Literature DB >> 26513203

Research as a Standard of Care in the PICU.

Jerry J Zimmerman1, Kanwaljeet J S Anand, Kathleen L Meert, Douglas F Willson, Christopher J L Newth, Rick Harrison, Joseph A Carcillo, John Berger, Tammara L Jenkins, Carol Nicholson, J Michael Dean.   

Abstract

OBJECTIVES: Excellence in clinical care coupled with basic and applied research reflects the maturation of a medical subspecialty, advances that field, and provides objective data for identifying best practices. PICUs are uniquely suited for conducting translational and clinical research. In addition, multiple investigations have reported that a majority of parents are interested in their children's participation in clinical research, even when the research offers no direct benefit to their child. However, such activity may generate ethical conflict with bedside care providers trying to acutely identify the best approach for an individual critically ill child. Ultimately, this conflict may diminish enthusiasm for the generation of scientific evidence that supports the application of evidence-based medicine into PICU clinical standard work. Accordingly this review endeavors to provide an overview of current state PICU clinical research strengths, liabilities, opportunities, and barriers and contrast this with an established pediatric hematology-oncology iterative research model that constitutes a learning healthcare system. DATA SOURCES, DATA EXTRACTION, AND DATA SYNTHESIS: Narrative review of medical literature published in English.
CONCLUSIONS: Currently, most PICU therapy is not evidence based. Developing a learning healthcare system in the PICU integrates clinical research into usual practice and fosters a culture of evidence-based learning and continual care improvement. As PICU mortality has significantly decreased, identification and validation of patient-centered, clinically relevant research outcome measures other than mortality is essential for future clinical trial design. Because most pediatric critical illness may be classified as rare diseases, participation in research networks will facilitate iterative, collaborative, multiinstitutional investigations that over time identify the best practices to improve PICU outcomes. Despite real ethical challenges, critically ill children and their families should have the opportunity to participate in translational/clinical research whenever feasible.

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Year:  2016        PMID: 26513203      PMCID: PMC5003779          DOI: 10.1097/PCC.0000000000000562

Source DB:  PubMed          Journal:  Pediatr Crit Care Med        ISSN: 1529-7535            Impact factor:   3.624


  99 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

Review 2.  On the need for observational studies to design and interpret randomized trials in ICU patients: a case study in stress ulcer prophylaxis.

Authors:  D Cook; D Heyland; J Marshall
Journal:  Intensive Care Med       Date:  2001-02       Impact factor: 17.440

3.  Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study.

Authors:  Sangeeta Mehta; Friederike Quittnat Pelletier; Maedean Brown; Cheryl Ethier; David Wells; Lisa Burry; Rod MacDonald
Journal:  Intensive Care Med       Date:  2011-11-26       Impact factor: 17.440

Review 4.  The design of future pediatric mechanical ventilation trials for acute lung injury.

Authors:  Robinder G Khemani; Christopher J L Newth
Journal:  Am J Respir Crit Care Med       Date:  2010-08-23       Impact factor: 21.405

5.  American pediatric academia: the looming question.

Authors:  Scott A Rivkees; Myron Genel
Journal:  J Pediatr       Date:  2007-09       Impact factor: 4.406

6.  The future of biomedical research.

Authors:  Ezekiel J Emanuel
Journal:  JAMA       Date:  2013-04-17       Impact factor: 56.272

7.  Guidelines for the acute medical management of severe traumatic brain injury in infants, children, and adolescents--second edition.

Authors:  Patrick M Kochanek; Nancy Carney; P David Adelson; Stephen Ashwal; Michael J Bell; Susan Bratton; Susan Carson; Randall M Chesnut; Jamshid Ghajar; Brahm Goldstein; Gerald A Grant; Niranjan Kissoon; Kimberly Peterson; Nathan R Selden; Robert C Tasker; Karen A Tong; Monica S Vavilala; Mark S Wainwright; Craig R Warden
Journal:  Pediatr Crit Care Med       Date:  2012-01       Impact factor: 3.624

Review 8.  Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam Consultation on Meta-Analysis.

Authors:  D J Cook; D L Sackett; W O Spitzer
Journal:  J Clin Epidemiol       Date:  1995-01       Impact factor: 6.437

9.  Impact of standard procedures and clinical standards on cost-effectiveness and intensive care unit performance in adult patients after cardiac surgery.

Authors:  H Kern; W J Kox
Journal:  Intensive Care Med       Date:  1999-12       Impact factor: 17.440

10.  Developing a clinically feasible personalized medicine approach to pediatric septic shock.

Authors:  Hector R Wong; Natalie Z Cvijanovich; Nick Anas; Geoffrey L Allen; Neal J Thomas; Michael T Bigham; Scott L Weiss; Julie Fitzgerald; Paul A Checchia; Keith Meyer; Thomas P Shanley; Michael Quasney; Mark Hall; Rainer Gedeit; Robert J Freishtat; Jeffrey Nowak; Raj S Shekhar; Shira Gertz; Emily Dawson; Kelli Howard; Kelli Harmon; Eileen Beckman; Erin Frank; Christopher J Lindsell
Journal:  Am J Respir Crit Care Med       Date:  2015-02-01       Impact factor: 21.405

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  11 in total

Review 1.  The intensive care medicine clinical research agenda in paediatrics.

