Open Access

Developing indicators of pattern identification in patients with stroke using traditional Korean medicine

  • Ju Ah Lee1,
  • Tae-Yong Park1Email author,
  • Jungsup Lee2,
  • Tae-Woong Moon1,
  • Jiae Choi1,
  • Byoung-Kab Kang1,
  • Mi Mi Ko1 and
  • Myeong Soo Lee1
BMC Research Notes20125:136

DOI: 10.1186/1756-0500-5-136

Received: 31 October 2011

Accepted: 13 March 2012

Published: 13 March 2012

Abstract

Background

The traditional Korean medical diagnoses employ pattern identification (PI), a diagnostic system that entails the comprehensive analysis of symptoms and signs. The PI needs to be standardized due to its ambiguity. Therefore, this study was performed to establish standard indicators of the PI for stroke through the traditional Korean medical literature, expert consensus and a clinical field test.

Methods

We sorted out stroke patterns with an expert committee organized by the Korean Institute of Oriental Medicine. The expert committee composed a document for a standardized pattern of identification for stroke based on the traditional Korean medical literature, and we evaluated the clinical significance of the document through a field test.

Results

We established five stroke patterns from the traditional Korean medical literature and extracted 117 indicators required for diagnosis. The indicators were evaluated by a field test and verified by the expert committee.

Conclusions

This study sought to develop indicators of PI based on the traditional Korean medical literature. This process contributed to the standardization of traditional Korean medical diagnoses.

Keywords

Pattern identification Indicator Stroke Standardization TKM

Background

Pattern identification is a system of diagnosis in traditional Korean medicine (TKM) that is characterized by its own theoretical basis and practical experience [1]. This unique system entails a comprehensive symptom analysis and an investigation of the illness, its cause and nature, the patient's physical condition and the patient's treatment through four examinations (inspection, listening and smelling, inquiry and palpation) [2]. TKM has advantages, such as one-to-one personalized care accompanying the patient's diagnosis. However, these characteristics are criticized because of the ambiguous process of diagnosis. Different ways of pattern identifications are often used for diagnosis by different Oriental medical clinicians in identical patients [3]. Oriental medical clinicians have claimed that differences exist between Western medicine and TKM in terms of therapy and the objective for treating and diagnosing patients. However, standardized and objective methods for diagnosis in TKM are needed. The Korea Institute of Oriental Medicine (KIOM) has conducted a fundamental study for the standardization and objectification of pattern identification in TKM for stroke (SOPI-Stroke) since 2005 [46]. We organized a committee comprised of physicians and researchers to draft a standardized document for pattern identification in stroke (D-SPI). This research concerned the process of developing standard indicators of pattern identification. This is a primary step of collecting and sorting clinical data toward further investigation on standardization of the pattern identification.

Methods

Collecting of pattern indicators

To determine important pattern indicators, the KIOM research team conducted manual searches of 10 academic sources: (1) the Dongeuibogam [7]; (2) A study of the standardization of diagnoses and diagnostic requirements in traditional Korean medicine II [8]; (3) Traditional Korean medicine diagnostics [9]; (4) Pattern identification diagnostics [10]; (5) Traditional Korean medicine pathology [11]; (6) A Standard form of pattern identification for stroke patients [12]; (7) A study of the standardization of diagnoses and diagnostic requirements in traditional Korean medicine III [13]; (8) The traditional Korean medical textbook on the digestive system [14]; (9) The traditional Korean medical textbook on the cardiovascular system [15]; and (10) Traditional Chinese medicine for encephalopathy [16]. Furthermore, we investigated clinical articles associated with stroke in the Korean literature, and then developed a set of necessary pattern indicators. Unnecessary pattern indicators included motor disability, dysphagia, dysarthria, and disturbances of consciousness. Although these indicators are primary symptoms of stroke, they were unhelpful in identifying a TKM pattern.

