Burden of Illness in Irritable Bowel Syndrome Comparing Rome I and Rome II Criteria Xavier Badia, 1,2 Fermin Mearin, 3 Agustin Balboa, 4 Eva Baró, 2 Ellen Caldwell, 5 Mercedes Cucala, 5 Manuel Díaz-Rubio, 6 Arturo Fueyo, 7 Julio Ponce, 8 Mentse Roset 1,2 and Nicholas J. Talley 9 1 Department of Clinical Epidemiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain 2 Health Outcomes Research Europe, Barcelona, Spain 3 Hospital Vall d’Hebron, Barcelona, Spain 4 Hospital Comarcal de la Selva, Barcelona, Spain 5 Novartis Farmacéutica, Barcelona, Spain 6 Hospital Clínico San Carlos, Madrid, Spain 7 GlaxoWellcome, Madrid, Spain 8 Hospital de la Fe, Valencia, Spain 9 University of Sydney, Sydney, Australia Abstract Objectives: To evaluate the burden of illness in irritable bowel syndrome (IBS), in terms of resource utilisation (direct and indirect) and health-related quality of life (HR-QOL), in individuals with IBS who meet Rome I and Rome II criteria. Methods: A cross-sectional study, carried out by personal interview, on a repre- sentative sample (n = 2000) of the Spanish population. Individuals with suspected IBS were identified via a screening question and subsequently given an epidemi- ological questionnaire to complete. The questionnaire collected information on IBS symptoms, resource utilisation, and HR-QOL [Medical Outcomes Study 36-item Short Form (SF-36)]. Results: Sixty-five individuals met Rome II criteria for IBS, while 146 individ- uals met exclusively Rome I criteria. Of Rome II individuals, 67.7% had con- sulted some type of healthcare professional in the previous 12 months, compared with only 41.8% of those individuals meeting exclusively Rome I criteria (p < 0.001). In the same vein, similar findings were observed (p < 0.01) for the vari- ables: ‘diagnostic tests’ (35.4 vs 17.1%); ‘drug consumption’ (70.8 vs 45.2%); and ‘reduced performance in main activity’ (60 vs 27.4%). Compared with the general population, the study sample reported significantly worse HR-QOL scores in four dimensions of the SF-36 (‘bodily pain’, ‘vitality’, ‘social function- ing’ and ‘role-emotional’. Additionally, individuals meeting Rome II criteria reported worse HR-QOL scores than those individuals meeting exclusively Rome I criteria, especially in the ‘bodily pain’ and ‘general health’ dimensions. Conclusions: The burden of illness in IBS is important and correlated to the ORIGINAL RESEARCH ARTICLE Pharmacoeconomics 2002; 20 (11): 749-758 1170-7690/02/0011-0749/$25.00/0 © Adis International Limited. All rights reserved.