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Linguistic Adaptation and Validation of the Spanish Version of the Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM®)

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Abstract

Background: The Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM®) is a self-reported quality-of-life questionnaire for measuring the impact of urinary/prostate symptoms on the quality of life of patients with BPH. The aim of the present study was to adapt the original instrument to Spanish (for use in Spain) and to assess the psychometric properties of the new version.

Methods: Linguistic adaptation was performed using the standard processes for establishing conceptual equivalence, and was partially conducted in parallel with original instrument development. Psychometric properties were assessed on a sample of 131 patients with BPH who were receiving treatment with doxazosin gastrointestinal therapeutic system (GITS).

Results: All the standardised items had response rates >99%; there were no floor or ceiling effects. Reliability in terms of Cronbach’s a was 0.96 and the intraclass correlation coefficient was 0.97. Construct validity was confirmed by factoranalysis. Convergent validity was confirmed in terms of the relationship to the 12-Item Short-Form Health Survey (SF-12) [p < 0.001], Health Utilities Index Mark III (HUI-3) [p < 0.001] and the International Prostate Symptom Score (IPSS) QOL item (p < 0.001). The instrument showed discriminant validity, in terms of IPSS groups (p < 0.001). The instrument was sensitive to change in terms of the correlation of the domain scores of the PIM to improvements in symptom scores (p < 0.001). Significant differences were observed for those who improved ≥3 points in the IPSS scale (p < 0.001).

Conclusion: A psychometric ally valid and conceptually equivalent version of the BPH-PIM questionnaire has been produced in Spanish to be used in Spain in patients with BPH.

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Acknowledgements

Two of the authors are employees at Pfizer (Javier Rejas and Asha Hareendran) and the study was funded by an unrestricted grant from Pfizer. The other authors have no conflicts of interest that are directly relevant to the contents of this study.

Members of the Collaborative Group for Spanish Validation of the BPH-PIM® questionnaire (in alphabetical order): M. Esteban (Hospital Príncipe de Asturias, Alcalá de Henares); I. Fernández (Unidad Médica, Pfizer SA, Madrid); F. González (H. Fundación Alcorcón, Alcorcón); A. Hareendran, (Outcomes Research, Pfizer Ltd, Sandwich); F. León (Centro de Salud-Pozuelo Norte, Pozuelo de Alarcón); E. López de la Fuente (Centro de Salud-Castroviejo, Madrid), E. Lledó (H. Fundación Alcorcón, Alcorcón); C. Llorente (H. Fundación Alcorcón, Alcorcón); C. Puig (H. Fundación Alcorcón, Alcorcón); J. Rejas (Outcomes Research, Pfizer SA, Madrid); D. Rengifo (H. Fundación Alcorcón, Alcorcón); M. Ruiz (Universidad Autónoma, Madrid); J.C. Ruiz de la Roja (H. De la Cruz Roja, Madrid); F. Villasante (Centro de Salud-Orcasitas, Madrid).

The Spanish version of the BPH-PIM® can be used for research but permission needs to be obtained from the corresponding author and it should not be translated without permission.

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Authors and Affiliations

  1. Department of Urology, Fundación Hospital Alcorcón, Universidad Rey Juan Carlos, Madrid, Spain

    Carlos Llorente

  2. Department of Methodology, College of Psychology, Universidad Autónoma, Madrid, Spain

    Miguel Ruiz

  3. Medical Unit, Health Outcomes Research, Pfizer España, Madrid, Spain

    Javier Rejas Gutiérrez

  4. Department of Urology, Hospital Príncipe de Asturias, Alcalá de Henares, Spain

    Manuel Esteban

  5. Primary Care Health Centre-Orcasitas, Madrid, Spain

    Fernando Villasante

  6. Worldwide Outcomes Research, Pfizer Ltd, Sandwich, UK

    Asha Hareendran

Authors
  1. Carlos Llorente
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  2. Miguel Ruiz
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  3. Javier Rejas Gutiérrez
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  4. Manuel Esteban
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  5. Fernando Villasante
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  6. Asha Hareendran
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Corresponding author

Correspondence to Javier Rejas Gutiérrez.

Appendix

Appendix

Spanish version of the BPH-PIM® questionnaire (table V).

Table V
figure Tab5

Spanish version of the BPH-PIM® questionnaire (truncated)

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Llorente, C., Ruiz, M., Rejas Gutiérrez, J. et al. Linguistic Adaptation and Validation of the Spanish Version of the Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM®). Clin. Drug Investig. 26, 103–112 (2006). https://doi.org/10.2165/00044011-200626020-00005

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