N Engl J Med
June 2023
From the Larner College of Medicine, University of Vermont, Burlington (L.W.Y.); the Departments of Biostatistics (S.T.O., Z.H., J.Y.L.) and Pediatrics (J.N.S.), University of Arkansas for Medical Sciences, Little Rock; the University of Cincinnati College of Medicine and Perinatal Institute and the Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati (S.L.M., W.R., J.M.M.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.), and the Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus (E.F.B.); the Institutional Development Awards Program of the States Pediatric Clinical Trials Network, Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville (A.E.S.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda (A.A.B., R.D.H., M.C.W.) - both in Maryland; the Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park (A.D., M.M.C.), and the Duke Clinical Research Institute, Duke University School of Medicine (R.G.G., P.B.S.), and the Department of Pediatrics, Duke University (S.K.S.), Durham - all in North Carolina; Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (B.B.P.); the Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers (R.D.H.), and the Department of Pediatrics, University of South Florida, Tampa (T.W.); St. Elizabeth Healthcare, Edgewood (W.R.), and the Department of Pediatrics, University of Louisville, Louisville (S.T., L.A.D.) - both in Kentucky; the Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, DE (D.A.P.); the University of New Mexico School of Medicine, Albuquerque (J.R.M.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (C.M.F.); the Department of Pediatrics, University at Buffalo, Buffalo (A.M.R.), and the University of Rochester School of Medicine and Dentistry, Rochester (J. Riccio) - both in New York; the Oklahoma University Health Sciences Center, Oklahoma City (D.W.H.); the Medical University of South Carolina, Health Shawn Jenkins Children's Hospital, Charleston (J. Ross), and the Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg (J.B.) - both in South Carolina; the Section on Newborn Medicine, Pennsylvania Hospital (K.M.P.), and the Hospital of the University of Pennsylvania (L.C.), Philadelphia; the Kapiolani Medical Center for Women and Children, Honolulu (K.W.R., A.); the Department of Pediatrics, University of Mississippi Medical Center, Jackson (L.T.); Winchester Hospital, Winchester, MA (K.R.M.); the Department of Pediatrics, University of Kansas Medical Center (K.D.), and Children's Mercy Hospital (J.W.) - both in Kansas City, MO; Sanford Health, Sioux Falls, SD (J.R.W.); Tulane University School of Medicine, New Orleans (M.P.H.); and the University of Nebraska Medical Center, Omaha (S.N.).
Background: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown.
Methods: In this cluster-randomized, controlled trial at 26 U.
J Med Internet Res
April 2023
Department of Biomedical Engineering, Duke University, Durham, NC, United States.
Background: Digital sensing solutions represent a convenient, objective, relatively inexpensive method that could be leveraged for assessing symptoms of various health conditions. Recent progress in the capabilities of digital sensing products has targeted the measurement of scratching during sleep, traditionally referred to as nocturnal scratching, in patients with atopic dermatitis or other skin conditions. Many solutions measuring nocturnal scratch have been developed; however, a lack of efforts toward standardization of the measure's definition and contextualization of scratching during sleep hampers the ability to compare different technologies for this purpose.
View Article and Find Full Text PDFTher Innov Regul Sci
July 2023
Florida Atlantic University, Boca Raton, FL, USA.
In this commentary, we urge that a Data Monitoring Committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations; it should not attribute opinions to individual members.
View Article and Find Full Text PDFAm J Cardiol
February 2023
Hôpital Bichat, Assistance Publique-Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) LVTS-U1148, French Alliance for Cardiovascular Trials (FACT), Université Paris-Cité, Paris, France; Institut Universitaire de France, Paris, France. Electronic address:
In patients with non-ST-elevation myocardial infarction (NSTEMI), total occlusion of the culprit coronary artery (OCA) is not uncommon. We sought to determine the frequency and clinical impact of OCA at presentation in a large population of patients presenting with NSTEMI and who underwent systematic early invasive management. We performed a post hoc analysis of the TAO (Treatment of Acute Coronary Syndrome with Otamixaban) randomized trial, which included patients with NSTEMI with systematic coronary angiography within 72 hours.
View Article and Find Full Text PDFAm J Public Health
November 2022
Emily M. D'Agostino is with the Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, and is also a guest editor of this special issue. Bryan J. Feger is with the Duke Clinical Research Institute, Duke University School of Medicine. Maria F. Pinzon and Rocio Bailey are with Hispanic Services Council, Tampa, FL. Warren A. Kibbe is with the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, and is also a guest editor of this special issue.
