Lebensqualität bei chronisch entzündlichen Darmerkrankungen (CED): die deutsche Version des Inflammatory Bowel Disease Questionnaire (IBDQ-D) zur krankheitsspezifischen Lebensqualitätsmessung - erste Anwendung und Vergleich mit anderen internationalen Fassungen

Abstract

International data suggest that the IBDQ-D is a suitable instrument for HRQOL-assessment in CD and UC. For both disease a statistically significant negative correlation with disease activity was found. Tested psychometric properties do not suggest that a revision of the IBDQ-D is required. The IBDQ-D offers the HRQOL-assessment as an primary or secondary outcome in clinical trials in IBD in Germany.

Comprehensive Lifestyle-Modification in Patients with Ulcerative Colitis–A Randomized Controlled Trial

“…The topic of health-related quality of life is of great importance for patients with ulcerative colitis. Although quality of life impairment is strongly related to disease activity, it is also limited during phases of mild disease activity or even in remission [34][35][36][37]. Therefore, the need to improve the quality of life, and thus relieve the overall disease burden, is very high and oftentimes not part of standard medical treatment [5,10,14].…”

The ABACHAI clinical trial protocol: Safety and efficacy of abatacept (s.c.) in patients with CTLA-4 insufficiency or LRBA deficiency: A non controlled phase 2 clinical trial

“…anti-fungal, or i.v. anti-viral treatments which are conducted solely for preventive reasons Secondary Efficacy assessment of abatacept overall survival (OS) event free survival (EFS) treatment failure, defined as any premature termination of treatment for any reason cumulative steroid dose cumulative dose of concomitant drugs to alleviate symptoms such as diarrhea medications or pain medication Clinical Global Impression – Improvement scale (CGI-I) quality of life measured by SF36 [ 23 ] CHAI-Morbidity Score laboratory parameters In addition, endpoints dependent on the patient's organ involvement: Patients with lung involvement: lung function parameters chest computed tomography (CT) scan St. George Respiratory Questionnaire (SGRQ) [ 24 ] Borg dyspnea scale Patients with gut involvement (enteropathy): stool frequency and quality Inflammatory Bowel Disease Questionnaire (IBDQ) [ [25] , [26] , [27] ] calprotectin level in stool Patients with cytopenias: number of bleeding episodes and/or number of platelet transfusions needed Transfusion independency or number of transfusions of red blood cells Patients with central nervous system (CNS) involvement: improvement in neurological assessment, based on neurological examination using the Neurologic Assessment in Neuro-Oncology (NANO) Scale [ 28 ] cranial magnetic resonance imaging (cMRI)/cranial computed tomography (cCT) Patients with lymphoproliferation: spleen size measured by ultrasonography number of enlarged abdominal + peripheral lymph node groups Patients with involvement of immune system: Absolute total lymphocyte count Absolute total CD4 + T cell count Naïve T cells (% of CD4 + , CD45RA+) Activated CD4 + T cells (HLA-DR+ in CD4 + ) PD1+ CD8 + cells (%) Switched memory B cells (CD19/20+, IgM-, CD27 + ) Patients with skin involvement: percentage of body surface involved kind and severity of lesions …”

Validation of the German Inflammatory Bowel Disease Fatigue (IBD-F) Questionnaire

“…The German Competence Network IBD version of the IBDQ-D assesses patients' quality of life. The total score of the 32-item IBDQ-D was calculated according to Haueser and colleagues [24]. The total score ranges from 1.0 to 7.0, with higher scores indicating a higher quality of life.…”