Manuscript Types: Original articles
Title: BCQs: A Body Constitution Questionnaire to Assess Stasis in Traditional Chinese Medicine
Short Title: BCQs to Access TCM Stasis Constitution
Contact details of the corresponding author: Name: Yi-Chang Su
Postal address: No. 91, Hsueh-Shih Road, Taichung, Taiwan 40421
School of Chinese Medicine, College of Chinese Medicine, China Medical University
Fax number: 886-4-22073605
E-mail address: juishan.lin@msa.hinet.net Telephone: 886-4-22053366 ext 3105
Name of other authors:
Jui-Shan Lin MD.,PhD.,1,2Jun-Dai Lin MS,1,3 Li-Li Chen PhD.,4 PhD., Chih-Hung Chang
PhD.,5,6 Yi-Chia Huang MD., 7 Yi-Chang Su MD., PhD. 1,2
Affiliations: 1: Graduate Institute of Chinese Medicine, College of Chinese Medicine,
China Medical University, Taichung, Taiwan
2: School of Chinese Medicine, College of Chinese Medicine, China Medical
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
University, Taichung, Taiwan
3: Nursing Department, Central Taiwan University of Science and
Technology, Taichung, Taiwan
4: School of Nursing, College of Health Care, China Medical University,
Taichung, Taiwan
5: Buehler Center on Aging, Health & Society, Feinberg School of Medicine,
Northwestern University, Chicago, USA
6: Graduate Institute of Biostatistics, China Medical University, Taichung,
Taiwan
7: ChanDer Clinic, Taipei, Taiwan
1 2 3 4 5 6 7 8 9 10
Abstract
Aim of the study: Stasis body constitution is crucial in making diagnosis and treatment decisions in traditional Chinese medicine (TCM) practice. A reliable tool to assess clinical aspects of Stasis is critically needed in order to maximize its clinical value in TCM and its integrative use with modern medicine (MM).
Methodology: Stasis-related items were first generated from TCM textbooks and a literature review. The 23-item Stasis body constitution questionnaire (BCQs) was then developed using the Delphi method involving 27 experts with TCM and MM
professional training and administered to 958 participants receiving physical
examination at a teaching hospital or at the TCM outpatient department. Exploratory and confirmatory factor analyses were conducted to derive and validate the underlying structures of the BCQs. Reliability and validity of each factor was also evaluated. Results: Four factors, corresponding to the manifestations of the Stasis level in 4 different areas of the body, were identified: Stasis in the trunk (5 items), head (5 items), body surface (3 items), and gastrointestinal tract (3 items). The Cronbach’s α coefficients were acceptable (0.62-0.88) and most intra-class correlation coefficients were > 0.7. The agreement of Stasis diagnosis by the BCQs and an experienced TCM doctor was high.
Conclusions: This TCM-based 16-item BCQs is a reliable and valid tool for evaluating the Stasis body constitution in clinical practice and research.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Key words: Stasis; Body Constitution; Traditional Chinese medicine (TCM); Evidence-based medicine (EBM); Personalized medicine; Delphi method 1
2 3
Introduction
Traditional Chinese Medicine (TCM) has gained popularity and acceptance as a prominent alternative to modern medicine (MM) [1-4]. In TCM, a person is considered to be in a healthy state when his or her Yin and Yang in the body keeps balance [5]. “Yang” consists of the energy for maintaining body function that can be observed from the physiological function of the organ systems, regulation of the interstitial fluid and body temperature, etc, while “Yin” consists of the material aspects of the body, such as the blood and interstitial fluid that provide means of delivering materials to the cells [5]. When Yin-Yang is either imbalanced (Yin-Xu or Yang-Xu) or loses its harmonizing dynamic (Stasis), physical symptoms and signs appear. A variety of illnesses can be induced when the materials (e.g., Yin: includes body fluid, blood, and essence) transported by the energy (e.g., Yang or Qi) are impeded by any external or
environmental stimuli (e.g., stressful life event or climate change) that cause blood stasis or phlegm to affect the entire body [6]. For example, the blood stasis in the knee meridians may cause joint pain, and blood stasis in the lung may produce chest
tightness or pain; while phlegm in the meridian may form nodules, and phlegm in the lung may induce cough. In TCM, it is thought that “The development of cancer is a progression from extreme stagnation.... Critical stasis means that a region of tissue is no longer governable by the ordinary circulatory and regulatory mechanisms of Qi, 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
leading eventually to a degeneration of coordinated activity [7].” Because of the great variety of manifestations caused by stasis, the identification and evaluation of the bodily “Stasis constitution” plays an important role in making clinical diagnosis and treatment decisions in TCM practice.
