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

Objective:According to the principle and processes of PRO instrument which is made by U.S. Food and Drug Administration (FDA), from the perspective of patients, develop an instrument based on patient-reported outcomes for Chronic Respiratory Failure, and further improve the scale concerning chronic respiratory diseases.Method:The primary scale areas, dimensions and item pool were formed after the relavent information of the most desirsable improved symptoms was gained through consultation with doctors and patient and through searching and reading a lot of relevant literature. And then the primary scale was formed after the correction of items in the aspect of experts and patients, and adjustment of the expressed language.160primary scale copies were issued in8hospitals in Taiyuan City for trial investigation, and those copies were collected for correction of item selection and dimention by using the classical test theory and item response theory (IRT). Finnally, the adjusted scale copited were issued in the former8hospitals for former investigation in large scale and the adjusted scale were under the correction again and the final scale was formed and the reliability, validity and feasibility were analysized. Results:1.The rating scale based on patient-reported outcomes with chronic respiratory failure suitable for Chinese people was formed with62items containing physical, psychological, social and therapeutic fields. The pysical field included three dimensions of physical symptoms, cognitive function and activities of everyday life; the psychological field included three dimensions of anxiety, depression, inferiority and fear; the social field included two dimensions of social contacts and family support; and therapeutic fields included two dimensions of compliance, satisfaction.2. Results from the analysis of data of364patients and97healthy people showed that the respiratory failure PRO scale has good reliability, validity and clinical feasibility. Reliability which were verified by Cronbach coefficient with0.905of total scale,0.874of the physical field,0.877of psychological field,0.807of social field, and 0.712of therapeutic fields.Conclusion:The results show that the scale based on patient-reported outcomes for chronic respiratory failure patients we have developed has good reliability、validity and feasibility. This scale can be used as a tool of evaluation studies of the clinical efficacy of chronic respiratory failure disease.