Clinical application of pattern indicators

We clinically applied these pattern indicators, verifying their usefulness and compatibility. Because the indicators were composed of old language, not all indicators fit the patients' symptoms. A total of 147 stroke patients, whose demographic parameters are presented in Table 1, were enrolled from these Oriental medicine hospitals: 2 Wonkwang University Oriental Medicine hospitals (WKU OHs) and Dae Jeon University Oriental Medicine Hospital (DJU OH). All patients provided informed consent under procedures approved by the respective Institutional Review Boards (IRB NO: I-0910/02-004).
Table 1

Demographic parameters of study subjects

Characteristics

Male

Female

number

71

76

Age(years)

62.01 ± 11.96

66.72 ± 10.05

Inclusion criteria were as follows: stroke patients within 30 days of symptom onset, confirmed by imaging, such as computerized tomography (CT) or magnetic resonance imaging (MRI). Exclusion criteria were as follows: traumatic stroke patients, such as subarachnoid, subdural and epidural hemorrhaging patients. Two TKM doctors independently completed the case report form (CRF). The clinical trial period ranged from May 1, 2005 to May 30, 2005.Q3

Expert committee approval

We organized a TKM expert committee (EC), which was launched on January 25, 2005, for our study: the fundamental study for the standardization and objectification of pattern identification in TKM for stroke (SOPI-Stroke). The EC was comprised of 19 members who majored in TKM from 11 Oriental medicine hospitals. More detailed description of the EC is presented in Table 2. At the first meeting of the EC that played a leading role in our study, the committee discussed the necessity of this project and the study design.
Table 2

The Member of Expert Committee

Name

Affiliation

Major, Position

Name

Affiliation

Major, Position

Byung Soon Moon

WKU

DCIM in TKM, professor

Ki Ho Cho

KHU

DCIM in TKM, professor

Seong Gyu Ko

KHU

DCIM in TKM, professor

In Lee

PNUKM

DCIM in TKM, professor

Jung Nam Kwon

DEU

DCIM in TKM, professor

Bum Sang Shim

KHU

DOPM in TKM, professor

Yun Sik Kim

DJU

DCIM in TKM, professor

Sang Kwan Lee

WKU

DCIM in TKM, professor

Sang Kwan Moon

KHU

DCIM in TKM, professor

Eun Chul Lim

DSOH

DSCM in TKM, head

Se Jin Park

DSOH

DCIM in TKM, head

In Soo Jang

WSU

DCIM in TKM, professor

Jong Hyung Park

KWU

DCIM in TKM, professor

Chan Yong Jun

KWU

DCIM in TKM, professor

Chi Sang Park

DGU-2

DCIM in TKM, professor

Chang Ho Han

DGU-1

DCIM in TKM, professor

In Chan Seol

DJU

DCIM in TKM, professor

Seok Hong

DSU

DCIM in TKM, professor

Gil Cho Shin

DGU-1

DCIM in TKM, professor

   

KHU; Kyung Hee University, DEU; Dong Eui University, DJU; Dae Jeon University, DSOH; Dong Seo Oriental Hospital, KWU; Kyung Won University, DGU-1; Dong Guk University, DGU-2; Dae Gu University, PNUKM; Pusan National University, school of Korean Medicine, WKU; Wonkwang University, WSU; Woo Suk University, DSU; Dong Shin University

DCIM; Department of Circulatory Internal Medicine, DOPM; Department of Oriental Pathology Medicine, DSCM; Department of Sasang Constitutional Medicine,

The case report form and standard operating procedures

We compiled the CRF to include the D-SPI and basic patient information. The CRF was composed of short-form questions in Korean for all clinicians to identify patterns without prejudice or difficulty. We developed standard operating procedures (SOPs) based on the CRF. All clinicians and researchers involved in this study were educated on the CRF and SOPs twice yearly to remove difficulties and misunderstandings and to enhance the concordance rate. We notified all clinicians of contested issues presented in the education process to minimize individual prejudices and enhance consistency.