TCM treatment is generally prescribed according to its characteristic theory and diagnosis, but inconsistencies and differences exist among TCM practitioners when making the same diagnosis and prescribing comparable regimens for the same group of patients. It is of concern that the TCM diagnostic variables and subcategories of disease appear to be subjective and not repeatable, making it challenging to integrate with mainstream medicine [8, 9]. To make TCM clinically useful, scientifically sound, and empirically supported, the standards of randomized controlled trial (RCT) and evidence-based medicine (EBM) should be routinely and rigorously applied in TCM clinical research [10-12]. Objective and reliable measurement tools that are developed based upon and fitted to the TCM theories through a scientifically sound method are absolutely necessary to fulfill the scientific research requirement and to integrate TCM with MM [13-15].
To meet these clinical demands and scientific requirements, we aimed to develop the Body Constitution Questionnaire (BCQs), an integrative measurement tool
specifically designed to assess the bodily “Stasis” constitution, through rigorous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
development and evaluation methods. We assessed the reliability and validity of the BCQs to ensure its feasibility and applicability in clinical research and practice. We further explored the possible factors or domains of Stasis to better understand their relationship to the manifestations of the Stasis constitution, as little or no research has been performed on this topic.
Methodology
Develop ing a provisional BCQs using the Delphi method Item development
Guided by our framework (see Figure 1), we first defined the terms “constitution” and “Stasis constitution”, and established the structure of the study concept to
facilitate the item development.
Constitution: “Constitution” is broadly defined as the fundamental components that constitute a human being, and includes the total expression of physiological, psychological and pathological traits that characterize a person’s health. It is a relative stable characteristic of an organism, and is affected by both nature and nurture [16-18]. In this study, “constitution” was narrowly defined to mean the physiological state maintained by the dynamic interaction of energy (Yang) and materials (Yin) in the body.
Stasis constitution: Yin (e.g., body fluid, blood, essence) is generally transported and distributed by Yang (eg. Qi) smoothly without any stagnation, but when the 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
transportation is attenuated or obstructed, “Stasis” is said to occur and will result in Qi-stagnation, fluid-retention, and blood stasis. “Stasis constitution” implies that a
person’s dynamic interaction between Yin and Yang is slowed down and less efficient, and they may express some physical symptoms, such as dizziness, chest tightness, or numbness in the limbs [19].
Structure of stasis constitution: Healthy, normal state is achieved by a dynamic balance between Yin and Yang, regarded as “plain constitution” in TCM. A person will show clinical manifestations either due to the decrease of Yin or Yang or the
disturbance of Yin-Yang mutual dependence and interaction [20]. “Yang-Xu” or “Yin-Xu” constitution is shaped by the persisting decrease of Yang or Yin, while “Stasis” constitution is formed by the persistent disruption of the dynamic balance between Yin and Yang (see Figure 2). According to the clinical classification of disease in TCM, manifest signs and symptoms may result from different parts of the body, i.e. internal organs, the meridian system or bodily anatomic regions [21-24]. To our best
knowledge, there is no relevant study that has investigated the relationship between the outer manifestations and inner bodily dimensions of the Stasis constitution. Therefore, we also aimed to explore and establish the latent structure of Stasis constitution by collecting data from patients using the provisional version of the BCQs derived from this study.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Item Generation from the Literature
We used “constitution”, “stasis”, “stagnation” and “phlegm” as key words to search for relevant items from the TCM textbooks and published literature to generate sufficient number of items to assess Stasis constitution. The physical symptoms and signs described by the items for inclusion had to be of “persistent” characteristics and appropriate for self-report. Items were excluded if they were: 1) not universally used; rarely cited or mentioned in the literature or by experts; 2) gender-specific; items related to female-specific clinical information were later added to the “demographic characteristics” section; or 3) related to tongue and pulse diagnosis as the signs of tongue and pulse vary in daily life and must be evaluated in person by TCM doctors. An initial set of items were complied.
Delphi process
For the Delphi process [25], prospective panel members were invited by phone and informed about the study objectives and procedures. Upon their agreeing to participate, the study documents with the initial set of items were mailed to them for their ratings. Each expert was asked to indicate their degree of agreement on the importance of each item and to suggest additional relevant items if not currently listed. Items were retained in this first stage if their content validity index (CVI) was ≥ 0.7, indicating that a sufficient group consensus in ratings was reached [26]. Input from the panelists on each item were classified as either “correct description with pending 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
revision” or “correct description without further modification”. Items needing revision were re-worded to be colloquially acceptable, and then sent back to the panelists for another round of evaluation. A total of 23 Items meeting the same cut-off criterion, CVI ≥ < 0.7, from the group consensus were checked for grammatical error, ease of
comprehension, and finalized for pilot testing to establish face and content validity. Pilot Testing
Convenience sampling was used to recruit participants attending for an annual health examination at the Department of Family Medicine and outpatients in TCM at the China Medical University Hospital, Taichung, and the National Taiwan University Hospital Yunlin Branch in Yunlin. People suffering from episodes of acute or chronic diseases in the past month were excluded to avoid the potential influence of the onset of disease on the stability of the constitution status. Eligible participants who agreed to participate gave their consent and completed a self-report questionnaire, including the 23-item provision version of the BCQs. Participants with limited literacy received assistance from the research assistants for questionnaire completion. The study protocol was approved by the Institutional Review Board of China Medical University Hospital.
