Establishment And Application Of TCM Syndrome Identification Tool For High-risk Population Of Osteoporosis Based On Delphi Method

BackgroundOsteoporosis(OP)brings great burden to individuals and society.However,it is preventable and treatable,and prevention is more important than treatment.Therefore,early screening and identification of high-risk groups should be strengthened.Currently,screening tools for osteoporosis mainly assess the risk of osteoporosis,which mostly rely on factors such as age and weight,etc.,and there are still some doubts about the accuracy and effectiveness of various assessment tools.Based on the theory of "Preventive treatment of disease" in traditional Chinese medicine(TCM),this study aims to identify the people who were not osteoporosis but are at high risk of developing osteoporosis,that is,to move the threshold of screening from the osteoporosis standard to the stage of osteopenia.TCM has unique characteristics in the identification of osteoporosis.Previous studies have shown that the changes of TCM syndromes can occur before the changes of bone mineral density(BMD),but there is no TCM identification tool specifically to identify high-risk groups of osteoporosis.Therefore,this study uses Delphi method to explore a more practical TCM syndrome identification tool for high-risk population of osteoporosis,and tests its reliability and validity and optimizes items,in order to better identify people with abnormal bone mass so as to carry out early prevention and treatment,and provide reference for clinical use and screening of high-risk population.Purpose1 The Delphi method was used to investigate experts in the field of osteoporosis and establish a TCM syndrome identification tool for people at high risk of osteoporosis.2 Test and optimize the reliability and validity of the tool,and verify its discriminant effect.3 To analyze the TCM syndrome characteristics and quality of life of people at high risk of osteoporosis in order to provide theoretical support for this tool.Methods1 Construction of TCM syndrome identification questionnaire for high-risk population of osteoporosis based on Delphi methodFirstly,a systematic search of the literature on osteoporosis assessment tools,influencing factors,evaluation indicators and TCM identification in various databases,combined with expert advice and previous research results of the research group,designed a questionnaire.Secondly,according to the selection criteria to select participating experts and conduct a questionnaire survey,statistics and analysis of the general information of experts,expert positive coefficient,calculate the average of each index,standard deviation,grade sum,coefficient of variation and so on.Finally,according to the survey results,the preliminary construction of osteoporosis TCM syndrome identification tools,clear this study of other monitoring indicators,evaluation tools and form a complete screening questionnaire.2 Testing,optimization and validation of TCM syndrome identification tools for high-risk population of osteoporosis.Screening questionnaire survey was conducted among people over 40 years old who may have the risk of osteoporosis,and dual energy X-ray absorptiometry(DXA)was used to detect bone mineral density.The feasibility of the questionnaire was evaluated by the completion of the questionnaire.Pearson correlation coefficient and factor analysis were used to test the validity of this tool.Internal consistency reliability Cronbach reliability coefficient a and half-fold coefficient were used to evaluate the reliability.According to the test results,the TCM syndromes items and answer selection were adjusted,and the TCM syndrome identification tools for high-risk population of osteoporosis were determined after optimization.The effect of TCM syndrome identification tool,IOF one-minute test question and OSTA index in identifying people with abnormal bone mass in high-risk groups of osteoporosis was compared to verify the ability of this tool in identifying people with high risk of OP.3 Clinical practice and application of TCM syndrome identification tool for high-risk population of osteoporosis.A total of 228 patients over 40 years old were investigated using TCM syndrome identification tools,IOF1 one-minute test,OSTA index,visual analogue scale(VAS),and SF-36.SPSS 20.0 statistical software was used for data processing.Measurement data was expressed as(x±s),and counting data was expressed as frequency and percentage.Chi-square test was performed for comparison between groups,and P<0.05 for bilateral test was considered statistically significant.Analyze the distribution of age,sex,body weight,body mass index,tongue and pulse characteristics,VAS