364 results match your criteria: "the Duke Clinical Research Institute[Affiliation]"
Attacking the Research-Practice Barrier.
Phys Ther
December 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, 300 W Morgan Street, Durham, North Carolina, 27701USA.
All I Really Needed to Know as a Researcher I Learned Playing D&D.
Phys Ther
November 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
My View of PTJ: 10 Months Later….
Phys Ther
October 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Ansa Cervicalis Stimulation Effects on Upper Airway Patency: A Structure-Based Analysis.
Eur Respir J
November 2024
Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.
Article Synopsis
- Ansa cervicalis stimulation (ACS) is being explored as a therapy for obstructive sleep apnea (OSA) by stabilizing the pharynx and addressing collapse of various flow-limiting structures in the airway.
- A study involving 41 OSA participants measured the effects of ACS on airflow and identified the specific structures causing airflow limitations during sleep.
- Results indicated that ACS significantly reduced the collapsibility of all tested airway structures, with the most marked effects observed on the palatal and oropharyngeal walls, while factors like lower apnea-hypopnea index were linked to greater improvements in airway pressure.
Association of Medication Adherence and Health Status in Heart Failure With Reduced Ejection Fraction: Insights From the CHAMP-HF Registry.
Circ Cardiovasc Qual Outcomes
September 2024
University of Missouri - Kansas City's Healthcare Institute for Innovation in Quality and Saint Luke's Mid America Heart Institute, Kansas City (R.S.E.-Z., M.M., D.D.N., M.N., J.A.S.).
Article Synopsis
- The study focuses on patients with heart failure with reduced ejection fraction (HFrEF) and the importance of adhering to prescribed medication guidelines to improve health status.
- Researchers analyzed the self-reported medication adherence of 3,495 outpatient participants over a 12-month period and found that nonadherent patients had worse health status at baseline and showed less improvement over time compared to those who followed their medication regimen.
- Additionally, for patients who improved their adherence, there was a trend toward better health outcomes, highlighting the significance of medication adherence in managing HFrEF.
A Tension Not Mentioned: When Clinical Research Favors Internal Over External Validity.
Phys Ther
June 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Acyclovir Dosing Practices Across a Multicenter Cohort of Neonatal Intensive Care Units.
Pediatr Infect Dis J
June 2024
From the Department of Pediatrics, Duke University School of Medicine, Durham, NC.
Background: Acyclovir is the first-line therapy for neonatal herpes simplex virus infections. Therapy can mitigate morbidity and mortality but carries a risk for toxicity. We aimed to compare acyclovir dosing in neonatal intensive care units to published recommendations based on population pharmacokinetic (PopPK) analysis.
View Article and Find Full Text PDFThe Atrial FibriLlatiOn (FLOW-AF) Registry in the Middle East and North Africa: Patient Characteristics, Treatment Patterns and Outcomes.
Adv Ther
July 2024
Cardiology Department, American University of Beirut, Beirut, Lebanon.
Introduction: Limited data on atrial fibrillation (AF) are available from the Middle East and North Africa region (MENA). The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) in MENA.
Methods: This multi-center, prospective, observational study (the FLOW-AF registry) enrolled patients newly diagnosed with NVAF across Egypt, Lebanon, Kingdom of Saudi Arabia, and United Arab Emirates.
Paving the Way for the Next Frontier of Community-Engaged Research.
Am J Public Health
May 2024
Emily M. D'Agostino is with the Duke Clinical Research Institute, the Duke Global Health Institute, and the Departments of Orthopaedic Surgery and Population Health Sciences, Duke University School of Medicine, Durham, NC. Debra Oto-Kent is with the Health Education Council, Sacramento, CA. Miriam Nuño is with the Division of Biostatistics, Department of Public Health Sciences, UC Davis Health Medical Center, Sacramento, CA. The authors were also Guest Editors of this supplemental issue.
Enhancing Community Engagement in Research: A Tiered Approach.
Am J Public Health
May 2024
Emily M. D'Agostino, Allyn Damman, Camille Brown-Lowery, Princess Abbot-Grimes, Saira Siddiqui, Tigidankay Fadika, Mark Ward, Mia Cooper, Sonya Sutton, Lindsay Kenton, Bob Spaziano, and Christoph P. Hornik are with the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Lauren M. Rosenberg is with the Duke Global Health Institute, Duke University School of Medicine, Durham, NC. Alan Richmond is with Community-Campus Partnerships for Health, Raleigh, NC. Janet Kasper is with the United Way of Merced County, Merced, CA. Nicole Barnes is with the Pitt County Health Department, Greenville, NC. Emily D'Agostino was also a Guest Editor for this supplemental issue.
