Development And Evaluation Of Patient-reported Outcomes Instrument For Asthma

Objective:Development of a patient-reported outcomes instrument for asthma to be valid, reliable and sensitive. The instrument is used to evaluate the clinical trials of new drugs and the clinical effects of treatment on asthma patients.Methods:According to the principle and processes of PRO instrument which is made by U.S. Food and Drug Administration (FDA), combining with the theoretical knowledge and clinical features of asthma, the item pool and4domain 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. The primary scale contained72items was formed. The data is obtained by hospitals and communities scene investigation. Advance investigation collected108asthma patients and50healthy persons. Adopting the classical theory test(CTT) and item response theory(IRT) to screen the items and test responsiveness and feasibility of the scale,67items were keeped to form a formal scale.Formal investigation collected366asthma patients and100healthy persons. The eventual instrument contained60items 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 Asthma-PRO instrument.Results;1.We developed the Asthma-PRO instrument. The domains of the instrument includes physical, psychological, social and treatment. The physical domain has two parts with physical symptoms, physical function; The psychological domain has five parts with anxiety, hostile, terror, paranoid and depression; The social domain has two parts with social activity, social support; The treatment domain has three parts with compliance, drugs evaluation and satisfaction. The instrument contains60items.2.We have analysised466valid data. The results show that Asthma-PRO instrument has good reliability, validity, responsiveness and clinical feasibility. The split half reliabilities of the instrument is0.958, the four domains is followed by0.913,0.950,0.846and0.894. The Cronbach’s alpha about instrument is0.919, the four domain also is followed by0.902,0.913,0.702and0.810. Confirmatory factor analysis shows that the scale has good construct validity. The scores of each of the facets and total scores between asthma patients and healthy people are different. The recovery rate and the efficient rate of the questionnaire more than95%, the time requaired to complete a questionnaire is within20minutes, indicating that the scale has a high clinical feasibility.Conclusion:According to the principle and process which is made by U.S. Food and Drug Administration(FDA), we have develop the Asthma-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.