OBJECTIVES: Our first objective was to explore the value of estimating 95% confidence intervals (CIs) of epidermal nerve fibers (ENFs)/mm for number of sections to be evaluated and for confidently judging normality or abnormality. Our second objective was to introduce a new continuous measure combining nerve conduction and ENFs/mm. METHODS: The 95% CI studies were performed on 1, 1-2, 1-3 - - - 1-10 serial skip sections of 3-mm punch biopsies of leg and thigh of 67 healthy subjects and 23 patients with diabetes mellitus. RESULTS: Variability of differences of ENFs/mm counts (and 95% CIs) from evaluation of 1, 1-2, 1-3 - - - 1-9 compared with 1-10 serial skip sections decreased progressively without a break point with increasing numbers of sections evaluated. Estimating 95% CIs as sections are evaluated can be used to judge how many sections are needed for adequate evaluation, i.e., only a few when counts and 95% CIs are well within the range of normality or abnormality and more when values are borderline. Also provided is a methodology to combine results of nerve conduction and ENFs/mm as continuous measures of normality or abnormality. CONCLUSION: Estimating 95% CIs of ENFs/mm is useful to judge how many sections should be evaluated to confidently declare counts to be normal or abnormal. Also introduced is a continuous measure of both large-fiber (nerve conduction) and small-fiber (ENFs/mm) normal structures/functions spanning the range of normality and abnormality for use in therapeutic trials.
OBJECTIVES: Our first objective was to explore the value of estimating 95% confidence intervals (CIs) of epidermal nerve fibers (ENFs)/mm for number of sections to be evaluated and for confidently judging normality or abnormality. Our second objective was to introduce a new continuous measure combining nerve conduction and ENFs/mm. METHODS: The 95% CI studies were performed on 1, 1-2, 1-3 - - - 1-10 serial skip sections of 3-mm punch biopsies of leg and thigh of 67 healthy subjects and 23 patients with diabetes mellitus. RESULTS: Variability of differences of ENFs/mm counts (and 95% CIs) from evaluation of 1, 1-2, 1-3 - - - 1-9 compared with 1-10 serial skip sections decreased progressively without a break point with increasing numbers of sections evaluated. Estimating 95% CIs as sections are evaluated can be used to judge how many sections are needed for adequate evaluation, i.e., only a few when counts and 95% CIs are well within the range of normality or abnormality and more when values are borderline. Also provided is a methodology to combine results of nerve conduction and ENFs/mm as continuous measures of normality or abnormality. CONCLUSION: Estimating 95% CIs of ENFs/mm is useful to judge how many sections should be evaluated to confidently declare counts to be normal or abnormal. Also introduced is a continuous measure of both large-fiber (nerve conduction) and small-fiber (ENFs/mm) normal structures/functions spanning the range of normality and abnormality for use in therapeutic trials.
Authors: Maria Nolano; Vincenzo Provitera; Claudio Crisci; Annamaria Stancanelli; Gwen Wendelschafer-Crabb; William Robert Kennedy; Lucio Santoro Journal: Ann Neurol Date: 2003-08 Impact factor: 10.422
Authors: B G McCarthy; S T Hsieh; A Stocks; P Hauer; C Macko; D R Cornblath; J W Griffin; J C McArthur Journal: Neurology Date: 1995-10 Impact factor: 9.910
Authors: J D England; G S Gronseth; G Franklin; G T Carter; L J Kinsella; J A Cohen; A K Asbury; K Szigeti; J R Lupski; N Latov; R A Lewis; P A Low; M A Fisher; D N Herrmann; J F Howard; G Lauria; R G Miller; M Polydefkis; A J Sumner Journal: Neurology Date: 2008-12-03 Impact factor: 9.910
Authors: Gary L Pittenger; Madhumita Ray; Niculina I Burcus; Patricia McNulty; Baher Basta; Aaron I Vinik Journal: Diabetes Care Date: 2004-08 Impact factor: 19.112
Authors: M Bakkers; I S J Merkies; G Lauria; G Devigili; P Penza; R Lombardi; M C E Hermans; S I van Nes; M De Baets; C G Faber Journal: Neurology Date: 2009-10-06 Impact factor: 9.910
Authors: Stephen A Johnson; Kamal Shouman; Shahar Shelly; Paola Sandroni; Sarah E Berini; P James B Dyck; Ernest Matthew Hoffman; Jay Mandrekar; Zhiyv Niu; Christopher J Lamb; Phillip A Low; Wolfgang Singer; Michelle L Mauermann; John Mills; Divyanshu Dubey; Nathan P Staff; Christopher J Klein Journal: Neurology Date: 2021-10-27 Impact factor: 9.910
Authors: Jenny L Davies; Janean K Engelstad; Linde E Gove; Linda K Linbo; Rickey E Carter; Christopher Lynch; Nathan P Staff; Christopher J Klein; P James B Dyck; David N Herrmann; Peter J Dyck Journal: Muscle Nerve Date: 2018-04-20 Impact factor: 3.217