Table 3.
Adjusted analyses of primary efficacy outcome with previously used and modified approaches
| Model* | n† | OR (95% CI) | P value |
| mRS score of 0 or 1 at 90 days, analysis adjusted for baseline NIHSS score, time from onset to treatment (OTT), smoking and prior hypertension as reported in Hacke et al 1 and Bluhmki et al 16 | |||
| Previously reported adjusted analysis1 16 | 785 | 1.42 (1.02 to 1.98) | 0.037 |
| Missing—impute, NIHSS score—continuous, OTT—continuous | 794 | 1.25 (0.91 to 1.73) | 0.173 |
| Missing—impute, NIHSS score—continuous, OTT—categorical | 794 | 1.33 (0.96 to 1.85) | 0.086 |
| Missing—impute, NIHSS score—categorical, OTT—continuous | 794 | 1.29 (0.94 to 1.78) | 0.121 |
| Missing—impute, NIHSS score—categorical, OTT—categorical | 794 | 1.38 (0.99 to 1.92) | 0.054 |
| Missing—exclude, NIHSS score—continuous, OTT—continuous | 785 | 1.30 (0.94 to 1.80) | 0.119 |
| Missing—exclude, NIHSS score—continuous, OTT—categorical | 785 | 1.38 (0.99 to 1.93) | 0.056 |
| Missing—exclude, NIHSS score—categorical, OTT—continuous | 785 | 1.33 (0.96 to 1.84) | 0.087 |
| Missing—exclude, NIHSS score—categorical, OTT—categorical | 785 | 1.42 (1.02 to 1.98) | 0.037 |
| mRS score of 0 or 1 at 90 days, analysis adjusted for history of stroke, baseline NIHSS score, OTT, smoking, prior hypertension and nine other variables as reported in Bluhmki et al 16 (‘full model’) | |||
| Previously reported ‘full model’16 | 784 | 1.43 (1.02 to 2.00) | 0.040 |
| Missing—impute, NIHSS score—continuous, OTT—continuous | 791 | 1.27 (0.91 to 1.76) | 0.156 |
| Missing—impute, NIHSS score—continuous, OTT—categorical | 791 | 1.34 (0.96 to 1.87) | 0.086 |
| Missing—impute, NIHSS score—categorical, OTT—continuous | 791 | 1.31 (0.94 to 1.81) | 0.112 |
| Missing—impute, NIHSS score—categorical, OTT—categorical | 791 | 1.38 (0.99 to 1.93) | 0.059 |
| Missing—exclude, NIHSS score—continuous, OTT—continuous | 782 | 1.32 (0.95 to 1.84) | 0.102 |
| Missing-exclude, NIHSS score-continuous, OTT-categorical | 782 | 1.39 (0.99 to 1.95) | 0.055 |
| Missing-exclude, NIHSS score-categorical, OTT-continuous | 782 | 1.35 (0.97 to 1.88) | 0.076 |
| Missing-exclude, NIHSS score-categorical, OTT-categorical | 782 | 1.43 (1.02 to 2.00) | 0.039 |
Statistically significant differences are in bold.
*Missing—impute means patients with missing components of baseline NIHSS score had a value of 0 imputed for the missing component(s) and then baseline NIHSS score was computed with range 0–46. Missing—exclude means patients with missing components of baseline NIHSS score were excluded from analysis. NIHSS score—continuous means baseline NIHSS score treated as a continuous variable. NIHSS score—categorical means baseline NIHSS score treated as a five-category (0–5, 6–10, 11–15, 16–20, 20+) variable. OTT—continuous means OTT treated as a continuous variable. OTT—categorical means OTT treated as a seven-category variable (15 min windows).
†n=794 for analyses excluding 27 patients with missing OTT data. n=785 same as for n=794 for analyses also excluding nine further patients with missing baseline NIHSS data. n=791 same as for n=794 analysis, also excluding one person missing dose information and two missing age. n=782 same as for n=791 analyses also excluding nine patients with missing baseline NIHSS data.
mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; OTT, time from symptom onset to treatment.