Table 3.
Diagnostic Performance of the Ophthalmic Grader Pathway for the Diagnosis of Proliferative Diabetic Retinopathy
| Results | Reference Standard | Diagnostic Parameter | No./Total No. | Estimate (95% Confidence Interval) | |
|---|---|---|---|---|---|
| Main | Ophthalmic graders referral∗ for PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye | Sensitivity (%) | 87/105 | 83% (75%–89%) |
| Specificity (%) | 86/160 | 54% (46%–61%) | |||
| Positive likelihood ratio | — | 1.79 (1.48–2.16) | |||
| Negative likelihood ratio | — | 0.32 (0.20–0.50) | |||
| Ophthalmic graders referral for PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye | Sensitivity (%) | 87/102 | 85% (77%–91%) | |
| Specificity (%) | 77/160 | 48% (41%–56%) | |||
| Positive likelihood ratio | — | 1.64 (1.39–1.95) | |||
| Negative likelihood ratio | — | 0.31 (0.19–0.50) | |||
| SENA1 | Ophthalmic graders identified active PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye | Sensitivity (%) | 66/105 | 63% (53%–71%) |
| Specificity (%) | 116/159 | 73% (66%–79%) | |||
| Positive likelihood ratio | — | 2.32 (1.73–3.12) | |||
| Negative likelihood ratio | — | 0.51 (0.39–0.66) | |||
| Ophthalmic graders identified active PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye | Sensitivity (%) | 70/99 | 71% (61%–79%) | |
| Specificity (%) | 110/158 | 70% (62%–76%) | |||
| Positive likelihood ratio | — | 2.33 (1.78–3.04) | |||
| Negative likelihood ratio | — | 0.42 (0.30–0.58) | |||
| Additional 1 | Ophthalmologist assessment identified active PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye | Sensitivity (%) | 74/103 | 72% (62%–80%) |
| Specificity (%) | 137/159 | 86% (80%–91%) | |||
| Positive likelihood ratio | — | 5.19 (3.46–7.80) | |||
| Negative likelihood ratio | — | 0.33 (0.24–0.45) | |||
| Ophthalmologist assessment identified active PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye | Sensitivity (%) | 65/98 | 66% (57%–75%) | |
| Specificity (%) | 134/154 | 87% (81%–91%) | |||
| Positive likelihood ratio | — | 5.11 (3.31–7.87) | |||
| Negative likelihood ratio | — | 0.39 (0.29–0.51) | |||
| SENA2 | Ophthalmic graders referral for PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye requiring treatment | Sensitivity (%) | 77/90 | 86% (77%–91%) |
| Specificity (%) | 91/175 | 52% (45%–59%) | |||
| Positive likelihood ratio | — | 1.78 (1.49–2.13) | |||
| Negative likelihood ratio | — | 0.28 (0.16–0.47) | |||
| Ophthalmic graders referral for PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye requiring treatment | Sensitivity (%) | 74/84 | 88% (79%–93%) | |
| Specificity (%) | 82/178 | 46% (39%–53%) | |||
| Positive likelihood ratio | — | 1.63 (1.40–1.91) | |||
| Negative likelihood ratio | — | 0.26 (0.14–0.47) | |||
| SENA4 | Ophthalmic graders referral for PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR with preretinal or vitreous hemorrhage in either eye | Sensitivity (%) | 62/71 | 87% (78%–93%) |
| Specificity (%) | 95/193 | 49% (42%–56%) | |||
| Positive likelihood ratio | — | 1.71 (1.45–2.02) | |||
| Negative likelihood ratio | — | 0.26 (0.14–0.48) | |||
| Ophthalmic graders referral for PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR with preretinal or vitreous hemorrhage in either eye | Sensitivity (%) | 53/66 | 80% (69%–88%) | |
| Specificity (%) | 79/196 | 40% (34%–47%) | |||
| Positive likelihood ratio | — | 1.35 (1.14–1.59) | |||
| Negative likelihood ratio | — | 0.49 (0.29–0.82) | |||
| Additional 2 | Ophthalmologist assessment identified active PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR with preretinal or vitreous hemorrhage in either eye | Sensitivity (%) | 57/70 | 81% (71%–89%) |
| Specificity (%) | 153/192 | 80% (73%–85%) | |||
| Positive likelihood ratio | — | 4.01 (2.96–5.42) | |||
| Negative likelihood ratio | — | 0.23 (0.14–0.38) | |||
| Ophthalmologist assessment identified active PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR with preretinal or vitreous hemorrhage in either eye | Sensitivity (%) | 42/64 | 66% (53%–76%) | |
| Specificity (%) | 145/188 | 77% (71%–83%) | |||
| Positive likelihood ratio | — | 2.87 (2.09–3.94) | |||
| Negative likelihood ratio | — | 0.45 (0.31–0.63) | |||
| SENA5 | Ophthalmic graders referral for PDR based on ultra-widefield fundus images | Enhanced reference standard | Sensitivity (%) | 110/138 | 80% (72%–86%) |
| Specificity (%) | 76/127 | 60% (51%–68%) | |||
| Positive likelihood ratio | — | 1.98 (1.58–2.49) | |||
| Negative likelihood ratio | — | 0.34 (0.24–0.49) | |||
| Ophthalmic graders referral for PDR based on 7-field ETDRS fundus images | Enhanced reference standard | Sensitivity (%) | 111/135 | 82% (75%–88%) | |
| Specificity (%) | 68/127 | 54% (45%–62%) | |||
| Positive likelihood ratio | — | 1.77 (1.45–2.17) | |||
| Negative likelihood ratio | — | 0.33 (0.22–0.49) | |||
| Additional 3 | Ophthalmic graders referral for PDR based on ultra-widefield fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye plus ophthalmologist assessment identified active PDR in either eye based on ultra-widefield fundus images | Sensitivity (%) | 101/125 | 81% (73%–87%) |
| Specificity (%) | 80/140 | 57% (49%–65%) | |||
| Positive likelihood ratio | — | 1.89 (1.53–2.32) | |||
| Negative likelihood ratio | — | 0.34 (0.23–0.49) | |||
| Ophthalmic graders referral for PDR based on 7-field ETDRS fundus images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye plus ophthalmologist assessment identified active PDR in either eye based on 7-field ETDRS fundus images | Sensitivity (%) | 103/122 | 84% (77%–90%) | |
| Specificity (%) | 73/140 | 52% (44%–60%) | |||
| Positive likelihood ratio | — | 1.76 (1.46–2.13) | |||
| Negative likelihood ratio | — | 0.30 (0.19–0.46) | |||
| SENA6 | Ophthalmic graders referral for PDR based on ultra-widefield fundus images in routine clinic | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye in routine clinic | Sensitivity (%) | 63/77 | 82% (72%–89%) |
| Specificity (%) | 47/92 | 51% (41%–61%) | |||
| Positive likelihood ratio | — | 1.67 (1.32–2.11) | |||
| Negative likelihood ratio | — | 0.36 (0.21–0.60) | |||
| Ophthalmic graders referral for PDR based on 7-field ETDRS fundus images in routine clinic | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy to assess active PDR in either eye in routine clinic | Sensitivity (%) | 60/74 | 81% (71%–88%) | |
| Specificity (%) | 41/91 | 45% (35%–55%) | |||
| Positive likelihood ratio | — | 1.48 (1.19–1.83) | |||
| Negative likelihood ratio | — | 0.42 (0.25–0.71) |
ETDRS = Early treatment diabetic retinopathy study; PDR = proliferative diabetic retinopathy; SENA = sensitivity analysis; — = not available.
∗
Grader referral for PDR: active + unsure + ungradable.