| ObjectiveMigraine is characterized by remission and relapse, it affects human health and quality of life seriously, prevention and effect assessment of migraine is a hotspot in the field of medical. The curative effect of TCM for migraine interictal is clear, but the current effect assessment confined to headache, or even though join syndromes grading, it's still ignore patients' psychological emotion and social function evaluation. With the develpoment of society, efficacy evaluation begin to pay close attention to the patients-reported outcomes (PRO) gradually, while data collected by TCM inquiry and PRO internally consistent with each other. Migraine is a recurrent alleviate disease, subjective feeling of patients is the main character of it. Efficacy evaluation should not only emphasize the headache, but also pay close attention to the state of mental state, ability and quality of life from patient-reported outcomes. In order to enrich and perfect the migraine curative effect evaluation, this research refers to the method of PRO development in international, base on the characteristics of migraine, explore to develop the PRO scale of migraine.Methods1 Construct theoretical framework and Form Item-Bank Refer to the Specific instructions of PRO research issued by the U.S.FDA, comply with the principle and requirement of Scale. Form a research team, on the basis of literature, through group discussion, build a scientific rigorous theoretical framework of scale, and make clear definition of the dimensionality of scale. From 102 medical records about headache in modern times to chose symptoms which frequency appears≥5% in all, and 218 clinical cases collected in previous trails, chose symptoms which frequency appears=≥5% and significantly changed(P≤0.05) after treatment, in conjunction with the patient interview, through group discussion and refining, confirmed the item-banks of PRO scale.2 Items selection According to the built theoretical framework and measurable symptoms indexes to design experts questionnaire, consulting experts who have long-term clinical study in brian department by Delphi method. After the first round of questionnaire, according to experts approval ratings and advices, in conjunction with discussion of research team, combining, increasing or decreasing items. Then, design experts questionnaire for the second round, analyse questionnaire through the mean, sum of grade score, rate of full marks, and coefficient of variation, weight coefficient.3 Form the draft scale After items selection, the scale item-banks which are consisted of 4 dimensionality included 12 items (5 items of headache dimensionality,4 items of physical dimensionality,2 items of psychological dimensionality,2 items of social dimensionality) was formed. After the discussion of research group, adopt Likert-5 to design score by five, identified foreword, developed detailed instruction, completed the format of scale, the draft scale formed. 4 Clinical validation of the draft scale From January 2011 to March 2011, we collected clinical datas from the Headache specialist out-patient of Dongzhimen hospital which affiliated to Beijing University of TCM for clinical validation of the draft scale, developed the database, analysised the datas by SPSS13.0 software, studied the application of the crowd of the scale and evaluated the scale reliability, validity and responsiveness.Results1 Item-Bank selection 55 items were selected from medical records and clinical cases and patient interview, included 19 items of headache degree, parts, nature and the incentive; 32 items of Somatic symptoms, psychological emotion; 4 items of function damage. After group discussion, preliminarily determine 33 symptoms can be used for clinical efficacy evaluation about migraine.2 Items selection and optimization Deleted 7 items which support rate< 70% after the first round of experts questionnaire, shaped up experts'suggestion and repeatedly discussed,12 items were integration. In the second round experts investigation, experts' opinions about the importance and operability of items was more consistency, excepts'CV about the importance of "exhaustion" was 26.57%> 25%, CV about other items were< 25%, experts'advice were coordinately, so the scale draft which consisted of 4 dimensionality include 12 items was formed. Based on the score of importance of items, using percentage weight method to determine the weight of every item, the result showed that there were little difference among the weight of all items, so we regard every item as equal weight.3 Clinical validation cf the draft scale(1)Operability of PRO scale 30 copies of questionnaires were delivered and took back, all 30 copied were completed, both acceptance rate and completion rate were 100%, completion time before and after treatment was 3.48 minutes and 3.55 minutes respectively, so items of this scale is terse and perspicuous, test time is ideal, ensure patient compliance during scale assessment.(2)Item discrimination Using correlation coefficient to measure Item discrimination of the scale, item discrimination of all items were>0.3, except "Sleep disorders" (0.247<0.3). The item discrimination of PRO scale is good.(3)Reliability of the scale The results showed that the split-half reliability of the scale one after another were 0.827 and 0.932, which indicated that the scale had high across entries consistency, overall reliability of 12 items showed Cronbach's Alpha coefficients were 0.784 and 0.905, indicated that the reliability of the scale is acceptable in general.(4)Validity of the scale Judging from the develop process, the correlation between entries score and its subordinate dimensionality score or other dimensionalities score, the scale has good content validity. Selected the SF-36 scale and VAS scale as school marked to study the standard validity. The results showed:total score of PRO and SF-36 one after anther were negatively correlated, the correlation coefficients were -0.594 and -0.629, total score of PRO and VAS one after anther were positively correlated, the correlation coefficients were 0.321 and -0.757, the standard validity of the scale was good. Studied construct validity of the scale by confirmatory factor analysis, results showed the comparative fit index (CFI) was 0.88, showed that internal structure of the scale can be fit in theoretical assumptions, so the scale has good construct validity.(5)Effect magnitude of the scale Effect magnitude of the scale is 1.37, paired T test of the total scores, t=7.93,P<0.01; Each items and each dimensionality of the PRO scale before and after analysised by paired T test or non-parametric rank sum test, all P values were<0.05, statistically significant results, except "depression in recent 4 weeks" (P=0.07), indicated that the scales had good responsiveness, it can reflect changes over time changes of the patients' quality of life.(6)Correlation analysis was performed according to improvement rate of PRO and patients self-assessment, results showed that they were positively correlated, correlation coefficient was 0.702, in other words the scale has ability to show the changes of patient self-conscious symptoms.ConclusionsIn this study, we introduced the method of PRO which were internationally recognized into clinical study of migraine, and based on the theory of TCM, combined with the clinical characteristics of migraine, formulated migraine PRO Scale.The scale has good reliability and validity and reactivity and feasibility, has ability to show changes of self-conscious symptoms of migraineur truly.This will enrich and perfect the methods of clinical efficacy evaluation of migraine appraisal, and provide reference for evaluation of therapeutic efficiency of TCM research about the recurrence alleviate diseases.
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