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Article ; Online: Development and utility of a clinical research informatics application for participant recruitment and workflow management for a return of results pilot trial in familial hypercholesterolemia in the Million Veteran Program.

Brunette, Charles A / Yi, Thomas / Danowski, Morgan E / Cardellino, Mark / Harrison, Alicia / Assimes, Themistocles L / Knowles, Joshua W / Christensen, Kurt D / Sturm, Amy C / Sun, Yan V / Hui, Qin / Pyarajan, Saiju / Shi, Yunling / Whitbourne, Stacey B / Gaziano, J Michael / Muralidhar, Sumitra / Vassy, Jason L

JAMIA open

2024 Volume 7, Issue 1, Page(s) ooae020

Abstract: Objective: The development of clinical research informatics tools and workflow processes associated with re-engaging biobank participants has become necessary as genomic repositories increasingly consider the return of actionable research results.: ... ...

Abstract	Objective: The development of clinical research informatics tools and workflow processes associated with re-engaging biobank participants has become necessary as genomic repositories increasingly consider the return of actionable research results. Materials and methods: Here we describe the development and utility of an informatics application for participant recruitment and enrollment management for the Veterans Affairs Million Veteran Program Return Of Actionable Results Study, a randomized controlled pilot trial returning individual genetic results associated with familial hypercholesterolemia. Results: The application is developed in Python-Flask and was placed into production in November 2021. The application includes modules for chart review, medication reconciliation, participant contact and biospecimen logging, survey recording, randomization, and documentation of genetic counseling and result disclosure. Three primary users, a genetic counselor and two research coordinators, and 326 Veteran participants have been integrated into the system as of February 23, 2023. The application has successfully handled 3367 task requests involving greater than 95 000 structured data points. Specifically, application users have recorded 326 chart reviews, 867 recruitment telephone calls, 158 telephone-based surveys, and 61 return of results genetic counseling sessions, among other available study tasks. Conclusion: The development of usable, customizable, and secure informatics tools will become increasingly important as large genomic repositories begin to return research results at scale. Our work provides a proof-of-concept for developing and using such tools to aid in managing the return of results process within a national biobank.
Language	English
Publishing date	2024-03-08
Publishing country	United States
Document type	Journal Article
ISSN	2574-2531
ISSN (online)	2574-2531
DOI	10.1093/jamiaopen/ooae020
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Article ; Online: Pharmacogenetic allele variant frequencies: An analysis of the VA's Million Veteran Program (MVP) as a representation of the diversity in US population.

Markianos, Kyriacos / Dong, Frederic / Gorman, Bryan / Shi, Yunling / Dochtermann, Daniel / Saxena, Uma / Devineni, Poornima / Moser, Jennifer / Muralidhar, Sumitra / Ramoni, Rachel / Tsao, Philip / Pyarajan, Saiju / Przygodzki, Ronald

PloS one

2023 Volume 18, Issue 2, Page(s) e0274339

Abstract: We present allele frequencies of pharmacogenomics relevant variants across multiple ancestry in a sample representative of the US population. We analyzed 658,582 individuals with genotype data and extracted pharmacogenomics relevant single nucleotide ... ...

Abstract	We present allele frequencies of pharmacogenomics relevant variants across multiple ancestry in a sample representative of the US population. We analyzed 658,582 individuals with genotype data and extracted pharmacogenomics relevant single nucleotide variant (SNV) alleles, human leukocyte antigens (HLA) 4-digit alleles and an important copy number variant (CNV), the full deletion/duplication of CYP2D6. We compiled distinct allele frequency tables for European, African American, Hispanic, and Asian ancestry individuals. In addition, we compiled allele frequencies based on local ancestry reconstruction in the African-American (2-way deconvolution) and Hispanic (3-way deconvolution) cohorts.
MeSH term(s)	Humans ; Pharmacogenetics ; Alleles ; Veterans ; Gene Frequency ; Genotype
Language	English
Publishing date	2023-02-24
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0274339
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Article ; Online: Overview of Efforts to Increase Women Enrollment in the Veterans Affairs Million Veteran Program.

Whitbourne, Stacey B / Li, Yanping / Brewer, Jessica V V / Deen, Jennifer / Gutierrez, Claudia / Murphy, Sybil A / Lord, Emily / Yan, Joseph / Nguyen, Xuan-Mai T / Tsao, Philip S / Gaziano, J Michael / Muralidhar, Sumitra

Health equity

2023 Volume 7, Issue 1, Page(s) 324–332

Abstract: Background: Ensuring enhanced delivery of care to women Veterans is a top Veterans Affairs (VA) priority; however, women are historically underrepresented in research that informs evidence-based health care. A primary barrier to women's participation is ...

