Good overall cross-laboratory, cross-platform, and counting method agreement were achieved in CCQM-P102, with mean CD4+ cell counts in good agreement.
However, the ICC for the orthotist method agreement is somewhat higher (0.86) than the ones for podiatrists (0.77) and pedorthists (0.77).
Inter-method agreement was assessed by calculation of the Cohen's kappa statistic for binary and categorical variables, and Spearman's correlation coefficient for continuous variables.
The analysis of inter-method agreement was performed using the mean of three ultrasound measurements and one digital assessment.
Inter-method agreement was also expressed using intraclass correlation coefficient (ICC) calculated as two-way random variation of average measurements.
Inter-method agreement was excellent for HER2 amplification status using three different definitions (HER2/CEP17 ratio > 2.2, HER2/CEP17 ratio >2.0, mean HER2 number >6.0) with overall concordance rates of 96%, 96%and97%7%, respectively.
Inter-method agreement was evaluated for the following HER2 FISH parameters: HER2 copy number, CEP17 copy number, HER2/CEP17 ratio, proportion of carcinoma cells with HER2/CEP17 ratio ≥ 2.2, HER2 amplification status, HER2 genetic heterogeneity, the presence of HER2 gene clusters, and chromosome 17 polyploidy.
Intra- and inter-method agreement were assessed using the two-way random, single measures, absolute agreement form of the intra-class correlation coefficient (ICC).
Inter- and intra-observer, as well as inter-method agreement were assessed using Cohen's kappa, a statistical metric useful for measuring inter-rater agreement [21].
High levels of inter-method agreement were also found for HER2 copy number, CEP17 copy number, HER2/CEP17 ratio, the percentage of carcinoma cells with HER2/CEP17 ratio >2.2, and the presence of HER2 genetic heterogeneity, HER2 clusters and CEP17 polyploidy.
