| Research Article |
Open Access |
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| Evaluating the Usefulness of the Diabetic Peripheral Neuropathy
Screening Process |
| Huijuan Yuan1, Jing Zhang1, Rui Tian1, Limin Wang1, Chunling Zhang2, Zhigang Zhao1* and Linong Ji3* |
| 1Department of Internal Medicine, Henan Provincial People’s Hospital, Zhengzhou, China |
| 2Henan University of Economics and Law, Zhengzhou, China |
| 3Department of Internal Medicine, Peking University People’s Hospital, Beijing, China |
| *Corresponding authors: |
Zhigang Zhao
7 Weiwu Lu, Department of Internal
Medicine
Henan Provincial People’s Hospital, Zhengzhou
Henan 450003, P.R.
China
Tel: +86 13803859882
Fax: +86 0371-65897717
E-mail: lmls3712@163.com |
| |
Linong Ji
11 Xizhimen Nandajie, Xicheng District
Department of Endocrinology
Peking University People’s Hospital
Beijing, 100044, P.R. China
Tel: +86 10-
88325373
Fax: +86 10-68318386
E-mail: jilinong@gmail.com |
|
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| Received March 28, 2012; Accepted April 28, 2012; Published April 30, 2012 |
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| Citation: Yuan H, Zhang J, Tian R, Wang L, Zhang C, et al. (2012) Evaluating the
Usefulness of the Diabetic Peripheral Neuropathy Screening Process. J Diabetes
Metab S5:007. doi:10.4172/2155-6156.S5-007 |
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| Copyright: © 2012 Yuan H, et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and
source are credited. |
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| Summary |
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| Aims: To evaluate the clinical utility of the diabetic peripheral neuropathy (DPN) screening process in the diagnosis
of DPN among diabetic patients. |
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| Methods: A total of 816 diabetic patients performed nerve conduction velocity (NCV), Somatosensory evoked
potential (SEP), Toronto clinical scoring system (TCSS), and DPN screening process at baseline. The NCV and SEP
were used as the ‘gold standard’ against which the sensitivity, specificity, positive predictive value, negative predictive
value and Youden’s index of the TCSS and the DPN screening process determined by the Chinese Diabetes Society
of the Chinese Medical Association in 2010. |
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| Results: According to the DPN screening process, 602 patients (73.77%) were positive while 458 patients (56.13%)
were positive according to the TCSS score. The sensitivity, specificity, positive predictive value, negative predictive
value, and Youden’s index of DPN screening process were 89.49%, 66.56%, 81.99%, 78.82%, and 0.5605, respectively.
Patients with DPN exhibited numbness (46.02%), pain (15.71%), paresthesia (16.59%), pinprick sensation (12.17%),
and others (10.62%). The sensitivity and specificity of the various DPN checks were as follows: pressure sensation
(19.44% and 95.62%), vibration perception (77.78% and 60.87%), temperature sensation (35.19% and 89.13%), and
pinprick (31.48% and 84.78%). The sensitivity, specificity, positive predictive value, negative predictive value, and
Youden’s index of a TCSS score ≥ 6 were 78.21%, 84.11%, 89.33%, 69.40%, and 0.6232, respectively. DPN screening
process took an average of 5.89 minutes, while TCSS spent an average of 10.32 minutes. |
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| Conclusion: DPN screening process is economical, simple, fast, accurate, and could be used for early clinical
screening of DPN in patients with diabetes. |
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| Keywords |
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| Diabetic peripheral neuropathy; TCSS; DPN screening
process |
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| Introduction |
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| Diabetic polyneuropathy is the main pattern of Diabetic peripheral
neuropathy (DPN) [1]. Furthermore, Diabetic distal symmetrical
polyneuropathy (DSPN), which is characterized by chronic,
symmetrical, length-dependent sensory and motor polyneuropathy
that spreads from the lower limbs to upper limbs, is the most common
type of DPN. Therefore, a method could be designed to screen out
different levels of diabetic polyneuropathy by using clinical symptoms
and signs, as well as an electrophysiological examination of the
nervous system. Late stage DPN may lead to serious consequences,
such as foot ulceration, gangrene, amputation, and neuropathic pain.
