Appendixe-2-Neurology.docVIP

Appendix e-2: Quantification of visit-to-visit variability in BP Visit-to-visit BP variability refers to variability between BP measurements taken on different days, with intervals of days, weeks or months between consecutive measurements. Intra-individual variability in such measurements will be comprised of contributions from both short-term and medium-term fluctuations in BP and longer-term underlying trends. Intra-individual visit-to-visit variability in BP can be estimated indirectly from group data on the distribution of BP values at single follow-up visits or can be calculated using individual patient data on actual BP values from repeated visits. 1. Use of group variability in BP at individual follow-up visits to estimate effects on intra-individual variability Variance in group BP at a single follow-up will be partly attributable to intra-individual visit-to-visit variation as well as differences between individuals in underlying mean BP. The expected inter-individual group variance of BP values at a single follow-up can therefore be estimated as the sum of the following variance components: inter-individual variance in mean BP, intra-individual visit-to-visit variance in BP and inter-individual variance in intra-individual visit-to-visit BP. Table e-4 shows an analysis of group and individual variability in SBP in which the observed levels of variance in group SBP at a single follow-up (taken as the average over several visits during two years of follow-up) is compared with expected levels in each of several cohorts based on the above model. The proportion of observed inter-individual group variance of SBP values at a single follow-up which could be attributed to intra-individual variability is estimated as the sum of the latter two variance components divided by the total variance and ranges from 41 to 51% depending on the cohort.e1 Effects of randomised treatment on group SD BP at single follow-ups has been shown to correlate well with effects on intra