Results

Definition of stroke in TKM and sets of subtypes

Researchers composed the stroke identification patterns and subtypes of pattern identification from the related literature, preliminary study and expert advice. The results were then agreed upon by the Korean Medical Stroke Diagnosis Standard Committee. Based on several theories for stroke identification in the TKM literature, all possible patterns for stroke were surveyed. Stroke was defined as focal neurological-deficit symptoms from cerebral circulatory disorders, including unconsciousness, hemiplegia, sluggish speech, numbness of the skin and other symptoms. Five patterns were identified: the Fire-heat pattern, the Dampness-phlegm pattern, the Yin deficiency pattern, the Qi deficiency pattern, and the Blood stasis pattern.

Fire-heat pattern

The Fire-heat pattern is characterized by any symptom of heat or fire that is contracted externally or engendered internally. This symptom can cause stroke through intense pathogenic heat and high fever. It is generally treated by externally clearing heat or internally eliminating fire.

Dampness-phlegm pattern

The Dampness-phlegm pattern is characterized by impeding Qi movement and its turbidity, heaviness, stickiness and downward-flowing properties. This symptom is due to the accumulation of damp phlegm in the lung and spleen in TKM. This pattern is caused by stroke and circulatory disturbances.

Blood stasis pattern

The Blood stasis pattern is characterized by blood stagnation, including extravagated blood and sluggish blood circulation or viscous or congested blood, all of which may become pathogenic factors.

Qi deficiency pattern

The Qi deficiency pattern is characterized by qi deficiency with diminished internal organ function, which is marked by shortness of breath, lassitude, listlessness, spontaneous sweating, a pale tongue and a weak pulse.

Yin deficiency pattern

The Yin deficiency pattern is characterized by yin deficiency with diminished moistening and the inability to restrain yang, which is usually manifested as fever.

Draft construction by the initial adjustment of selected indicators

Overall, pattern indicators were obtained from the above procedures (Table 3). The pattern indicators were reorganized into 22 items. These items allowed TKM doctors to easily perform four examinations in stroke patients. The 22 items were: physique, headache, dizziness, complexion, eyes, tinnitus, mouth, tongue diagnosis, throat, sputum, chest, palpitation, abdomen, skin, extremities, pulse diagnosis, digestion, defecation, urine, insomnia, temperature and sweating. These items were systematically organized from the head to the foot according to the table of contents in the Dongeuibogam, the well-known encyclopedia of TKM [17]. Dongeuibogam (Treasured Paragon of Eastern Medicine) After the Japanese Invasion in year 1592, Heo, Joon received orders from King Seonjo to consolidate data with Jung, Jak; Yang, Ye-su; Kim, Eung-tak; Lee, Myeong-won; and Jung, Ye-nam to write Dongeuibogam. Dongeuibogam is very important book in TKM several aspects. After all procedures were completed, a draft document was composed for the standardization of pattern identification for stroke (D-SPI). Overall, 122 indicators of pattern identification in stroke were obtained, excluding common symptoms, such as exercise, consciousness, and language disorders. After the selection, the indicators were integrated with the indicator for every cause and translated into Korean. When indicators had uncertain meanings, they were written in Chinese characters.
Table 3

Pattern indicators

Number

Item

 

Pattern Indicator

Freq. (%)

1

body type

 

underweight

35 (23.8)

   

overweight

36 (24.48)

2

headache

time

severe and sudden headache

5 (3.4)

   

old headache

14 (9.52)

   

continuous pain

20 (13.6)

  

site

headache in the whole head

22 (14.96)

   

site-fixed headache

8 (5.44)

   

radiating headache

3 (2.04)

  

aspect

severe and seems to be bursting

4 (2.72)

   

tightened feeling

8 (5.44)

   

headache with a pulling sensation

5 (3.4)

   

deterioration of headache by fatigue

5 (3.4)

   

hot head

3 (2.04)

   

headache with anger

5 (3.4)

   

heavy-headedness

25 (17)

   

an unpleasant sensation with an urge to vomit and pain in the head

6 (4.08)

   

un-refreshed head

29 (19.72)

   

headache accompanied by stabbing pain

5 (3.4)

   

headache accompanied by empty pain

6 (4.08)

   

headache accompanied by a hot flush

3 (2.04)

