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2. Harnessing electronic health records for real-world evidence

Author

Hou, Jue, Zhao, Rachel, Gronsbell, Jessica, Beaulieu-Jones, Brett K., Webber, Griffin, Jemielita, Thomas, Wan, Shuyan, Hong, Chuan, Lin, Yucong, Cai, Tianrun, Wen, Jun, Panickan, Vidul A., Bonzel, Clara-Lea, Liaw, Kai-Li, Liao, Katherine P., and Cai, Tianxi

Subjects
Statistics - Applications
Abstract

While randomized controlled trials (RCTs) are the gold-standard for establishing the efficacy and safety of a medical treatment, real-world evidence (RWE) generated from real-world data (RWD) has been vital in post-approval monitoring and is being promoted for the regulatory process of experimental therapies. An emerging source of RWD is electronic health records (EHRs), which contain detailed information on patient care in both structured (e. g., diagnosis codes) and unstructured (e. g., clinical notes, images) form. Despite the granularity of the data available in EHRs, critical variables required to reliably assess the relationship between a treatment and clinical outcome can be challenging to extract. We provide an integrated data curation and modeling pipeline leveraging recent advances in natural language processing, computational phenotyping, modeling techniques with noisy data to address this fundamental challenge and accelerate the reliable use of EHRs for RWE, as well as the creation of digital twins. The proposed pipeline is highly automated for the task and includes guidance for deployment. Examples are also drawn from existing literature on EHR emulation of RCT and accompanied by our own studies with Mass General Brigham (MGB) EHR., Comment: 39 pages, 1 figure, 1 table

Published
2022

4. International comparisons of laboratory values from the 4CE collaborative to predict COVID-19 mortality

Author

Weber, Griffin M, Hong, Chuan, Xia, Zongqi, Palmer, Nathan P, Avillach, Paul, L’Yi, Sehi, Keller, Mark S, Murphy, Shawn N, Gutiérrez-Sacristán, Alba, Bonzel, Clara-Lea, Serret-Larmande, Arnaud, Neuraz, Antoine, Omenn, Gilbert S, Visweswaran, Shyam, Klann, Jeffrey G, South, Andrew M, Loh, Ne Hooi Will, Cannataro, Mario, Beaulieu-Jones, Brett K, Bellazzi, Riccardo, Agapito, Giuseppe, Alessiani, Mario, Aronow, Bruce J, Bell, Douglas S, Benoit, Vincent, Bourgeois, Florence T, Chiovato, Luca, Cho, Kelly, Dagliati, Arianna, DuVall, Scott L, Barrio, Noelia García, Hanauer, David A, Ho, Yuk-Lam, Holmes, John H, Issitt, Richard W, Liu, Molei, Luo, Yuan, Lynch, Kristine E, Maidlow, Sarah E, Malovini, Alberto, Mandl, Kenneth D, Mao, Chengsheng, Matheny, Michael E, Moore, Jason H, Morris, Jeffrey S, Morris, Michele, Mowery, Danielle L, Ngiam, Kee Yuan, Patel, Lav P, Pedrera-Jimenez, Miguel, Ramoni, Rachel B, Schriver, Emily R, Schubert, Petra, Balazote, Pablo Serrano, Spiridou, Anastasia, Tan, Amelia LM, Tan, Byorn WL, Tibollo, Valentina, Torti, Carlo, Trecarichi, Enrico M, Wang, Xuan, Kohane, Isaac S, Cai, Tianxi, and Brat, Gabriel A

Subjects
Health Services and Systems, Health Sciences, Basic Behavioral and Social Science, Behavioral and Social Science, Good Health and Well Being, Consortium for Clinical Characterization of COVID-19 by EHR, Health services and systems
Abstract

Given the growing number of prediction algorithms developed to predict COVID-19 mortality, we evaluated the transportability of a mortality prediction algorithm using a multi-national network of healthcare systems. We predicted COVID-19 mortality using baseline commonly measured laboratory values and standard demographic and clinical covariates across healthcare systems, countries, and continents. Specifically, we trained a Cox regression model with nine measured laboratory test values, standard demographics at admission, and comorbidity burden pre-admission. These models were compared at site, country, and continent level. Of the 39,969 hospitalized patients with COVID-19 (68.6% male), 5717 (14.3%) died. In the Cox model, age, albumin, AST, creatine, CRP, and white blood cell count are most predictive of mortality. The baseline covariates are more predictive of mortality during the early days of COVID-19 hospitalization. Models trained at healthcare systems with larger cohort size largely retain good transportability performance when porting to different sites. The combination of routine laboratory test values at admission along with basic demographic features can predict mortality in patients hospitalized with COVID-19. Importantly, this potentially deployable model differs from prior work by demonstrating not only consistent performance but also reliable transportability across healthcare systems in the US and Europe, highlighting the generalizability of this model and the overall approach.

Published
2022

5. ML4H Abstract Track 2019

Author

McDermott, Matthew B. A., Alsentzer, Emily, Finlayson, Sam, Oberst, Michael, Falck, Fabian, Naumann, Tristan, Beaulieu-Jones, Brett K., and Dalca, Adrian V.

Subjects
Computer Science - Machine Learning, Statistics - Machine Learning
Abstract

A collection of the accepted abstracts for the Machine Learning for Health (ML4H) workshop at NeurIPS 2019. This index is not complete, as some accepted abstracts chose to opt-out of inclusion.

Published
2020

6. Validation of an internationally derived patient severity phenotype to support COVID-19 analytics from electronic health record data

Author

Klann, Jeffrey G, Estiri, Hossein, Weber, Griffin M, Moal, Bertrand, Avillach, Paul, Hong, Chuan, Tan, Amelia LM, Beaulieu-Jones, Brett K, Castro, Victor, Maulhardt, Thomas, Geva, Alon, Malovini, Alberto, South, Andrew M, Visweswaran, Shyam, Morris, Michele, Samayamuthu, Malarkodi J, Omenn, Gilbert S, Ngiam, Kee Yuan, Mandl, Kenneth D, Boeker, Martin, Olson, Karen L, Mowery, Danielle L, Follett, Robert W, Hanauer, David A, Bellazzi, Riccardo, Moore, Jason H, Loh, Ne-Hooi Will, Bell, Douglas S, Wagholikar, Kavishwar B, Chiovato, Luca, Tibollo, Valentina, Rieg, Siegbert, Li, Anthony LLJ, Jouhet, Vianney, Schriver, Emily, Xia, Zongqi, Hutch, Meghan, Luo, Yuan, Kohane, Isaac S, EHR, The Consortium for Clinical Characterization of COVID-19 by, Brat, Gabriel A, and Murphy, Shawn N

Subjects
Health Services and Systems, Health Sciences, Patient Safety, HIV/AIDS, Good Health and Well Being, COVID-19, Electronic Health Records, Hospitalization, Humans, Machine Learning, Prognosis, ROC Curve, Sensitivity and Specificity, Severity of Illness Index, novel coronavirus, disease severity, computable phenotype, medical informatics, data networking, data interoperability, Consortium for Clinical Characterization of COVID-19 by EHR (4CE), Information and Computing Sciences, Engineering, Medical and Health Sciences, Medical Informatics, Biomedical and clinical sciences, Health sciences, Information and computing sciences
Abstract

ObjectiveThe Consortium for Clinical Characterization of COVID-19 by EHR (4CE) is an international collaboration addressing coronavirus disease 2019 (COVID-19) with federated analyses of electronic health record (EHR) data. We sought to develop and validate a computable phenotype for COVID-19 severity.Materials and methodsTwelve 4CE sites participated. First, we developed an EHR-based severity phenotype consisting of 6 code classes, and we validated it on patient hospitalization data from the 12 4CE clinical sites against the outcomes of intensive care unit (ICU) admission and/or death. We also piloted an alternative machine learning approach and compared selected predictors of severity with the 4CE phenotype at 1 site.ResultsThe full 4CE severity phenotype had pooled sensitivity of 0.73 and specificity 0.83 for the combined outcome of ICU admission and/or death. The sensitivity of individual code categories for acuity had high variability-up to 0.65 across sites. At one pilot site, the expert-derived phenotype had mean area under the curve of 0.903 (95% confidence interval, 0.886-0.921), compared with an area under the curve of 0.956 (95% confidence interval, 0.952-0.959) for the machine learning approach. Billing codes were poor proxies of ICU admission, with as low as 49% precision and recall compared with chart review.DiscussionWe developed a severity phenotype using 6 code classes that proved resilient to coding variability across international institutions. In contrast, machine learning approaches may overfit hospital-specific orders. Manual chart review revealed discrepancies even in the gold-standard outcomes, possibly owing to heterogeneous pandemic conditions.ConclusionsWe developed an EHR-based severity phenotype for COVID-19 in hospitalized patients and validated it at 12 international sites.

