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Neurotron, Incorporated Innovative Medical Technology Established 1981 |
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AANEM Neurometer Technology Review More Than 150 Factual Errors |
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The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), formerly known as the American Association of Electrodiagnostic Medicine (AAEM) published a Neurometer "Technology Review" in 1999 that is available at the following links: American Association of Electrodiagnostic Medicine Technology Review: The Neurometer Current Perception Threshold (CPT). Muscle & Nerve, Vol. 22,:523-531, 1999. (pdf of entire review) or AANEM web site posting This page cites the factual errors of the literature evaluations conducted for this above cited publication. Court documents, available upon request, establish the article was not peer reviewed, does not represent the consensus of a committee, was not written by 20 of the 21 authors listed. Additionally less than 19% of the cited papers in this opinion piece were actually reviewed. This review included inaccurate statements which were pointed out to the AAEM/AANEM soon after the original April 1999 publication. Those falsely cited as authors for this publication were: William F. Brown, MD, FRCP(C) Allthough all of the above cited individuals had been notified of this misrepresentation of their names on this publication soon after it was published in 1999 none of these individuals has ever publically acknowledged this fact as of 2010 except Dr. John Kincaid. Dr. Kincaid had knowledge the manuscript for this publication. Dr. Kincaid did not author any of this publication. The sole author of this AAEM publication George Baquis of Massachesettes. The following list of the factual errors in the evaluations written by Dr. Baquis for the review. The author of the publication, George Baquis, MD, stated in sworn testimony that he had no knowledge of statistics although the review evaluation criteria required such knowledge. The errors of Dr. Baquis’ evaluations are summarized on a table on the next page of this document. The April 1999 Neurometer® AANEM Technology Review’s citations reference numbers are used to cite the references below. The AANEM reviews evaluation criteria are defined on page 524 of the original publication as follows: “The 6 criteria used in the
evaluation are: This document cites the factual errors with respect to these six evaluation criteria in the published review. These appear in the “References Section” of this paper Muscle & Nerve, Supplement 8, pages S242-S259, 1999. The reviews in the
publications Reference List section were later published in Muscle & Nerve
(Aug. 1999) and is currently available from their webs site at the following
URL: The following Table with reference numbers is a summary of the factual errors in the cited Reference List based on the Criteria #’s defined on page 524 of the review and cited above on this page. The number in the “( )” in the middle two columns indicates the total number of papers cited in the cell in the table where it appears. The individual reviews are evaluated on the following pages of this document. The following is a listing of the factual errors in these “evaluations” specifically including errors with respect to the six AAEM/AANEM evaluation criteria cited above from this publication that were relied upon according to the author of the publication to formulate the his opinion of the Neurometer technology and the Current Perception Threshold (CPT) electrodiagnostic evaluation.
References Reviewed by Dr. Baquis 1. American Association of Electrodiagnostic Medicine Quality Assurance Committee. Jablecki CK, Andary MT, So YT, Wilkins DE, Williams FH: Literature review of the usefulness of nerve conduction studies and electromyography for the evaluation of patients with carpal tunnel syndrome. Muscle Nerve 1993; 16:1392-1414. The AAEM Technology Review that calls for insurance reimbursement for sNCV for Carpal Tunnel Syndrome (CTS). This is not a publication about the Current Perception Threshold (CPT) evaluation. 2. Appenzeller, O.A., Wood,
S.C., Appenzeller, T. Pentoxifylline, Altitude, and Peripheral Nerve
Function. Annals of Sports Medicine, Volume 4(4):286-288, 1988. 1) The reviewer indicates that Criteria #3, “Detailed description of methodology (sufficient to permit replication)” was not satisfied. This is not true. A detailed description of the methodology is provided in this publication. 2) The reviewer states in their second sentence, “The number of climbers is not specified.” The reviewer did not look at the cited detailed reference of the population which appeared in a preceding article in the same issue of this journal. 3) The reviewer indicates that Criteria #4, “Attention to testing conditions which could potentially affect the results” was not satisfied. This is not true. This publication included detailed information related to conditions which could potentially affect results (e.g., altitude and temperature) - no credit was given for this point by the AAEM reviewer. 4) Although this study demonstrated the neuroselectivity of the CPT measures the reviewer failed to notice this point 5) The reviewer indicates that Criteria #5, “A suitable reference population from the same laboratory (obtained either concurrently or obtained in the same laboratory)” was not satisfied. This is not true, the design of this study had a reference population. 3. Avram, M.W. Severe