Evaluation of Reliability and Validity Participants
The same patient inclusion and exclusion criteria used in the pilot testing were 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
applied. Participants were recruited during their annual health examination at the Department of Family Medicine and TCM outpatient clinic of China Medical University Hospital in Taichung, and the National Taiwan University Hospital Yunlin Branch in Yunlin. The study protocol was approved by the Institutional Review Board of both the China Medical University Hospital and the National Taiwan University Hospital.
Instrument
In addition to demographic and clinical information, the 23-item provisional version of the BCQs (see Appendix 1) was used in the data collection.
Symptom frequency and intensity in the previous month were reported on a 5-point Likert-type scale (never, occasionally, sometimes, often and always) [27, 28], with higher frequency and intensity scores indicating a more pronounced constitution of Stasis.
Psychometric Evaluation
Intra-Class Consistency, Test-Retest Reliability, Discrimination and Construct Validity: In this phase, subjects were recruited to explore the factor structure of BCQs and its reliability and validity. Data with incomplete responses from 32 (out of 840)
participants were excluded. To assess the test-retest reliability, 10% of the subjects (n = 81) were randomly selected to answer BCQs twice, at an interval of 2 weeks. Among these, 59 subjects completed both assessments.
Criterion-Related Validity: Another 150 study participants with stable, controlled 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
chronic diseases were recruited and tested with BCQs for subjective signs and symptoms within one month. Each participant was also examined by a TCM doctor (JSL) with 7 years clinical experience and a doctorate degree, in order to clinically determine whether they had Stasis constitution using the diagnostic criteria of Ho [29]. The diagnostic results from the TCM doctor were used for criterion-related validity testing via logistic regression and ROC curve analysis, in order to provide an easy-applied instrument to diagnose whether a person has Stasis constitution. The diagnostic cut-off point of Stasis constitution was calculated when the sum of the sensitivity and specificity achieved the maximum [30].
Data Analysis
Statistical analyses were performed using the Statistical Package for the Social Science (SPSS) version 12.0. Both the demographic characteristics of the participants and difficulties in answering the questionnaire were described by frequency,
percentage, mean and standard deviation. Discriminant validity of each question was evaluated by comparing the scores below the 25th and above the 75th percentile using the Mann-Whitney test [31]. The reliability of the derived scales was evaluated by Cronbach’s α coefficient, a corrected item-total coefficient and the intraclass correlation coefficient (ICC). Cronbach’s α (> 0.7) and the corrected item-total correlation coefficient (> 0.3) were used to examine internal consistency. The ICC (> 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
0.7) was applied to evaluate the test-retest reliability of BCQs [32] . Exploratory factor analyses (EFA) was conducted to examine the domain structure of the Stasis
constitution. The factors were extracted by principal components analysis (PCA) with Promax oblique rotation and the number of factors was determined by those factors whose eigenvalue was > 1. Student’s t-test was used to compare the consistency between the BCQs score and the diagnosis by the TCM doctor. Finally, the logistic regression analysis and ROC curve analysis were employed to calculate the diagnostic cut-off point of Stasis constitution.
Results
Among the 990 subjects approached, 958 were eligible for one of the 3 different groups described in detail in Table 1.
Developing a provisional BCQs using the Delphi method Characteristics of Panel Experts
The basic characteristics of the invited 27 experts are shown in Table 2. It should be noted that one expert died from a brain tumor during the 2 stages of Delphi process and the rest completed the whole Delphi process smoothly.
Generation of Items: After searching TCM textbooks and published literature using the key words “constitution”, “stasis”, “stagnation” and “phlegm”, 27 relevant items were compiled. Using our pre-set item inclusion and exclusion criteria, 19 out of these 27 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
items were kept and listed in the round-1 questionnaire for the panelists’ ratings. After the round-1 Delphi process, 19 items with CVI ≥ 0.7 were kept. Additionally, another 4 items suggested by the panelists’ were included in the questionnaire for review in round 2. In round 2, these suggested 4 items with CVI > 0.7 were added. A total of 23 items were retained after round 1 and 2 of stage 1 the Delphi process. Wording of Questions and Face and Content Validity Test
The retained 23 items were rewritten to ensure colloquial appropriateness, and their face and content validity were evaluated in stage 2 of the Delphi process. The CVI of each of the 23 questions was between 0.81-1.00, indicating that most of the TCM experts agreed with the selected items. Nonetheless, 5 colloquial questions (Q2, Q5, Q14, Q15 and Q16) were further revised according to the experts’ suggestions in order to measure the respondents’ signs and symptoms more precisely.
