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Methods for generalizing inferences from cluster randomized controlled trials to target populations

Award Number: R01LM013616
ORGANIZATION: NATIONAL LIBRARY OF MEDICINE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/04/2022
PERIOD OF PERFORMANCE END DATE: 12/31/2025

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Methods for generalizing inferences from cluster randomized controlled trials to target populations - PROJECT SUMMARY/ABSTRACT Cluster trials are the study design of choice when interventions are best applied at the group level and when exposure of one individual may affect the outcomes of other individuals in the same cluster. Cluster trials are increasingly embedded within large health care systems, allowing the use of routinely collected data to increase research efficiency. There is concern, however – and this proposal provides supportive evidence – that randomized clusters are not representative the target populations seen in routine care. When treatment effects vary over factors that influence trial participation, treatment effects from the trial cannot be directly applied to real-world target populations of substantive interest. Thus, even in well-designed cluster trials, selective participation can lead to bias in drawing causal inferences about the target population. Given the increasing number of cluster trials being conducted, investigators need rigorous methods for generalizing findings from cluster trials to target populations that address selective participation bias and can account for multiple data science challenges, including stochastic dependence among observations in the same cluster; availability of randomized trial data from only a few clusters or from clusters with relatively small sample sizes; lack of knowledge of predictors of trial participation and the outcome, when candidate covariates often exceed the number of available clusters and necessitate the use of flexible machine learning approaches; and missing outcome data. In response to Notice of Special Interest NOT-LM-19-003, we propose novel, domain- independent, reusable causal and statistical methods to address these data-science challenges and to increase the ability of cluster trials to inform clinical and policy decisions by eliminating bias due to selective participation when estimating average treatment effects and when estimating the optimal covariate-dependent treatment strategy. We will evaluate the methods in realistic simulation studies and in empirical analyses using data from 3 large-scale cluster trials of influenza vaccination strategies in U.S. nursing homes.


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 = $306,159 )
2025	2025	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	4	2/14/2025	NON-COMPETING CONTINUATION	$306,159
														Subtotal = $306,159

Issue Date FY: 2024 ( Subtotal = $340,155 )
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	001	3	5/2/2024	NON-COMPETING CONTINUATION	$34,015
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	3	4/8/2024	NON-COMPETING CONTINUATION	$306,140
														Subtotal = $340,155

Issue Date FY: 2023 ( Subtotal = $340,138 )
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	2	1/31/2023	NON-COMPETING CONTINUATION	$340,138
														Subtotal = $340,138

Issue Date FY: 2022 ( Subtotal = $369,681 )
2022	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	1	2/4/2022	NEW	$369,681
														Subtotal = $369,681

Grand Total All Awards = $1,356,133

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Methods for generalizing inferences from cluster randomized controlled trials to target populations

Award Number: R01LM013616

ORGANIZATION: NATIONAL LIBRARY OF MEDICINE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/04/2022

PERIOD OF PERFORMANCE END DATE: 12/31/2025

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