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Article ; Online: Association of COVID-19 Infection With Survival After In-Hospital Cardiac Arrest Among US Adults.

Girotra, Saket / Chan, Maya L / Starks, Monique Anderson / Churpek, Matthew / Chan, Paul S

JAMA network open

2022 Volume 5, Issue 3, Page(s) e220752

MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; COVID-19/complications ; Cohort Studies ; Female ; Heart Arrest/complications ; Heart Arrest/mortality ; Hospitalization ; Humans ; Male ; Middle Aged ; Resuscitation ; Survival Rate ; United States
Language	English
Publishing date	2022-03-01
Publishing country	United States
Document type	Letter ; Observational Study
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2022.0752
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Article ; Online: Compliance with results reporting at ClinicalTrials.gov.

Anderson, Monique L / Peterson, Eric D

The New England journal of medicine

2015 Volume 372, Issue 24, Page(s) 2370–2371

MeSH term(s)	Clinical Trials as Topic/legislation & jurisprudence ; Databases, Factual ; Humans ; Registries
Language	English
Publishing date	2015-06-11
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1504513
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Article ; Online: Corrigendum to "Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: Race as an example" [Contemporary Clinical Trials volume 88 (2020) 105775].

Yang, Siyun / Starks, Monique Anderson / Hernandez, Adrian F / Turner, Elizabeth L / Califf, Robert M / O'Connor, Christopher M / Mentz, Robert J / Choudhury, Kingshuk Roy

Contemporary clinical trials

2021 Volume 103, Page(s) 106298

Language	English
Publishing date	2021-02-09
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2182176-8
ISSN	1559-2030 ; 1551-7144
ISSN (online)	1559-2030
ISSN	1551-7144
DOI	10.1016/j.cct.2021.106298
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Article ; Online: Sex Differences in Causes of Death After Stroke: Evidence from a National, Prospective Registry.

Phan, Hoang T / Gall, Seana / Blizzard, Christopher L / Lannin, Natasha A / Thrift, Amanda G / Anderson, Craig S / Kim, Joosup / Grimley, Rohan / Castley, Helen C / Kilkenny, Monique F / Cadilhac, Dominique A

Journal of women's health (2002)

2020 Volume 30, Issue 3, Page(s) 314–323

Abstract: Background: ...

Abstract	Background:
MeSH term(s)	Australia/epidemiology ; Cardiovascular Diseases ; Cause of Death ; Female ; Humans ; Male ; Registries ; Risk Factors ; Sex Characteristics ; Sex Factors ; Stroke
Language	English
Publishing date	2020-11-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1139774-3
ISSN	1931-843X ; 1059-7115 ; 1540-9996
ISSN (online)	1931-843X
ISSN	1059-7115 ; 1540-9996
DOI	10.1089/jwh.2020.8391
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Article ; Online: Implementing a Family-Centered Rounds Intervention Using Novel Mentor-Trios.

Khan, Alisa / Patel, Shilpa J / Anderson, Michele / Baird, Jennifer D / Johnson, Tyler M / Liss, Isabella / Graham, Dionne A / Calaman, Sharon / Fegley, April E / Goldstein, Jenna / O'Toole, Jennifer K / Rosenbluth, Glenn / Alminde, Claire / Bass, Ellen J / Bismilla, Zia / Caruth, Monique / Coghlan-McDonald, Sally / Cray, Sharon / Destino, Lauren A /

Dreyer, Benard P / Everhart, Jennifer L / Good, Brian P / Guiot, Amy B / Haskell, Helen / Hepps, Jennifer H / Knighton, Andrew J / Kocolas, Irene / Kuzma, Nicholas C / Lewis, Kheyandra / Litterer, Katherine P / Kruvand, Elizabeth / Markle, Peggy / Micalizzi, Dale A / Patel, Aarti / Rogers, Jayne E / Subramony, Anupama / Vara, Tiffany / Yin, H Shonna / Sectish, Theodore C / Srivastava, Rajendu / Starmer, Amy J / West, Daniel C / Spector, Nancy D / Landrigan, Christopher P

Pediatrics

2024 Volume 153, Issue 2

MeSH term(s)	Humans ; Child ; Mentors ; Parents ; Hospitals, Teaching ; Communication ; Language ; Teaching Rounds
Language	English
Publishing date	2024-02-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	207677-9
ISSN	1098-4275 ; 0031-4005
ISSN (online)	1098-4275
ISSN	0031-4005
DOI	10.1542/peds.2023-062666
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Article ; Online: Outcomes for patients with anterior myocardial infarction and prior cardiac arrest in the home automated external defibrillator trial (HAT).

