54 results on '"Michelson KN"'
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2. Associations of Patient and Parent Characteristics With Parental Decision Regret in the PICU: A Secondary Analysis of the 2015-2017 Navigate Randomized Comparative Trial.
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Ashworth RC, Malone JR, Franklin D, Sorce LR, Clayman ML, Frader J, White DB, and Michelson KN
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- Humans, Male, Female, Child, Child, Preschool, Infant, Adolescent, Self Report, Adult, Intensive Care Units, Pediatric, Parents psychology, Decision Making, Emotions
- Abstract
Objectives: To identify self-reported meaningful decisions made by parents in the PICU and to determine patient and parent characteristics associated with the development of parental decision regret, a measurable, self-reported outcome associated with psychologic morbidity., Design: Secondary analysis of the Navigate randomized comparative trial (NCT02333396)., Setting: Two tertiary, academic PICUs., Patients: Spanish- or English-speaking parents of PICU patients aged less than 18 years who were expected to remain in the PICU for greater than 24 hours from time of enrollment or who had a risk of mortality greater than 4% based on Pediatric Index of Mortality 2 score., Interventions: None., Measurements and Main Results: Between April 2015 and March 2017, 233 parents of 209 patients completed a survey 3-5 weeks post-PICU discharge which included the Decision Regret Scale (DRS), a 5-item, 5-point Likert scale tool scored from 0 (no regret) to 100 (maximum regret). Two hundred nine patient/parent dyads were analyzed. The decisions parents reported as most important were categorized as: procedure, respiratory support, medical management, parent-staff interactions and communication, symptom management, fluid/electrolytes/nutrition, and no decision. Fifty-one percent of parents had some decision regret (DRS > 0) with 19% scoring in the moderate-severe range (DRS 26-100). The mean DRS score was 12.7 ( sd 18.1). Multivariable analysis showed that parental Hispanic ethnicity was associated with greater odds ratio (OR 3.12 [95% CI, 1.36-7.13]; p = 0.007) of mild regret. Being parents of a patient with an increased PICU length of stay (LOS) or underlying respiratory disease was associated with greater odds of moderate-severe regret (OR 1.03 [95% CI, 1.009-1.049]; p = 0.004 and OR 2.91 [95% CI, 1.22-6.94]; p = 0.02, respectively)., Conclusions: Decision regret was experienced by half of PICU parents in the 2015-2017 Navigate study. The characteristics associated with decision regret (parental ethnicity, PICU LOS, and respiratory disease) are easily identifiable. Further study is needed to understand what contributes to regret in this population and what interventions could provide support and minimize the development of regret., Competing Interests: Drs. Michelson, Frader, Sorce, Clayman, and White’s institutions received from Patient-Centered Outcomes Research Institute. Dr. Sorce disclosed she is a member of the Executive Committee Board of the Society of Critical Care Medicine. Dr. White was supported by the National Institute of Health grant K24HL148314. Dr. White reports personal fees from American Thoracic Society and personal fees from UpToDate. Dr. Frader received funding from Direct Relief/Takeda Pharmaceuticals and Premier Research/Dicerna Pharmaceutical; he disclosed government work. Dr. Michelson’s institution received funding from the Greenwall Foundation and the National Institutes of Health; he received funding from the Friends of Prentice Northwestern Alliance for Research in Chicagoland Communities. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)
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- 2024
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3. Durability of Original Monovalent mRNA Vaccine Effectiveness Against COVID-19 Omicron-Associated Hospitalization in Children and Adolescents - United States, 2021-2023.
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Zambrano LD, Newhams MM, Simeone RM, Payne AB, Wu M, Orzel-Lockwood AO, Halasa NB, Calixte JM, Pannaraj PS, Mongkolrattanothai K, Boom JA, Sahni LC, Kamidani S, Chiotos K, Cameron MA, Maddux AB, Irby K, Schuster JE, Mack EH, Biggs A, Coates BM, Michelson KN, Bline KE, Nofziger RA, Crandall H, Hobbs CV, Gertz SJ, Heidemann SM, Bradford TT, Walker TC, Schwartz SP, Staat MA, Bhumbra SS, Hume JR, Kong M, Stockwell MS, Connors TJ, Cullimore ML, Flori HR, Levy ER, Cvijanovich NZ, Zinter MS, Maamari M, Bowens C, Zerr DM, Guzman-Cottrill JA, Gonzalez I, Campbell AP, and Randolph AG
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- Humans, Adolescent, Child, United States epidemiology, mRNA Vaccines, Vaccine Efficacy, SARS-CoV-2, Hospitalization, RNA, Messenger, COVID-19 Vaccines, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Pediatric COVID-19 vaccination is effective in preventing COVID-19-related hospitalization, but duration of protection of the original monovalent vaccine during SARS-CoV-2 Omicron predominance merits evaluation, particularly given low coverage with updated COVID-19 vaccines. During December 19, 2021-October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19-related hospitalization and critical illness among U.S. children and adolescents aged 5-18 years, using a case-control design. Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness. Most case-patients (persons with a positive SARS-CoV-2 test result) were unvaccinated, despite the high frequency of reported underlying conditions associated with severe COVID-19. VE of the original monovalent vaccine against COVID-19-related hospitalizations was 52% (95% CI = 33%-66%) when the most recent dose was administered <120 days before hospitalization and 19% (95% CI = 2%-32%) if the interval was 120-364 days. VE of the original monovalent vaccine against COVID-19-related hospitalization was 31% (95% CI = 18%-43%) if the last dose was received any time within the previous year. VE against critical COVID-19-related illness, defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death, was 57% (95% CI = 21%-76%) when the most recent dose was received <120 days before hospitalization, 25% (95% CI = -9% to 49%) if it was received 120-364 days before hospitalization, and 38% (95% CI = 15%-55%) if the last dose was received any time within the previous year. VE was similar after excluding children and adolescents with documented immunocompromising conditions. Because of the low frequency of children who received updated COVID-19 vaccines and waning effectiveness of original monovalent doses, these data support CDC recommendations that all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Danielle M. Zerr reports institutional support from Merck and consulting fees from AlloVir. Melissa S. Stockwell reports institutional support from the National Institutes of Health (NIH). Mary Allen Staat reports institutional support from NIH, Pfizer, Cepheid, and Merck and receipt of royalties from UpToDate for chapters on adoption and immunization. Jennifer E. Schuster reports institutional support from NIH, the Food and Drug Administration, and the State of Missouri, receipt of an honorarium from the Missouri chapter of the American Academy of Pediatrics (AAP) and participation on the advisory board of the Association of American Medical Colleges and the Association for Professionals in Infection Control and Epidemiology. Adrienne G. Randolph reports institutional support from NIH, royalties for UpToDate for work as a section editor, consulting fees from Inotrem, Inc. and ThermoFisher, Inc., receipt of honoraria from St. Jude Children’s Research Center and Volition, Inc., travel support from the International Sepsis Forum, participation on a data safety monitoring board for NIH and the Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia, serving as chair (2023–2024) of the International Sepsis Forum, and receipt of equipment from Illumina, Inc. (for institutional use). Pia S. Pannaraj reports institutional support from the National Institute on Allergy and Infectious Diseases, the National Institute of Child Health and Human Development, and AstraZeneca, receipt of honoraria from IDweek and Infectious Diseases in Children Symposium, payment for expert testimony from BBV Law Firm and Helsell Fetterman Law Firm, waiver of registration fee for IDweek meeting, uncompensated participation on three data safety monitoring boards 1) Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of One or Two Doses of Multimeric-001 (M-001) Followed by One or Two Doses of an Influenza A/H7N9 Vaccine, 2) Therapeutic Fecal Transplant on the Gut Microbiome in Children with Ulcerative Colitis, and 3) Safety of Fecal Transplant in maintenance of pediatric Crohn's disease), and uncompensated services as president of the California Immunization Coalition and the AAP Committee on Infectious Diseases. Kanokporn Mongkolrattanothai reports institutional support from Gilead. Samina S. Bhumbra reports travel support from CDC to present a plenary lecture at the Conference on Emerging Infectious Diseases. Kathleen Chiotos reports institutional support from the Agency for Healthcare Research and Quality and travel support from IDWeek (2022), Society for Healthcare Epidemiology of America (2022), and Pediatric Academic Societies (2022). Bria M. Coates reports institutional support from the National Heart, Lung, and Blood Institute and the American Lung Association, payment for expert testimony from Triplett Woolf Garretson, and participation on a Sobi Data Safety Monitoring Board. Thomas J. Connors reports grant support from NIH. Melissa L. Cullimore reports institutional support from NIH. Heidi R. Flori reports receipt of consulting fees from Lucira Health for advisory role for rapid diagnostic devices for COVID-19. Shira J. Gertz reports ownership of Pfizer stock. Ivan Gonzalez reports receipt of honoraria from the Florida Chapter of AAP for educational infection control initiatives and travel support from the Florida Chapter of AAP for regional conference attendance. Judith A. Guzman-Cottrill reports receipt of a consulting contract from the Oregon Health Authority. Natasha B. Halasa reports receipt of investigator-initiated grants from Sanofi, Quidel, and Merck. Charlotte V. Hobbs reports receipt of consulting fees from Dynamed.com and royalties as a content reviewer for UpToDate.com. Janet R. Hume reports institutional support from NIH and uncompensated participation on a data safety monitoring board for a study at the University of Minnesota (Magnesium sulfate as adjuvant analgesia and its effect on opiate use by postoperative transplant patients in the pediatric intensive care unit). Satoshi Kamidani reports institutional support from NIH, Pfizer, Moderna, Meissa, and Bavarian Nordic and receipt of honoraria from AAP. Michele Kong reports institutional support from NIH and uncompensated service on the Board of Directors for Jefferson County Department of Health, Callahan Eye Hospital, University of Alabama at Birmingham, and KultureCity. Regina M. Simeone reports payments received by her spouse from a previously managed Pfizer investment, which was sold in April 2023. No other potential conflicts of interest were disclosed.
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- 2024
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4. Northwestern University resource and education development initiatives to advance collaborative artificial intelligence across the learning health system.
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Luo Y, Mao C, Sanchez-Pinto LN, Ahmad FS, Naidech A, Rasmussen L, Pacheco JA, Schneider D, Mithal LB, Dresden S, Holmes K, Carson M, Shah SJ, Khan S, Clare S, Wunderink RG, Liu H, Walunas T, Cooper L, Yue F, Wehbe F, Fang D, Liebovitz DM, Markl M, Michelson KN, McColley SA, Green M, Starren J, Ackermann RT, D'Aquila RT, Adams J, Lloyd-Jones D, Chisholm RL, and Kho A
- Abstract
Introduction: The rapid development of artificial intelligence (AI) in healthcare has exposed the unmet need for growing a multidisciplinary workforce that can collaborate effectively in the learning health systems. Maximizing the synergy among multiple teams is critical for Collaborative AI in Healthcare., Methods: We have developed a series of data, tools, and educational resources for cultivating the next generation of multidisciplinary workforce for Collaborative AI in Healthcare. We built bulk-natural language processing pipelines to extract structured information from clinical notes and stored them in common data models. We developed multimodal AI/machine learning (ML) tools and tutorials to enrich the toolbox of the multidisciplinary workforce to analyze multimodal healthcare data. We have created a fertile ground to cross-pollinate clinicians and AI scientists and train the next generation of AI health workforce to collaborate effectively., Results: Our work has democratized access to unstructured health information, AI/ML tools and resources for healthcare, and collaborative education resources. From 2017 to 2022, this has enabled studies in multiple clinical specialties resulting in 68 peer-reviewed publications. In 2022, our cross-discipline efforts converged and institutionalized into the Center for Collaborative AI in Healthcare., Conclusions: Our Collaborative AI in Healthcare initiatives has created valuable educational and practical resources. They have enabled more clinicians, scientists, and hospital administrators to successfully apply AI methods in their daily research and practice, develop closer collaborations, and advanced the institution-level learning health system., Competing Interests: This work was supported by the grants from the National Institutes of Health (NIH) Yuan Luo, Kristi Holmes, Luke Rasmussen, Andrew Naidech, Lazaro Sanchez‐Pinto, Richard Wunderink, Jennifer Pacheco, Matthew Carson, Susan Clare. Kristi Holmes is a member of Learning Health Systems Editorial Board. Donald Lloyd‐Jones serves as a board member of the American Heart Association. Michael Markl receives grant support by Siemens and Circle Cardiovascular Imaging; co‐founder and co‐owner of Third Coast Dynamics. Susanna McColley reports grants from the NIH National Center for Advancing Translational Science, the Centers for Disease Control and Prevention, the Cystic Fibrosis Foundation, and the Rosenau Family Research Foundation. She receives compensation as an advisor to Vertex Pharmaceuticals, Inc. Huiping Liu is the scientific co‐founder of ExoMira Medicine. Justin Starren reports grants from the NIH and Greenwall Foundation. Theresa Walunas receives research funding from Gilead Sciences. Kelly Michelson reports grants from the NIH, Greenwall Foundation, and the Patient‐Centered Outcomes Research Institute. Richard D’Aquila reports grants from the NIH, serving on external advisory boards for NIH‐funded projects, serving on the NIAID AIDS Research Advisory Council, and serving on the editorial board of the Journal of Clinical Investigation. Abel Kho is an advisor to Datavant. Sanjiv Shah is supported by grants from the NIH and AHA. Lee Cooper reports grants from the NIH and has invention disclosures registered at the Northwestern Office of Innovation and New Ventures, consults for Tempus, and advises Veracyte and Targeted Bioscience. Feng Yue is supported by grants from NIH and is a co‐founder of Sariant Therapeutics, Inc. Deyu Fang is co‐founder of ExoMira Medicine. Ronald Ackermann is supported by grants from the NIH, CDC, and the UnitedHealth Group., (© 2024 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)
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- 2024
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5. Challenges of Families of Patients Hospitalized in the PICU: A Preplanned Secondary Analysis From the Navigate Dataset.