Published
2021

7. Clinical phenotypes and outcomes in children with multisystem inflammatory syndrome across SARS-CoV-2 variant eras: a multinational study from the 4CE consortium

Author

Aaron, James R., Adam, Atif, Agapito, Giuseppe, Albayrak, Adem, Albi, Giuseppe, Alessiani, Mario, Alloni, Anna, Amendola, Danilo F., Angoulvant, François, Anthony, Li LLJ., Aronow, Bruce J., Ashraf, Fatima, Atz, Andrew, Avillach, Paul, Panickan, Vidul Ayakulangara, Azevedo, Paula S., Badenes, Rafael, Balshi, James, Batugo, Ashley, Beaulieu-Jones, Brendin R., Beaulieu-Jones, Brett K., Bell, Douglas S., Bellasi, Antonio, Bellazzi, Riccardo, Benoit, Vincent, Beraghi, Michele, Bernal-Sobrino, José Luis, Bernaux, Mélodie, Bey, Romain, Bhatnagar, Surbhi, Blanco-Martínez, Alvar, Boeker, Martin, Bonzel, Clara-Lea, Booth, John, Bosari, Silvano, Bourgeois, Florence T., Bradford, Robert L., Brat, Gabriel A., Bréant, Stéphane, Brown, Nicholas W., Bruno, Raffaele, Bryant, William A., Bucalo, Mauro, Bucholz, Emily, Burgun, Anita, Cai, Tianxi, Cannataro, Mario, Carmona, Aldo, Cattelan, Anna Maria, Caucheteux, Charlotte, Champ, Julien, Chen, Jin, Chen, Krista Y., Chiovato, Luca, Chiudinelli, Lorenzo, Cho, Kelly, Cimino, James J., Colicchio, Tiago K., Cormont, Sylvie, Cossin, Sébastien, Craig, Jean B., Cruz-Bermúdez, Juan Luis, Cruz-Rojo, Jaime, Dagliati, Arianna, Daniar, Mohamad, Daniel, Christel, Das, Priyam, Devkota, Batsal, Dionne, Audrey, Duan, Rui, Dubiel, Julien, DuVall, Scott L., Esteve, Loic, Estiri, Hossein, Fan, Shirley, Follett, Robert W., Ganslandt, Thomas, García-Barrio, Noelia, Garmire, Lana X., Gehlenborg, Nils, Getzen, Emily J., Geva, Alon, Goh, Rachel SJ., González, Tomás González, Gradinger, Tobias, Gramfort, Alexandre, Griffier, Romain, Griffon, Nicolas, Grisel, Olivier, Gutiérrez-Sacristán, Alba, Guzzi, Pietro H., Han, Larry, Hanauer, David A., Haverkamp, Christian, Hazard, Derek Y., He, Bing, Henderson, Darren W., Hilka, Martin, Ho, Yuk-Lam, Holmes, John H., Honerlaw, Jacqueline P., Hong, Chuan, Huling, Kenneth M., Hutch, Meghan R., Issitt, Richard W., Jannot, Anne Sophie, Jouhet, Vianney, Kainth, Mundeep K., Kate, Kernan F., Kavuluru, Ramakanth, Keller, Mark S., Kennedy, Chris J., Kernan, Kate F., Key, Daniel A., Kirchoff, Katie, Klann, Jeffrey G., Kohane, Isaac S., Krantz, Ian D., Kraska, Detlef, Krishnamurthy, Ashok K., L'Yi, Sehi, Leblanc, Judith, Lemaitre, Guillaume, Lenert, Leslie, Leprovost, Damien, Liu, Molei, Will Loh, Ne Hooi, Long, Qi, Lozano-Zahonero, Sara, Luo, Yuan, Lynch, Kristine E., Mahmood, Sadiqa, Maidlow, Sarah E., Makoudjou, Adeline, Makwana, Simran, Malovini, Alberto, Mandl, Kenneth D., Mao, Chengsheng, Maram, Anupama, Maripuri, Monika, Martel, Patricia, Martins, Marcelo R., Marwaha, Jayson S., Masino, Aaron J., Mazzitelli, Maria, Mazzotti, Diego R., Mensch, Arthur, Milano, Marianna, Minicucci, Marcos F., Moal, Bertrand, Ahooyi, Taha Mohseni, Moore, Jason H., Moraleda, Cinta, Morris, Jeffrey S., Morris, Michele, Moshal, Karyn L., Mousavi, Sajad, Mowery, Danielle L., Murad, Douglas A., Murphy, Shawn N., Naughton, Thomas P., Breda Neto, Carlos Tadeu, Neuraz, Antoine, Newburger, Jane, Ngiam, Kee Yuan, Njoroge, Wanjiku FM., Norman, James B., Obeid, Jihad, Okoshi, Marina P., Olson, Karen L., Omenn, Gilbert S., Orlova, Nina, Ostasiewski, Brian D., Palmer, Nathan P., Paris, Nicolas, Patel, Lav P., Pedrera-Jiménez, Miguel, Pfaff, Ashley C., Pfaff, Emily R., Pillion, Danielle, Pizzimenti, Sara, Priya, Tanu, Prokosch, Hans U., Prudente, Robson A., Prunotto, Andrea, Quirós-González, Víctor, Ramoni, Rachel B., Raskin, Maryna, Rieg, Siegbert, Roig-Domínguez, Gustavo, Rojo, Pablo, Romero-Garcia, Nekane, Rubio-Mayo, Paula, Sacchi, Paolo, Sáez, Carlos, Salamanca, Elisa, Samayamuthu, Malarkodi Jebathilagam, Sanchez-Pinto, L. Nelson, Sandrin, Arnaud, Santhanam, Nandhini, Santos, Janaina C.C., Sanz Vidorreta, Fernando J., Savino, Maria, Schriver, Emily R., Schubert, Petra, Schuettler, Juergen, Scudeller, Luigia, Sebire, Neil J., Serrano-Balazote, Pablo, Serre, Patricia, Serret-Larmande, Arnaud, Shah, Mohsin A., Hossein Abad, Zahra Shakeri, Silvio, Domenick, Sliz, Piotr, Son, Jiyeon, Sonday, Charles, South, Andrew M., Sperotto, Francesca, Spiridou, Anastasia, Strasser, Zachary H., Tan, Amelia LM., Tan, Bryce W.Q., Tan, Byorn W.L., Tanni, Suzana E., Taylor, Deanne M., Terriza-Torres, Ana I., Tibollo, Valentina, Tippmann, Patric, Toh, Emma MS., Torti, Carlo, Trecarichi, Enrico M., Vallejos, Andrew K., Varoquaux, Gael, Vella, Margaret E., Verdy, Guillaume, Vie, Jill-Jênn, Visweswaran, Shyam, Vitacca, Michele, Wagholikar, Kavishwar B., Waitman, Lemuel R., Wang, Xuan, Wassermann, Demian, Weber, Griffin M., Wolkewitz, Martin, Wong, Scott, Xia, Zongqi, Xiong, Xin, Ye, Ye, Yehya, Nadir, Yuan, William, Zachariasse, Joany M., Zahner, Janet J., Zambelli, Alberto, Zhang, Harrison G., Zöller, Daniela, Zuccaro, Valentina, Zucco, Chiara, Li, Xiudi, Rofeberg, Valerie N., Elias, Matthew D., Laird-Gion, Jessica, and Newburger, Jane W.

Published
2023
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8. Characterization of long COVID temporal sub-phenotypes by distributed representation learning from electronic health record data: a cohort study

Author

Aaron, James R., Agapito, Giuseppe, Albayrak, Adem, Albi, Giuseppe, Alessiani, Mario, Alloni, Anna, Amendola, Danilo F., François Angoulvant, Anthony, Li L.L.J., Aronow, Bruce J., Ashraf, Fatima, Atz, Andrew, Avillach, Paul, Azevedo, Paula S., Balshi, James, Beaulieu-Jones, Brett K., Bell, Douglas S., Bellasi, Antonio, Bellazzi, Riccardo, Benoit, Vincent, Beraghi, Michele, Bernal-Sobrino, José Luis, Bernaux, Mélodie, Bey, Romain, Bhatnagar, Surbhi, Blanco-Martínez, Alvar, Bonzel, Clara-Lea, Booth, John, Bosari, Silvano, Bourgeois, Florence T., Bradford, Robert L., Brat, Gabriel A., Bréant, Stéphane, Brown, Nicholas W., Bruno, Raffaele, Bryant, William A., Bucalo, Mauro, Bucholz, Emily, Burgun, Anita, Cai, Tianxi, Cannataro, Mario, Carmona, Aldo, Caucheteux, Charlotte, Champ, Julien, Chen, Jin, Chen, Krista Y., Chiovato, Luca, Chiudinelli, Lorenzo, Cho, Kelly, Cimino, James J., Colicchio, Tiago K., Cormont, Sylvie, Cossin, Sébastien, Craig, Jean B., Cruz-Bermúdez, Juan Luis, Cruz-Rojo, Jaime, Dagliati, Arianna, Daniar, Mohamad, Daniel, Christel, Das, Priyam, Devkota, Batsal, Dionne, Audrey, Duan, Rui, Dubiel, Julien, DuVall, Scott L., Esteve, Loic, Estiri, Hossein, Fan, Shirley, Follett, Robert W., Ganslandt, Thomas, Barrio, Noelia García, Garmire, Lana X., Gehlenborg, Nils, Getzen, Emily J., Geva, Alon, Gradinger, Tobias, Gramfort, Alexandre, Griffier, Romain, Griffon, Nicolas, Grisel, Olivier, Gutiérrez-Sacristán, Alba, Han, Larry, Hanauer, David A., Haverkamp, Christian, Hazard, Derek Y., He, Bing, Henderson, Darren W., Hilka, Martin, Ho, Yuk-Lam, Holmes, John H., Hong, Chuan, Huling, Kenneth M., Hutch, Meghan R., Issitt, Richard W., Jannot, Anne Sophie, Jouhet, Vianney, Kavuluru, Ramakanth, Keller, Mark S., Kennedy, Chris J., Key, Daniel A., Kirchoff, Katie, Klann, Jeffrey G., Kohane, Isaac S., Krantz, Ian D., Kraska, Detlef, Krishnamurthy, Ashok K., L'Yi, Sehi, Le, Trang T., Leblanc, Judith, Lemaitre, Guillaume, Lenert, Leslie, Leprovost, Damien, Liu, Molei, Will Loh, Ne Hooi, Long, Qi, Lozano-Zahonero, Sara, Luo, Yuan, Lynch, Kristine E., Mahmood, Sadiqa, Maidlow, Sarah E., Makoudjou, Adeline, Malovini, Alberto, Mandl, Kenneth D., Mao, Chengsheng, Maram, Anupama, Martel, Patricia, Martins, Marcelo R., Marwaha, Jayson S., Masino, Aaron J., Mazzitelli, Maria, Mensch, Arthur, Milano, Marianna, Minicucci, Marcos F., Moal, Bertrand, Ahooyi, Taha Mohseni, Moore, Jason H., Moraleda, Cinta, Morris, Jeffrey S., Morris, Michele, Moshal, Karyn L., Mousavi, Sajad, Mowery, Danielle L., Murad, Douglas A., Murphy, Shawn N., Naughton, Thomas P., Breda Neto, Carlos Tadeu, Neuraz, Antoine, Newburger, Jane, Ngiam, Kee Yuan, Njoroge, Wanjiku F.M., Norman, James B., Obeid, Jihad, Okoshi, Marina P., Olson, Karen L., Omenn, Gilbert S., Orlova, Nina, Ostasiewski, Brian D., Palmer, Nathan P., Paris, Nicolas, Patel, Lav P., Pedrera-Jiménez, Miguel, Pfaff, Emily R., Pfaff, Ashley C., Pillion, Danielle, Pizzimenti, Sara, Prokosch, Hans U., Prudente, Robson A., Prunotto, Andrea, Quirós-González, Víctor, Ramoni, Rachel B., Raskin, Maryna, Rieg, Siegbert, Roig-Domínguez, Gustavo, Rojo, Pablo, Rubio-Mayo, Paula, Sacchi, Paolo, Sáez, Carlos, Salamanca, Elisa, Samayamuthu, Malarkodi Jebathilagam, Sanchez-Pinto, L. Nelson, Sandrin, Arnaud, Santhanam, Nandhini, Santos, Janaina C.C., Sanz Vidorreta, Fernando J., Savino, Maria, Schriver, Emily R., Schubert, Petra, Schuettler, Juergen, Scudeller, Luigia, Sebire, Neil J., Serrano-Balazote, Pablo, Serre, Patricia, Serret-Larmande, Arnaud, Shah, Mohsin, Hossein Abad, Zahra Shakeri, Silvio, Domenick, Sliz, Piotr, Son, Jiyeon, Sonday, Charles, South, Andrew M., Spiridou, Anastasia, Strasser, Zachary H., Tan, Amelia L.M., Tan, Bryce W.Q., Tan, Byorn W.L., Tanni, Suzana E., Taylor, Deanne M., Terriza-Torres, Ana I., Tibollo, Valentina, Tippmann, Patric, Toh, Emma M.S., Torti, Carlo, Trecarichi, Enrico M., Tseng, Yi-Ju, Vallejos, Andrew K., Varoquaux, Gael, Vella, Margaret E., Verdy, Guillaume, Vie, Jill-Jênn, Visweswaran, Shyam, Vitacca, Michele, Wagholikar, Kavishwar B., Waitman, Lemuel R., Wang, Xuan, Wassermann, Demian, Weber, Griffin M., Wolkewitz, Martin, Wong, Scott, Xia, Zongqi, Xiong, Xin, Ye, Ye, Yehya, Nadir, Yuan, William, Zambelli, Alberto, Zhang, Harrison G., Zo¨ller, Daniela, Zuccaro, Valentina, Zucco, Chiara, Mesa, Rebecca, and Verdy, Guillame