Abstract	Background: Ensuring enhanced delivery of care to women Veterans is a top Veterans Affairs (VA) priority; however, women are historically underrepresented in research that informs evidence-based health care. A primary barrier to women's participation is the inability to engage with research in person due to a number of documented challenges. The VA Million Veteran Program (MVP) is committed to increasing access for women Veterans to participate in research, thereby better understanding conditions specific to this population and how disease manifests differently in women compared to men. The goal of this work is to describe the results of the MVP Women's Campaign, an effort designed to increase outreach to and awareness of remote enrollment options for women Veterans. Materials and methods: The MVP Women's Campaign launched two phases between March 2021 and April 2022: the Multimedia Phase leveraged a variety of strategic multichannel communication tactics and the Email Phase focused on direct email communication to women Veterans. The effect of the Multimedia Phase was determined using Results: Overall, 4694 women Veterans enrolled during the MVP Women's Campaign (54% during the Multimedia Phase and 46% during the Email Phase). For the Multimedia Phase, the percentage of older women online enrollees increased, along with women from the southwest and western regions of the United States. Differences for women Veteran online enrollment across different ethnicity and race groups were not observed. During the Email Phase, the enrollment rate increased with age. Compared to White women Veterans, Blacks, Asians, and Native Americans were significantly less likely to enroll while Veterans with multiple races were more likely to enroll. Conclusion: The MVP Women's Campaign is the first large-scale outreach effort focusing on recruitment of women Veterans into MVP. The combination of print and digital outreach tactics and direct email recruitment resulted in over a fivefold increase in women Veteran enrollees during a 7-month period. Attention to messaging and communication channels, combined with a better understanding of effective recruitment methods for certain Veteran populations, allows MVP the opportunity to advance health and health care not only for women Veterans, but beyond. Lessons learned will be applied to increase other populations in MVP such as Blacks, Hispanics, Asians, Native Americans, younger Veterans, and Veterans with certain health conditions.
Language	English
Publishing date	2023-05-26
Publishing country	United States
Document type	Journal Article
ISSN	2473-1242
ISSN (online)	2473-1242
DOI	10.1089/heq.2023.0006
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Article: Leveraging the Million Veteran Program Infrastructure and Data for a Rapid Research Response to COVID-19.

Whitbourne, Stacey B / Moser, Jennifer / Cho, Kelly / Deen, Jennifer / Churby, Lori L / Justice, Amy C / Casas, Juan P / Pyarajan, Saiju / Tsao, Phil S / Gaziano, J Michael / Muralidhar, Sumitra

Federal practitioner : for the health care professionals of the VA, DoD, and PHS

2023 Volume 40, Issue 11 Suppl 5, Page(s) S23–S28

Abstract: Background: The Veterans Health Administration Office of Research and Development (ORD) played a key role in the federal government's response to the COVID-19 pandemic. The ORD effectively leveraged existing resources to answer questions related to the ... ...

Abstract	Background: The Veterans Health Administration Office of Research and Development (ORD) played a key role in the federal government's response to the COVID-19 pandemic. The ORD effectively leveraged existing resources to answer questions related to the SARS-CoV-2 virus and COVID-19. Observations: When the COVID-19 pandemic hit in 2020, the Million Veteran Program (MVP), one of the largest genomic cohorts in the world, extended the centralized recruitment and enrollment infrastructure to develop a COVID-19 research volunteer registry to assist enrollment in the vaccine and treatment trials in which the US Department of Veterans Affairs (VA) participated. In addition, the MVP allowed for new data collection and a large genomic cohort to understand host contributions to COVID-19. This article describes ways the MVP contributed to the VA's rapid research response to COVID-19. Several host genetic factors believed to play a role in the development and severity of COVID-19 were identified. Furthermore, existing MVP partnerships with other federal agencies, particularly with the Department of Energy, were leveraged to improve understanding and management of COVID-19. Conclusions: A previously established enterprise approach and research infrastructure were essential to the VA's successful and timely COVID-19 research response. This infrastructure not only supported rapid recruitment in vaccine and treatment trials, but also leveraged the unique MVP and VA electronic health record data to drive rapid scientific discovery and inform clinical operations. Extending the models that VA research applied to the federal government at large and establishing centralized resources for shared or federated data analyses across federal agencies will better equip the nation to respond to future public health crises.
Language	English
Publishing date	2023-11-01
Publishing country	United States
Document type	Journal Article
ISSN	1078-4497
ISSN	1078-4497
DOI	10.12788/fp.0416
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Article ; Online: COVID-19 Insights Partnership: Leveraging big data from the Department of Veterans Affairs and supercomputers at the Department of Energy under the public health authority.

