Diagnostic accuracy of the 5.07 monofilament test for diabetes polyneuropathy: influence of age, sex, neuropathic pain and neuropathy severity
Dunker, Øystein; Uglem, Martin; Kvaløy, Marie Bu; Løseth, Sissel; Hjelland, Ina Elen; Allen, Sara Maria; Vigeland, Maria Dehli; Kleggetveit, Inge Petter; Sand, Trond Halfdan; Nilsen, Kristian Bernhard
Peer reviewed, Journal article
Published version
Permanent lenke
https://hdl.handle.net/11250/3104872Utgivelsesdato
2023Metadata
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Originalversjon
10.1136/bmjdrc-2023-003545Sammendrag
ntroduction There is a need for simple and cheap
diagnostic tools for diabetic polyneuropathy (DPN).
We aimed to assess the diagnostic accuracy of the
5.07/10 g monofilament test in patients referred to
polyneuropathy assessments, as well as to examine how
disease severity, age, sex and neuropathic pain (NP)
impact diagnostic accuracy.
Research design and methods Five Norwegian
university hospitals recruited patients with diabetes aged
18–70 referred to neurological outpatient clinics for
polyneuropathy assessments. The 5.07/10 g Semmes-
Weinstein monofilament examination (SWME) was
validated against the Toronto consensus for diagnosing
diabetic neuropathies; the results were stratified by age,
sex and NP. Disease severity was graded by a combined
nerve conduction study (NCS) Z-score, and logistic
regression was applied to assess whether disease
severity was a predictor of diagnostic accuracy.
Results In total, 506 patients were included in the
study. Global sensitivity was 0.60 (95% CI 0.55, 0.66),
specificity 0.82 (95% CI 0.75, 0.87), positive and
negative predictive values were 0.86 (95% CI 0.81,
0.90) and 0.52 (95% CI 0.46, 0.58), respectively, positive
and negative likelihood ratios were 3.28 (95% CI 2.37,
4.53) and 0.49 (95% CI 0.42, 0.57), respectively. The
SWME was less sensitive in females (0.43), had lower
specificity in patients with NP (0.56), and performed
worse in patients ≥50 years. NCS-based disease severity
did not affect diagnostic accuracy (OR 1.15, 95% CI
0.95, 1.40).
Conclusions This multicenter study demonstrates
poor diagnostic performance for the 5.07/10 g SWME
in patients with diabetes referred to polyneuropathy
assessments; it is particularly unsuited for female
patients and those with NP. The diagnostic accuracy of
the SWME was not influenced by NCS-based disease
severity, demonstrating that it does not perform better in
patients with later stages of DPN. We do not recommend
the use of the 5.07/10 g monofilament in the evaluation
of patients with diabetes referred to polyneuropathy
assessments.