pain score,SF-36 in different groups of bone mass,analyze the frequency of TCM syndromes in different populations and do variance analysis and incidence test,in order to understand the health status and risk factors of high-risk population of osteoporosis,and clarify the characteristics of TCM syndromes of high-risk population.Results1 Construction of TCM syndrome identification questionnaire for high-risk population of osteoporosis based on Delphi method.1.1 Questionnaire distribution and recovery and information of participating expertsTwenty and 30 questionnaires were issued in the two rounds of expert surveys,twenty and 28 effective questionnaires were received,and the positive coefficient of experts was 100%and 93.33%,respectively.The experts participated in the survey were from more than 20 hospitals or scientific research institutes in 10 provinces and cities of Beijing,Shanghai,Guangdong,Fujian,Shaanxi,Jilin,Hunan,Hubei,Heilongjiang and Henan.Among the 28 experts who participated in the second round of survey,there were 23 males and 5 females,with an average age of 53.07±8.66 years old and an average working life of 28.55±10.97 years,including 14 TCM physicians,9 Western medicine physicians and 5 integrated Chinese and Western medicine physicians,with research directions including orthopedics and endocrinology,etc.,and they had good authority and regional representation.1.2 Selection of experts on osteoporosis risk assessment tools,auxiliary examinations and evaluation indicatorsExperts have a high degree of concentration and coordination on the IOF one-minute test,OSTA and public instruments of TCM assessment,which can be used as a preliminary screening tool for risk assessment.The degree of concentration and coordination of expert opinions of DXA,bone turnover index and blood calcium and phosphorus are the highest,which can be used as the main auxiliary examination contents,all of which meet the requirements of x>7,R=0 and CV<20%.The selection of BMD,TCM syndrome score,serum calcium and phosphorus,balance ability,quality of life,bone turnover index,VAS pain score,number of falls and fracture occurrences met the standrad of x>8%,K>90%and CV<20%,which can be used as the outcome evaluation index of high-risk population of osteoporosis.1.3 Selection of TCM syndrome identification tools for people at high risk of osteoporosis by experts.A total of 32 TCM symptoms and signs were included in the second round of questionnaire as TCM identification indicators for people at high risk of osteoporosis.The experts' selection of 7 indexes of low back pain,back pain,body pain,waist and knee pain,hunchback,short height,lower limb cloneness met the requirements of X>7,K>70%,R=0,CV<20%;Experts selected 3 indicators of tiredness,fatigue,sleepiness and weight of lower limbs,and heel pain to meet K?50%,X>6.5,CV<25%.These 10 indicators have a good degree of expert opinion concentration and coordination,and can be used as TCM syndrome identification items for high-risk population of osteoporosis.According to the expert opinion,the preliminary osteoporosis TCM syndrome identification questionnaire contains four parts:basic information,disease-related risk factors,somatic symptoms and clinical signs.2 Testing,optimization and validation of TCM syndrome identification tools for high-risk population of osteoporosis.2.1 The Feasibility of the questionnaire.The questionnaire survey adopts the way of on-the-spot survey,and the recovery rate and effective rate are as high as 90%.The time to complete the screening questionnaire of the research group is less than 20 minutes,which shows that this questionnaire survey has good feasibility and practical operation.2.2 Reliability of the screening questionnaireIn this questionnaire,the Cronbach coefficient a of the whole TCM syndrome field is 0.882,and the Spearman-Brown coefficient of its split half reliability was 8.891,indicating that the items of this questionnaire in the whole field of TCM syndromes identification had a good consistency and a good split half reliability.2.3 Validity evaluation of screening questionnaireFactor analysis was used to investigate the structural validity of the questionnaire,and exploratory factor analysis was used to analyze the obtained data.The results showed that the load values of the two items of hand and foot irritation(item 16)and forgetfulness(item 25)were low on all factors,and it was deleted after discussion by the research group.The other 30 items with high correlation of common factors were re-analyzed by factor analysis.The results showed that the Kaiser-Mayer-Olkin(KMO)test value was 0.838.The Bartlett approximate chi-square test was 2087.76,sphericity of