Evaluation Of Reliability, Validity And Responsiveness Of The PRO Scale For TCM Syndrome Of Knee Osteoarthritis

Knee osteoarthritis(KOA)is a kind of chronic arthropathy which caused by degeneration of articular cartilage,Suffer damage,hyperosteogeny of knee.The disease is more common in women.Pain of joint,stiff,functional limitation and abnormal sound are the features of KOA.Since the 70s of last century,WOMAC Osteoarthritis Index,Hungerford Knee scoring system,Bristol Knee scoring system,HSS Knee scoring system,Lower limb function assessment scale(LEFS),EQ-5D scales are applied to evaluate pain and function of KOA patient in abroad.In the former research,according to the Guidance for Industry Patient-Reported Outeome Measures:Use in Medical Product Development to Support Labeling Claims drafted by U.S.Food and Drug Administration in February 2006,we have organized research group,consulted literatures,sorted,selected items and consulted expert to form a draft KOA scale.We have managed clinical test for the first.The result showed that the scale has good reliability and responsibility.In this research,we made clinical research for the second time to test the scale's reliability,validity and responsibility.ObjectiveThrough testing Knee Osteoarthritis TCM Syndrome Evaluation Scale of PRO,to prove scale's reliability,validity and responsibility,whether it can be used in clinical.Methods1.We conducted survey for some patients,who are diagnosed KOA in Department of Orthopedics,Guang'an men Hospital,China Academy of Chinese Medical Science.Patients test first time with PRO scale and Womac Osteoarthritis Index.After four weeks later,they test second time only with PRO scale.2.From October 2016 to March 2017,We conducted a survey among 100 KOA patients in Department of Orthopedics,Guang'anmen Hospital,China Academy of Chinese Medical Science.According to test,we set up a database and analysised the datas by SPSS 12.0 software.Using Cronbach's alpha and split-half reliability to evaluate scale's reliability;Using content validity,construct validity,criterion validity to evaluate scale 's validity;Comparing datas before treatment and after treatment to ebaluate scale ' s responsibility.Results1.Analysis of scale's feasibility A total payment of scales are 100,all were delivered and took back,both acceptance rate and completion rate were 100%.Average completion time of the scale was 2 minutes 36 seconds.That means scale has a good feasibility2.Analysis of scale's reliability2.1 Analysis of scale's Internal consistency reliability:The PRO's Cronbach's alpha coefficient of the scale was 0.840,which means it has a good reliability.2.2 Analysis of scale's split-half reliability:The PRO's parity split-half alpha coefficient of the scale was 0.851,also means it has a good reliability.3.Analysis of scale's validity3.1 Analysis of scale's content validity:11 of the 10 items' correlation coefficient between item and total scores>0.4,1 item's score>0.3,which shows it has a good validity.3.2 Analysis of scale's construct validity:Kaiser-Meyer-Olkin coefficient of the scale was 0.869,Principal component factor analysisTotal cumulative contribution rat e was 53.990%.From factor analysis found two dimensions.The two sub dimensions of the external environment and the symptoms unrelated to the outside world.It is accord with the characteristics of etiology and pathogenesis of TCM diagnosis.3.3 Analysis of scale's criterion validity:We use the international standard WOMAC Osteoarthritis Index as the standard.Spearman correlation analysis was used to analyze the correlation between PRO and WOMAC.The correlation coefficient was 0.748.4.Analysis of scale's responsibilityBefore and after treatment,the total score of the scale can reflect the response of the scale.The P value of<0.01 was measured by different TCM Syndromes,different ages and different educational backgrounds,and the scale could reflect the difference before and after treatment.Conclusion The PRO scale of TCM syndrome of knee osteoarthritis has good reliability,validity and responsiveness,and can be used to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of knee osteoarthritis.