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Using GI-specific patient outcome measures in renal transplant patients: Validation of the GSRS and GIQLI

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Abstract

Introduction: Gastrointestinal (GI) side-effects occur frequently as a result of immunosuppressant regimens used in renal transplant patients. Little effort has been made to quantify the impact of these side-effects on patients’ health-related quality of life and symptom severity. Objective: To assess the psychometric characteristics of two GI-specific outcome instruments (the Gastrointestinal Rating Scale (GSRS) and the Gastrointestinal Quality of Life Index (GIQLI)) for use in post-renal transplant patients. Methods: Cross-sectional study conducted at 5 clinical centers in 4 countries. Patients were required to be on mycophenolate mofetil and a calcineurin inhibitor. Patients completed the GSRS, GIQLI and two generic instruments (the Psychological General Well-Being Index and the EQ-5D) at one timepoint. Reliability, construct and known groups validity were assessed. Results: In general the GSRS and the GIQLI demonstrated Cronbach’s alphas higher than 0.70. The GIQLI was moderately to highly correlated with the PGWB and EQ-5D. Correlations among the GSRS and generic instruments were slightly lower. The GSRS and GIQLI both distinguished between patients with and without GI complaints (all p<0.05). Conclusions: The GSRS and the GIQLI are appropriate for use in a post-renal transplant population. Scores on both instruments demonstrated significant differences between renal transplant patients with GI complications and without GI complications.

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Authors and Affiliations

  1. Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA

    Leah Kleinman & Mary Kay Margolis

  2. Novartis Pharma AG, Basel, Switzerland

    Anne Kilburg & Gerardo Machnicki

  3. Royal Adelaide Hospital, Adelaide, Australia

    Randall Faull

  4. The Royal Melbourne Hospital, Melbourne, Australia

    Rowan Walker

  5. St. Michael’s Hospital, Toronto, Canada

    Ramesh Prasad

  6. Renal Division, University Hospital Zurich, Switzerland

    Patrice Ambuehl

  7. KfH Kuratorium für Dialyse u Nierentrasplantation, Würzburg, Germany

    Udo Bahner

  8. Center for Health Outcomes Research, United Biosource Corporation, 2601 Fourth Avenue, Suite 200, 98121, Seattle, WA, USA

    Leah Kleinman

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  1. Leah Kleinman
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  2. Anne Kilburg
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  3. Gerardo Machnicki
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  4. Randall Faull
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  7. Patrice Ambuehl
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  9. Mary Kay Margolis
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Correspondence to Leah Kleinman.

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Kleinman, L., Kilburg, A., Machnicki, G. et al. Using GI-specific patient outcome measures in renal transplant patients: Validation of the GSRS and GIQLI. Qual Life Res 15, 1223–1232 (2006). https://doi.org/10.1007/s11136-006-0053-5

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  • DOI: https://doi.org/10.1007/s11136-006-0053-5

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