Development And Evaluation Of Patient-reported Outcomes Instrument For Chronic Heart Failure

Objective: To develop a rating scale based on patient-reported outcomes with chronic heartfailure suitable for Chinese people. This scale is compiled according to patient’s own feelings,under the guidance of the compiling principles and processes as prescribed by the U.S.Food andDrug Administration (FDA). This scale shall further perfect the Scale concerning chroniccardiovascular diseases.Method: The primary scale areas, dimensions and item pool were formed after the relaventinformation of the most desirsable improved symptoms was gained through consultation withdoctors and patient and through searching and reading a lot of relevant literature. And then theprimary scale was formed after the correction of items in the aspect of experts and patients, andadjustment of the expressed language.100 primary scale copies were issued in 8 hospitals in Taiyuan City for trial investigation, andthose copies were collected for correction of item selection and dimention by using the classicaltest theory and item response theory(IRT). Finnally, the adjusted scale copited were issued in theformer 8 capitals for former investigation in large scale and the adjusted scale were under thecorrection again and the final scale was formed and the reliability , validity and feasibility wereanalysized.Results: 1. The rating scale based on patient-reported outcomes with chronic heart failuresuitable for Chinese people was formed with 57 items containing physical, psychological ,socialand therapeutic fields. The pysical field included three dimensions of physical symptoms,appetite and sleep, and independence; the psychological field included four dimensions ofanxiety, depression, fear and paranoid; the social field included two dimensions of social supportand utilization of support; and therapeutic fields included three dimensions of compliance,satisfaction, side effects of medicine.2.Results from the analysis of data of 360 patients and 100 healthy people showed that the heartfailure PRO scale has good reliability, validity and clinical feasibility. Reliability which wereverified by Cronbach coefficient with 0.913 of total scale, 0.903 of the physical field, 0.941 ofpsychological field, 0.827 of social field, and 0.839 of therapeutic fields.Conclusion：The results show that the scale based on patient-reported outcomes for chronic heartfailure patients we have developed has good reliability、validity and feasibility. This scale can beused as a tool of evaluation studies of the clinical efficacy of chronic heart failure disease.