Starks, Monique Anderson / Jackson, Larry R / Hellkamp, Anne / Al-Khatib, Sana M / Mark, Daniel B / Thomas, Kevin L / Nichol, Graham / Lee, Kerry L / Davidson-Ray, Linda / Poole, Jeanne / Anderson, Jill / Johnson, George / Bardy, Gust H

Resuscitation

2021 Volume 168, Page(s) 75–83

Abstract: Background: Patients with sudden cardiac arrest occurring in the acute phase of myocardial infarction (MI-SCA) are believed to be at similar risk of death after revascularization compared with MI patients without SCA (MI-no SCA). Among patients with ... ...

Abstract	Background: Patients with sudden cardiac arrest occurring in the acute phase of myocardial infarction (MI-SCA) are believed to be at similar risk of death after revascularization compared with MI patients without SCA (MI-no SCA). Among patients with anterior MI, we examined whether those with MI-SCA were at greater risk of all-cause mortality or sudden cardiac death (SCD) than MI-no SCA patients. Methods: The Home Automated External Defibrillator Trial enrolled patients with anterior MI who had not received or were candidates for an implantable cardioverter defibrillator (ICD). Our cohort included patients with a reported SCA event, in the acute phase of an MI, prior to HAT trial enrollment. Cox proportional hazards models examined the adjusted association between MI-SCA versus MI-no SCA patients and all-cause mortality and sudden cardiac death (SCD). We also determined whether the relationship between prior SCA and outcomes changed with subsequent events (syncope, revascularization, and recurrent MI) during follow-up. Results: Of 6849 patients, 650 (9.5%) had MI-SCA before trial enrollment. Approximately 48% of patients had the MI-SCA event ≤1 year prior to enrollment; 71% of SCA events were in-hospital. MI-SCA patients were younger, more frequently white, and had higher rates of prior PCI versus MI-no SCA patients. There were no differences in adjusted all-cause mortality (hazard ratio [HR 0.95; 95% CI 0.65-1.38]) or SCD (HR 1.12; 95% CI 0.68-1.83) for MI-SCA vs. MI-no SCA. After ICD implantation, MI-SCA patients experienced higher all-cause mortality risk (HR 5.01, 95% CI 1.05-23.79) versus MI-no SCA patients; there was no mortality difference between MI-SCA and MI-no SCA patients without ICD implantation (HR 0.89, 95% CI 0.60-1.31), [interaction p = 0.035]. Conclusions: Patients with MI-SCA had similar adjusted risk of all-cause mortality and SCD compared with MI-no SCA. After ICD implantation, MI-SCA patients had higher mortality compared with MI-no SCA patients.
MeSH term(s)	Death, Sudden, Cardiac/epidemiology ; Death, Sudden, Cardiac/etiology ; Death, Sudden, Cardiac/prevention & control ; Defibrillators, Implantable ; Heart Arrest ; Humans ; Myocardial Infarction/complications ; Percutaneous Coronary Intervention ; Risk Factors
Language	English
Publishing date	2021-09-07
Publishing country	Ireland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	189901-6
ISSN	1873-1570 ; 0300-9572
ISSN (online)	1873-1570
ISSN	0300-9572
DOI	10.1016/j.resuscitation.2021.08.047
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Article ; Online: Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

Anderson, Monique L / Califf, Robert M / Sugarman, Jeremy

Clinical trials (London, England)

2015 Volume 12, Issue 3, Page(s) 276–286

Abstract: Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems ... ...

Abstract	Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.
MeSH term(s)	Confidentiality ; Ethics Committees, Research/ethics ; Ethics Committees, Research/legislation & jurisprudence ; Informed Consent ; National Institutes of Health (U.S.) ; Randomized Controlled Trials as Topic/ethics ; Randomized Controlled Trials as Topic/legislation & jurisprudence ; Randomized Controlled Trials as Topic/methods ; Research Design ; United States
Language	English
Publishing date	2015-06
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/1740774515571140
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Article ; Online: Protocol for a single patient therapy plan: A randomised, double-blind, placebo-controlled N-of-1 trial to assess the efficacy of cannabidiol in patients with intractable epilepsy.