The prevalence of type 2 diabetes in China is estimated to be 9.7%
[2]. An accurate and early diagnosis can lead to a timely treatment,
and prevent a potential risk of disease progression. Nearly half of
diabetes patients do not exhibit any signs and symptoms of peripheral
neuropathy. Electrophysiological examination of the nervous system
is the only way to identify subclinical DPN. In the present study, we
evaluated the usefulness of the DPN screening process, which proposed
by the Chinese Diabetes Society of the Chinese Medical Association,
by comparing this process with an electrophysiological examination of
the nervous system and the Toronto clinical scoring system (TCSS) in
patients with diabetes mellitus. |
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| Subjects and Methods |
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| Subjects |
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| The study was conducted at Henan Provincial People’s Hospital from October 2010 to June 2011. All included patients had DM, as
defined according to the 1999 World Health Organization (WHO)
criteria. The subjects were consisted of 468 males (57.35%) and 348
females (42.65%), with average age of 56.2 ± 9.72 years. The mean
duration of disease was 7.05 ± 6.36 years and the mean HbA1c level
was 8.82 ± 2.23%. Patients with lumbar intervertebral discprotrusion,
cerebral hemorrhage, peripheral vascular disease or neuropathy
caused by other relevant factors, including family history, alcoholism,
trophism, and uremia, were excluded. |
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| Methods |
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| Somatosensory evoked potential and nerve conduction velocity
examination: Somatosensory evoked potentials (SEP) and nerve
conduction velocity (NCV) were measured using an electromyograph
(MEB-5504K, Photoelectric Company, Japan). The surface electrode was used during stimulation and record. The results were compared
to a table of normal data from our hospital electromyography lab.
Patients were diagnosed with DPN when either the SEP or NCV results
were abnormal. |
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| DPN clinical screening: |
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| • DPN screening: Firstly, each patient was asked whether they
had symptoms of neuropathy (pain, numbness, acantesthesia
or other sensory abnormalities). Subsequently, ankle reflex,
pressure sensation, vibration sensation, pinprick sensation
and temperature sensation were tested which being commonly
used in daily treatment work. |
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| • Diagnostic criteria of DPN screening process: Primarily,
neuropathy symptoms, such as pain, numbness, acantesthesia,
and weakness were assessed while cervical or lumbar degenerative
diseases, nerve root compression, paraneoplastic syndrome,
cerebrovascular disease, spinal cord disease or other causes of
peripheral neuropathy were excluded. Then, neuropathy signs,
including ankle reflex, pressure sensation, vibration sensation,
pinprick sensation and temperature sensation, were estimated.
DPN screening process was considered as suspected diagnoses
which had mere nerve symptoms or any one symptom among
ankle reflex, pressure sensation, vibration sensation, pinprick
sensation and temperature sensation. Whereas Clinical
diagnoses was assigned with both symptoms and signs of DPN.
Both suspected diagnoses and clinical diagnoses were used to
analyze the sensitivity, specificity, positive predictive value, negative predictive value and Youden’s index. |
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| • DPN screening process established by Chinese Diabetes Society
of the Chinese Medical Association in 2010 (Figure 1). |
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|
Figure 1: DPN screening process (Chinese Diabetes Society of the Chinese Medical Association, 2010). |
|
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| • Toronto clinical scoring system: The Toronto Clinical Scoring
System (TCSS) included a symptom score, reflection score, and
sensory score, all of which totaled a possible 19 points. A score
of greater than six was considered positive. |
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| Symptom scores including lower extremity pain, numbness, tingling,
weakness, walking imbalance and upper extremity symptoms,
normal was drafted as 0 point, exception as 1 point, a total of 6 points. |
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| Reflex scores, including the bilateral patellar reflex and ankle
reflex, were normal 0 point, weakened 1 point and disappeared 2
points, a total of 8 points. |
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| Sensory score, including a light touch in the right great toe joint
position sense, vibration sense, pinprick, temperature sensation, were
normal 0 point, exception 1 point, a total of 5 points. |
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| TCSS and DPN screening |
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| TCSS and DPN screening process were conducted by the same
physician and examination time was recorded when each case were
inspected. |
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| Statistical analysis |
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| The data were analyzed using SPSS software package, version 17.0
(SPSS Inc., Chicago, IL, USA). The sensitivity, specificity, positive predictive value, negative predictive value and Youden’s index of the
two screening methods were carried out comprehensive analysis under
comparison. We calculated the abnormal rates of all test results between
patients with neural symptoms and patients who had no neurologic
symptoms. The comparison of diagnostic methods was assessed with
chi-square tests of paired, fourfold table data. P value < 0.05 was taken
for statistically significant. |
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| Results |
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| Basic analysis of the general information |
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| According to the completed assessments, among 816 cases had
nerve symptoms which were 561 cases (68.75 %), none of nerve
symptoms were 255 cases (31.25 %). The abnormal rate of Symptoms
of DPN included numbness (46.02%), pain (15.71%), paresthesia
(16.59%), pinprick sensation (12.17%), and weakness (10.62%). |
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| During the electrophysiological examination 514 patients were
positive (62.99%). 602 patients in the DPN group were positive
(73.77%), and 458 patients in the TCSS group were positive (56.13%).
