Dissertation
Dissertation > Medicine, health > Preventive Medicine,Health > Health care organizations and career ( Health Management ) > Health Survey and Statistics

Development and Evaluation of Patient-reported Outcomes Instrument for Hypertension

Author LiuQiaoJun
Tutor ZhangYanBo
School Shanxi Medical
Course Epidemiology and Biostatistics,
Keywords Hypertension Scale patient reported outcomes (PRO) Item Response Theory (IRT) Entry Screening Confirmatory factor analysis
CLC R195
Type Master's thesis
Year 2011
Downloads 166
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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 .

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