3

dizziness

 

severe and accompanied nausea and vomiting

6 (4.08)

   

slight dizziness

41 (27.89)

4

facial complexion

 

reddened complexion

37 (25.17)

   

dark face discoloration

36 (24.48)

   

black face with black eyelids

21 (14.28)

   

white complexion

23 (15.64)

   

pale face and red zygomatic site

20 (13.6)

5

eye's abnormal condition

 

red eyes

31 (21.08)

   

purpura in the sclera

4 (2.72)

   

dry eyes

11 (7.48)

   

excessive gum in the corner of the eye

11 (7.48)

6

tinnitus

 

tinnitus is incidental

1 (0.68)

   

tinnitus is continuous

4 (2.72)

   

tinnitus is intermittent

7 (4.76)

7

tongue and mouth

 

bitter taste in the mouth

45 (30.61)

   

thirst in the mouth

48 (32.65)

   

aphta and tongues sores

4 (2.72)

   

excessive saliva in the mouth

17 (11.56)

   

cyanotic lips

17 (11.56)

   

dry mouth

77 (52.38)

   

fetid mouth odor

26 (17.68)

8

sputum

 

sticky sputum

18 (12.24)

   

phlegm rale

32 (21.76)

9

oppression in the chest

 

heat vexation in the chest

10 (6.8)

   

feeling of oppression in the chest

21 (14.28)

   

bloated feeling in the chest and hypochondriac region

1 (0.68)

10

palpitations and fearful throbbing

 

palpitations and shortness of breath

(0)

   

palpitation with anxiety or discomfort

(0)

11

abdomen

 

tenderness and fever in abdominal diagnosis

6 (4.08)

   

sounds heard in abdominal diagnosis

17 (11.56)

   

tenderness of the lower abdomen and accompanied pain

22 (14.96)

   

mass in the abdomen

6 (4.08)

   

no resistance to touch of the abdomen

44 (29.93)

   

tension is felt when pressing the abdomen

40 (27.21)

12

skin

 

burning skin sensation

7 (4.76)

   

attachment sensation of derma

18 (12.24)

   

purpura

7 (4.76)

   

feeling like insects' crawling

7 (4.76)

   

feeling chilly on the skin

16 (10.88)

   

dry skin

31 (21.08)

13

palm and sole

 

vexing heat in the extremities

14 (9.52)

   

a subjective heaviness sensation of the body

76 (51.7)

   

a pronounced cold in the extremities up to the knees and elbows or beyond

26 (17.68)

   

a lack of physical strength in the four extremities

75 (51.02)

   

heat in the palms and soles

20 (13.6)

14

digestion

 

stomach feels full

19 (12.92)

   

feeling gastric reflux

9 (6.12)

   

excessive appetite with increased food intake and

recurrence of hunger sensation shortly after eating

4 (2.72)

   

an unpleasant sensation with an urge to vomit

17 (11.56)

   

loss of appetite

41 (27.89)

15

feces

 

hardened feces difficult to evacuate

36 (24.48)

   

discharge of soft, unformed stools: a loose stool

7 (4.76)

16

urine

 

dark yellow or reddish urine

49 (33.33)

   

a high volume of transparent urine

(0)

   

failure of voluntary control of urination

49 (33.33)

17

sleeping

 

inability to sleep well due to fever and oppression

10 (6.8)

   

excessive sleepiness night and day

4 (2.72)

   

inability to sleep or abnormal wakefulness: insomnia

7 (4.76)

   

inability to sleep due to anxiety

9 (6.12)

18

heat condition

 

high fever

34 (23.12)

   

tidal fever

4 (2.72)

19

sweat

 

profuse sweating with fever: sweating when having fever

38 (25.85)

   

lack of physical strength, excessive sweating during the daytime with no apparent cause, such as physical exertion, hot weather, thick clothing or medication

24 (16.32)

   

night sweating

21 (14.28)

20

vocal sound energy

 

inclined to speak or speaking at a high volume

58 (39.45)

   

disinclined to speak or speaking at a low volume

37 (25.17)