Ong, Katherine S / Carlin, John B / Fahey, Michael / Freeman, Jeremy L / Scheffer, Ingrid E / Gillam, Lynn / Anderson, Monique / Huque, Md Hamidul / Legge, Donna / Dirnbauer, Nicole / Lilley, Brian / Slota-Kan, Simon / Cranswick, Noel

Journal of paediatrics and child health

2020 Volume 56, Issue 12, Page(s) 1918–1923

Abstract: Aim: This paper describes the use of the single patient therapy plan (SPTP). The SPTP has been designed to assess the efficacy at an individual level of a commercially available cannabinoid product, cannabidiol, in reducing seizure frequency in ... ...

Abstract	Aim: This paper describes the use of the single patient therapy plan (SPTP). The SPTP has been designed to assess the efficacy at an individual level of a commercially available cannabinoid product, cannabidiol, in reducing seizure frequency in paediatric patients with intractable epilepsy. Methods: The SPTP is a randomised, double-blind, placebo-controlled N-of-1 trial designed to assess the efficacy of treatment in a neurology outpatient setting. The primary objective of the SPTP is to assess the efficacy of cannabidiol in reducing seizure frequency in each patient with intractable epilepsy, with change in seizure frequency being the primary outcome of interest. The analysis adopts a Bayesian approach, which provides results in the form of posterior probabilities that various levels of benefit (based on the primary outcome measure, seizure frequency) have been achieved under active treatment compared to placebo, accompanied by decision rules that provide thresholds for deciding whether treatment has been successful in the individual patient. The SPTP arrangement is most accurately considered part of clinical practice rather than research, since it is aimed at making clinical treatment decisions for individual patients and is not testing a hypothesis or collecting aggregate data. Therefore, Human Research Ethics Committee approval was considered not to be required, although it is recommended that hospital Clinical Ethics Committees provide ethical oversight. Conclusion: These SPTP resources are made available so that they may inform clinical practice in the treatment of severe epilepsy or adapted for use in other conditions.
MeSH term(s)	Anticonvulsants/therapeutic use ; Bayes Theorem ; Cannabidiol/therapeutic use ; Child ; Double-Blind Method ; Drug Resistant Epilepsy/drug therapy ; Drug Therapy, Combination ; Humans ; Randomized Controlled Trials as Topic ; Treatment Outcome
Chemical Substances	Anticonvulsants ; Cannabidiol (19GBJ60SN5)
Language	English
Publishing date	2020-09-23
Publishing country	Australia
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	1024476-1
ISSN	1440-1754 ; 1034-4810
ISSN (online)	1440-1754
ISSN	1034-4810
DOI	10.1111/jpc.15078
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Article ; Online: Implications of a recurrent in-hospital cardiac arrest on survival and neurological outcomes.

Chan, Maya L / Spertus, John A / Tang, Yuanyuan / Starks, Monique Anderson / Chan, Paul S

American heart journal

2018 Volume 202, Page(s) 139–143

Abstract: Background: Despite the high incidence of in-hospital cardiac arrest (IHCA) in US hospitals, the prognosis and end-of-life decision-making patterns of a patient with a recurrent IHCA are unknown.: Methods: Within Get-With-The-Guidelines-Resuscitation, ...

