Development and Evaluation of Patient-reported Outcomes Instrument for Hypertension
|Course||Epidemiology and Biostatistics,|
|Keywords||Hypertension Scale patient reported outcomes (PRO) Item Response Theory (IRT) Entry Screening Confirmatory factor analysis|
Objective: According to the U.S. Food and Drug Administration (FDA) requirements PRO scale production principles and processes, from the patient's point of view, the preparation of a report based on clinical outcomes in patients with hypertension rating scale (PRO scale ) , and then through a large sample of clinical investigation , revised scale , and the scale of measurement of psychological characteristics were evaluated. Methods: Scale development program in accordance with international norms , combined with theoretical knowledge of hypertension , through a lot of literature , learn from the relevant scale, and ask the patient to form scale domain structure and item pool , and then by a number of multi-disciplinary experts modify the entries pools formed by pre- survey -language debugging , the early formation of scale . Through the hospital and the community to carry out on-site investigations to obtain samples of the data using a variety of statistical methods of entry screening , forming the final scale . Of the final scale reliability , validity, responsiveness and other indicators were evaluated. Results: 1 . Designed to form a \Scale is divided into areas of physiology , psychology field , the social sphere, a dimension of four therapeutic areas , including areas such as physical symptoms of physiological , independence , cognitive three aspects ; psychological areas include paranoia , anxiety, depression, hostility four aspects ; social fields , including social support, support utilization two aspects ; therapeutic areas including compliance, satisfaction, and medication side effects 3 , a total of 12 two dimensions. Scale contains 55 entries. 2 of 536 cases of valid data for analysis. Evaluation results show that the scale hypertensive patients with good reliability , validity, responsiveness and clinical feasibility . Split-half reliability coefficient : 0.882 physiological field , psychological field 0.924 , social sphere 0.834 0.950 therapeutic areas , the entire scale 0.950 . Cronbach ? Factor: 0.839 physiological field , psychological field 0.905 , 0.770 social sphere , therapeutic areas 0.859 , 0.948 entire scale . Conclusion: According to FDA regulations, we developed a report based on clinical outcomes in patients with hypertension rating scale . Using a combination of classical measurement methods and item response theory be evaluated . The results showed that: the scale has good reliability , validity, responsiveness and clinical feasibility of clinical evaluation as hypertension research tool .