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In the focal score, the following seven areas were assessed: (1) body symmetry, (2) gait, (3) climbing, (4) circling behavior, (5) front limb symmetry, (6) compulsory circling, and (7) whisker response.
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The LSM difference in TDI focal score versus placebo was also significantly superior with NVA237 at weeks 12 and 52 (p=0.024 and p=0.038, respectively), and with tiotropium at week 52 (p=0.037; table 2).
NVA237 also significantly improved dyspnoea at week 26 (mean treatment difference in TDI focal score: 0.81; p=0.002), health status at week 52 (mean treatment difference in SGRQ total score: -3.32; p<0.001), and reduced the risk of moderate-to-severe COPD exacerbations (p=0.001) and the use of rescue medication (p=0.039), versus placebo.
A one-unit change in the TDI focal score represented the minimal important difference.
The test-retest reliability was assessed using scores from patients whose clinician endorsed zero for the TDI focal score.
significantly improved the TDI focal score at week 26 (2.13) compared with placebo (1.32), with a LSM treatment difference of 0.81 (95% CI 0.299 1.320; p=0.299 1.320
Dyspnoea was assessed using the Baseline Dyspnoea Index (BDI) focal score at baseline, and the Transition Dyspnoea Index (TDI) focal score on Days 28, 56 and 84.
A change of 1 point in the transitional dyspnoea index focal score is considered clinically meaningful [ 23], and there was a significant improvement in the cyclophosphamide group compared with placebo (+1.4 versus -1.3; P < 0.001).
Moreover, some authors proposed that the presence of a given focal score in MSGs could be the mandatory criterion to classify a patient as having SS [ 5].
The pre-specified analysis of the key secondary end point (Mahler Transition Dyspnoea Index focal score at 24 weeks (combined data set)) showed statistically significant improvements for both tiotropium+olodaterol FDCs versus their mono-components (nominal p<0.05) (table S6 in the online supplementary material).
Changes in TDI focal score were in the range of one unit when the group was stratified by a minimal change in the physician's global evaluation.
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