Table 3.
Interobserver Reproducibility of Quantitative Autofluorescence in Patients With Recessive Stargardt Disease 1 Specified per Study Site
| All sites | Site #1 | Site #2 | Site #3 | Site #4 | Site #5 | Site #6 | |
|---|---|---|---|---|---|---|---|
| Intraclass correlation, ICC estimate (95% CI) | |||||||
| Interobserver Reproducibility | 0.95 (0.93–0.97) | 0.99 (0.98–0.99) | 0.98 (0.90–0.99) | 0.91 (0.84–0.95) | 0.87 (0.64–0.94) | n.a.† | 0.95 (0.90–0.98) |
| Screening values only | 0.96 (0.94–0.97) | 0.98 (0.96–0.99) | 0.98 (0.91–0.99) | 0.90 (0.78–0.95) | 0.79 (0.43–0.92) | n.a.† | 0.90 (0.73–0.97) |
| Baseline values only | 0.95 (0.91–0.97) | 1.00 (0.99–1.00) | 0.98 (0.86–0.99) | 0.95 (0.88–0.98) | 0.93 (0.60–0.98) | 0.46 (−0.15–0.88) | 1.00 (0.99–1.00) |
| One sample t-test of difference, mean difference in qAF units ±SD (P value) | |||||||
| Interobserver reproducibility | 16.30 ± 45.09 (P < 0.001)* | 4.22 ± 26.71 (P = 0.128) | 21.86 ± 26.64 (P < 0.001)* | 9.44 ± 68.81 (P = 0.357) | 21.03 ± 32.28 (P < 0.001)* | n.a.† | 9.16 ± 34.60 (P = 0.144) |
| Screening values only | 14.59 ± 47.77 (P < 0.001)* | 7.23 ± 33.74 (P = 0.129) | 23.13 ± 30.22 (P < 0.001)* | 8.74 ± 84.72 (P = 0.589) | 22.64 ± 40.98 (P = 0.023)* | n.a.† | 13.64 ± 48.54 (P = 0.279) |
| Baseline values only | 18.29 ± 41.85 (P < 0.001)* | 0.51 ± 13.27 (P = 0.804) | 20.24 ± 21.55 (P < 0.001)* | 10.53 ± 33.68 (P = 0.202) | 19.42 ± 21.30 (P = 0.001)* | 162.56 ± 67.53 (P = 0.001)* | 4.69 ± 8.68 (P = 0.047)* |
| Coefficient of repeatability, CR ±% | |||||||
| Interobserver Reproducibility | ±20.2 | ±20.8 | ±10.8 | ±25.4 | ±18.4 | n.a.† | ±15.0 |
| Screening values only | ±23.8 | ±26.9 | ±11.8 | ±31.3 | ±24.4 | n.a.† | ±22.5 |
| Baseline values only | ±18.2 | ±6.4 | ±9.0 | ±18.8 | ±10.6 | ±24.3 | ±3.1 |
Interobserver reproducibility: site value was subtracted from reading center value.
CI, confidence interval; CR, coefficient of repeatability; ICC, intraclass correlation; SD, standard deviation;
Not applicable due to protocol change for this site.
P < 0.05.