21

tongue

 

a larger than normal tongue, pale in color and

delicate, usually bearing dental indentations on the

margin-enlarged tongue

9 (6.12)

   

a tongue with dental indentations on its margin: a teeth-marked tongue

40 (27.21)

   

a tongue thinner than normal

11 (7.48)

   

a tongue redder than normal, indicating the presence of

heat

56 (38.09)

   

a tongue with thorn-like protrusions on the surface

10 (6.8)

   

a cyanotic tongue, indicating blood stasis or heat toxin in the nutrient-blood

17 (11.56)

   

a tongue with red, white or black spots as well as thorn-like protrusions on its surface

9 (6.12)

   

a tongue less red than normal, indicating qi and blood deficiency or the presence of cold deficiency

74 (50.34)

   

dry tongue

25 (17)

   

mirror tongue

17 (11.56)

   

thin fur

76 (51.7)

   

thick fur

26 (17.68)

   

tongue coating white in color

67 (45.57)

   

tongue coating yellow in color

41 (27.89)

   

tongue coating black in color

1 (0.68)

22

pulse

 

floating pulse

26 (17.68)

   

sunken pulse

33 (22.44)

   

slow pulse

15 (10.2)

   

rapid pulse

13 (8.84)

   

strong purse

26 (17.68)

   

weak purse

28 (19.04)

   

string-like pulse

27 (18.36)

   

slippery pulse

33 (22.44)

   

fine pulse

20 (13.6)

   

rough pulse

2 (1.36)

Korea standard pattern identification for stroke I

Based on the originally developed indicators, symptoms written in the foreign literature were found to have the same meaning as in the Korean literature. To determine frequency, we implemented a month-long preliminary study on 147 patients (June, 2005) in three Oriental medicine hospitals (Table 3). After this clinical field test, some pattern indicators were separated or combined, which led. Few indicators were eliminated. The remaining indicators were then discussed. The researchers developed consensus upon the Korea standard pattern identification for stroke I (K-SPI-Stroke I) to be presented at the Korean Medical Stroke Diagnosis Standard Committee on July 2005 (Figure 1), (Tables 4, 5, 6, 7 and 8).
https://static-content.springer.com/image/art%3A10.1186%2F1756-0500-5-136/MediaObjects/13104_2011_Article_1466_Fig1_HTML.jpg
Figure 1

Flow chart of our research.

Table 4

Indicators of the Fire-heat pattern (31)

Item

pattern indicator

headache

radiating headache(both temporal region and parietal region)

 

severe and seems to be bursting

 

hot head

 

headache with anger

 

severe and sudden headache

 

seems to break and to be bursting

dizziness

severe and accompanied nausea and vomiting

facial complexion

reddened complexion

eye's abnormal condition

red eyes

tinnitus

ringing in the ear strongly

tongue and mouth

bitter taste and thirst in the mouth

 

aphta and tongue sores

 

fetid mouth odor

sputum

sticky and yellow sputum

oppression in the chest

heat vexation in the chest

palpitation and fearful throbbing

palpitation quickly

 

palpitation with oppression

abdomen

tenderness and fever in abdominal diagnosis

skin

burning skin sensation

palm and sole

vexing heat in the extremities

digestion

feeling full and feeling gastric reflux in stomach

 

excessive appetite with increased food intake and recurrence of hunger sensation shortly after eating

feces

hardened feces difficult to evacuate

urine

reddish urine and does not come out easily

sleeping

inability to sleep well due to fever and oppression

sweating

profuse sweating with fever: sweating when having fever

tongue

red tongue

 

a tongue with thorn-like protrusions on its surface

 

thick and yellow fur

 

dry and black fur

purse

surging and rapid purse

Table 5

Indicators of the Dampness-phlegm pattern (22)

