Development And Assessment Of The Self-measuring Scales Of Syndrome Of Spleen Qi Deficiency,Dampness-heat Of Spleen-stomach And Dampness-heat Due To Spleen Qi Deficiency

ObjectiveThis topic takes the clinically high incidence of spleen and stomach system diseases as a breakthrough.It mainly develops the syndrom of spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency self-test identification scales of spleen and stomach diseases through literature research,Delphi method,group discussion and other forms.Through clinical investigation,the scale was evaluated and revised,and finally the "Spleen Qi Deficiency Self-Test Identification Scale","dampness-heat of spleen-stomach Self-Test Identification Scale",and"Dampness-heat due to Spleen Qi Deficiency Self-Test Identification Scale"were formed to serve as a tool for scientific syndrome differentiation of spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency for patients with spleen and stomach diseases.MethodsThrough literature review and discussion,the symptom entry library of spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency of spleen and stomach diseases are constructed.Use warehousing,selection,and Delphi methods to filter and optimize items.Develop preliminary scale and symptom information collection table for clinical investigation,analyze data and apply the subjective and objective joint weighting method to empower the items.The ROC curve is used to determine the diagnostic threshold of the scale,and the "Spleen Qi Deficiency Self-Test Identification Scale","dampness-heat of spleen-stomach Self-Test Identification Scale",and "Dampness-heat due to Spleen Qi Deficiency Self-Test Identification Scale" are prepared.Finally,the feasibility,reliability,validity,and item response theory are used as indicators to assess the scientificity and effectiveness of the scales.ResultsFirst part:Development of the Self-measuring Scales of Syndrome of Spleen Qi Deficiency,Dampness-heat of Spleen-stomach and Dampness-heat due to Spleen Qi Deficiency1.The construction and screening of the item library:The standards in the textbooks,consensus or guidelines issued by the national or industry organizations are the main source of the TCM syndrome entries in this study.A total of 337 TCM syndromes were collected from the initial collection of spleen qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency.Because the self-rating scales are reported by the patient,88 items of tongue and pulse that the patient could not judge were deleted,and finally 249 items were reserved to form a preliminary item library.Using the warehousing-method and the selection method to filter and optimize the item library,after optimizing and sub-packaging the item library,the spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency formed 23,25,and 24 items respectively,and the item was changed to the question form.2.Delphi survey:The positive coefficients of the experts in the three rounds of Delphi survey are 70%,75%,and 70%,respectively;the average authoritative coefficient is above 0.9.The three syndrome types of spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency were finally determined from 10,9,and 11 in the initial 23,25,and 24,and the coefficient of variation were between 0.08-0.28,0.13-0.25,and 0.21-0.36,respectively.The coordination coefficients were 0.394,0.369,and 0.193,respectively,P<0.05.3.Entity empowerment:Apply the subjective and objective joint weighting method to empower the items.The final entries’ weights of the spleen Qi deficiency are:appetite 3,abdominal distension/stomach distension 4,abdominal pain/stomach pain 3,fatigue 5,fatigue Do not want to talk 4,face yellowing 4,stomach drooping 3,stool thinning 4,stool mixed with indigestible food 4,defecation weakness 3.The entries’ weights of the spleen dampness-heat of spleen-stomach are:appetite 3,abdominal distension/stomach distension 3,abdominal pain/stomach pain 3,upper abdomen burning 4,heavy hands and feet 4,sticky in the mouth 4,bad breath 4,mouth bitter 3,dry mouth 4,stool sticky stagnation 4,urinary short yellow 4.The weights of each entry of dampness-heat due to spleen Qi deficiency are:appetite 4,abdominal distension/stomach distension 4,abdominal pain/stomach pain 4,fatigue 4,heavy hands and feet 5,sticky in the mouth 5,bad breath 4,stool thinning 4,stool sticky and unhappy 4.4.Determining the diagnostic threshold:Taking the expert’ s dialectical results as the gold standard,the patient scale score and the healthy person’ s scale score as the diagnostic score,the syndrom of spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency respectively construct the ROC curve.Drawn by the Youden index,the diagnostic score of spleen Qi deficiency self-test identification scale is≥10 points,the diagnosis score of the dampness-heat of spleen-stomach self-test identification scale is≥16.5 points,and the dampness-heat due to spleen Qi deficiency self-test identification scale diagnosis score≥12.5 points.Second part:Development of the Self-measuring Scales of Syndrome of Spleen Qi Deficiency,Dampness-heat of Spleen-stomach and Dampness-heat due to Spleen Qi DeficiencyThe clinical investigation of the scale investigated 101 cases of spleen-Qi deficiency syndrome,90 cases of dampness-heat of spleen-stomach syndrome,99 cases of dampness-heat due to spleen Qi deficiency syndrome,and 88 cases of healthy people group(three scales were filled out respectively).The three scales were evaluated in terms of feasibility,reliability,validity,and item response theory.1.FeasibilityThe spleen Qi deficiency self-test