The primary study into the ease of use of Neuropad® is “Evaluation of the Self-Administered Indicator Plaster Neuropad® for the Diagnosis of Neuropathy in Diabetes” (Tentolouris et al., 2008).
In this study, a total of 156 subjects were recruited from the outpatient diabetes clinic of the authors’ hospital. The study was dual-purpose, both:
- to assess the accuracy and diagnostic usefulness of the Neuropad® test and
- to gauge the intelligibility of the user interface to a broad user base.
Participants were assessed for neuropathy at the first visit to the clinic. Diagnosis of neuropathy was based on clinical examination using the neuropathy symptom score and the neuropathy disability score. The Neuropad® was applied for 10 min in the sitting position at both feet and evaluated as normal (pink colour bilaterally) or abnormal (blue colour or any other combinations of colours bilaterally) by the doctor at the same visit.
Afterwards, the Neuropad® for self-testing at home in the sitting position together with written instructions for its use and evaluation were provided.
A questionnaire was given asking for:
- the easiness to understand the instructions for the use of the Neuropad®
- the easiness to the use the Neuropad®
- the easiness to evaluate the result of the Neuropad® (visual analogue scale 0–10, with 0 the most difficult and 10 the easiest for each question).
Moreover, patients were asked to report whether they required any help for self-examination. Participants were instructed to return the results of the IPN and the completed questionnaires in a second visit to another participating doctor who was blind to results of the tests of the first visit.
Results of the study
The evaluation of the instructions and the test by the patients (median values, interquartile range) was as follows:
- easiness to understand the instructions for the use of the IPN 10.0 (9.0 – 10.0)
- easiness to use the IPN 10.0 (9.0 –10.0)
- easiness to evaluate the test as normal or abnormal 10.0 (8.0 – 10.0).
It was noted that 32 patients (20.5%) reported that they requested help to perform self-testing. They were and reported more often kinetic and vision problems; sex, neuropathy status, and presence of foot ulceration were not associated with difficulty in self-testing. No adverse event has been reported.
Conclusions of the study
In conclusion, the high degree of reliability and the easiness of the Neuropad® suggests that it is proper for self-testing for the identification of peripheral neuropathy when clear instructions for its use and evaluation are provided. However, older patients and those with visual and / or kinetic impairment may not be able to perform self-examination.