Neuropathy in Urban Dialysis Patients: Neurological Complications in Chronic
Uremic Management. Contemporary Dialysis and Nephrology, Volume
15(4):22-23,34, April, 1994. This paper meets criteria #1, #3, #5 and #6. 4. Chado HN: The current perception threshold evaluation of sensory nerve function in pain management. Pain Digest 1995; 5:127-134. This is a review article- not a scientific research paper. 5. Dent MT, Ward JD, Ryder REJ: Testing for diabetic neuropathy; part 1, somatic nerve function. Practical Diabetes 1992; 9:24-28 This is a review article- not a scientific research paper. 6. Drobny, E., Rendell, M., Dovgan D., Bergman, T., O’Donnell, G., Katims, J. #113: Mapping Diabetic Sensory Neuropathy by Constant Current Perception Threshold (CPT) Testing. Diabetes, Volume 38, Sup. 2, 1989. This publication was not included in this AAEM technology review. 7. Evans, E.R., Rendell, M.S., Bartek, J.P., Bamisedun, without ., Connor, S., Giitter, M. Current Perception Thresholds in Ageing. Age and Ageing, Volume 21:273-279, 1992. Criteria Met (3/6: 1,3,6) The AAEM reviewer cite only three of the six Criteria were satisfied in this publication. 1) The reviewer indicates that Criteria #1, “A prospective study” was satisfied. This is not true. 2) The reviewer indicates that Criteria #2, “Independent ascertainment of the clinical condition evaluated by CPT” was not satisfied. This is not true. An independent ascertainment of the clinical condition evaluated by the CPT was conducted in this study. Either the reviewer did not read this publication or they did not understand it. 3) The reviewer statement that, ”No comment is made regarding blinding of each study portion.” is not true about the CPT measures in this study. The methods section (page 275) mentions several presentations to the subjects of a “dummy” or a “placebo” stimulus. 4) The statement that “No comment is made regarding validation of the symptom and physical examination scoring technique or whether the patients were age and sex matched with the controls.” is not true. These points are discussed in the methods and results sections of this publication. 5) The statement that, “Data is presented as correlation coefficients.” is false and misleading. Actual frequency and body site specific average CPT data is presented in Figures 1 and 2 of this publication and discussed in the text. 8. Franzblau, A., Werner, R.A., Johnston, E., Torrey, S. Evaluation of Current Perception Threshold Testing as a Screening Procedure for Carpal Tunnel Syndrome among Industrial Workers. Journal of Occupational Medicine, Volume 36(9):1015-1021, 1994. Criteria Met (4/6: 1,2,3,6) The AAEM reviewer made several false statements about this University of Michigan publication including the following: 1) The reviewer twice states that this study was “prospective”. This is false. This is clearly a one time screening study and not a prospective study. This discrepancy is disturbing as a “prospective study” was one of the Criteria of this AAEM Technology Review Committee and reviewer are expected to understand their own review Criteria 1 is not met.. 2) The reviewer states, “Criteria used for the clinical diagnosis of carpal tunnel syndrome are clearly described.” This is false. No clinician conducted any evaluation of any subject in this screening study and no “clinical diagnosis” was described in this publication. 3) The reviewer states, “surface temperature was controlled for electrodiagnostic testing”. This is not true. The paper states that skin temperatures varied over a 3 degree Celsius range for the electrodiagnostic testing and, “No correction for temperature was applied to raw latency results in this study.” This paper is one of the two publications that the AAEM committee was provided with supplementary related letters to the editor indicating how this study was not conducted using the Neurometer® CPT measurements according to manufacturers recommended guidelines. These letters were published in the Journal of Occupational and Environmental Medicine, Volume 37 (7) 790-793, (July 1995). 9. Gavin, L.A. A
Comprehensive Approach to Sidestep Diabetic Foot Problems. The
Endocrinologist, Volume 3(3):191-203, 1993. “Criteria Met (0/6)” This is a review article- not a scientific research paper even though it was evaluated as if it were such. 10. Guthrie D, Gomes R,
Guthrie R, Topham B, Childs B, Parks L: Neuropathy in This publication was not included in this AAEM technology review. 11. Katims, J.J., Appenzeller, Without. Differential Susceptibility to Noxious Stimuli: Exercise-Associated Insensitivity to Pain. Neurology, Volume 36(4:1):306, 1986. This publication was not included in this AAEM technology review. 12. Katims, J.J., Long,
D.M., Ng, L.K.Y. Transcutaneous Nerve Stimulation (TNS): Frequency and
Waveform Specificity in Humans. Applied Neurophysiology, Volume 49:86-91,