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Tager JB, Hinojosa JT, LiaBraaten BM, Balistreri KA, Aniciete D, Charleston E, Frader JE, White DB, Clayman ML, Sorce LR, Davies WH, Rothschild CB, and Michelson KN
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- Child, Humans, Communication, Hospitals, Intensive Care Units, Pediatric, Hospitalization, Parents
- Abstract
Objectives: To describe challenges experienced by parents of children hospitalized in the PICU during PICU admission as reported by family navigators., Design: A preplanned secondary analysis of open-response data coded via inductive qualitative approach from the Navigate randomized controlled trial (RCT) dataset (ID NCT02333396)., Setting: Two university-affiliated PICUs in the Midwestern United States as part of an RCT., Patients: Two hundred twenty-four parents of 190 PICU patients., Interventions: In 2015-2017, trained family navigators assessed and addressed parent needs, offered weekly family meetings, and provided post-PICU discharge parent check-ins as part of a study investigating the effectiveness of a communication support intervention ("PICU Supports")., Measurements and Main Results: We analyzed qualitative data recorded by family navigators weekly across 338 encounters. Navigators described families' "biggest challenge," "communication challenges," and ways the team could better support the family. We used an inductive qualitative coding approach and a modified member-checking exercise. The most common difficulties included home life , hospitalization , and diagnosis distress (45.2%, 29.0%, and 17.2% of families, respectively). Navigators often identified that parents had co-occurring challenges. Communication was identified as a "biggest challenge" for 8% of families. Communication challenges included lack of information, team communication , and communication quality (7.0%, 4.8%, and 4.8% of families, respectively). Suggestions for improving care included better medical communication, listening, rapport, and resources., Conclusions: This study describes families' experiences and challenges assessed throughout the PICU stay. Family navigators reported families frequently experience stressors both internal and external to the hospital environment, and communication challenges between families and providers may be additional sources of distress. Further research should develop and assess interventions aimed at improving provider-family communication and reducing stressors outside the hospitalization itself, such as home life difficulties., Competing Interests: Drs. Tager and Balistreri were supported by the UWM Cialdini Fellowship. The project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UL1TR001436, and by the generosity of Froedtert Hospital. The content is solely the responsibility of the author(s) and does not necessarily represent the official views of the NIH. Drs. Charleston and Michelson’s institutions received funding from the Patient-Centered Outcomes Research Institute (PCORI). Dr. Charleston received support for article research from the PCORI. Dr. White received support for article research from the National Institutes of Health. Dr. Source disclosed she is on the Executive Board for the Society of Critical Care Medicine. Dr. Michelson’s institution received funding from the NIH, the Greenwall Foundation, and Friends of Prentice; They received funding from Northwestern Alliance for Research in the Chicagoland Communities; They disclosed they are a board member of Normal Moments; They disclosed they are the co-founder of Missing Pieces of the HAP Foundation. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)
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- 2024
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6. A Qualitative Study of Nurses' Perspectives on Neonatologist Continuity of Care.
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Machut KZ, Gilbart C, Murthy K, and Michelson KN
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- Infant, Newborn, Infant, Humans, Neonatologists, Intensive Care Units, Neonatal, Qualitative Research, Continuity of Patient Care, Nurses, Neonatal, Nurses
- Abstract
Background: Families and staff in neonatal intensive care units (NICUs) value continuity of care (COC), though definitions, delivery, and impacts of COC are incompletely described. Previously, we used parental perspectives to define and build a conceptual model of COC provided by neonatologists. Nursing perspectives about COC remain unclear., Purpose: To describe nursing perspectives on neonatologist COC and revise our conceptual model with neonatal nurse input., Methods: This was a qualitative study interviewing NICU nurses. The investigators analyzed transcripts with directed content analysis guided by an existing framework of neonatologist COC. Codes were categorized according to previously described COC components, impact on infants and families, and improvements for neonatologist COC. New codes were identified, including impact on nurses, and codes were classified into themes., Results: From 15 nurses, 5 themes emerged: (1) nurses validated parental definitions and benefits of COC; (2) communication is nurses' most valued component of COC; (3) neonatologist COC impact on nurses; (4) factors that modulate the delivery of and need for COC; (5) conflict between the need for COC and the need for change. Suggested improvement strategies included optimizing staffing and transition processes, utilizing clinical guidelines, and enhancing communication at all levels. Our adapted conceptual model describes variables associated with COC., Implications for Practice and Research: Interdisciplinary NICU teams need to develop systematic strategies tailored to their unit's and patients' needs that promote COC, focused to improve parent-clinician communication and among clinicians. Our conceptual model can help future investigators develop targeted interventions to improve COC., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 by The National Association of Neonatal Nurses.)
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- 2023
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7. Effectiveness of Maternal mRNA COVID-19 Vaccination During Pregnancy Against COVID-19-Associated Hospitalizations in Infants Aged <6 Months During SARS-CoV-2 Omicron Predominance - 20 States, March 9, 2022-May 31, 2023.
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Simeone RM, Zambrano LD, Halasa NB, Fleming-Dutra KE, Newhams MM, Wu MJ, Orzel-Lockwood AO, Kamidani S, Pannaraj PS, Irby K, Maddux AB, Hobbs CV, Cameron MA, Boom JA, Sahni LC, Kong M, Nofziger RA, Schuster JE, Crandall H, Hume JR, Staat MA, Mack EH, Bradford TT, Heidemann SM, Levy ER, Gertz SJ, Bhumbra SS, Walker TC, Bline KE, Michelson KN, Zinter MS, Flori HR, Campbell AP, and Randolph AG
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- Female, Pregnancy, Infant, Humans, COVID-19 Vaccines, RNA, Messenger, Stored, Case-Control Studies, Hospitalization, Mothers, Vaccination, SARS-CoV-2, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
Infants aged <6 months are not eligible for COVID-19 vaccination. Vaccination during pregnancy has been associated with protection against infant COVID-19-related hospitalization. The Overcoming COVID-19 Network conducted a case-control study during March 9, 2022-May 31, 2023, to evaluate the effectiveness of maternal receipt of a COVID-19 vaccine dose (vaccine effectiveness [VE]) during pregnancy against COVID-19-related hospitalization in infants aged <6 months and a subset of infants aged <3 months. VE was calculated as (1 - adjusted odds ratio) x 100% among all infants aged <6 months and <3 months. Case-patients (infants hospitalized for COVID-19 outside of birth hospitalization and who had a positive SARS-CoV-2 test result) and control patients (infants hospitalized for COVID-19-like illness with a negative SARS-CoV-2 test result) were compared. Odds ratios were determined using multivariable logistic regression, comparing the odds of receipt of a maternal COVID-19 vaccine dose (completion of a 2-dose vaccination series or a third or higher dose) during pregnancy with maternal nonvaccination between case- and control patients. VE of maternal vaccination during pregnancy against COVID-19-related hospitalization was 35% (95% CI = 15%-51%) among infants aged <6 months and 54% (95% CI = 32%-68%) among infants aged <3 months. Intensive care unit admissions occurred in 23% of all case-patients, and invasive mechanical ventilation was more common among infants of unvaccinated (9%) compared with vaccinated mothers (1%) (p = 0.02). Maternal vaccination during pregnancy provides some protection against COVID-19-related hospitalizations among infants, particularly those aged <3 months. Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Regina M. Simeone reports payments received by her spouse from a previously managed Pfizer investment, which was sold in April 2023. Natasha Halasa reports grant support from Sanofi, Quidel, and Merck, and testing and vaccine donation for Sanofi; and an education grant for delivering a lecture. Satoshi Kamidani reports institutional support from the National Institutes of Health (NIH), Pfizer, Meissa, and Emergent BioSolutions; and honoraria from the American Academy of Pediatrics (AAP). Pia S. Pannaraj reports institutional support from AstraZeneca and NIH, payment for expert testimony, and unpaid service on the AAP’s Committee on Infectious Diseases and the California Immunization Coalition. Aline B. Maddux reports support from the International Severe Acute Respiratory and Emerging Infections Consortium for conference attendance. Charlotte V. Hobbs reports receipt of consulting fees from Dynamed.com for review of a clinical database and honoraria from bioMérieux for speaking at Biofire (bioMérieux) 2022. Julie A. Boom reports receipt of royalties from UpToDate, Inc. for chapter authorship. Michele Kong reports institutional support from NIH and KultureCity board membership. Jennifer E. Schuster reports institutional support from NIH and the Food and Drug Administration, consulting fees from the Association for Professionals in Infection Control and Epidemiology and the Association of American Medical Colleges, and honoraria from the Missouri American Academy of Pediatrics. Janet R. Hume reports institutional support from the National Institute of Child Health and Human Development and NIH, consulting fees from Entegrion, and uncompensated service on a data safety managing board for an institutional study at the University of Minnesota. Mary A. Staat reports institutional support from NIH, Merck, and Cepheid, and royalties from UpToDate, Inc. for unrelated subject matter. Emily R. Levy reports institutional support from the National Institute on Allergy and Infectious Diseases and consulting fees from the Health Resources and Service Administration Regional Pediatric Pandemic Network. Heidi R. Flori reports consulting fees from NOTA Laboratories and Lucira Health, unrelated to the current work; housing compensation from the Society of Critical Care Medicine for participation in the Pediatric Surviving Sepsis Campaign; and unfunded participation on a data safety monitory board for normoxia in cardiothoracic surgery and cyclodextrin in Niemann-Pick disease. Adrienne G. Randolph reports grant support from NIH for work related to COVID-19, royalties from UpToDate, Inc. for work as the Pediatric Critical Care Medicine section editor; honoraria from grand rounds presentations on multisystem inflammatory syndrome in children and sepsis; meeting attendance support from the International Sepsis Forum, participation on a data safety monitoring board for the NIH Grace Study; chair of the Families Fighting Flu International Sepsis Forum medical advisory board; and receipt of reagents from Illumina, Inc. No other potential conflicts of interest were disclosed.
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- 2023
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8. The value and limitations of using predetermined criteria in decision making for maternal-fetal interventions.
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Premkumar A, Fry JT, Bolden JR, Grobman WA, and Michelson KN
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- Pregnancy, Child, Female, Humans, Fetus surgery, Prenatal Care, Family, Decision Making, Meningomyelocele surgery
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Maternal-fetal interventions-such as prenatal fetal myelomeningocele (MMC) repair-are at the forefront of clinical innovation within maternal-fetal medicine, pediatric surgery, and neonatology. Many centers determine eligibility for innovative procedures using pre-determined inclusion and exclusion criteria based on seminal studies, for example, the "Management of Myelomeningocele Study" for prenatal MMC repair. What if a person's clinical presentation does not conform to predetermined criteria for maternal-fetal intervention? Does changing criteria on a case-by-case basis (i.e., ad hoc) constitute an innovation in practice and flexible personalized care or transgression of commonly held standards with potential negative consequences? We outline principle-based, bioethically justified answers to these questions using fetal MMC repair as an example. We pay special attention to the historical origins of inclusion and exclusion criteria, risks and benefits to the pregnant person and the fetus, and team dynamics. We include recommendations for maternal-fetal centers facing these questions., (© 2023 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd.)
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- 2023
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9. Community-Onset Bacterial Coinfection in Children Critically Ill With Severe Acute Respiratory Syndrome Coronavirus 2 Infection.
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Moffitt KL, Nakamura MM, Young CC, Newhams MM, Halasa NB, Reed JN, Fitzgerald JC, Spinella PC, Soma VL, Walker TC, Loftis LL, Maddux AB, Kong M, Rowan CM, Hobbs CV, Schuster JE, Riggs BJ, McLaughlin GE, Michelson KN, Hall MW, Babbitt CJ, Cvijanovich NZ, Zinter MS, Maamari M, Schwarz AJ, Singh AR, Flori HR, Gertz SJ, Staat MA, Giuliano JS Jr, Hymes SR, Clouser KN, McGuire J, Carroll CL, Thomas NJ, Levy ER, and Randolph AG
- Abstract
Background: Community-onset bacterial coinfection in adults hospitalized with coronavirus disease 2019 (COVID-19) is reportedly uncommon, though empiric antibiotic use has been high. However, data regarding empiric antibiotic use and bacterial coinfection in children with critical illness from COVID-19 are scarce., Methods: We evaluated children and adolescents aged <19 years admitted to a pediatric intensive care or high-acuity unit for COVID-19 between March and December 2020. Based on qualifying microbiology results from the first 3 days of admission, we adjudicated whether patients had community-onset bacterial coinfection. We compared demographic and clinical characteristics of those who did and did not (1) receive antibiotics and (2) have bacterial coinfection early in admission. Using Poisson regression models, we assessed factors associated with these outcomes., Results: Of the 532 patients, 63.3% received empiric antibiotics, but only 7.1% had bacterial coinfection, and only 3.0% had respiratory bacterial coinfection. In multivariable analyses, empiric antibiotics were more likely to be prescribed for immunocompromised patients (adjusted relative risk [aRR], 1.34 [95% confidence interval {CI}, 1.01-1.79]), those requiring any respiratory support except mechanical ventilation (aRR, 1.41 [95% CI, 1.05-1.90]), or those requiring invasive mechanical ventilation (aRR, 1.83 [95% CI, 1.36-2.47]) (compared with no respiratory support). The presence of a pulmonary comorbidity other than asthma (aRR, 2.31 [95% CI, 1.15-4.62]) was associated with bacterial coinfection., Conclusions: Community-onset bacterial coinfection in children with critical COVID-19 is infrequent, but empiric antibiotics are commonly prescribed. These findings inform antimicrobial use and support rapid de-escalation when evaluation shows coinfection is unlikely., Competing Interests: Potential conflicts of interest. K. L. M. reports receiving funds from ContraFect as site investigator of a drug study and as patent beneficiary of technology licensed to Affinivax, Inc, outside the submitted work. C. V. H. reports receiving funds from UpToDate, Dynamed.com, and bioMérieux, outside the submitted work. M. W. H. reports receiving licensing fees from Kiadis, consulting fees from AbbVie for service on a data and safety monitoring board, consulting fees from the American Board of Pediatrics for service on a subboard, fees from Sobi for participating in a drug study, and fees from Partner Therapeutics for participating in a drug study, outside the submitted work. E. R. L. reports receiving grants to the institution from the National Institute of Allergy and Infectious Diseases (NIAID; AI 144301-01) and the CDC (CDC 75D30120C07725-01). A. G. R. reports receiving grants from NIAID and funds from UpToDate for editorial work. All other authors report no potential conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2023
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10. Prognostic Conversations Between Parents and Physicians in the Pediatric Intensive Care Unit.