df=435,p<0.01.The principal component method was used to extract the principal component method,and the rotation method was used to extract the maximum variance method.According to the eigenvalues greater than 1,nine common factors with eigenvalues more than 1 were extracted,and the contribution rate of cumulative variance was 61.215%,which showed good structure validity.The nine extracted factors include head symptoms,lower limb symptoms,somatic symptoms,pain symptoms,head signs,physical signs and other dimensions.After expert consultation and TCM syndrome discrimination,nine factors of TCM syndrome reflect the characteristics of high-risk population and pathogenesis of osteoporosis,and are basically consistent with the TCM classification of primary osteoporosis.The top 10 TCM syndrome items determined according to the expert opinion were tested,and the KMO value was 0.831>0.8.The Bartlett approximate chi-square=623.069(P<0.001).The principal component analysis was used for factor analysis,and three common factors were extracted.The cumulative variance was 61.2%and the three common factors were named somatic symptoms,pain and physical signs,respectively.The structural equation model was established by AMOS 24,and the maximum likelihood method was used to carry out confirmatory factor analysis on the above three factor analysis models,and the fitness index was calculated.The results showed that CMIN/DF=2.052,GFI=0.949,NFI=0.897,IFI=0.944,CFI=0.943,RMSEA=0.068,which indicated that the fitting indexes were basically within a reasonable range,indicating that the model fit well.The validity of TCM syndrome identification tool was tested by using BMD as calibration standard.The results showed that the scores of top 10 TCM syndrome items and the whole TCM syndrome items were negatively correlated with BMD diagnosis,lumbar BMD and hip/femoral neck BMD(Pearson correlation coefficient r=0.272,r=0.144,P<0.01 or P<0.05),indicating that the more TCM syndrome entries appear,the greater the possibility of abnormal BMD and the lower the BMD.2.4 TCM syndrome identification tool score distributionsThe scores of TCM syndromes were calculated according to the 2-level classification of "with" and "without".The scores of TCM syndromes were gradually increased in the three groups of people with normal bone mass,low bone mass and osteoporosis.Through analysis of variance,the scores of the first 10 syndromes F=5.389,P=0.005,and the scores of 30 syndromes F=6.856,P=0.001.According to the classification of normal bone mass and abnormal bone mass groups,the scores of the first 10 syndromes F=10.817,P=0.001,and the scores of 30 syndromes F=13.296,P<0.001,the differences were statistically significant(P<0.05),indicating that there were differences in TCM syndromes among different groups of bone mass.2.5 Discriminant effect of TCM syndrome identification toolsDraw the receiver-operating characteristic curve(ROC)and analyze the area under the curve(AUC),the sensitivity,and specific degrees.According to the bone mass,the BMD was divided into two categories:normal bone mass and abnormal bone mass.The first 10 TCM syndrome scores and all the 30 TCM syndrome scores and bone mineral density were qualitatively fitted to the ROC curve,and the first 10 TCM syndromes AUC=0.636(95%CI:0.564?0.709),30 TCM syndromes AUC=0.650(95%CI:0.579?0.721),wich showed that both of them have certain predictive value.The sensitivity,specificity,positive predictive value and negative predictive value of the first 10 TCM syndromes were 82.14%,45.69%,59.35%and 75.9%when the cutoff value was 2.When the cutoff value of 30 TCM syndromes value was 5,the sensitivity,specificity,positive predictive value and negative predictive value were 79.46%,43.97%,57.79%and 68.92%,respectively.2.6 Discriminant effect of OSTA and IOF questionnarieThe sensitivity,specificity,positive predictive value and negative predictive value of IOF 1 questionnarie for identifying abnormal bone mass were 98.21%,10.34%,51.40%and 85.71%,respectively(95%CI:0.468?0.618).The sensitivity,specificity,positive predictive value and negative predictive value of osteoporosis were 96.15%,6.44%,11.68%and 92.86%,respectively(95%CI:0.397?0.629).The sensitivity,specificity,positive predictive value,negative predictive value and negative predictive value of OSTA index for identifying abnormal bone mass in women were 49.46%,81.67%,80.70%,51.0%and 51.04%,respectively(95%CI:0.585?0.754).The sensitivity,specificity,positive predictive value and negative predictive value of osteoporosis were 38.10%,95.45%,57.14%and 90.65%,respectively.3.Clinical practice and application of TCM syndrome identification tool for high-risk population of osteoporosis.3.1 