1986. Nowhere in this publication are the words “Neurometer®” or “CPT” mentioned. 13. Katims, J.J., Naviasky, E., Ng, L.K.Y., Bleecker, M.L., Rendell, M. New Screening Device for Assessment of Peripheral Neuropathy. Journal of Occupational Medicine, Volume 28(12):1219-1221, 1986. Criteria Met (1/6: 6) 1) This study does not satisfy Criteria #1. 2) This study satisfies Criteria #2, #3, #4 and #6. 3) The reviewer states, “It is not stated whether the groups are age and sex matched.” This is not true as the ‘Results’ and ‘Discussion’ sections of this publication discuss age in detail. 4) The reviewer states, “Independent ascertainment of clinical condition is not provided for comparison with the CPT values.” This is not true. It is described in the methods section of this study that “all participants received a limited neurologic examination to determine the presence of neuropathy.” 14. Katims, J.J., Naviasky, E., Rendell, M.S., Ng, L.K.Y., Bleecker, M.L. Constant Current Sine Wave Transcutaneous Nerve Stimulation for the Evaluation of Peripheral Neuropathy. Archives of Physical Medicine and Rehabilitation, Volume 68:210-213, 1987. Criteria Met (2/6: 1,6) 16. Katims, J.J., Rouvelas, P., Sadler, B.T., Weseley, S.A. Current Perception Threshold: Reproducibility and Comparison with Nerve Conduction in Evaluation of Carpal Tunnel Syndrome. Transactions of the American Society of Artificial Internal Organs, Volume 35(3):280-284, 1989. “Criteria Met (1/6: 6)” 1) The reviewer indicates
that Criteria #1, “A prospective study” was not satisfied. This is not true
. This publication includes a prospective reproducibility study and
presents the coefficients of variation for repeated measures. 17. Katims, J.J., Taylor, D.N., Wallace, J.I. Bekesi, J.G., Masdeu, J.C. Current Perception Threshold in HIV-Positive Patients. Proceedings of the Fifth International Conference on AIDS, p. 463, Montreal, 1989. This publication was not included in this AAEM technology review. 18. Katims, J.J., Taylor,
D.N., Weseley, S.A. Sensory Perception in Uremic Patients. Transactions of
the American Society of Artificial Internal Organs, Volume 37(3):M370-M372,
1991. The AAEM reviewer cite one Criteria was satisfied in this publication. The reviewer missed important information that was described in detail or referenced citations. 1) The reviewer indicates that Criteria #1, “A prospective study” was satisfied. This is not true. This study was not a prospective study of the Neurometer® CPT electrodiagnostic sensory Nerve Conduction Threshold (sNCT) evaluation 19. Kempler, P., Kádár, É., Marton, A., Vargha, P., Hermányi, Zs., Keresztes, K. Sensory nerve dysfunction in NIDDM and in newly diagnosed NIDDM detected by the NEUROMETER®CPT: Relation to autonomic function. Diabetic neuropathy: new concepts and insights, Proceedings of the 3rd International Symposium on Diabetic Neuropathy, Kanagawa, Japan, 3-5 November, 1994, Hotta, N., Greene, D.A., Ward, J.D., Sima, A.A.F., Boulton, A.J.M., eds., Elsevier Science Publishing Co. Inc., New York, NY, pp 291-296, 1995. “Criteria Met (0/6)” 1) This paper satisfies Criteria #2, 3, 4, 5 and 6. 2) The reviewer report that this publication “appears to be the same data presented by Kempler P, et al, at the 22nd Congress of the International Society of Internal Medicine. It should be noted that information and analysis provided in this publication does not appear in the 22nd Congress of the International Society of Internal Medicine publication. 3) The reviewer gave both the 22nd and 23rd Congress of the International Society of Internal Medicine publications credit for satisfying Criteria #5 and #6. Similar information was presented in this publication, yet this paper was cited as fulfilling zero Criteria. This is an example of the apparently arbitrary nature of the reviewer evaluation of this literature. 20. Kempler, P., Keresztes, K., Marton, A., Váradi, A., Hermányi, Zs., Márczy, V., Kádár, É., Vargha, P. Evaluation of current perception threshold (CPT) by the NEUROMETER®: a diagnostic tool to detect early abnormalities of peripheral sensory nerve function in non-insulin-dependent diabetes mellitus. Proceedings of the 22nd Congress of the International Society of Internal Medicine, Varró, V., de Châtel, R., eds., Monduzzi Editore, Bologna, Italy, pp. 765-769, 1994. “Criteria Met (2/6: 5,6)” Criteria #3 is satisfied, 21. Kempler, P., Váradi, A., Kádár, É., Szalay, F. Autonomic and peripheral neuropathy in primary biliary cirrhosis: evidence of small sensory fibre damage and prolongation of the QT interval. Journal of Hepatology, Volume 21:1150-1151, 1994. Never evaluated this scientific paper. 22. Kempler, P., Váradi, A., Pap, A., Kádár, É., Vargha, P., Hermányi, Z., Márczy, V., Galiffy, G., Szalay, F.I. Comparative Evaluation of Autonomic and Peripheral Sensory Nerve Function in Primary Biliary Cirrhosis. Zeitschrift für Gastroenterology, Volume 31:336, 1993. This publication was not included in this AAEM technology review. 23. Lee, Y., Robinson, M., Wong, N., Chan, E., Charles, M. A. The effect of pentoxifylline on current perception thresholds in patients with diabetic sensory neuropathy. Journal of Diabetes Complications, Volume 11(5):274-278, 1997. Never evaluated this scientific paper, would have fulfilled all 6 Criteria. 24. Liu, S., Kopacz, K.J., Carpenter, R.L. Quantitative Assessment of Differential Sensory Nerve Block after Lidocaine Spinal Anesthesia. Anesthesiology, Volume 82(1):60-63, 1995. “Criteria Met (3/6: 1,3,6)” 1) The reviewer indicates
that Criteria #2, “Independent ascertainment of the clinical condition
evaluated by CPT” was not satisfied. This is not true. An independent
ascertainment of the clinical condition evaluated by the CPT was repeatedly
