A meta-analysis of the diagnostic accuracy of the monofilament in detecting diabetic peripheral neuropathy
Nowakowski, Patricia E.
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The purpose of this investigation was to identify the diagnostic accuracy of the monofilament assessment in identification of diabetic peripheral neuropathy (DPN) in people with diabetes. A meta-analysis was conducted on a full set of 14 studies from 1950-2007 to determine the diagnostic accuracy of the monofilament assessment of DPN. Total sample included 3142 people with DPN, with a mean age of 54.98 years and mean diabetes duration of 15.72 years. The studies were conducted in the United States, Canada, England, Korea, Japan & Spain. All subjects were tested with a monofilament assessment and a gold standard. Results of monofilament assessment were compared to results of reference standard. Reference standards reported in the 14 studies were: nerve conduction velocity (NCV) (2); vibration perception threshold (VPT) (7); San Antonio consensus clinical exam (2); medical record (2); and neurometer (1). Data analysis was performed on the 14 studies (full set) and also on a subset of 10 studies (restricted set). Outcome measures reported for diagnostic accuracy were sensitivity, specificity, diagnostic odds ratio (DOR) and AUC (area under receiver operating characteristic curve). Random effects model was utilized since heterogeneity was identified. Pooled sensitivity, specificity, and DOR of full set were: 62.2%, 73.3% and 17.345, respectively. The sensitivity, specificity, and DOR of the restricted set were: 73.8%, 71.5%; and 19.68, respectively. AUC values for full set and restricted set were: 0.8835 and 0.8963 which indicates a strong indicator of diagnostic accuracy. Meta-regression was performed to assess the effects of co-variates on the diagnostic accuracy of the monofilament in detection of DPN in people with diabetes. No significance was noted for number of monofilament sites used, size of monofilament, duration of diabetes, examiner expertise and gender. Patient age (p = 0.378*) and choice of monofilament technique (p = 0.0448*) were found to have significant effects on diagnostic accuracy of the monofilament assessment in detecting DPN. The findings from this research indicate that the monofilament demonstrates fairly good diagnostic accuracy in detecting diabetic peripheral neuropathy. The monofilament may be helpful as a screening tool but should not be used as a sole diagnostic tool.