The Preparation And Evaluation Of Clinical Outcome Scale For Patients With COPD Combined With Pulmonary Heart Disease

Objective:Based on the developed principles of PRO scale regulated by FDA and the subjective feelings of patients, the PRO scale of COPD combined with pulmonary heart disease was developed, and the reliability, validity and extent of reaction of the scale were evaluated.Methods:Using the interview outline of 20 patients with COPD or pulmonary heart disease interviews, scale entry pool was formed. Preliminary screening and language testing of the entry pool by consulting experts and pre survey, a test version of the scale was formed. Through the field investigation of 101 patients with COPD and pulmonary heart disease, using the distribution of survey items method, discrete trend method, factor analysis method, the correlation coefficient and Cronbach’s a coefficient method and multiple statistical methods to screen items, the final scale was formed. And reliability, validity and extent of reaction of the final scale were evaluated.Results:1. Items and fields of scale:the test version of the scale contains 47 items, 10 items would be deleted after items screening. The final COPD combined with pulmonary heart disease PRO scale contains 37 items, which are divided into 4 dimensions:physiology, psychology, society and treatment; 2. Reliability of scale: The test-retest correlation coefficient were between 0.748-0.962 in the physical dimension, psychological dimension, social dimension and treatment dimension; and in which the split-half coefficient were 0.462 and 0.841,502,0.325, Cronbach’s a coefficient were 0.686,0.820,0.608 and 0.535 respectively; 3. Validity of scale:all items in this study were derived from the patient’s subjective feeling, covering the disease affects the physiological, psychological, social, and treatment of content, so the content validity of the scale was ensured. Correlation coefficient method provide the result that the score of each item was in the maximum correlation with their own area score, and low correlation with other areas.13 common factors were extracted by factor analysis, the cumulative variance contribution rate was 70.22%. There is a clear logical relationship between the intrinsic structure of scale and each factor. After induction and analysis, the field of common factor is basically consistent with the expected structure.4. extent of reaction of scale:the results showed that there were significant differences in the physiological and psychological fields between the first and the third results, and no significant differences in the social and treatment fields. The SRM values in different fields were between 0.92 and-1.15.5. Feasibility of scale:the recovery rate was 95.50%, the effective rate was 93.20%, the response rate was 97.81%, the completion time of the scale was less than 20 minutes, good feasibility.Conclusion:The PRO scale developed by COPD combined with pulmonary heart disease has a certain reliability, validity, extent of reaction and clinical feasibility. It can be used as a tool for the evaluation of clinical efficacy of COPD combined with pulmonary heart disease.