Quantitative Method Selection Of Collapse Degree In TCM Therapeutic Effect Evaluation Criterion For Osteonecrosis Of The Femoral Head

Osteonecrosis of the Femoral Head(ONFH)is the predominant disease treated by Traditional Chinese Medicine(TCM),but there are still many problems in the evaluation of the effect of TCM treatment for femoral head necrosis.TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head issued in 2019 can well reflect the effect characteristics of the TCM treatment for femoral head necrosis.The criterion have very positive significance for regulating the curative effect evaluation exit of femoral head necrosis.The popularization and application of TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head still needs multiple efforts,and the criterion itself also needs to be gradually improved Currently,there is no standard method for quantifying the index of collapse degree in the criterion.Objectives1 Based on the systematic review method,the current quantitative method for the collapse degree of femoral head necrosis is standardized to form an optional method for quantifying the collapse degree index in TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head.2 Reliability and agreement evaluation and comparison of standardized quantification methods for the collapse degree of femoral head necrosis were done,with a view to recommending the selection of quantification methods for the collapse degree index in TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head.Methods1 Standardization of the methods for quantifying the collapse degree of ONFHWe searched literature published till 2019 in four electronic databases(Embase,PubMed,ISI,and the Cochrane Library)for articles introducing quantization methods for the collapse degree of ONFH with Medical Subject Headings(MeSH)and text words.The key words:Femur Head Necrosis,osteonecrosis of femoral head,avascular necrosis of femoral head,ischemic necrosis of femoral head,collapse,measurement,evaluate,concentric circle.Additionally,Google Scholar search and retrospective search related references are used to avoid missing documents.Literature inclusion was performed according to the inclusion and exclusion criterion.The specific operation and evolution process of the quantification method of the collapse degree appearing in the literature are combed,and the characteristics of each method,whether it is widely used,actual measurement experience,expert opinions and other factors are used to clarify and standardize the quantification method of the collapse degree of the necrotic femoral head.2 Evaluation and comparison of different quantification methods of collapse degree after standardizationHip X-ray images of ONFH patients who were hospitalized in the Department of Orthopedics,Wangjing Hospital,China Academy of Chinese Medical Sciences from November 01,2018 to December 31,2019 was collected retrospectively.From the hospital case system,determine the patient list and X-ray registration number,then the X-ray data were exported from the hospital's CR imaging workstation in the JPG image format for storage,and finally,the inclusion was carried out.The included X-ray images are numbered,and two orthopedic doctors(A,B)who have been in the clinic for a long time use visual evaluation to assess the X-rays independently.The evaluation options are<2mm,2mm-4mm,>4mm.15 days later,Dr.A used the same method to perform a visual evaluation of the X-rays in reverse order.After the completion of the visual evaluation method,two orthopedic surgeons(A,B)were trained in standardized quantization methods.After the training was completed,the vertical and non-vertical methods were used to measure the X-ray respectively by two doctors(A,B).After 15 days,Dr.A used the same way in reverse order to measure the X-ray again.30 days after the measurement was completed,two orthopedic doctors(A,B)performed visual evaluation on the X-rays respectively under the guidance of the vertical method.After 15 days,Dr.A used the same visual evaluation method in reverse order to re-evaluate the X-ray.The measurement is realized with the Digimizer Version 5.3.5 software,and the included JPG format pictures were imported into the software.First it needs to reconstruct the outline of the normal femoral head.Adjust the software ratio to 100%,place the femoral head to be measured at the center of the interface,and select the "circle to center" tool in the toolbar.Then the inner lower corners of the femoral head are selected as the reference starting point to make a circle because the necrotic femoral heads don't generally affect the structure of the inner lower corners,and the requirement for the circle to be made is a circle with the smallest diameter that best fits the contour trend of the residual femoral head.Hyperostosis,Bone fragments and head and neck deformities should not affect the fitting process of concentric circles.The circle is based on the actual normal contour of the femoral head.After the circle is completed,the position or size of the circle is fine-tuned according to the actual situation.The optimal circle is finally used as the contour of the normal uncollapsed femoral head.Then it needs to determine the measurement location.Select the"Length" tool in the toolbar.The vertical measurement location is the distance the femoral head dome is compressed on the vertical line passing through the center of the circle.The non-vertical measurement location is the distance from the deepest recesses of the femoral head along a straight line through the center of the circle to the contour of the reconstructed normal femoral head.The Shapiro Wilk test was used for the normal test,and the paired t-test was used to compare the differences in normal data.The Pearson correlation coefficient(r)was