| ObjectiveReport the outcome of evaluation questionnaire in patients with migraine based on the clinical application of further validation.MethodUse the multi-center clinical research method, the treatment group and control group were included in the 357 cases included in the standard, by 15 to participate in clinical research center. By EPIDATA database entry and management, the use of secondary school.Statistical analysis using SPSS 16.0 statistical analysis software to calculate. Using Wilcoxon rank and inspection and correlation coefficient analysis, from multiple points, multiple dimensions of comprehensive science to PRO scale for examination and assessment of the clinical application of migraine, perfect the clinical curative effect evaluation method of migraine.This study has not yet been revealed blind, is only for migraine patients with remission is based on the feedback of PRO scale, not to analyze data treatment group and control group respectively.ResultParticipants included 357 patients with migraine, of which 117 male patients, 240 female patients. Youngest patients 18 years old, biggest 65 years old, the average age was 39.38+/-12.17 years old, with migraine in young people, women see more features.PRO rating scale can comprehensive reaction cases of headache days there was a significant change For cases of headache days in half, each point PRO scale, scores after treatment compared with before treatment PRO scale scores have' significant difference (P< 0.01). For headache days in half of cases,4 weeks,8 weeks,12 weeks after treatment, and follow-up PRO scale four dimensions and baseline PRO scale analyses four dimensions have significant difference (P< 0.01). PRO scale to measure the headache days have the change of the case of significant change before and after treatment, the headache days half the rate sensitivity, and the dimension of the evaluation is more comprehensive.PRO scale embodies the evaluation idea of TCM symptoms in each point attack frequency of headache days, with PRO scale scores of correlation coefficient> 0.5, moderate intensity is related, and with the extension of treatment time, the correlation coefficient increases gradually, correlation between increased;Each point attack frequency of headache days, and PRO scale headache dimension is most relevant, correlation coefficient> 0.7, was strongly correlated.For 4 weeks after treatment headache days and PRO scale of mental dimension no correlation (r = 0.032), the rest of the time the headache days, number and scale of attack the body symptoms, mental, and functional status are relevance, relevance is slightly low, patients with migraine, in addition to the symptoms of headache, there are such as insomnia, mood be agitated, decreased appetite, and other aspects.From the point of relative strength, PRO scale headache situation dimension score can reflect the changes in the number of headache days,, and the other dimension is the evaluation of the influence of other aspects of external headache complement the pure to the change of the headache itself to evaluate curative effect of the limitations of, at the same time embodies the evaluation idea of TCM symptoms in agreement.PRO scale headache dimension score to be able to reflect exactly the improve the number of headache days each time a headache days after treatment by half the number of headache days, headache and headache PRO scale dimension correlation coefficient> 0.8, was highly correlated, and with the extension of treatment time, the correlation coefficient of a trend of increase gradually, that with the increase of the reduction and efficacy of treatment of headache days PRO scale headache of dimension score and the correlation between the number of headache days, the stronger, PRO scale headache dimension score can exactly reflect the number of headache days to improve.ConelusionsMigraines occur among widely, seriously affect the quality of life.Rapid accurate curative effect evaluation is to determine whether or not treatment effective, into the next phase of the basis of a treatment plan.For the patient's subjective feeling, because of the headache to patients in the investigators conducted under a subjective description.In the clinical evaluation mostly confined to the degree of headache, medication after 2 d 'remission rate, etc. within the lack of comprehensive evaluation;Health survey profiles (SF-36) quality of life in patients with detailed description, but the entry is various, patients with clinical applications need to better cooperate;Facebook method such as prone to bias.Use scale as measuring tool, introduce the report of clinical outcome assessment PRO scale effect assessment of TCM, has been widely recognized and applied at present.Of this study was to verify the PRO scale is developed under the background in order to make up for the inadequacy of the above migraine curative effect evaluation method, the PRO scale has conducted a preliminary performance evaluation in 2013, the headache itself, body feeling and spirit of the psychological and social function of four dimensions of the assessment, the results showed that the scale of comprehensive, reasonable structure, suitable for the clinical characteristics of migraine, curative effect evaluation method of science, has the good performance.Developed by this study, enlarge the sample size and the PRO scale further application in clinical verification, the study of 357 cases investigation PRO scale rate and the completion rate was 100%, the average completion time measurement are within six minutes, and preliminary scale performance evaluation in the study of basic consistent, further verified the scale structure is compact, the problem easy to understand, easy to understanding in the general patients accepted, feasibility is good.PRO scale scores before and after treatment of exact objective change in the number of days with headache, the number of significant changes before and after the treatment, the number of headache days, half of cases, each point PRO scale score comparison before and after the treatment are the significant difference (P< 0.01), and four dimensions to compare PRO scale before and after the treatment are the significant difference (P< 0.01).Show PRO scale to measure the number of headache days, there are significant changes of cases, the headache have exact evaluation value before and after treatment.From the point of relative strength, the PRO scale headache situation in clinical application of dimension score can exactly reflect the changes, the number of headache days, the body feeling, mental and social function dimensions are outside the evaluation of the influence of other aspects of headache added to pure headache itself changes to evaluate the curative effect of limitations, can fully reflect the efficacy of treatment.At the same time the PRO scale reflects the disease of traditional Chinese medicine consistency evaluation concept, can more accurately reflect patients feel about their disease, and patients in the process of fill in the questionnaire about their state of migraine have a basic understanding, more conducive to individualized treatment, increase the enthusiasm and compliance, and not affected by the third party.PRO scale in the state of the patients understand their diseases at the same time, also give physicians specific opportunity to understand the status of the patients with migraine, favorable doctor-patient communication effectively.Clinical verification results are to be believed, again based on migraine patients report the end of the scale in the evaluation of the clinical application of treating migraine have exact value and has unique advantages. |
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