| ObjectiveChinese medicine can relieve the physiological and psychological disorders of Parkinson's disease and effectively improve the quality of life of patients.However,research about quality of life in patients with Parkinson's disease is just started in China.The quality of life scale was adopted abroad.There are few studies in the theory of traditional Chinese medicine developed under the guidance of quality of life scale,which impacts on the objective evaluation of the clinical effect of Chinese medicine in treatment of Parkinson's disease.Therefore,in order to design Parkinson disease patient reported outcome scale(Patient-reported,outcome,PRO),this study analyzed Parkinson's disease syndrome distribution and assess the scale and clinical investigation,which provide standard evaluation tools for the Chinese medicine in treatment of Parkinson's disease.Methods(1)Scale development: According to the clinical outcome assessment provisions from FDA,follow the psychological measurement,social research methods,quality of life scale and other related materials,we designed Parkinson's disease PRO scale includes the following contents: the establishment of the research team,the definition of scale concept,construction scale theory the framework,through literatureand patient interview from the item pool;through frequency analysis,Delphi method,patient survey analysis to screen items and the formation of the draft scale.(2)Scale evaluation: Based on the results of patients' data,the feasibility,reliability and validity of the scale were evaluated.Feasibility analysis: including the acceptance rate,completion rate and time,respectively questionnaire recovery rate,effective questionnaire rate and the average completion time;reliability analysis: the split half reliability and internal consistency coefficient test;validity analysis: including content validity,criterion validity,structure validity.Results(1)Scale development:(1)Definition of scale fields: physiological field,psychological field,social function field and satisfaction field.(2)The items were screened by the research team.The number of physiological field is 59,16 items in psychological field,18 items in social field,3 items in patient satisfaction field and all the 96 items were screened by program Delphi method.(3)Delphy Fa: Two rounds of expert positive coefficient was 100% respectively.According to expert opinion concentration and coordination degree of the results,the items were adjusted to 34 after the first round of expert consultation.After second rounds of expert consultation,the items were adjusted to 33 entries.(4)Item selection and analysis: 33 items were retained.The entries had positive consistency in terms of centralization,sensitivity,representativeness and internal consistency.According to the results of the survey,the structure of the item is adjusted.(5)The design of foreword and instruction,which contain the basic information and disease investigation including 33 entries in Parkinson's disease PRO scale.(2)Scale evaluation:(1)Feasibility analysis: the scale recovery rate was 100%.The completion rate was 100%.The average use time was10.45 ±2.972 minutes.(2)Reliability analysis: the Spearman-Brown coefficient in split half reliability is the 0.945.Cronbach's Alpha is 0.917,which reflects the internal consistency.(3)Content validity: PRO scale is designed according to the guidelines for Parkinson's disease and TCM syndrome of rigorous design,which is reasonable and validity.Standard validity,the correlation coefficient with PDQ39 and UPDRS is 0.650 and 0.474 respectively.Construct validity,CFI is 0.93.ConclusionsIn this study,through literature review,patient interviews and expert evaluation,we have screened 33 entries including physiological,psychological,physiological and social function areas,treatment satisfaction.The performance evaluation shows that the scale has good feasibility,reliability,validity and reaction degree,which indicates that the scale has a strong representation.This PRO scale provides clinical tool which evaluates curative effects of Chinese medicine in the treatment of Parkinson's disease... |
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