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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

Award Number: K01AG073651
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 08/01/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $125,280 )
2025	2025	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Aging Research	000	4	8/20/2025	NON-COMPETING CONTINUATION	$125,280
														Subtotal = $125,280

Issue Date FY: 2024 ( Subtotal = $124,800 )
2024	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Aging Research	000	3	5/20/2024	NON-COMPETING CONTINUATION	$124,800
														Subtotal = $124,800

Issue Date FY: 2023 ( Subtotal = $124,610 )
2023	2023	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Aging Research	000	2	4/7/2023	NON-COMPETING CONTINUATION	$124,610
														Subtotal = $124,610

Issue Date FY: 2022 ( Subtotal = $124,732 )
2022	2022	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Aging Research	000	1	7/28/2022	NEW	$124,732
														Subtotal = $124,732

Grand Total All Awards = $499,422

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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

Award Number: K01AG073651

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 08/01/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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