Pilot Testing
A total of 81 participants were enrolled in the pilot study and completed the questionnaire. The mean age was 37.2 ± 16.6 years, 62% were female; 30% had less than high-school education and 47% had college or postgraduate degree.
Participants had no difficulty in answering most of the questions.
Finally, the provisional version of the Stasis constitution (BCQs) with 23 questions was written. (see Appendix I)
Evaluation of Reliability and Validity 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
Intra-Class Consistency, Test-Retest Reliability, Power of Discrimination and Construct Validity
Skewed distribution for each item was observed, as evidenced by the coefficient of skewness > 1 (see Table 3) and the raw data had a higher proportion of floor effect. Item discrimination was assessed by Z score (Mann-Whitney test), and it ranged between -16.50 and approximately -7.81 (P < 0.01) (see Table 3) indicating good discrimination. The corrected item-total correlation coefficient of each question ranged between 0.23 and 0.68. Q1 (“poor appetite”) was removed as its corrected item-total correlation coefficient was < 0.3 (Table 4). The Spearman correlation coefficient of each question between test and retest ranged from 0.28 to 0.77 (P < 0.05), and the
Cronbach’s α of these 22 questions was 0.88. The ICC ranged between 0.37 and 0.89, and the ICC for the entire questionnaire was 0.91 (see Table 4).
Data from the 22-item version were then subjected to an exploratory factor analysis. The Kaiser-Meyer-Olkin value was 0.917; the Kaiser-Bartlett’s test of Sphericity yielded χ2 = 5498.14 (P < 0.001), indicating that these 22 questions were highly
correlated and suitable for factor analysis. PCA with Promax oblique rotation and the eigenvalue > 1 criterion resulted in 4 factors which explained 56.9% of the total variance. The factor loading of each item on its respective factor was all > 0.46. The item composition for the 4 extracted factors, the explained variance, factor loading, 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
and the correlation coefficients of inter-factor, as well as Cronbach’s coefficient α of each factor and the ranges of the inter-item correlation coefficient are shown in Table 5. Six items (Q14, Q9, Q20, Q21, Q12 and Q19) were removed. Inspection of the item contents in their respective 4 factor suggests that the level of Stasis can be measured in 4 different areas of the body: trunk, body surface, head, and gastrointestinal tract. The score distributions of these 4 domains in the BCQs domains are shown in Table 6. Criterion-Related Validity
Out of the 150 participants, 91 (60.7%) were diagnosed with Stasis constitution by the TCM doctor. Participants with higher score in any of the factors were significantly more likely to be diagnosed with Stasis constitution (P < 0.01). Thus, the assessment of BCQs and the diagnosis of the TCM doctor were consistent (see Table 7). Moreover, using logistic regression model, when the sum of the sensitivity and specificity
achieved the maximum [30], the sensitivity of the whole questionnaire was 0.733, and the specificity was 0.724. By constructing the ROC curve, when the sum of the
sensitivity and specificity achieved the maximum, the area under of the ROC curve (AUC) was 0.790 (95% CI: 0.717-0.864, p < 0.001), and the odds ratio was 1.205 (95% CI: 1.121-1.296, p < 0.001. The diagnostic cut-off point of BCQs was suggested to be 26.5. When this cut-off point was used to examine the 808 participants in group A (see Table 1), 352 (43.6%) were classified to have Stasis constitution.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Discussion
Despites the changes of disease spectrum, medical models and health concepts, the acceptance of TCM as a real therapeutic option by Western medicine has only emerged in recent decades. The diagnostic and therapeutic approach of TCM is receiving more and more attention as patient outcome assessment moves from “disease-based” to “patient-based” models [33]. Each individual’s body constitution is emphasized in determining the following phenomenon: (1) the liability of people with different types of constitution to different environmental pathogenic stimuli; (2) the diversity of manifestations among patients with the same disease; (3) the non-unified response among the patients with the same disease receiving the same treatment. Thus, the phenotypic assessment of a person to identify the body constitution is crucial in TCM diagnosis, which guides the tailored treatment and disease prevention for each individual. Therefore, TCM can be viewed as “personalized medicine”.
