Table 5:
Effect of study site and surgeon experience variability on (i) in vivo accuracy of PTeye® with surgeon as the gold standard, (ii) ex vivo accuracy of PTeye® with histology as gold standard and (iii) ex vivo accuracy of surgeons with histology as gold standard. The effects of these study design variables were analyzed using generalized linear mixed-effect model with logistic regression for both in vivo and ex vivo analysis.
| Effect of study design variables on in vivo accuracy of PTeye®. Gold Standard: Surgeon opinion | |||
| Study Design Variable | Odds Ratio | 95% Confidence Interval | p-value |
| Site 2 vs Site 1 | 2.53 | 0.91 – 7.00 | 0.07 |
| Site 3 vs Site 1 | 2.43 | 0.97 – 6.06 | 0.06 |
| Senior vs Junior Surgeons | 1.89 | 0.84 – 4.26 | 0.13 |
| Effect of study design variables on ex vivo accuracy of PTeye®. Gold Standard: Histology | |||
| Study Design Variable | Odds Ratio | 95% Confidence Interval | p-value |
| Site 2 vs Site 1 | 2.37 | 0.44 – 12.71 | 0.31 |
| Site 3 vs Site 1 | 2.35 | 0.76 – 7.28 | 0.14 |
| Senior vs Junior Surgeons | 0.44 | 0.12 – 1.68 | 0.23 |
| Effect of study design variables on ex vivo accuracy of surgeons. Gold Standard: Histology | |||
| Study Design Variable | Odds Ratio | 95% Confidence Interval | p-value |
| Site 2 vs Site 1 | 0.64 | 0.12 – 3.38 | 0.60 |
| Site 3 vs Site 1 | 0.80 | 0.24 – 2.64 | 0.71 |
| Senior vs Junior Surgeons | 3.14 | 1.13 – 8.70 | 0.03** |
p-value < 0.05 is suggestive of that particular variable having a significant effect on the accuracy in tissue classification accuracy.