Using GI-specific patient outcome measures in renal transplant patients: validation of the GSRS and GIQLI.
BACKGROUND
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.
Kleinman
Leah
L
Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA. leah.kleinman@unitebiosource.com
Kilburg
Anne
A
Machnicki
Gerardo
G
Faull
Randall
R
Walker
Rowan
R
Prasad
Ramesh
R
Ambuehl
Patrice
P
Bahner
Udo
U
Margolis
Mary Kay
MK
D000328:Adult; D003430:Cross-Sectional Studies; D019049:Developed Countries; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011594:Psychometrics; D011788:Quality of Life
D007166:Immunosuppressive Agents