Am J Public Health
November 2022
Emily M. D'Agostino is with the Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, and is also a guest editor of this special issue. Gaurav Dave is with the Division of General Medicine and Clinical Epidemiology, University of North Carolina, Chapel Hill. Callie Dyer is with the Finney County Health Coalition, Garden City, KS. Aliyha Hill is with the Chicago Department of Public Health, Chicago, IL. Detra McCarty is with A Community of Caring Christians, Shubuta, MS. Sandra Melvin is with the Institute for the Advancement of Minority Health, Ridgeland, MS. Marcus Layer and Judy Jean are with the Duke Clinical Research Institute, Duke University School of Medicine, Durham. Krista Perreira is with the Department of Social Medicine, University of North Carolina School of Medicine, Chapel Hill.
N Engl J Med
December 2022
From the Duke Pediatric and Congenital Heart Center (K.D.H., J.W.T., J.S.L.) and the Duke Clinical Research Institute (K.D.H., S.M.O., J.L.K., D.S.G., J.S.L.) - both in Durham, NC; Vanderbilt University Medical Center, Nashville (P.J.K., H.S.B., D.P.B.); the University of Florida Congenital Heart Center, Gainesville (J.P.J., M.B.); Johns Hopkins University School of Medicine, Baltimore (M.L.J., B.M.); the Medical University of South Carolina, Charleston (E.M.G.); the UPMC Children's Hospital of Pittsburgh, Pittsburgh (B.B.); the Section of Pediatric Cardiac Anesthesiology, Texas Children's Hospital, Department of Anesthesiology, Baylor College of Medicine, Houston (A.R., D.F.V.), and the Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (R.B.); the University of Utah-Primary Children's Hospital, Salt Lake City (A.S.H.); the University of Southern California and the Heart Institute, Children's Hospital of Los Angeles - both in Los Angeles (S.R.K.); the University of Cincinnati, Cincinnati Children's Hospital Medical Center, Cincinnati (A.B.), the Division of Pediatric Cardiac Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic Children's, Cleveland (T.K.), and the Department of Cardiothoracic Surgery, Nationwide Children's Hospital, and Ohio State University, Columbus (P.I.M.) - all in Ohio; the Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago (E.W.), and the Advocate Children's Heart Institute, Advocate Children's Hospital, Division of Pediatric Cardiac Critical Care, Oak Lawn (A.H.V.B.) - both in Illinois; the Division of Cardiovascular Surgery, Children's Minnesota, Minneapolis (D.O.); the Section of Pediatric Cardiothoracic Surgery, Washington University School of Medicine, St. Louis (P.E.); the Division of Cardiology, Department of Pediatrics, Heart Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (J.S.K.); Children's Wisconsin, Medical College of Wisconsin, Milwaukee (J.P.S.); and the Division of Pediatric Cardiology, New York-Presbyterian Hospital-Columbia University Irving Medical Center, New York (B.R.A.), and the University of Rochester Medical Center, Rochester (M.F.S.) - both in New York.
Background: Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown.
Methods: We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes.
Pediatr Infect Dis J
January 2023
From the Duke Clinical Research Institute, Durham, North Carolina.
Background: Infants frequently receive metronidazole at variable doses and duration for surgical site infection prophylaxis and treatment of intra-abdominal infections. Seizures are a rare (but potentially devastating) side effect of metronidazole, yet the prevalence of seizures in infants, as well as the relationship with metronidazole dose and exposure, are unknown.
Methods: We examined the Pediatrix Clinical Data Warehouse for infants in neonatal intensive care units from 1997 to 2018 who received at least 1 dose of metronidazole during their first 120 days of life.
Am J Public Health
November 2022
Giselle Corbie and Krista M. Perreira are with the Center for Health Equity Research, Department of Social Medicine, University of North Carolina, Chapel Hill. Giselle Corbie is also a guest editor of this special issue. Emily M. D'Agostino is with the Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, and is also a guest editor of this special issue. Susan Knox, Lisa M. Wruck, and Michael Cohen-Wolkowiez are with the Duke Clinical Research Institute, Duke University School of Medicine. Michael Cohen-Wolkowiez is also a guest editor of this special issue. Al Richmond is with Community-Campus Partnerships for Health, Raleigh, NC. Christopher W. Woods is with the Hubert-Yeargan Center for Global Health, Duke University Department of Medicine, Duke University School of Medicine. Gaurav Dave is with the Division of General Medicine and Clinical Epidemiology, University of North Carolina, Chapel Hill. Keith Marsolo is with the Department of Population Health Sciences, Duke University School of Medicine. Warren A. Kibbe is with the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, and is also a guest editor of this special issue.
Circulation
November 2022
Department of Cardiology, University Hospital of Bern, Switzerland (G.C.M.S., S.W., M.V.).