Ramoni, Rachel / Klote, Molly / Muralidhar, Sumitra / Brandt, Cynthia / Bernstein, Maya A / McMahon, Benjamin H / Jacobson, Daniel A / Justice, Amy C

Journal of the American Medical Informatics Association : JAMIA

2021 Volume 28, Issue 7, Page(s) 1578–1581

MeSH term(s)	Artificial Intelligence ; Big Data ; COVID-19 ; Computers ; Datasets as Topic ; Humans ; Information Dissemination ; Public Health Administration ; United States ; United States Department of Veterans Affairs ; United States Government Agencies
Language	English
Publishing date	2021-03-28
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1205156-1
ISSN	1527-974X ; 1067-5027
ISSN (online)	1527-974X
ISSN	1067-5027
DOI	10.1093/jamia/ocab062
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Zs.A 4128: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: The Million Veteran Program 1990-1991 Gulf War Era Survey: An Evaluation of Veteran Response, Characteristics, and Representativeness of the Gulf War Era Veteran Population.

Harrington, Kelly M / Quaden, Rachel / Steele, Lea / Helmer, Drew A / Hauser, Elizabeth R / Ahmed, Sarah T / Aslan, Mihaela / Radhakrishnan, Krishnan / Honerlaw, Jacqueline / Nguyen, Xuan-Mai T / Muralidhar, Sumitra / Concato, John / Cho, Kelly / Gaziano, J Michael / Whitbourne, Stacey B / On Behalf Of The Va Million Veteran Program

International journal of environmental research and public health

2024 Volume 21, Issue 1

Abstract: To address gaps in understanding the pathophysiology of Gulf War Illness (GWI), the VA Million Veteran Program (MVP) developed and implemented a survey to MVP enrollees who served in the U.S. military during the 1990-1991 Persian Gulf War (GW). Eligible ... ...

Abstract	To address gaps in understanding the pathophysiology of Gulf War Illness (GWI), the VA Million Veteran Program (MVP) developed and implemented a survey to MVP enrollees who served in the U.S. military during the 1990-1991 Persian Gulf War (GW). Eligible Veterans were invited via mail to complete a survey assessing health conditions as well as GW-specific deployment characteristics and exposures. We evaluated the representativeness of this GW-era cohort relative to the broader population by comparing demographic, military, and health characteristics between respondents and non-respondents, as well as with all GW-era Veterans who have used Veterans Health Administration (VHA) services and the full population of U.S. GW-deployed Veterans. A total of 109,976 MVP GW-era Veterans were invited to participate and 45,270 (41%) returned a completed survey. Respondents were 84% male, 72% White, 8% Hispanic, with a mean age of 61.6 years (
MeSH term(s)	Humans ; Female ; Male ; Middle Aged ; Veterans ; Gulf War ; Military Personnel ; Health Status ; Health Surveys
Language	English
Publishing date	2024-01-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph21010072
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Article: Characterization of Post-COVID-19 Definitions and Clinical Coding Practices: Longitudinal Study.

Online journal of public health informatics

2024 Volume 16, Page(s) e53445

Abstract: Background: Post-COVID-19 condition (colloquially known as "long COVID-19") characterized as postacute sequelae of SARS-CoV-2 has no universal clinical case definition. Recent efforts have focused on understanding long COVID-19 symptoms, and electronic ... ...

