K01AG073651

Optimizing care for older adults in the new treatment era for type 2 diabetes and heart failure: strengthening causal inference through novel approaches and evidence triangulation - project summary/abstract.

This application for a K01 mentored research scientist award is submitted by Xiaojuan Li, PhD in response to PA-20-190. Dr. Li is a pharmacoepidemiologist and instructor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. Her long-term goal is to develop an independent research career contributing to the appropriate and optimal use of medical treatments in patients with complex healthcare needs.

Dr. Li has a background in pharmacoepidemiologic methods and causal inference. This mentored research and training experience will integrate her methodological research skills into clinical geriatric research. Within the highly productive and supportive research environment at the Department of Population Medicine, Dr. Li will work with an interdisciplinary team of highly committed and collaborative mentors that have deep expertise and extensive experience in the specific areas of her proposed training: clinical geriatrics, diabetology, frailty, semiparametric methods, and machine learning.

The overarching objective of this K01 application is to understand the long-term comparative effectiveness and safety of newer antihyperglycemic agents in older adults in routine care while applying, developing, and disseminating state-of-the-art analytical and causal inference methods, ultimately optimizing clinical care decisions for older adults with diabetes and heart failure.

While these newer antihyperglycemic agents have reported cardiovascular benefit in placebo-controlled, randomized controlled trials (RCTs), little is known about how to choose among an expanded range of medication choices for older patients who are often excluded or underrepresented. These trials do not provide head-to-head comparisons either.

This proposal seeks to fill the critical gaps in the evidence base by utilizing the rich information in high-dimensional electronic healthcare databases, the target trial emulation framework, and novel causal inference and statistical tools. Aim 1 will refine the trial emulation framework by emulating two published RCTs using modern causal and statistical approaches and benchmark these methods by comparing effect estimates from each RCT with those from their observational emulation. The extent of agreement between the effect estimates measures the validity of the emulation framework and analytical methods and will guide our confidence in the observational emulation of other target trials to assess comparative safety and effectiveness of the newer agents with different eligibility criteria, head-to-head treatment comparisons, and outcomes for which actual RCTs are not available or infeasible (Aims 2 & 3).

The findings will improve the evidence base for decision-making available for clinicians treating older patients, promote effective and safe drug therapy, and ultimately improve the care of older patients, which aligns with the National Institute on Aging's missions and initiatives.

Completion of the proposed career development and mentored research will position Dr. Li to successfully compete for future R01 funding and make significant contributions to geriatric pharmacoepidemiology research and improve the lives of older adults.

Harvard Pilgrim Health Care

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Boston, Massachusetts 022153369 United States

Single Zip Code

Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed) (PA-20-190)

Amendment Since initial award the total obligations have increased 300% from $124,732 to $499,422.