Statistical analysis
migraine
MIGRAINE, HEAT
A statistical analysis plan was developed prior to the execution of this post-hoc analysis. In this post-hoc analysis, reliability, validity, responsiveness (ability to detect change), and meaningful within-patient change in WPAI score were assessed before the use of the 3 anchor-based responder definitions indicated above. WPAI absenteeism, presenteeism, overall work productivity, and non-work-related activity impairment scores are calculated from the responses of the 6 items of the WPAI (employment status, hours missed from work due to migraine, hours missed from work for other reasons, hours actually worked, degree migraine affected productivity while working and degree migraine affected productivity in regular unpaid activities) as impairment percentages [The methods for anchor selection included evaluating Spearman’s correlation analyses to test hypotheses about relationships between outcome variables at baseline (overall, and EM/CM subpopulations). Correlations between outcomes were determined using the non-parametric Spearman’s rank correlation coefficient (Rho) because the data is not assumed to be normally distributed. Multiple outcomes were evaluated, and heat maps were created by plotting Spearman’s Rank Correlation Coefficients (Rho) between these outcomes and the WPAI. Absolute value of Rho > 0.90 to ≤ 1.00 indicated very high correlation, ≥ 0.70 to ≤ 0.90 indicated high correlation, ≥ 0.60 to < 0.70 indicated moderate high correlation, ≥ 0.50 to < 0.6 indicated moderate correlation, ≥ 0.40 to < 0.50 indicated moderate low correlation, ≥ 0.30 to < 0.40 indicated low correlation, and 0.00 to ≤ 0.30 indicated negligible correlation. These methods resulted in the selected anchors, as the other outcomes had weaker associations and were not suitable anchors, such as the MSQ Emotional Domain [