Reliability and Validity Analysis of a Standard Instrument of Diagnosis and Assessment for Spleen Qi Deficiency Pattern in Chronic Dyspepsia Patients

Article information

J Korean Med. 2015;36(3):23-34
1KM Fundamental Research Division, Korea Institute of Oriental Medicine
2Dept. of Gastroenterology, College of Korean Medicine, Kyung-Hee University
Correspondence to: 김근호(Keun Ho Kim), 대전광역시 유성구 유성대로 1672 한국한의학연구원 한의기반연구부, Tel: +82-42-868-9365, Fax: +82-42-868-9480, E-mail: rkim70@kiom.re.kr
Received 2015 June 24; Revised 2015 September 24; Accepted 2015 September 24.

Abstract

Objectives:

This study is aimed at assessing the reliability of a standard instrument of diagnosis and assessment for Spleen Qi deficiency pattern questionnaire (SQDQ) and examining the validity of the SQDQ by comparing the pattern identification scores of different groups.

Methods:

We conducted a survey of 72 participants (60 patients with chronic dyspepsia and 12 healthy subjects) using self-reported questionnaire. Participants were given written consent and this study was performed under the permission of institutional review board of Kyung-Hee university Korean medicine hospital.

Results:

The reliability and the validity of the questionnaire were inspected. Internal consistency of the SQDQ was excellent. Construct validity analyzed by exploratory factor analysis produced 4 factors, which were selected from eigenvalues that are greater than 1.0. The factor 1, 2, 3 and 4 showed ‘fatigue’, ‘meal’, ‘diagnosis’ and ‘figure’ respectively. For most of SQDQs’ items, there were significant differences observed between the Spleen Qi and the non-Spleen Qi groups. However, the ‘emaciation’, ‘tongue diagnosis’ and ‘pulse diagnosis’ showed no significant differences.

Conclusions:

The SQDQ restructured in this study may provide a fundamental questionnaire and a further study is required for a more advanced, standardized and statistically proven questionnaire.

Fig. 1.

Flow chart of clinical study

Demographic Characteristics of Patients with Chronic Dyspepsia and Controls (N=72)

Internal Consistency of Spleen Qi Deficiency Pattern Questionnaire (N=60)

Rotated Component Matrix (N=60)

Factor Analysis Results of Spleen Qi Deficiency Pattern Questionnaire (N=60)

Rotated Component Matrix about 9 items (N=60)

Comparison of Spleen Qi Deficiency Pattern Questionnaire Scores on Controls and Chronic Dyspepsia Patients (N=72)

Comparison of Spleen Qi Deficiency Pattern Questionnaire Scores on Spleen Qi deficiency and non-Spleen Qi deficiency groups (N=60)

