Development And Evaluation Of Patient-reported Outcomes Instrument For COPD

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 instrumentbased on patient-reported outcomes for COPD. Through the investigation and a large number ofclinical formal investigation, the revision scale, and the measurement psychology characteristicmake evaluation.Methods：Follow the procedures norms of development the international instrument, combiningwith the theoretical knowledge of chronic obstructive pulmonary disease theoretical, through theliterature and the patient interview, access from the domestic and foreign relevant scale formscale domain structure and entry pool, Then, the established item pool can be modifying bynumber of multidisciplinary experts. Through advance investigation make some languagemodifications to make it a raw instrument. Then we will do the preliminary screening and checkadjustment through the pilot study, the formal scale is formation.The sample data is obtained byhospitals and communities scene investigation. we ll analyze indexes such as validity，reliabilityand reactivity of formal scale,form the final scale after adjustment.Results：1.We developed the clinical outcomes assessment instrument based onPatient-Reported Outcomes for COPD. The domains of the instrument includes physiology,psychological、social and therapeutic. The physiology domain has three parts with specificsymptoms, general symptom and independence; The psychological domain has two parts with,anxiety, depression; The social domain has three parts with cognize of disease,the influce ofdisease to the social activity,social support; The therapeutic domain has three parts withcompliance, medication side-effects, satisfaction. The instrument contains52Items.2.We analysis395valid data.The results showed that the split half reliabilities of the COPD-PROinstrument and each dimension were greater than0.7. In the analysis of internal consistency ofeach dimension，he cronbach s alpha was greater than0.7excpet theraieutic domian.Conclusion：According to the principle and process which is made by U.S. Food and DrugAdministration(FDA), we have develop an COPA-PRO instrument. Adopting the classical theorytest(CTT)and item response theory(IRT) to evaluation the instrument. The results shows that the...