While each individual is persistently affected by environmental stimuli, such as lifestyle, diet, pathogens and disease, the prolonged decrease of “Yang” or “Yin” will shape one’s constitution into Yang-Xu or Yin-Xu type, respectively. Our research team developed the body constitution questionnaire “BCQ+” [34, 35] and “BCQ-“ to measure the Yang-Xu and Yin-Xu constitution, respectively. Besides the BCQ+ and BCQs, BCQs was developed because it is also important to measure the bodily stasis in TCM clinical 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
diagnosis and treatment decision-making.
“Stasis” is both a pathological causative factor and product which appears when Yin is not transported by Yang efficiently. For example, “tumor” is viewed as a form of pathologic product of stasis in TCM, and the stasis accumulates in the meridian is the key pathogenesis of the symptom “pain” [7]. Therefore, while deciding the treatment strategy for patients with cancer or pain, “activating blood circulation, removing blood stasis, and dissolving phlegm” are the main options [36-39]. Then, TCM formulae and herbs are prescribed according to these treatment strategies.
The BCQs was designed as a measurement tool that can be applied to clinical trials adopting TCM interventions. Hence, the experts who participated in the Delphi method had professional knowledge and training of both MM and TCM. This is a unique
advantage of our research, as the Delphi process was conducted with TCM doctors who had all graduated from medical university with complete professional education and training of both MM and TCM. Three-fifths of them had both MM and TCM doctor licenses. Nearly 90% of the experts had a master’s degree, while 40% had advanced Ph.D. degree. Furthermore, three-quarters of the experts had experience of conducting constitution investigations. The educational background of the panelists was
homogenous as there is only one medical university in Taiwan that provides the training program for modern TCM doctors. Thus, to minimize the sampling error, we 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
invited TCM doctors of different departments or from different areas in Taiwan. Considering this was an exploratory study to develop an objective questionnaire to evaluate Stasis constitution, and the TCM experts may not be familiar with the epidemiological methodology to develop psychometrically sound questionnaire, our research team made ample efforts to clearly describe the aim and procedure of the Delphi method to the TCM experts.
Delphi method is applied in qualitative studies to establish the content and face validity of experts and is especially suitable for new research areas and exploratory studies [40-42]. The items were set to be kept with CVI ≥ 0.7 in our study, which is lower than the general standard of Delphi method (CVI 0.8-1.0) [42]. The impact of this slight lower criterion is minimal, because the 23-item provisional version of BCQs was subsequently tested with a large sample to establish its reliability and validity. Actually, among the 23 items evaluated by the TCM experts, only 1 item had CVI < 0.8.
Previously, another set of diagnostic standards for Xin-Blood Stasis Syndrome were established by Wei et al. also by Delphi method [43]. However, the validity and reliability of Wei’s criteria had not been further assessed.
Considering its application by MM clinical investigators and doctors, the items to assess Stasis constitution were selected and translated into colloquial questions so as to be as easy to understand as possible. Although most study participants in the pilot 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
testing had no difficulties answering all 23, we took their feedback and modified Q2, Q5, Q14, Q15 and Q16 to ensure they measured the signs and symptoms of Stasis constitution more precisely.
When all 16 items of the final BCQs are used, the investigators or physicians can use the total (summed) score to quantify and understand the Stasis constitution state of their study participants or patients. Thus, BCQs may serve as a useful integration tool for outcome measurement and decision-making in research and clinical settings.
Our results revealed a floor effect slightly over 10% in all the BCQs items and a skewed-to-right distribution (most items with the coefficient of skewness > 1). This may be because we excluded participants who had acute onset of disease in the past month and most participants considered themselves as healthy, which possibly made their scores in the lower proportion of Stasis constitution score distribution. When the BCQs is applied to patients, the score of Stasis is expected to higher than that of study participants.
Four factors underlying the latent structure of Stasis constitution were extracted from the factor analysis. Items in their respective factor appeared to be the
manifestations resulting from the Stasis distributed in the trunk, body surface, head, and gastrointestinal tract. We labeled each factor based on the location and
pathophysiology behind each manifestation accordingly: “Stasis in the trunk”, “Stasis in the head”, “Stasis in the body surface”, and “Stasis in the gastrointestinal tract.” These 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
4 levels of Stasis together represent the “Stasis of the whole body.” (cf. Table 6) For example: the items gathered in factor 1 were manifestations mainly located from the central part of the body from which extends the neck and limbs and caused by the blood stasis in the meridians; while the items in factor 2 were manifestations located in the body surface, which is the interface between the human body and environment.
The latent structure of stasis identified from this study is similar to that of the Yang-Xu and Yin-Xu constitution measured by the BCQ+ [35] and BCQ-, respectively. This can be reasonably expected from the TCM pathophysiological point of view as they closely meet the descriptions of function, transportation and distribution of Yang-qi and Yin-blood recorded in the ancient TCM bible “Huangdi’s Internal Classic” [21-24].