References

1. The Textbook Compliation Committee of Oriental Pathology. Oriental Pathology Seoul: Haniminhwasa; 2008. p. 172–579.
2. Park WH, Cha YY, Song YK, Park TY, Kim HJ, Chung WS, et al. The Review on the Study of Oriental Obesity Pattern Identification: Focused on Korean Research Papers. Journal of Korean Medicine Rehabilitation 2014;24(2):83–93.
3. Kim SK, Park YB. Development of Questionnarire for Cold-Heat Patternization. The Journal of the Society of Korean Medicine Diagnostics 2003;7(1):64–75.
4. Ryu H, Lee H, Kim H, Kim J. Reliability and validity of a cold-heat pattern questionnaire for traditional Chinese medicine. J Altern Complement Med 2010;16(6):663–667.
5. Park YJ, Lim JS, Park YB. Development of a valid and reliable food retention questionnaire. European Journal of Integrative Medicine 2013;5(5):432–437.
6. Lim JS, Park YB, Lee SC, Oh HS. Developing Questionnaire for Pathogenesis Analysis of Pyungweesan Symptom. The Journal Of The Korea Institute Of Oriental Medical Diagnostics 2007;11(1):72–81.
7. Lee BH, Park YB, Park YJ, Oh HS, Kim MY. A study on reliability and validity of the guibitang patternization questionnaire. Journal of Korea Institute of Oriental Medical Diagnostics 2009;13(1):45–53.
8. Kim SH, Park YB, Park YJ, Oh HS. Co-relation between Questionnaire for Buzhongyiqi-Tang and Electrogastrography. Journal of Korea Institute of Oriental Medical Diagnostics 2009;13(2):34–44.
9. Yoon TD, Park YJ, Park YB, Lee SC, Oh HS. Development of questionnaires for pathogenesis analysis of bojungikgitang symptom. Journal of Korea Institute of Oriental Medical Diagnostics 2007;11(2):45–58.
10. Park YJ, Yang DH, Lee JM, Park YB. Development of a valid and reliable blood stasis questionnaire and its relationship to heart rate variability. Complement Ther Med 2013;21(6):633–640.
11. Yang DH, Park YJ, Park YB, Lee SC. Development of questionnaires for blood stasis pattern. The Journal of Korean Institute of Oriental Medicine Diagnostics 2006;10(1):141–152.
12. Park YJ, Park JS, Kim MY, Park YB. Development of a valid and reliable phlegm pattern questionnaire. J Altern Complement Med 2011;17(9):851–858.
13. Oh HW, Lee JW, Kim JS, Song EY, Shin SW, Han GJ, et al. Study on the Development of a Standard Instrument of Diagnosis and Assessment for Spleen Deficiency Pattern. J Korean Med 2014;35(1):157–170.
14. Woo HJ, Kim SH, Lee SB, Choi MY, Kim YC, Lee JH. Development of Questionnaires for Differentiation of qi-xū, xue-xū, yang-xū, yīn-xū analysis. Korean J. Orient. Int. Med 2008;29(4):856–870.
15. Kim JH, Ku BC, Kim JE, Kim YS, Kim KH. Study on Reliability and Validity of the ‘Qi Blood Yin Yang Deficiency Questionnaire’. Korean Journal of Oriental Physiology and Pathology 2014;28(3):346–354.
16. Kang KW, Moon JS, Kang BG, Kim BY, Shin MS, Choi SM. The comparison of pattern identification diagnosis according to symptom scale based on obesity pattern identification questionnaire. Journal of Society of Korean Medicine for Obesity Research 2009;9(1):37–44.
17. Koo BS, Lee SJ, Han CH, Kim HJ, Park SH. The Basic Study for Building the Depression Prescription Guideline of Gamiguibi-Tang-The Evaluation of Reliability and Validity of the Depression Pattern-Identification Questionnaire. Journal of Oriental Neuropsychiatry 2009;20(4):1–13.
18. Wei YM, Lee GE, Jung SH, Lee HK, Lyu YS, Kang HW. A Study on the Reliability and Factor analysis of Pattern Identification for Tic Disorders in children. Journal of Oriental Neuropsychiatry 2012;23(1):59–82.
19. Kang BK, Moon TW, Lee JA, Park TY, Ko MM, Lee MS. The fundamental study for the standardisation and objectification of pattern identification in traditional Korean medicine for stroke (SOPI-Stroke) : development and interobserver agreement of the Korean standard pattern identification for stroke (K-SPI-Stroke) tool. European Journal of Integrative Medicine 2012;4(2):133–139.
20. Jeong HS, Ha KT, Shin SW, Lee KG. Study on the Endogenous Dampness Caused by Gi Deficiency of the Spleen and Sagunja-tang. Korean J. Oriental Physiology & Pathology 2010;24(6):903–906.
21. Teaching material compilation committee of oriental pathology. Oriental pathology 2nd editionth ed. Seoul: Hanuimunhwasa; 2008. p. 411–4.
22. Kim SY, Kim JS, Kim YS, Hong IA, Hur WY, Eom GH, et al. Correlation Study between Dry mouth and Comprehensive Diagnosis of Qi xu·Qi yu in Patients with Halitosis. Korean J. Orient.Int. Med 2007;28(1):97–105.
23. Kim JS, Lee KJ, Kim JH, Hahm KB, Cho SW. Functional Gastrointestinal Disorders in Patients Referred to Specialist Gastroenterologists in a Tertiary Hospital. Kor J Neurogastroenterol Motil 2004;10(2):111–117.
24. Yang SY, Lee OY, Bak YT, Jun DW, Lee SP, Lee SH, et al. Prevalence of gastroesophageal reflux disease symptoms and uninvestigated dyspepsia in Korea: a population-based study. Dig Dis Sci 2008;53(1):188–193.
25. Li XB, Liu WZ, Ge ZZ, Zhang DR, Zhao YJ, Dai J, et al. Analysis of clinical characteristics of dyspeptic symptoms in Shanghai patients. Chin J Dig Dis 2005;6(2):62–67.
26. Lee JH, Kim HY, Rho SH, Yoon DH, Kim KH, Lee JY, et al. Dyspepsia in Korean Population: Who Needs Endoscopy? Korean J Gastrointest Endosc 2001;22(1):1–7.
27. Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ. Functional gastroduodenal disorders. Gut 1999;45(suppl 2):1137–1142.
28. Hong IA, Yoon SH. A Study of Gastrointestinal Parasympathetic Nerve Activity and Pyloric Valve Function, and Clinical Characteristerics in Patients with Functional Dyspepsia - Analysis of Bowel Sound. Korean J. Orient. Int. Med 2008;29(3):666–674.
29. Lee JH. The annual report on the Traditional Korean Medicine R&D Project, Ministry of Health & Welfare HW Oh, et al. 137 (The Modeling of Gut Hormone Profiling of Spleen Qi Deficiency Pattern and the Development of Efficacy Evaluation Technique of Related Herbal Medicine (HI13C0623)). 2014. 31–6.
30. Berle CA, Cobbin D, Smith N, Zaslawski C. A novel approach to evaluate Traditional Chinese Medicine treatment outcomes using pattern identification. J Altern Complement Med 2010;16(4):357–367.
31. Cho SW, Park YJ, Park YB, Kim MY, Lee SC. A Study on Reliability and Validity of the Yukmijiwhang-tang Patternization Questionnaire. The Journal of Korean Institute of Oriental Medicine Diagnostics 2009;13(1):55–65.
32. Smith F. Survey Research: Instruments, Validity and Reliability. In : Smith F, ed. Research Methods in Pharmacy Practice London: Pharmaceutical Press; 2002. p. 43–84.
33. Tak JK. Psychological testing:understanding of development and evaluation of the psychological testing In : Tak JK, ed. Seoul: Hak-Ji Press; 2001. p. 135–50.

