Development And Evaluation Of Patient-reported Outcome (PRO) Scale For Elderly Patients With Coronary Heart Disease (yang Deficiency Syndrome)

Purpose:This study takes the senile coronary heart disease and yang deficiency syndrome as the starting point,combines the disease and syndrome organically,and establishes the evaluation index of TCM curative effect of senile coronary heart disease based on the weak pulse at yang and stringy pulse at yin theory of traditional Chinese medicine.It fully understands and analyzes the disease,and constructs the TCM clinical efficacy evaluation method of the patient report outcome scale with TCM characteristics,so as to provide new ideas for exploring and evaluating the TCM intervention effect of elderly patients with coronary heart disease from the point of view of patients.Material and method: The structural model of(PRO)scale for elderly patients with coronary heart disease(Yang deficiency syndrome)was established according to the guidelines for the development of international scale and its research standards.Through collecting relevant standards,sorting out teaching materials and searching modern literature,this study summarizes the syndrome elements of senile coronary heart disease(Yang deficiency syndrome)and constructs the initial theoretical framework of senile coronary heart disease(Yang deficiency syndrome)based on the theory of senile coronary heart disease(Yang deficiency syndrome)and the(PRO)mode of patients' reporting outcome.The target patients were interviewed in a semi-structured way,the symptom items of senile coronary heart disease(yang deficiency syndrome)were screened and extracted,and the initial entry pool was constructed based on the in-depth interview method of "rooted theory".The items were scored,screened and added,and the item database was reorganized to construct the final report outcome(PRO)scale for elderly patients with coronary heart disease(Yang deficiency syndrome)through three rounds of expert Delphi questionnaire consultation.The data were collated and analyzed,and the reliability,validity and responsiveness of the scale were evaluated.Results:1.The theoretical framework of scale(PRO)for elderly patients with coronary heart disease(Yang deficiency syndrome)was established.In addition,a(PRO)scale for elderly patients with coronary heart disease(Yang deficiency syndrome)was formed,which consisted of 15 items in 2 dimensions of disease and syndrome.2.Reliability evaluation: The Pearson coefficient of the total scale was 0.729.Besides,the Pearson coefficient of the disease dimension was 0.641.In addition,the Pearson coefficient of the syndrome dimension was 0.742,(P < 0.05).It indicated that there was a significant difference.The Cronbach's ? coefficient of the total scale was 0.837,the Cronbach's ? coefficient of the disease dimension was 0.754,and the Cronbach's ?coefficient of the syndrome dimension was 0.87.It indicated that there was a great internal consistency among the total scale,disease dimension and syndrome dimension.3.Validity evaluation: The KMO test value of the scale was 0.613,and the Bartlett sphere test P value was < 0.05,which accorded with the condition of factor analysis.It indicated that the scale has structural validity.By calculating its characteristic value,the first three eigenvalues were greater than 1,and the cumulative contribution rate was 67.877%.Three common factors were extracted by using the orthogonal rotation method,which was consistent with the basic theoretical framework of the expectation scale.4.Responsiveness evaluation: The t-test was carried out on two independent samples of senile coronary heart disease(yang deficiency syndrome)and healthy groups.As a result,the average score of healthy group was 66.66 ±4.116 and that of disease group was 27.06±5.133.The test data show that the P value of disease and syndrome dimension of senile coronary heart disease group and healthy group was less than 0.05.As a consequence,the scale has a great degree of response.Conclusion:The report outcome scale(PRO)of elderly patients with senile coronary heart disease(yang deficiency syndrome)has great reliability,validity and responsiveness.Big data's clinical investigation and study is needed to evaluate the curative effect of senile coronary heart disease(yang deficiency syndrome).Besides,the scale needs to be improved.