Characteristics of the Included Studies, With Nerve Conduction Study as Reference Standard
| Characteristic | Lee, 200314a,b | Perkins, 200115a,c | Shin, 200019d |
|---|---|---|---|
| CI=confidence interval; QUADAS = Quality Assessment of Diagnostic Accuracy Studies, LR = likelihood ratio; MT = metatarsal, NR = not reported. | |||
| a QUADAS limitation: selection criteria not clearly described. | |||
| b QUADAS limitation: test results possibly not interpreted without knowledge of the other test results. | |||
| c QUADAS limitation: withdrawals from study not clearly explained. | |||
| d QUADAS limitation: execution of index test and reference standard not described in sufficient detail. | |||
| Participants n (% women) | 37 (46) | 478 (34) | 126 (54) |
| Age, mean, y | 59 | 54 | 58 |
| Population | Unselected type 2 diabetic outpatients in Pusan, Korea | a. 426 Unselected diabetic patients attending secondary and tertiary diabetic clinics, and recruited through advertisements b. 52 Nondiabetic reference subjects in Toronto General Hospital/University Health Network, Canada | Consecutive diabetic patients referred to a secondary foot clinic in Seoul, Korea |
| Methods of monofilament testing | |||
| Sites, No. and Location | 10, Dorsal between base digit 1–2; ventral digit 1,3,5; MT heads 1,3,5; medial and lateral midfoot; heel | 1, Hallux | NR |
| Threshold | ≥ 5 of 10 incorrect (1 foot) | a. ≥ 5 of 8 incorrect (both feet) b. ≥ 2 of 8 incorrect (both feet) | NR |
| Sensitivity (95% CI) | 93.1 (0.77–0.99) | a. 40.9 (0.36–0.46) b. 77.0 (0.72–0.81) | 56.7 (0.44–0.69) |
| Specificity (95% CI) | 100.0 (0.63–1.00) | a. 96.2 (0.90–0.99) b. 68.3 (0.58–0.77) | 94.9 (0.86–0.99) |
| LR+ (95% CI) | 16.5 (1.1–245.0) | a. 10.6 (4.0–28.0) b. 2.4 (1.8–3.2) | 11.2 (4.0–34.0) |
| LR– (95% CI) | 0.07 (0.02–0.26) | a. 0.61 (0.56–0.67) b. 0.34 (0.27–0.42) | 0.46 (0.35–0.60) |