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. 2019 Jul 31;26(12):1664–1674. doi: 10.1093/jamia/ocz094

Table 4.

Median RR and 95% SI from electronic data analysis with outcome misclassification present and following QBA using predictive values in a simulated immunization schedule cohort study, with simulated RR = 1.00

Simulation Scenario Simulated levels of outcome misclassification Mean overall outcome PPV PPV1, PPV0 Mean overall outcome NPV NPV1, NPV0 Median RR (95% SI)
From analysis of electronic data with outcome misclassification present
Following QBA using PPV1, PPV0, NPV1, NPV0
Following QBA using PPV1, PPV0, and assuming nondifferential sensitivity
Formula 1 Formula 2 Formula 3
Nondifferential misclassification
1  SN = 95%, SP = 99% 84.1% 84.1%, 84.1% 99.7% 99.7%, 99.7% 1.00 (0.90-1.11) 5.0% type I error 1.00 (0.90-1.11) 1.00 (0.90-1.12)
2  SN = 90%, SP = 98% 71.5% 71.4%, 71.5% 99.4% 99.4%, 99.4% 1.00 (0.90-1.11) 4.6% type I error 1.00 (0.90-1.11) 1.00 (0.88-1.11)
Differential specificity
3  SN1 = 95%; SN0 = 95% 79.8% 99.7% 2.43 1.00 1.00
 SP1 = 90%; SP0 = 99% 34.6%, 84.1% 99.7%, 99.7% (2.28-2.59) 100% type I error (0.90-1.11) (0.89-1.11)
4  SN1 = 95%; SN0 = 95% 72.9% 99.7% 0.86 1.00 1.00
 SP1 = 99%; SP0 = 98% 84.1%, 72.5% 99.7%, 99.7% (0.78-0.95) 80.7% type I error (0.90-1.11) (0.89-1.11)
Differential sensitivity
5  SN1 = 70%; SN0 = 95% 84.0% 99.7% 0.78 1.00 0.74
 SP1 = 99%; SP0 = 99% 79.4%, 84.1% 98.3%, 99.7% (0.69-0.87) 99.2% type I error (0.90-1.11) (0.64-0.83)
6  SN1 = 50%; SN0 = 95% 83.9% 99.6% 0.60 1.00 0.52
 SP1 = 99%; SP0 = 99% 73.5%, 84.1% 97.3%, 99.7% (0.52-0.68) 100% type I error (0.90-1.11) (0.44-0.61)
Differential specificity and sensitivity
7  SN1 = 70%; SN0 = 95% 72.7% 99.7% 0.67 1.00 0.73
 SP1 = 99%; SP0 = 98% 79.6%, 72.6% 98.3%, 99.7% (0.60-0.75) 100% type I error (0.90-1.11) (0.64-0.83)
8  SN1 = 90%; SN0 = 95% 79.7% 99.7% 2.38 1.00 0.95
 SP1 = 90%; SP0 = 99% 33.4%, 84.1% 99.4%, 99.7% (2.23-2.55) 100% type I error (0.90-1.11) (0.84-1.06)

The 95% SI represents the 2.5th and 97.5th percentiles of the RR from across the 1000 replications for each simulated scenario. The 95% SI for the simulated RR of 1.00 before applying any misclassification was 0.90-1.11.

PPV0: positive predictive value among unexposed; PPV1: positive predictive value among exposed; QBA: quantitative bias analysis; SI: simulation interval; SN: overall outcome sensitivity; SN0: outcome sensitivity among unexposed; SN1: outcome sensitivity among exposed; SP: overall outcome specificity; SP0: outcome specificity among unexposed; SP1: outcome specificity among exposed.