conducted in this study. 25. Masson, E.A., Boulton, A.J.M. The Neurometer: Validation and Comparison with Conventional Tests for Diabetic Neuropathy. Diabetic Medicine, Volume 8:S63-S66, 1991. “Criteria Met (0/6)” This publication was not included in this AAEM technology review. 27. Masson, E.A., Fernando, D.J.S., Veves, A., Boulton, A.J.M. Independent evaluation of a novel device for assessment of diabetic neuropathy. Diabetologia, Volume 32:515A, 1989. This publication was not included in this AAEM technology review. 28. Masson, E.A., Veves, A., Fernando, D., Boulton, A.J.M. Current perception thresholds: a new, quick, and reproducible method for the assessment of peripheral neuropathy in diabetes mellitus. Diabetologia, Volume 32:724-728, 1989. “Criteria Met (2/6: 1,5)” 1) The reviewer indicates
that Criteria #2, “Independent ascertainment of the clinical condition
evaluated by CPT” was not satisfied. This is not true. An independent
ascertainment of the clinical condition evaluated by the CPT was conducted
in this study. 3) The reviewer indicates that Criteria #6, “Criteria for abnormality obtained from the reference population and defined in statistical terms” was not satisfied. This is not true. 29. McAllister, R.M.R., Urban, L.A., Dray, A. Smith, P.J., Comparison of the Sensory Threshold in Healthy Human Volunteers with the Sensory Nerve Response of the Rat In Vitro Hindlimb Skin and Saphenous Nerve Preparation on Cutaneous Electrical Stimulation. Journal of Hand Surgery (British and European) Volume 20(B:4):437-443, 1995. Criteria Met (4/6: 1,3,5,6) This is not a Neurometer® CPT publication 30. Meijer, J.W.G., Tack, C.J.J., Netten, P.M., Lutterman, J.A. Current Perception Threshold Testing: A Reliable Method to Quantify Diabetic Neuropathy? Journal of Internal Medicine, Netherlands, 1-53, 1992. This is a full length favorable paper that was not evaluated. 31. Mittman, N., Avram, M.M. Management of Uremic Peripheral Neuropathy. Dialysis Therapy, 2nd edition, edited by Nissenson, A.R. & Fine, R.N, pp. 277-279, 1993. This is a review paper from a text book, not a scientific research article. 32. Moss, K., Holewski, J.J., Adams, S., Grunfeld, C. #536: Comparison of Aesthesiometry, Biothesiometry and Neuroselective Current Perception Threshold Test to Quantify Sensory Deficit in Diabetic Peripheral Neuropathy. Diabetes, Volume 38, Sup. 2: 136A, 1989. This publication was not included in this AAEM technology review. 33. Neurometer CPT Clinical Applications, Int-Med New Port Richey, Florida, 1993. This is commercial, not scientific literature. 34. Neurotron Inc: Neurometer CPT Quantitative Sensory Nerve Tester. Baltimore, MD, 1989-1991. This is commercial, not scientific literature. This ignores all Neurotron, Inc.’s annual submissions to the AAEM or AANEM for their “technology review” after 1991 with over 500 related publications. 35. Olmos, P.R., Cataland, S., O'Dorisio, T.M., Casey, C.A., Smead, W.L., Simon, S.R. The Semmes-Weinstein Monofilament as a Potential Predictor of Foot Ulceration in Patients with Noninsulin-Dependent Diabetes. The American Journal of the Medical Sciences, Volume 309(2):76-82, 1995. “Criteria Met (5/6: 1,2,3,4,6)” 36. Pitei, D.L., Watkins,
P.J., Stevens, M.J., Edmonds, M.E. The Value of the “Criteria Met (4/6: 1,3,5,6)” 1) The reviewer indicates that Criteria #2, “Independent ascertainment of the clinical condition evaluated by CPT” was not satisfied. This is not true. An independent ascertainment of the clinical condition evaluated by the CPT was conducted in this study. 2) The reviewer indicates that Criteria #4, “Attention to testing conditions which could potentially affect the results” was not satisfied. The reviewer states that “Testing conditions were not presented”, this is not true. 37. Quantitative sensory testing: A consensus report from the Peripheral Neuropathy Association. Neurology 1993; 43:1050-1052. This is publication by Dr. Peter Dyck who has a commercial conflict of interest with the Neurometer® CPT. This paper is a review paper that is not about the Neurometer® CPT. 38. Rendell, M., Bamisedun,
0. Skin Blood Flow and Current Perception in Pentoxifylline-Treated
Diabetic Neuropathy. Angiology, Volume 43(10):843-851, 1992. 1) The reviewer reports that 6 of the 30 subjects in this study “dropped out”. This is not true. These 6 subjects were “excluded” for valid scientific reasons as cited in the text of this publication. 2) The reviewer report that
the diabetic neuropathy was “not precisely defined” in this study. This is
not true. This definition is clearly defined in the methods section of this
publication. 4) The reviewer indicates that Criteria #5, “A suitable reference population from the same laboratory (obtained either concurrently or obviously in the same laboratory)” was not satisfied. This is not true. This study used “a normal nondiabetic control population consisting of 97 individuals”. 5) The reviewer indicates that Criteria #6, “Criteria for abnormality obtained from the reference population and defined in statistical terms” was not satisfied. This is not true. Several pages of this publication are dedicated to this subject. 39. Rendell, M.S., Dovgan, D.J., Bergman, T.F., O'Donnell, G.P., Drobny, E.P., Katims, J.J. Mapping Diabetic Sensory Neuropathy by Current Perception Threshold Testing. Diabetes Care, Volume 12(9):636-640, 1989. “Criteria Met (3/6: 3,5,6)” 1) The reviewer report that the “scale validation for the measurement of sensory polyneuropathy is not presented”. This is not true. 2) The reviewer states, “it is not clear whether this (repeated examinations by CPT) is assessed in the study groups”. This is not true. It is clear that this publication is not a repeated measures study. 