Article information Continued

Fig. 1.

Flow chart of clinical study

Table 1.

Demographic Characteristics of Patients with Chronic Dyspepsia and Controls (N=72)

Controls (n=12) Chronic dyspepsia patients (n=60) p-value
Age 42.6 ± 14.9 40.0 ± 12.7 0.535
Height 162.0 ± 7.5 160.0 ± 7.8 0.995
Weight 60.0 ± 7.5 59.8 ± 10.1 0.936

Table 2.

Internal Consistency of Spleen Qi Deficiency Pattern Questionnaire (N=60)

Cronbach’s α 95% C.I.
Original questionnaire 0.808 0.735–0.868
Restructure Questionnaire 0.827 0.760–0.881

Restructure questionnaire was excluded the pulse diagnosis item and tongue diagnosis item from original questionnaire.

Table 3.

Rotated Component Matrix (N=60)

Items Component

Factor 1 Factor 2 Factor 3 Factor 4
Q03 .735 .298 −.102 −.105
Q05 .572 .207 −.285 .191
Q06 .827 .078 .125 .119
Q08 .684 −.008 .372 .185
Q04 .206 .872 −.076 .090
Q09 .127 .876 .040 .102
Q02 .303 .190 .531 .328
Q10 −.169 −.089 .751 −.067
Q11 .121 −.025 .727 −.242
Q01 .016 .000 −.183 .782
Q07 .166 .161 .020 .693

Eigenvalue 2.240 1.735 1.661 1.377

% Variance explained 20.359 36.135 51.235 63.748

Extraction method : Principal component analysis

Rotation method : Varimax

Table 4.