Abstract	Background: Despite the high incidence of in-hospital cardiac arrest (IHCA) in US hospitals, the prognosis and end-of-life decision-making patterns of a patient with a recurrent IHCA are unknown. Methods: Within Get-With-The-Guidelines-Resuscitation, we identified 192,250 patients from 711 hospitals with an IHCA from 2000 to 2015. Patients were categorized as having no recurrent IHCA (only 1 event), recurrent IHCA (≥2 IHCAs), and recurrent out-of-hospital cardiac arrest (OHCA), defined as an IHCA after an OHCA. Using multivariable hierarchical logistic regression, rates of survival to discharge and favorable neurological survival (mild or no disability) between the 3 groups were compared. Rates of de novo "do not attempt resuscitation" (DNAR) and withdrawal of care orders among successfully resuscitated patients were also evaluated. Results: Overall, 165,446 (86.1%) had no recurrent IHCA, 23,643 (12.3%) had recurrent IHCA, and 3162 (1.6%) had recurrent OHCA. Compared with patients with no recurrent IHCA, patients with recurrent IHCA were less than half as likely to survive to discharge (12.7% vs 22.1%; adjusted OR: 0.46 [0.44-0.48], P < .001) and have favorable neurological survival (7.0% vs 13.1%; adjusted OR: 0.44 [0.42-0.47], P < .001). Compared with patients with recurrent OHCA, patients with recurrent IHCA also had lower rates of survival to discharge (12.7% vs 16.1%; adjusted OR: 0.81 [0.71-0.94], P = .005) and favorable neurological survival (7.0% vs 8.9%; adjusted OR: 0.66 [0.54-0.81], P < .001). Despite worse survival outcomes, patients with recurrent IHCA were least likely to adopt DNAR orders within the first 24 hours after successful resuscitation compared with patients with no recurrent IHCA or recurrent OHCA (17.2% vs 18.9% and 26.6%, respectively) or withdraw care at any time (17.7% vs 24.4% and 31.2%, respectively). Conclusions: Nearly 1 in 8 patients with an IHCA has a recurrent IHCA, and these patients have worse outcomes than patients with only a single IHCA and those with an IHCA after being hospitalized for an OHCA. Despite worse survival, rates of DNAR and withdrawal of care were lowest for patients with recurrent IHCA. These findings provide important prognostic information for clinicians caring for patients with recurrent IHCA and suggest the need to better align resuscitation and end-of-life decisions with patients' prognoses after IHCA.
MeSH term(s)	Aged ; Cardiopulmonary Resuscitation ; Decision Making ; Female ; Heart Arrest/complications ; Heart Arrest/mortality ; Heart Arrest/therapy ; Hospitalization ; Humans ; Logistic Models ; Male ; Middle Aged ; Prognosis ; Recurrence ; Resuscitation Orders ; Survival Rate ; Withholding Treatment
Language	English
Publishing date	2018-05-09
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2018.04.016
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Article ; Online: Natural killer cells and BNT162b2 mRNA vaccine reactogenicity and durability.

Graydon, Elizabeth K / Conner, Tonia L / Dunham, Kim / Olsen, Cara / Goguet, Emilie / Coggins, Si'Ana A / Rekedal, Marana / Samuels, Emily / Jackson-Thompson, Belinda / Moser, Matthew / Lindrose, Alyssa / Hollis-Perry, Monique / Wang, Gregory / Maiolatesi, Santina / Alcorta, Yolanda / Reyes, Anatalio / Wong, Mimi / Ramsey, Kathy / Davies, Julian /

Parmelee, Edward / Ortega, Orlando / Sanchez, Mimi / Moller, Sydney / Inglefield, Jon / Tribble, David / Burgess, Timothy / O'Connell, Robert / Malloy, Allison M W / Pollett, Simon / Broder, Christopher C / Laing, Eric D / Anderson, Stephen K / Mitre, Edward

Frontiers in immunology

2023 Volume 14, Page(s) 1225025

Abstract: Introduction: Natural killer (NK) cells can both amplify and regulate immune responses to vaccination. Studies in humans and animals have observed NK cell activation within days after mRNA vaccination. In this study, we sought to determine if baseline ... ...

Abstract	Introduction: Natural killer (NK) cells can both amplify and regulate immune responses to vaccination. Studies in humans and animals have observed NK cell activation within days after mRNA vaccination. In this study, we sought to determine if baseline NK cell frequencies, phenotype, or function correlate with antibody responses or inflammatory side effects induced by the Pfizer-BioNTech COVID-19 vaccine (BNT162b2). Methods: We analyzed serum and peripheral blood mononuclear cells (PBMCs) from 188 participants in the Prospective Assessment of SARS-CoV-2 Seroconversion study, an observational study evaluating immune responses in healthcare workers. Baseline serum samples and PBMCs were collected from all participants prior to any SARS-CoV-2 infection or vaccination. Spike-specific IgG antibodies were quantified at one and six months post-vaccination by microsphere-based multiplex immunoassay. NK cell frequencies and phenotypes were assessed on pre-vaccination PBMCs from all participants by multi-color flow cytometry, and on a subset of participants at time points after the 1 Results: Key observations include: 1) circulating NK cells exhibit evidence of activation in the week following vaccination, 2) individuals with high symptom scores after 1 Discussion: These results suggest that NK cell activation by BNT162b2 vaccination may contribute to vaccine-induced inflammatory symptoms and reduce durability of vaccine-induced antibody responses.
MeSH term(s)	Animals ; Humans ; BNT162 Vaccine ; Leukocytes, Mononuclear ; Prospective Studies ; COVID-19/prevention & control ; SARS-CoV-2 ; Drug-Related Side Effects and Adverse Reactions ; Immunoglobulin G ; mRNA Vaccines
Chemical Substances	BNT162 Vaccine ; Immunoglobulin G
Language	English
Publishing date	2023-08-25
Publishing country	Switzerland
Document type	Observational Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1225025
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