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ABSTRACT: Background and aims
To inform their future use in regulated clinical trials to evaluate treatment efficacy hypotheses, the measurement properties of three histological indices, Geboes Score [GS], Robarts Histopathology Index [RHI] and Nancy Index [NI], were evaluated among patients with ulcerative colitis.Methods
Analyses were conducted on data from a Phase 3 clinical trial of adalimumab [M14-033, n = 491] and focused on evaluating the measurement properties of the GS, RHI and NI. Specifically, internal consistency and inter-rater reliability, convergent, discriminant and known-group validity, and sensitivity to change were assessed at Baseline, and at Weeks 8 and 52.Results
Internal consistency for the RHI showed lower alpha [α] values at Baseline [α = 0.62] relati
SUBMITTER: Peyrin-Biroulet L
PROVIDER: S-EPMC10673803 | biostudies-literature | 2023 Nov
REPOSITORIES: biostudies-literature