| Objective:Study of diabetic retinopathy syndrome related literature research, induction diabetic retinopathy of TCM syndrome distribution rules and syndrome element distribution rule, to provide basic research for the traditional Chinese medicine on diabetic retinopathy in the standardization of syndrome, syndrome effect indicators reference for research and diabetic retinopathy PRO assessment scale; develop diabetic retinopathy PRO assessment scale, and carries on the scientific evaluation, to explore a new method for evaluating the efficacy of traditional Chinese medicine treatment of diabetic retinopathy.Method:Literature research method:nearly 10 years related diabetic retinopathy of literature retrieval, through computer retrieval and manual retrieval combining the literature retrieval, and the literature summarize finishing syndromes distribution statistics and syndrome element split statistics. Diabetic retinopathy PRO scale development methods:follow the guidelines made PRO scale (FDA-2009). The establishment of theoretical framework, data references on the formation of the draft scale item pool with interview method, to quantify the item pool in small range of adaptability to further optimize the entry draft scale was formed. The draft scale for clinical investigation, statistical methods are used to select the items, to form the final scale. Finally, the final scale from the feasibility, reliability, validity and responsiveness of the four aspects of the assessment. Reduce the content distribution of three pro diabetic retinopathy scale, and the result of the research:the first draft of a total of 31 item pool, physiological, psychological and social dimensions, including from 1 to 9 for diabetic retinopathy specific symptom index, item 10 to 18 include dry eyes, feel fever, fatigue, loss of appetite, sleep, decreased libido, dizziness, headache. Selected items in the PRO scale entries screening and scientific evaluation process are indicated that these items can be very good as a representative of the syndrome effect indicators, to meet the various needs of the scale function. The variation coefficient of 10-18 in the selection process of the discrete trend method is more than 0.25, which indicates that these items are different from different patients.Results:literature research results show that appeared in the statistics literature of TCM syndrome type of top 10 syndromes:deficiency of both qi and Yin, Yin heat yin and yang deficiency, blood stasis, phlegm, yin deficiency of liver and kidney, Yin Huo Wang, liver qi stagnation, spleen and kidney deficiency of both liver and kidney deficiency; the analysis associated with the disease syndrome known as 16 kinds. Which involves disease syndrome known as liver,kidney, spleen, lung, stomach; to a disease known as yin deficiency. Qi deficiency, heat, blood stasis and yang deficiency, damp, phlegm, spleen, Qi and blood deficiency, bleeding, body fluid deficiency. Factor analysis of item 10-18 are a common factor 1, illustrate these entries can be on behalf of Xiaoke eye disease syndrome effect index; correlation coefficient method in entry 10-18 and scale and dimension of the Pearson correlation coefficient>0.3, indicating that the overall and dimensions are consistent with these items and quantity form; the Cronbach's alpha coefficient only poor appetite can consider deleting, entry distribution method do not have a choice of more than 80% of the entries were selected; regression analysis selected entries have dry eyes, poor appetite, the second. Overall entry 10-18 no entries selected number less than 5 times of, so these items can retained to Xiaoke eye disease Pro scale in the final draft, shows the representative and good discrimination of Xiaoke eye disease syndrome effect index selection. There is no need to delete the entry; in factor molecules, the entry "quality of life" in the two factors on the load factor is similar, so you need to consider the deletion of the entry. Correlation coefficient method test results show that the correlation coefficient between health and total score is 0.221, so we need to consider deleting "health". Krone Bach coefficient test results show that if the item is deleted, the psychological dimension of the clone Bach coefficient can be increased to 0.890, so you can consider the deletion of the entry. The results of the stepwise regression analysis were:the problems were as blurred vision, visual distortion.dry eye, poor appetite,urine,stool,bad mood, economy, communication, and health. The comprehensive evaluation results of the method are selected or most (>5) were selected items. Remove nineteenth and 30,31, taking into account the first 30.31 are comprehensive indicators in the form of a patient's own scoring in the form of existence, final scale entry pool to determine. Scale scientific evaluation results:scale reliability analysis of the Cronbach's alpha coefficient> 0.8, the split half reliability is 0.834; structure validity analysis extracted five factors, the cumulative variance contribution rate for 66.755%, scale the final draft of the determination results and the structure to the amount of table is consistent with the. The results showed that there was a significant difference between the four groups(P<0.01)in the latitude and the total score in the groups. There were significant differences between the groups and the total score in the four groups. To determine the significance of the formulation of scores of Xiaoke eye disease patients'quality of life according to the total score of the percentile of the grading standard. According to the quality of survival from good to bad is divided into 5. X is less than or equal to the 30.64 is basically normal,3.64<X< 44.06 is slightly worse,44.06<X< 49.75 difference,49.75<X< 56.29 is serious,>56.29 is very serious.Conclusion:This study through the literature study of diabetic retinopathy syndrome distribution rules and syndrome distribution, some representative syndrome effect index form part of a scale, item 10 to Item 18 content have dry eyes, feeling of low heat, fatigue, loss of appetite down low, poor sleep, decreased libido, dizziness, headache,2 to be not moved can contain all the disease syndrome), and most of the disease syndrome elements. Selected items in the scale of PRO item selection and scientific evaluation process show that these items can be very good as the syndrome effect index, to meet the various needs of scale function. The screening process of the discrete trend method the variation coefficient in item 10-18 was> 0.25, indicating that these items differences of quality of life in patients with different content measured in the entry of the good. Factor analysis of item 10-18 are a common factor 1, illustrate these entries can be on behalf of diabetic retinal lesion syndrome syndrome effect index; correlation coefficient method in entry 10-18 and scale and dimension of the Pearson correlation coefficient was more than 0.3, indicating that these items and quantity table and the overall dimensions of consistency is good; the Cronbach's alpha coefficient only poor appetite can consider deleting, entry distribution method do not have a choice of more than 80% of the entries were selected; regression analysis selected entries have dry eyes, poor appetite, stool. Overall entry 10-18 no entries selected number less than 5 times, so these items can retained to the diabetic retinopathy disease Pro scale in the final draft, shows the representative and good discrimination of diabetic retinopathy syndrome effect index selection. The diabetic retinopathy Pro was the scientific evaluation show that has good feasibility, reliability, validity and reaction degree, can be used to evaluate the curative effect of traditional Chinese medicine in the treatment of diabetic retinopathy, and can be popularized and applied further. |
PDF Full Text Request