-reported outcomes (the example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process) . Drug Inf J . 2002;36:209–238
  36. Revicki DA , Osoba D , Fairclough D , et al.   Recommendations on health-related quality of life research to support labeling and promotional claims in the United States . Qual Life Res . 2000;9:887–900
  37. European Agency for the Evaluation of Medicinal Products and Committee for Proprietary Medicinal Products (Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence) . 2002; London,
  38. European Agency for the Evaluation of Medicinal Products and Committee for Proprietary Medicinal Products (Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products) . 2004; London,
  39. Sloan JA , Aaronson N , Cappelleri JC , et al.   Assessing the clinical significance of single items relative to summated scores . Mayo Clin Proc . 2002;77:479–487
  40. McHorney CA , Kosinski M , Ware JE . Comparisons of the costs and quality of norms for the SF-36 health survey collected by mail versus telephone interview (results from a national survey) . Med Care . 1994;32:551–567
  41. Weinberger M , Oddone EZ , Samsa GP , et al.   Are health-related quality-of-life measures affected by the mode of administration? . J Clin Epidemiol . 1996;49:135–140

PII: S0090-4295(06)00773-4

doi: 10.1016/j.urology.2006.05.045

Urology
Volume 68, Issue 2, Supplement , Pages 3-8 , August 2006

Article Tools