Published
2023
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9. International electronic health record-derived COVID-19 clinical course profiles: the 4CE consortium

Author

Brat, Gabriel A, Weber, Griffin M, Gehlenborg, Nils, Avillach, Paul, Palmer, Nathan P, Chiovato, Luca, Cimino, James, Waitman, Lemuel R, Omenn, Gilbert S, Malovini, Alberto, Moore, Jason H, Beaulieu-Jones, Brett K, Tibollo, Valentina, Murphy, Shawn N, Yi, Sehi L’, Keller, Mark S, Bellazzi, Riccardo, Hanauer, David A, Serret-Larmande, Arnaud, Gutierrez-Sacristan, Alba, Holmes, John J, Bell, Douglas S, Mandl, Kenneth D, Follett, Robert W, Klann, Jeffrey G, Murad, Douglas A, Scudeller, Luigia, Bucalo, Mauro, Kirchoff, Katie, Craig, Jean, Obeid, Jihad, Jouhet, Vianney, Griffier, Romain, Cossin, Sebastien, Moal, Bertrand, Patel, Lav P, Bellasi, Antonio, Prokosch, Hans U, Kraska, Detlef, Sliz, Piotr, Tan, Amelia LM, Ngiam, Kee Yuan, Zambelli, Alberto, Mowery, Danielle L, Schiver, Emily, Devkota, Batsal, Bradford, Robert L, Daniar, Mohamad, Daniel, Christel, Benoit, Vincent, Bey, Romain, Paris, Nicolas, Serre, Patricia, Orlova, Nina, Dubiel, Julien, Hilka, Martin, Jannot, Anne Sophie, Breant, Stephane, Leblanc, Judith, Griffon, Nicolas, Burgun, Anita, Bernaux, Melodie, Sandrin, Arnaud, Salamanca, Elisa, Cormont, Sylvie, Ganslandt, Thomas, Gradinger, Tobias, Champ, Julien, Boeker, Martin, Martel, Patricia, Esteve, Loic, Gramfort, Alexandre, Grisel, Olivier, Leprovost, Damien, Moreau, Thomas, Varoquaux, Gael, Vie, Jill-Jênn, Wassermann, Demian, Mensch, Arthur, Caucheteux, Charlotte, Haverkamp, Christian, Lemaitre, Guillaume, Bosari, Silvano, Krantz, Ian D, South, Andrew, Cai, Tianxi, and Kohane, Isaac S

Subjects
Health Services and Systems, Health Sciences, Good Health and Well Being, Databases, Outcomes research, Viral infection, Health services and systems
Abstract

We leveraged the largely untapped resource of electronic health record data to address critical clinical and epidemiological questions about Coronavirus Disease 2019 (COVID-19). To do this, we formed an international consortium (4CE) of 96 hospitals across five countries (www.covidclinical.net). Contributors utilized the Informatics for Integrating Biology and the Bedside (i2b2) or Observational Medical Outcomes Partnership (OMOP) platforms to map to a common data model. The group focused on temporal changes in key laboratory test values. Harmonized data were analyzed locally and converted to a shared aggregate form for rapid analysis and visualization of regional differences and global commonalities. Data covered 27,584 COVID-19 cases with 187,802 laboratory tests. Case counts and laboratory trajectories were concordant with existing literature. Laboratory tests at the time of diagnosis showed hospital-level differences equivalent to country-level variation across the consortium partners. Despite the limitations of decentralized data generation, we established a framework to capture the trajectory of COVID-19 disease in patients and their response to interventions.

Published
2020

10. Examining the Use of Real‐World Evidence in the Regulatory Process

Author

Beaulieu‐Jones, Brett K, Finlayson, Samuel G, Yuan, William, Altman, Russ B, Kohane, Isaac S, Prasad, Vinay, and Yu, Kun‐Hsing

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Clinical Trials as Topic, Decision Making, Evidence-Based Medicine, Humans, United States, United States Food and Drug Administration, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

The 21st Century Cures Act passed by the United States Congress mandates the US Food and Drug Administration to develop guidance to evaluate the use of real-world evidence (RWE) to support the regulatory process. RWE has generated important medical discoveries, especially in areas where traditional clinical trials would be unethical or infeasible. However, RWE suffers from several issues that hinder its ability to provide proof of treatment efficacy at a level comparable to randomized controlled trials. In this review article, we summarized the advantages and limitations of RWE, identified the key opportunities for RWE, and pointed the way forward to maximize the potential of RWE for regulatory purposes.

Published
2020

11. Privacy-Preserving Distributed Deep Learning for Clinical Data

Author

Beaulieu-Jones, Brett K., Yuan, William, Finlayson, Samuel G., and Wu, Zhiwei Steven

Subjects
Computer Science - Machine Learning, Statistics - Machine Learning
Abstract

Deep learning with medical data often requires larger samples sizes than are available at single providers. While data sharing among institutions is desirable to train more accurate and sophisticated models, it can lead to severe privacy concerns due the sensitive nature of the data. This problem has motivated a number of studies on distributed training of neural networks that do not require direct sharing of the training data. However, simple distributed training does not offer provable privacy guarantees to satisfy technical safe standards and may reveal information about the underlying patients. We present a method to train neural networks for clinical data in a distributed fashion under differential privacy. We demonstrate these methods on two datasets that include information from multiple independent sites, the eICU collaborative Research Database and The Cancer Genome Atlas., Comment: Machine Learning for Health (ML4H) Workshop at NeurIPS 2018 arXiv:1811.07216

Published
2018

12. Machine Learning for Health (ML4H) Workshop at NeurIPS 2018

Author

Antropova, Natalia, Beam, Andrew L., Beaulieu-Jones, Brett K., Chen, Irene, Chivers, Corey, Dalca, Adrian, Finlayson, Sam, Fiterau, Madalina, Fries, Jason Alan, Ghassemi, Marzyeh, Hughes, Mike, Jedynak, Bruno, Kandola, Jasvinder S., McDermott, Matthew, Naumann, Tristan, Schulam, Peter, Shamout, Farah, and Yahi, Alexandre

Subjects
Computer Science - Machine Learning, Statistics - Machine Learning
Abstract

This volume represents the accepted submissions from the Machine Learning for Health (ML4H) workshop at the conference on Neural Information Processing Systems (NeurIPS) 2018, held on December 8, 2018 in Montreal, Canada., Comment: Machine Learning for Health (ML4H) Workshop at NeurIPS 2018 arXiv:1811.07216

Published
2018

13. Learning Contextual Hierarchical Structure of Medical Concepts with Poincair\'e Embeddings to Clarify Phenotypes

Author

Beaulieu-Jones, Brett K., Kohane, Isaac S., and Beam, Andrew L.

Subjects
Quantitative Biology - Quantitative Methods, Computer Science - Computation and Language
Abstract

Biomedical association studies are increasingly done using clinical concepts, and in particular diagnostic codes from clinical data repositories as phenotypes. Clinical concepts can be represented in a meaningful, vector space using word embedding models. These embeddings allow for comparison between clinical concepts or for straightforward input to machine learning models. Using traditional approaches, good representations require high dimensionality, making downstream tasks such as visualization more difficult. We applied Poincar\'e embeddings in a 2-dimensional hyperbolic space to a large-scale administrative claims database and show performance comparable to 100-dimensional embeddings in a euclidean space. We then examine disease relationships under different disease contexts to better understand potential phenotypes., Comment: To appear in 2019 Pacific Symposium on Biocomputing

Published
2018

14. Machine Learning for Structured Clinical Data

Author

Beaulieu-Jones, Brett K.