identification scale recovery rate is 99%,completion rate is 100%,the completion time is up to 20 minutes,the shortest is 2 minutes,and the median is 4 minutes.The dampness-heat of spleen-stomach self-test identification scale recovery rate is 100%,the completion rate is 100%,the completion time is up to 22 minutes,the shortest is 2 minutes,and the median is 4 minutes.The dampness-heat due to spleen Qi deficiency self-test identification scale recovery rate is 100%,the completion rate is 100%,the completion time is up to 20 minutes,the shortest is 2 minutes,and the median is 4 minutes.2.ReliabilityInternal consistency reliability:The Cronbach a of the spleen Qi deficiency,dampness-heat of spleen-stomach,and dampness-heat due to spleen Qi deficiency self-test identification scales were 0.642,0.651,and 0.739,respectively.Split-half reliability:The split-half reliability coefficients of the two semi-scales are calculated by the parity-half method for each scale entry,and the reliability of the complete scale is calculated by the Spearman-Brown formula.The split-half reliability coefficients of the three scales are all>0.65.3.ValidityContent validity:Spleen Qi deficiency self-test identification scale except for entry 2,entry 3,I-CVI are>0.78.Entry 3 has the lowest I-CVI,0.43,which can be considered for deletion.S-CVI/Ave is 0.83;content validity is good.Dampness-heat of spleen-stomach self-test identification scale except for entry 1,entry 3,entry 4,I-CVI are>0.78.Entry 3 has the lowest I-CVI,which is 0.64,and can be considered for deletion.S-CVI/Ave is 0.83;content validity is good.The dampness-heat due to spleen Qi deficiency self-test identification scale only 4 entries ’ s I-CVI>0.78,of which the lowest of entry 3 is 0.29,which can be considered for deletion;S-CVI/Ave is 0.72;content validity is general.The structural validity:Firstly,carried out the KMO statistic and the Bartlett spherical test.The KMO of the spleen Qi deficiency self-test identification scale sample was 0.641,x 2=169.388,df=45,P=0.000,the KMO of the sample of the dampness-heat of spleen-stomach self-test identification scale is 0.638,x 2=157.436,df=55,P=0.000,the KMO of the sample of the dampness-heat due to spleen Qi deficiency self-test identification scale is 0.662,x 2=176.689,df=36,P=0.000.Above results indicate that the data is suitable for factor analysis.The principal component method is used to extract the common factor and the maximum rotation of the variance is used to extract the common factor with the eigenvalue>1.Results There were 4,5,and 3 common factors for the eigenvalues>1 of the three scales,and the cumulative contribution rates of variance were 63.822%,67.421%,and 59.669%,respectively.The results showed that the factor load of all the items in the three scales was>0.5,indicating that the structural validity is good.Discriminant validity:The non-parametric test was performed on the scores of the three syndrome scales of the patient group and the scores of the three syndrome scales of the healthy group.The statistical results show that the three scales are statistically different between the patient group and the healthy group.The difference(P<0.05)indicates that the scale has good discriminant validity.The standard validity:Taking the dialectical results of experts as the gold standard,according to the diagnostic threshold,diagnostic rate of the spleen Qi deficiency self-test identification scale,the dampness-heat of spleen-stomach self-test identification scale,and the dampness-heat due to spleen-deficiency self-test identification scale are 93%,94%,94%respectively.The diagnostic rate is consistent with the expert dialectical results,indicating that the standard validity is good.4.Item Response TheoryIn this study,the R 3.2.4 software was used,and the grade reaction model(GRM)was selected to perform IRT analysis on the scale entries.The results of the study showed that the lowest discrimination of the spleen Qi deficiency self-test identification scale is item 7 "Do you have stomach ptosis?",which is 0.12,followed by item 3 "Do you have abdominal pain/stomach pain?",which is 0.16.The parameter is between[0.3,3.5]and the discrimination is good.The difficulty parameter of entry 4“Do you feel tired?”is the largest,3.40,and the minimum is-6.77.The remaining entry difficulty parameters are between[-5.39,1.05],9 of which b3 are<-2.95.The lowest discrimination of the dampness-heat of spleen-stomach self-test identification scale is item 3“Do you have abdominal pain/stomach pain?”,which is 0.22.This item can be considered for deletion.The other items have a discrimination parameter between[0.4,1.4],and the discrimination is good.The entry difficulty parameter is<2.95.The overall difficulty parameter is between[-5.74,2.44],and most of the entries’ b3 are<-2.95.The discrimination parameter of the dampness-heat due to spleen Qi deficiency self-test identification scale item is between[0.4,2.3],and the discrimination degree is good.The entry difficulty parameters are mostly in[-2.92,1.96],where entries 5-9’ b3 are<-2.95.ConclusionThe syndrom of spleen Qi deficiency,dampness-heat of spleen-stomach,dampness-heat due to spleen Qi deficiency self-test identification scales have good feasibility,reliability and validity,and can be used for patient self-test.In terms of item response theory,the three scales have good discrimination,but the difficulty parameters are not ideal.The item options may be set unreasonably,and the sample size may affect the results.Subsequent increases can be further verified by increasing the sample size.