OBJECTIVES: To develop and validate a brief questionnaire to evaluate the effects of gastrointestinal (GI) symptoms on HRQoL in solid-organ transplant recipients. METHODS: Two phases study: 1)Development of pilot version of questionnaire (SIGIT-QOL): bibliography review, list of areas and items included in the questionnaire, panels of 8 experts and 50 patients and questionnaire modification to reach consensus and final version, and 2)Questionnaire validation: multicenter (34 centers) observational 6 weeks study in solid-organ transplant recipients (kidney, liver, heart and lung) 3 to 12 weeks post-transplantation. Patients responded to the new questionnaire and to the GastroIntestinal Quality of Life Index-GIQLI; age, sex, transplant date, acute rejection and GI symptoms evaluated by physicians were registered. Psychometric properties of SIGIT-QOL questionnaire (feasibility, content, construct and convergent validity and reliability) were evaluated. RESULTS: The first phase generated a questionnaire of 17 items. 274 patients participated in second phase: mean age 52.7(7.59)years, 66.3%males. Mean time from transplant 6.7(3.1) months, 44(16.4%) patients presented acute rejection and 44.4% GI symptoms. 95.5% patients responded to all items of SIGIT-QOL in 6.37(5.6) minutes vs 12.12(11.83) minutes of GIQLI. According to factorial analysis, all items were grouped in one dimension with a reliability (Cronbach’s alpha) of 0.88. Mean score was 57.80(9.8) (theoretical range:0-68). A moderate, positive significant correlation with GIQLI (r= 0.67), and a mild negative correlation with physician’s evaluation of GI symptoms, were found. CONCLUSIONS: A new 17-items questionnaire SIGIT-QOL has been developed; it shows good feasibility, validity and reliability to evaluate the effects of gastrointestinal symptoms on health related-QoL in solid-organ transplant recipients with a functioning graft.