title: Gastrointestinal (GI)-Specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a South American cohort.
abstract: BACKGROUND
  Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance. Patients on different immunosuppressant regimens may feel less bothered by Gastrointestinal (GI) side effects or report better health-related quality of life (HRQL). We evaluated the reliability and validity of two GI-specific outcome instruments (Gastrointestinal Symptom Rating Scale (GSRS; higher scores = increased severity) and Gastrointestinal Quality of Life Index (GIQLI; higher scores = better GI-specific HRQL)) in renal transplant patients in South America.
  
  
  METHODS
  Data from 5 South American centers participating in an international, longitudinal, observational study were analyzed. Patients were > or = 1 month post transplant and on mycophenolate mofetil (MMF) and a calcineurin inhibitor. Patients completed the GSRS, GIQLI, and Psychological General Well-Being (PGWB; higher scores = better HRQL) Index at baseline and at 4-6 weeks. Internal consistency, test-retest reliability and construct and discriminant validity were assessed.
  
  
  RESULTS
  Sixty-two participants were enrolled. Mean age was 42 years; mean time since transplant was 3.3 years; 57% were male; 65% received a deceased organ transplant and 68%had GI events. The GSRS and GIQLI demonstrated high internal consistency (Cronbach's alphas 0.72-0.96). Test-retest reliability was adequate (intraclass correlation coefficient > 0.6) for all GIQLI subscales and all GSRS subscales except Diarrhea and Reflux syndrome. Correlations between the GSRS and PGWB were moderate (range: -0.21 to -0.53, all p < 0.001 except 6 correlations with p < 0.05); correlations between the GIQLI and PGWB were higher (range: 0.36 to 0.71 p < 0.001), indicating good construct validity. The GSRS and GIQLI demonstrated good discriminant validity, as they clinically and statistically distinguished between patients with and without GI complaints and among patients with varying GI complication severity. Patients with GI complaints reported higher GSRS scores than patients without complaints (all p < 0.001). GIQLI scores were lower in patients with GI complaints than patients without complaints (all p < 0.001). The GSRS and GIQLI differentiated among patients with four GI severity levels (overall Kruskall-Wallis test p < 0.001, except for one scale). The GSRS and GIQLI are acceptable for use in South American renal transplant patients. These two instruments demonstrate adequate reliability and validity. Patients with GI complaints reported poor HRQL and strategies are needed to improve patients' HRQL.
authors.affiliation: Global Health Economics and Outcomes Research, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA. gerardo.machnicki@novartis.com
authors.forename: Gerardo
authors.initials: G
authors.lastname: Machnicki
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Pefaur
authors.forename: Luis
authors.initials: L
authors.lastname: Gaite
authors.forename: Ana M
authors.initials: AM
authors.lastname: Linchenco
authors.forename: Clemente
authors.initials: C
authors.lastname: Raimondi
authors.forename: Ruben
authors.initials: R
authors.lastname: Schiavelli
authors.forename: Alcira
authors.initials: A
authors.lastname: Otero
authors.forename: Mary Kay
authors.initials: MK
authors.lastname: Margolis
mesh_terms: D000328:Adult; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D016030:Kidney Transplantation / Q000276:immunology / Q000523:psychology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D013020:South America; D011795:Surveys and Questionnaires
chemical_list: D007166:Immunosuppressive Agents