Translation, validation and psychometric properties of the Dutch version of the Inflammatory Bowel Disease-Fatigue (IBD-F) self-assessment scale.

BACKGROUND: In patients with inflammatory bowel disease (IBD), a symptom with major impact on health-related quality of life is fatigue. To assess fatigue and conduct research regarding fatigue in IBD patients, a validated disease specific assessment tool is required. The aim of this study was to translate the Inflammatory Bowel Disease Fatigue patient self-assessment scale (IBD-F) into Dutch and to validate this translated scale in a Dutch IBD population. METHODS: The study comprised three phases. In phase 1, the original IBD-F was translated into Dutch. Phase 2 comprised a pilot-test of the pre-final Dutch IBD-F to assess content validity by applying a semi-structured interview design. In phase 3, construct validity, internal consistency and test-retest reliability were assessed using a cross-sectional design. RESULTS: Phase 1 resulted in the pre-final version of the Dutch IBD-F. After five semi-structured interviews with IBD patients in phase 2, minor adjustments were made which resulted in the final version of the Dutch IBD-F. Evaluation of this final version in 133 IBD patients showed adequate psychometric properties: good convergent validity with the Multidimensional Fatigue Inventory subscales (Spearman's r 0.57-0.86) and excellent internal consistency (Cronbach's alpha 0.94 for Section I and 0.97 for Section II). Test-retest reliability in 102 patients was shown to be good (Section I ICC 0.85 (95% CI 0.79-0.90) and Section II ICC 0.88 (95% CI 0.83-0.92)). CONCLUSIONS: The thorough translation process resulted in a comprehensible, valid and reliable version of the Dutch IBD-F. Convergent validity with the MFI-20 appeared to be good. This study found excellent internal consistency and good test-retest reliability.

Relapse rates after withdrawal versus maintaining biologic therapy in IBD patients with prolonged remission.

Biologic treatment withdrawal in inflammatory bowel disease patients with prolonged remission may lead to benefits but also increases the risk of getting a relapse. The risk of relapse after biologic withdrawal according to the Dutch STOP-criteria is still unknown. The aim of this study was to compare the cumulative incidence of relapse in inflammatory bowel disease patients that discontinued biologic therapy after applying the STOP-criteria with patients who maintained biologic therapy. We performed a mono-centre, observational, retrospective study by evaluating relapse risk of patients treated with biologic agents who discontinued this treatment according to the STOP-criteria (STOP-group) compared to patients who were in remission for more than 3 years before withdrawal (LATERSTOP-group) and patients who continued their biologic (MAINTAIN-group). The cumulative risk was calculated at 12 and 36 months using the log-rank test to compare Kaplan-Meier curves. Eighty-three of 398 patients that used biologics between 1 January 2010 and 1 January 2020 were included. The cumulative relapse incidences in the STOP-group and the LATERSTOP-group were, respectively, 29% and 42% at 12 months and 47% versus 58% at 36 months. Patients in the MAINTAIN-group showed a lower (p = 0.03) cumulative relapse incidence of 10% at 12 months and 18% at 36 months. Patients who discontinued their biologic therapy according to the STOP-criteria had significantly more relapses at 12 and 36 months than patients who maintained biologic treatment.