Abstract	Background: Post-COVID-19 condition (colloquially known as "long COVID-19") characterized as postacute sequelae of SARS-CoV-2 has no universal clinical case definition. Recent efforts have focused on understanding long COVID-19 symptoms, and electronic health record (EHR) data provide a unique resource for understanding this condition. The introduction of the International Classification of Diseases, Tenth Revision (ICD-10) code U09.9 for "Post COVID-19 condition, unspecified" to identify patients with long COVID-19 has provided a method of evaluating this condition in EHRs; however, the accuracy of this code is unclear. Objective: This study aimed to characterize the utility and accuracy of the U09.9 code across 3 health care systems-the Veterans Health Administration, the Beth Israel Deaconess Medical Center, and the University of Pittsburgh Medical Center-against patients identified with long COVID-19 via a chart review by operationalizing the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) definitions. Methods: Patients who were COVID-19 positive with either a U07.1 ICD-10 code or positive polymerase chain reaction test within these health care systems were identified for chart review. Among this cohort, we sampled patients based on two approaches: (1) with a U09.9 code and (2) without a U09.9 code but with a new onset long COVID-19-related ICD-10 code, which allows us to assess the sensitivity of the U09.9 code. To operationalize the long COVID-19 definition based on health agency guidelines, symptoms were grouped into a "core" cluster of 11 commonly reported symptoms among patients with long COVID-19 and an extended cluster that captured all other symptoms by disease domain. Patients having ≥2 symptoms persisting for ≥60 days that were new onset after their COVID-19 infection, with ≥1 symptom in the core cluster, were labeled as having long COVID-19 per chart review. The code's performance was compared across 3 health care systems and across different time periods of the pandemic. Results: Overall, 900 patient charts were reviewed across 3 health care systems. The prevalence of long COVID-19 among the cohort with the U09.9 ICD-10 code based on the operationalized WHO definition was between 23.2% and 62.4% across these health care systems. We also evaluated a less stringent version of the WHO definition and the CDC definition and observed an increase in the prevalence of long COVID-19 at all 3 health care systems. Conclusions: This is one of the first studies to evaluate the U09.9 code against a clinical case definition for long COVID-19, as well as the first to apply this definition to EHR data using a chart review approach on a nationwide cohort across multiple health care systems. This chart review approach can be implemented at other EHR systems to further evaluate the utility and performance of the U09.9 code.
Language	English
Publishing date	2024-05-03
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2606835-7
ISSN	1947-2579
ISSN	1947-2579
DOI	10.2196/53445
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Article ; Online: Centralized Interactive Phenomics Resource: an integrated online phenomics knowledgebase for health data users.

Honerlaw, Jacqueline / Ho, Yuk-Lam / Fontin, Francesca / Murray, Michael / Galloway, Ashley / Heise, David / Connatser, Keith / Davies, Laura / Gosian, Jeffrey / Maripuri, Monika / Russo, John / Sangar, Rahul / Tanukonda, Vidisha / Zielinski, Edward / Dubreuil, Maureen / Zimolzak, Andrew J / Panickan, Vidul A / Cheng, Su-Chun / Whitbourne, Stacey B /

Gagnon, David R / Cai, Tianxi / Liao, Katherine P / Ramoni, Rachel B / Gaziano, J Michael / Muralidhar, Sumitra / Cho, Kelly

Journal of the American Medical Informatics Association : JAMIA

2024 Volume 31, Issue 5, Page(s) 1126–1134

Abstract: Objective: Development of clinical phenotypes from electronic health records (EHRs) can be resource intensive. Several phenotype libraries have been created to facilitate reuse of definitions. However, these platforms vary in target audience and utility. ...

Abstract	Objective: Development of clinical phenotypes from electronic health records (EHRs) can be resource intensive. Several phenotype libraries have been created to facilitate reuse of definitions. However, these platforms vary in target audience and utility. We describe the development of the Centralized Interactive Phenomics Resource (CIPHER) knowledgebase, a comprehensive public-facing phenotype library, which aims to facilitate clinical and health services research. Materials and methods: The platform was designed to collect and catalog EHR-based computable phenotype algorithms from any healthcare system, scale metadata management, facilitate phenotype discovery, and allow for integration of tools and user workflows. Phenomics experts were engaged in the development and testing of the site. Results: The knowledgebase stores phenotype metadata using the CIPHER standard, and definitions are accessible through complex searching. Phenotypes are contributed to the knowledgebase via webform, allowing metadata validation. Data visualization tools linking to the knowledgebase enhance user interaction with content and accelerate phenotype development. Discussion: The CIPHER knowledgebase was developed in the largest healthcare system in the United States and piloted with external partners. The design of the CIPHER website supports a variety of front-end tools and features to facilitate phenotype development and reuse. Health data users are encouraged to contribute their algorithms to the knowledgebase for wider dissemination to the research community, and to use the platform as a springboard for phenotyping. Conclusion: CIPHER is a public resource for all health data users available at https://phenomics.va.ornl.gov/ which facilitates phenotype reuse, development, and dissemination of phenotyping knowledge.
MeSH term(s)	Phenomics ; Phenotype ; Electronic Health Records ; Knowledge Bases ; Algorithms
Language	English
Publishing date	2024-03-13
Publishing country	England
Document type	Journal Article
ZDB-ID	1205156-1
ISSN	1527-974X ; 1067-5027
ISSN (online)	1527-974X
ISSN	1067-5027
DOI	10.1093/jamia/ocae042
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Zs.A 4128: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 312: Show issues

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Article ; Online: Framework of the Centralized Interactive Phenomics Resource (CIPHER) standard for electronic health data-based phenomics knowledgebase.

