Colon to Rectum

Aliment Pharmacol Ther. 2024;59(9):1082–95

Bokemeyer B, Plachta-Danielzik S, Steiner IM, Pohlschneider D, Urzica E, Hartmann P, Zemke J, Tappe U, Schreiber S, Steinkat N, Langbrandtner J, Hüppe A, Stargardt T

Inflammatory bowel disease (IBD) patients with impaired quality of life on biologic therapy benefit from the support of an IBD nurse specialist: Results of a randomised controlled trial in Germany (IBDBIO-ASSIST study)

Background: IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by inflammatory bowel disease (IBD) nurse specialists in Germany in improving health-related quality of life (QoL) in IBD patients on biologic therapy.
Aim: To evaluate patient-related outcomes and economic consequences associated with integrating IBD nurses into usual care.
Methods: The authors randomly assigned 1086 patients with IBD on biologic therapy to a control group (CG) receiving usual care or an intervention group (IG) receiving additional care from an IBD nurse specialist. The primary outcome was disease-specific QoL (sIBDQ) assessed at 6, 12 and 18 months.
Results: At baseline, patients in both groups were highly satisfied with their treatment situation and had relatively high sIBDQ values (range, 1–7; CG 5.12; IG 4.92). In the intention-to-treat analysis of the overall sample, there was no significant difference in sIBDQ between groups at the assessment time points. However, a per-protocol analysis of patients with impaired QoL at baseline (EQ-VAS < 75 [median]), showed improvement in sIBDQ over 6 months that became significant at month 12 and remained significant through month 18 (baseline: IG 4.24; CG 4.31; 18 months: IG 5.02; CG 4.76; p = 0.017).

Conclusion: High baseline satisfaction of inflammatory bowel disease (IBD) patients with treatment and the relatively high baseline disease-specific quality of life (sIBDQ) values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired quality of life derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term.

DOI: 10.1111/apt.17926