Accuracy of Monofilament Testing to Diagnose Peripheral Neuropathy: A Systematic Review

Jacquelien Dros; Astrid Wewerinke; Patrick J. Bindels; Henk C. van Weert

doi:10.1370/afm.1016

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Figure 1.
Flowchart of the study selection process.

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Table 1.

Characteristics of the Included Studies, With Nerve Conduction Study as Reference Standard

Characteristic	Lee, 2003^14a,b	Perkins, 2001^15a,c	Shin, 2000^19d
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)

Supplemental Appendixes

Supplemental Appendix 1. Search Strategy; Supplemental Appendix 2. QUADAS

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Supplemental data: Appendix 1-2 - PDF file, 3 pages, 132 KB
The Article in Brief

Accuracy of Monofilament Testing to Diagnose Peripheral Neuropathy: A Systematic Review

Jacquelien Dros , and colleagues

Background This systematic review evaluates monofilament testing for diagnosis of peripheral neuropathy of the feet, a condition that causes numbness or a complete loss of sensation.

What This Study Found Despite frequent recommendations for use of the test, researchers conclude that existing data are limited in their ability to draw conclusions about its accuracy because of a lack of diagnostic studies with adequate methods.

Implications

The authors recommend against the sole use of microfilament testing to diagnose peripheral neuropathy.