Drug-Induced Liver Injury in Pregnancy: The U.S. Drug-Induced Liver Injury Network Experience.
Obstet Gynecol
June 2024
Division of Liver Diseases and the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York; Duke University School of Medicine and the Duke Clinical Research Institute, Durham, and Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina; National Institutes of Health, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; and Albert Einstein Medical Center, Philadelphia, Pennsylvania.
There are limited data on the causative agents and characteristics of drug-induced liver injury in pregnant individuals. Data from patients with drug-induced liver injury enrolled in the ongoing multicenter Drug-Induced Liver Injury Network between 2004 and 2022 and occurring during pregnancy or 6 months postpartum were reviewed and compared with cases of drug-induced liver injury in nonpregnant women of childbearing age. Among 325 individuals of childbearing age in the Drug-Induced Liver Injury Network, 16 cases of drug-induced liver injury (5%) occurred during pregnancy or postpartum.
View Article and Find Full Text PDFEmpagliflozin after Acute Myocardial Infarction.
N Engl J Med
April 2024
From Baylor Scott and White Research Institute, Dallas (J. Butler); the Department of Medicine, University of Mississippi, Jackson (J. Butler); the Division of Cardiology, Department of Medicine, Duke University Medical Center (W.S.J., J.H., A.F.H.), and the Duke Clinical Research Institute (R.D.L.) - both in Durham, NC; Women's College Hospital (J.A.U.), the Peter Munk Cardiac Centre, University Health Network, University of Toronto (J.A.U., S.G.G.), and the Division of Cardiology, Department of Medicine, St. Michael's Hospital, Unity Health Toronto (S.G.G.), Toronto, the Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg (S.Z.) - all in Canada; the Department of Cardiology, German Heart Center Charité, Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim Pharma (M.M., I.Z.) and Boehringer Ingelheim International (T.G., W.J., M.B., M. Sumin), Ingelheim, the Department of Cardiology and Angiology, Hannover Medical School, Hannover (J. Bauersachs), and the First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M.B.) - all in Germany; the School of Cardiovascular and Medical Sciences, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (M.C.P.); the Heart Institute, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem (O.A.); Instituto de Neurología (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); the Heart Institute, Hospital Universitari Germans Trias i Pujol, and the Department of Medicine, Universitat Autònomoa de Barcelona, Barcelona (A.B.-G.), and Son Espases University Hospital, Health Research Institute of the Balearic Islands, University of the Balearic Islands, Palma de Mallorca (X.R.) - all in Spain; the Department of Cardiology, First Medical Center of Chinese People's Liberation Army General Hospital, Beijing (Y.C.), and the Department of Cardiology, Zhongshan Hospital, Fudan University, and the Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai (J.G.) - both in China; the Department of Cardiology, Medanta, Gurgaon, India (V.K.C.); the Faculty of Medicine and Health, University of Sydney, Sydney (G.F.); the Department of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (N.G.); Tokai University School of Medicine, Isehara, Japan (S.G.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.L.J.); Chonnam National University Hospital and Medical School, Gwangju, South Korea (M.H.J.); Volgograd State Medical University, Volgograd, Russia (Y.L.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); the Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook (P.B.P.), and Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York (D.L.B.) - both in New York; the Ukrainian Institute of Cardiology M.D. Strazhesko, National Academy of Medical Sciences, Kyiv, Ukraine (A.P.); Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza (T.G.), and the Institute for Heart Diseases Medical University (P.P.) and Jan Mikulicz-Radecki University Clinical Hospital (J.S.), Wrocław - all in Poland; the Department of Cardiology, Herlev and Gentofte University Hospital, Copenhagen (M. Schou); the Department of Cardiovascular Diseases, University Clinical Center Belgrade, Belgrade, Serbia (D.S.); Université Paris-Cité, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris (P.G.S.); the Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (P.M.); and University and Emergency Hospital of Bucharest, Bucharest, Romania (D.V.).
Article Synopsis
- Empagliflozin is known to improve cardiovascular outcomes in various patient groups, but its safety and effectiveness in those who have experienced an acute myocardial infarction were previously unclear.
- In a study involving 6522 patients at risk for heart failure after a heart attack, participants were given either empagliflozin or a placebo, with their health monitored over about 18 months.
- The results showed that empagliflozin did not significantly reduce the risk of hospitalization for heart failure or death compared to placebo, though it did show some potential benefits regarding hospitalizations specifically for heart failure.
My View of PTJ: How Potential for Impact Is Factored Into Article Review.
