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Statistical methods and designs for correlated outcome and covariate errors in studies of HIV/AIDS

Award Number: R37AI131771
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/25/2018
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Statistical methods and designs for correlated outcome and covariate errors in studies of HIV/AIDS - PROJECT SUMMARY/ASBTRACT Electronic health record (EHR) and other routinely collected data are often used as cost-effective data sources for HIV/AIDS research. These data sources, however, are known to be prone to errors, typically across multiple variables, which can lead to biased study results and misleading conclusions. In addition, EHR data sources often lack gold-standard measurements that are needed to clearly define the presence or absence of co-morbidities (e.g., liver fibrosis). To address limitations of EHR data sources, researchers can validate or collect additional data on a subsample of their patient records. By combining the rich, but error-prone EHR data on all study subjects with the gold-standard / validated data collected on a subsample of subjects, researchers can improve study estimates. Specifically, researchers can eliminate the bias of estimates had they only used the EHR data, and they can improve the precision (e.g., narrower confidence intervals) of study estimates had they only used the subsample with gold-standard / validated data. In earlier research, we developed statistical methods and software to combine EHR data with validated sub-samples of data. We developed optimal, multi-wave designs for targeting records for data validation. Importantly, we applied these methods to multiple HIV studies using retrospective observational data from the International epidemiology Databases to Evaluate AIDS (IeDEA). However, in our applications, we have encountered additional challenges that have not yet been addressed. In particular, there is great potential in combining expensive, prospectively collected, gold-standard data that are sparsely measured (e.g., once per year) on a sub-sample of patients with EHR data that are collected much more frequently on a larger number of patients. We will develop methods to handle this setting, and we will develop statistical designs to better select which participants should be approached for prospective data collection and which patient records should be validated. We will also develop statistical methods to address other challenges encountered with using EHR data, including how to incorporate validation data into studies when inclusion in the study is error-prone, and methods to address more complex types of data (e.g., interval censored data), for which there are a lack of techniques to handle error-prone data. Our methods and designs will focus on extensions of multiple imputation, maximum likelihood, and generalized raking techniques. Open source tools and tutorials will be developed to help researchers to implement these novel methods and study designs. The methods and designs will be applied to data from the IeDEA network to estimate the incidence of and risk factors for liver fibrosis/steatosis and frailty among people living with HIV in East Africa and Latin America.


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: 2026 ( Subtotal = $823,258 )
2026	2026	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	004	9	2/20/2026	SUPPLEMENT FOR EXPANSION	$30,654
2026	2026	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	005	9	5/21/2026	SUPPLEMENT FOR EXPANSION	$0
2026	2026	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	003	9	2/18/2026	SUPPLEMENT FOR EXPANSION	$5,535
2026	2026	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	002	9	2/17/2026	SUPPLEMENT FOR EXPANSION	$12,371
2026	2026	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	001	9	2/16/2026	SUPPLEMENT FOR EXPANSION	$8,774
2026	2026	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	9	2/2/2026	NON-COMPETING CONTINUATION	$765,924
														Subtotal = $823,258

Issue Date FY: 2025 ( Subtotal = $822,881 )
2025	2025	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	8	2/18/2025	NON-COMPETING CONTINUATION	$822,881
														Subtotal = $822,881

Issue Date FY: 2024 ( Subtotal = $845,194 )
2024	2024	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	7	2/1/2024	NON-COMPETING CONTINUATION	$760,675
2024	2024	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	001	7	5/23/2024	NON-COMPETING CONTINUATION	$84,519
														Subtotal = $845,194

Issue Date FY: 2023 ( Subtotal = $893,452 )
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	6	1/18/2023	COMPETING CONTINUATION	$893,452
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	002	6	8/11/2023	COMPETING CONTINUATION	$0
2023	2023	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	001	6	4/21/2023	COMPETING CONTINUATION	$0
														Subtotal = $893,452

Grand Total All Awards = $3,384,785

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Statistical methods and designs for correlated outcome and covariate errors in studies of HIV/AIDS

Award Number: R37AI131771

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/25/2018

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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