Abstract
Introduction and hypothesis
This work was designed to explore the ability of the self-administered Overactive Bladder 8-Question Awareness Tool (OAB-V8) to predict patient self-assessed effectiveness of antimuscarinic therapy on OAB symptoms in daily practice. Also, the ability of the tool to predict clinician evaluation of improvement was explored.
Methods
Patients of both genders, >18 years, with symptomatic OAB (score >8 on OAB-V8), and able to understand patient-reported outcome instruments were enrolled in this 3-month study. Patients were prescribed treatment with an antimuscarinic drug according to usual practice. Treatment effectiveness was assessed by the clinician and patient using the Clinical Global Impression of Improvement and Treatment Benefit Scale and by improved self-perceived quality of life using the Overactive Bladder Questionnaire Short Form (OAB-q SF) 3 months after initiating or changing an antimuscarinic therapy. Multivariate linear and logistic regression models were applied to explore the predictive validity of OAB-V8 scores at the baseline visit.
Results
A total of 246 patients (57.7 years, 67 % women) were analyzed. Based on baseline OAB-V8 scores, logistic regression models were capable of predicting clinical improvement and patient self-perceived treatment benefit in 70 % of cases. OAB-V8 scores significantly correlated with OAB-q SF domains at baseline: 0.790 and – 0.659 for symptom bother and health-related quality of life domains, respectively (p < 0.001 in both cases). Baseline OAB-V8 score was able to predict changes in both domains of the OAB-q SF: R 2 = 0.212 and 0.162 for symptom bother and health-related quality of life, respectively.
Conclusions
The OAB-V8 scale showed evidence of predictive validity for antimuscarinic effectiveness in daily practice based on physician assessment and patient self-assessment of improved quality of life and treatment benefit.
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Abbreviations
- CGI-I:
-
Clinical Global Impression of Improvement
- HRQL:
-
Health-related quality of life
- OAB:
-
Overactive bladder
- OAB-q SF:
-
Overactive Bladder Questionnaire Short Form
- OAB-V8:
-
Overactive Bladder-Validated 8-question Awareness Tool
- TBS:
-
Treatment Benefit Scale
References
Abrams P, Cardozo L, Fall M et al (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178
Haylen BT, de Ridder D, Freeman RM et al (2010) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 29:4–20
Irwin DE, Milsom I, Hunskaar S et al (2006) Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 50:1306–1314
Stewart WF, Van Rooyen JB, Cundiff GW et al (2003) Prevalence and burden of overactive bladder in the United States. World J Urol 20:327–336
Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ (2001) How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 87:760–766
Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG (2005) Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther 22(4):381–394
Ricci JA, Baggish JS, Hunt TL et al (2001) Coping strategies and health care-seeking behavior in a US national sample of adults with symptoms suggestive of overactive bladder. Clin Ther 23:1245–1259
Berges R, Pientka L, Höfner K, Senge T, Jonas U (2001) Male lower urinary tract symptoms and related health care seeking in Germany. Eur Urol 39:682–687
Coyne KS, Sexton CC, Kopp ZS, Ebel-Bitoun C, Milsom I, Chapple C (2011) The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS. BJU Int 108(9):1459–1471
Dmochowski RR, Gomelsky A (2011) Update on the treatment of overactive bladder. Curr Opin Urol 21:286–290
Acquadro C, Kopp Z, Coyne KS, Corcos J, Tubaro A, Choo MS (2006) Translating overactive bladder questionnaires in 14 languages. Urology 67:536–540
Arlandis A, Ruiz MR, Errando C et al (2012) Quality of life in patients with overactive bladder: validation and psychometric properties of the Spanish overactive bladder questionnaire-short form. Clin Drug Investig 32:523–532
Coyne KS, Lai JS, Zyczynski T, Kopp Z, Avery K, Abrams P (2004) An Overactive Bladder Symptom and Quality-of-Life Short Form: Development of the Overactive Bladder Questionnaire Short Form (OAB-q SF). 34th Joint Meeting of the International Continence Society and the International Urogynecological Association, 23–27 August 2004, Paris, France
García-Portilla MP, Bascarán MT, Sáiz PA, Parellada M, Bousoño M, Bobes J (2011) Banco de instrumentos básicos para la práctica de la psiquiatría clínica. Comunicación y Ediciones Sanitarias, S.L. Majadahonda (Madrid), pp 231-238
Colman S, Chapple C, Nitti V, Haag-Molkenteller C, Hastedt C, Massow U (2008) Validation of treatment benefit scale for assessing subjective outcomes in treatment of overactive bladder. Urology 72:803–807
Errando-Smet C, Ruiz MA, Villacampa-Aubá F, Arlandis-Guzmán S, Rejas J, García-Vargas M (2012) Spanish cultural adaptation and psychometrical validation of the Treatment Benefit Scale (TBS) in the symptomatic treatment of overactive bladder. Med Clin. doi:10.1016/j.medcli.2011.11.013
Bech P (1993) Rating scales for psychopathology, health status, and quality of life. Springer, Berlin, pp 33–35
Morisky DE, Green LW, Levine DM (1986) Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 24:67–74
Val Jiménez A, Amorós Ballestero G, Martínez Visa P, Fernández Ferré ML, León Sanromà M (1992) Estudio descriptivo del cumplimiento del tratamiento farmacológico antihipertensivo y validación del test Morisky y Green. Aten Primaria 10:767–770
Nunnally JC, Berstein IH (1994) Psychometric theory, 3rd edn. McGraw-Hill, New York
Coyne K, Revicki D, Hunt T et al (2002) Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 11:563–574
Committee for Proprietary Medical Products (2002) Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence. European Agency for the Evaluation of Medicinal Products, London
Guy W (1976) Early clinical drug evaluation (ECDEU). Assessment manual. National Institute of Mental Health, Rockville
Revicki D, Hays RD, Cella D, Sloan J (2008) Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 61:102–109
Acknowledgments
The authors would like to thank all participating patients, colleagues, and the staff of the institutions for their contributions to data collection. Special thanks to Mercedes García-Vargas for the idea of the study and her invaluable contribution in the initial steps of the study.
Conflicts of interest
This study was funded by Pfizer, S.L.U. Daniel Arumí, Isabel Lizarraga, and Javier Rejas are full-time employees of Pfizer. Miguel Ruiz received a grant from Pfizer, S.L.U. for data analysis. Editorial support was not hired. All other authors have no competing interests.
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Villacampa, F., Ruiz, M.A., Errando, C. et al. Predicting self-perceived antimuscarinic therapy effectiveness on overactive bladder symptoms using the Overactive Bladder 8-Question Awareness Tool. Int Urogynecol J 24, 573–581 (2013). https://doi.org/10.1007/s00192-012-1921-x
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DOI: https://doi.org/10.1007/s00192-012-1921-x