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Rissman L, Derrington S, and Michelson KN
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- Child, Humans, Prognosis, Communication, Intensive Care Units, Pediatric, Parents, Physicians
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Background: Up to 80% of pediatric intensive care unit (PICU) patients experience new morbidities upon discharge. Patients and families rely on clear communication to prepare for post-PICU morbidities., Methods: Surveys were given at PICU discharge to parents and attending physicians of patients who developed multi-organ dysfunction within 24 hours of PICU admission and whose parents completed an initial survey 5 to 10 days after PICU admission. Participants were asked about prognostic conversations regarding PICU mortality; patient post-PICU physical, cognitive, and psychological morbidities; and parent post-PICU psychological morbidities. Parents also indicated whether they wanted more prognostic information., Results: Forty-nine parents and 20 PICU attending physicians completed surveys for 49 patients. Thirty parent (61%) and 29 physician (59%) surveys reported participating in any prognostic conversations. Concordance between parents and physicians about prognostic conversations was slight (κ = 0.19). Parent (n = 22; 45%) and physician (n = 23; 47%) surveys most commonly reported prognostic conversations about post-PICU physical morbidities. Parents less commonly reported conversations about post-PICU cognitive morbidities (n = 10; 20%). According to parents, bedside nurses and physicians provided most prognostic information; social workers (54%) most commonly discussed parent psychological morbidities. Twenty-six parents (53%) requested more prognostic information., Conclusions: Most parents and physicians reported having prognostic conversations, primarily about post-PICU physical morbidities. More than half of parents wanted more information about potential post-PICU morbidities. More research is needed to understand how and when medical professionals should have prognostic conversations with parents., (©2023 American Association of Critical-Care Nurses.)
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- 2023
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11. BNT162b2 mRNA Vaccination Against Coronavirus Disease 2019 is Associated With a Decreased Likelihood of Multisystem Inflammatory Syndrome in Children Aged 5-18 Years-United States, July 2021 - April 2022.
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Zambrano LD, Newhams MM, Olson SM, Halasa NB, Price AM, Orzel AO, Young CC, Boom JA, Sahni LC, Maddux AB, Bline KE, Kamidani S, Tarquinio KM, Chiotos K, Schuster JE, Cullimore ML, Heidemann SM, Hobbs CV, Nofziger RA, Pannaraj PS, Cameron MA, Walker TC, Schwartz SP, Michelson KN, Coates BM, Flori HR, Mack EH, Smallcomb L, Gertz SJ, Bhumbra SS, Bradford TT, Levy ER, Kong M, Irby K, Cvijanovich NZ, Zinter MS, Bowens C, Crandall H, Hume JR, Patel MM, Campbell AP, and Randolph AG
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- Child, Humans, SARS-CoV-2, BNT162 Vaccine, Vaccination, RNA, Messenger, COVID-19 prevention & control, Connective Tissue Diseases
- Abstract
Background: Multisystem inflammatory syndrome in children (MIS-C), linked to antecedent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is associated with considerable morbidity. Prevention of SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19) by vaccination might also decrease MIS-C likelihood., Methods: In a multicenter, case-control, public health investigation of children ages 5-18 years hospitalized from 1 July 2021 to 7 April 2022, we compared the odds of being fully vaccinated (2 doses of BNT162b2 vaccine ≥28 days before hospital admission) between MIS-C case-patients and hospital-based controls who tested negative for SARS-CoV-2. These associations were examined by age group, timing of vaccination, and periods of Delta and Omicron variant predominance using multivariable logistic regression., Results: We compared 304 MIS-C case-patients (280 [92%] unvaccinated) with 502 controls (346 [69%] unvaccinated). MIS-C was associated with decreased likelihood of vaccination (adjusted OR [aOR]: .16; 95% CI: .10-.26), including among children ages 5-11 years (aOR: .22; 95% CI: .10-.52), ages 12-18 years (aOR: .10; 95% CI: .05-.19), and during the Delta (aOR: .06; 95% CI: .02-.15) and Omicron (aOR: .22; 95% CI: .11-.42) variant-predominant periods. This association persisted beyond 120 days after the second dose (aOR: .08; 95% CI: .03-.22) in 12-18-year-olds. Among all MIS-C case-patients, 187 (62%) required intensive care unit admission and 280 (92%) vaccine-eligible case-patients were unvaccinated., Conclusions: Vaccination with 2 doses of BNT162b2 is associated with reduced likelihood of MIS-C in children ages 5-18 years. Most vaccine-eligible hospitalized patients with MIS-C were unvaccinated., Competing Interests: Potential conflicts of interest. J. E. S. reports institutional support from Merck for an RSV research study, unrelated to the current work. A. G. R. reports institutional support from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); royalties from UpToDate as the Pediatric Critical Care Section Editor; and participation on a data safety monitoring board (DSMB) for a National Institute of Child Health and Human Development (NICHD)–funded study. P. S. P. reports institutional support from AstraZeneca and Pfizer, consulting fees from Sanofi-Pasteur and Seqirus, payment from law firms for expert testimony, participation on a Division of Microbiology and Infectious Diseases DSMB (paid to author), and an unpaid leadership role in the California Immunization Coalition. R. A. N. reports institutional support from NIH for participation in a multicenter influenza study. S. K. reports institutional support from NIH and Pfizer. C. V. H. reports consulting fees from Dynamed (clinical database, reviewer) and honoraria from Biofire/Biomerieux, and funding from CDC to the University of Mississippi Medical Center. N. B. H. reports grants from Sanofi and Quidel and an educational grant from Genentech. N. Z. C. reports a speaker’s registration discount at the Society of Critical Care Medicine meeting and grants or contracts from the NIH, unrelated to this work and paid to their institution. S. S. B. reports receipt of an NIH, NIAID training grant during 1 September 2019–31 August 2020 (T32AI007637). M. L. C. reports grants or contracts unrelated to this work from the CDC, paid to their institution. H. R. F. reports grants or contracts unrelated to this work from the National Heart, Lung, and Blood Institute (NHLBI) and NICHD, paid to their institution; support for attending meetings and/or travel from the Society of Critical Care Medicine; participation on a DSMB for a cardiothoracic surgery trial—single center—and for intrathecal chemotherapy trial; an unpaid leadership or fiduciary role on the Michigan Thoracic Society Executive Committee and PALISI Network Executive Committee; other financial or nonfinancial interests in the Lucira Health advisory committee and Aerogen Pharma—advisor—unfunded. J. R. H. reports grants or contracts unrelated to this work from the NICHD, paid to their institution; participation on a DSMB for institutional study at the University of Minnesota, “Magnesium sulfate as adjuvant analgesia and its effect on opiate use by post-operative transplant patients in the pediatric ICU” (Magnesium sulfate as Investigational New Drug [IND] per the Food and Drug Administration [FDA]; no financial reimbursements). E. R. L. reports the following grants or contracts unrelated to this work and paid to their institution—AI 144301-01: An Observational Cohort Study to Determine Late Outcomes and Immunological Responses after Infection with SARS-CoV-2 in Children with and without MIS-C; and NIH AI 154470-01: Immunobiology of Influenza Virus-related Critical Illness in Young Hosts. E. H. M. reports an unpaid role as Vice President of the South Carolina Chapter of the American Academy of Pediatrics. L. S. reports conference attendance allowance from Medical University of South Carolina. Matthew Zinter reports the following grant or contract unrelated to this work: NHLBI K23HL146936. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2022.)
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- 2023
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12. Availability of bereavement support following traumatic pediatric death in a large metropolitan area.
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Divakar A, James K, Mayorga A, and Michelson KN
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- Humans, Child, Grief, Self-Help Groups, Bereavement, Terminal Care
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Following an unexpected pediatric death, survivors undergo unique trauma. Medical examiners (MEs) evaluate most of these deaths. We evaluated the bereavement support available to survivors in the Chicagoland area following a pediatric death. We had two goals: to characterize the available bereavement support options and compare the locations (by zip code) of support groups with the locations (by zip code) in which pediatric ME cases occurred. We identified 48 organizations that provided bereavement support services at 74 locations in the summer and fall of 2020. Locations by zip codes in which the largest number of ME cases occurred did not have support groups. Locations in which more ME cases occurred generally had lower-income populations and a greater proportion of Black or Hispanic residents. Bereavement support following pediatric death is inadequate and unevenly distributed across the Chicagoland area.
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- 2023
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13. A Core Outcome Measurement Set for Pediatric Critical Care.
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Pinto NP, Maddux AB, Dervan LA, Woodruff AG, Jarvis JM, Nett S, Killien EY, Graham RJ, Choong K, Luckett PM, Heneghan JA, Biagas K, Carlton EF, Hartman ME, Yagiela L, Michelson KN, Manning JC, Long DA, Lee JH, Slomine BS, Beers SR, Hall T, Morrow BM, Meert K, Arias Lopez MDP, Knoester H, Houtrow A, Olson L, Steele L, Schlapbach LJ, Burd RS, Grosskreuz R, Butt W, Fink EL, and Watson RS
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- Child, Humans, Outcome Assessment, Health Care, Consensus, Critical Illness, Delphi Technique, Quality of Life, Critical Care
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Objectives: To identify a PICU Core Outcome Measurement Set (PICU COMS), a set of measures that can be used to evaluate the PICU Core Outcome Set (PICU COS) domains in PICU patients and their families., Design: A modified Delphi consensus process., Setting: Four webinars attended by PICU physicians and nurses, pediatric surgeons, rehabilitation physicians, and scientists with expertise in PICU clinical care or research ( n = 35). Attendees were from eight countries and convened from the Pediatric Acute Lung Injury and Sepsis Investigators Pediatric Outcomes STudies after PICU Investigators and the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network PICU COS Investigators., Subjects: Measures to assess outcome domains of the PICU COS are as follows: cognitive, emotional, overall (including health-related quality of life), physical, and family health. Measures evaluating social health were also considered., Interventions: None., Measurements and Main Results: Measures were classified as general or additional based on generalizability across PICU populations, feasibility, and relevance to specific COS domains. Measures with high consensus, defined as 80% agreement for inclusion, were selected for the PICU COMS. Among 140 candidate measures, 24 were delineated as general (broadly applicable) and, of these, 10 achieved consensus for inclusion in the COMS (7 patient-oriented and 3 family-oriented). Six of the seven patient measures were applicable to the broadest range of patients, diagnoses, and developmental abilities. All were validated in pediatric populations and have normative pediatric data. Twenty additional measures focusing on specific populations or in-depth evaluation of a COS subdomain also met consensus for inclusion as COMS additional measures., Conclusions: The PICU COMS delineates measures to evaluate domains in the PICU COS and facilitates comparability across future research studies to characterize PICU survivorship and enable interventional studies to target long-term outcomes after critical illness., Competing Interests: Dr. Maddux’s institution received funding from the National Institute of Child Health and Human Development (NICHD) (K23HD096018) and the Francis Family Foundation, Parker B Francis Fellowship. Drs. Maddux, Jarvis, Killien, Meert, Olson, and Fink received support for article research from the National Institutes of Health (NIH). Drs. Jarvis, Michelson, Beers, Meert, and Fink’s institutions received funding from the NIH. Dr. Jarvis received funding from the NIH (T32 HD040686). Dr. Killien and Olson’s institutions received funding from the NICHD. Dr. Choong’s institution received funding from the AFP Innovation Fund; she received funding from McMaster University. Dr. Michelson’s institution received funding from The National Palliative Care Research Center, and the Greenwall Foundation. Dr. Lee’s institution received funding from the National Medical Research Council, Singapore. Dr. Slomine received funding from the National Academy of Neuropsychology and Cambridge University Press. Dr. Beers’ institution received funding from the National Football League Brain Health Study. Dr. Morrow received funding from EduPro, Imperial College Press, the University of Cape Town, and the South African Society of Physiotherapy. Dr. Fink’s institution received funding from the Neurocritical Care Society; she received funding from the Child Nervous Society and the American Board of Pediatrics CCM Subsection member. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2022 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)
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- 2022
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14. Family Outcomes After the Pediatric Intensive Care Unit: A Scoping Review.
