| BackgroundThe body constitution theory of Chinese Medicine(CM)has been developed and improved for more than 40 years.There are three issues of key importance:the body constitution can be divided;the body constitution and diseases are associated;and body constitutions can be adjusted.Classification and identification of CM body constitutions belong to the first part of the three issues.The Classification and Determination of Chinese Medicine constitution,compiled and published by the China Society of Traditional Chinese Medicine,is an important reference and standard for performing identification of body constitution in adult groups.However,there is still lack of standard for body constitution for children.Due to the characteristics of the children group themselves,as well as the CM understanding of their unique physiological and pathological characteristics,it is inappropriate to apply the current identification system for adult’s CM body constitution to children.ObjectiveBased on the previous scale preparation,the objectives of the present study include:(1)to evaluate the scientific nature of the scale and make according revisions to suit children aged 2-14 years old through a cross-sectional study;(2)to develop a CM body constitution scale with high feasibility and wide application,by methods of psychometric evaluation and reliability and validity assessment;(3)to analyse the characteristics of CM body constitutions of children in Guangdong.Methods1.Based on previous literature review,clinical experience summary and collections of expert’s opinion,seven types of CM body constitution for children in Guangdong was proposed,i.e.,the balanced constitution,Qi-deficiency,Yang-deficiency,Yin-deficiency,phlegm-dampness,dampness-heat,Qi-depression.The core characteristic index of each type of body constitutions was abstracted.Lastly,50 items of the Chinese Medicine Body Constitution Scale for Children were confirmed,in a way that parents of children could easily understand.2.As a cross-sectional study performed in Guangdong Provincial Hospital of Chinese Medicine(both branches in Guangzhou and Zhuhai),Shaoguan Hospital of Chinese Medicine,Shantou Hospital of Chinese Medicine,it intended to collect more than 300 eligible subjects according to sample size estimation.The physical examiners interviewed children’s families to collect information for identifying children’s CM body constitution.Children were also required to come for assessment by the four CM diagnostic methods.3.The collected data were analyzed to evaluate the reliability and validity of the scale.Decisive value was applied to examine the items of the scale.Kappa coefficient,Guttman split-half coefficient,Spearman-Brown coefficient and Cronbach’s coefficient were calculated to assess the re-test reliability,split-half reliability,and internal consistency of the scale.The validity of the scale was assessed by Kappa coefficient for consistency,experience validity and structure validity by factor analysis.Finally,this scale was released by Medical and Health Standardization Platform of Guangdong Association of CM to solicit expert opinions of CM paediatricians.Their opinions will guide further revisions of the scale.4.The distribution rules of constitution types of the included subjects were analyzed.It mainly focused on the first two or the first three complicated body constitutions and was also stratified according to gender and age.Results1.In total,673 questionnaires with participant information sheets were distributed,and 668 valid questionnaires were fulfilled,with a recovery rate of 99.2%.The average completion time of each scale was 24 minutes and 13 seconds.Among the 668 eligible children who received CM body constitution identification,357 were boys,and 311 were girls,with an median age of 5.0(3.0,7.0)years(non-normally distributed data,t=0.158,P<0.001),ranging from 2-14 years old.Among the respondents,418 children came from the Pearl River Delta region in Guangdong province,123 from Shaoguan city,and 127 from Shantou city.2.In the analysis of the items,the scale was evaluated by the decision value.The analysis results showed that the t-statistic of the 50 items were all>3.000,and the difference between the high and low groups was statistically significant(P<0.05),indicating that the decision value of each item was within the normal range and that there were no items to delete.For the intercommunity and factor loading,in the Qi-deficiency sub-scale,Item 5 had an intercommunity<0.20 and factor load loading<0.45.It was assumed that there was a weak relationship between this item and the total scale so that it could be deleted.3.For the reliability evaluation,93 children were selected for the test-retest reliability examination.The results of two assessments were tested for the consistency of weighted kappa values,showing the kappa values for 50 items ranging between 0.492 and 0.897.Among them,the kappa of each of the 39 items was greater than 0.7,indicating good test-retest reliability of this scale,while there were five items having kappa<0.6,showing that the test-retest reliability is general.For internal consistency reliability,the a coefficient for sub-scale of the balanced constitution,Qi-deficiency,Yang-deficiency,Yin-deficiency,phlegm-dampness,dampness-heat,Qi-depression were 0.706,0.709,0.661,0.695,0.664,0.732,and 0.739,respectively.Among them,Cronbach’s alpha of Yang-deficiency,Yin-deficiency,phlegm-dampness sub-scale were all<0.7;however,after removing one item from each of the three sub-scales,Cronbach’s alpha was elevated to more than 0.7.For the split-half reliability,the coefficients of all items in this scale were greater than 0.7,indicating good reliability.4.For the validity assessment,firstly,when designing the items of this scale,the opinions of local CM pediatrics experts were widely solicited to guide revisions of the items,making sure that the content validity of this scale was satisfactory.Then,in the experience validity aspect,since there was not a gold standard for body constitution identification,the reference used for experience validity is the body constitution identification opinions of CM pediatric clinicians.They collected children’s information by the four CM diagnostic methods and formed a diagnosis based on their CM body constitution.Kappa coefficient for the consistency between expert opinion and results indicated by the scale were between 0.697 and 0.899(P<0.001),showing good consistency.The KMO value in this study was 0.825,The Bartlett spherical test with an approximate chi-square of 10276.87(P<0.001),indicating that it was suitable for performing exploratory factor analysis.By the known common factor number method,15 common factors were extracted,with a cumulative contribution rate of 61.76%.Variables and load coefficient were obtained by maximum variation method of rotation with the 15 common factors and each item,and the connections between the common factor and the CM body constitutions were analyzed.5.Combined with the measurement evaluation of the preliminary version and the opinions of the research group through discussion,necessary revisions of the scale were made,including deleting Item 8 of the Yin-deficiency subscale and Item 7 of the Dampness-heat subscale.Eventually,a 48-item CM body constitution scale was developed.6.For the distribution of children’s CM body constitution,it showed that the types of the body constitution in more than 80%of children in this region were mainly jaundiced,among which the complicated body constitution accounted for the majority(518 cases,accounting for 94.2%of all jaundiced constitutions).In contrast,the single body constitution was less commonly seen(32 cases,accounting for 5.8%).Less than 1%of children failed to identify an explicit body constitution using this scale.There was no significant difference in the distribution of the body constitution types between different genders(χ2=4.175,P=0.124).7.Apriori algorithm was used to analyze the first two combined body constitutions rules.Fifteen association rules were found,among which Yin deficiency-Qi depression was the most supported association rule.For rules of the first three body constitutions combined,40 association rules were found,among which Qi depression-Yin deficiency-phlegm-dampness and Qi depression-Yin deficiency-Qi deficiency were the most supported association rules.Conclusion1.The Chinese Medicine Body Constitution Scale for Children has completed its reliability and validity assessment,showing good rationality and feasibility.It is suitable for children aged 2-14 years old and can be used as a CM body constitution identification tool for children of this age group.2.Complicated body constitutions are common among children in Guangdong,among which jaundiced and complicated body constitutions take the majority.Yin deficiency,Qi depression and Qi deficiency often appear;Qi deficiency-Yin deficiency and Qi depression combined with various other body constitutions are also commonly seen. |
