| Background and Objective:Gastroesophageal reflux disease(GERD) is the kind of disease which has symptoms caused by something in stomach refluxing to esophagus and(or) the complications. The disease is the chronic disease, but it has diversified and atypical symptoms and often is overlooked or misdiagnosed, recurrent attacks, has protracted course. Patients also often fear to his suffering from heart diseases or upper gastrointestinal tumors and so on and associated with severe mental anxiety, depression, which seriously influence the quality of life. Modern medical treatment is in order to relieve symptoms, improve life quality and prevent recurrence primarily. Although there are a lot of treatment protocols of traditional Chinese medicine, there is no one unified evaluation method of curative effect. As a evaluation methods of clinical curative effect, Patient reported outcomes (PRO) scale is gradually applied to domestic medical research field. There is not any development research in China on rating scales about GERD of TCM especially from PRO angle of measuring at present.This study works out an evaluation scale of TCM based on PRO, which applied to GERD patients, in accordance with sequencing ways of PRO scale manufacture, combined with the TCM theory of GERD and the clinical characteristics, and the connotation of the PRO. Then we analyses its reliability and validity. This scale will be used for the evaluation of TCM clinical curative effect of the GERD, so as to make better treatment protocols and to guide clinical drug use.Methods:We collected measurement indexes in order to build entries pool:according to the principle of making PRO scale, combined with the theory of TCM understanding and the clinical characteristics of GERD, collecting measurement indexes from the beginning of understanding the patients' condition changes. And the main specific methods were the typical case interviews and the questionnaire by patients, combining the experts group heuristic discussion and core group opinions, also referring to the literature of domestic and foreign relevant scale. The screening and optimization of the entries:the core group discussed repeatedly remove repetition, semantic similar items; The remaining items will be made the counseling questionnaire of experts and patient, then we repeatedly screened and optimized the entries from entry importance, patients understanding; Finally we certained the25entries related to GERD, concerned most by patients, which can be used in the evaluation of clinical curative effect.Determine the dimensions:We organized experts to discuss screening of entries and determined the demarcation of entries:reverse flow, indigestion, whole body condition, psychological, social5dimensions; We formed the preliminary scale, and perfected and modified through multiple small sample survey. Data collection:We collected120GERD cases in xiyuan hospital for clinical scale investigation, and retrieved120effective scales, then make the inspection of reliability and validity.Result:The TCM scale(including5dimensions,25entries) based on GERD PRO. Reaction degree analysis showed that only a entries have three rating response rate<10%. This scale internal consistency is better, the total crowns Bach a coefficient is0.7743, the standardized krona Bach coefficient is0.7780, binary reliability were0.6673and0.7365, the coefficient between two parts correlation is0.7135. We can know that this questionnaire reliability is better.We applied to the maximum variance orthogonal rotating factor analysis structural, according to the characteristic root value>1extraction five factors, accumulative total accounted for53.56%, used different methods of initial factor loading matrix maximum variance orthogonal rotating, and we found that after turn and the meaning of each factor is more reasonable, respectively for the flow can be explained, indigestion, whole body condition, disease affects (psychological and social function), pharyngeal stimulation symptoms. So we certained5male factors representative dimension and GERD clinical characteristics consistent with the actual symptoms, and the design of similar theoretical assumption that structural validity is better.Conclusion:The PRO scale of GERD had good reliability and validity and reaction degree, which can be used in TCM preliminary clinical study, also it had certain practical value on the evaluation of GERD clinical curative effect of TCM, but it always need to be studied thoroughly, and constantly improved. |
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