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O'Meara A, Akande M, Yagiela L, Hummel K, Whyte-Nesfield M, Michelson KN, Radman M, Traube C, Manning JC, and Hartman ME
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- Child, Critical Illness psychology, Critical Illness therapy, Family, Humans, Intensive Care Units, Pediatric, Patient Discharge, Aftercare, Quality of Life
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Background: Intensivists are increasingly attuned to the postdischarge outcomes experienced by families because patient recovery and family outcomes are interdependent after childhood critical illness. In this scoping review of international contemporary literature, we describe the evidence of family effects and functioning postpediatric intensive care unit (PICU) as well as outcome measures used to identify strengths and weaknesses in the literature., Methods: We reviewed all articles published between 1970 and 2017 in PubMed, Embase, PsycINFO, Cumulative Index of Nursing and Allied Health Literature (CINAHL), or the Cochrane Controlled Trials Registry. Our search used a combination of terms for the concept of "critical care/illness" combined with additional terms for the prespecified domains of social, cognitive, emotional, physical, health-related quality of life (HRQL), and family functioning., Results: We identified 71 articles reporting on the postPICU experience of more than 2400 parents and 3600 families of PICU survivors in 8 countries. These articles used 101 different metrics to assess the various aspects of family outcomes; 34 articles also included open-ended interviews. Overall, most families experienced significant disruption in at least five out of six of our family outcomes subdomains, with themes of decline in mental health, physical health, family cohesion, and family finances identified. Almost all articles represented relatively small, single-center, or disease-specific observational studies. There was a disproportionate representation of families of higher socioeconomic status (SES) and Caucasian race, and there was much more data about mothers compared to fathers. There was also very limited information regarding outcomes for siblings and extended family members after a child's PICU stay., Conclusions: Significant opportunities remain for research exploring family functioning after PICU discharge. We recommend that future work include more diverse populations with respect to the critically ill child as well as family characteristics, include more intervention studies, and enrich existing knowledge about outcomes for siblings and extended family.
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- 2022
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15. A Scoping Review on the Concept of Physician Caring.
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Burstein DS, Svigos F, Patel A, Reddy NK, Michelson KN, O'Dwyer LC, Linzer M, Linder JA, and Victorson D
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- Burnout, Psychological, Emotions, Health Personnel, Humans, Burnout, Professional, Physicians psychology
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Background: Physicians' interest in the health and well-being of their patients is a tenet of medical practice. Physicians' ability to act upon this interest by caring for and about their patients is central to high-quality clinical medicine and may affect burnout. To date, a strong theoretical and empirical understanding of physician caring does not exist. To establish a practical, evidence-based approach to improve health care delivery and potentially address physician burnout, we sought to identify and synthesize existing conceptual models, frameworks, and definitions of physician caring., Methods: We performed a scoping review on physician caring. In November 2019 and September 2020, we searched PubMed MEDLINE, Embase, PsycINFO, CINAHL, and CENTRAL Register of Controlled Trials to identify conceptual models, frameworks, and definitions of physician caring. Eligible articles involved discussion or study of care or caring among medical practitioners. We created a content summary and performed thematic analysis of extracted data., Results: Of 11,776 articles, we reviewed the full text of 297 articles; 61 articles met inclusion criteria. Commonly identified concepts referenced Peabody's "secret of care" and the ethics of care. In bioethics, caring is described as a virtue. Contradictions exist among concepts of caring, such as whether caring is an attitude, emotion, or behavior, and the role of relationship development. Thematic analysis of all concepts and definitions identified six aspects of physician caring: (1) relational aspects, (2) technical aspects, (3) physician attitudes and characteristics, (4) agency, (5) reciprocity, and (6) physician self-care., Discussion: Caring is instrumental to clinical medicine. However, scientific understanding of what constitutes caring from physicians is limited by contradictions across concepts. A unifying concept of physician caring does not yet exist. This review proposes six aspects of physician caring which can be used to develop evidence-based approaches to improve health care delivery and potentially mitigate physician burnout., (© 2022. The Author(s) under exclusive licence to Society of General Internal Medicine.)
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- 2022
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16. Parental Views of Social Worker and Chaplain Involvement in Care and Decision Making for Critically Ill Children with Cancer.
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Michelson KN, Arenson M, Charleston E, Clayman ML, Brazg T, Rychlik K, Rosenberg AR, and Frader J
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Background: Social workers (SWs) and chaplains are trained to support families facing challenges associated with critical illness and potential end-of-life issues. Little is known about how parents view SW/chaplain involvement in care for critically ill children with cancer., Methods: We studied parent perceptions of SW/chaplain involvement in care for pediatric intensive care unit (PICU) patients with cancer or who had a hematopoietic cell transplant. English- and Spanish-speaking parents completed surveys within 7 days of PICU admission and at discharge. Some parents participated in an optional interview., Results: Twenty-four parents of 18 patients completed both surveys, and six parents were interviewed. Of the survey respondents, 66.7% and 75% interacted with SWs or chaplains, respectively. Most parents described SW/chaplain interactions as helpful (81.3% and 72.2%, respectively), but few reported their help with decision making (18.8% and 12.4%, respectively). Parents described SW/chaplain roles related to emotional, spiritual, instrumental, and holistic support. Few parents expressed awareness about SW/chaplain interactions with other healthcare team members., Conclusions: Future work is needed to determine SWs'/chaplains' contributions to and impact on parental decision making, improve parent awareness about SW/chaplain roles and engagement with the healthcare team, and understand why some PICU parents do not interact with SWs/chaplains.
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- 2022
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17. Ethical Considerations Related to Using Machine Learning-Based Prediction of Mortality in the Pediatric Intensive Care Unit.
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Michelson KN, Klugman CM, Kho AN, and Gerke S
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- Child, Humans, Intensive Care Units, Intensive Care Units, Pediatric, Machine Learning
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- 2022
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18. Maternal Vaccination and Risk of Hospitalization for Covid-19 among Infants.
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Halasa NB, Olson SM, Staat MA, Newhams MM, Price AM, Pannaraj PS, Boom JA, Sahni LC, Chiotos K, Cameron MA, Bline KE, Hobbs CV, Maddux AB, Coates BM, Michelson KN, Heidemann SM, Irby K, Nofziger RA, Mack EH, Smallcomb L, Schwartz SP, Walker TC, Gertz SJ, Schuster JE, Kamidani S, Tarquinio KM, Bhumbra SS, Maamari M, Hume JR, Crandall H, Levy ER, Zinter MS, Bradford TT, Flori HR, Cullimore ML, Kong M, Cvijanovich NZ, Gilboa SM, Polen KN, Campbell AP, Randolph AG, and Patel MM
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- Female, Humans, Infant, Mothers, Pregnancy, SARS-CoV-2, Vaccination statistics & numerical data, Vaccines, Synthetic, COVID-19 epidemiology, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, COVID-19 Vaccines therapeutic use, Hospitalization statistics & numerical data, Pregnancy Complications, Infectious epidemiology, Pregnancy Complications, Infectious prevention & control, mRNA Vaccines adverse effects, mRNA Vaccines therapeutic use
- Abstract
Background: Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants., Methods: We used a case-control test-negative design to assess the effectiveness of maternal vaccination during pregnancy against hospitalization for Covid-19 among infants younger than 6 months of age. Between July 1, 2021, and March 8, 2022, we enrolled infants hospitalized for Covid-19 (case infants) and infants hospitalized without Covid-19 (control infants) at 30 hospitals in 22 states. We estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among case infants and control infants during circulation of the B.1.617.2 (delta) variant (July 1, 2021, to December 18, 2021) and the B.1.1.259 (omicron) variant (December 19, 2021, to March 8, 2022)., Results: A total of 537 case infants (181 of whom had been admitted to a hospital during the delta period and 356 during the omicron period; median age, 2 months) and 512 control infants were enrolled and included in the analyses; 16% of the case infants and 29% of the control infants had been born to mothers who had been fully vaccinated against Covid-19 during pregnancy. Among the case infants, 113 (21%) received intensive care (64 [12%] received mechanical ventilation or vasoactive infusions). Two case infants died from Covid-19; neither infant's mother had been vaccinated during pregnancy. The effectiveness of maternal vaccination against hospitalization for Covid-19 among infants was 52% (95% confidence interval [CI], 33 to 65) overall, 80% (95% CI, 60 to 90) during the delta period, and 38% (95% CI, 8 to 58) during the omicron period. Effectiveness was 69% (95% CI, 50 to 80) when maternal vaccination occurred after 20 weeks of pregnancy and 38% (95% CI, 3 to 60) during the first 20 weeks of pregnancy., Conclusions: Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age. (Funded by the Centers for Disease Control and Prevention.)., (Copyright © 2022 Massachusetts Medical Society.)
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- 2022
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19. A Description of COVID-19-Directed Therapy in Children Admitted to US Intensive Care Units 2020.
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Schuster JE, Halasa NB, Nakamura M, Levy ER, Fitzgerald JC, Young CC, Newhams MM, Bourgeois F, Staat MA, Hobbs CV, Dapul H, Feldstein LR, Jackson AM, Mack EH, Walker TC, Maddux AB, Spinella PC, Loftis LL, Kong M, Rowan CM, Bembea MM, McLaughlin GE, Hall MW, Babbitt CJ, Maamari M, Zinter MS, Cvijanovich NZ, Michelson KN, Gertz SJ, Carroll CL, Thomas NJ, Giuliano JS, Singh AR, Hymes SR, Schwarz AJ, McGuire JK, Nofziger RA, Flori HR, Clouser KN, Wellnitz K, Cullimore ML, Hume JR, Patel M, and Randolph AG
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- Child, Critical Illness, Hospitalization, Hospitals, Pediatric, Humans, Intensive Care Units, United States, COVID-19 Drug Treatment
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Background: It is unclear how acute coronavirus disease 2019 (COVID-19)-directed therapies are used in children with life-threatening COVID-19 in US hospitals. We described characteristics of children hospitalized in the intensive care unit or step-down unit (ICU/SDU) who received COVID-19-directed therapies and the specific therapies administered., Methods: Between March 15, 2020 and December 27, 2020, children <18 years of age in the ICU/SDU with acute COVID-19 at 48 pediatric hospitals in the United States were identified. Demographics, laboratory values, and clinical course were compared in children who did and did not receive COVID-19-directed therapies. Trends in COVID-19-directed therapies over time were evaluated., Results: Of 424 children in the ICU/SDU, 235 (55%) received COVID-19-directed therapies. Children who received COVID-19-directed therapies were older than those who did not receive COVID-19-directed therapies (13.3 [5.6-16.2] vs 9.8 [0.65-15.9] years), more had underlying medical conditions (188 [80%] vs 104 [55%]; difference = 25% [95% CI: 16% to 34%]), more received respiratory support (206 [88%] vs 71 [38%]; difference = 50% [95% CI: 34% to 56%]), and more died (8 [3.4%] vs 0). Of the 235 children receiving COVID-19-directed therapies, 172 (73%) received systemic steroids and 150 (64%) received remdesivir, with rising remdesivir use over the study period (14% in March/April to 57% November/December)., Conclusion: Despite the lack of pediatric data evaluating treatments for COVID-19 in critically ill children, more than half of children requiring intensive or high acuity care received COVID-19-directed therapies., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2022
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20. Top Ten Tips Palliative Care Clinicians Should Know About Their Work's Intersection with Clinical Ethics.
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Weaver MS, Boss RD, Christopher MJ, Gray TF, Harman S, Madrigal VN, Michelson KN, Paquette ET, Pentz RD, Scarlet S, Ulrich CM, and Walter JK
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- Adult, Child, Communication, Ethicists, Ethics, Clinical, Humans, Hospice and Palliative Care Nursing, Palliative Care
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Palliative care (PC) subspecialists and clinical ethics consultants often engage in parallel work, as both function primarily as interprofessional consultancy services called upon in complex clinical scenarios and challenging circumstances. Both practices utilize active listening, goals-based communication, conflict mediation or mitigation, and values explorations as care modalities. In this set of tips created by an interprofessional team of ethicists, intensivists, a surgeon, an attorney, and pediatric and adult PC nurses and physicians, we aim to describe some paradigmatic clinical challenges for which partnership may improve collaborative, comprehensive care.
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- 2022
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21. Navigating Clinical and Business Ethics While Sharing Patient Data.
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Michelson KN, Adams JG, and Faber JMM
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- Humans, Ethics, Business, Ethics, Clinical, Information Dissemination ethics, Patient Generated Health Data ethics
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- 2022
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22. Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents.
