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Clinical Drug Investigation

, Volume 32, Issue 8, pp 523–532 | Cite as

Quality of Life in Patients with Overactive Bladder

Validation and Psychometric Properties of the Spanish Overactive Bladder Questionnaire-Short Form
  • Salvador Arlandis-Guzmán
  • Miguel A. Ruiz
  • Carlos Errando
  • Felipe Villacampa
  • Daniel Arumí
  • Isabel Lizarraga
  • Javier Rejas
Original Research Article

Abstract

Background: Overactive bladder (OAB) is characterized by the symptoms of urinary urgency or urge incontinence, which appear without a local patho logical or metabolic explanation. OAB is defined by symptoms and the evaluation of treatment effectiveness should be based upon patient perceptions. The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a brief, self-administered patient-reported outcomes tool with two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB.

Objective: This study aimed to adapt the OAB-q SF into Spanish and to estimate its psychometric properties in patients with symptomatic overactive bladder.

Methods: The Spanish version of the OAB-q SF was administered on two occasions, 3 months apart, to a set of patients of both sexes, over 18 years of age, diagnosed with OAB, scoring ≥8 on the OAB-V8 scale (a self-reported 8-item OAB screening and awareness tool), and able to understand patient-reported-outcome instruments written in Spanish. Patients were recruited consecutively at urology clinics. Feasibility, internal consistency (Cronbach’s alpha), test-retest reliability, structure of instrument, criteria and construct validity and responsiveness were examined using classic test theory statistics.

Results: Data from 246 OAB patients (mean age 57.7 years, 76% women, 99% Caucasian, 37% workers and 36% with a primary education) were evaluated. Floor and ceiling effects ranged between 0.8% and 33%, and missing items were below 2%. Cronbach’ alphas attained 0.811 and 0.922 for symptom-botherz and HR-QOL domains, respectively. These two subscales matched the original structure and explained variances above 50%, which correlated moderately with EQ-5D (EuroQol) [r=−0.28 and r=+0.31, respectively (p< 0.001 in both cases)]. A significant change in OAB−q SF mean domain scores (−23.8; 95% CI −26.3, −21.3; and +17.7; 95% CI 15.4, 20.6; p<0.001 in both cases; [effect sizes: 1.32 and 0.98]) was observed after 3 months of medical treatment.

Conclusion: The Spanish version of the OAB-q SF demonstrated sufficiently strong psychometric properties of reliability, validity and responsiveness to be used in the measurement of O AB symptom severity and HR-QOL.

Keywords

Overactive Bladder Minimal Important Difference Symptomatic Overactive Bladder Awareness Tool Minimal Important Difference Estimate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

(i) This study was funded by Pfizer, S.L.U. SA, CE, FV, DA and IL participated in the design of the study and interpretation of results and were responsible for drafting the manuscript and searching the bibliography. MR was responsible for the analysis and interpretation of data, drafting the manuscript, and searching the bibliography. JR participated in the logistics of the study, interpretation of data, drafting the manuscript, and searching the bibliography. SA, CE and FV also participated in recruitment of patients. All authors approved the final version of the manuscript.

(ii) DA, IL and JR are full-time employees of Pfizer, the company that sponsored the study. MR received a grant from Pfizer, S.L.U. for analysis of the data. Editorial support was not employed. All other authors declare that they do not have competing interests.

(iii) The authors would like to thank all participating patients, colleagues and the staff of the institutions for their contributions to the 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 and to Ana Cañadas for administrative support.

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Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  • Salvador Arlandis-Guzmán
    • 1
  • Miguel A. Ruiz
    • 2
  • Carlos Errando
    • 3
  • Felipe Villacampa
    • 4
  • Daniel Arumí
    • 5
  • Isabel Lizarraga
    • 6
  • Javier Rejas
    • 7
  1. 1.Department of UrologyHospital Universitari I Politecnic La FeValenciaSpain
  2. 2.Department of Methodology, School of PsychologyUniversidad Autónoma de MadridMadridSpain
  3. 3.Department of UrologyFundación PuigvertBarcelonaSpain
  4. 4.Department of UrologyHospital 12 de OctubreMadridSpain
  5. 5.Pfizer Inc.MadridSpain
  6. 6.Medical UnitPfizer, S.L.U., AlcobendasMadridSpain
  7. 7.Health Economics and Outcomes Research DepartmentPfizer, S.L.U., AlcobendasMadridSpain

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