Subjects
Computer Science - Learning
Abstract

Research is a tertiary priority in the EHR, where the priorities are patient care and billing. Because of this, the data is not standardized or formatted in a manner easily adapted to machine learning approaches. Data may be missing for a large variety of reasons ranging from individual input styles to differences in clinical decision making, for example, which lab tests to issue. Few patients are annotated at a research quality, limiting sample size and presenting a moving gold standard. Patient progression over time is key to understanding many diseases but many machine learning algorithms require a snapshot, at a single time point, to create a usable vector form. Furthermore, algorithms that produce black box results do not provide the interpretability required for clinical adoption. This chapter discusses these challenges and others in applying machine learning techniques to the structured EHR (i.e. Patient Demographics, Family History, Medication Information, Vital Signs, Laboratory Tests, Genetic Testing). It does not cover feature extraction from additional sources such as imaging data or free text patient notes but the approaches discussed can include features extracted from these sources.

Published
2017

16. Predicting seizure recurrence after an initial seizure-like episode from routine clinical notes using large language models: a retrospective cohort study

Author

Beaulieu-Jones, Brett K, primary, Villamar, Mauricio F, additional, Scordis, Phil, additional, Bartmann, Ana Paula, additional, Ali, Waqar, additional, Wissel, Benjamin D, additional, Alsentzer, Emily, additional, de Jong, Johann, additional, Patra, Arijit, additional, and Kohane, Isaac, additional

Published
2023
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18. Minimum information about clinical artificial intelligence modeling: the MI-CLAIM checklist

Author

Norgeot, Beau, Quer, Giorgio, Beaulieu-Jones, Brett K., Torkamani, Ali, Dias, Raquel, Gianfrancesco, Milena, Arnaout, Rima, Kohane, Isaac S., Saria, Suchi, Topol, Eric, Obermeyer, Ziad, Yu, Bin, and Butte, Atul J.

Subjects
Medical research -- Standards -- Ethical aspects, Medicine, Experimental -- Standards -- Ethical aspects, Artificial intelligence -- Models -- Usage, Disclosure of information -- Standards, Clinical trials -- Standards -- Ethical aspects, Machine learning -- Models -- Usage, Artificial intelligence, Biological sciences, Health
Abstract

Here we present the MI-CLAIM checklist, a tool intended to improve transparent reporting of AI algorithms in medicine., Author(s): Beau Norgeot [sup.1] , Giorgio Quer [sup.2] , Brett K. Beaulieu-Jones [sup.3] , Ali Torkamani [sup.2] , Raquel Dias [sup.2] , Milena Gianfrancesco [sup.4] , Rima Arnaout [sup.1] , [...]

Published
2020
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19. Clinical phenotypes and outcomes in children with multisystem inflammatory syndrome across SARS-CoV-2 variant eras: a multinational study from the 4CE consortium

Author

Sperotto, Francesca, primary, Gutiérrez-Sacristán, Alba, additional, Makwana, Simran, additional, Li, Xiudi, additional, Rofeberg, Valerie N., additional, Cai, Tianxi, additional, Bourgeois, Florence T., additional, Omenn, Gilbert S., additional, Hanauer, David A., additional, Sáez, Carlos, additional, Bonzel, Clara-Lea, additional, Bucholz, Emily, additional, Dionne, Audrey, additional, Elias, Matthew D., additional, García-Barrio, Noelia, additional, González, Tomás González, additional, Issitt, Richard W., additional, Kernan, Kate F., additional, Laird-Gion, Jessica, additional, Maidlow, Sarah E., additional, Mandl, Kenneth D., additional, Ahooyi, Taha Mohseni, additional, Moraleda, Cinta, additional, Morris, Michele, additional, Moshal, Karyn L., additional, Pedrera-Jiménez, Miguel, additional, Shah, Mohsin A., additional, South, Andrew M., additional, Spiridou, Anastasia, additional, Taylor, Deanne M., additional, Verdy, Guillaume, additional, Visweswaran, Shyam, additional, Wang, Xuan, additional, Xia, Zongqi, additional, Zachariasse, Joany M., additional, Newburger, Jane W., additional, Avillach, Paul, additional, Aaron, James R., additional, Adam, Atif, additional, Agapito, Giuseppe, additional, Albayrak, Adem, additional, Albi, Giuseppe, additional, Alessiani, Mario, additional, Alloni, Anna, additional, Amendola, Danilo F., additional, Angoulvant, François, additional, Anthony, Li LLJ., additional, Aronow, Bruce J., additional, Ashraf, Fatima, additional, Atz, Andrew, additional, Panickan, Vidul Ayakulangara, additional, Azevedo, Paula S., additional, Badenes, Rafael, additional, Balshi, James, additional, Batugo, Ashley, additional, Beaulieu-Jones, Brendin R., additional, Beaulieu-Jones, Brett K., additional, Bell, Douglas S., additional, Bellasi, Antonio, additional, Bellazzi, Riccardo, additional, Benoit, Vincent, additional, Beraghi, Michele, additional, Bernal-Sobrino, José Luis, additional, Bernaux, Mélodie, additional, Bey, Romain, additional, Bhatnagar, Surbhi, additional, Blanco-Martínez, Alvar, additional, Boeker, Martin, additional, Booth, John, additional, Bosari, Silvano, additional, Bradford, Robert L., additional, Brat, Gabriel A., additional, Bréant, Stéphane, additional, Brown, Nicholas W., additional, Bruno, Raffaele, additional, Bryant, William A., additional, Bucalo, Mauro, additional, Burgun, Anita, additional, Cannataro, Mario, additional, Carmona, Aldo, additional, Cattelan, Anna Maria, additional, Caucheteux, Charlotte, additional, Champ, Julien, additional, Chen, Jin, additional, Chen, Krista Y., additional, Chiovato, Luca, additional, Chiudinelli, Lorenzo, additional, Cho, Kelly, additional, Cimino, James J., additional, Colicchio, Tiago K., additional, Cormont, Sylvie, additional, Cossin, Sébastien, additional, Craig, Jean B., additional, Cruz-Bermúdez, Juan Luis, additional, Cruz-Rojo, Jaime, additional, Dagliati, Arianna, additional, Daniar, Mohamad, additional, Daniel, Christel, additional, Das, Priyam, additional, Devkota, Batsal, additional, Duan, Rui, additional, Dubiel, Julien, additional, DuVall, Scott L., additional, Esteve, Loic, additional, Estiri, Hossein, additional, Fan, Shirley, additional, Follett, Robert W., additional, Ganslandt, Thomas, additional, Garmire, Lana X., additional, Gehlenborg, Nils, additional, Getzen, Emily J., additional, Geva, Alon, additional, Goh, Rachel SJ., additional, Gradinger, Tobias, additional, Gramfort, Alexandre, additional, Griffier, Romain, additional, Griffon, Nicolas, additional, Grisel, Olivier, additional, Guzzi, Pietro H., additional, Han, Larry, additional, Haverkamp, Christian, additional, Hazard, Derek Y., additional, He, Bing, additional, Henderson, Darren W., additional, Hilka, Martin, additional, Ho, Yuk-Lam, additional, Holmes, John H., additional, Honerlaw, Jacqueline P., additional, Hong, Chuan, additional, Huling, Kenneth M., additional, Hutch, Meghan R., additional, Jannot, Anne Sophie, additional, Jouhet, Vianney, additional, Kainth, Mundeep K., additional, Kate, Kernan F., additional, Kavuluru, Ramakanth, additional, Keller, Mark S., additional, Kennedy, Chris J., additional, Key, Daniel A., additional, Kirchoff, Katie, additional, Klann, Jeffrey G., additional, Kohane, Isaac S., additional, Krantz, Ian D., additional, Kraska, Detlef, additional, Krishnamurthy, Ashok K., additional, L'Yi, Sehi, additional, Leblanc, Judith, additional, Lemaitre, Guillaume, additional, Lenert, Leslie, additional, Leprovost, Damien, additional, Liu, Molei, additional, Will Loh, Ne Hooi, additional, Long, Qi, additional, Lozano-Zahonero, Sara, additional, Luo, Yuan, additional, Lynch, Kristine E., additional, Mahmood, Sadiqa, additional, Makoudjou, Adeline, additional, Malovini, Alberto, additional, Mao, Chengsheng, additional, Maram, Anupama, additional, Maripuri, Monika, additional, Martel, Patricia, additional, Martins, Marcelo R., additional, Marwaha, Jayson S., additional, Masino, Aaron J., additional, Mazzitelli, Maria, additional, Mazzotti, Diego R., additional, Mensch, Arthur, additional, Milano, Marianna, additional, Minicucci, Marcos F., additional, Moal, Bertrand, additional, Moore, Jason H., additional, Morris, Jeffrey S., additional, Mousavi, Sajad, additional, Mowery, Danielle L., additional, Murad, Douglas A., additional, Murphy, Shawn N., additional, Naughton, Thomas P., additional, Breda Neto, Carlos Tadeu, additional, Neuraz, Antoine, additional, Newburger, Jane, additional, Ngiam, Kee Yuan, additional, Njoroge, Wanjiku FM., additional, Norman, James B., additional, Obeid, Jihad, additional, Okoshi, Marina P., additional, Olson, Karen L., additional, Orlova, Nina, additional, Ostasiewski, Brian D., additional, Palmer, Nathan P., additional, Paris, Nicolas, additional, Patel, Lav P., additional, Pfaff, Ashley C., additional, Pfaff, Emily R., additional, Pillion, Danielle, additional, Pizzimenti, Sara, additional, Priya, Tanu, additional, Prokosch, Hans U., additional, Prudente, Robson A., additional, Prunotto, Andrea, additional, Quirós-González, Víctor, additional, Ramoni, Rachel B., additional, Raskin, Maryna, additional, Rieg, Siegbert, additional, Roig-Domínguez, Gustavo, additional, Rojo, Pablo, additional, Romero-Garcia, Nekane, additional, Rubio-Mayo, Paula, additional, Sacchi, Paolo, additional, Salamanca, Elisa, additional, Samayamuthu, Malarkodi Jebathilagam, additional, Sanchez-Pinto, L. Nelson, additional, Sandrin, Arnaud, additional, Santhanam, Nandhini, additional, Santos, Janaina C.C., additional, Sanz Vidorreta, Fernando J., additional, Savino, Maria, additional, Schriver, Emily R., additional, Schubert, Petra, additional, Schuettler, Juergen, additional, Scudeller, Luigia, additional, Sebire, Neil J., additional, Serrano-Balazote, Pablo, additional, Serre, Patricia, additional, Serret-Larmande, Arnaud, additional, Hossein Abad, Zahra Shakeri, additional, Silvio, Domenick, additional, Sliz, Piotr, additional, Son, Jiyeon, additional, Sonday, Charles, additional, Sperotto, Francesca, additional, Strasser, Zachary H., additional, Tan, Amelia LM., additional, Tan, Bryce W.Q., additional, Tan, Byorn W.L., additional, Tanni, Suzana E., additional, Terriza-Torres, Ana I., additional, Tibollo, Valentina, additional, Tippmann, Patric, additional, Toh, Emma MS., additional, Torti, Carlo, additional, Trecarichi, Enrico M., additional, Vallejos, Andrew K., additional, Varoquaux, Gael, additional, Vella, Margaret E., additional, Vie, Jill-Jênn, additional, Vitacca, Michele, additional, Wagholikar, Kavishwar B., additional, Waitman, Lemuel R., additional, Wassermann, Demian, additional, Weber, Griffin M., additional, Wolkewitz, Martin, additional, Wong, Scott, additional, Xiong, Xin, additional, Ye, Ye, additional, Yehya, Nadir, additional, Yuan, William, additional, Zahner, Janet J., additional, Zambelli, Alberto, additional, Zhang, Harrison G., additional, Zöller, Daniela, additional, Zuccaro, Valentina, additional, and Zucco, Chiara, additional