Phys Ther
April 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham NC, USA.
Leadless pacemaker tine damage and fracture: novel complications of a novel device fixation mechanism.
Heart Rhythm O2
January 2024
Division of Cardiovascular Medicine, University of Utah Health Sciences Center, Salt Lake City, Utah.
Background: Leadless pacemakers represent a paradigm-changing advancement. However, they required innovative and novel device design, including the use of nitinol tines for fixation.
Objective: We aimed to understand the potential for fracture in the novel tine-based fixation mechanism.
Cardiac Implantable Electronic Devices.
N Engl J Med
February 2024
From the Division of Cardiology and the Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Factors Associated With Successful Extubation Readiness Testing in Children With Congenital Heart Disease.
Respir Care
March 2024
Mr Miller, Dr Kumar, Dr Allareddy, and Dr Rotta are affiliated with the Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina. Mr Miller, Ms Brown, Ms Marshburn, Mr. Mattin, and Ms Muddiman are affiliated with the Respiratory Care Services, Duke University Medical Center, Durham, North Carolina. Dr Kumar is affiliated with the Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
Background: In children with congenital heart disease, extubation readiness testing (ERT) is performed to evaluate the potential for liberation from mechanical ventilation. There is a paucity of data that suggests what mechanical ventilation parameters are associated with successful ERT. We hypothesized that ERT success would be associated with certain mechanical ventilator parameters.
View Article and Find Full Text PDFAim: To investigate the effects of Cimlanod, a nitroxyl donor with vasodilator properties, on water and salt excretion after an administration of an intravenos bolus of furosemide.
Methods And Results: In this randomized, double-blind, mechanistic, crossover trial, 21 patients with left ventricular ejection fraction <45%, increased plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and receiving loop diuretics were given, on separate study days, either an 8 h intravenous (IV) infusion of cimlanod (12 μg/kg/min) or placebo. Furosemide was given as a 40 mg IV bolus four hours after the start of infusion.
Outcomes According to Coronary Revascularization Modality in the ISCHEMIA Trial.
J Am Coll Cardiol
February 2024
Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York, USA. Electronic address:
Article Synopsis
- - In the ISCHEMIA trial, patients with stable coronary artery disease showed similar risk levels for ischemic events whether they underwent invasive treatments (like PCI or CABG) or conservative medical therapy.
- - The study specifically analyzed outcomes after revascularization, finding that CABG had a higher incidence of early primary outcome events compared to PCI, with 16.4% vs. 9.8% respectively, and many events occurring shortly after the procedures.
- - Overall, while early revascularization increased immediate risks of cardiovascular events, both CABG and PCI were linked to lower risks in the long term compared to conservative treatment, suggesting a complex risk-benefit scenario.
Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation.
N Engl J Med
January 2024
From the Population Health Research Institute, McMaster University, Hamilton, ON (J.S.H., W.F.M., D.C., J.A.W., L.X., K.S., S.N., R.M., S.J.C.), the Montreal Heart Institute, University of Montreal, Montreal (L.R.), the University of Ottawa Heart Institute, Ottawa (D.H.B.), Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Quebec, QC (F.P.), the Department of Clinical Neurosciences, Radiology, and Community Health Sciences, Hotchkiss Brain Institute, University of Calgary, Calgary, AB (S.B.C.), and the Université de Sherbrooke, Sherbrooke, QC (F.A.-P.) - all in Canada; the Duke Clinical Research Institute, Duke University, Durham, NC (R.D.L., C.B.G.); Amphia Ziekenhuis, Breda, the Netherlands (M.A.); Oslo University Hospital and the University of Oslo, Oslo (D.A.); the University of Modena and Reggio Emilia, Modena (G.B.), and the Department of Clinical Sciences and Community Health, University of Milan, and the Division of Subacute Care, IRCCS Istituti Clinici Scientifici Maugeri, Milan (M. Proietti) - all in Italy; St. George's, University of London, London (A.J.C.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - both in the United Kingdom; J.W. Goethe University, University Hospital Department of Cardiology, Frankfurt, Germany (J.W.E., S.H.H.); the Medical University of South Carolina, Charleston (M.R.G.); Michigan State University, Lansing (J.I.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the University of Rochester, Rochester, NY (V.K.); Semmelweis University, Budapest, Hungary (V.K.); Karolinska Institutet and the Heart, Vascular, and Neurology Theme, Karolinska University Hospital, Stockholm (C.L.); the University of Rennes, Rennes, France (P.M.); Cliniques du Sud-Luxembourg, Arlon, Belgium (G.M.); Hospital Universitario La Luz, Madrid (J.B.M.), and Hospital Costa del Sol, Marbella (M. Pombo) - both in Spain; Aarhus University Hospital and Aarhus University, Aarhus, Denmark (J.C.N.); University Hospital Basel, University of Basel, Basel, Switzerland (C.S.); the Veterans Affairs Portland Health Care System, Portland, OR (I.G.Z.); and Abrazo Arrowhead Hospital, Glendale, AZ (A.K.).
