| Backgrouds: In the recent 20 years, the medical area gradually had givenreconstruction to the quality of life, and initially had formed tothe quality of life weight,the appraisal method and the target system.The Ch-QOL scale was developed according tothe method of development health related quality of life, under the Chinese medicine basictheory instruction. In the recent several dozens years, overseas of medical experts hadstarted to pay attention to the importance of patient's subjective feeling in the clinicalpractice, the domestic and foreign medical experts more and more many applied the patientreported outcomes(PRO) in the clinical practice. Scale of PRO, of which the patientreported outcomes became emphases and mainly extruded subjective feeling of patient. Thepatient provided its own opinion for the curative effect, Scale of PRO surveyed all aspectsof the state of health about patient, and completely came from the patient. At present, theScale of PRO that it is being developed will be used to curative effect assessment in theclinical trial.Objective: (FDA) according to the developing principle and making flow of Scale ofPRO, the testing of the scale was based on the patient's feeling, and formulated the Scale ofPRO that would be use for the curative effect appraise of Chinese medicine, throughthe big sample, the multi-central clinical investigation and study, the scale was revised andreliability, validity were inspected; Scale of PRO was developed, and it was compared withCh-QOL scale, then inspected the the PRO characteristic of Ch-QOL scale. If it had thePRO characteristic it woul more widespread be used in the clinical curative effectassessment.Methods: According to the Scale of PRO developing principle, in union healthyconcept frame of Chinese medicine theory, the items were formed through inquiring thepatient. Again to the item pond-which had formed carried on the deletion or the revisionitems through the experts group, and formed the initial scale .Again through the expert toappraise, making grade of the importance and doing pilot study of the small range, theInitial scale was formed. A sample of 300 cases was taken from the northern and southern area of China (Zhengzhou, Guangzhou, Panyu, Zhuhai).The sample covered male andfemale, healthy people and patients with chronic illness of various kinds ofdiseases,different situation on education levels ,ages, districts, and professionals.Afterapplying 6 kinds of methods, The methods of analysis were used by expert consultinggraded approach, discrete tendency , principal component analysis and correlationcoefficient method, and factor analysis method. 60 items were closen to form a formal scale.A Reliability inspection included retesting Reliability, divided in half the Reliability andinternal uniformity. A validity inspection included the content validity, the dimensionCorrelation and used the factor analysis and the confirmation factor analysis method toinspect the structure validity of scale. Meanwhile The reliability and the validity were usedto the Ch-QOL scale so that to assess its the characteristic of PRO.Result:s: the Ch-PRO scale Internal consistency:the Cronbach's a for theUnification of Form and Spirit Domain was 0.73,the Cronbach' s a for Man and NatureDomain was 0.74, the Cronbach' s a for Man and Society Domain was 0.82. split-halfreliability: The three domains were 0.71,0.70,0.78. Goodness of fit (CFI) of Scalemodel was 0.925, goodness of fit for the substructures of four domains respectively were0.968, 0.901, 0.902, 0.934. The the Cronbach's a of the Ch-QOL scale and theChQOL-PRO scale were about 0.77 through comparison between consistency reliabilityand validity. The Pearson correlation coefficient of total score for the scales was 0.81, eachdomain correlation coefficient respectively were 0.74, 0.85, 0.99.Cone lusion: Reliability analysis indicated that, the ChQOL-PRO scale had betterreliability.The Unification of Form and the society domains had the ability to distinguishhealthy person and patients, the Ch-PRO scale had discrimination validity. Analyzed theresult from above obviously ,this scale had better validity. Overall, the results ofreliability and validity inspection in seven sentiments domains most surpassed other variousdomains. The results showed that the Correlation of the scales was higher by thecomparative of the Ch-QOL scale and the Ch-PRO scale in the item, the facet, thedomain, the results of reliability and validity inspection showed that the Ch-QOL scalealso had the certain characteristic of PRO. |
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