Research Article

Noninferiority and Equivalence Evaluation of Clinical Performance among Computed Radiography, Film, and Digitized Film for Telemammography Services

Table 4

Equivalence tests () for TN, TP, FN, and FP by paired devices.

VariableCompared devicesMean difference ()SE⁢(1-2α)% confidence interval for equivalence testing
() device() deviceLowerUpper

TNLUMIXICR −0.006 0.0102 −0.023 0.011−9.22<0.001Ha
LUMIXCR −0.006 0.0084 −0.020 0.008−11.20<0.001Ha
LUMIXFILM −0.016 0.0098 −0.032 0.000−8.53<0.001Ha
ICRCR 0.000 0.0091 −0.015 0.015−10.96<0.001Ha
ICRFILM −0.010 0.0097 −0.026 0.006−9.25<0.001Ha
FILMCR 0.010 0.0067 −0.001 0.021−13.49<0.001Ha

TPLUMIXICR 0.016 0.0098 0.000 0.032−8.53<0.001Ha
LUMIXCR −0.008 0.0104 −0.025 0.009−8.86<0.001Ha
LUMIXFILM −0.031 0.0122 −0.051 −0.011−5.68<0.001Ha
ICRCR −0.024 0.0104 −0.042 −0.007−7.26<0.001Ha
ICRFILM −0.047 0.0135 −0.069 −0.025−3.94<0.001Ha
FILMCR 0.022 0.0152 −0.003 0.047−5.11<0.001Ha

FNLUMIXICR −0.016 0.0098 −0.032 0.000−8.53<0.001Ha
LUMIXCR 0.008 0.0104 −0.009 0.025−8.86<0.001Ha
LUMIXFILM 0.031 0.0122 0.011 0.051−5.68<0.001Ha
ICRCR 0.024 0.0104 0.007 0.042−7.26<0.001Ha
ICRFILM 0.047 0.0135 0.025 0.069−3.94<0.001Ha
FILMCR −0.022 0.0152 −0.047 0.003−5.11<0.001Ha

FPLUMIXICR 0.006 0.0102 −0.011 0.023−9.22<0.001Ha
LUMIXCR 0.006 0.0084 −0.008 0.020−11.20<0.001Ha
LUMIXFILM 0.016 0.0098 0.000 0.032−8.53<0.001Ha
ICRCR 0.000 0.0091 −0.015 0.015−10.96<0.001Ha
ICRFILM 0.010 0.0097 −0.006 0.026−9.25<0.001Ha
FILMCR −0.010 0.0067 −0.021 0.001−13.49<0.001Ha

Each comparison was calculated from 980 observations (70 cases, seven radiologists, and two devices). TN: true negative proportion, TP: true positive proportion, FN: false negative proportion, FP: false positive proportion, SE: standard error of the mean, Ho: null hypothesis, Ha: alternative hypothesis for testing equivalence, α: significance of the test (0.05), δ: difference of the means allowed to achieve equivalence, : test for difference of compared devices, that is, = (Difference ()δ)/SE, : retained hypothesis equivalence at level (“Ha” indicates equivalence achieved and “Ho” indicates failing to reject the null hypothes).
Ho: difference ()δ = 0.
Ha: difference ()δ < 0.