Goddard Kate, Vas Prashanth, Purves Alistair, McMillan Viktoria, Langford Thomas, Reid Fiona, Edmonds Michael
King's Technology Evaluation Centre, King's College London, London, United Kingdom.
King's College London Hospital NHS Trust, London, United Kingdom.
JMIR Res Protoc. 2018 Apr 6;7(4):e72. doi: 10.2196/resprot.7438.
Various tests are used to detect diabetic peripheral neuropathy by assessing sense perception in the feet. Tests vary in terms of time and resources required. Simple tests are those that can be conducted quickly and easily in primary care without laboratory equipment. There are some limitations to these simple tests, an example being the variable amplitude of the 128 Hz tuning fork. A new test, VibraTip (McCallan Medical, UK), might be a valuable alternative as it emits a consistent amplitude and may offer improved diagnostic accuracy.
The aims of this study are to estimate the diagnostic accuracy of the VibraTip device for diabetic peripheral neuropathy against the reference standard of sural nerve conduction velocity measurement, and to assess whether the VibraTip offers superior diagnostic accuracy to other routine tests based on vibration or touch.
The study will prospectively recruit adults with type 2 diabetes who are due to attend a routine follow-up clinic. A cross-sectional study design will be employed to assess the diagnostic accuracy of 5 standard index tests for peripheral neuropathy, including VibraTip. The reference test will be sural nerve conduction velocity measurement.
Funding is being sought to conduct this research. The outcomes assessed will be the diagnostic accuracy of the 5 index tests against sural nerve conduction velocity measurement, including sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio. Receiver operating characteristic curves will be constructed and compared for each test.
This study will be the first within-study comparison of 5 simple tests for screening diabetic peripheral neuropathy and will address uncertainties in the potential benefits of using VibraTip in comparison with the other tests.
通过评估足部的感觉来检测糖尿病周围神经病变的方法有多种。这些检测方法在所需时间和资源方面各不相同。简单检测是指那些无需实验室设备即可在初级保健机构快速简便进行的检测。这些简单检测存在一些局限性，例如128赫兹音叉的振幅可变。一种新的检测工具VibraTip（英国麦卡伦医疗公司）可能是一种有价值的替代方法，因为它能发出恒定的振幅，可能会提高诊断准确性。
本研究旨在根据腓肠神经传导速度测量这一参考标准，评估VibraTip设备对糖尿病周围神经病变的诊断准确性，并评估VibraTip与其他基于振动或触觉的常规检测相比，是否具有更高的诊断准确性。
本研究将前瞻性招募2型糖尿病成年患者，这些患者将前往常规随访诊所就诊。将采用横断面研究设计来评估包括VibraTip在内的5种外周神经病变标准指标检测的诊断准确性。参考检测将是腓肠神经传导速度测量。
正在寻求资金开展这项研究。评估的结果将是5种指标检测相对于腓肠神经传导速度测量的诊断准确性，包括敏感性、特异性、阳性预测值、阴性预测值、阳性似然比和阴性似然比。将为每种检测构建并比较受试者工作特征曲线。
本研究将是首次对5种筛查糖尿病周围神经病变的简单检测进行研究内比较，并将解决与其他检测相比使用VibraTip的潜在益处方面的不确定性。
