| Objective:To develop a preliminary approach for evaluating the clinical efficacy of Chinese medicine for ASO based on the theory of Chinese medicine and the combination of the disease and evidence:(1)to form a preliminary pool of entries for clinical efficacy evaluation under different TCM syndromes of ASO based on literature survey method;(2)To conduct a new round of clinical validation of the reliability,validity,and responsiveness of the"Gangrene PRO Scale 201604" based on the survey and research method in evaluating the clinical efficacy of ASO patients,to lay the foundation for promoting the widespread use of the scale.(3)To analyze and evaluate the sensitivity and specificity of the entries of the"Gangrene PRO Scale 201604" under different TCM syndromes of ASO,to further explore the clinical efficacy evaluation method of "Combination of disease and TCM syndromes" of ASO based on the scale evaluation,and to improve the clinical efficacy evaluation system of Chinese medicine in ASO.Methodology:(1)Literature survey method:By searching the journal literature on clinical efficacy observation of ASO published in 2012.01-2022.08 in CNKI,CQVIP,and Wanfangdata journal databases,organized and summarized TCM syndromes and the efficacy evaluation entries of symptoms and signs,then established a database.(2)Scale evaluation and validation:91 ASO patients who visited four TCM hospitals,Beijing University of Traditional Chinese Medicine Dongfang Hospital,Dongzhimen Hospital,Beijing Gulou Hospital,and Xuanwu Hospital of Traditional Chinese Medicine from June 2022 to December 2022,were evaluated by using " Gangrene PRO Scale 201604".(ⅰ)Feasibility:including scale recall,completion rate,efficiency rate,and mean completion time.(ⅱ)Reliability:including split-half reliability,internal consistency,and retest reliability,split-half reliability is to divide the content of the scale into two parts,and analyzes the Cronbach’s a and Spearman-Brown coefficients of the two parts;internal consistency is measured by the Cronbach’s a coefficient of the total scale;retest reliability is measured by conducting two pre and post(14-day interval)scale reviews on the same patient.The scale reliability was measured by the correlation coefficient of the two assessments.(ⅲ)Validity:including content,criterion,and structurally,and structural validity was evaluated by KMO and Bartlett’s spherical test in exploratory factor analysis.(ⅳ)Responsiveness:The total score and each domain score of the PRO scale of gangrene obtained from the two pre-and postassessments were subjected to a rank sum test and evaluated according to the test results.(3)Preliminary application of the scale in the evaluation of the efficacy of ASO patients:The results of the scale for ASO patients with different TCM syndromes and different treatment modalities were analyzed using the Jonckheere-Terpstra test in nonparametric testing,to analyze the differences in the results of the PRO scale in ASO patients with different evidence types,to clarify the sensitivity of the scale for the evaluation of the clinical efficacy of different evidence types in ASO.Results:(1)Results of the literature survey method:127 literature articles with 7 types of TCM syndromes and 11 entries of clinical efficacy evaluation symptoms and signs were included.The preliminary pool of Chinese medicine clinical efficacy evaluation entries for ASO(some types of TCM syndromes):blood stasis evidence:main entry:pain;secondary entries:skin color,skin temperature,intermittent claudication.Cold condensation and dampness obstruction evidence:main entry:pain;secondary entries:skin temperature,intermittent claudication.Qi deficiency and blood stasis:main entry:pain;secondary entries:skin color,skin temperature,intermittent claudication.(2)Scale evaluation and validation:(ⅰ)Feasibility:Scale recall rate 100.00%,completion rate 96.00%,effective rate 90.67%,the average time taken for scale completion 6.31 ± 4.27 minutes.(ⅱ)Reliability:split-half reliability:Cronbach’s alpha coefficient of 0.892 and 0.864 for the front and back parts,respectively,and Spearman-Brown coefficient of 0.868;internal consistency:Cronbach’s alpha coefficient of 0.916 for the total scale;retest reliability:correlation coefficient of 0.859 for the total scale(P<0.01).(ⅲ)Validity:the KMO coefficient of the scale in structural validity was 0.859,and Bartlett’s sphericity test result was 0.000.(ⅳ)Responsiveness:there was a statistical difference in the total score between the before and after assessment results Z=-5.243(P<0.01).(3)Preliminary results of the application of the scale in the evaluation of the efficacy of ASO patients:there was a statistical difference between the cold condensation and dampness obstruction evidence and blood stasis evidence in general(P<0.01),and in the physiological domain,the physiological and social function domain,and the treatment satisfaction domain,respectively(all P<0.01).There was a statistical difference between the outcome of Chinese medicine treatment and combined Chinese and Western medicine treatment scale evaluation in general(P<0.01),and in the physiological domain,psychological and spiritual domain,physiological and social function domain,and treatment satisfaction domain,respectively(all P<0.01).Conclusion:(1)A pool of entries for clinical efficacy evaluation of TCM syndromes of ASO was initially formed,which included cold condensation and dampness obstruction,blood stasis,and qi deficiency and blood stasis,containing major and minor entries,to provide a reference for the establishment of a TCM clinical efficacy evaluation system for the combination of disease and TCM syndromes of ASO.(2)The scale was evaluated and validated,the "Gangrene PRO Scale 201604" still showed good feasibility,reliability,validity,and responsiveness in the ASO population.On this basis,the content of the scale was modified and supplemented to form "ASO TCM PRO Scale 2023",a subscale of the "PRO Scale 201604",which can be used to evaluate the clinical efficacy of TCM in ASO patients and can truly reflect the clinical efficacy of TCM,which has certain guiding significance for TCM clinical decision-making and helps to improve the overall diagnosis and treatment of ASO.Further evaluation and validation are needed for other desiccated diseases.(3)After the preliminary application of the scale in the evaluation of the efficacy of ASO patients,it was suggested that the evaluation results of different TCM syndromes of the scale had significant differences and different treatment modalities also caused different patientreported outcomes,which provided a basis for the evaluation of the clinical efficacy of Chinese medicine in the combination of ASO disease and TCM syndromes. |
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