| BackgroundMigraine is a recurrence alleviate disease mainly characterized by subjective feeling of patients.Its high incidence and high recurrence rate seriously affect the spirit of human psychological and social function, making a serious loss to human health and quality of life. Thus medical profession at home and abroad focuse on the prevention of migraine and curative effect evaluation research. Modern Chinese medicine curative effect on migraine remission is clear, but the curative effect of observation is limited to the evaluation of headache situation itself, or copying western evaluation method, ignoring patients" psychological and mental function.The report (Patient reported outcomes) is the health of the patient’s own overall reaction, while the inquiring information from doctor of traditional Chinese medicine (TCM) and PRO data from patients, both has the intrinsic similarities. As the medical model from the biomedical model to biological transformation of social pattern, people pay more attention to impact of disease on people’s quality of life, Treatment of migraine is mainly around disease itself gradually transformed into patients as the center. Therefore, assessment and intervention of patients with migraine on the body, psychological and social function will be pay attention to in clinical work in future with Chinese and western medicine theory instruction migraine patients form a healthy lifestyle, having the practical significance to improve the patients quality of life, etc. Clinical efficacy evaluation of traditional Chinese medicine has become an important project in today’s Chinese medicine research, the clinical curative effect of migraine research is in this context came into being. On the basis of prophase work, our reseach made a clinical revalidation for migraine remission based on patient report outcomes assessment scale, further to evaluating its performance, forming a suitable questionnaire for modern Chinese medicine efficacy evaluation, finally establish a suitable for own law of development of traditional Chinese medicine evaluation system, in order to improve the clinical curative effect of traditional Chinese medicine for migraine evaluation system to provide effective method to promote the modernization of traditional Chinese medicine.ObjectiveValidation of magrain remussuon based on patient reported outcome assessment scale has o good performance.MethodsGroup conducted a preliminary performance evaluation of migraine patients report outcomes, with good reliability and validity, to entry after further modification eventually formed migraine PRO scale contains four dimensions12items. For a further performance evaluation to migraine PRO scale, this study adopts the multi-center clinical validation, in June,2012-February2013, the center collects30cases, establishing a database, using SPSS13.0statistical software for data analysis to evaluate the performance of the scale.Results1Generally According to the results of120survey, migraine population is at an average age of44, and the male female ratio is7:13, educationis mainly with high school and above degree, career is more financial,students, cadres and teachers, course is62months on average,30%merger in patients with cervical spondylosis, in the first place, followed by16%with high blood pressure. Episodes of26.8%patients choose Finn as painkillers, so the study was thus to young and middle-aged women, patients with highly educated people as the main, reconciled to migraine population characteristics in mainly mental work crowd characteristics are similar, a longer duration.2Scale performance evaluationOur research object is120and acceptance rate, completion rate are both100%. Scale items are simple, concise and refined, the scale for assessment2times before and after the average completion time is within5minutes, the test time in1to9minutes, clinical evaluation is relatively ideal, to ensure the patients compliance,and has good feasibility. Mainly from the1/2reliability and Cronbach’s alpha coefficient to evaluate the reliability, the reliability is greater than0.8, the reliability is good. Results before and after two and a half reliability is0.876and0.910respectively, and show consistency across items is higher.2times before and after the Cronbach’s alpha coefficient is0.884and0.888, respectively showed high internal consistency, PRO scale reliability is good. Mainly from the content validity and criterion validity assessment scale validity. Scale score12items and the dimension scores of correlation coefficients were greater than other dimension scores of correlation coefficient, indicated that the scale has good content validity. SF-36and VAS as standard scale assessment scale of validity, and the results before and after the two assessment PRO scores and VAS scores were positively correlated, and negative correlation with SF-36scores, correlation coefficient were0.700,0.601and-0.613,-0.685, shows that scale criterion validity is good.Scale effect size is1.19, this study by nonparametric test analysis PRO scale, SF-36scale overall reaction degrees, results show that P=0.00, and PRO scores are less than before treatment, after treatment by SF-36total score after treatment than before treatment, PRO scale overall reaction degree good, overall health status of patients after treatment is good, objective and comprehensive sensitive reflect patients to improve the overall health status. Will PRO2times before and after the rating scale, the overall self-evaluation, respectively, and two patients before and after improvement degree,2VAS before and after the review, the correlation analysis, found that both are positively correlated, the correlation coefficient was0.612and0.654, really reflect the patient subjective symptom change.Conclusions Group has developed the migraine patient reported outcome (PRO) scale including headache, body feeling,spirit of psychological and social function of four dimensions, comprehensive and reasonable structure, suitable for the clinical characteristics of migraine, with good reliability, validity and reaction degree, the development and effectiveness evaluation method is more scientific and reliable clinical validation and evaluation results, further perfect the migraine evaluation index system of clinical curative effect of traditional Chinese medicine. And laid a solid foundation for clinical application. |
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