Diabetes complications

Diagnostic accuracy of the 5.07 monofilament test for diabetes polyneuropathy: influence of age, sex, neuropathic pain and neuropathy severity

BMJ Open Diabetes Res CarePublished Diagnostic accuracy study

Authors' conclusion

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.

Study context

Population
Patients with diabetes aged 18–70 referred to neurological outpatient clinics for polyneuropathy assessments, 5 Norwegian university hospitals
Participants
506 patients
Comparison
5.07/10 g Semmes-Weinstein monofilament examination (SWME) vs Toronto consensus diagnosis of diabetic polyneuropathy (DPN)
Outcome
Diagnostic accuracy of the 5.07/10 g monofilament test for DPN
Methodological detailsmulticentre
  • Multicentre

Performance

As reported in the abstract

Diagnostic accuracy of 5.07/10 g SWME vs Toronto consensus for DPN
Global sensitivity
0.60 (95% CI 0.55, 0.66)
Specificity
0.82 (95% CI 0.75, 0.87)
PPV
0.86 (95% CI 0.81, 0.90)
NPV
0.52 (95% CI 0.46, 0.58)
Positive likelihood ratio
3.28 (95% CI 2.37, 4.53)
Negative likelihood ratio
0.49 (95% CI 0.42, 0.57)

Further findings

Accuracy by sex, neuropathic pain (NP) and age

Sensitivity in females (lower)
0.43
Specificity in patients with NP (lower)
0.56
Performed worse in patients ≥50 years

Nerve conduction study (NCS)-based disease severity as predictor of diagnostic accuracy

Disease severity did not affect diagnostic accuracy, OR
1.15 (95% CI 0.95, 1.40)

Original publication

Diagnostic accuracy of the 5.07 monofilament test for diabetes polyneuropathy: influence of age, sex, neuropathic pain and neuropathy severity. BMJ Open Diabetes Res Care. Published 20 November 2023. doi:10.1136/bmjdrc-2023-003545

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