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Olson SM, Newhams MM, Halasa NB, Price AM, Boom JA, Sahni LC, Pannaraj PS, Irby K, Walker TC, Schwartz SP, Maddux AB, Mack EH, Bradford TT, Schuster JE, Nofziger RA, Cameron MA, Chiotos K, Cullimore ML, Gertz SJ, Levy ER, Kong M, Cvijanovich NZ, Staat MA, Kamidani S, Chatani BM, Bhumbra SS, Bline KE, Gaspers MG, Hobbs CV, Heidemann SM, Maamari M, Flori HR, Hume JR, Zinter MS, Michelson KN, Zambrano LD, Campbell AP, Patel MM, and Randolph AG
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- Adolescent, COVID-19 mortality, COVID-19 therapy, COVID-19 Testing, COVID-19 Vaccines, Case-Control Studies, Child, Female, Hospitalization statistics & numerical data, Humans, Immunization, Secondary, Intensive Care Units, Life Support Care, Male, Patient Acuity, SARS-CoV-2, United States, BNT162 Vaccine, COVID-19 prevention & control, Vaccine Efficacy
- Abstract
Background: The increasing incidence of pediatric hospitalizations associated with coronavirus disease 2019 (Covid-19) caused by the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States has offered an opportunity to assess the real-world effectiveness of the BNT162b2 messenger RNA vaccine in adolescents between 12 and 18 years of age., Methods: We used a case-control, test-negative design to assess vaccine effectiveness against Covid-19 resulting in hospitalization, admission to an intensive care unit (ICU), the use of life-supporting interventions (mechanical ventilation, vasopressors, and extracorporeal membrane oxygenation), or death. Between July 1 and October 25, 2021, we screened admission logs for eligible case patients with laboratory-confirmed Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2) in case patients as compared with two hospital-based control groups: patients who had Covid-19-like symptoms but negative results on testing for SARS-CoV-2 (test-negative) and patients who did not have Covid-19-like symptoms (syndrome-negative)., Results: A total of 445 case patients and 777 controls were enrolled. Overall, 17 case patients (4%) and 282 controls (36%) had been fully vaccinated. Of the case patients, 180 (40%) were admitted to the ICU, and 127 (29%) required life support; only 2 patients in the ICU had been fully vaccinated. The overall effectiveness of the BNT162b2 vaccine against hospitalization for Covid-19 was 94% (95% confidence interval [CI], 90 to 96); the effectiveness was 95% (95% CI, 91 to 97) among test-negative controls and 94% (95% CI, 89 to 96) among syndrome-negative controls. The effectiveness was 98% against ICU admission and 98% against Covid-19 resulting in the receipt of life support. All 7 deaths occurred in patients who were unvaccinated., Conclusions: Among hospitalized adolescent patients, two doses of the BNT162b2 vaccine were highly effective against Covid-19-related hospitalization and ICU admission or the receipt of life support. (Funded by the Centers for Disease Control and Prevention.)., (Copyright © 2022 Massachusetts Medical Society.)
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- 2022
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23. Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19-Associated Hospitalization in Infants Aged <6 Months - 17 States, July 2021-January 2022.
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Halasa NB, Olson SM, Staat MA, Newhams MM, Price AM, Boom JA, Sahni LC, Cameron MA, Pannaraj PS, Bline KE, Bhumbra SS, Bradford TT, Chiotos K, Coates BM, Cullimore ML, Cvijanovich NZ, Flori HR, Gertz SJ, Heidemann SM, Hobbs CV, Hume JR, Irby K, Kamidani S, Kong M, Levy ER, Mack EH, Maddux AB, Michelson KN, Nofziger RA, Schuster JE, Schwartz SP, Smallcomb L, Tarquinio KM, Walker TC, Zinter MS, Gilboa SM, Polen KN, Campbell AP, Randolph AG, and Patel MM
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- Case-Control Studies, Female, Hospitals, Pediatric, Humans, Immunization, Passive, Infant, Infant, Newborn, Pregnancy, United States epidemiology, COVID-19 prevention & control, COVID-19 Vaccines immunology, Hospitalization statistics & numerical data, Immunity, Maternally-Acquired, SARS-CoV-2 immunology, Vaccines, Synthetic immunology, mRNA Vaccines immunology
- Abstract
COVID-19 vaccination is recommended for persons who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future, to protect them from COVID-19.
§ Infants are at risk for life-threatening complications from COVID-19, including acute respiratory failure (1). Evidence from other vaccine-preventable diseases suggests that maternal immunization can provide protection to infants, especially during the high-risk first 6 months of life, through passive transplacental antibody transfer (2). Recent studies of COVID-19 vaccination during pregnancy suggest the possibility of transplacental transfer of SARS-CoV-2-specific antibodies that might provide protection to infants (3-5); however, no epidemiologic evidence currently exists for the protective benefits of maternal immunization during pregnancy against COVID-19 in infants. The Overcoming COVID-19 network conducted a test-negative, case-control study at 20 pediatric hospitals in 17 states during July 1, 2021-January 17, 2022, to assess effectiveness of maternal completion of a 2-dose primary mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization in infants. Among 379 hospitalized infants aged <6 months (176 with COVID-19 [case-infants] and 203 without COVID-19 [control-infants]), the median age was 2 months, 21% had at least one underlying medical condition, and 22% of case- and control-infants were born premature (<37 weeks gestation). Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months was 61% (95% CI = 31%-78%). Completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy might help prevent COVID-19 hospitalization among infants aged <6 months., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Adrienne G. Randolph reports institutional support from the National Institute of Allergy and Infectious Diseases and National Institutes of Health (NIH) and being the UpToDate Pediatric Critical Care Section Editor. Matt S. Zinter reports institutional support from the National Heart, Lung, and Blood Institute (NHLBI), NIH and the American Thoracic Society. Laura Smallcomb reports support from the Medical University of South Carolina for conference attendance. Jennifer E. Schuster reports institutional support from Merck. Ryan A. Nofziger reports institutional support from NIH. Emily R. Levy reports institutional support from NIH. Michele Kong reports institutional support from NIH. Satoshi Kamidani reports institutional support from NIH and Pfizer. Janet R. Hume reports institutional support from the National Institute for Child Health and Development, NIH, and serving on a data safety monitoring board for an institutional study of magnesium for analgesia in complex medical patients. Charlotte V. Hobbs reports consultant fees from BioFire (bioMérieux). Natalie Z. Cvijanovich reports institutional support from NIH. Bria M. Coates reports institutional support from NHLBI, NIH, the American Lung Association, and the American Thoracic Society. Kathleen Chiotos reports institutional support from the Agency for Healthcare Research and Quality and serving as the Society for Healthcare Epidemiology of America Research Network Chair. Samina S. Bhumbra reports receipt of an NIH, National Institute for Allergy and Infectious Diseases training grant. Pia S. Pannaraj reports institutional support from AstraZeneca and Pfizer, consulting fees from Sanofi-Pasteur and Seqirus, payment from law firms for expert testimony, serving in the Division of Microbiology and Infectious Diseases, and unpaid service on the California Immunization Coalition. Mary A. Staat reports institutional support from NIH and receipt of lecture fees from the American Academy of Pediatrics for PREP ID Course. Natasha B. Halasa reports grant support from Sanofi and Quidel and honoraria from Genentech. No other potential conflicts of interest were disclosed.- Published
- 2022
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24. Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021.
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Zambrano LD, Newhams MM, Olson SM, Halasa NB, Price AM, Boom JA, Sahni LC, Kamidani S, Tarquinio KM, Maddux AB, Heidemann SM, Bhumbra SS, Bline KE, Nofziger RA, Hobbs CV, Bradford TT, Cvijanovich NZ, Irby K, Mack EH, Cullimore ML, Pannaraj PS, Kong M, Walker TC, Gertz SJ, Michelson KN, Cameron MA, Chiotos K, Maamari M, Schuster JE, Orzel AO, Patel MM, Campbell AP, and Randolph AG
- Subjects
- Adolescent, Case-Control Studies, Child, Female, Hospitalization statistics & numerical data, Humans, Male, Patient Acuity, SARS-CoV-2 immunology, United States epidemiology, COVID-19 Drug Treatment, BNT162 Vaccine therapeutic use, COVID-19 complications, Systemic Inflammatory Response Syndrome drug therapy, Vaccine Efficacy
- Abstract
Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5),
§ and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Jennifer E. Schuster reports institutional support from Merck for an RSV research study, unrelated to the current work. Adrienne G. Randolph reports institutional support from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), royalties from UpToDate as the Pediatric Critical Care Section Editor, and participation on a data safety monitoring board (DSMB) for a National Institute of Child Health and Human Development-funded study. Pia S. Pannaraj reports institutional support from AstraZeneca and Pfizer, consulting fees from Sanofi-Pasteur and Seqirus, payment from law firms for expert testimony, participation on a Division of Microbiology and Infectious Diseases DSMB, and an unpaid leadership role in the California Immunization Coalition. Ryan A. Nofziger reports institutional support from NIH for participation in a multicenter influenza study. Satoshi Kamidani reports institutional support from NIH and Pfizer. Charlotte V. Hobbs reports consulting fees from Dynamed and honoraria from Biofire/Biomerieux. Natasha B. Halasa reports grants from Sanofi and Quidel and an educational grant from Genentech. Natalie Z. Cvijanovich reports a speaker’s registration discount at the Society of Critical Care Medicine meeting. Samina S. Bhumbra reports receipt of an NIH, NIAID training grant during September 1, 2019–August 31, 2020. No other potential conflicts of interest were disclosed.- Published
- 2022
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25. A Qualitative Study Describing Pediatric Palliative Care in Non-Metropolitan Areas of Illinois.
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Murday P, Downing K, Gaab E, Misasi J, and Michelson KN
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- Child, Family, Humans, Parents, Qualitative Research, Hospice and Palliative Care Nursing, Palliative Care
- Abstract
Background: There is little information about providing pediatric palliative care (PPC) in non-metropolitan areas., Objective: Describe the strengths of and challenges to delivering PPC in non-metropolitan communities and identify opportunities to improve care delivery., Design: A qualitative study involving focus groups (FGs) with PPC stakeholders., Setting/participants: From 4 non-metropolitan areas in Illinois, we recruited 3 stakeholder groups: healthcare providers (HPs); bereaved parents; and parents caring for a seriously ill child (SIC)., Measurements: At each site, we held an FG with people of the same stakeholder group and then an FG involving all stakeholders. Discussion topics included: availability and strengths of local PPC services, barriers to local PPC, opportunities for improving local PPC access and quality, and clinician educational needs. We analyzed data using phenomenology and directed content analysis., Results: Thirty people, 12 parents and 18 HPs, participated in FGs. Identified themes related to: PPC perceptions; availability and use of local resources; and challenges associated with travel, care coordination, and finances. Participants described benefits of and limits to local PPC including pediatric-specific issues such as attending to siblings, creating child peer-support activities, providing school guidance, and financing for PPC. Recommendations included suggestions to enhance care coordination, use existing resources, improve community and provider education, develop community networks, and minimize financial challenges., Conclusion: Unique PPC challenges exist in non-metropolitan areas. PPC in non-metropolitan areas would benefit from enhancing local resource utilization and quality. Future work should address the challenges to providing PPC in non-metropolitan areas with a focus on pediatric-specific issues.
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- 2022
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26. Parental Perspectives on Neonatologist Continuity of Care.
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Machut KZ, Gilbart C, Murthy K, and Michelson KN
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- Continuity of Patient Care, Female, Humans, Infant, Infant, Newborn, Intensive Care Units, Neonatal, Mothers, Neonatologists, Parents
- Abstract
Background: Continuity of care (COC) is highly regarded; however, data about benefits are mixed. Little is known about components, parental views, or the value COC may provide to neonatal intensive care unit (NICU) infants and families., Purpose: To describe parents' perspectives on definitions, reasons they value, and suggested improvements regarding COC provided by neonatologists., Methods: We performed a qualitative study of in-person, semistructured interviews with parents of NICU infants hospitalized for 28 days or more. We analyzed interview transcripts using content analysis, identifying codes of parental experiences, expressed value, and improvement ideas related to neonatologist COC, and categorizing emerging themes., Results: Fifteen families (15 mothers and 2 fathers) described 4 themes about COC: (1) longitudinal neonatologists: gaining experience with infants and building relationships with parents over time; (2) background knowledge: knowing infants' clinical history and current condition; (3) care plans: establishing patient-centered goals and management plans; and (4) communication: demonstrating consistent communication and messaging. Parents described benefits of COC as decreasing knowledge gaps, advancing clinical progress, and decreasing parental stress. Suggested improvement strategies included optimizing staffing and sign-out/transition processes, utilizing clinical guidelines, and enhancing communication. Using parent input and existing literature, we developed a definition and conceptual framework of COC., Implications for Practice: NICUs should promote practices that enhance COC. Parental suggestions can help direct improvement efforts., Implications for Research: Our COC definition and conceptual framework can guide development of research and quality improvement projects. Future studies should investigate nursing perspectives on NICU COC and the impact of COC on infant and family outcomes., (Copyright © 2021 by The National Association of Neonatal Nurses.)
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- 2021
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27. Simulation of Ventilator Allocation in Critically Ill Patients with COVID-19.
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Bhavani SV, Luo Y, Miller WD, Sanchez-Pinto LN, Han X, Mao C, Sandıkçı B, Peek ME, Coopersmith CM, Michelson KN, and Parker WF
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- Black or African American, Aged, Clinical Protocols, Computer Simulation, Female, Hispanic or Latino, Hospitalization, Humans, Male, Middle Aged, Monte Carlo Method, Patient Selection, Survival Rate, White People, COVID-19 epidemiology, COVID-19 therapy, Critical Care organization & administration, Triage organization & administration, Ventilators, Mechanical supply & distribution
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- 2021
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28. Parent and Physician Report of Discussions About Prognosis for Critically Ill Children.
