Abstract

characteristic (ROC) curves. The strength of relationship was evaluated according to conventional thresholds whereby 0.2, 0.5, and 0.8 indicate small, moderate, and large degrees of responsiveness, respectively.1 Results: Among 121 patients, 29 were clinically unchanged and 92 were changed (Table 1). Between weeks 0 and 6 or 10, the effect sizes and Guyatt's responsiveness statistics (95% confidence intervals [CIs]) based on mean scores for the MMCS, MBS, and UCEIS were 0.49 (0.28, 0.71), 0.49 (0.28, 0.71), and 0.58 (0.36, 0.81) and 0.32 (0.11, 0.53), 0.33 (0.12, 0.54), and 0.47 (0.25, 0.69), respectively. The corresponding estimates (95% CI) for the areas under the ROC curves were 0.66 (0.55, 0.78), 0.65 (0.54, 0.77), and 0.68 (0.58, 0.79) The ROC curves are displayed in Figure 1. Conclusion: Although the UCEIS had greater numerical values, the MMCS, MBS, and UCEIS displayed similar, small-to-moderate, responsiveness for the assessment of UC disease activity. These results have important implications for sample size in early drug development.

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