title: ViibraTip for Testing Vibration Perception to Detect Diabetic Peripheral Neuropathy: A NICE Medical Technology Guidance.
abstract: VibraTip™ was selected by the Medical Technologies Advisory Committee (MTAC) to undergo evaluation through the National Institute for Health and Care Excellence (NICE). VibraTip™ provides a vibratory stimulus for the purpose of detecting diabetic peripheral neuropathy (DPN) in patients with type 1 or 2 diabetes mellitus, and is intended to replace the current practice of using the 128 Hz tuning fork or 10 g monofilament (comparators). The sponsor (McCallan Medical) provided clinical and economic submissions which were evaluated by an External Assessment Centre (EAC). Of six diagnostic studies identified, the EAC considered that only one was directly relevant to the assessment. This study indicated VibraTip™ had a sensitivity of 0.79 (95 % CI 0.69-0.90) and specificity of 0.82 (95 % CI 0.74-0.90) for DPN using a neurothesiometer at 25 V as a reference standard. This was non-inferior to the comparators, but the sample size (n = 141) was too small to draw unequivocal conclusions and it is unclear how generalisable results were to clinical practice. The sponsor presented a de facto cost-minimisation model that in the base case showed minimal cost savings and, in sensitivity analysis which assumed diagnostic superiority of VibraTip™, showed large savings. The EAC appraised this model and concluded it was flawed as it was not evidence based and costs were likely to be unrealistic. The MTAC considered that the technology showed promise but decided the case for adoption was not proven, and therefore made a research recommendation as is reflected in NICE Medical Technology Guidance 22.
authors.affiliation: NICE External Assessment Centre (EAC), Regional Medical Physics Department, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK, iain.willits@nuth.nhs.uk.
authors.forename: Iain
authors.initials: I
authors.lastname: Willits
authors.forename: Helen
authors.initials: H
authors.lastname: Cole
authors.forename: Roseanne
authors.initials: R
authors.lastname: Jones
authors.forename: Paul
authors.initials: P
authors.lastname: Dimmock
authors.forename: Mick
authors.initials: M
authors.lastname: Arber
authors.forename: Joyce
authors.initials: J
authors.lastname: Craig
authors.forename: Andrew
authors.initials: A
authors.lastname: Sims
mesh_terms: D003362:Cost-Benefit Analysis; D003929:Diabetic Neuropathies / Q000175:diagnosis* / Q000503:physiopathology; D003943:Diagnostic Techniques, Neurological / Q000191:economics / Q000295:instrumentation*; D004739:England; D019317:Evidence-Based Medicine; D006801:Humans; D013222:State Medicine / Q000191:economics / Q000592:standards; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000592:standards; D014732:Vibration; D014852:Wales