Table 2.
Diagnostic Performance of the Ophthalmic Grader Pathway for the Diagnosis of Diabetic Macular Edema
| Positive Test Results | Reference Standard | Diagnostic Parameter | No./ Total No. | Estimate (95% Confidence Interval) | |
|---|---|---|---|---|---|
| Main | Ophthalmic graders referral∗ for DME based on SD OCT images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy with the addition of SD OCT scans to assess active DME in either eye | Sensitivity (%) | 142/147 | 97% (92%–99%) |
| Specificity (%) | 35/113 | 31% (23%–40%) | |||
| Positive likelihood ratio | — | 1.40 (1.23–1.59) | |||
| Negative likelihood ratio | — | 0.11 (0.04–0.27) | |||
| SENA1 | Ophthalmic graders identified active DME based on SD OCT images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy with the addition of SD OCT scans to assess active DME in either eye | Sensitivity (%) | 139/146 | 95% (90%–98%) |
| Specificity (%) | 43/113 | 38% (30%–47%) | |||
| Positive likelihood ratio | — | 1.54 (1.32–1·78) | |||
| Negative likelihood ratio | — | 0.13 (0.06–0.27) | |||
| SENA2 | Ophthalmic graders referral for DME based on SD OCT images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy with the addition of SD OCT scans to assess active DME in either eye requiring treatment | Sensitivity (%) | 81/85 | 95% (89%–98%) |
| Specificity (%) | 36/175 | 21% (15%–27%) | |||
| Positive likelihood ratio | — | 1.20 (1.10–1.31) | |||
| Negative likelihood ratio | — | 0.23 (0.08–0.62) | |||
| SENA3 | Ophthalmic graders identified central involving active DME based on SD OCT images | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy with the addition of SD OCT scans to assess central involving active DME in either eye | Sensitivity (%) | 121/129 | 94% (88%–97%) |
| Specificity (%) | 72/128 | 56% (48%–65%) | |||
| Positive likelihood ratio | — | 2.14 (1.75–2.62) | |||
| Negative likelihood ratio | — | 0.11 (0.06–0.22) | |||
| SENA6 | Ophthalmic graders referral for DME based on SD OCT images in routine clinic | Ophthalmologist face-to-face clinical evaluation using slit-lamp biomicroscopy with the addition of SD OCT scans to assess active DME in either eye in routine clinic | Sensitivity (%) | 81/85 | 95% (89%–98%) |
| Specificity (%) | 26/65 | 40% (29%–52%) | |||
| Positive likelihood ratio | — | 1.59 (1.30–1.95) | |||
| Negative likelihood ratio | — | 0.12 (0.04–0.32) |
DME = diabetic macular edema; SD = spectral-domain; SENA = sensitivity analysis; — = not available.
∗
Grader referral for DME: active + unsure + ungradable.