Apostolos Tsapas1, Aris Liakos2, Paschalis Paschos2, Thomas Karagiannis2, Eleni Bekiari2, Nikolaos Tentolouris3, Panagiota Boura4. 1. Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University Thessaloniki, 49 Konstantinoupoleos Street, 54642 Thessaloniki, Greece; Harris Manchester College, University of Oxford, Oxford, OX1 3TD, United Kingdom. Electronic address: atsapas@auth.gr. 2. Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University Thessaloniki, 49 Konstantinoupoleos Street, 54642 Thessaloniki, Greece. 3. First Department of Propedeutic and Internal Medicine, University of Athens School of Medicine, 17 Ag. Thoma Street, 11527 Athens, Greece. 4. Second Medical Department, Aristotle University Thessaloniki, 49 Konstantinoupoleos Street, 54642 Thessaloniki, Greece.
Abstract
OBJECTIVE: Neuropad is an adhesive indicator test applied at the plantar surface of the foot that detects sweating through color change. We examined the diagnostic accuracy of this simple plaster as triage test for screening for clinically relevant diabetic sensorimotor polyneuropathy in adult outpatients with type 1 or type 2 diabetes. MATERIALS/ METHODS: Systematic review and meta-analysis of diagnostic accuracy studies. We searched Medline, Embase, Cochrane Library, Biosis Previews, Web of Science, Scopus and gray literature without date or language restrictions. We pooled estimates of sensitivity and specificity, and fitted hierarchical models to produce summary receiver operating characteristic curves. We assessed methodological quality of included studies utilizing the Quality Assessment of Diagnostic Accuracy Studies 2 tool. RESULTS: Eighteen studies with 3470 participants met the inclusion criteria. Average sensitivity and specificity were 86% (95% CI 79 to 91) and 65% (95% CI 51 to 76) respectively. Likelihood ratios (LRs) were LR+=2.44 and LR-=0.22. Subgroup analyses per reference standard utilized provided similar estimates. Most studies were at risk of bias for patient selection and use of index or reference test, and had concerns regarding applicability due to patient selection. CONCLUSION: The adhesive indicator test has reasonable sensitivity and could be used for triage of diabetic neuropathy to rule out foot at risk. Patients who tested positive should be referred to specialized care to establish a definite diagnosis. There is insufficient evidence for effectiveness on patient-important outcomes and cost-effectiveness of implementation in the diagnostic pathway compared with the standard clinical examination.
OBJECTIVE: Neuropad is an adhesive indicator test applied at the plantar surface of the foot that detects sweating through color change. We examined the diagnostic accuracy of this simple plaster as triage test for screening for clinically relevant diabetic sensorimotor polyneuropathy in adult outpatients with type 1 or type 2 diabetes. MATERIALS/ METHODS: Systematic review and meta-analysis of diagnostic accuracy studies. We searched Medline, Embase, Cochrane Library, Biosis Previews, Web of Science, Scopus and gray literature without date or language restrictions. We pooled estimates of sensitivity and specificity, and fitted hierarchical models to produce summary receiver operating characteristic curves. We assessed methodological quality of included studies utilizing the Quality Assessment of Diagnostic Accuracy Studies 2 tool. RESULTS: Eighteen studies with 3470 participants met the inclusion criteria. Average sensitivity and specificity were 86% (95% CI 79 to 91) and 65% (95% CI 51 to 76) respectively. Likelihood ratios (LRs) were LR+=2.44 and LR-=0.22. Subgroup analyses per reference standard utilized provided similar estimates. Most studies were at risk of bias for patient selection and use of index or reference test, and had concerns regarding applicability due to patient selection. CONCLUSION: The adhesive indicator test has reasonable sensitivity and could be used for triage of diabetic neuropathy to rule out foot at risk. Patients who tested positive should be referred to specialized care to establish a definite diagnosis. There is insufficient evidence for effectiveness on patient-important outcomes and cost-effectiveness of implementation in the diagnostic pathway compared with the standard clinical examination.