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Causal inference for the treatment and management of multidrug-resistant tuberculosis

Award Number: F31AI157333
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: FELLOWSHIP/SCHOLARSHIP/STUDENT LOANS
PERIOD OF PERFORMANCE START DATE: 12/01/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Causal inference for the treatment and management of multidrug-resistant tuberculosis - PROJECT SUMMARY/ABSTRACT Approximately 10 million people globally developed tuberculosis disease in 2018. Of these, nearly 500,000 were sick with isolates resistant to at least isoniazid and/or rifampin, referred to as multidrug-resistant TB (MDR-TB). Conventional treatment for MDR-TB is long, difficult, and toxic. Regulatory approval of two new TB drugs, bedaquiline and delamanid, for the treatment of MDR-TB has offered the potential for more effective and less toxic regimens. This study will use observational data from the endTB Project. The observational study of the endTB Project is the largest study cohort of MDR-TB patients receiving treatment with bedaquiline and delamanid to date. We will implement robust causal inference methods to generate evidence on the effectiveness and safety of regimens containing bedaquiline and delamanid for the treatment of MDR-TB. We will explore the following Specific Aims: (1) identify the optimal adverse events management strategy that maximizes safety and effectiveness for patients receiving linezolid; (2) examine whether the effect of delamanid on successful treatment outcome when added to an MDR-TB regimen varies according to the number of drugs in the regimen that are likely to be effective; (3) investigate the magnitude of bias due to time-dependent confounding affected by previous exposure in analyses of MDR-TB treatment. The results of these Specific Aims will inform clinical practice, treatment guidance, and future approaches to analyzing MDR-TB treatment cohort data. Causal inference theory and frameworks will be applied; Robins' generalized methods (“g-methods”), such as inverse probability of treatment weighting in marginal structural models and the parametric g-formula, will be used in analyses.


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: 2023 ( Subtotal = -$1,201 )
2023	2021	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	11/23/2022	NEW	-$1,201
														Subtotal = -$1,201

Issue Date FY: 2022 ( Subtotal = -$6,459 )
2022	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	12/2/2021	NEW	-$6,459
														Subtotal = -$6,459

Issue Date FY: 2021 ( Subtotal = $36,461 )
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	1	2/18/2021	NEW	$516
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	12/1/2020	NEW	$35,945
														Subtotal = $36,461

Grand Total All Awards = $28,801

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Causal inference for the treatment and management of multidrug-resistant tuberculosis

Award Number: F31AI157333

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: FELLOWSHIP/SCHOLARSHIP/STUDENT LOANS

PERIOD OF PERFORMANCE START DATE: 12/01/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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