Finally, the criterion validity test was performed to verify the consistency of Stasis constitution diagnosed by the BCQs and by the TCM doctor. A high correlation was found between the scores of the 4 factors in the BCQs and the diagnosis by the TCM doctor. Out of the 150 participants, 90 (60.7%) were diagnosed with Stasis constitution by the TCM doctor, while 352 out of 808 subjects (43.6%) were classified to have Stasis constitution by the BCQs. This was quite reasonable since the subjects for criterion-validity test were recruited from the outpatient of the TCM clinic, the rate of being diagnosed with Stasis constitution was higher (60.7%). The subjects for establishing the construct validity were recruited from the annual preventive health examination, and 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
most of these subjects were generally healthy. Therefore, the rate of being diagnosed with Stasis constitution was lower.
The BCQs along with the BCQ+ and the BCQ- are collectively named as the “BCQ” to capture aspects related to of Yin-Yang balance (see Figure 2). The BCQ has been adopted and used to explore the relationships among constitution, stress, and discomfort in pregnant women during their first trimester [44]. It was found that the BCQs score was a predictor of the discomfort of “nausea”, while the BCQ+ and BCQ- scores were predictors of the discomfort of “frequent urination”. In addition to this study, the BCQ has also been applied in several large-scale clinical studies. In Hong Kong, the BCQ was applied to establish the prevalence and epidemiology of body constitution in Chinese population. In Taiwan, the BCQ has been applied in multi-center clinical trials to evaluate the constitution changes in the cancer patients receiving chemotherapy or radiotherapy. Furthermore, the BCQ has also been applied to explore the relationship between the mountain trekkers’ constitution types and the incidence of acute mountain sickness. The results of these clinical trials are now under
preparation for submission.
Although the BCQ was originally developed in Chinese (the English translated version of the BCQs shown in Appendix II was for illustration purpose), our
interdisciplinary research team has and will continue to perform different language 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
translations and cultural adaptations to expand the global use of the BCQ. The BCQs should also be continuously revised and validated to improve its clinical use in different patient populations and clinical settings.
Conclusion
The BCQs was developed using a thorough and scientific method in order to obtain an objective, accurate, and easily-applied tool for TCM Stasis constitution measurement. The BCQs has 4 structured domains representing 4 different bodily areas of the Stasis level. Findings showed that BCQs is a psychometrically sound and clinically meaningful questionnaire, with satisfactory reliability and validity. Finally, BCQs may be a good measurement tool and classification integration instrument for evaluating Stasis constitution in MM clinical trials adopting TCM interventions.
Conflict of interest
The authors have declared that no conflict of interest exists.
Acknowledgment
This study was supported in part by the Committee on Chinese Medicine and Pharmacy, Department of Health, Executive Yuan, Taiwan (Grant # CCMP93-RD-026, CCMP94-RD-107, and CCMP95-RD-014)
We would also like to thank all participators in this investigation. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
References
[1] Feng Y, Wu Z, Zhou X, Zhou Z, Fan W. Knowledge discovery in traditional Chinese medicine: state of the art and perspectives. Artif Intell Med 2006;38:219-36. [2] Khalsa PS, Pearson NJ. Financial support for research training and career
development in complementary and alternative medicine from the National Institutes of Health. J Manipulative Physiol Ther 2007;30:483-90.
[3] Jiang M, Zhang C, Cao H, Chan K, Lu A. The Role of Chinese Medicine in the Treatment of Chronic Diseases in China. Planta Med 2011;77:873-81.
[4] Yuan R, Lin Y. Traditional Chinese medicine: an approach to scientific proof and clinical validation. Pharmacol Ther 2000;86:191-8.
[5] Zhanwen Liu, Liang Liu: Essentials of Chinese Medicine (Volume 1). New York, Springer, 2009, pp.13-21.
[6] Zhanwen Liu, Liang Liu: Essentials of Chinese Medicine (Volume 1). New York, Springer, 2009, pp.151-6.
[7] Beinfield H, Korngold E. Chinese medicine and cancer care. Altern Ther Health Med 2003;9:38-52.
[8] O'Brien KA, Abbas E, Zhang J, Guo ZX, Luo R, Bensoussan A, et al. Understanding the reliability of diagnostic variables in a Chinese Medicine examination. J Altern Complement Med 2009;15:727-34. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
[9] Zhang GG, Bausell B, Lao L, Handwerger B, Berman BM. Assessing the consistency of traditional Chinese medical diagnosis: an integrative approach. Altern Ther Health Med 2003;9:66-71.