Published
2023
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20. What Every Reader Should Know About Studies Using Electronic Health Record Data but May Be Afraid to Ask

Author

Kohane, Isaac S, Aronow, Bruce J, Avillach, Paul, Beaulieu-Jones, Brett K, Bellazzi, Riccardo, Bradford, Robert L, Brat, Gabriel A, Cannataro, Mario, Cimino, James J, García-Barrio, Noelia, Gehlenborg, Nils, Ghassemi, Marzyeh, Gutiérrez-Sacristán, Alba, Hanauer, David A, Holmes, John H, Hong, Chuan, Klann, Jeffrey G, Loh, Ne Hooi Will, Luo, Yuan, Mandl, Kenneth D, Daniar, Mohamad, Moore, Jason H, Murphy, Shawn N, Neuraz, Antoine, Ngiam, Kee Yuan, Omenn, Gilbert S, Palmer, Nathan, Patel, Lav P, Pedrera-Jiménez, Miguel, Sliz, Piotr, South, Andrew M, Tan, Amelia Li Min, Taylor, Deanne M, Taylor, Bradley W, Torti, Carlo, Vallejos, Andrew K, Wagholikar, Kavishwar B, Weber, Griffin M, and Cai, Tianxi

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract

Coincident with the tsunami of COVID-19–related publications, there has been a surge of studies using real-world data, including those obtained from the electronic health record (EHR). Unfortunately, several of these high-profile publications were retracted because of concerns regarding the soundness and quality of the studies and the EHR data they purported to analyze. These retractions highlight that although a small community of EHR informatics experts can readily identify strengths and flaws in EHR-derived studies, many medical editorial teams and otherwise sophisticated medical readers lack the framework to fully critically appraise these studies. In addition, conventional statistical analyses cannot overcome the need for an understanding of the opportunities and limitations of EHR-derived studies. We distill here from the broader informatics literature six key considerations that are crucial for appraising studies utilizing EHR data: data completeness, data collection and handling (eg, transformation), data type (ie, codified, textual), robustness of methods against EHR variability (within and across institutions, countries, and time), transparency of data and analytic code, and the multidisciplinary approach. These considerations will inform researchers, clinicians, and other stakeholders as to the recommended best practices in reviewing manuscripts, grants, and other outputs from EHR-data derived studies, and thereby promote and foster rigor, quality, and reliability of this rapidly growing field.

Published
2021
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22. Generate Analysis-Ready Data for Real-world Evidence: Tutorial for Harnessing Electronic Health Records With Advanced Informatic Technologies

Author

Hou, Jue, primary, Zhao, Rachel, additional, Gronsbell, Jessica, additional, Lin, Yucong, additional, Bonzel, Clara-Lea, additional, Zeng, Qingyi, additional, Zhang, Sinian, additional, Beaulieu-Jones, Brett K, additional, Weber, Griffin M, additional, Jemielita, Thomas, additional, Wan, Shuyan Sabrina, additional, Hong, Chuan, additional, Cai, Tianrun, additional, Wen, Jun, additional, Ayakulangara Panickan, Vidul, additional, Liaw, Kai-Li, additional, Liao, Katherine, additional, and Cai, Tianxi, additional

Published
2023
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24. Generate Analysis-Ready Data for Real-world Evidence: Tutorial for Harnessing Electronic Health Records With Advanced Informatic Technologies (Preprint)

Author

Hou, Jue, primary, Zhao, Rachel, additional, Gronsbell, Jessica, additional, Lin, Yucong, additional, Bonzel, Clara-Lea, additional, Zeng, Qingyi, additional, Zhang, Sinian, additional, Beaulieu-Jones, Brett K, additional, Weber, Griffin M, additional, Jemielita, Thomas, additional, Wan, Shuyan Sabrina, additional, Hong, Chuan, additional, Cai, Tianrun, additional, Wen, Jun, additional, Ayakulangara Panickan, Vidul, additional, Liaw, Kai-Li, additional, Liao, Katherine, additional, and Cai, Tianxi, additional

Published
2023
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25. Long-term kidney function recovery and mortality after COVID-19-associated acute kidney injury: an international multi-centre observational cohort study

