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Original Contribution |

“Unequivocally Abnormal” vs “Usual” Signs and Symptoms for Proficient Diagnosis of Diabetic Polyneuropathy:  Cl vs N Phys Trial

Peter J. Dyck, MD; Carol J. Overland; Phillip A. Low, MD; William J. Litchy, MD; Jenny L. Davies, BA; P. James B. Dyck, MD; Rickey E. Carter, PhD; L. Joseph Melton, MD; Henning Andersen, MD; James W. Albers, MD; Charles F. Bolton, MD; John D. England, MD; Christopher J. Klein, MD; Gareth Llewelyn, MD; Michelle L. Mauermann, MD; James W. Russell, MD; Dinesh Selvarajah, MD; Wolfgang Singer, MD; A. Gordon Smith, MD; Solomon Tesfaye, MD; Adrian Vella, MD
Arch Neurol. 2012;69(12):1609-1614. doi:10.1001/archneurol.2012.1481.
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Objective  To repeat the Clinical vs Neurophysiology (Cl vs N Phys) trial using “unequivocally abnormal” signs and symptoms (Trial 2) compared with the earlier trial (Trial 1), which used “usual” signs and symptoms.

Design  Standard and referenced nerve conduction abnormalities were used in both Trials 1 and 2 as the standard criterion indicative of diabetic sensorimotor polyneuropathy. Physician proficiency (accuracy among evaluators) was compared between Trials 1 and 2.

Setting  Academic medical centers in Canada, Denmark, England, and the United States.

Participants  Thirteen expert neuromuscular physicians. One expert was replaced in Trial 2.

Results  The marked overreporting, especially of signs, in Trial 1 was avoided in Trial 2. Reproducibility of diagnosis between days 1 and 2 was significantly (P = .005) better in Trial 2. The correlation of the following clinical scores with composite nerve conduction measures spanning the range of normality and abnormality was improved in Trial 2: pinprick sensation (P = .03), decreased reflexes (P = .06), touch-pressure sensation (P = .06), and the sum of symptoms (P = .06).

Conclusions  The simple pretrial decision to use unequivocally abnormal signs and symptoms—taking age, sex, and physical variables into account—in making clinical judgments for the diagnosis of diabetic sensorimotor polyneuropathy (Trial 2) improves physician proficiency compared with use of usual elicitation of signs and symptoms (Trial 1); both compare to confirmed nerve conduction abnormality.

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Figure 1. The clothing, masks, and dark glasses used to disguise the identity of patients (only 12 of the 24 patients are seen in the front row). The voices of patients were electronically altered. Patients did not speak unless physicians wore earphones. Some study personnel are also shown.

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Figure 2. The frequency of at least 75% of expert physicians' elicitation of signs, symptoms, and clinical diagnosis of diabetic sensorimotor polyneuropathy. Confirmed nerve conduction (NC) abnormality (calculated as the composite standard normal deviate score of 5 attributes of NC abnormality [Σ 5 NC nds ≤2.5th percentile]) is compared with results on days 1 and 2 of the Cl vs N Phys Trial 1 (A) and Trial 2 (a replication of Trial 1) (B). Percentages are calculated from 576 physician evaluations for 24 patients. Ellipses indicate not applicable. *Overreported clinical diagnoses were defined as the presence of clinical abnormalities but no NC abnormalities.

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