Using GI-Specific Patient Outcome Measures in Renal Transplant Patients: Validation of the GSRS and GIQLI

• Published in: Quality of life research Vol. 15; no. 7; pp. 1223 - 1232
• Main Authors: Kleinman, Leah, Kilburg, Anne, Machnicki, Gerardo, Faull, Randall, Walker, Rowan, Prasad, Ramesh, Ambueh, Patrice, Bahner, Udo, Margolis, Mary Kay
• Format: Journal Article
• Language: English
• Published: Netherlands Springer 01.09.2006; Springer Nature B.V
• Subjects: Abdominal pain; Adult; Constipation; Cross-Sectional Studies; Developed Countries; Diarrhea; Dyspepsia; Female; Gastrointestinal Tract - drug effects; Gastrointestinal Tract - physiopathology; Humans; Immunosuppressive Agents - adverse effects; Instrument Development and Evaluation; Kidney Transplantation - immunology; Kidney transplants; Male; Middle Aged; Outcome Assessment (Health Care); Psychometrics; Quality of Life; Questionnaires; Symptoms; Transplantation; Transplants & implants; Wellbeing
• ISSN: 0962-9343; 1573-2649
• DOI: 10.1007/s11136-006-0053-5

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.