P688 The SOLE Survey: Disease related concerns of a large cohort of Italian patients with active Crohn's Disease
A. Armuzzi*1, G. Riegler2, F. Furfaro3, M. Baldoni4, F. Costa5, M. Fortuna6, M. Vecchi7, G. Iaquinto8, P. Paese9, C. Papi10, F. Bossa11, V. Tornatore12, F. Rizzello13
1Complesso Integrato Columbus, Università Cattolica del Sacro Cuore, IBD Unit, Roma, Italy, 2Seconda Università di Napoli, Gastroenterology, Napoli, Italy, 3Ospedale Universitario L. Sacco, Gastroenterology, Milano, Italy, 4Università di Perugia, Gastroenterology, Perugia, Italy, 5Azienda Ospedaliero-Universitaria Pisana, Gastroenterology, Pisa, Italy, 6Ospedale Sacro Cuore Don Calabria, Gastroenterology, Negrar-Verona, Italy, 7Irccs Policlinico San Donato, Gastroenterology, Milano, Italy, 8Azienda Ospedaliera San Giuseppe Moscati, Gastroenterology, Avellino, Italy, 9Azienda Ospedaliera di Cosenza, Gastroenterology, Cosenza, Italy, 10Azienda Ospedaliera San Filippo Neri, Gastroenterology, Roma, Italy, 11Ospedale Casa Sollievo della Sofferenza, Gastroenterology, San Giovanni Rotondo, Italy, 12AbbVie srl, Medical Affairs, Campoverde, Italy, 13Policlinico S. Orsola-Malpighi, Gastroenterology, Bologna, Italy
Background
A large Survey on Quality Of Life in Crohn's PatiEnts (SOLE) was conducted in 38 Italian IBD centres on adults with active moderate-to-severe Crohn's disease (Harvey-Bradshaw Index [HBI] ≥ 8), with the aim to assess health-related quality of life (QoL) over a 12-month period. Namely, patients' perception of their experience and discomfort, as a number of social, cultural and psychological factors, was gathered. Here we report the final results on patients' disease-related worries and its correlation with demographic and clinical variables.
Methods
Disease-related worries were measured at baseline and at 3, 6, and 12 months by the Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC). Results were correlated with demographic and clinical variables with multilevel mixed effect linear regression models.
Results
552 patients with active CD (51% males, mean age 41.3 ± 13 yr, range 18-84) were recruited.
Mean HBI was 10.3 (SD 3.2) at baseline, dropped to 5.6 (3.2) at the first follow-up visit and to 4.4 (3.2) at the last visit. Accordingly, all associated symptoms (nausea, vomit, weight loss, anemia, asthenia, fever) showed at least a 50% decrease at last visit.
Mean RFIPC was 47.5 (21.9; range 0-100) at baseline and progressively declined to 44.5 (21.8) at 12 months; the decrease was statistically significant both at the 6 and at the 12 months visit (p=0.026 and p<0.01).
Higher worries were having an ostomy bag and undergoing surgery (68.6 and 67.9 at baseline, with no significant reduction at 12 months).
Significant changes in RFIPC scores from baseline are shown in table 1.
Variables significantly associated with a higher global RFIPC score based on a linear regression model included disease activity (p<0.001), age older than 41y.o. (p=0.0016), and being a smoker (p<0.001). Patient’s with high treatment adherence (defined as Medication Adherence Rating Score [MARS] ***25) had lower mean RFIPC scores at all study visits compared to those with low adherence (<0.001).
Conclusion
Our survey underlines that major worries among CD patients are having an ostomy bag and undergoing surgery. Moreover, major worries are significantly associated with the degree of disease activity and low adherence to treatment.