In other words, the positive rate of DPN screening was higher than
with TCSS. |
|
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| Sensitivity, specificity, positive predictive value, negative
predictive value and Youden’s index of the two screening
methods |
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| We divided the 816 diabetics into positive group and negative
group by taking the results of the NCV and SEP as the ‘gold standard’.
The sensitivity, specificity, positive predictive value, negative predictive
value and Youden’s index of both the DPN screening process and TCSS
were summarized in Table 1. |
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|
Table 1: Comparison of the DPN screening process and TCSS. |
|
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| The result of temperature sensation, pinprick, pressure and
vibration perception could be seen in table 2. |
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Table 2: Sensitivity and specificity of all DPN checks. |
|
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| The comparison of the time of the two kinds of screening |
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| We recorded how much time was required to screen for DPN using
the clinical screening process and TCSS among DM patients. DPN
screening process took an average of 5.89 minutes, while the TCSS
expended an average of 10.32 minutes. |
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| Discussion |
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| Many methods can be used to diagnose DPN, including the
Michigan Neuropathy Screening Instrument (MNSI), Michigan
Diabetic Neuropathy Score (MDNS), TCSS and so forth. In
addition to these systems, nerve and skin biopsies can be used for
evaluation of peripheral neuropathy. However, these morphological
examinations are currently used predominantly in research rather than in medical institution. Depending on the screening method
employed, the prevalence of DPN can range from 2.4 to 75.1% [3,4].
A nerve electrophysiological examination is more objective and
realistic compared to other methods, and is considered to represent
the “gold standard” [5]. Despite its high sensitivity, specificity and
repeatability, nerve electrophysiological examination is expensive
and time-consuming, and has not been widely adopted in the hospital
setting. The incidence of DPN rises along with the progression of
diabetes, and could be as high as 60%-90% [1]. Since DPN can often be
dormant and inconsistent with clinical symptoms, numerous patients
stay in delitescence without symptoms. Since peripheral neuropathy
is a pivotal element in the causal pathway to foot ulceration and
amputation, selecting a quick, inexpensive, and accurate method to
evaluate the high-risk patient is essential for clinical decision making
[6]. |
| |
| The DPN screening process was formulated by the Chinese
Diabetes Society of the Chinese Medical Association in 2010, and
aimed at searching for an economical, simple, fast and accurate
method. Is it a practical and useful method of DPN screening process
in daily clinical work? Our study found that the sensitivity, specificity,
positive predictive value, negative predictive value, and Youden’s index
of the DPN screening process were 89.49%, 66.56%, 81.99%, 78.82%,
and 0.5605, respectively. Thus, this screening process had a moderate
consistency with electrophysiological examination. |
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| TCSS was an apparently useful method to screen DPN, however
the processes and contents were too complicated which were arduous
to conduct in clinical work, meanwhile might cost too much time for
clinical doctors. We used the two methods of DPN screening process
and TCSS with 816 T2DM cases in studies, the results were compared
with NCV and SEP which were used as the ‘gold standard’. We found
that the advantage of DPN screening process was more sensitive and
less time-consuming, which could lead to the accurate completion of
the screening program in a relative short time, the specificity was less
lower, but through adjusting Youden’s index, its clinical value was
close to TCSS. The results showed that, on average, the DPN screening
process took approximately half the time required for completion
of the TCSS. The diversity in time made the screening of peripheral
neuropathy in diabetic patients more practical for clinicians. |
| |
| In addition, selection of ankle reflex, pressure sensation, vibration
sensation, pinprick sensation and temperature sensation of the
inspection and electrical physiological detection control study to
evaluate the practicality of the DPN screening process is possible in
theory. Although DPN is one of the diabetic foot risk factors, there may
be no obvious clinical symptoms during the early part of the disease
process. Indeed, if a physician merely based diagnosis on the presence
of patient symptoms, a proper diagnosis and early intervention of
DPN will likely be delayed. From a pathophysiological perspective, the effect of diabetes on the nervous system starts at the myelinated
and unmyelinated nerve fibers, causing pain and diminishing
temperature sensation and finally bringing about myelinated nerve
fiber damage, which led to cause vibration hypoesthesia. While
conventional electrophysiological examination, such as NCV, can
detect large myelinated fibers and pain nerve fibers, it could not detect
autonomic neuropathy fibrosis. However, small fiber involvement
often occurs during the early phase of DM that may be identified
using sensory quantitative testing. With the progression of symptoms,
large fibers become involved, and these changes may be detected by
electrophysiological testing. Our study also used TCSS for assessing
peripheral neuropathy. TCSS includes a nerve symptom score, reflex
score, and a sensory function check. As established by Perkins, et al.