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Rissman L, Derrington S, Rychlik K, and Michelson KN
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- Child, Cross-Sectional Studies, Humans, Intensive Care Units, Pediatric, Prognosis, Prospective Studies, Critical Illness, Physicians
- Abstract
Objectives: Parents value clear communication with PICU clinicians about possible patient and family outcomes (prognostic conversations). We describe PICU parent and attending physician reports and agreement regarding the occurrence of prognostic conversations. We queried parents and physicians about prognostic conversation content, which healthcare providers had prognostic conversations, and whether parents wanted more prognostic information., Design: Prospective cross-sectional survey study., Setting: University-based 40-bed PICU., Participants: Parents and attending physicians of PICU patients with multiple organ dysfunction within 24 hours of PICU admission., Interventions: Surveys administered to parents and attending PICU physicians 5-10 days after PICU admission., Measurements and Main Results: Surveys asked parents and physicians to report the occurrence of prognostic conversations related to PICU length of stay, risk of PICU mortality, and anticipated post-PICU physical, neurologic, and psychologic morbidities for patients and post-PICU psychologic morbidities for parents. Of 101 participants, 87 parents and 83 physicians reported having prognostic conversations. Overall concordance between parents and physicians was fair (Kappa = 0.22). Parents and physicians most commonly reported prognostic conversations about PICU length of stay (67.3% and 63.3%, respectively) and patient post-PICU physical morbidity (n = 48; 48.5% and n = 45; 44.5% respectively). Conversations reported less often by parents and physicians were about patient post-PICU psychologic morbidity (n = 13; 12.9% and n = 20; 19.8%, respectively). Per parent report, bedside nurses and physicians provided most prognostic information. Chaplains (n = 14; 50%) and social workers (n = 17; 60%) were more involved in conversations regarding parent psychologic morbidities. Most commonly, parents requested more information about length of stay and their child's physical morbidities. Parents less frequently wanted information about their own psychologic morbidities., Conclusions: Most parents and physicians report having prognostic conversations, primarily about length of stay and post-ICU physical morbidities. Concordance between parents and physicians is suboptimal. Future studies should evaluate prognostic conversations at other timepoints, how information is delivered, and how these conversations impact the PICU experience., Competing Interests: Dr. Rissman received support for article research from Northwestern McGaw’s Center for Bioethics Department. Drs. Derrington’s and Michelson’s institutions received funding from Northwestern University Feinberg School of Medicine, Center for Bioethics and Medical Humanities. Dr. Derrington received funding from Loma Linda University Medical Center and the American Society for Bioethics and Humanities. Dr. Michelson’s institution received funding from the National Palliative Care Research Center, the National Institute of Diabetes and Digestive and Kidney Diseases, and Northwestern University Alliance for Research in Chicagoland Communities. Dr. Rychlik has disclosed that she does not have any potential conflicts of interest., (Copyright © 2021 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)
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- 2021
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29. Neurologic Involvement in Children and Adolescents Hospitalized in the United States for COVID-19 or Multisystem Inflammatory Syndrome.
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LaRovere KL, Riggs BJ, Poussaint TY, Young CC, Newhams MM, Maamari M, Walker TC, Singh AR, Dapul H, Hobbs CV, McLaughlin GE, Son MBF, Maddux AB, Clouser KN, Rowan CM, McGuire JK, Fitzgerald JC, Gertz SJ, Shein SL, Munoz AC, Thomas NJ, Irby K, Levy ER, Staat MA, Tenforde MW, Feldstein LR, Halasa NB, Giuliano JS Jr, Hall MW, Kong M, Carroll CL, Schuster JE, Doymaz S, Loftis LL, Tarquinio KM, Babbitt CJ, Nofziger RA, Kleinman LC, Keenaghan MA, Cvijanovich NZ, Spinella PC, Hume JR, Wellnitz K, Mack EH, Michelson KN, Flori HR, Patel MM, and Randolph AG
- Subjects
- Adolescent, COVID-19 etiology, COVID-19 mortality, Child, Child, Preschool, Critical Care, Female, Hospitalization, Humans, Male, Nervous System Diseases mortality, Patient Discharge statistics & numerical data, Respiratory Distress Syndrome etiology, Respiratory Distress Syndrome therapy, Systemic Inflammatory Response Syndrome complications, Treatment Outcome, United States epidemiology, COVID-19 complications, Nervous System Diseases etiology, Systemic Inflammatory Response Syndrome etiology
- Abstract
Importance: Coronavirus disease 2019 (COVID-19) affects the nervous system in adult patients. The spectrum of neurologic involvement in children and adolescents is unclear., Objective: To understand the range and severity of neurologic involvement among children and adolescents associated with COVID-19., Setting, Design, and Participants: Case series of patients (age <21 years) hospitalized between March 15, 2020, and December 15, 2020, with positive severe acute respiratory syndrome coronavirus 2 test result (reverse transcriptase-polymerase chain reaction and/or antibody) at 61 US hospitals in the Overcoming COVID-19 public health registry, including 616 (36%) meeting criteria for multisystem inflammatory syndrome in children. Patients with neurologic involvement had acute neurologic signs, symptoms, or diseases on presentation or during hospitalization. Life-threatening involvement was adjudicated by experts based on clinical and/or neuroradiologic features., Exposures: Severe acute respiratory syndrome coronavirus 2., Main Outcomes and Measures: Type and severity of neurologic involvement, laboratory and imaging data, and outcomes (death or survival with new neurologic deficits) at hospital discharge., Results: Of 1695 patients (909 [54%] male; median [interquartile range] age, 9.1 [2.4-15.3] years), 365 (22%) from 52 sites had documented neurologic involvement. Patients with neurologic involvement were more likely to have underlying neurologic disorders (81 of 365 [22%]) compared with those without (113 of 1330 [8%]), but a similar number were previously healthy (195 [53%] vs 723 [54%]) and met criteria for multisystem inflammatory syndrome in children (126 [35%] vs 490 [37%]). Among those with neurologic involvement, 322 (88%) had transient symptoms and survived, and 43 (12%) developed life-threatening conditions clinically adjudicated to be associated with COVID-19, including severe encephalopathy (n = 15; 5 with splenial lesions), stroke (n = 12), central nervous system infection/demyelination (n = 8), Guillain-Barré syndrome/variants (n = 4), and acute fulminant cerebral edema (n = 4). Compared with those without life-threatening conditions (n = 322), those with life-threatening neurologic conditions had higher neutrophil-to-lymphocyte ratios (median, 12.2 vs 4.4) and higher reported frequency of D-dimer greater than 3 μg/mL fibrinogen equivalent units (21 [49%] vs 72 [22%]). Of 43 patients who developed COVID-19-related life-threatening neurologic involvement, 17 survivors (40%) had new neurologic deficits at hospital discharge, and 11 patients (26%) died., Conclusions and Relevance: In this study, many children and adolescents hospitalized for COVID-19 or multisystem inflammatory syndrome in children had neurologic involvement, mostly transient symptoms. A range of life-threatening and fatal neurologic conditions associated with COVID-19 infrequently occurred. Effects on long-term neurodevelopmental outcomes are unknown.
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- 2021
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30. Evaluation of Organ Dysfunction Scores for Allocation of Scarce Resources in Critically Ill Children and Adults During a Healthcare Crisis.
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Sanchez-Pinto LN, Parker WF, Mayampurath A, Derrington S, and Michelson KN
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- Adolescent, Adult, Child, Child, Preschool, Cohort Studies, Critical Illness therapy, Female, Hospital Mortality, Humans, Male, Middle Aged, Multiple Organ Failure therapy, Outcome Assessment, Health Care, Retrospective Studies, Risk Factors, Time Factors, Critical Illness mortality, Multiple Organ Failure mortality, Organ Dysfunction Scores, Severity of Illness Index
- Abstract
Objectives: When healthcare systems are overwhelmed, accurate assessments of patients' predicted mortality risks are needed to ensure effective allocation of scarce resources. Organ dysfunction scores can serve this essential role, but their evaluation in this context has been limited so far. In this study, we sought to assess the performance of three organ dysfunction scores in both critically ill adults and children at clinically relevant mortality thresholds and timeframes for resource allocation and compare it with two published prioritization schemas., Design: Retrospective observational cohort study., Setting: Three large academic medical centers in the United States., Patients: Critically ill adults and children., Interventions: None., Measurements and Main Results: We calculated the daily Sequential Organ Failure Assessment score in adults and the Pediatric Logistic Organ Dysfunction 2 score and the Pediatric Sequential Organ Failure Assessment score in children. There were 49,290 (11.6% mortality) and 19,983 children (2.5% mortality) included in the analysis. Both the Sequential Organ Failure Assessment and Pediatric Sequential Organ Failure Assessment scores had adequate discrimination across relevant timeframes and adequate distribution across relevant mortality thresholds. Additionally, we found that the only published state prioritization schema that includes pediatric and adult patients had poor alignment of mortality risks, giving adults a systematic advantage over children., Conclusions: In the largest analysis of organ dysfunction scores in a general population of critically ill adults and children to date, we found that both the Sequential Organ Failure Assessment and Pediatric Sequential Organ Failure Assessment scores had adequate performance across relevant mortality thresholds and timeframes for resource allocation. Published prioritization schemas that include both pediatric and adult patients may put children at a disadvantage. Furthermore, the distribution of patient and mortality risk in the published schemas may not adequately stratify patients for some high-stakes allocation decisions. This information may be useful to bioethicists, healthcare leaders, and policy makers who are developing resource allocation policies for critically ill patients., Competing Interests: Drs. Sanchez-Pinto, Parker, and Mayampurath received support for article research from the National Institutes of Health (NIH). Dr. Mayampurath received funding from Litmus Health. Dr. Derrington received funding from the American Society for Bioethics and Humanities. Dr. Michelson’s institution received funding from the National Palliative Care Research Center and the National Alliance for Grieving Children. Dr. Sanchez-Pinto has disclosed that he does not have any potential conflicts of interest., (Copyright © 2020 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)
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- 2021
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31. A Randomized Comparative Trial to Evaluate a PICU Navigator-Based Parent Support Intervention.
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Michelson KN, Frader J, Charleston E, Rychlik K, Aniciete DY, Ciolino JD, Sorce LR, Clayman ML, Brown M, Fragen P, Malakooti M, Derrington S, and White D
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- Child, Communication, Humans, Parents, Personal Satisfaction, Intensive Care Units, Pediatric, Terminal Care
- Abstract
Objectives: Communication breakdowns in PICUs contribute to inadequate parent support and poor post-PICU parent outcomes. No interventions supporting communication have demonstrated improvements in parental satisfaction or psychologic morbidity. We compared parent-reported outcomes from parents receiving a navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure., Design: Patient-level, randomized trial., Setting: Two university-based, tertiary-care children's hospital PICUs., Participants: Parents of patients requiring more than 24 hours in the PICU., Interventions: PICU Supports included adding a trained navigator to the patient's healthcare team. Trained navigators met with parents and team members to assess and address communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and did a post-PICU discharge parent check-in. The comparator arm received an informational brochure providing information about PICU procedures, terms, and healthcare providers., Measurements and Main Results: The primary outcome was percentage of "excellent" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge. Secondary outcomes included parental psychologic and physical morbidity and perceptions of team communication. We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure. Fifty-seven percent (216/382) completed the 3-5 weeks post-PICU discharge survey. The mean percentage of excellent responses to the Pediatric Family Satisfaction in the ICU 24 decision-making items was 60.4% for PICU Supports versus 56.1% for the brochure (estimate, 3.57; SE, 4.53; 95% CI, -5.77 to 12.90; p = 0.44). Differences in secondary outcomes were not statistically significant. Most parents (91.1%; 113/124) described PICU Supports as "extremely" or "somewhat" helpful., Conclusions: Parents who received PICU Supports rated the intervention positively. Differences in decision-making satisfaction scores between those receiving PICU Supports and a brochure were not statistically significant. Interventions like PICU Supports should be evaluated in larger studies employing enhanced recruitment and retention of subjects.
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- 2020
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32. Navigator-Based Intervention to Support Communication in the Pediatric Intensive Care Unit: A Pilot Study.
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Michelson KN, Charleston E, Aniciete DY, Sorce LR, Fragen P, Persell SD, Ciolino JD, Clayman ML, Rychlik K, Jones VA, Spadino P, Malakooti M, Brown M, and White D
- Subjects
- Adolescent, Attitude of Health Personnel, Child, Child, Preschool, Decision Making, Emotions, Family psychology, Humans, Infant, Intensive Care Units, Pediatric standards, Patient Discharge, Pilot Projects, Socioeconomic Factors, Communication, Intensive Care Units, Pediatric organization & administration, Parents psychology, Professional-Family Relations
- Abstract
Background: Communication in the pediatric intensive care unit (PICU) between families and the health care team affects the family experience, caregiver psychological morbidity, and patient outcomes., Objective: To test the feasibility of studying and implementing a PICU communication intervention called PICU Supports, and to assess families' and health care teams' perceptions of the intervention., Methods: This study involved patients requiring more than 24 hours of PICU care. An interventionist trained in PICU-focused health care navigation, a "navigator," met with parents and the health care team to discuss communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and checked in with parents after PICU discharge. The feasibility of implementing the intervention was assessed by tracking navigator activities. Health care team and family perceptions were assessed using surveys, interviews, and focus groups., Results: Of 53 families approached about the study, 35 (66%) agreed to participate. The navigator met with parents on 71% and the health care team on 85% of possible weekdays, and completed 86% of the postdischarge check-ins. Family meetings were offered to 95% of eligible patients. The intervention was rated as helpful by 97% of parents, and comments during interviews were positive., Conclusions: The PICU Supports intervention is feasible to implement and study and is viewed favorably by parents., (© 2020 American Association of Critical-Care Nurses.)
