Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items

Journal of Patient-Reported Outcomes

Table 9 ROC-based responder definitions for NAVQ-P total score at Month 3

Anchor	AUC (95% CI)	ROC curve estimates (Change from Baseline to Month 3)
Anchor	AUC (95% CI)	Method 1	Method 2	Method 3	Method 4
NAVQ-P Total Score
PGI-S (1 grade)	0.776 (0.706,0.845)	-8.0	-6.0	-8.0	-8.0
PGI-S (2 grade)	0.892 (0.832,0.953)	-8.0	-11.0	-8.0	-14.0
PGI-C	0.831 (0.775,0.887)	-8.0	-5.0	-8.0	-6.0
NVCI
PGI-S (1 grade)	0.695 (0.625,0.766)	-1.0	-1.0	-1.0	-1.0
PGI-S (2 grade)	0.761 (0.651,0.871)	-1.0	-1.0	-1.0	-1.0
PGI-C	0.773 (0.714,0.831)	-1.0	-1.0	-1.0	-1.0
NVS
PGI-S (1 grade)	0.711 (0.640,0.782)	1.0	1.0	1.0	1.0
PGI-S (2 grade)	0.828 (0.740,0.916)	2.0	2.0	2.0	2.0
PGI-C	0.811 (0.757,0.865)	1.0	1.0	1.0	1.0

AUC: Area Under the Curve; CI: Confidence Interval; ROC: Receiver Operating Characteristic. Responder thresholds are based on the change score that optimally discriminates between improved and stable groups defined by the anchor.
AUC and 95% CI are calculated from the ROC curve for each score using the randomised population.
Method 1: Threshold defined by maximising the sum of sensitivity and specificity, also referred to as Youden’s J index.
Method 2: Threshold defined by minimising the absolute difference between sensitivity and specificity.
Method 3: Threshold defined by minimising the sum of 1- sensitivity and 1– specificity
Method 4: Threshold defined by selecting the point in the ROC space which minimises the sum of squares.
Negative NAVQ-P and NVCI change scores and positive NVS change scores represent improvement in symptoms.