C. Greis1, N. Mayer2, P. Guder3, P. Hendy4, D. Burger4, N. Martin4, L. Young4, G. Holtmann4, 1University of Duisburg-Essen, Germany, 2University of Tuebingen, Germany, 3LMU Munich, Germany, 4Princess Alexandra Hospital, Department of Gastroenterology and Hepatology, Brisbane, Australia
Controlling inflammatory activity and healing of mucosal lesions as well as Quality of Life (QoL) are now considered to be major targets for treatment of patients with inflammatory bowel disease (IBD). However, in the clinical setting the patient's subjective unmet need is rarely assessed.
Thus we aimed a) to develop and validate an instrument that assesses the unmet need of IBD patients and b) to identify the role of inflammatory activity on the unmet need. In focus group interviews 14 items were identified. These items were tested in a cohort of 80 consecutive IBD patients (Age: 40.26±1.52; years of disease: 9.4±1.18), 52 patients with Crohn's disease (CD; Montreal Classification [%] A1:5.3 A2:78.9 A3:15.8; L1:32.5 L2:22.5 L3:45.0; B1:61.1 B2:30.6 B3:8.3; p+:43.2) and 28 ulcerative colitis (UC; Montreal Classification [%] A1:0 A2:93.3 A3:6.7; E1:23.1 E2:46.2 E3:30.7).
Factor analysis revealed 5 factors that explained more than 70% of variance. These factors were labelled: 1) Disease Control, 2) Treatment simplicity, 3) Diarrhoea & Prevention, 4) Cure, 5) Abdominal Pain.
The highest unmet need scores were reported for the factors Diarrhoea & Prevention (6.54±0.11), Abdominal Pain (6.49±0.13) and Disease Control (6.23±0.11), followed by the factors Cure (5.78±0.14) and Simplicity of Treatment (5.52±0.13). Interestingly, the various unmet need scores of IBD-Patients were statistically not significant correlated with CRP (Table 1).
| ||Disease control||Treatment simplicity||Diarrhoea & Prevention||Cure||Abdominal pain|
The newly developed “Unmet Need questionnaire” is a tool to better characterise and target patients' needs. Unmet Need to treat “Diarrhoea” and “Abdominal Pain” were ranked highest by the patients. However, the Unmet Need was not linked to disease activity as measured by CRP or other inflammatory markers. While the medical management primarily now targets control of inflammation and long term prevention of complications, there is a substantial Unmet Need in relation to symptoms and in a broader term “concerns”, that are not linked to inflammatory activity.