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

Award Number: R01AI131771
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract (Shepherd and Shaw, R01, Statistical methods for correlated outcome and covariate errors in studies of HIV/AIDS) There is growing interest in using administrative electronic health record (EHR) data and other routinely collected data sources as cost-effective means to support HIV/AIDS research. Validation of observational cohort and EHR data demonstrate the substantial presence of errors in these types of data. There may be errors in failure and censoring times (e.g., time from ART initiation to clinical events), event classifications, and covariates (e.g., CD4 at ART initiation), with strong correlation between the magnitudes of errors in these variables. These correlated errors can bias estimation. Ideally, researchers could validate a subsample of their data and use information learned from this subsample to improve estimation for the entire cohort, thereby obtaining valid estimates without validating the entire database. However, the current lack of available methods and software to correct for these types of errors for time-to-event outcomes are major barriers to performing correct inference on these types of data. There is also little guidance on what records and variables to validate to optimize resources. This project will create novel statistical methods for estimation to reduce or eliminate bias caused by correlated errors in failure-time outcomes and associated covariates. The developed methods will use information on the structure of the measurement error, gained by data validation or audit subsets, to adjust estimation and correct for errors that remain in the unvalidated data. The project will develop and examine extensions of regression calibration, corrected scores, and multiple imputation methods, augmented with raking techniques to address these correlated errors. The project will also develop efficient data validation and audit sampling designs that use adaptive, multi-wave sampling in order to target successive validation and audit subsets towards informative subgroups of patients. Open source tools will be developed to allow researchers to implement these methods and study designs. The methods and designs will be applied to data from the International Epidemiologic Databases to Evaluate AIDS (IeDEA) to estimate the incidence of tuberculosis and Kaposi's sarcoma and their outcomes, risk factor associations, and temporal trends among persons 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: 2022 ( Subtotal = $659,129 )
2022	2022	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	001	5	2/1/2022	NON-COMPETING CONTINUATION	$659,129
2022	2021	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	4	12/15/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $659,129

Issue Date FY: 2021 ( Subtotal = $659,345 )
2021	2021	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	4	1/19/2021	NON-COMPETING CONTINUATION	$659,345
														Subtotal = $659,345

Issue Date FY: 2020 ( Subtotal = $534,133 )
2020	2020	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	3	2/14/2020	NON-COMPETING CONTINUATION	$534,133
														Subtotal = $534,133

Issue Date FY: 2019 ( Subtotal = $498,218 )
2019	2019	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	2	2/2/2019	NON-COMPETING CONTINUATION	$498,218
														Subtotal = $498,218

Issue Date FY: 2018 ( Subtotal = $641,524 )
2018	2018	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Allergy and Infectious Diseases Research	000	1	1/25/2018	NEW	$641,524
														Subtotal = $641,524

Grand Total All Awards = $2,992,349

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

Award Number: R01AI131771

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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