used for the correlation analysis.The inter-observer(A,B)and intra-observer(A)reliability of the vertical and non-vertical methods were expressed by intraclass correlation coefficient(ICC),ICC selects two-way random model,absolute agreement type,ICC>0.750 represents high reliability.21 The inter-observer(A,B)and intra-observer(A)agreement of vertical method and non-vertical method used the Bland-Altman method,calculating the 95%Limits of Agreement(95%LoA)and 95%confidence interval(95%CI).22 According to clinical needs and the literature set,the acceptable error range as±25%,LoA width<40%,22,23 and the agreement limit being within the acceptable error range represents high agreement.Agreement between vertical method measurement results and the visual evaluation results under the guidance of vertical method,The inter-observer(A,B)and intra-observer(A)agreement of visual evaluation used Cohen's weighted Kappa coefficient,weighted Kappa coefficient>0.610 for high agreement.Statistical analysis with IBM SPSS Statistics 24.0 software and MedCalc Version 19.1.3,and P<0.05 was considered statistically significant.Results1 Standardization of the methods for quantifying the collapse degree of ONFHFinally,35 papers were included,7 papers in Chinese and 28 papers in English.The methods for quantifying the degree of collapse of femoral head necrosis can be divided into concentric circle measurement and other methods.Concentric circle measurement is the most widely used quantification method,but it also has many limitations,such as measurement basis and measurement location are not uniform.Other methods have enriched the content of femoral head necrosis collapse quantification methods and provided a lot of reference,but the shortcomings are also obvious and the application is very limited.The method of quantifying the collapse degree of femoral head necrosis is standardized into three parts:determining the basis for measurement,determining the path to reconstruct the normal femoral head contour,and determining the measurement site.In the terms of measurement basis,Quantitative measurement should be based on standard positive X-ray;in the terms of reconstruction of the normal femoral head contour approach,the center level of the femoral head is used as the baseline,and the electronic concentric circle method is used to reconstruct the normal contour;In terms of measurement locations,both vertical and non-vertical distances have their own advantages,and both are widely used in scientific research practice.After standardization,two quantization methods have been formed:standard positive X-ray digital concentric circle vertical method and non-vertical methodStandard positive X-ray digital concentric circle vertical method and non-vertical method are two methods that can be selected to quantify the degree of collapse index in TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head.2 Evaluation and comparison of different quantification methods of collapse degree after standardizationA total of 30 cases(41 hips)ONFH patients were included.The resolution of the X-ray was 72 PPI,1mm=7 px,19 cases were unilateral,11 cases were bilateral,25 were male,and 5 were female.;aged 40.37±12.58 years.For the same group of subjects,the results of the non-vertical method of the concentric circles measured by the measurers A and B are larger than those of the vertical method of the concentric circles(P<0.05);For the concentric circle vertical method,The difference was not statistically significant(P>0.05).The first measurement result of the measurer A was smaller than the second measurement result after 15 days(P<0.05).For the concentric circle non-vertical method,the measurer B's result was greater than the measurer A's(P<0.05).0.05),the first measurement result of measurer A is smaller than the second measurement result after 15 days(P<0.05).The correlation coefficients among the results of the first measurement by surveyor A,the second measurement by surveyor A,and the measurement by surveyor B are r=0.967(p=0.000),r=0.938(p=0.000),r=0.933(p=0.000).The data are normally distributed,and the data behavior conforms to the Bland-Altman LoA method.Both the vertical method and the non-vertical method have high inter-observer and intra-observer reliability,The inter-and intra-observer agreement of vertical method is high,rather than that of non-vertical method.For visual evaluation,the weighted Kappa value between the observer(A,B)before training was 0.462(0.248-0.676),p=0.000,the weighted Kappa value within the observer(A)was 0.597(0.407-0.787),p=0.000.The weighted Kappa value between the observer(A,B)under the guidance of the vertical method after training was 0.898(0.792-1.000)),p=0.000,the weighted Kappa value within the observer(A)was 0.963(0.892-1.000),and p=0.000.Under the guidance of the vertical method,the weighted Kappa values between the visual evaluation and actual measurement results for observer A,B,the second evaluation of observer A were:0.737(0.552-0.923),p=0.000,0.658(0.458-0.858),p=0.000,0.776(0.603-0.948),and p=0.000 respectivelyConclusions1 After standardization,Standard positive X-ray digital concentric circle vertical method and non-vertical method are two methods that can be selected to quantify the degree of collapse index in TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head.2 Because of the higher reliability and agreement,Standard positive X-ray digital concentric circle vertical method is recommended as the quantitative method of the collapse degree index in TCM Therapeutic Effect Evaluation Criterion for Osteonecrosis of the Femoral Head.3 The visual measurement method guided by the concentric circle vertical method has high agreement and accuracy,which can be used in clinical work instead of actual measurement.