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Computational methods using electronic health records and registry data to detect and predict clinical outcomes in rheumatic disease

Award Number: K01AR075085
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

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PROJECT SUMMARY / ABSTRACT This is a new application for a K01 award for Dr. Milena Gianfrancesco, an epidemiologist at the University of California, San Francisco (UCSF) School of Medicine, who plans a research program focusing on understanding risk factors as they relate to rheumatic disease patient outcomes, such as adverse events. Combined with a training plan focused on computational text mining methods and advanced causal inference statistics, the goal of the current study is to use large electronic health record and national registry data that reflects real-world prescribing patterns to examine the risk of infection attributed to biologic disease-modifying anti-rheumatic drugs in individuals with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). While biologic medications have improved disease control and are associated with significant gains in patients’ quality of life, several studies have demonstrated that biologic use is associated with an increased risk of serious adverse events, such as infection. How this risk differs based on a variety of patient factors, such as age, race, and ethnicity, is currently unknown, leaving clinicians with insufficient information to predict the probability of an adverse event occurring in a given patient who is prescribed a particular biologic. This proposal will utilize established local electronic health record and national registry data to examine over 80,000 individuals with RA and SLE to address three specific aims. In Aim 1, Dr. Gianfrancesco will apply and validate a text mining system to identify incident clinical and opportunistic infections from clinical notes. In Aim 2, Dr. Gianfrancesco will use the same databases to determine the longitudinal causal effect of biologics on risk of infection. In Aim 3, a risk-assessment model to predict risk of infection will be developed and validated in a rheumatology clinic. Findings from this study will further elucidate factors associated with infectious risk for individuals prescribed biologics, thereby improving their safety in the ambulatory settings. Dr. Gianfrancesco has assembled an exceptional mentorship team with expertise in computational text mining methods, advanced causal inference statistics, rheumatology and patient safety outcomes, as well as experience using national registry data to address these questions. She will have access to a rich research environment and provided support for career development through programs such as the UCSF Clinical and Translational Science Institute K-scholars program. Formal coursework and mentoring will also be supplemented with attendance at national conferences related to rheumatology, epidemiology, and informatics. Completing the proposed research and career development plan will allow Dr. Gianfrancesco to gain experience in state-of-the-art computational methods using large datasets to better understand important patient outcomes, such as serious adverse events. This mentored career development award will provide the skills, mentorship, and experience necessary to propel her to independence and enable her to lead an independent multidisciplinary research program.


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 = -$114,891 )
2023	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	4	1/6/2023	NON-COMPETING CONTINUATION	-$12,577
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	3	1/6/2023	SUPPLEMENT FOR EXPANSION	-$29,958
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	1/6/2023	NON-COMPETING CONTINUATION	-$72,356
														Subtotal = -$114,891

Issue Date FY: 2022 ( Subtotal = $12,577 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	4	8/30/2022	NON-COMPETING CONTINUATION	-$117,847
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	2/4/2022	NON-COMPETING CONTINUATION	$130,424
														Subtotal = $12,577

Issue Date FY: 2021 ( Subtotal = $184,424 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	2/11/2021	NON-COMPETING CONTINUATION	$130,424
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	8/5/2021	SUPPLEMENT FOR EXPANSION	$54,000
														Subtotal = $184,424

Issue Date FY: 2020 ( Subtotal = $130,424 )
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	1/17/2020	NON-COMPETING CONTINUATION	$130,424
														Subtotal = $130,424

Issue Date FY: 2019 ( Subtotal = $130,424 )
2019	2019	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	4/10/2019	NEW	$130,424
														Subtotal = $130,424

Grand Total All Awards = $342,958

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Computational methods using electronic health records and registry data to detect and predict clinical outcomes in rheumatic disease

Award Number: K01AR075085

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

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