Author

Tan, Byorn W.L., primary, Tan, Bryce W.Q., additional, Tan, Amelia L.M., additional, Schriver, Emily R., additional, Gutiérrez-Sacristán, Alba, additional, Das, Priyam, additional, Yuan, William, additional, Hutch, Meghan R., additional, García Barrio, Noelia, additional, Pedrera Jimenez, Miguel, additional, Abu-el-rub, Noor, additional, Morris, Michele, additional, Moal, Bertrand, additional, Verdy, Guillaume, additional, Cho, Kelly, additional, Ho, Yuk-Lam, additional, Patel, Lav P., additional, Dagliati, Arianna, additional, Neuraz, Antoine, additional, Klann, Jeffrey G., additional, South, Andrew M., additional, Visweswaran, Shyam, additional, Hanauer, David A., additional, Maidlow, Sarah E., additional, Liu, Mei, additional, Mowery, Danielle L., additional, Batugo, Ashley, additional, Makoudjou, Adeline, additional, Tippmann, Patric, additional, Zöller, Daniela, additional, Brat, Gabriel A., additional, Luo, Yuan, additional, Avillach, Paul, additional, Bellazzi, Riccardo, additional, Chiovato, Luca, additional, Malovini, Alberto, additional, Tibollo, Valentina, additional, Samayamuthu, Malarkodi Jebathilagam, additional, Serrano Balazote, Pablo, additional, Xia, Zongqi, additional, Loh, Ne Hooi Will, additional, Chiudinelli, Lorenzo, additional, Bonzel, Clara-Lea, additional, Hong, Chuan, additional, Zhang, Harrison G., additional, Weber, Griffin M., additional, Kohane, Isaac S., additional, Cai, Tianxi, additional, Omenn, Gilbert S., additional, Holmes, John H., additional, Ngiam, Kee Yuan, additional, Aaron, James R., additional, Agapito, Giuseppe, additional, Albayrak, Adem, additional, Albi, Giuseppe, additional, Alessiani, Mario, additional, Alloni, Anna, additional, Amendola, Danilo F., additional, Angoulvant, François, additional, Anthony, Li L.L.J., additional, Aronow, Bruce J., additional, Ashraf, Fatima, additional, Atz, Andrew, additional, Panickan, Vidul Ayakulangara, additional, Azevedo, Paula S., additional, Balshi, James, additional, Beaulieu-Jones, Brett K., additional, Beaulieu-Jones, Brendin R., additional, Bell, Douglas S., additional, Bellasi, Antonio, additional, Benoit, Vincent, additional, Beraghi, Michele, additional, Bernal-Sobrino, José Luis, additional, Bernaux, Mélodie, additional, Bey, Romain, additional, Bhatnagar, Surbhi, additional, Blanco-Martínez, Alvar, additional, Boeker, Martin, additional, Booth, John, additional, Bosari, Silvano, additional, Bourgeois, Florence T., additional, Bradford, Robert L., additional, Bréant, Stéphane, additional, Brown, Nicholas W., additional, Bruno, Raffaele, additional, Bryant, William A., additional, Bucalo, Mauro, additional, Bucholz, Emily, additional, Burgun, Anita, additional, Cannataro, Mario, additional, Carmona, Aldo, additional, Cattelan, Anna Maria, additional, Caucheteux, Charlotte, additional, Champ, Julien, additional, Chen, Jin, additional, Chen, Krista Y., additional, Cimino, James J., additional, Colicchio, Tiago K., additional, Cormont, Sylvie, additional, Cossin, Sébastien, additional, Craig, Jean B., additional, Cruz-Bermúdez, Juan Luis, additional, Cruz-Rojo, Jaime, additional, Daniar, Mohamad, additional, Daniel, Christel, additional, Devkota, Batsal, additional, Dionne, Audrey, additional, Duan, Rui, additional, Dubiel, Julien, additional, DuVall, Scott L., additional, Esteve, Loic, additional, Estiri, Hossein, additional, Fan, Shirley, additional, Follett, Robert W., additional, Ganslandt, Thomas, additional, García-Barrio, Noelia, additional, Garmire, Lana X., additional, Gehlenborg, Nils, additional, Getzen, Emily J., additional, Geva, Alon, additional, González, Tomás González, additional, Gradinger, Tobias, additional, Gramfort, Alexandre, additional, Griffier, Romain, additional, Griffon, Nicolas, additional, Grisel, Olivier, additional, Guzzi, Pietro H., additional, Han, Larry, additional, Haverkamp, Christian, additional, Hazard, Derek Y., additional, He, Bing, additional, Henderson, Darren W., additional, Hilka, Martin, additional, Honerlaw, Jacqueline P., additional, Huling, Kenneth M., additional, Issitt, Richard W., additional, Jannot, Anne Sophie, additional, Jouhet, Vianney, additional, Kavuluru, Ramakanth, additional, Keller, Mark S., additional, Kennedy, Chris J., additional, Kernan, Kate F., additional, Key, Daniel A., additional, Kirchoff, Katie, additional, Krantz, Ian D., additional, Kraska, Detlef, additional, Krishnamurthy, Ashok K., additional, L'Yi, Sehi, additional, Le, Trang T., additional, Leblanc, Judith, additional, Lemaitre, Guillaume, additional, Lenert, Leslie, additional, Leprovost, Damien, additional, Liu, Molei, additional, Will Loh, Ne Hooi, additional, Long, Qi, additional, Lozano-Zahonero, Sara, additional, Lynch, Kristine E., additional, Mahmood, Sadiqa, additional, Makwana, Simran, additional, Mandl, Kenneth D., additional, Mao, Chengsheng, additional, Maram, Anupama, additional, Maripuri, Monika, additional, Martel, Patricia, additional, Martins, Marcelo R., additional, Marwaha, Jayson S., additional, Masino, Aaron J., additional, Mazzitelli, Maria, additional, Mazzotti, Diego R., additional, Mensch, Arthur, additional, Milano, Marianna, additional, Minicucci, Marcos F., additional, Ahooyi, Taha Mohseni, additional, Moore, Jason H., additional, Moraleda, Cinta, additional, Morris, Jeffrey S., additional, Moshal, Karyn L., additional, Mousavi, Sajad, additional, Murad, Douglas A., additional, Murphy, Shawn N., additional, Naughton, Thomas P., additional, Breda Neto, Carlos Tadeu, additional, Newburger, Jane, additional, Njoroge, Wanjiku F.M., additional, Norman, James B., additional, Obeid, Jihad, additional, Okoshi, Marina P., additional, Olson, Karen L., additional, Orlova, Nina, additional, Ostasiewski, Brian D., additional, Palmer, Nathan P., additional, Paris, Nicolas, additional, Pedrera-Jiménez, Miguel, additional, Pfaff, Ashley C., additional, Pfaff, Emily R., additional, Pillion, Danielle, additional, Pizzimenti, Sara, additional, Priya, Tanu, additional, Prokosch, Hans U., additional, Prudente, Robson A., additional, Prunotto, Andrea, additional, Quirós-González, Víctor, additional, Ramoni, Rachel B., additional, Raskin, Maryna, additional, Rieg, Siegbert, additional, Roig-Domínguez, Gustavo, additional, Rojo, Pablo, additional, Rubio-Mayo, Paula, additional, Sacchi, Paolo, additional, Sáez, Carlos, additional, Salamanca, Elisa, additional, Sanchez-Pinto, L. Nelson, additional, Sandrin, Arnaud, additional, Santhanam, Nandhini, additional, Santos, Janaina C.C., additional, Sanz Vidorreta, Fernando J., additional, Savino, Maria, additional, Schubert, Petra, additional, Schuettler, Juergen, additional, Scudeller, Luigia, additional, Sebire, Neil J., additional, Serrano-Balazote, Pablo, additional, Serre, Patricia, additional, Serret-Larmande, Arnaud, additional, Shah, Mohsin, additional, Hossein Abad, Zahra Shakeri, additional, Silvio, Domenick, additional, Sliz, Piotr, additional, Son, Jiyeon, additional, Sonday, Charles, additional, Sperotto, Francesca, additional, Spiridou, Anastasia, additional, Strasser, Zachary H., additional, Tan, Byorn W.L., additional, Tanni, Suzana E., additional, Taylor, Deanne M., additional, Terriza-Torres, Ana I., additional, Toh, Emma M.S., additional, Torti, Carlo, additional, Trecarichi, Enrico M., additional, Vallejos, Andrew K., additional, Varoquaux, Gael, additional, Vella, Margaret E., additional, Vie, Jill-Jênn, additional, Vitacca, Michele, additional, Wagholikar, Kavishwar B., additional, Waitman, Lemuel R., additional, Wang, Xuan, additional, Wassermann, Demian, additional, Wolkewitz, Martin, additional, Wong, Scott, additional, Xiong, Xin, additional, Ye, Ye, additional, Yehya, Nadir, additional, Zachariasse, Joany M., additional, Zahner, Janet J., additional, Zambelli, Alberto, additional, Zuccaro, Valentina, additional, and Zucco, Chiara, additional

Published
2023
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26. Examining the Use of Real-World Evidence in the Regulatory Process.

Author

Beaulieu-Jones, Brett K, Beaulieu-Jones, Brett K, Finlayson, Samuel G, Yuan, William, Altman, Russ B, Kohane, Isaac S, Prasad, Vinay, Yu, Kun-Hsing, Beaulieu-Jones, Brett K, Beaulieu-Jones, Brett K, Finlayson, Samuel G, Yuan, William, Altman, Russ B, Kohane, Isaac S, Prasad, Vinay, and Yu, Kun-Hsing

Abstract

The 21st Century Cures Act passed by the United States Congress mandates the US Food and Drug Administration to develop guidance to evaluate the use of real-world evidence (RWE) to support the regulatory process. RWE has generated important medical discoveries, especially in areas where traditional clinical trials would be unethical or infeasible. However, RWE suffers from several issues that hinder its ability to provide proof of treatment efficacy at a level comparable to randomized controlled trials. In this review article, we summarized the advantages and limitations of RWE, identified the key opportunities for RWE, and pointed the way forward to maximize the potential of RWE for regulatory purposes.

Published
2020

29. Multinational characterization of neurological phenotypes in patients hospitalized with COVID-19.

Author

Le, Trang T., Gutiérrez-Sacristán, Alba, Son, Jiyeon, Hong, Chuan, South, Andrew M., Beaulieu-Jones, Brett K., Loh, Ne Hooi Will, Luo, Yuan, Morris, Michele, Ngiam, Kee Yuan, Patel, Lav P., Samayamuthu, Malarkodi J., Schriver, Emily, Tan, Amelia L. M., Moore, Jason, Cai, Tianxi, Omenn, Gilbert S., Avillach, Paul, Kohane, Isaac S., and The Consortium for Clinical Characterization of COVID-19 by EHR (4CE)

Subjects
REVERSE transcriptase polymerase chain reaction, NEUROLOGIC manifestations of general diseases, NEUROLOGICAL disorders, CONSCIOUSNESS disorders, INTRACRANIAL hemorrhage, PHENOTYPES, COVID-19
Abstract

Neurological complications worsen outcomes in COVID-19. To define the prevalence of neurological conditions among hospitalized patients with a positive SARS-CoV-2 reverse transcription polymerase chain reaction test in geographically diverse multinational populations during early pandemic, we used electronic health records (EHR) from 338 participating hospitals across 6 countries and 3 continents (January–September 2020) for a cross-sectional analysis. We assessed the frequency of International Classification of Disease code of neurological conditions by countries, healthcare systems, time before and after admission for COVID-19 and COVID-19 severity. Among 35,177 hospitalized patients with SARS-CoV-2 infection, there was an increase in the proportion with disorders of consciousness (5.8%, 95% confidence interval [CI] 3.7–7.8%, pFDR < 0.001) and unspecified disorders of the brain (8.1%, 5.7–10.5%, pFDR < 0.001) when compared to the pre-admission proportion. During hospitalization, the relative risk of disorders of consciousness (22%, 19–25%), cerebrovascular diseases (24%, 13–35%), nontraumatic intracranial hemorrhage (34%, 20–50%), encephalitis and/or myelitis (37%, 17–60%) and myopathy (72%, 67–77%) were higher for patients with severe COVID-19 when compared to those who never experienced severe COVID-19. Leveraging a multinational network to capture standardized EHR data, we highlighted the increased prevalence of central and peripheral neurological phenotypes in patients hospitalized with COVID-19, particularly among those with severe disease. [ABSTRACT FROM AUTHOR]

Published
2021
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30. Evolving phenotypes of non-hospitalized patients that indicate long COVID.