Age,weight and other risk factorsAmong the 228 respondents,75 were males and 153 were females,with an average age of 64.8 years.One-way ANOVA was conducted for the ages of the three groups with different bone mass,and the results showed that F=7.224,P=0.001,indicated that the BMD decreased with the increase of age.The average height of the survey population was 163.62 cm,and the standard deviation was 7.143 cm.Through variance analysis,F=13.248,P<0.001,showed that the height decreased with the decrease of BMD.The average body weight of the respondents was 67.88 kg±11.786 kg,and the body weight gradually decreased with the decrease of BMD(F=26.44,P<0.001).The mean body mass index(BMI)of the respondents was 25.2545 kg/m2,and the standard deviation was 3.42576 kg/m2(F=18.441,P<0.001),showed that the average BMI of the investigated population decreased with the decrease of BMD.3.2 Distribution characteristics of tongue and pulse.Among the surveyed people,161 cases(70.6%)had normal tongue shape(,?2=8.989,P=0.174);there were 91 cases of normal thin white fur(39.9%),followed by yellow greasy fur(15.4%)and thin yellow fur(14.9%),respectively(?2=13.36,P=0.498);There were 67 cases of sinking pulse and 66 cases of string pulse,respectively(?2=20.204,P=0.124).There was no significant difference in the distribution of tongue shape,tongue fur and pulse among all groups(P>0.05).3.3 Quality of life and VAS pain scoreSF-36 scores of the three groups were statistically analyzed according to 8 dimensions,and the results showed that with the decrease of bone mass,the scores of each dimension of SF-36 gradually decreased,the quality of life was lower.The average score of VAS pain in the investigated population was 3.63±2.447,indicating that there was mild pain.The VAS score of the three groups showed that the pain increased with the decrease of bone mass.3.4 Distribution of TCM syndromes.This study shows that the incidence of most TCM syndromes such as low back pain,back pain,lumbar and knee soreness and lower limb clonus increases with the decrease of BMD,that is,the incidence of TCM syndromes is the lowest in people with normal bone mass and the highest in people with osteoporosis.In accordance with the standards of alpha=0.05,it can be concluded that back pain,knee soreness and weakness,height becoming shorter,lower limb clonus,fatigue and fatigue,fatigue of lower limbs,heel pain,shaken hair,chills,chills,weight loss,dreaming,shortness of breath,insomnia,tinnitus,dizziness,dry mouth,blurred vision,dry eyes and dizziness were different in normal and abnormal bone groups(P<0.05).It showed that the distribution proportion of these TCM syndromes is different between the two groups.According to the incidence test,there were significant differences between the two groups in the incidence of 14 TCM syndromes including low back pain,sore waist and knees,shorter height,lower limb clonus,chills,dreaminess,shortness of breath,insomnia,forgetfulness,dizziness,dry mouth,blurred vision,dry eyes and dizziness(P<0.05).The incidence of these 14 TCM syndromes in people with abnormal bone is higher than that in people with normal bone.Conclusion.1 The TCM syndrome identification tool for high-risk population of osteoporosis based on Delphi method summarized the clinical experience of experts,and the items include low back pain,back pain,general pain,waist and knee pain,hunchback,shorter height,lower limb contracture,fatigue,fatigue of lower limbs,heel pain and other indicators,which can provide reference for clinical identification of high-risk population of osteoporosis.2 After testing and optimizing the TCM syndrome identification tool,it showed that the tool was satisfactory in reliability and validity,and had a certain correlation with the qualitative diagnosis of BMD,lumbar BMD and hip/femoral neck BMD,and the calibration validity was good.Our study showed that the TCM syndrome identification tool has a better ability to distinguish people with abnormal bone mass.When there are two or more of the first 10 items or 5 or more of all items appear,they are identified as people at high risk of osteoporosis,indicating a high possibility of abnormal bone mass.Therefore,it is suggested to be used for clinical screening of high-risk groups of osteoporosis.3 Our study showed that the incidence of TCM syndrome was different in groups of different bone mass,and more of these symptoms and signs appeared in people with abnormal bone mass can be used to identify people at high risk of osteoporosis.It not only provides a theoretical basis for TCM syndrome to identify high-risk population of osteoporosis,but also provides a reference for further research and optimization of this tool.