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)
© 2024 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd..
BACKGROUND: IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by 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: We 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 (ITT) 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 IBD patients with treatment and the relatively high baseline sIBDQ values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired QoL derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:59 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 59(2024), 9 vom: 01. Apr., Seite 1082-1095 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bokemeyer, Bernd [VerfasserIn] |
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| Links: |
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| Themen: |
IBD nurse specialist |
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| Anmerkungen: |
Date Completed 10.04.2024 Date Revised 10.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/apt.17926 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM369197666 |
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| 245 | 1 | 0 | |a Inflammatory bowel disease (IBD) patients with impaired quality of life on biologic therapy benefit from the support of an IBD nurse specialist |b Results of a randomised controlled trial in Germany (IBDBIO-ASSIST study) |
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| 520 | |a © 2024 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by IBD nurse specialists in Germany in improving health-related quality of life (QoL) in IBD patients on biologic therapy | ||
| 520 | |a AIM: To evaluate patient-related outcomes and economic consequences associated with integrating IBD nurses into usual care | ||
| 520 | |a METHODS: We 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 | ||
| 520 | |a 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 (ITT) 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) | ||
| 520 | |a CONCLUSION: High baseline satisfaction of IBD patients with treatment and the relatively high baseline sIBDQ values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired QoL derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a IBD nurse specialist | |
| 650 | 4 | |a inflammatory bowel disease (IBD) | |
| 650 | 4 | |a quality of life (QoL) | |
| 650 | 4 | |a sIBDQ | |
| 700 | 1 | |a Plachta-Danielzik, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Steiner, Isa Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Pohlschneider, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Urzica, Eugen |e verfasserin |4 aut | |
| 700 | 1 | |a Hartmann, Petra |e verfasserin |4 aut | |
| 700 | 1 | |a Zemke, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Tappe, Ulrich |e verfasserin |4 aut | |
| 700 | 1 | |a Schreiber, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Steinkat, Nadine |e verfasserin |4 aut | |
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| 700 | 1 | |a Hüppe, Angelika |e verfasserin |4 aut | |
| 700 | 1 | |a Stargardt, Tom |e verfasserin |4 aut | |
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