Factor Analysis Results of Spleen Qi Deficiency Pattern Questionnaire (N=60)

Index Items Symptoms
Fatigue Q03 Tiredness of extremities (肢体倦怠)
Q05 Sallow complexion (面色萎黄)
Q06 Shortness of breath and reluctance to speak (少氣懶言)
Q08 Lethargy (神疲)

Meal Q04 Inability to eat (納少)
Q09 Reduced appetite (食欲减退)

Diagnosis Q02 Abdominal distension after eating (腹胀食後尤甚)
Q10 Weak pulse (脈緩弱)
Q11 Pale tongue and white fur (舌淡苔白)

Figure Q01 Loose stool (大便溏薄)
Q07 Emaciation (消瘦)

Table 5.

Rotated Component Matrix about 9 items (N=60)

Items Component

Factor 1 Factor 2 Factor 3
Q06 .807 .165 .088
Q08 .793 .004 .092
Q03 .659 .395 −.157
Q02 .531 .051 .209
Q05 .381 .378 .268
Q04 .121 .888 .106
Q09 .104 .852 .083
Q01 .006 .033 .798
Q07 .203 .152 .692

Eigenvalue 2.208 1.868 1.289

% Variance explained 24.539 45.293 59.615

Extraction method : Principal component analysis

Rotation method : Varimax

Table 6.

Comparison of Spleen Qi Deficiency Pattern Questionnaire Scores on Controls and Chronic Dyspepsia Patients (N=72)

Controls (n=12) Chronic dyspepsia patients (n=60) p-value
Q01 1.50 ± 1.00 1.83 ± 0.96 0.279
Q02 0.25 ± 0.45 2.40 ± 0.87 0.000**
Q03 0.92 ± 0.51 2.18 ± 0.89 0.000**
Q04 0.25 ± 0.45 1.67 ± 1.12 0.000**
Q05 0.75 ± 0.75 1.83 ± 1.12 0.002**
Q06 0.42 ± 0.67 1.47 ± 1.03 0.001**
Q07 0.50 ± 0.52 1.03 ± 1.03 0.084
Q08 1.00 ± 0.85 2.22 ± 0.87 0.000**
Q09 0.25 ± 0.45 1.57 ± 1.02 0.000**
Q10 1.17 ± 1.19 2.57 ± 0.98 0.000**
Q11 1.33 ± 0.99 2.37 ± 1.13 0.004**

Total score 17.68 ± 7.34 48.67 ± 12.58 0.000**

Table 7.

Comparison of Spleen Qi Deficiency Pattern Questionnaire Scores on Spleen Qi deficiency and non-Spleen Qi deficiency groups (N=60)

Spleen Qi deficiency (n=41) Non-Spleen Qi deficiency (n=19) p-value
Q01 2.00 ± 0.92 1.47 ± 0.96 0.047*
Q02 2.68 ± 0.69 1.79 ± 0.92 0.000**
Q03 2.51 ± 0.75 1.47 ± 0.77 0.000**
Q04 1.98 ± 1.13 1.00 ± 0.75 0.001**
Q05 2.29 ± 0.96 0.84 ± 0.77 0.000**
Q06 1.83 ± 0.97 0.68 ± 0.67 0.000**
Q07 1.20 ± 1.08 0.68 ± 0.82 0.072
Q08 2.54 ± 0.71 1.53 ± 0.77 0.000**
Q09 1.90 ± 0.97 0.84 ± 0.69 0.000**
Q10 2.49 ± 0.93 2.74 ± 1.10 0.365
Q11 2.41 ± 1.10 2.26 ± 1.24 0.634

Total score 55.42 ± 8.01 34.12 ± 6.98 0.000**