Item

pattern indicator

headache

heavy -headedness

 

an unpleasant sensation with an urge to vomit and pain in the head

 

un-refreshed head

 

tightened feeling

 

headache in whole head

dizziness

severe and accompanied nausea and vomiting

facial complexion

dark face discoloration

 

black face with black eyelids

tinnitus

ringing in the ear strongly

mouth and lip

excessive saliva in the mouth

sputum

phlegm rale

 

sticky and yellow sputum

oppression in the chest

feeling of oppression in the chest

palpitation and fearful throbbing

palpitation with oppression

abdomen

sounds heard in abdominal diagnosis

skin

attachment sensation of derma

digestion

an unpleasant sensation with an urge to vomit

tongue

larger than normal tongue, pale in color and delicate, usually bearing dental indentations on the margin-enlarged tongue

 

a tongue with dental indentations on its margin: a-teeth -marked tongue

 

thick and yellow or white fur

purse

surging purse

Table 6

Indicators of the Blood stasis pattern (16)

Item

pattern indicator

headache

headache with a pulling sensation

 

site-fixed headache

 

old headache

facial

complexion

black face with black eyelid

eye's

abnormal

condition

purpura in the sclera

mouth

cyanotic lips

sputum

fishy smell mouth odor

oppression

in the chest

bloated feeling in the chest and hypochondriac region

palpitations

fearful

throbbing

palpitation with anxiety or discomfort

abdomen

tension in the upper abdomen and complain of lower abdominal tenderness

 

mass in the abdomen

skin

purpura

tongue

tongue purple in color

 

tongue with red, white or black spots as well as thorn-like protrusions on its surface

 

cyanotic tongue

Pulse

rough pulse

Table 7

Indicators of the Qi deficiency pattern (26)

Item

pattern indicator

headache

continuous pain

 

headache accompanied by empty pain

 

deterioration of headache by fatigue

dizziness

slight dizziness

facial complexion

white complexion

tinnitus

ringing in the ear slightly

sputum

spitting phlegm with a low viscosity

palpitations fearful throbbing

palpitations and shortness of breath

abdomen

no resistance to touch of the abdomen

skin

feeling like insects' crawling

 

feeling chilly on the skin

palm and sole

a pronounced cold in the extremities up to the knees and elbows or beyond, also the same as cold extremities

 

a lack of physical strength in the four extremities

digestion

loss of appetite

feces

discharge of soft, unformed stools: loose stool

urine

a high volume of transparent urine

 

failure of voluntary control of urination

sweat

lack of physical strength, excessive sweating during the daytime with no apparent cause such as physical exertion, hot weather, thick clothing or medication

voice sound

disinclined to speak at a low volume

tongue

larger than normal tongue, pale in color and delicate, usually bearing dental indentations on the margin: enlarged tongue

 

tongue with dental indentations on its margin: a-teeth-marked tongue

 

a tongue less red than normal

 

thin fur

pulse

a pulse that is deep, soft, thin and forceless

Table 8

Indicators of the Yin deficiency pattern (22)

Item

pattern indicator

headache

headache accompanied by hot flush

 

continuous pain

 

headache accompanied by empty pain

dizziness

dizziness slightly

facial complexion

pale face and red zygomatic site

tinnitus

ringing in the ear slightly

mouth and lip

dry mouth

 

aphta and tongues sores

sputum

sputum with blood

palpitation and fearful throbbing

palpitation with anxiety or discomfort

abdomen

no resistance to touch of the abdomen

skin

dry skin

palm and sole

heat in the palms and soles

sleeping

inability to sleep due to anxiety

heat condition

afternoon tidal fever

sweat

night sweating

tongue

a tongue thinner than normal

 

dry and red tongue

 

thin fur or mirror tongue

 

peeled fur

purse

fine and rapid tongue

The principles for developing indicators were as follows:

1) To reflect characteristic stroke symptoms

2) To clinically identify stroke patterns based on the present state of TKM

3) To consider associations with previous studies

4) To reflect the recent trend of stroke in the TKM literature

Discussion

TKM occupies an independent position guaranteed by Korean medical laws [1]. Korea has is one national TKM school and 11 traditional Korean medicine colleges offering 6-year courses. Both the national school and colleges have their own hospitals, the majority of which are filled with a considerable number of stroke patients. Thus, we chose to standardize the TKM method of stroke diagnosis. One of the decisive procedures before stroke treatment is pattern identification, which determines the therapeutic method, such as acupuncture or herbs[18]. Pattern identification in stroke is a series of collection procedures that involves not only specific neurological deficits but also unspecific symptoms and indicators obtained by four examinations as well as determining treatment goals after integrating all data. When the cause and disease conditions are determined using pattern identification, TKM doctors adopt proper therapeutic methods to restore the imbalance [19]. Specific and unspecific symptoms do not tend to be visualized or digitized but assessed comparatively and synthetically during the diagnosis process [20]. Despite this feature, a standardized diagnosis is vital for TKM. Since 1996, China has endeavored to establish standardized diagnoses to establish new criteria [12]. However, neither developmental processes nor clinical verifications were found in the literature. This study involved verifying and standardizing clinical indicators and patterns from the classical literature. Several types of pattern identification exist, such as the cold-heat, deficiency-excess, visceral, and constitutional patterns of identification. Therefore, the first step towards standardizing pattern identification was to select only the patterns of identification most frequently observed. The diagnosis and treatment of stroke in Korea have been influenced by the publication of the Dongeuibogam, which contains medical theories of successive generations and clinical experiences from the 17th century [17]. Additionally, on halfway through the medical exchange between China and Korea, the blood stasis pattern concept was introduced. Currently, the wind, fire-heat, dampness-phlegm, blood stasis, and deficiency patterns are prevalent in clinics [4]. We constructed the patterns of Korean stroke considering pathological changes in TKM. Wind was excluded from the study because it is a pattern that explains the condition of a patient rather than the cause of stroke. Because deficiency has excessive sub-deficiency patterns, qi deficiency and yin deficiency, which were thought to be meaningful in investigating stroke, were included exclusively. The following step was to determine what clinical indicators belonged to each identification pattern and compose a draft from the clinical data. First, primary headings were sorted from the Dongeuibogam, and clinical indicators were supplemented from the ten academic sources frequently referred to by TKM doctors. A field test confirmed the frequency and difference between significant and insignificant indicators. Then, the Korea standard pattern identification for stroke I (K-SPI-Stroke I) was produced. Through the field test, we were able to investigate several indicators. Some indicators in the literature were unhelpful pattern identification for stroke (e.g., underweight or overweight), and some indicators required adjustment. For example, the tinnitus category needed to differentiate tinnitus intensity rather than tinnitus aspects. Also, some indicators of purse were combined due to their common combined use in clinical. It is notable that a consensus on clinical indicator measurement was obtained. Even doctors with the same medical education can potentially conduct different assessments. Therefore, we developed the CRF and SOP to standardize and digitize clinical indicators.

A limitation of our study was that the concepts of reliability and validity, which are used to assess diagnosis criteria in modern western medicine [21], were not introduced. Additionally, the concepts of patterns and clinical indicators are rooted in the TKM literature and can generate divergences among the literature from China, Japan, and other countries in eastern Asia. Some indicators were assessed considering the feature of Korean people.

Conclusions

A strength of this study was that we determined 5 patterns and 117 clinical indicators composed of high-frequency indicators and stroke symptoms. We aimed to determine the significant clinical indicators and distinguishing patterns of stroke. Greater focus was placed on indicators of pathological conditions than on those of physiological conditions, and we endeavored to determine clinical significance by conducting a field test and discussions with experts. Given the high probability of different levels of experience among the experts, we first produced the CRF and SOP and placed importance on education and training to eliminate differences between experts. Consequently, we developed a systematic questionnaire after the literature search, expert consensus, and a field test, which provided an example for an objective and standardized pattern identification for stroke in TKM. We shall be able to develop various standardized differentiations of symptoms and indicators that fit the actual conditions of other disease.

Declarations

Acknowledgements

This research was supported by a grant from the Korea Institute of Oriental Medicine (K11131).

Authors’ Affiliations

(1)
Brain Disease Research Center, Korea Institute of Oriental Medicine
(2)
National Rehabilitation Center

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This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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