3) Although this publication provides only a brief description of the CPT testing methodology (with detailed references), the reviewer indicated that this publication satisfied their Criteria #3, “Detailed description of methodology (sufficient to permit replication)”. This discrepancy with other papers with similar descriptions that were not given credit for Criteria #3 suggests that the reviewer evaluation of the Neurometer® CPT technology was arbitrary. 4) The reviewer states, “diabetic sensory neuropathy is not defined”. This is not true. This definition is clearly defined in the methods section of this publication. 5) The reviewer states that the blinding of examiners and patients is not mentioned. This is not true. The blinding of patients as part of the standardized CPT sNCT electrodiagnostic testing methodology is referenced and the blinding of the examiners is discussed in the second paragraph of the “Research Design and Methods” section. 40. Rendell, M.S., Katims, J.J., Richter, R., Rowland, F. A comparison of nerve conduction velocities and current perception thresholds as correlates of clinical severity of diabetic sensory neuropathy. Journal of Neurology, Neurosurgery and Psychiatry, Volume 52:502-511, 1989. Criteria Met (5/6: 1,2,3,4,6) 2) This paper was incorrectly classified as satisfying Criteria #1. This was not a prospective study. 1) The reviewer states, “ The strongest correlation was between physical score and median nerve motor conduction”. This is not true as clearly indicated by comparing Table 4 and Table 5 of this publication. The truth was that the strongest correlation was between physical score and peroneal nerve 2000 Hz CPT measures. 2) The reviewer indicates that Criteria #6, “Criteria for abnormality obtained from the reference population and defined in statistical terms” was not satisfied. This is not true as indicated in Table 1. 41. Rice, B.I., Schindler, J.V. Increased Sensory Nerve Function of the Peroneal Nerve in Response to Biofeedback Assisted Relaxation Training in a Population with Diabetes. Diabetes, Volume 41, (supp 1):33A, 1992. This publication was not included in this AAEM technology review. 42. Romano, T.J., Stiller, J. Abnormal Cutaneous Perception in Fibromyalgia Patients. Arthritis and Rheumatism, Volume 31(1):R44, 1988. This publication was not included in this AAEM technology review. 43. Shields, M., Beckmann, S.L., Cassidy-Brinn, G. Improvement in Perception of Transcutaneous Nerve Stimulation Following Detoxification in Firefighters Exposed to PCBs, PCDDs and PCDFs. Clinical Ecology, Volume 6(2):47-50, 1989. “Criteria Met (0/6)” 1) The reviewer indicates that Criteria #1, “A prospective study” was not satisfied. This is not true the reviewer actually state, “CPT values before and after treatment were compared”, a factual admission that this study was in reality a “prospective study”. 2) The reviewer indicates that Criteria #2, “Independent ascertainment of the clinical condition evaluated by CPT” was not satisfied. This is not true. An independent ascertainment of the clinical condition evaluated by the CPT was conducted in this study. 44. Tack, C.J.J., Netten, P.M., Sheepers, M.H., Meijer, J.W.G., Smits, P. and Lutterman, J. Comparison of clinical examination, current and vibratory perception threshold in diabetic neuropathy. Netherlands Journal of Medicine, Volume 44:41-49, 1994. “Criteria Met (4/6: 1,3,5,6)” 1) The reviewer report, “CPT did not reliably discriminate between a group with a high prevalence of disease and healthy controls. This is a false and misleading statement. This publication reports in the third paragraph of its abstract “As expected, there were highly significant differences (Wilcoxin) in CPT, VPT and neurological scores between H/DIABETIC- and DIABETIC+ (p<0.001) but not between H and DIABETIC-”. H is healthy controls, DIABETIC- are diabetics without clinical signs or symptoms of diabetic neuropathy and DIABETIC+ are diabetic patients with overt diabetic neuropathy. The electrodiagnostic sNCT evaluation is a test of sensory nerve function (neuropathy) and not of diabetes. The CPT did reliably discriminate between a group with a high prevalence of disease (polyneuropathy) and healthy controls. 45. Tay, B., Wallace, M.S., Irving, G. Quantitative Assessment of Differential Sensory Blockade after Lumbar Epidural Lidocaine. Anesthesia and Analgesia, Volume 84:1071-1075, 1997. “Criteria Met (2/6: 1,3)” 1) The reviewer indicates that Criteria #2, “Independent ascertainment of the clinical condition evaluated by CPT” was not satisfied. This is not true. An independent ascertainment of the clinical condition that received the electrodiagnostic CPT evaluation was conducted in this study. 2) The reviewer indicates that Criteria #4, “Attention to testing conditions which could potentially affect the results” was not satisfied. The reviewer states that “Testing conditions were not presented”, this is not true. 3) The reviewer indicates that Criteria #5, “A suitable reference population from the same laboratory (obtained either concurrently or obviously in the same laboratory)” was not satisfied. This is not true the design of this study had each subject serving as their own control for the CPT measures. 