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- 2020
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33. Comparing Software Determination of Readmission Preventability With Chart Review, Provider, and Family Assessments.
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Rodriguez VA, Goodman DM, Bayldon B, Budin L, Michelson KN, Bunag K, Rychlik K, and Schroeder SK
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- Child, Hospitalization, Humans, Patient Discharge, Software, Patient Readmission, Physicians
- Abstract
Objectives: To explore the concordance between software, chart reviewer, provider, and parent perspectives when assessing whether readmissions are preventable or clinically related to the initial admission., Methods: Providers and parents of patients readmitted within 3 days to a tertiary children's hospital were enrolled in this single-site observational study. 3M Potentially Preventable Readmissions Grouping Software, chart reviewers, discharge and readmission providers, and parents assessed if readmissions were clinically related to the index admission or potentially preventable. Agreement between perspectives was measured by using Cohen's κ values., Results: The software found 67 of 118 (57%) clinically related readmissions; the identical 67 of 118 cases (57%) were found to be potentially preventable. Chart reviewers found 107 of 125 (86%) clinically related and 60 of 125 (47%) preventable readmissions compared to 68 of 92 (74%) and 27 of 92 (28%) for discharge physicians and 69 of 93 (74%) and 33 of 93 (34%) for readmitting physicians. Parents reported 9 of 36 (25%) preventable readmissions. Cohen κ values revealed no to minimal agreement on clinical relatedness of readmissions between software and chart reviewer, discharge provider, and readmission provider (0.12-0.20), whereas chart reviewers and providers had weak to moderate agreement with each other (0.43-0.75). There was no to minimal agreement on preventability between software and the other perspectives (-0.04 to 0.21), whereas chart reviewers and providers had minimal to weak agreement (0.27-0.56)., Conclusions: Measurement of preventable readmissions remains problematic, and using financial penalties for readmissions on the basis of software determinations may be unwise given low levels of agreement. Chart review supplemented by information from providers and families offers a more inclusive way to identify potentially preventable readmissions., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2020 by the American Academy of Pediatrics.)
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- 2020
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34. Association Between Resilience and Psychological Morbidity in Parents of Critically Ill Children.
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Rothschild CB, Rychlik KL, Goodman DM, Charleston E, Brown ML, and Michelson KN
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- Adolescent, Child, Humans, Intensive Care Units, Morbidity, Parents, Prospective Studies, Anxiety epidemiology, Critical Illness
- Abstract
Objective: To determine whether parental resilience, measured at ICU admission, is associated with parent-reported symptoms of depression, anxiety, posttraumatic stress, and satisfaction with ICU care 3-5 weeks following ICU discharge., Design: Planned prospective, observational study nested in a randomized comparative trial., Setting: PICUs and cardiac ICUs in two, free-standing metropolitan area children's hospitals., Participants: English- and Spanish-speaking parents whose children were younger than 18 years old and had anticipated ICU stay of greater than 24 hours or Pediatric Index of Mortality score of greater than or equal to 4 at the time of consent. All ICU admissions were screened for inclusion. Of 4,251 admissions reviewed, 1,360 were eligible. Five hundred families were approached and 382 enrolled. Two hundred thirty-two parents from 210 families with complete data were included in analysis., Interventions: All participating parents completed the Connor-Davidson Resilience Scale at the time of consent and outcome measures 3-5 weeks after ICU discharge., Measurements and Main Results: All parents completed the Patient-Reported Outcome Measurement Information System Short Forms 8a for Depression and Anxiety, Impact of Event Scale-Revised for posttraumatic stress, and Pediatric Family Satisfaction-ICU 24 for parental satisfaction 3-5 weeks after ICU discharge. Higher parental resilience was associated with fewer symptoms of depression, anxiety, and posttraumatic stress in the final model (all p < 0.0001). Shorter length of stay, early mechanical ventilation, Latino ethnicity, and lower illness severity (both objective and parental perceptions) were associated with less morbidity in some or all measured mental health outcomes., Conclusions: Higher parental resilience is associated with fewer reported symptoms of anxiety, depression, and posttraumatic stress 3-5 weeks after ICU discharge. Parental resilience may impact parental post-ICU psychological morbidity. Measuring parental resilience could be one approach to identify parents at risk for post-ICU psychological morbidity. Future research into the impact of interventions designed to boost parental resilience is warranted.
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- 2020
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35. A Call for New Guidelines and Research in PICU End-of-Life and Bereavement Care.
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Michelson KN
- Subjects
- Child, Family, Humans, Intensive Care Units, Pediatric, Parents, Qualitative Research, Hospice Care
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- 2019
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36. Patient and Family Engagement During Treatment Decisions in an ICU: A Discourse Analysis of the Electronic Health Record.
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Kruser JM, Benjamin BT, Gordon EJ, Michelson KN, Wunderink RG, Holl JL, and Schwarze ML
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- Aged, Aged, 80 and over, Chronic Disease, Communication, Electronic Health Records, Female, Humans, Life Support Care, Male, Middle Aged, Organ Dysfunction Scores, Patient Care Planning, Qualitative Research, Critical Illness therapy, Decision Making, Shared, Intensive Care Units, Physician-Patient Relations, Professional-Family Relations
- Abstract
Objectives: Shared decision-making is recommended for critically ill adults who face major, preference-sensitive treatment decisions. Yet, little is known about when and how patients and families are engaged in treatment decision-making over the longitudinal course of a critical illness. We sought to characterize patterns of treatment decision-making by evaluating clinician discourse in the electronic health record of critically ill adults who develop chronic critical illness or die in an ICU., Design, Setting, and Patients: We conducted qualitative content analysis of the electronic health record of 52 adult patients, admitted to a medical ICU in a tertiary medical center from January 1, 2016, to December 31, 2016. We included patients who met a consensus definition of chronic critical illness (26 patients) and a matched sample who died or transitioned to hospice care in the ICU before developing chronic critical illness (26 patients)., Interventions: None., Measurements and Main Results: Characterization of clinician decision-making discourse documented during the course of an ICU stay. Clinician decision-making discourse in the electronic health record followed a single, consistent pattern across both groups. Initial decisions about admission to the ICU focused on specific interventions that can only be provided in an ICU environment (intervention-focused decisions). Following admission, the documented rationale for additional treatments was guided by physiologic abnormalities (physiology-centered decisions). Clinician discourse transitioned to documented engagement of patients and families in decision-making when treatments failed to achieve specified physiologic goals. The phrase "goals of care" is common in the electronic health record and is used to indicate poor prognosis, to describe conflict with families, and to provide rationale for treatment limitations., Conclusions: Clinician discourse in the electronic health record reveals that patient physiology strongly guides treatment decision-making throughout the longitudinal course of critical illness. Documentation of patient and family engagement in treatment decision-making is limited until available medical treatments fail to achieve physiologic goals.
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- 2019
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37. Pediatric Readmissions Within 3 Days of Discharge: Preventability, Contributing Factors, and Necessity.
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Rodriguez VA, Goodman DM, Bayldon B, Budin L, Michelson KN, Garfield CF, Rychlik K, Smythe K, and Schroeder SK
- Subjects
- Child, Female, Humans, Male, Retrospective Studies, Hospitals, Pediatric, Medication Reconciliation statistics & numerical data, Patient Discharge statistics & numerical data, Patient Readmission statistics & numerical data, Quality Indicators, Health Care statistics & numerical data
- Abstract
Objectives: Among pediatric 30-day readmissions, 20% to 30% are preventable, and ∼25% are within 3 days of discharge. We investigated the preventability, contributing factors, and necessity of 3-day pediatric readmissions., Methods: We enrolled patients who were readmitted within 3 days at a freestanding tertiary children's hospital in this single-site observational study from July 2016 to February 2017. We performed chart reviews and interviews with discharge and readmission providers and families. Preventability was defined by the chart reviewer's determination. Contributing factors for readmission, demographics, and clinical characteristics were analyzed for association with preventability and necessity. We analyzed qualitative data using content analysis., Results: Of the 125 readmission cases included, 60 (48%) were preventable per chart reviewer compared with 27 of 92 (29%) per discharge providers, 33 of 93 (35%) per readmission providers, and 9 of 36 (25%) per families. Preventability was associated with the following contributing factors: problems with clinical decision-making in 54 of 125 (43%) readmissions ( P < .001), issues with the discharge process in 25 of 125 (20%) readmissions ( P = .01), clinically related admission and readmission ( P = .004), and weekday of initial discharge ( P = .02). Seventeen percent were unnecessary per readmission provider. Clinically unnecessary readmissions were associated with Hispanic ethnicity ( P = .02), outside-hospital transfer ( P = .05), and problems with clinical decision-making ( P = .01). Qualitative data highlighted disagreement on readiness for discharge and the necessity of readmission among various providers and family., Conclusions: More than one-half of 3-day readmissions were considered either preventable or unnecessary. Clinical decision-making, discharge processes, and improving consensus among families and providers may be valuable areas for future efforts to reduce readmission., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)
- Published
- 2019
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38. Biobanking in the Pediatric Critical Care Setting: Adolescent/Young Adult Perspectives.
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Paquette ED, Derrington SF, Shukla A, Sinha N, Oswald S, Sorce L, and Michelson KN
- Subjects
- Adolescent, Adult, Child, Comprehension, Cross-Sectional Studies, Decision Making, Ethics, Research, Female, Humans, Informed Consent By Minors, Intensive Care Units, Male, Middle Aged, Parents, Patient Participation, Pediatrics, Surveys and Questionnaires, Young Adult, Attitude, Biological Specimen Banks ethics, Biomedical Research ethics, Critical Care, Informed Consent
- Abstract
Biorepository research in children raises numerous ethical questions that are heightened in the pediatric intensive care unit (PICU) setting. We conducted a cross-sectional, interview-based study of 20 adolescent/young adult (A/YA) PICU patients and 75 parents of PICU patients to elucidate perspectives on biorepository research. A/YAs had a positive attitude toward biobanking. In young adults, comprehension was higher for knowledge of a choice to withdraw and participate in the research and lower for purpose, procedures, risks, and benefits of participation. All but one A/YA wanted to have a say in whether their samples would be used. Parent views on child assent were mixed; 55% of parents favored child involvement in decisions. Efforts should be made to improve comprehension by A/YAs and involvement of A/YAs in decisions.
- Published
- 2018
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39. Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.
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Michelson KN, Reubenson G, Weiss SL, Fitzgerald JC, Ackerman KK, Christie L, Bush JL, Nadkarni VM, Thomas NJ, and Schreiner MS
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- Humans, Prevalence, Prospective Studies, Research Design statistics & numerical data, Sepsis therapy, Surveys and Questionnaires, Time Factors, Ethical Review, Ethics Committees, Research statistics & numerical data, Sepsis epidemiology
- Abstract
Objectives: Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study., Design: Survey., Setting: Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies., Subjects: Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies., Interventions: None., Measurements and Main Results: Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16)., Conclusions: Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.
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- 2018
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40. Dimensions and Role-Specific Mediators of Surrogate Trust in the ICU.
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Hutchison PJ, McLaughlin K, Corbridge T, Michelson KN, Emanuel L, Sporn PH, and Crowley-Matoka M
- Subjects
- Adolescent, Adult, Aged, Female, Humans, Interpersonal Relations, Interviews as Topic, Male, Middle Aged, Physician-Patient Relations, Prospective Studies, Qualitative Research, Young Adult, Intensive Care Units, Proxy psychology, Third-Party Consent, Trust psychology
- Abstract
Objective: In the ICU, discussions between clinicians and surrogate decision makers are often accompanied by conflict about a patient's prognosis or care plan. Trust plays a role in limiting conflict, but little is known about the determinants of trust in the ICU. We sought to identify the dimensions of trust and clinician behaviors conducive to trust formation in the ICU., Design: Prospective qualitative study., Setting: Medical ICU of a major urban university hospital., Subjects: Surrogate decision makers of intubated, mechanically ventilated patients in the medical ICU., Measurements and Main Results: Semistructured interviews focused on surrogates' general experiences in the ICU and on their trust in the clinicians caring for the patient. Interviews were audio-recorded, transcribed verbatim, and coded by two reviewers. Constant comparison was used to identify themes pertaining to trust. Thirty surrogate interviews revealed five dimensions of trust in ICU clinicians: technical competence, communication, honesty, benevolence, and interpersonal skills. Most surrogates emphasized the role of nurses in trust formation, frequently citing their technical competence. Trust in physicians was most commonly related to honesty and the quality of their communication with surrogates., Conclusions: Interventions to improve trust in the ICU should be role-specific, since surrogate expectations are different for physicians and nurses with regard to behaviors relevant to trust. Further research is needed to confirm our findings and explore the impact of trust modification on clinician-family conflict., Competing Interests: The remaining authors have disclosed that they do not have any potential conflicts of interest.
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- 2016
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41. The Process and Impact of Stakeholder Engagement in Developing a Pediatric Intensive Care Unit Communication and Decision-Making Intervention.
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Michelson KN, Frader J, Sorce L, Clayman ML, Persell SD, Fragen P, Ciolino JD, Campbell LC, Arenson M, Aniciete DY, Brown ML, Ali FN, and White D
- Abstract
Stakeholder-developed interventions are needed to support pediatric intensive care unit (PICU) communication and decision-making. Few publications delineate methods and outcomes of stakeholder engagement in research. We describe the process and impact of stakeholder engagement on developing a PICU communication and decision-making support intervention. We also describe the resultant intervention. Stakeholders included parents of PICU patients, healthcare team members (HTMs), and research experts. Through a year-long iterative process, we involved 96 stakeholders in 25 meetings and 26 focus groups or interviews. Stakeholders adapted an adult navigator model by identifying core intervention elements and then determining how to operationalize those core elements in pediatrics. The stakeholder input led to PICU-specific refinements, such as supporting transitions after PICU discharge and including ancillary tools. The resultant intervention includes navigator involvement with parents and HTMs and navigator-guided use of ancillary tools. Subsequent research will test the feasibility and efficacy of our intervention., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
- Published
- 2016
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42. The use of family conferences in the pediatric intensive care unit.