in 2001 [7], the TCSS is a valid instrument for detecting the presence
and severity of DPN as measured by sural nerve morphology and
electrophysiology. In our study, the sensitivity, specificity, positive
predictive value, negative predictive value and Youden’s index of a
TCSS score ≥ 6 were 78.21%, 84.11%, 89.33%, 69.40%, and 0.6232,
respectively. |
| |
| In our study, using nerve electrophysiology as ‘gold standard’,
we confirmed that the DPN screening process and TCSS both had a
comparably high sensitivity, specificity and similar Youden’s index, and
had considerable clinical value. The advantages of TCSS included its
clear rating classification system, which could be used for the diagnosis
of DPN, as well as for judging the severity of DPN. The study suggested
that the peripheral neuropathy patients with diabetes be in 47.12% of
the mild disease, moderate 33.85%, severe degree occupy 9.07%, very
severe be up to 9.96%. Clinical observations indicated that as the TCSS
score increased, its consistency with NCV also gradually increased.
Domestic and foreign researches had confirmed the correlation between
TCSS neuropathy grading and NCV, suggesting the utility of TCSS in
the evaluation of DPN severity [8]. Our study was conducted to explore
the value of the DPN screening process, and whether it had a better
clinical value compared with TCSS. The results indicated that the DPN
screening process was more economical, accurate, and easier method.
Thus, when a diagnosis of DPN needs to be determined, particularly in large-scale epidemiological investigations involving general hospital
outpatients, this simple DPN screening process could be utilized. |
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| Conclusion |
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| In conclusion, the limitations of the various DPN check methods
cause difficulties in epidemiological investigations and limit their
widespread use in the out-patient setting. The American Diabetes
Association (ADA) recommends that patients with diabetes should
annually use at least one of the screening methods to screen for DPN [9].
The results of this study indicate that both the DPN screening process
and TCSS score have good consistency with a NCV check and can be
used for DPN screening in the clinical setting and in epidemiological
surveys. |
| |
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| References |
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- Perkins BA, Bril V (2003) Diabetic neuropathy: a review emphasizing diagnostic methods. Clin Neurophysiol 114: 1167-175.
- Yang W, Lu J, Weng J, Jia W, Ji L, et al. (2010) Prevalence of Diabetes among Men and Women in China. N Engl J Med 362: 1090-1101.
- Fabian W, Majkowska L, Stefanski A, Moleda P (2005) Prevalence of diabetes, antidiabetic treatment and chronic diabetic complications reported by general practitioners. Przegl Lek 62: 201-205.
- Janghorbani M, Rezvanian H, Kachooei A, Ghorbani A, Chitsaz A, et al. (2006) Peripheral neuropathy in type 2 diabetes mellitus in lsfahan, Iran: prevalence and risk factors. Acta Neurol Scand 114: 384-391.
- Bird SJ, Brown MJ, Spino C, Watling S, Foyt HL (2006) Value of repeated measures of nerve conduction and quantitative sensory testing in a diabetic neuropathy trial. Muscle Nerve 34: 214-224.
- Lavery LA, Wunderlich RP, Tredwell JL (2005) Disease management for the diabetic foot; effectiveness of a diabetic foot prevention program to reduce amputations and hospitalizations. Diabetes Res Clin Pract 70: 31-37.
- Perkins BA, Olaleye D, Zinman B, Bril V (2001) Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care 24: 250-256.
- Bril V, Perkins BA (2002) Validation of the Toronto Clinical Scoring System for diabetic neuropathy. Diabetes Care 25: 2048-2052.
- Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, et al. (2005) Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care 28: 956-962.
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