Author

Estiri, Hossein, Strasser, Zachary H., Brat, Gabriel A., Semenov, Yevgeniy R., The Consortium for Characterization of COVID-19 by EHR (4CE), Aaron, James R., Agapito, Giuseppe, Albayrak, Adem, Alessiani, Mario, Amendola, Danilo F., Anthony, Li L. L. J., Aronow, Bruce J., Ashraf, Fatima, Atz, Andrew, Avillach, Paul, Balshi, James, Beaulieu-Jones, Brett K., Bell, Douglas S., Bellasi, Antonio, and Bellazzi, Riccardo

Subjects
POST-acute COVID-19 syndrome, PHENOTYPES, CHEST pain, COVID-19, TYPE 2 diabetes, ELECTRONIC health records, CHRONIC fatigue syndrome
Abstract

Background: For some SARS-CoV-2 survivors, recovery from the acute phase of the infection has been grueling with lingering effects. Many of the symptoms characterized as the post-acute sequelae of COVID-19 (PASC) could have multiple causes or are similarly seen in non-COVID patients. Accurate identification of PASC phenotypes will be important to guide future research and help the healthcare system focus its efforts and resources on adequately controlled age- and gender-specific sequelae of a COVID-19 infection.Methods: In this retrospective electronic health record (EHR) cohort study, we applied a computational framework for knowledge discovery from clinical data, MLHO, to identify phenotypes that positively associate with a past positive reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19. We evaluated the post-test phenotypes in two temporal windows at 3-6 and 6-9 months after the test and by age and gender. Data from longitudinal diagnosis records stored in EHRs from Mass General Brigham in the Boston Metropolitan Area was used for the analyses. Statistical analyses were performed on data from March 2020 to June 2021. Study participants included over 96 thousand patients who had tested positive or negative for COVID-19 and were not hospitalized.Results: We identified 33 phenotypes among different age/gender cohorts or time windows that were positively associated with past SARS-CoV-2 infection. All identified phenotypes were newly recorded in patients' medical records 2 months or longer after a COVID-19 RT-PCR test in non-hospitalized patients regardless of the test result. Among these phenotypes, a new diagnosis record for anosmia and dysgeusia (OR 2.60, 95% CI [1.94-3.46]), alopecia (OR 3.09, 95% CI [2.53-3.76]), chest pain (OR 1.27, 95% CI [1.09-1.48]), chronic fatigue syndrome (OR 2.60, 95% CI [1.22-2.10]), shortness of breath (OR 1.41, 95% CI [1.22-1.64]), pneumonia (OR 1.66, 95% CI [1.28-2.16]), and type 2 diabetes mellitus (OR 1.41, 95% CI [1.22-1.64]) is one of the most significant indicators of a past COVID-19 infection. Additionally, more new phenotypes were found with increased confidence among the cohorts who were younger than 65.Conclusions: The findings of this study confirm many of the post-COVID-19 symptoms and suggest that a variety of new diagnoses, including new diabetes mellitus and neurological disorder diagnoses, are more common among those with a history of COVID-19 than those without the infection. Additionally, more than 63% of PASC phenotypes were observed in patients under 65 years of age, pointing out the importance of vaccination to minimize the risk of debilitating post-acute sequelae of COVID-19 among younger adults. [ABSTRACT FROM AUTHOR]

Published
2021
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33. Opportunities and obstacles for deep learning in biology and medicine

Author

Ching, Travers, primary, Himmelstein, Daniel S., additional, Beaulieu-Jones, Brett K., additional, Kalinin, Alexandr A., additional, Do, Brian T., additional, Way, Gregory P., additional, Ferrero, Enrico, additional, Agapow, Paul-Michael, additional, Zietz, Michael, additional, Hoffman, Michael M., additional, Xie, Wei, additional, Rosen, Gail L., additional, Lengerich, Benjamin J., additional, Israeli, Johnny, additional, Lanchantin, Jack, additional, Woloszynek, Stephen, additional, Carpenter, Anne E., additional, Shrikumar, Avanti, additional, Xu, Jinbo, additional, Cofer, Evan M., additional, Lavender, Christopher A., additional, Turaga, Srinivas C., additional, Alexandari, Amr M., additional, Lu, Zhiyong, additional, Harris, David J., additional, DeCaprio, Dave, additional, Qi, Yanjun, additional, Kundaje, Anshul, additional, Peng, Yifan, additional, Wiley, Laura K., additional, Segler, Marwin H. S., additional, Boca, Simina M., additional, Swamidass, S. Joshua, additional, Huang, Austin, additional, Gitter, Anthony, additional, and Greene, Casey S., additional

Published
2018
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40. Opportunities and obstacles for deep learning in biology and medicine

Author

Ching, Travers, primary, Himmelstein, Daniel S., additional, Beaulieu-Jones, Brett K., additional, Kalinin, Alexandr A., additional, Do, Brian T., additional, Way, Gregory P., additional, Ferrero, Enrico, additional, Agapow, Paul-Michael, additional, Zietz, Michael, additional, Hoffman, Michael M., additional, Xie, Wei, additional, Rosen, Gail L., additional, Lengerich, Benjamin J., additional, Israeli, Johnny, additional, Lanchantin, Jack, additional, Woloszynek, Stephen, additional, Carpenter, Anne E., additional, Shrikumar, Avanti, additional, Xu, Jinbo, additional, Cofer, Evan M., additional, Lavender, Christopher A., additional, Turaga, Srinivas C., additional, Alexandari, Amr M., additional, Lu, Zhiyong, additional, Harris, David J., additional, DeCaprio, Dave, additional, Qi, Yanjun, additional, Kundaje, Anshul, additional, Peng, Yifan, additional, Wiley, Laura K., additional, Segler, Marwin H.S., additional, Boca, Simina M., additional, Swamidass, S. Joshua, additional, Huang, Austin, additional, Gitter, Anthony, additional, and Greene, Casey S., additional

Published
2017
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44. Disease progression strikingly differs in research and real-world Parkinson's populations.

Author

Beaulieu-Jones BK, Frau F, Bozzi S, Chandross KJ, Peterschmitt MJ, Cohen C, Coulovrat C, Kumar D, Kruger MJ, Lipnick SL, Fitzsimmons L, Kohane IS, and Scherzer CR

Abstract

Characterization of Parkinson's disease (PD) progression using real-world evidence could guide clinical trial design and identify subpopulations. Efforts to curate research populations, the increasing availability of real-world data and recent advances in natural language processing, particularly large language models, allow for a more granular comparison of populations and the methods of data collection describing these populations than previously possible. This study includes two research populations and two real-world data derived (RWD) populations. The research populations are the Harvard Biomarkers Study (HBS, N = 935), a longitudinal biomarkers cohort study with in-person structured study visits; and Fox Insights (N = 36,660), an online self-survey-based research study of the Michael J. Fox Foundation. Real-world cohorts are the Optum Integrated Claims-electronic health records (N = 157,475), representing wide-scale linked medical and claims data and de-identified data from Mass General Brigham (MGB, N = 22,949), an academic hospital system. Structured, de-identified electronic health records data at MGB are supplemented using natural language processing with a large language model to extract measurements of PD progression. This extraction process is manually validated for accuracy. Motor and cognitive progression scores change more rapidly in MGB than HBS (median survival until H&Y 3: 5.6 years vs. >10, p<0.001; mini-mental state exam median decline 0.28 vs. 0.11, p<0.001; and clinically recognized cognitive decline, p=0.001). In the real-world populations, patients are diagnosed more than eleven years later (RWD mean of 72.2 vs. research mean of 60.4, p<0.001). After diagnosis, in real-world cohorts, treatment with PD medications is initiated 2.3 years later on average (95% CI: [2.1-2.4]; p<0.001). This study provides a detailed characterization of Parkinson's progression in diverse populations. It delineates systemic divergences in the patient populations enrolled in research settings vs. patients in the real world. These divergences are likely due to a combination of selection bias and real population differences, but exact attribution of the causes is challenging using existing data. This study emphasizes a need to utilize multiple data sources and to diligently consider potential biases when planning, choosing data sources, and performing downstream tasks and analyses., Competing Interests: Competing Interest FF, SB, KJC, MJP, CC, DK, CC are employees of Sanofi and may hold shares and/or stock options in the company. All authors declare no other competing financial or non-financial interests.

Published
2024
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45. Changes in laboratory value improvement and mortality rates over the course of the pandemic: an international retrospective cohort study of hospitalised patients infected with SARS-CoV-2.

Author

Hong C, Zhang HG, L'Yi S, Weber G, Avillach P, Tan BWQ, Gutiérrez-Sacristán A, Bonzel CL, Palmer NP, Malovini A, Tibollo V, Luo Y, Hutch MR, Liu M, Bourgeois F, Bellazzi R, Chiovato L, Sanz Vidorreta FJ, Le TT, Wang X, Yuan W, Neuraz A, Benoit V, Moal B, Morris M, Hanauer DA, Maidlow S, Wagholikar K, Murphy S, Estiri H, Makoudjou A, Tippmann P, Klann J, Follett RW, Gehlenborg N, Omenn GS, Xia Z, Dagliati A, Visweswaran S, Patel LP, Mowery DL, Schriver ER, Samayamuthu MJ, Kavuluru R, Lozano-Zahonero S, Zöller D, Tan ALM, Tan BWL, Ngiam KY, Holmes JH, Schubert P, Cho K, Ho YL, Beaulieu-Jones BK, Pedrera-Jiménez M, García-Barrio N, Serrano-Balazote P, Kohane I, South A, Brat GA, and Cai T

Subjects
Hospitalization, Humans, Retrospective Studies, SARS-CoV-2, COVID-19, Pandemics
Abstract

Objective: To assess changes in international mortality rates and laboratory recovery rates during hospitalisation for patients hospitalised with SARS-CoV-2 between the first wave (1 March to 30 June 2020) and the second wave (1 July 2020 to 31 January 2021) of the COVID-19 pandemic., Design, Setting and Participants: This is a retrospective cohort study of 83 178 hospitalised patients admitted between 7 days before or 14 days after PCR-confirmed SARS-CoV-2 infection within the Consortium for Clinical Characterization of COVID-19 by Electronic Health Record, an international multihealthcare system collaborative of 288 hospitals in the USA and Europe. The laboratory recovery rates and mortality rates over time were compared between the two waves of the pandemic., Primary and Secondary Outcome Measures: The primary outcome was all-cause mortality rate within 28 days after hospitalisation stratified by predicted low, medium and high mortality risk at baseline. The secondary outcome was the average rate of change in laboratory values during the first week of hospitalisation., Results: Baseline Charlson Comorbidity Index and laboratory values at admission were not significantly different between the first and second waves. The improvement in laboratory values over time was faster in the second wave compared with the first. The average C reactive protein rate of change was -4.72 mg/dL vs -4.14 mg/dL per day (p=0.05). The mortality rates within each risk category significantly decreased over time, with the most substantial decrease in the high-risk group (42.3% in March-April 2020 vs 30.8% in November 2020 to January 2021, p<0.001) and a moderate decrease in the intermediate-risk group (21.5% in March-April 2020 vs 14.3% in November 2020 to January 2021, p<0.001)., Conclusions: Admission profiles of patients hospitalised with SARS-CoV-2 infection did not differ greatly between the first and second waves of the pandemic, but there were notable differences in laboratory improvement rates during hospitalisation. Mortality risks among patients with similar risk profiles decreased over the course of the pandemic. The improvement in laboratory values and mortality risk was consistent across multiple countries., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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46. International Comparisons of Harmonized Laboratory Value Trajectories to Predict Severe COVID-19: Leveraging the 4CE Collaborative Across 342 Hospitals and 6 Countries: A Retrospective Cohort Study.

