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Methods: Mind the Gap

Webinar Series

N-of-1 and Novel Within-Subject Trial Methods

May 20, 2016
Karina W. Davidson, PhD
​Karina W. Davidson, Ph.D., M.A.Sc.

Professor of Behavioral Health
Department of Medicine, Cardiology
Columbia University

View the Webinar

About the Webinar

In a clinical encounter, both clinician and patient want the patient to achieve health behavior change, so the clinician reviews the evidence from between-subject randomized controlled trials and recommends the best intervention to the patient. However, due to the heterogeneity of response in the randomized controlled trial (RCT), we know it is unknown if the intervention will be successful for the individual patient.

The most scientifically rigorous—and potentially efficient—method for determining optimal clinical care for a specific patient is a single-patient (N-of-1) RCT, in which data are collected objectively, continuously, and in the real world for a sufficient time period to determine whether the intervention, compared to a placebo, another intervention, or a different type of delivery or schedule, is optimal for that particular patient. Systematic data collection can also obtain off-target changes for particular patients, so that a more complex picture can emerge about the overall therapeutic benefits and harms that can be attributed to the intervention for that patient.

With sufficient data from several N-of-1 trials of the same design, we can engage in inductive phenotype identification, but N-of-1 trials are only useful under certain circumstances.

About Karina W. Davidson

Dr. Davidson is the Director of the Center for Behavioral Cardiovascular Health in Cardiology and the Vice-Dean of Organizational Effectiveness at Columbia University Medical Center. She received her Ph.D. in Clinical Health Psychology and her master’s in Industrial/Organizational Psychology from the University of Waterloo, Canada. She came to Columbia University Medical Center to grow an interdisciplinary think tank of cardiologists, internists, psychologists, exercise physiologists, and other related scientists. The guiding purpose of this collaboration is to tackle the way behavior, health disparities, and psychosocial conditions affect the biology and incidence of hypertension and heart disease, as well as a patient’s disease course and outcomes.

She has conducted randomized controlled trials of anger management, stress reduction, and depression treatments for healthy, hypertensive, and post-myocardial infarction patients. She has won numerous national and international awards for her research accomplishments, as well as teaching and mentoring awards for her efforts to train the next generation of physician leaders. She has served as elected president of most of her professional organizations. She was recently appointed to the United States Preventive Services Task Force, where she is honored to help evaluate a broad range of clinical preventive health care services. She has authored over 200 peer-reviewed articles, numerous editorials and book chapters, served as editor for various handbooks, and served on multiple scientific journal editorial boards. Her current research interests include N-of-1 trial designs for health behaviors, and health services research to improve the education of future physicians and the care of our hospital patients.

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