Tanyanyiwa, Simbarashe, Richard (2021) The Effectiveness of Nerve Conduction and Transcutaneous Oxygen Devices Against Existing Methods in the Assessment of Neuroischaemia in the Feet of Adult Participants With Type 2 Diabetes in the Community. University of Southampton, Doctoral Thesis, 435pp.
Abstract
NICE NG19 (2015) guides the early identification of neuroischaemia to help prevent diabetes foot complications, but these largely subjective assessments are not standardised. The aim of this doctoral thesis was to explore the concept that new technological devices (DPNCheck® and Medicap) could give a picture that is clearer and closer to that truth of underlying neuroischaemia, than existing NICE NG19 methods (10g monofilament and TBI). To achieve this, a series of cross-sectional observational investigations were undertaken to establish the reliability, validity and clinical effectiveness of the DPNCheck® against the 10g monofilament in the assessment of sensory neuropathy, and the Medicap against the TBI in the assessment of ischaemia, in adults with type 2 diabetes. Experimental Study 1 investigated DPNCheck® reliability in 21 healthy participants, and found ICC (2,1)velocity = 0.97 (95% CI = 0.91- 0.99), and ICC (2,1)amplitude between 0.76 – 0.96 (95% CI = 0.63 – 0.99). Medicap validity was investigated against a TCM400 amongst healthy (Experimental Study 2) and low risk diabetes (Experimental Study 3) participants. The Medicap demonstrated criterion validity, but overestimated TcPO2 by a mean of 24.8 (± 18.4) mmHg. Experimental Study 4 found TBI intrarater reliability ICC (2,2) ranging from 0.79 – 0.99 (SEM = 0.03; 95% CI; 0.68 – 0.99), and interrater reliability with ICC(2,2) between 0.81 – 0.98 (SEM 0.03; 95% CI; 0.65 – 0.99) ; and overall ICC (2,3) =0.96 (95% CI; 0.93 – 0.98). Experimental study 5 investigated the intrarater reliability of the TBI, DPNCheck®, Medicap and 10g monofilament in people with diabetes, and found ICC (3,1)TBI = 0.97 (95% CI = 0.84-0.99), and for ICC(3,1)DPNCheck® velocity and amplitude =0.96 ((95% CI = 0.87-0.99); ICC(3,1) Medicap = 0.66 (95% CI = 0.24 – 0.87), and ICC(3,1) 10g monofilament = 0.38 (95% CI = -0.08 – 0.73). In Experimental Study 6, from 92 participants with diabetes, the DPNCheck® suspected 45 participants of having neuropathy, against 21 by the 10g monofilament which had a false negative rate of 35.2%, a sensitivity of 44.4% (95% CI = 30.9 – 58.8%), specificity of 97.9% (95% CI = 88.9 -99.6%) and k=0.43 (95%C1:0.26 - 0.54; p < 0.001). In Experimental Study 7, both the TBI and Medicap each suspected 10 participants of ischaemia, but did not agree on any cases. Against the TBI, Medicap sensitivity was 0% (95% CI = 0 – 30.9%); specificity 86.6% (95% CI = 77.3- 93.1%), and - 0.12 (p = 0.24). The Medicap demonstrated criterion validity and fair reliability, whilst the DPNCheck® demonstrated and excellent reliability. The DPNCheck® was more effective at assessing sensory neuropathy than the 10g monofilament, whilst the Medicap and the TBI were poorly comparable in the assessment of ischaemia. Findings from these thesis investigations point to a new clinical paradigm for earlier detection of peripheral neuropathy in which the quality and quantity components of neuroischaemia assessment could be combined. The implications for this would be in the detection of neuropathy at the stage where interventions have the potential to change the course of tissue damage and thus prevent diabetes related foot ulceration and amputation.
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