Background: Subclinical atrial fibrillation is short-lasting and asymptomatic and can usually be detected only by long-term continuous monitoring with pacemakers or defibrillators. Subclinical atrial fibrillation is associated with an increased risk of stroke by a factor of 2.5; however, treatment with oral anticoagulation is of uncertain benefit.
View Article and Find Full Text PDFStakeholder Reflections on Implementing the National Institutes of Health's Policy on Single Institutional Review Boards.
Ethics Hum Res
November 2023
Executive director of North Star Review Board in Freeport, ME.
The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads.
View Article and Find Full Text PDFOutcomes and Complications for Concurrent Hernia Repair Among Women Undergoing Hysterectomy.
Obstet Gynecol
November 2023
Department of Obstetrics and Gynecology, and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, the Duke University School of Medicine, the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, the Duke Clinical Research Institute, and the Duke Cancer Institute, Durham, North Carolina.
Objective: To assess whether concurrent hernia repair at time of hysterectomy is associated with increased complications.
Methods: In this retrospective cohort study, patients who underwent hysterectomy and hysterectomy with concurrent hernia repair were queried using the American College of Surgeons' National Surgical Quality Improvement Program participant use file (2005-2019). Propensity score matching was performed 1:1 with respect to preoperative and operative characteristics.
Inhaled Fluticasone Furoate for Outpatient Treatment of Covid-19.
N Engl J Med
September 2023
From the University of Minnesota, Minneapolis (D.R.B.); Vanderbilt University Medical Center, Nashville (C.J.L., S.C.); the University of Virginia, Charlottesville (T.G.S.); the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.F.H., G.M.F., A.D., A.R., R.W., S.W., S.N.); Weill Cornell Medicine, New York (M.W.M.); the University of Miami, Miami (D.J.), and the University of Florida, Gainesville (E.S.); the Lewis Katz School of Medicine at Temple University, Philadelphia (N.G.); the University of Kansas Medical Center, Kansas City (M.C.); Johns Hopkins University, Baltimore (M.S.), and the National Center for Advancing Translational Sciences (S.E.D.) and the Foundation for the National Institutes of Health (S.J.A.), Bethesda - all in Maryland; the University of Pittsburgh Medical Center (K.M.) and the ACTIV-6 Stakeholder Advisory Committee, University of Pittsburgh (F.T.) - both in Pittsburgh; the University of Colorado Denver-Anschutz, Denver (A.A.G.); and the Biomedical Advanced Research and Development Authority, Washington, DC (G.H.).
Background: The effectiveness of inhaled glucocorticoids in shortening the time to symptom resolution or preventing hospitalization or death among outpatients with mild-to-moderate coronavirus disease 2019 (Covid-19) is unclear.
Methods: We conducted a decentralized, double-blind, randomized, placebo-controlled platform trial in the United States to assess the use of repurposed medications in outpatients with confirmed coronavirus disease 2019 (Covid-19). Nonhospitalized adults 30 years of age or older who had at least two symptoms of acute infection that had been present for no more than 7 days before enrollment were randomly assigned to receive inhaled fluticasone furoate at a dose of 200 μg once daily for 14 days or placebo.
Use of guideline-directed medical therapy (GDMT) for treatment of heart failure with reduced ejection fraction (HFrEF) remains unacceptably low. The purpose of this study was to determine whether a digital health tool can augment GDMT for patients with HFrEF. Participants ≥ 18 years old with symptomatic HFrEF (left ventricular ejection fraction ≤ 40%) and with access to a mobile phone with internet were included.
View Article and Find Full Text PDFEfficacy and Safety of Adjunctive and Primary Use of the TightRail Mechanical Cutting Sheath for Lead Extraction.
Circ Arrhythm Electrophysiol
June 2023
Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center & the Duke Clinical Research Institute, Durham, NC.
Background: Rotational cutting tools are increasingly used in transvenous lead extraction. There are limited data on their safety and efficacy, particularly when used adjunctively for stalled progression. The aim of this study was to evaluate the utilization, safety, and effectiveness of mechanical rotational cutting tools for transvenous lead extraction.
View Article and Find Full Text PDFEat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
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.