Visit-wise changes in LS mean MADRS total score are shown in Figure 2.
Inferential statistical analyses were not conducted for the visit-wise data, as there were limited numbers of observations, instead the visit-wise data are summarized using descriptive statistics including means, percentages, medians, standard deviation, and p-values.
Visit-wise mean PANSS Total scores were compared by group using ANOVA adjusted for study at each time point.
Visit-wise mean PANSS Total score for patients in the learning data set are shown in Figure 4.
When MMRM analysis results indicated significant treatment-group trend differences (p < 0.05), post hoc visit-wise analyses were performed using patient data at each visit.
MRMM analysis of each QOLIE-89 subscales showed more improvement in patients allocated to VNS + BMP than in those receiving BMP alone; however, the differences were not significant: Epilepsy-targeted score (p = 0.06), Cognitive (p = 0.20), Mental Health (p = 0.33), and Physical Health (p = 0.17) (Table S2; visit-wise ANOVA data are provided in Table S3).
Visit-wise ANOVA showed that the benefit of VNS + BMP was significant for patients allocated to VNS + BMP, compared with those allocated to BMP alone at 3 and 12 months (p-values of 0.01 and 0.03, respectively), and a trend was observed at 9 months (p = 0.05) but not at 6 months (p = 0.49) (Fig. 4).
Visit-wise ANOVA showed that the benefit of VNS + BMP was maximal at 12 months (p = 0.01), with a mean (± standard deviation [SD]) improvement of 5.5 (±7.2) in patients allocated to VNS + BMP (n = 31) compared with 1.2 (±6.9) in those allocated to BMP alone (n = 29) (Fig. 2).
The visit-wise ANOVA data for the other time points were as follows: 3 months (p = 0.12; 47 VNS + BMP patients and 47 BMP patients), 6 months (p = 0.07; 38 VNS + BMP patients and 45 BMP patients), and 9 months (p = 0.50; 33 VNS + BMP patients and 35 BMP patients).
An e-mail or phone call a few weeks before your scheduled visit is wise, but at the very least, stop by their offices and introduce yourself.