[10] Zheng MH, Fan YC, Shi KQ, Chen YP. Methodological quality assessment for traditional Chinese medicine: CONSORT is better. Hepatology 2011;53:2148-9. [11] Wang G, Mao B, Xiong ZY, Fan T, Chen XD, Wang L, et al. The quality of reporting
of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China. Clin Ther 2007; 29:1456-67. [12] Wang L, Li Y, Li J, Zhang M, Xu L, Yuan W, et al. Quality of reporting of trial
abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine. Trials. 2010;11:75.
[13] Lao L, Huang Y, Feng C, Berman BM, Tan MT. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology:
Application to a randomized controlled acupuncture trial. Stat Med. 2012;31:619-27.
[14] Lu AP, Jia HW, Xiao C, Lu QP. Theory of traditional Chinese medicine and therapeutic method of diseases. World J Gastroenterol 2004;10:1854-6. [15] Jiang WY. Therapeutic wisdom in traditional Chinese medicine: a perspective
from modern science. Trends Pharmacol Sci 2005;26:558-63. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
[16] Su YC: The study of the physical constitution among SLE patients in Chinese medical perspective. Taichung, China Medical University, 1995. Chinese. [17] Wang Q: Status and prospect of constitutional theory in traditional Chinese
medicine. Chinese Journal of Basic Medicine in Traditional Chinese Medicine 2002;8:6-15.
[18] Kuang DY: Human constitutionology-principles of individualized diagnosis and traditional Chinese medicine. Shanghai, Science Technology, 2003.
[19] Zhanwen Liu, Liang Liu: Essentials of Chinese Medicine (Volume 1). New York, Springer, 2009, pp.184-8.
[20] Zhanwen Liu, Liang Liu: Essentials of Chinese Medicine (Volume 1). New York, Springer, 2009, pp.165-88.
[21] Yin hh, Zheng BN: Meridian and collateral; in Yin hh, Zheng BN (eds): Basic theory of traditional Chinese medicine. Taipei, Chih Yin, 1997, pp.176-84.
[22] Yin hh, Zheng BN: Mechanism of disease; in Yin hh, Zheng BN (eds): Basic theory of traditional Chinese medicine. Taipei, Chih Yin, 1997, pp.283-5.
[23] Anonymous: Ni-shun-fei-shou; Ling-shu-jing shi yi jiao-shi. “Huangdi’s Internal Classic”. (in Chinese) Beijing, People's Health Publishing House, 1982, pp.236-49. [24] Anonymous: Bai-bing-shi-sheng; Ling-shu-jing shi yi jiao-shi. in “Huangdi’s
Internal Classic”. (in Chinese) Beijing, People's Health Publishing House, 1982, pp.542-50. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
[25] Graham B, Regehr G, Wright JG: Delphi as a method to establish consensus for diagnostic criteria. J Clin Epidemiol 2003;56:1150-6.
[26] Lynn MR. Determination and quantification of content validity. Nurs Res 1986;35:382-5.
[27] Crocker LM, Algina J: Introduction to classical and modern test theory. New York, Holt, Rinehart, and Winston, 1986.
[28] Chen LL, Lin JD, Huang YC, Lin JS, Huang CH, Su YC: Scale descriptor selection for a Taiwan-version of a body constitution questionnaire in traditional Chinese
medicine. Mid Taiwan J. Med 2008;13:35-42. Chinese.
[29] Ho YM: Study on the syndrome traits and treatment principle of TCM from the investigation of constitution. J Tradit Chin Med 1986;5:47-50. Chinese.
[30] Youden WJ: Index for rating diagnostic tests. Cancer 1950;3:32-5. [31] Maryr L: Determination and quantification of content validity. Nurs Res
1986;35:382-5.
[32] Hinkin TR: A review of scale development practices in the study of organizations. J Manage 1995;21:967-88.
[33] Wei HF, Zheng PY, Ji G. General methods for clinical effect assessment of
traditional Chinese medicine. Zhong Xi Yi Jie He Xue Bao 2005;3:184-90. Chinese. [34] Su YC, Chen LL, Lin JD, Lin JS, Huang YC, Lai JS. BCQ+: a body constitution
questionnaire to assess Yang-Xu. Part I: establishment of a first final version through a Delphi process. Forsch Komplementmed. 2008;15:327-34.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
[35] Chen LL, Lin JS, Lin JD, Chang CH, Kuo HW, Liang WM, et al. BCQ+: a body
constitution questionnaire to assess Yang-Xu. Part II: Evaluation of reliability and validity. Forsch Komplementmed. 2009;16:20-7.
[36] Li XH, Liang WN, Liu XX. Clinical observation on curative effect of dissolving phlegm-stasis on 50 cases of knee osteoarthritis. J Tradit Chin Med 2010;30:108-12.
[37] Wei P, Xu L, Sun D, Shi J, Qin Z, Lu Y. Relations between phlegm and generation and development of gastric cancer. J Tradit Chin Med 2008;28:152-5.