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Michelson KN, Clayman ML, Haber-Barker N, Ryan C, Rychlik K, Emanuel L, and Frader J
- Subjects
- Adolescent, Adult, Child, Child, Preschool, Female, Hospitals, University, Humans, Infant, Male, Medical Audit, Prospective Studies, United States, Young Adult, Communication, Decision Making, Intensive Care Units, Pediatric, Professional-Family Relations
- Abstract
Background: Data about pediatric intensive care unit (PICU) family conferences (FCs) are needed to enhance our understanding of the role of FCs in patient care and build a foundation for future research on PICU communication and decision making., Objective: The study's objective was to describe the use and content of PICU FCs., Design: The study design was a prospective chart review comparing patients who had conferences with those who did not, and a sub-analysis of patients with chronic care conditions (CCCs)., Setting/subjects: The study setting was an academic PICU from January 2011 through June 2011., Measurements: Medical events under consideration were placement of tracheostomy or gastrostomy tube; initiation of chronic ventilation; palliative care involvement; use of extracorporeal membrane oxygenation, continuous renal replacement, or cardiopulmonary resuscitation; care limitation orders; death; length of stay; and discharge to a new environment., Results: From 661 admissions, we identified 74 conferences involving 49 patients. Sixty-four conferences (86%) were held about 40 patients with CCCs. Having a conference was associated with (p<0.05): length of PICU admission; palliative care involvement; initiation of chronic ventilation; extracorporeal membrane oxygenation; cardiopulmonary resuscitation; death; discharge to a new environment; and care limitation orders. Twenty-nine percent of patients who had a new tracheostomy or gastrostomy tube placed had a conference. We identified two categories of discussion topics: information exchange and future management., Conclusions: Most identified FCs involved complex patients or patients who faced decisions affecting the child's quality of life or dying. For many patients who faced life changing decisions we did not identify a FC. Further research is needed to understand how to best utilize FCs and less formal conversations.
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- 2013
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43. Bereavement photography for children: program development and health care professionals' response.
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Michelson KN, Blehart K, Hochberg T, and James K
- Subjects
- Adult, Attitude to Health, Child, Female, Humans, Male, Middle Aged, Bereavement, Hospital-Patient Relations, Object Attachment, Parent-Child Relations, Parents psychology, Photography methods
- Abstract
Reports of in-hospital bereavement photography focus largely on stillborns and neonates. Empiric data regarding the implementation of bereavement photography in pediatrics beyond the neonatal period and the impact of such programs on healthcare professionals (HCPs) is lacking. The authors describe the implementation of a pediatric intensive care unit (PICU) bereavement photography program and use questionnaire data from HCPs to describe HCPs' reflections on the program and to identify program barriers. From July 2007 through April 2070, families of 59 (36%) of the 164 patients who died in the PICU participated in our bereavement photography program. Forty questionnaires from 29 HCPs caring for 39 participating patients/families indicated that families seemed grateful for the service (n = 34; 85%) and that the program helped HCPs feel better about their role (n = 30; 70%). Many HCPs disagreed that the program consumed too much of his/her time (n = 34; 85%) and that the photographer made his/her job difficult (n = 37; 92.5%). Qualitative analysis of responses to open-ended questions revealed 4 categories: the program's general value; positive aspects of the program; negative aspects of the program; and suggestions for improvements. Implementing bereavement photography in the PICU is feasible though some barriers exist. HCPs may benefit from such programs.
- Published
- 2013
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44. Family communication in the PICU: beyond the conference room.
- Author
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Michelson KN
- Subjects
- Female, Humans, Male, Attitude of Health Personnel, Intensive Care Units, Pediatric, Parents, Physicians, Professional-Family Relations
- Published
- 2013
- Full Text
- View/download PDF
45. End-of-life care decisions in the PICU: roles professionals play.
- Author
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Michelson KN, Patel R, Haber-Barker N, Emanuel L, and Frader J
- Subjects
- Adult, Aged, Child, Child, Preschool, Clergy, Communication, Female, Focus Groups, Health Personnel, Humans, Infant, Infant, Newborn, Interviews as Topic, Male, Middle Aged, Parents, Patient Care Planning, Retrospective Studies, Social Work, Young Adult, Decision Making, Intensive Care Units, Pediatric, Professional Role, Terminal Care
- Abstract
Objective: Describe the roles and respective responsibilities of PICU healthcare professionals in end-of-life care decisions faced by PICU parents., Design: Retrospective qualitative study., Setting: University-based tertiary care children's hospital., Participants: Eighteen parents of children who died in the pediatric ICU and 48 PICU healthcare professionals (physicians, nurses, social workers, child-life specialists, chaplains, and case managers)., Interventions: In depth, semi-structured focus groups and one-on-one interviews designed to explore experiences in end-of-life care decision making., Measurements and Main Results: We identified end-of-life care decisions that parents face based on descriptions by parents and healthcare professionals. Participants described medical and nonmedical decisions addressed toward the end of a child's life. From the descriptions, we identified seven roles healthcare professionals play in end-of-life care decisions. The family supporter addresses emotional, spiritual, environmental, relational, and informational family needs in a nondirective way. The family advocate helps families articulate their views and needs to healthcare professionals. The information giver provides parents with medical information, identifies decisions or describes available options, and clarifies parents' understanding. The general care coordinator helps facilitate interactions among healthcare professionals in the PICU, among healthcare professionals from different subspecialty teams, and between healthcare professionals and parents. The decision maker makes or directly influences the defined plan of action. The end-of-life care coordinator organizes and executes functions occurring directly before, during, and after dying/death. The point person develops a unique trusting relationship with parents., Conclusions: Our results describe a framework for healthcare professionals' roles in parental end-of-life care decision making in the pediatric ICU that includes directive, value-neutral, and organizational roles. More research is needed to validate these roles. Actively ensuring attention to these roles during the decision-making process could improve parents' experiences at the end of a child's life.
- Published
- 2013
- Full Text
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46. A new satisfaction tool: what do we do with it?
- Author
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Michelson KN
- Subjects
- Female, Humans, Male, Intensive Care, Neonatal standards, Parents, Patient Satisfaction, Process Assessment, Health Care, Surveys and Questionnaires
- Published
- 2012
- Full Text
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47. Pediatric intensive care unit family conferences: one mode of communication for discussing end-of-life care decisions.
- Author
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Michelson KN, Emanuel L, Carter A, Brinkman P, Clayman ML, and Frader J
- Subjects
- Adult, Child, Child, Preschool, Family psychology, Female, Focus Groups, Hospitals, University, Humans, Infant, Interviews as Topic, Male, Middle Aged, Retrospective Studies, Young Adult, Communication, Decision Making, Intensive Care Units, Pediatric, Professional-Family Relations, Terminal Care, Withholding Treatment
- Abstract
Objective: To examine clinicians' and parents' reflections on pediatric intensive care unit family conferences in the context of discussion about end-of-life care decision making., Design: Retrospective qualitative study., Setting: A university-based hospital., Participants: Eighteen parents of children who died in the pediatric intensive care unit and 48 pediatric intensive care unit clinicians (physicians, nurses, social workers, child-life specialists, chaplains, and case managers)., Interventions: In-depth, semistructured focus groups and one-on-one interviews designed to explore experiences in end-of-life care decision making., Measurements and Main Results: We identified comments about family conferences in all clinician focus groups/interviews, except one individual nurse interview, and in 13 of the 18 parent interviews. Comments from parents were sparse compared with those from clinicians. Four topics emerged: purpose, structural aspects, challenges, and suggestions for improvement. We identified three purposes for family conferences: communication between clinicians and parents; communication among clinicians; and support of families. Described structural aspects of family conferences included: preconference planning, communication during conferences, and postconference processing. Challenges noted involved communicating with parents during family conferences, such as: difficulties associated with having multiple services involved; balancing messages of hope and realism; using understandable language; and communicating with non-English-speakers. Participants described additional challenges related to the logistics of organizing family conferences. Suggestions focused on methods to improve communication in, organization of, and preparation for family conferences., Conclusions: Pediatric intensive care unit clinicians in this study perceive family conferences as having an important role in end-of-life care decision making. The paucity of data from parents, an important finding itself, limits our ability to comment on parents' perceptions of family conferences. Prospective research of pediatric intensive care unit family conferences, with specific attention to parents' experiences and to all aspects of family conferences, including pre- and postconference events, should seek to understand the role and impact of this mode of communication on end-of-life care decision making and to determine the need for improvement to family conferences.
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- 2011
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48. Parental views on withdrawing life-sustaining therapies in critically ill children.
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Michelson KN, Koogler T, Sullivan C, Ortega Mdel P, Hall E, and Frader J
- Subjects
- Adolescent, Adult, Child, Child, Preschool, Female, Health Care Costs, Humans, Infant, Intensive Care Units, Pediatric, Interviews as Topic, Intuition, Male, Middle Aged, Pain prevention & control, Pain psychology, Professional-Family Relations, Quality of Life, Religion, Time, Treatment Failure, Trust, Young Adult, Critical Illness, Decision Making, Parents psychology, Withholding Treatment
- Abstract
Objective: To broaden existing knowledge of pediatric end-of-life decision making by exploring factors described by parents of patients in the pediatric intensive care unit (PICU) as important/influential if they were to consider withdrawing life-sustaining therapies., Design: Quantitative and qualitative analysis of semi-structured one-on-one interviews., Setting: The PICUs at 2 tertiary care hospitals., Participants: English- or Spanish-speaking parents who were older than 17 years and whose child was admitted to the PICU for more than 24 hours to up to 1 week., Intervention: Semi-structured one-on-one interviews., Results: Forty of 70 parents (57%) interviewed said they could imagine a situation in which they would consider withdrawing life-sustaining therapies. When asked if specific factors might influence their decision making, 64% of parents said they would consider withdrawing life-sustaining therapies if their child were suffering; 51% would make such a decision based on quality-of-life considerations; 43% acknowledged the influence of physician-estimated prognosis in their decision; and 7% said financial burden would affect their consideration. Qualitative analysis of their subsequent comments identified 9 factors influential to parents when considering withdrawing life-sustaining therapies: quality of life, suffering, ineffective treatments, faith, time, financial considerations, general rejection of withdrawing life-sustaining therapies, mistrust/doubt toward physicians, and reliance on self/intuition., Conclusion: Parents describe a broad range of views regarding possible consideration of withdrawing life-sustaining therapies for their children and what factors might influence such a decision.
- Published
- 2009
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49. Pediatric residents' and fellows' perspectives on palliative care education.
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Michelson KN, Ryan AD, Jovanovic B, and Frader J
- Subjects
- Adult, Clinical Competence, Female, Health Care Surveys, Humans, Male, Middle Aged, United States, Fellowships and Scholarships, Health Knowledge, Attitudes, Practice, Internship and Residency, Palliative Care, Pediatrics education
- Abstract
Background: The American Academy of Pediatrics recommends that pediatricians become knowledgeable in and comfortable with providing palliative care., Objective: The study goals included: determining the extent of training, knowledge, experience, comfort and competence in palliative care communication and symptom management of pediatric residents and fellows; obtaining residents' and fellows' views on key palliative care concepts; identifying topics and methods for palliative care education; and identifying differences in responses between residents and fellows., Design/methods: In academic year 2006-2007 pediatrics residents and fellows completed a survey on: training, experience, knowledge, competence, and comfort in delivering palliative care; palliative care practices; and suggestions for delivering palliative care education., Results: Fifty-two (60%) and 44 (62%) residents and fellows respectively completed the survey. Residents and fellows described none to moderate levels of training, experience, knowledge, competence and comfort in palliative care. Most respondents said they would benefit from more formal palliative care training. Respondents identified discussing prognosis, delivering bad news, and pain control as the three most important areas of needed education. Learning about supporting families spiritually and emotional support for physicians were among the least important educational areas identified. Respondents recommended delivering education via observation, bedside teaching, and participation in multidisciplinary groups., Conclusions: Efforts to improve education in pediatric palliative care are needed. A palliative care team could facilitate palliative care education through engaging trainees in "real-life" interactions. The role of physicians in providing spiritual support and the need for educating physicians in obtaining emotional support for themselves merit further investigation.
- Published
- 2009
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50. Pediatric End-of-Life Issues and Palliative Care.
- Author
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Michelson KN and Steinhorn DM
- Abstract
Optimizing the quality of medical care at the end of life has achieved national status as an important health care goal. Palliative care, a comprehensive approach to treating the physical, psychosocial and spiritual needs of patients and their families facing life-limiting illnesses, requires the coordinated efforts of a multidisciplinary group of caregivers. Understanding the basic principles of palliative care can aid emergency department staff in identifying patients who could benefit from palliative care services and in managing the challenging situations that arise when such patients present to the hospital for care.In this article we present the overall philosophy of pediatric palliative care, describe key elements of quality palliative care, and identify additional referral sources readers can access for more information.
- Published
- 2007
- Full Text
- View/download PDF
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