Gastrointestinal (GI)-Specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a South American cohort

Gerardo Machnicki¹ , Jacqueline Pefaur² , Luis Gaite³ , Ana M Linchenco⁴ , Clemente Raimondi⁵ , Ruben Schiavelli⁶ , Alcira Otero⁷ and Mary Kay Margolis⁸

¹Global Health Economics and Outcomes Research, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA

²Nephrology and Transplant, Hospital Barros Luco, Santiago, Chile

³Nephrology and Transplant, Clinica de Urologia y Nefrologia, Santa Fe, Argentina

⁴Nephrology and Transplant, Hospital Italiano, Rosario, Argentina

⁵Neprhology and Transplant, Hospital Español, La Plata, Argentina

⁶Nephrology and Transplant, Hospital Argerich, Buenos Aires, Argentina

⁷Medical Department, Novartis Argentina, Buenos Aires, Argentina

⁸Center for Health Outcomes Research, United BioSource Corporation, Bethesda, MD, USA

author email corresponding author email

Health and Quality of Life Outcomes 2008, 6:53doi:10.1186/1477-7525-6-53


Published:	21 July 2008

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 ≥ 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.