4) The reviewer indicates that Criteria #6, “Criteria for abnormality obtained from the reference population and defined in statistical terms” was not satisfied. This is not true as indicated in Figures 1 and 2. 5) The reviewer report, “The possibility of simultaneous effect on different nerve populations is not addressed”. This is not true and this point is the entire purpose of this publication. 46. Taylor, D.N., Katims, J.J., Ng, L.K.Y. Sine-Wave Auricular TENS Produces Frequency-Dependent Hypesthesia in the Trigeminal Nerve. The Clinical Journal of Pain, Volume 9(3):216-219, 1993. “Criteria Met (2/6: 1,3)” 1) The reviewer indicates that Criteria #4, “Attention to testing conditions which could potentially affect the results” was not satisfied. This is not true. 2) The reviewer indicates that Criteria #5, “A suitable reference population from the same laboratory (obtained either concurrently or obtained in the same laboratory)” was not satisfied. This is not true, the design of this study had a reference population defined in statistical terms. 3) The reviewer report, “The Criteria used to select normal volunteers is not presented.” This is not true. 4) The reviewer report, “ The pretreatment CPT (absolute and SD values) for the baseline 5 Hz TENS group appears to be significantly different from the placebo TENS group (i.e. is equal to or greater than the CPT values for the after TENS 5 Hz and 2000 Hz post treatment groups). The reviewer is saying that CPT values (in mAmperes) of 0.21(SD=0.06), 0.27 (SD=0.1), 0.25 (0.09) and 0.26 (SD=0.09) are significantly different. Assuming a normal (or Gaussian) distribution of the population of subjects in this study, the CPT values plus or minus one SD would equal the 95% confidence limits for the population. Based on this statistical fact the reviewer were incorrect when they stated that these CPT values were “significantly different”. Criteria #6 was satisfied. 47. Taylor, D.N., Wallace, J.G., Masdeu, J.C. Perception of Different Frequencies of Cranial Transcutaneous Electrical Nerve Stimulation in Normal and HIV-Positive Individuals. Perceptual and Motor Skills, Volume 74:259-264, 1992. “Criteria Met (0/6)” 48. Veves, A., Malik, R., Townsend, C., Thompson, S., Boulton, A.J.M. Unmyelinated Fibre Pathology in Diabetic Patients with Mild Neuropathy. Diabetologia, Volume 35, (supp 1):A16, 1992. This publication was not included in this AAEM technology review. 49. Veves, A., Malik, R.A., Lye, R.H., Masson, E.A., Sharma, A.K., Schady, W., Boulton, A.J.M. The Relationship Between Sural Nerve Morphometric Findings and Measures of Peripheral Nerve Function in Mild Diabetic Neuropathy. Diabetic Medicine, Volume 8:917-921, 1991. “Criteria Met (2/6: 1,2) “ 1) The reviewer indicates that Criteria #1, “A prospective study” was satisfied. This is not true. 2) Criteria #6 is satisfied. 50. Veves, A., Young, M.J., Manes, C., Boulton, A.J.M. Differences in peripheral and autonomic nerve function measurements in painful and painless neuropathy: A clinical study. Diabetes Care, Volume 17(10):1200-1202, 1994. “Criteria Met (3/6: 2,5,6)” The AAEM reviewer cite two of the six Criteria satisfied in this publication. The reviewer missed important information (such as the methodology) that was described in detail in referenced citations but not extensively detailed in the body of the publication. The reviewer acknowledge in their statement that, “The details including methods and testing conditions are referenced to other publications and are not described in this paper”. 51. Vinik, A.I., Suwanwalaikorn, S., Stansberry, K.B., Holland, M.T., McNitt, P.M., Colen, L.E. Quantitative Measurement of Cutaneous Perception in Diabetic Neuropathy. Muscle & Nerve, Volume 18:574-584, 1995. “Criteria Met (6/6)” This is one of the two publications that the AAEM committee was provided with supplementary related letters to the editor that were not commented upon in this review. They were published in Muscle and Nerve 19: 403-407, 1996 titled “Quantitative measurement of cutaneous perception in diabetic neuropathy”. The manufacturer of the Neurometer® CPT devices, Neurotron, Inc. (Balto., MD) indicated to the AAEM committee with these letters that this publication did not use the Neurometer® CPT device according to the manufacturers recommended guidelines. The AAEM reviewer rate this study as one of only two of the 43 studies they ‘reviewed’ that satisfied all six of the review Criteria. The reviewer is wrong about this rating. The reviewer indicates this study was “prospective” and therefore satisfied the prospective Criteria was satisfied. This is false. This is clearly a one time study and not a prospective study. This discrepancy is disturbing as a “prospective study” was one of the Criteria of this AAEM Technology Review Committee and reviewer are at the very least expected to understand their own review Criteria. 52. Wallace, M.S., Dyck, J.B., Rossi, S.S., Yaksh, T.L. Computer Controlled Lidocaine Infusion for the Evaluation of Neuropathic Pain after Peripheral Nerve Injury. Pain, Volume 66:69-77, 1996. “Criteria Met (6/6)” 53. Weseley, S.A., Liebowitz, B., Katims, J.J. Neuropathy of Uremia: Evaluation by Nerve Conduction Velocity versus Neurospecific Current Perception Threshold. Nephron, Volume 52:317-322, 1989. “Criteria Met (1/6: 6)” 2) The reviewer states that this publication did not include (normal laboratory values for nerve conduction testing”. This is not true. This information is provide in Table 3. 