Author

Weber GM, Hong C, Palmer NP, Avillach P, Murphy SN, Gutiérrez-Sacristán A, Xia Z, Serret-Larmande A, Neuraz A, Omenn GS, Visweswaran S, Klann JG, South AM, Loh NHW, Cannataro M, Beaulieu-Jones BK, Bellazzi R, Agapito G, Alessiani M, Aronow BJ, Bell DS, Bellasi A, Benoit V, Beraghi M, Boeker M, Booth J, Bosari S, Bourgeois FT, Brown NW, Bucalo M, Chiovato L, Chiudinelli L, Dagliati A, Devkota B, DuVall SL, Follett RW, Ganslandt T, García Barrio N, Gradinger T, Griffier R, Hanauer DA, Holmes JH, Horki P, Huling KM, Issitt RW, Jouhet V, Keller MS, Kraska D, Liu M, Luo Y, Lynch KE, Malovini A, Mandl KD, Mao C, Maram A, Matheny ME, Maulhardt T, Mazzitelli M, Milano M, Moore JH, Morris JS, Morris M, Mowery DL, Naughton TP, Ngiam KY, Norman JB, Patel LP, Pedrera Jimenez M, Ramoni RB, Schriver ER, Scudeller L, Sebire NJ, Serrano Balazote P, Spiridou A, Tan AL, Tan BW, Tibollo V, Torti C, Trecarichi EM, Vitacca M, Zambelli A, Zucco C, Kohane IS, Cai T, and Brat GA

Abstract

Objectives: To perform an international comparison of the trajectory of laboratory values among hospitalized patients with COVID-19 who develop severe disease and identify optimal timing of laboratory value collection to predict severity across hospitals and regions., Design: Retrospective cohort study., Setting: The Consortium for Clinical Characterization of COVID-19 by EHR (4CE), an international multi-site data-sharing collaborative of 342 hospitals in the US and in Europe., Participants: Patients hospitalized with COVID-19, admitted before or after PCR-confirmed result for SARS-CoV-2., Primary and Secondary Outcome Measures: Patients were categorized as "ever-severe" or "never-severe" using the validated 4CE severity criteria. Eighteen laboratory tests associated with poor COVID-19-related outcomes were evaluated for predictive accuracy by area under the curve (AUC), compared between the severity categories. Subgroup analysis was performed to validate a subset of laboratory values as predictive of severity against a published algorithm. A subset of laboratory values (CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin) was compared between North American and European sites for severity prediction., Results: Of 36,447 patients with COVID-19, 19,953 (43.7%) were categorized as ever-severe. Most patients (78.7%) were 50 years of age or older and male (60.5%). Longitudinal trajectories of CRP, albumin, LDH, neutrophil count, D-dimer, and procalcitonin showed association with disease severity. Significant differences of laboratory values at admission were found between the two groups. With the exception of D-dimer, predictive discrimination of laboratory values did not improve after admission. Sub-group analysis using age, D-dimer, CRP, and lymphocyte count as predictive of severity at admission showed similar discrimination to a published algorithm (AUC=0.88 and 0.91, respectively). Both models deteriorated in predictive accuracy as the disease progressed. On average, no difference in severity prediction was found between North American and European sites., Conclusions: Laboratory test values at admission can be used to predict severity in patients with COVID-19. Prediction models show consistency across international sites highlighting the potential generalizability of these models., Competing Interests: COMPETING INTEREST STATEMENT There are no competing interests to report.

Published
2021
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47. Multinational Prevalence of Neurological Phenotypes in Patients Hospitalized with COVID-19.

Author

Le TT, Gutiérrez-Sacristán A, Son J, Hong C, South AM, Beaulieu-Jones BK, Loh NHW, Luo Y, Morris M, Ngiam KY, Patel LP, Samayamuthu MJ, Schriver E, Tan AL, Moore J, Cai T, Omenn GS, Avillach P, Kohane IS, Visweswaran S, Mowery DL, and Xia Z

Abstract

Objective: Neurological complications can worsen outcomes in COVID-19. We defined the prevalence of a wide range of neurological conditions among patients hospitalized with COVID-19 in geographically diverse multinational populations., Methods: Using electronic health record (EHR) data from 348 participating hospitals across 6 countries and 3 continents between January and September 2020, we performed a cross-sectional study of hospitalized adult and pediatric patients with a positive SARS-CoV-2 reverse transcription polymerase chain reaction test, both with and without severe COVID-19. We assessed the frequency of each disease category and 3-character International Classification of Disease (ICD) code of neurological diseases by countries, sites, time before and after admission for COVID-19, and COVID-19 severity., Results: Among the 35,177 hospitalized patients with SARS-CoV-2 infection, there was increased prevalence of disorders of consciousness (5.8%, 95% confidence interval [CI]: 3.7%-7.8%, p FDR <.001) and unspecified disorders of the brain (8.1%, 95%CI: 5.7%-10.5%, p FDR <.001), compared to pre-admission prevalence. During hospitalization, patients who experienced severe COVID-19 status had 22% (95%CI: 19%-25%) increase in the relative risk (RR) of disorders of consciousness, 24% (95%CI: 13%-35%) increase in other cerebrovascular diseases, 34% (95%CI: 20%-50%) increase in nontraumatic intracranial hemorrhage, 37% (95%CI: 17%-60%) increase in encephalitis and/or myelitis, and 72% (95%CI: 67%-77%) increase in myopathy compared to those who never experienced severe disease., Interpretation: Using an international network and common EHR data elements, we highlight an increase in the prevalence of central and peripheral neurological phenotypes in patients hospitalized with SARS-CoV-2 infection, particularly among those with severe disease.

Published
2021
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48. Learning Contextual Hierarchical Structure of Medical Concepts with Poincairé Embeddings to Clarify Phenotypes.

Author

Beaulieu-Jones BK, Kohane IS, and Beam AL

Subjects
Databases, Factual, Humans, International Classification of Diseases, Machine Learning, Medical Informatics, Natural Language Processing, Phenotype, Semantics, Computational Biology methods, Deep Learning
Abstract

Biomedical association studies are increasingly done using clinical concepts, and in particular diagnostic codes from clinical data repositories as phenotypes. Clinical concepts can be represented in a meaningful, vector space using word embedding models. These embeddings allow for comparison between clinical concepts or for straightforward input to machine learning models. Using traditional approaches, good representations require high dimensionality, making downstream tasks such as visualization more difficult. We applied Poincaré embeddings in a 2-dimensional hyperbolic space to a large-scale administrative claims database and show performance comparable to 100-dimensional embeddings in a euclidean space. We then examine disease relationships under different disease contexts to better understand potential phenotypes.

Published
2019

49. Mapping Patient Trajectories using Longitudinal Extraction and Deep Learning in the MIMIC-III Critical Care Database.

Author

Beaulieu-Jones BK, Orzechowski P, and Moore JH

Subjects
Computational Biology methods, Databases, Factual statistics & numerical data, Electronic Health Records statistics & numerical data, Female, Humans, Male, Supervised Machine Learning statistics & numerical data, Unsupervised Machine Learning statistics & numerical data, Critical Care statistics & numerical data, Machine Learning statistics & numerical data
Abstract

Electronic Health Records (EHRs) contain a wealth of patient data useful to biomedical researchers. At present, both the extraction of data and methods for analyses are frequently designed to work with a single snapshot of a patient's record. Health care providers often perform and record actions in small batches over time. By extracting these care events, a sequence can be formed providing a trajectory for a patient's interactions with the health care system. These care events also offer a basic heuristic for the level of attention a patient receives from health care providers. We show that is possible to learn meaningful embeddings from these care events using two deep learning techniques, unsupervised autoencoders and long short-term memory networks. We compare these methods to traditional machine learning methods which require a point in time snapshot to be extracted from an EHR.

Published
2018

50. MISSING DATA IMPUTATION IN THE ELECTRONIC HEALTH RECORD USING DEEPLY LEARNED AUTOENCODERS.

Author

Beaulieu-Jones BK and Moore JH

Subjects
Amyotrophic Lateral Sclerosis physiopathology, Bias, Clinical Trials as Topic statistics & numerical data, Computational Biology, Databases, Factual statistics & numerical data, Disease Progression, Humans, Neural Networks, Computer, Electronic Health Records statistics & numerical data
Abstract

Electronic health records (EHRs) have become a vital source of patient outcome data but the widespread prevalence of missing data presents a major challenge. Different causes of missing data in the EHR data may introduce unintentional bias. Here, we compare the effectiveness of popular multiple imputation strategies with a deeply learned autoencoder using the Pooled Resource Open-Access ALS Clinical Trials Database (PRO-ACT). To evaluate performance, we examined imputation accuracy for known values simulated to be either missing completely at random or missing not at random. We also compared ALS disease progression prediction across different imputation models. Autoencoders showed strong performance for imputation accuracy and contributed to the strongest disease progression predictor. Finally, we show that despite clinical heterogeneity, ALS disease progression appears homogenous with time from onset being the most important predictor.

Published
2017
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