Statistical methods for primary and secondary outcomes {20a}
SECONDARY
A descriptive analysis of all collected patient information and data (as well as the scales that can be formed from the instruments) is performed: mean, standard deviation, median, minimum, and maximum, for continuous variables and absolute and relative frequencies for categorical variables.For all (primary and secondary) analyses, the intervention arm (HELP intervention: decision coaching and decision aid) will be compared against the control arm (standard care/decision situation). The primary outcome measure is the sum score of the clarity of personal attitude dimension of the Decisional Conflict Scale (DCS). In addition to the descriptive evaluation, it will be analyzed by group comparisons (non-parametric comparison: van Elteren test) between the two study groups in which the stratification of randomization is considered.For the sum scores and scales of the secondary outcomes, group comparisons (taking stratification into account) are also performed in order to detect significant differences. Depending on the group, the Cochran-Mantel-Haenszel test, the van Elteren test, or an analysis of covariance are used.Results are reported along with descriptive Variables, measures, and methods of analysis