Development And Evaluation Of Patient-reported Outcomes Instrument For Hypertension

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 hypertension. And then through the large sample, the instrument is revised, and the psychometric performance are been evaluated.Methods : Follow the procedures norms of development the international instrument, combining with the theoretical knowledge of hypertension, the item pool and 4 domain systems were established by reviewing a large number of literatures, referring to related instruments, and asking the patient. Then, the established item pool can be modifying by number of multidisciplinary experts. Through advance investigation make some language modifications to make it a raw instrument. The data is obtained by hospitals and communities scene investigation. The evevtually instrument is formed by a variety of statistical methods analysis. At the same time, we'll analyze indexes such as validity,reliability and reactivity in the Hyper-PRO instrument.Results : 1.We developed the"clinical outcomes assessment instrument based on Patient-Reported Outcomes for hypertension". The domains of the instrument includes physiology, psychological,social and therapeutic. The physiology domain has four parts with somatic symptoms, independence and cognition; The psychological domain has four parts with paranoid, anxiety, depression, and hostile; The social domain has two parts with social support, support by degrees; The therapeutic domain has three parts with compliance, satisfaction, medication side-effects. The instrument contains 55 Items.2.We analysis 536 valid data. The results showed that the split half reliabilities of the Hyper-PRO instrument and each dimension were greater than 0.8. In the analysis of internal consistency of each dimension,the cronbach's alpha was greater than 0.7.Conclusion:According to the principle and process which is made by U.S. Food and Drug Administration(FDA), we have develop an Hyper-PRO instrument. Adopting the classical theory test(CTT)and item response theory(IRT) to evaluation the instrument. The results shows that the instrument has good reliability,validity,responsiveness and clinical feasibility. It can be applied in clinical evaluation.