[38] Lu X, Li B. Exploration of the effect and mechanism of activating blood circulation and stasis-removing therapy on tumor metastasis. Chin J Integr Med
2009;15:395-400.
[39] Gao L. Qi-promoting and phlegm-resolving method for treatment of diabetic microvascular complications. J Tradit Chin Med 2000;20:104-9.
[40] Okoli C, Pawlowski SD: The delphi method as a research tool: an example, design considerations and applications. Information & Management 2004;42:15-29. [41] Schnyer RN, Conboy LA, Jacobson E, Mcknight P, Goddard T, Moscatelli F, et al:
Development of a Chinese medicine assessment measure: An interdisciplinary approach using the Delphi method. J Altern Complement Med 2005;11:1005-13. [42] Ciałkowska M, Adamowski T, Piotrowski P, Kiejna A: What is the Delphi method?
Strengths and shortcomings. Psychiatr Pol 2008;42:5-15. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
[43] Wei W, Jing L, Xu FQ. Using Delphi method to establish diagnostic standard for Xin-blood stasis syndrome. Zhongguo Zhong Xi Yi Jie He Za Zhi 2010;30:585-8. Chinese.
[44] Wang HL, Lee TC, Kuo SH, Chou FH, Chen LL, Su YC, Chen LM. Relationships among Constitution, Stress, and Discomfort in the First Trimester. Evid Based Complement Alternat Med. 2012;2012:486757. 1 2 3 4 5 6
Appendix I
Items and questions generated by Delphi method - a provisional version of the Stasis questionnaire (BCQs)
Items Questions / Descriptions
Poor appetite 1. My appetite is poor.
Sputum in throat 2. I feel there is sputum in my throat, even I am not catching a cold.
Head heaviness 3. I feel heavy or dizzy in my head.
Thick sticky saliva 4. I feel sticky in my mouth or my saliva is thick. Heavy feeling in body 5. I feel heavy in my whole or lower body.
Dull pain 6. There is dull pain in my body which makes me uncomfortable.
Tingling pain 7. There is tingling pain in my body which makes me uncomfortable.
Sleepiness 8. Even with sufficient sleep time, I still feel sleepy. Loose or watery stool 9. My stool is loose or watery. (Diarrhea).
Numbness in limbs 10. I feel numbness in limbs.
Chest tightness 11. I feel chest tightness which seems oppressed by something.
Abdominal bloating 12. Just eating a little, then I feel abdominal bloating. Easy bruising 13. Bruise will appear on my skin without obvious 1
2 3
causes.
Lumps 14. Lumps can be felt over my body.
Dry and scaly skin 15. My skin gets dry, cracked, scaly or tough.
Varicose veins 16. Enlarged and tortuous veins (eg. varicose veins) can be seen over my trunk or limbs.
Lateral costal dull pain 17. There is dull or pain sensation over the lateral side or costal region of my body.
Edema 18. There is edema in my limbs, trunk, face or around the eyes.
Hypogeusia 19. I have diminished sense of taste.
Dark face 20. I feel my face looks dark.
Dark lips 21. I feel my lips are dark or with petechiae. Thick tongue coating 22. My tongue coating is thick or sticky.
Fatigue 23. I feel tired and don’t want to move.
Appendix II Stasis Constitutional Questionnaire (BCQs) final version
Dear Mr / Ms :
Please recall if you have experienced the following signs or symptoms in the past month and mark with “” the appropriate intensity or frequency of the respective signs or symptoms.
Thank you!
1. There is dull pain in my body which makes me uncomfortable. □ □ □ □ □ 2. There is tingling pain in my body which makes me
uncomfortable. □ □ □ □ □
3. I feel chest tightness which seems oppressed by something. □ □ □ □ □
4. I feel numbness in limbs. □ □ □ □ □
5. There is dull or pain sensation over the lateral side or costal
region of my body. □ □ □ □ □
6. Enlarged and tortuous veins (eg. varicose veins ) can be seen
over my trunk or limbs □ □ □ □ □
7. My skin gets dry, cracked, scaly or tough. □ □ □ □ □
8. Bruise will appear on my skin without causes. □ □ □ □ □
1 2
9. There is edema in my limbs, trunk, face or around the eyes. □ □ □ □ □
10. I feel heavy in my whole or lower body. □ □ □ □ □
11. Even with sufficient sleep time, I still feel sleepy. □ □ □ □ □
12. I feel tired and don’t want to move. □ □ □ □ □
13. I feel heavy or dizzy in my head. □ □ □ □ □
14. I feel there is sputum in my throat, even I am not catching a
cold. □ □ □ □ □
15. I feel sticky in my mouth or my saliva is thick. □ □ □ □ □
16. My tongue coating is thick or sticky. □ □ □ □ □
