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FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

Autor: Melissa Beck, Karen M Mahoney, Rima Izem, Sara Travis, Elande Baro, Janet Woodcock, Amanda Pike-McCrudden, Claudia Squire, Barbara R Cohen

Publikováno v: New England Journal of Medicine. 382:2129-2136

The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model dru

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6f2d108b34c06241dc642f5c6ed4cb67
https://doi.org/10.1056/nejmsa1912403

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Electronic phenotyping of health outcomes of interest using a linked claims-electronic health record database: Findings from a machine learning pilot project

Autor: Sarah Bloemers, Robert Ball, Frank Yoon, Sengwee Toh, Sai Dharmarajan, Rita Ouellet-Hellstrom, Adee Kennedy, Elande Baro, Timothy A Burrell, Michael D. Nguyen, Cory Pack, Yong Ma, Wei Hua, Jenna Wong, Teresa B. Gibson

Publikováno v: J Am Med Inform Assoc

Objective Claims-based algorithms are used in the Food and Drug Administration Sentinel Active Risk Identification and Analysis System to identify occurrences of health outcomes of interest (HOIs) for medical product safety assessment. This project a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::69946e0e57d3faa0e024e2a844936b7c
https://pubmed.ncbi.nlm.nih.gov/33712852

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FDA Label for Over-the-Counter Naloxone

Autor: Elande Baro, Barbara R. Cohen, Amanda Pike-McCrudden

Publikováno v: The New England journal of medicine. 383(11)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::af188ea57f31ca264c32770bf1ab7391
https://pubmed.ncbi.nlm.nih.gov/32905692

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A General Propensity Score for Signal Identification Using Tree-Based Scan Statistics

Autor: Efe Eworuke, Sandra DeLuccia, Judith C. Maro, Elande Baro, Rita Ouellet-Hellstrom, Ella Pestine, David E. C. Cole, Inna Dashevsky, Elisabetta Patorno, Martin Kulldorff, Michael Nguyen, Danijela Stojanovic, Yong Ma, Aaron Hansbury, Shirley V. Wang, Joshua J. Gagne, Sushama Kattinakere

Publikováno v: American journal of epidemiology. 190(7)

The tree-based scan statistic (TreeScan; Martin Kulldorff, Harvard Medical School, Boston, Massachusetts) is a data-mining method that adjusts for multiple testing of correlated hypotheses when screening thousands of potential adverse events for sign

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d0aff8817e28f5cf10a47e396037198
https://pubmed.ncbi.nlm.nih.gov/33615330

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Performance evaluation of regression splines for propensity score adjustment in post-market safety analysis with multiple treatments

Autor: Yuxi Tian, Rongmei Zhang, Elande Baro

Observational studies provide a core resource in assessing post-market drug safety and effectiveness. Propensity scores are a predominant method for confounding adjustment to achieve unbiased estimation of average treatment effects in observational d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::995a54dcd649d86ce244c0e6f86970dc

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Acute Kidney Injury During Treatment with Intravenous Acyclovir for Suspected or Confirmed Neonatal Herpes Simplex Virus Infection

Publikováno v: J Pediatr

OBJECTIVE: To describe the epidemiology of and risk factors associated with acute kidney injury (AKI) during acyclovir treatment in neonates and infants. STUDY DESIGN: We conducted a multicenter (n = 4), retrospective cohort study of all hospitalized

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c4c2587fb31d2a5a1ca5f443aee1f635
https://doi.org/10.1016/j.jpeds.2019.12.056

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Data mining for adverse drug events with a propensity score matched tree-based scan statistic

Autor: Shirley V. Wang, Jacqueline M. Major, Joshua J. Gagne, Megan Reidy, Esther H. Zhou, Austin Cosgrove, Judith C. Maro, Elande Baro, Martin Kulldorff, James R. Rogers, Krista F. Huybrechts, Elisabetta Patorno, Rima Izem, Sebastian Schneeweiss, Michael Nguyen, Inna Dashevsky

The tree-based scan statistic is a statistical data mining tool that has been used for signal detection with a self-controlled design in vaccine safety studies. This disproportionality statistic adjusts for multiple testing in evaluation of thousands

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a93367cddd10f687a972f458bc53b86
https://europepmc.org/articles/PMC6167151/

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The Reply

Autor: David J, Graham, Elande, Baro, Michael, Wernecke, Jeffrey A, Kelman

Publikováno v: The American Journal of Medicine. 132:e754-e755

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ad497ea0ef7988ef382a423ce59e4290
https://doi.org/10.1016/j.amjmed.2019.06.046

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Comparative Stroke, Bleeding, and Mortality Risks in Older Medicare Patients Treated with Oral Anticoagulants for Nonvalvular Atrial Fibrillation

Autor: Margie R. Goulding, Elande Baro, David J. Graham, Marsha E. Reichman, Mary Ross Southworth, Jiemin Liao, Rongmei Zhang, Yoganand Chillarige, Onyekachukwu A. Illoh, Mao Hu, Thomas E. MaCurdy, Yuqin Wei, Michael Wernecke, Jeffrey A. Kelman

Publikováno v: The American Journal of Medicine. 132:596-604.e11

Nonvitamin K antagonist oral anticoagulants (NOACs) are alternatives to warfarin in patients with nonvalvular atrial fibrillation. Randomized trials compared NOACs with warfarin, but none have compared individual NOACs against each other for safety a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e9ae14a9f1d1d21d646b487f7b302d73
https://doi.org/10.1016/j.amjmed.2018.12.023

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