Overview Bernice Ruo, MD is an academic general internist whose career goal is to improve patient- centered outcomes among patients with heart failure. She is applying for a Mentored Patient-Oriented Research Career Development Award to develop and enhance the skills necessary to become a successful independent investigator and national leader in patient-centered outcomes research. Her research interests have focused on patient-centered outcomes including health-related quality of life in cardiovascular disease. Topic Symptoms are often a person's initial perception of an abnormal state and cause individuals to seek medical care. Key symptoms for heart failure include dyspnea, fatigue, and emotional distress. We believe that symptoms are the most responsive to changes in disease course and treatment. Yet more commonly, symptoms are measured with more """"""""downstream"""""""" domains such as functional status and quality of life. While these domains are important, they may be insensitive to changes in symptoms and affected by confounding influences. Despite the advances in outcomes research, a need exists for a brief precise method to assess heart failure symptoms in clinical trials and for use in clinical decision-making. Development Plan Central to Dr. Ruo's career development plan are the strong institutional commitment and mentoring team that she has assembled. Her multidisciplinary educational plan is built upon acquiring new skills in survey design, psychometrics (including item banking and computer adaptive testing), and longitudinal data analysis. Research Plan The goal of the mentored research plan is to use psychometric methods including computer adaptive testing to develop a symptom assessment tool that will allow for rapid precise measurement of key symptoms of heart failure. Phase 1 consists of administering dyspnea questions to a group of patients with heart failure to develop an item bank for dyspnea. The dyspnea item bank along with the fatigue and emotional distress item banks (generated in the NIH roadmap initiative PROMIS) will be used to generate a computer adaptive test to assess key heart failure symptoms (Aim 1). Phase 2 is a cohort study to determine the test characteristics of the heart failure symptom assessment tool (Aim 2). Phase 3 will evaluate whether the tool reflects clinically meaningful changes (Aim 3). At the conclusion of this research plan, Dr. Ruo will be well-positioned with this innovative computer adaptive symptom tool to evaluate the impact of heart failure on patient lives and assess treatment efficacy. Significance Given the prevalence of heart failure, we can strive to improve quality of care, optimize resource use, and reduce the impact on patients' health. Development of a dyspnea item bank and utilizing computer adaptive testing can help achieve these goals by improving symptom assessment. ? ? ?
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