| Objective:Currently,there is not a relatively credible way to evaluate the Chinese medicine therapeutic effect of Graves disease.Patient-reported outcome is widely used as a therapeutic evaluation scale in foreign countries and it has a great prospect in the evaluation of TCM efficacy.There is not any PRO scale for Graves disease now.Through the theoretical analysis of Graves' disease and the quantitative and qualitative clinical study,the PRO of graves disease can be formed.It can be applied in clinical practice and will be helpful for clinical efficacy evaluation of Chinese medicine after the scientific assessment.Methods:(1)A preliminary study of the rule of syndromes and treatments:A total of 240 medical records of Graves disease patients were included in the study from November 2017 to March 2018 in Guang'anmen Hospital.The relevant information was collected and statistical analysis was made by SPASS 23.0 to explore the differences in patients with the characteristics of symptoms,major syndromes and representative formula.(2)Development of PRO scale;Firstly,the conceptual framework of the PRO will be developed according to the international scale development standards and the basic theories of traditional Chinese medicine.Secondly,an item pool can be formed through case review,patient heuristic interviews,brainstorming,and expert consultation.The 5-grade scoring method will be used as the entry pool to form a preliminary scale.To further optimize the scale formation,cognitive assessment interviews can be applied.Thirdly,200 eligible Graves disease patients in the Guang'anmen Hospital will be selected in the study.After calculating the basic information of patients,completing time and scale results,we will use SPASS 23.0 software to evaluate the scale including the feasibility,reliability,validity and other aspects of the scale.Information collection and statistics will be included for the patients' symptoms,indicators and syndromes,and questionnaires for experts will be applied to explore the patterns of TCM syndromes.Results:(1)A preliminary study of the rule of syndromes and treatments:Patients with Graves' disease are predominantly female,and the incidence of females is significantly greater than that of males.Young people and middle-aged people are at high risk of disease,and patients are mostly concentrated in high-cultural levels.Newly diagnosed patients'syndrome is mainly yin deciciency and yang hyperactivity and the fulmula can use Zi Yin Qian Yang Jia Kang Fang.After treatment,the drug-reducing period patients' syndrome is mainly Qi and Yin deciciency.Shen Qi Di Huang Tang and Huo Pu Xia Xi Tang fulmula are usually used.(2)Development of PRO scale:Based on the FDA guidelines and the basic theories of traditional Chinese medicine,the four concepts of pathology,physiology,psychology,society,and treatment are taken into consideration to form a conceptual framework for the PRO scale.A total of 100 cases of patients with Graves' disease were extracted from the endocrine ward of Guang'anmen Hospital from January 1st,2013 to December 31st,2017.The basic information and symptoms were collected to form the basis items pool.Conceptual heuristic interviews with 30 patients helped to summarize the 57 basic items.Through the group brainstorming on the language translation of the basic items and the expert group merging the items,the primary Graves disease PRO contains a total of 42 items,of which 33 items are in the physiology and pathology field,3 in the social field,and 3 in the psychological field.Five-grade scales were used as scales to form questionnaires.Through the cognitive evaluation interviews with 10 patients,the wording of the scale was further optimized to form a final selection scale.In the endocrinology clinic of Guang'anmen Hospital,a total of 200 PRO scales were issued to patients eligible for inclusion.Finally,194 scales were recovered,192 scales were valid.The recovery rate was 97%and the completion rate was 96%.93%of patients were able to complete the volume within 10 minutes.It shows that the scale has good feasibility.In the evaluation of reliability,the Cronbach's coefficient of the total table is 0.917,and the half-time coefficient is 0.943.The Cronbach's coefficient and the half-half coefficient of the physiological and pathological fields,social fields,and psychological fields all show the good reliability of the scale.After eliminating item 42,the treatment field also showed a good degree of reliability,indicating that the overall scale reliability was good.On the validity of the scale,the content validity was tested by Speannan correlation coefficient.The correlation coefficient between each item and the four fields was evaluated.The results showed that the entries in each field except item 2 are related to the field.The high correlation indicates that the content of the scale is valid.The evaluation of the construct validity is based on the factor analysis method.After the common factor is extracted by the principal component method and the maximum variance is rotated,67.67%of the variables can be explained using common factors.It means the scale has good structural validity.The PRO scale of Graves Disease has been scientifically tested with good feasibility,reliability and validity.Conclusion:(1)A preliminary study of the rule of syndromes and treatments:Newly diagnosed patients' syndrome is mainly yin deciciency and yang hyperactivity.Zi Yin Qian Yang Jia Kang Fang is always used in this pieriod.After treatment,the drug-reducing period patients' syndrome is mainly Qi and Yin deciciency.Shen Qi Di Huang Tang and Huo Pu Xia Xi Tang fulmula are usually used.(2)Development of PRO scale:The final PRO scale includes 40 items,32 items in the field of physiology and pathology,3 in the social field,3 in the psychological field,and 2 in the therapeutic field.After statistical tests,the PRO scale of Graves' disease has good feasibility,reliability,and validity.It is proved that the scale is scientific. |
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