Development And Preliminary Evaluation Of Report Outcome Evaluation Scale For TCM Syndromes Of Knee

Knee osteoarthritis(KOA) is a degenerative disease which is common among older people. With the increase of population aging trend in China, the incidence of KOA gradually rise. Chinese medicine treatment can be effective with satisfaction in the treatment of KOA, but if completely follow the western medicine standards to measure the clinical effect of TCM, the evaluation of effect of TCM syndrome will often be neglected, which is a core part of effect assessment of traditional Chinese medicine. Clinically, the effect of TCM syndrome evaluation pay special attention to the subjective symptoms of the patients, which is quite similar with PRO, so PRO scale form is introduced to syndrome of traditional Chinese medicine efficacy evaluation, in accordance with its own rules and characteristics of TCM syndrome effect evaluation. There hasn’t been KOA related research of TCM Syndromes of PRO at present.Objective:To formulate the Knee Osteoarthritis TCM Syndrome Evaluation Scale of PROMethods: 1 Development of the conceptual framework, formation of the original item pool Refer to the specific instructions of PRO,comply with the principle and requirement of scale, we set up a research team, then according to the situation of TCM efficacy evaluation, make clear definition of the dimensionality of scale. On the basis of literature search, interview and patient interview, we collect all kinds of syndrome types of KOA. Research team collected and classified the subjective symptoms, formed the original item pool which contained 24 subjective symptoms.2 Item selection According to the original item pool,we compiled expert questionnaire, calculated the weight coefficient of items using Delphy method and then analysed.formed the item pool of the Knee Osteoarthritis TCM Syndrome Evaluation Scale of PRO.3 Item weight measurement From June 2014 to October 2014, We conducted a survey among 100 KOA patients in Department of Orthopedics, Guang’anmen Hospital, China Academy of Chinese Medical Science. According to the degree of patients’concern on the items, we collected item ranking and gave corresponding score.4 Clinical validation of the draft scale From December 2014 to February 2015,we conducted a clinical validation among 100 KOA patients in Department of Orthopedics, Guang’anmen Hospital.China Academy of Chinese Medical Science,developed the database,analysised the datas by SPSS19.0 software, evaluated the scale operability, item discrimination and scale reliability.Results:1 Item selection and formation of draft scale After questionnaire survey of experts and research team’s discussion, we kept 11 items with expert weight coefficient>0.042 (average expert weight coefficient is 0.042). We determined the item form, used 11 degree grading method, improved the scale structure and formed the draft scale.2 Item weight measurement After patients survey, we determined the patient weight coefficient using Delphi method, combined with the draft scale, formed the score calculation method of Knee Osteoarthritis TCM Syndrome Evaluation Scale of PRO.3 Clinical validation of the draft scale3.1 Operability of scale 100 copies of questionnaires were delivered and took back, all 100 copied were completed, both acceptance rate and completion rate were 100%. Average completion time of the scale was 2 minutes 3 seconds. The scale has a good evaluation time. So the scale has good Operability.3.2 Item discrimination We used Spearman’s correlation coefficient as a measure of discrimination.8 items had a correlation coefficient with) 0.3,and their correlation were significant when confidence (bilateral) was 0.01.3 items had a correlation coefficient between 0.2 to 0.29,and their correlation were significant when confidence (bilateral) was 0.05. So the item discrimination of the scale was good.3.3 Reliability of the scale The results showed that the split-half reliability of the scale was 0.769, which indicated that it had good across entries consistency. The Cronbach’s alpha coefficient of the scale was 0.728, which indicated that it had good internal consistency. Therefore, the reliability of the scale was good.Conclusion:We introduced the method of PRO into effect evaluation study of KOA TCM syndrome. Basing on the characteristics of TCM syndrome differentiation and treatment, referencing the international PRO scale development standard,we formulated the KOA TCM Syndrome Evaluation Scale of PRO. In terms of weight, we outstanded the weight measurement on patient’s attention, which made the scale more suitable for clinical effect evaluation.The scale had good operability, discrimination and relabitity. In general, the scale has characteristic of TCM, conforms to the characteristic of TCM syndrome curative effect evaluation, enriches and perfects methods to evaluate the clinical effect of KOA, provides new ideas for TCM syndrome curative effect.