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Item Executive Summary of the Second International Guidelines for the Diagnosis and Management of Pediatric Acute Respiratory Distress Syndrome (PALICC-2)(Wolters Kluwer, 2023) Emeriaud, Guillaume; López-Fernández, Yolanda M.; Iyer, Narayan Prabhu; Bembea, Melania M.; Agulnik, Asya; Barbaro, Ryan P.; Baudin, Florent; Bhalla, Anoopindar; de Carvalho, Werther Brunow; Carroll, Christopher L.; Cheifetz, Ira M.; Chisti, Mohammod J.; Cruces, Pablo; Curley, Martha A. Q.; Dahmer, Mary K.; Dalton, Heidi J.; Erickson, Simon J.; Essouri, Sandrine; Fernández, Analía; Flori, Heidi R.; Grunwell, Jocelyn R.; Jouvet, Philippe; Killien, Elizabeth Y.; Kneyber, Martin C. J.; Kudchadkar, Sapna R.; Korang, Steven Kwasi; Lee, Jan Hau; Macrae, Duncan J.; Maddux, Aline; Alapont, Vicent Modesto I.; Morrow, Brenda M.; Nadkarni, Vinay M.; Napolitano, Natalie; Newth, Christopher J. L.; Pons-Odena, Martí; Quasney, Michael W.; Rajapreyar, Prakadeshwari; Rambaud, Jerome; Randolph, Adrienne G.; Rimensberger, Peter; Rowan, Courtney M.; Sanchez-Pinto, L. Nelson; Sapru, Anil; Sauthier, Michael; Shein, Steve L.; Smith, Lincoln S.; Steffen, Katerine; Takeuchi, Muneyuki; Thomas, Neal J.; Tse, Sze Man; Valentine, Stacey; Ward, Shan; Watson, R. Scott; Yehya, Nadir; Zimmerman, Jerry J.; Khemani, Robinder G.; Pediatrics, School of MedicineObjectives: We sought to update our 2015 work in the Second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) guidelines for the diagnosis and management of pediatric acute respiratory distress syndrome (PARDS), considering new evidence and topic areas that were not previously addressed. Design: International consensus conference series involving 52 multidisciplinary international content experts in PARDS and four methodology experts from 15 countries, using consensus conference methodology, and implementation science. Setting: Not applicable. Patients: Patients with or at risk for PARDS. Interventions: None. Measurements and main results: Eleven subgroups conducted systematic or scoping reviews addressing 11 topic areas: 1) definition, incidence, and epidemiology; 2) pathobiology, severity, and risk stratification; 3) ventilatory support; 4) pulmonary-specific ancillary treatment; 5) nonpulmonary treatment; 6) monitoring; 7) noninvasive respiratory support; 8) extracorporeal support; 9) morbidity and long-term outcomes; 10) clinical informatics and data science; and 11) resource-limited settings. The search included MEDLINE, EMBASE, and CINAHL Complete (EBSCOhost) and was updated in March 2022. Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to summarize evidence and develop the recommendations, which were discussed and voted on by all PALICC-2 experts. There were 146 recommendations and statements, including: 34 recommendations for clinical practice; 112 consensus-based statements with 18 on PARDS definition, 55 on good practice, seven on policy, and 32 on research. All recommendations and statements had agreement greater than 80%. Conclusions: PALICC-2 recommendations and consensus-based statements should facilitate the implementation and adherence to the best clinical practice in patients with PARDS. These results will also inform the development of future programs of research that are crucially needed to provide stronger evidence to guide the pediatric critical care teams managing these patients.Item Executive Summary: International Clinical Practice Guidelines for Pediatric Ventilator Liberation, A PALISI Network Document(American Thoracic Society Journals, 2022-08-15) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C.J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A.Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M.M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith Ju Ming; Emeriaud, Guillaume; Mastropietro, Christopher W; Napolitano, Natalie; Newth, Christopher J.L.; Khemani, Robinder G.RATIONALE: Pediatric specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients' readiness for extubation. METHODS: Twenty-six international experts comprised a multi-professional panel to establish pediatric specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. Systematic review was conducted for questions which did not meet an a-priori threshold of ≥80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence, drafted, and voted on the recommendations. MEASUREMENTS AND MAIN RESULTS: Three questions related to systematic screening, using an extubation readiness testing bundle and use of a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ≥80% agreement. For the remaining 8 questions, 5 systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials; measures of respiratory muscle strength; assessment of risk of post-extubation upper airway obstruction and its prevention; use of post-extubation non-invasive respiratory support; and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. CONCLUSION: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.Item Executive Summary: International Clinical Practice Guidelines for Pediatric Ventilator Liberation, A Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network Document(American Thoracic Society, 2023) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C. J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A. Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M. M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith J. M.; Emeriaud, Guillaume; Mastropietro, Christopher W.; Napolitano, Natalie; Newth, Christopher J. L.; Khemani, Robinder G.; Pediatrics, School of MedicineRationale: Pediatric-specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients’ readiness for extubation. Methods: Twenty-six international experts comprised a multiprofessional panel to establish pediatrics-specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. A systematic review was conducted for questions that did not meet an a priori threshold of ⩾80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence and drafted and voted on the recommendations. Measurements and Main Results: Three questions related to systematic screening using an extubation readiness testing bundle and a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ⩾80% agreement. For the remaining eight questions, five systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials, measures of respiratory muscle strength, assessment of risk of postextubation upper airway obstruction and its prevention, use of postextubation noninvasive respiratory support, and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. Conclusions: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.Item Operational Definitions related to Pediatric Ventilator Liberation(Elsevier, 2022-12-20) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C.J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A.Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M.M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith Ju Ming; Emeriaud, Guillaume; Mastropietro, Christopher W.; Napolitano, Natalie; Newth, Christopher J.L.; Khemani, Robinder G.BACKGROUND: Common, operational definitions are crucial to assess interventions and outcomes related to pediatric mechanical ventilation. These definitions can reduce unnecessary variability amongst research and quality improvement efforts, to ensure findings are generalizable and can be pooled to establish best practices. RESEARCH QUESTION: Can we establish operational definitions for key elements related to pediatric ventilator liberation using a combination of detailed literature review and consensus-based approaches? STUDY DESIGN AND METHODS: A panel of 26 international experts in pediatric ventilator liberation, two methodologists and two librarians conducted systematic reviews on eight topic areas related to pediatric ventilator liberation. Through a series of virtual meetings, we established draft definitions which were voted upon using an anonymous web-based process. Definitions were revised by incorporating extracted data gathered during the systematic review and discussed in another consensus meeting. A second round of voting was conducted to confirm the final definitions. RESULTS: In eight topic areas identified by the experts, 16 preliminary definitions were established. Based on initial discussion and the first round of voting, modifications were suggested for 11 of the 16 definitions. There was significant variability in how these items were defined in the literature reviewed. The final round of voting achieved ≥80% agreement for all 16 definitions in the following areas: what constitutes respiratory support (invasive mechanical ventilation and non-invasive respiratory support), liberation and failed attempts to liberate from invasive mechanical ventilation, liberation from respiratory support, duration of non-invasive respiratory support, total duration of invasive mechanical ventilation, spontaneous breathing trials, extubation readiness testing, 28-ventilator free days, and planned vs rescue use of post-extubation non-invasive respiratory support. INTERPRETATION: We propose these consensus-based definitions for elements of pediatric ventilator liberation, informed by evidence, be used for future quality improvement initiatives and research studies to improve generalizability, and facilitate comparison.Item Pediatric Organ Dysfunction Information Update Mandate (PODIUM) Contemporary Organ Dysfunction Criteria: Executive Summary(American Academy of Pediatrics, 2022) Bembea, Melania M.; Agus, Michael; Akcan-Arikan, Ayse; Alexander, Peta; Basu, Rajit; Bennett, Tellen D.; Bohn, Desmond; Brandão, Leonardo R.; Brown, Ann-Marie; Carcillo, Joseph A.; Checchia, Paul; Cholette, Jill; Cheifetz, Ira M.; Cornell, Timothy; Doctor, Allan; Eckerle, Michelle; Erickson, Simon; Farris, Reid W.D.; Faustino, E. Vincent S.; Fitzgerald, Julie C.; Fuhrman, Dana Y.; Giuliano, John S.; Guilliams, Kristin; Gaies, Michael; Gorga, Stephen M.; Hall, Mark; Hanson, Sheila J.; Hartman, Mary; Hassinger, Amanda B.; Irving, Sharon Y.; Jeffries, Howard; Jouvet, Philippe; Kannan, Sujatha; Karam, Oliver; Khemani, Robinder G.; Kissoon, Niranjan; Lacroix, Jacques; Laussen, Peter; Leclerc, Francis; Lee, Jan Hau; Leteurtre, Stephane; Lobner, Katie; McKiernan, Patrick J.; Menon, Kusum; Monagle, Paul; Muszynski, Jennifer A.; Odetola, Folafoluwa; Parker, Robert; Pathan, Nazima; Pierce, Richard W.; Pineda, Jose; Prince, Jose M.; Robinson, Karen A.; Rowan, Courtney M.; Ryerson, Lindsay M.; Sanchez-Pinto, L. Nelson; Schlapbach, Luregn J.; Selewski, David T.; Shekerdemian, Lara S.; Simon, Dennis; Smith, Lincoln S.; Squires, James E.; Squires, Robert H.; Sutherland, Scott M.; Ouellette, Yves; Spaeder, Michael C.; Srinivasan, Vijay; Steiner, Marie E.; Tasker, Robert C.; Thiagarajan, Ravi; Thomas, Neal; Tissieres, Pierre; Traube, Chani; Tucci, Marisa; Typpo, Katri V.; Wainwright, Mark S.; Ward, Shan L.; Watson, R. Scott; Weiss, Scott; Whitney, Jane; Willson, Doug; Wynn, James L.; Yehya, Nadir; Zimmerman, Jerry J.; Pediatrics, School of MedicinePrior criteria for organ dysfunction in critically ill children were based mainly on expert opinion. We convened the Pediatric Organ Dysfunction Information Update Mandate (PODIUM) expert panel to summarize data characterizing single and multiple organ dysfunction and to derive contemporary criteria for pediatric organ dysfunction. The panel was composed of 88 members representing 47 institutions and 7 countries. We conducted systematic reviews of the literature to derive evidence-based criteria for single organ dysfunction for neurologic, cardiovascular, respiratory, gastrointestinal, acute liver, renal, hematologic, coagulation, endocrine, endothelial, and immune system dysfunction. We searched PubMed and Embase from January 1992 to January 2020. Study identification was accomplished using a combination of medical subject headings terms and keywords related to concepts of pediatric organ dysfunction. Electronic searches were performed by medical librarians. Studies were eligible for inclusion if the authors reported original data collected in critically ill children; evaluated performance characteristics of scoring tools or clinical assessments for organ dysfunction; and assessed a patient-centered, clinically meaningful outcome. Data were abstracted from each included study into an electronic data extraction form. Risk of bias was assessed using the Quality in Prognosis Studies tool. Consensus was achieved for a final set of 43 criteria for pediatric organ dysfunction through iterative voting and discussion. Although the PODIUM criteria for organ dysfunction were limited by available evidence and will require validation, they provide a contemporary foundation for researchers to identify and study single and multiple organ dysfunction in critically ill children.