Honerlaw, Jacqueline / Ho, Yuk-Lam / Fontin, Francesca / Gosian, Jeffrey / Maripuri, Monika / Murray, Michael / Sangar, Rahul / Galloway, Ashley / Zimolzak, Andrew J / Whitbourne, Stacey B / Casas, Juan P / Ramoni, Rachel B / Gagnon, David R / Cai, Tianxi / Liao, Katherine P / Gaziano, J Michael / Muralidhar, Sumitra / Cho, Kelly

Journal of the American Medical Informatics Association : JAMIA

2023 Volume 30, Issue 5, Page(s) 958–964

Abstract: The development of phenotypes using electronic health records is a resource-intensive process. Therefore, the cataloging of phenotype algorithm metadata for reuse is critical to accelerate clinical research. The Department of Veterans Affairs (VA) has ... ...

Abstract	The development of phenotypes using electronic health records is a resource-intensive process. Therefore, the cataloging of phenotype algorithm metadata for reuse is critical to accelerate clinical research. The Department of Veterans Affairs (VA) has developed a standard for phenotype metadata collection which is currently used in the VA phenomics knowledgebase library, CIPHER (Centralized Interactive Phenomics Resource), to capture over 5000 phenotypes. The CIPHER standard improves upon existing phenotype library metadata collection by capturing the context of algorithm development, phenotyping method used, and approach to validation. While the standard was iteratively developed with VA phenomics experts, it is applicable to the capture of phenotypes across healthcare systems. We describe the framework of the CIPHER standard for phenotype metadata collection, the rationale for its development, and its current application to the largest healthcare system in the United States.
MeSH term(s)	United States ; Phenomics ; Electronic Health Records ; Phenotype ; Algorithms ; Metadata
Language	English
Publishing date	2023-03-07
Publishing country	England
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1205156-1
ISSN	1527-974X ; 1067-5027
ISSN (online)	1527-974X
ISSN	1067-5027
DOI	10.1093/jamia/ocad030
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Zs.A 4128: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 312: Show issues

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Article ; Online: Million Veteran Program's response to COVID-19: Survey development and preliminary findings.

Whitbourne, Stacey B / Nguyen, Xuan-Mai T / Song, Rebecca J / Lord, Emily / Lyden, Michelle / Harrington, Kelly M / Ward, Rachel / Li, Yanping / Brewer, Jessica V V / Cho, Kelly M / Djousse, Luc / Muralidhar, Sumitra / Tsao, Philip S / Gaziano, J Michael / Casas, Juan P

PloS one

2022 Volume 17, Issue 4, Page(s) e0266381

Abstract: Background: In response to the novel Coronavirus Disease 2019 (COVID-19) pandemic, the Department of Veterans Affairs (VA) Million Veteran Program (MVP) organized efforts to better understand the impact of COVID-19 on Veterans by developing and ... ...

Abstract	Background: In response to the novel Coronavirus Disease 2019 (COVID-19) pandemic, the Department of Veterans Affairs (VA) Million Veteran Program (MVP) organized efforts to better understand the impact of COVID-19 on Veterans by developing and deploying a self-reported survey. Methods: The MVP COVID-19 Survey was developed to collect COVID-19 specific elements including symptoms, diagnosis, hospitalization, behavioral and psychosocial factors and to augment existing MVP data with longitudinal collection of key domains in physical and mental health. Due to the rapidly evolving nature of the pandemic, a multipronged strategy was implemented to widely disseminate the COVID-19 Survey and capture data using both the online platform and mailings. Results: We limited the findings of this paper to the initial phase of survey dissemination which began in May 2020. A total of 729,625 eligible MVP Veterans were invited to complete version 1 of the COVID-19 Survey. As of October 31, 2020, 58,159 surveys have been returned. The mean and standard deviation (SD) age of responders was 71 (11) years, 8.6% were female, 8.2% were Black, 5.6% were Hispanic, and 446 (0.8%) self-reported a COVID-19 diagnosis. Over 90% of responders reported wearing masks, practicing social distancing, and frequent hand washing. Conclusion: The MVP COVID-19 Survey provides a systematic collection of data regarding COVID-19 behaviors among Veterans and represents one of the first large-scale, national surveillance efforts of COVID-19 in the Veteran population. Continued work will examine the overall response to the survey with comparison to available VA health record data.
MeSH term(s)	Aged ; COVID-19/epidemiology ; COVID-19 Testing ; Female ; Humans ; Male ; Mental Health ; Surveys and Questionnaires ; Veterans/psychology
Language	English
Publishing date	2022-04-25
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0266381
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