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European content validation of the Self-Assessment Goal Achievement (SAGA) questionnaire in patients with overactive bladder

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Abstract

Introduction and hypothesis

The Self-Assessment Goal Achievement (SAGA) questionnaire is a patient-completed instrument designed to assess goal attainment in the behavioral or pharmacologic treatment of lower urinary tract symptoms (LUTS), including overactive bladder (OAB). The SAGA questionnaire allows patients to identify and rank the importance of treatment goals before treatment is initiated; the follow-up SAGA questionnaire quantifies the achievement of these patient-identified goals. The objective of this qualitative research was to confirm the content validity of the German, Spanish, Swedish, and English (UK) language versions of the SAGA questionnaire in patients with OAB with or without other LUTS.

Methods

The SAGA questionnaire was translated to each language in accordance with a well-established forward and backward harmonization method. Patient interviews were then conducted according to a cognitive debriefing methodology. Qualitative analysis of patients’ input allowed assessment of content validity of each linguistically adapted SAGA questionnaire.

Results

All patients (n = 29; six to eight per targeted country) found the SAGA questionnaire easy to understand and to complete. Most patients completed the nine prespecified (fixed) treatment goals and were able to add up to five personal goals in the open-ended portion and rate each goal by importance. Differences were identified in how the various languages communicated some of the concepts assessed with the SAGA questionnaire. Rewording of the translated versions of the questionnaire was necessary in some cases.

Conclusions

This linguistic content validation study in four European languages indicates that SAGA is a comprehensive, easy-to-understand, and relevant questionnaire for patient-completed evaluation of LUTS/OAB symptoms and treatment goal attainment.

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Acknowledgments

This study was sponsored by Pfizer. Shannon E. Tully, Elisabeth C. Piault are employees of Mapi Values who were paid consultants to Pfizer in connection with the development of this manuscript. Editorial assistance was provided by Diane DeHaven-Hudkins and Peter A. Rittenhouse from Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Conflicts of interest

VK was a paid consultant to Pfizer in connection with the development of this manuscript and is the vice chair of the British Society of Urogynaecology. CJK was a paid consultant to Pfizer in connection with the development of this manuscript and serves on the boards of Astellas, Pfizer, and Johnson and Johnson. SET was a paid consultant to Pfizer in connection with the development of this manuscript and is an employee of Mapi Values, who were paid contractors to Pfizer in the development of this manuscript. ECP is an employee of Mapi Values, who were paid contractors to Pfizer in the development of this manuscript. DW, AB, and MK are employees of Pfizer Inc.

Author information

Authors and Affiliations

  1. Department of Urogynecology, St. Mary’s Hospital, Imperial College, Cambridge Wing, Praed Street, London, W2 1NY, UK

    Vik Khullar

  2. Private Urological Office, Frankfurt, Germany

    Daniela Marschall-Kehrel

  3. Hospital Clinic, ICGON, Barcelona, Spain

    Montserrat Espuna-Pons

  4. Guys and St. Thomas’ Hospital, NHS Foundation Trust, London, UK

    Con J. Kelleher

  5. Mapi Values, Boston, MA, USA

    Shannon E. Tully & Elisabeth C. Piault

  6. Loyola University Chicago, Chicago, IL, USA

    Linda Brubaker

  7. Karolinska University Hospital, Stockholm, Sweden

    Aino Fianu-Jonasson

  8. Pfizer International, Paris, France

    David Weinstein, Agneta Bergqvist & Marion Kvasz

Authors
  1. Vik Khullar
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  2. Daniela Marschall-Kehrel
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  3. Montserrat Espuna-Pons
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  4. Con J. Kelleher
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  5. Shannon E. Tully
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  6. Elisabeth C. Piault
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  7. Linda Brubaker
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  8. Aino Fianu-Jonasson
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  9. David Weinstein
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  10. Agneta Bergqvist
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  11. Marion Kvasz
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Corresponding author

Correspondence to Vik Khullar.

Additional information

VK, CJK, SET, ECP, LB, DW, AB, and MK have contributed to the development of the SAGA questionnaire. All authors contributed substantially to the conception and design of the present study. VK, DMK, CJK, MEP, and AFJ were responsible for data collection. SET and ECP were responsible for data analysis. All authors participated in interpreting the data and drafting/critically revising the manuscript, and all authors have approved submission of the final draft of the manuscript.

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Khullar, V., Marschall-Kehrel, D., Espuna-Pons, M. et al. European content validation of the Self-Assessment Goal Achievement (SAGA) questionnaire in patients with overactive bladder. Int Urogynecol J 24, 1529–1536 (2013). https://doi.org/10.1007/s00192-012-2039-x

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  • DOI: https://doi.org/10.1007/s00192-012-2039-x

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