3) The reviewer states that Table 4 of this publication is the same as Table 4 in the following publication (43). The reviewer neglected to mention that Table 4 of this publication presents only 1 years data, whereas Table 4 in the following publication (43) presents 2 years data. 4) The reviewer indicates that Criteria #3, “Detailed description of methodology (sufficient to permit replication)” was not satisfied. This is not true. A more detailed description of the methodology is provided in this publication than most of the other publications in this “Literature Review” given credit for fulfilling this Criteria. 54. Weseley, S.A., Sadler, B., Katims, J.J. Current Perception: Preferred Test for Evaluation of Peripheral Nerve Integrity. Transactions of the American Society of Artificial Internal Organs, Volume 34(3):188-193, 1988. “Criteria Met (1/6: 6)” The AAEM reviewers rated this publication as satisfying only one of their 6 review Criteria, #6, “Criteria for abnormality obtained from the reference population and defined in statistical terms.” 1) The reviewer indicates
that Criteria #1, “A prospective study” was not satisfied. This is not
true. This publication is prospective as it includes electrodiagnostic
measures obtained over a two year period. 55. Weseley SA, Sadler B, Katims J, Goodman AI: Longitudinal assessment of current perception threshold versus nerve conduction velocity in ESRD patients. Kidney Int 1988; 33:241. Not a valid citation - has two different citations mixed up. 56. Wisner, R.M., Root, D., Shields, M., Beckmann, S.L. Neurotoxicity and Toxic Body Burdens: Relationship and Treatment Potentials. International Conference on Peripheral Nerve Toxicity, Proceedings Edited by K. Hashimoto, Kanazawa, pp. 49-50, June, 1993. “Criteria Met (0/6)” The AAEM reviewer cite zero Criteria were satisfied in this publication. The reviewer missed important information (such as the methodology) that was described in detail in referenced citations but not extensively detailed in the body of the publication. 1) The reviewer indicates that Criteria #1, “A prospective study” was not satisfied. This is not true the, reviewer actually state, “”Evaluation was performed before and after therapy”, a factual admission that this study was in reality a “prospective study”. 2) The reviewer indicates that Criteria #2, “Independent ascertainment of the clinical condition evaluated by CPT” was not satisfied. This is not true. An independent ascertainment of the clinical condition evaluated by the CPT was conducted in this study. Although the AAEM/AANEM original publication states that “A summary and review of each publication in the bibliography is available upon request”, when the association published the bibliography which included 102 citations, only 14 had a summary and evaluation. It is easy to understand how the executive director of the AAEM/AANEM Sherlyn Adkins, J.D., characterized the statement that “A summary and review of each publication in the bibliography is available upon request” was “misleading at best”. The following is a listing
of the factual errors that appear in the bibliography papers for the
AAEM/AANEM Neurometer technology that have “evaluations”. This bibliography
is posted on the AAEM/AANEM web site at the following URL: Avram, M.M. Neurological Complications in Chronic Uremia Management. Morbidity and Mortality of Dialysis NIH Consensus Development Conference, pp. 123-128, November, 1993. Bilgi, C., Pelmear, P.L.
Hand-Arm Vibration Syndrome: A Guide to Medical Impairment Assessment.
Journal of Occupational Medicine, Volume 35(9):936-942, September, 1993. Bleecker, M.L. Quantifying Sensory Loss in Peripheral Neuropathies. Neurobehavioral Toxicology and Teratology, Volume 7:305-308, 1985. Not evaluated. Bleecker ML, Lindgren KN,
Tiburzi MJ, Ford DP: Curvilinear relationship between blood lead level and
reaction time. J Occup Environ Med 1997; 39:426-431. Chaudhry V: Technology review: Nervepace digital electro-neurometer. Muscle Nerve 1997;20:1200-1203. This is not a Neurometer® CPT publication. Chu, N.S. Current Perception Thresholds in Toe-To-Digit Transplantation and Digit-To-Digit Replantation. Muscle & Nerve, Volume 19(2):183-186, 1996. “Criteria Met (2/6: 3,4) “ 1) This study is criticized because it does not have an independent control group. This statement misses the fact that this study has two within subject independent control sites. Criteria #5 is satisfied. 2) This AAEM publication is also criticized because “Normal values for CPT are not presented.” This is not true, these values are presented in table 2 of this publication. 3) Criteria #2 #5 and #6 are satisfied Donaghue, V.M., Giurini, J.M., Rosenblum, B.I., Weissman, P.N., Veves, A. Variability in Function Measurements of Three Sensory Foot Nerves in Neuropathic Diabetic Patients. Diabetes Research and Clinical Practice, Volume 29:37-42, 1995. “Criteria Met (4/6: 1,2,3,6)” 1) This publication included a “modified” Neurometer® CPT as the reviewers correctly pointed out. Because this “modified” Neurometer was employed that does not provide the standardized CPT measurements that are the topic of this review, it was in appropriate to include it in this review. 