title: Using GI-specific patient outcome measures in renal transplant patients: validation of the GSRS and GIQLI.
abstract: 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.
authors.affiliation: Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA. leah.kleinman@unitebiosource.com
authors.forename: Leah
authors.initials: L
authors.lastname: Kleinman
authors.forename: Anne
authors.initials: A
authors.lastname: Kilburg
authors.forename: Gerardo
authors.initials: G
authors.lastname: Machnicki
authors.forename: Randall
authors.initials: R
authors.lastname: Faull
authors.forename: Rowan
authors.initials: R
authors.lastname: Walker
authors.forename: Ramesh
authors.initials: R
authors.lastname: Prasad
authors.forename: Patrice
authors.initials: P
authors.lastname: Ambuehl
authors.forename: Udo
authors.initials: U
authors.lastname: Bahner
authors.forename: Mary Kay
authors.initials: MK
authors.lastname: Margolis
mesh_terms: 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
chemical_list: D007166:Immunosuppressive Agents