N Engl J Med
September 2022
From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
PLoS One
August 2022
Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
People living in rural regions in the United States face more health challenges than their non-rural counterparts which could put them at additional risks during the COVID-19 pandemic. Few studies have examined if rurality is associated with additional mortality risk among those hospitalized for COVID-19. We studied a retrospective cohort of 3,991 people hospitalized with SARS-CoV-2 infections discharged between March 1 and September 30, 2020 in one of 17 hospitals in North Carolina that collaborate as a clinical data research network.
View Article and Find Full Text PDFCirc Cardiovasc Interv
August 2022
Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora (C.N.H.).
Background: Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI.
Methods: Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry.
Nat Rev Cardiol
December 2022
University of Florida College of Medicine, Jacksonville, FL, USA.
For 20 years, dual antiplatelet therapy (DAPT), consisting of the combination of aspirin and a platelet P2Y receptor inhibitor, has been the gold standard of antithrombotic pharmacology after percutaneous coronary intervention (PCI). In the past 5 years, several investigations have challenged this paradigm by testing the efficacy and safety of P2Y inhibitor monotherapy (that is, without aspirin) following a short course of DAPT. Collectively, these studies suggested a reduction in the risk of major bleeding and no significant increase in thrombotic or ischaemic events compared with guideline-recommended DAPT.
View Article and Find Full Text PDFAm Heart J
September 2022
Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT.
Introduction: The decision to shorten the duration of DAPT following PCI in patients with ACS remains controversial because of the concern for increased ischemic events.
Methods: We performed a comprehensive literature search in seven databases to explore the efficacy of 1 to 3 months of DAPT in patients who underwent PCI for ACS. Randomized controlled trials that compared 1 to 3 months with 6 to 12 months of DAPT after PCI for ACS were identified.
Pain Med
October 2022
Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa, USA.
Eur Heart J Cardiovasc Pharmacother
September 2022
Division of Cardiology, Thomas Jefferson University Hospitals, 111 S 11th Street, Philadelphia, PA 19107, USA.
Aims: The relative safety and efficacy of de-escalation, extended duration (ED) (>12-months), and standard dual antiplatelet therapy for 12-months (DAPT-12) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) remains controversial.
Methods And Results: Online databases were queried to identify relevant randomized control trials (RCTs). ED-DAPT, high-potency (HP) DAPT, shorter duration (SD) DAPT, and low-dose (LD) DAPT were compared with DAPT-12.
Lupus Sci Med
March 2022
Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA.
Objective: Multiple guidelines recommend continuing hydroxychloroquine (HCQ) for SLE during pregnancy based on observational data. The goal of this individual patient data meta-analysis was to identify the potential benefits and harms of HCQ use within lupus pregnancies.
Methods: Eligible studies included prospectively collected pregnancies in women with lupus.
J Card Fail
July 2022
From the Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.
Background: For patients hospitalized for heart failure with reduced ejection fraction (HFrEF), guidelines recommend optimization of medical therapy prior to discharge. The degree to which changes in medical therapy occur during hospitalizations for HFrEF in North American clinical practice is unclear.
Methods: The VICTORIA registry (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) enrolled patients hospitalized for worsening chronic HFrEF across 51 sites in the United States and Canada from February 2018-January 2019.
Eur J Heart Fail
June 2022
Division of Clinical Electrophysiology, Department of Cardiology, J. W. Goethe University, Frankfurt, Germany.
Aims: Limited therapeutic options are available for the management of atrial fibrillation/flutter (AF/AFL) with concomitant heart failure (HF) with preserved (HFpEF) and mildly reduced ejection fraction (HFmrEF). Dronedarone reduces the risk of cardiovascular events in patients with AF, but sparse data are available examining its role in patients with AF complicated by HFpEF and HFmrEF.
Methods And Results: ATHENA was an international, multicentre trial that randomized 4628 patients with paroxysmal or persistent AF/AFL and cardiovascular risk factors to dronedarone 400 mg twice daily versus placebo.
Heart Rhythm O2
February 2022
Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center and the Duke Clinical Research Institute, Durham, North Carolina.
Am J Cardiol
April 2022
Division of Cardiology, Department of Medicine.
It has been suggested that maintaining low mean arterial pressure (MAP) in left ventricular assist device (LVAD) recipients is associated with a reduced risk of stroke/death. However, the lower limit of the optimal MAP range has not been established. We aimed to identify this lower limit in a contemporary cohort of LVAD recipients with frequent longitudinal MAP measurements.
View Article and Find Full Text PDFN Engl J Med
October 2021
From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).
Background: Experimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder.
Methods: We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder.
Background: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates.
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