2) The reviewer statement that “CPT values were not greater in diabetic patients than controls”, is false. This comparison is presented on Table 2 of this publication. This Table shows a significant difference at p<0.001 between the diabetic and healthy control groups electrodiagnostic Neurometer® CPT measures obtained from the 1st toe and 5th MPJ and the plantar test sites. 3) This paper satisfies Criteria #4 AND #5. Green, J., Clewell, W., Hickey, S., Karstsonis, P. An Alternate Method of Objectively Assessing Subjective Sensory Complaints by Perceptual Threshold Testing in a Series of Silicone-Exposed Female Patients Complaining of Dysesthesias, Numbness, and/or Tingling of One or More Extremities. Pain Digest, Volume 7:13-15, 1997. The AAEM reviewer cite zero Criteria were satisfied in this publication. The reviewer missed important information (such as the methodology) that was described in detail in referenced citations but not extensively detailed in the body of the publication. The AAEM reviewers stated that there was a “fundamental problem” as to how to compare the Neurometer® CPT electrodiagnostic evaluation to other electrodiagnostic tests. This publication is one of many cited in this review that specifically and successfully addresses this point. Hill, R.S., Lawrence, A. Current Perception Threshold in Evaluating Foot Pain. Journal of the American Podiatric Medical Association, Volume 81(3): 150-154, 1991. The AAEM reviewer cite zero Criteria were satisfied in this publication. The reviewer missed important information (such as the methodology) that was described in detail in referenced citations but not extensively detailed in the body of the publication. 1) The reviewer indicates that Criteria #2, “Independent ascertainment of the clinical condition evaluated by CPT” was not satisfied. This is not true. An independent ascertainment of the clinical condition evaluated by the CPT was conducted in this publication. Kempler, P., Barna, I., Keresztes, K., Marton, A., Hermányi, Z., Tamási, L., Kádár, É., Vargha, P., de Chatel, R. Severe peripheral sensory nerve dysfunction detected by the NEUROMETER® - CPT in alcoholic diabetic patients: implications for treatment with benfotiamin. Presented at the 23rd Congress of the International Society of Internal Medicine, Manila, Philippines, (PS081), Aquino,A.V., Piedad, F.F., Sulit, Y.Q.M., eds, Monduzzi Editore, Bologna, Italy, pp 245-249, 1996. The AAEM reviewer cite two Criteria were satisfied in this publication. This is an example of the reviewer missing important information that was described in detail in this publication. 1) The reviewer reported that “definitions of the patient populations were not provided. This is not true. Liu, S.S., Gerancher, J.C., Bainton, B.G., Kopacz, D.J., Carpenter, R.L. Effects of Electrical Stimulation at Different Frequencies on Perception and Pain in Human Volunteers: Epidural Versus Intravenous Administration of Fentanyl. Anesthesia and Analgesia, Volume 82:98-102, 1996. The reviewer neglected or missed the pertinent points of this study as it relates to the painless Neurometer® CPT measure - the topic of their review. They overlooked the most important finding of this study about the painless CPT measure, that is - neuroselective CPT measurements are not effected by either the epidural or intravenous administration of a potent opiate such as fentanyl. These reviewer focused their review of this publication on electrically evoked pain sensation which was not the topic of their “Neurometer® CPT” technology assessment. New, P. Neuro-selective Current Perception Threshold (CPT) quantitative sensory test: A re-evaluation, Neurology, Volume 49(5):1482, 1997. Several of the publications cited in the “Textbook chapters, Reviews, Abstracts, Letters, Presentations” had absolutely nothing to do with the Neurometer® CPT electrodiagnostic evaluation although the misleading inference in the “Technology Review Publication was that they did refer to this evaluation. There have been two letters published by the AAEM, one in Muscle and Nerve in 1998 (Cohen, R.P., Neuroselective Current Perception Threshold (CPT) Electrodiagnostic Sensory Test. Letters to the Editor. Muscle & Nerve 1998;21:1810-1814. and the other in Positive Waves, page 11, March, 1996. Letter from Dr. Katims to Dr. Kincaid the editor. Also a written apology dated Oct. 18, 1996 was sent to Neurotron, Inc. from the Executive Director of the AAEM for this mistake. Yet this unfortunate “mistake” has now happened for a third time. Pelmear, P.L. and Kusiak, R. Clinical Assessment of Hand-Arm Vibration Syndrome. Nagoya Journal of Medical Science, Volume 57:27-41, 1994. The AAEM reviewer cite only
one of the six Criteria were satisfied in this publication. The reviewer
missed important information (such as the methodology and the patient
population) that was described in detail in referenced citations but not
extensively detailed in the body of the publication. Pelmear , P.L., Wills, M. Impact Vibration and Hand-Arm Vibration Syndrome. Journal of Occupational and Environmental Medicine, Volume 39 (11):1092-1097, 1997. The AAEM reviewer cite zero of the six Criteria satisfied in this publication. The reviewer missed important information (such as the methodology) that was described in detail in referenced citations but not extensively detailed in the body of the publication.
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