Authors:  Mark J Peters; Andrew Argent; Marino Festa; Stéphane Leteurtre; Jefferson Piva; Ann Thompson; Douglas Willson; Pierre Tissières; Marisa Tucci; Jacques Lacroix
Journal:  Intensive Care Med       Date:  2017-03-17       Impact factor: 17.440

Review 2.  Design and conduct of early phase drug studies in children: challenges and opportunities.

Authors:  Michael Rieder; Daniel Hawcutt
Journal:  Br J Clin Pharmacol       Date:  2016-08-08       Impact factor: 4.335

Review 3.  Brain-related outcome measures in trials recruiting critically-ill children.

Authors:  Ericka L Fink; Robert C Tasker
Journal:  Curr Opin Pediatr       Date:  2019-12       Impact factor: 2.856

4.  Epidemiology of Pediatric Critical Illness in a Population-Based Birth Cohort in Olmsted County, MN.

Authors:  Sheri S Crow; Chaitanya Undavalli; David O Warner; Slavica K Katusic; Pujan Kandel; Sinead L Murphy; Darrell R Schroeder; R Scott Watson
Journal:  Pediatr Crit Care Med       Date:  2017-03       Impact factor: 3.624

5.  International Survey of Critically Ill Children With Acute Neurologic Insults: The Prevalence of Acute Critical Neurological Disease in Children: A Global Epidemiological Assessment Study.

Authors:  Ericka L Fink; Patrick M Kochanek; Robert C Tasker; John Beca; Michael J Bell; Robert S B Clark; Jamie Hutchison; Monica S Vavilala; Anthony Fabio; Derek C Angus; R Scott Watson
Journal:  Pediatr Crit Care Med       Date:  2017-04       Impact factor: 3.624

6.  Postdischarge health resource use in pediatric survivors of prolonged mechanical ventilation for acute respiratory illness.

Authors:  Michelle Vo; Kristen Miller; Tellen D Bennett; Peter M Mourani; Jaime LaVelle; Todd C Carpenter; R Scott Watson; Laura L Pyle; Aline B Maddux
Journal:  Pediatr Pulmonol       Date:  2022-04-26

7.  Methods Used to Maximize Follow-Up: Lessons Learned From the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials.

Authors:  Marianne R Gildea; Frank W Moler; Kent Page; Kathleen Meert; Richard Holubkov; J Michael Dean; James R Christensen; Beth S Slomine
Journal:  Pediatr Crit Care Med       Date:  2020-01       Impact factor: 3.624

8.  The Collaborative Pediatric Critical Care Research Network: Recent Progress and Future Directions.

Authors:  Kathleen L Meert; Daniel A Notterman
Journal:  Pediatr Clin North Am       Date:  2017-10       Impact factor: 3.278

Review 9.  Patient and public involvement in Paediatric Intensive Care research: considerations, challenges and facilitating factors.

Authors:  J C Menzies; K P Morris; H P Duncan; J F Marriott
Journal:  Res Involv Engagem       Date:  2016-11-07

10.  GA4GH: International policies and standards for data sharing across genomic research and healthcare.

Authors:  Heidi L Rehm; Angela J H Page; Lindsay Smith; Jeremy B Adams; Gil Alterovitz; Lawrence J Babb; Maxmillian P Barkley; Michael Baudis; Michael J S Beauvais; Tim Beck; Jacques S Beckmann; Sergi Beltran; David Bernick; Alexander Bernier; James K Bonfield; Tiffany F Boughtwood; Guillaume Bourque; Sarion R Bowers; Anthony J Brookes; Michael Brudno; Matthew H Brush; David Bujold; Tony Burdett; Orion J Buske; Moran N Cabili; Daniel L Cameron; Robert J Carroll; Esmeralda Casas-Silva; Debyani Chakravarty; Bimal P Chaudhari; Shu Hui Chen; J Michael Cherry; Justina Chung; Melissa Cline; Hayley L Clissold; Robert M Cook-Deegan; Mélanie Courtot; Fiona Cunningham; Miro Cupak; Robert M Davies; Danielle Denisko; Megan J Doerr; Lena I Dolman; Edward S Dove; L Jonathan Dursi; Stephanie O M Dyke; James A Eddy; Karen Eilbeck; Kyle P Ellrott; Susan Fairley; Khalid A Fakhro; Helen V Firth; Michael S Fitzsimons; Marc Fiume; Paul Flicek; Ian M Fore; Mallory A Freeberg; Robert R Freimuth; Lauren A Fromont; Jonathan Fuerth; Clara L Gaff; Weiniu Gan; Elena M Ghanaim; David Glazer; Robert C Green; Malachi Griffith; Obi L Griffith; Robert L Grossman; Tudor Groza; Jaime M Guidry Auvil; Roderic Guigó; Dipayan Gupta; Melissa A Haendel; Ada Hamosh; David P Hansen; Reece K Hart; Dean Mitchell Hartley; David Haussler; Rachele M Hendricks-Sturrup; Calvin W L Ho; Ashley E Hobb; Michael M Hoffman; Oliver M Hofmann; Petr Holub; Jacob Shujui Hsu; Jean-Pierre Hubaux; Sarah E Hunt; Ammar Husami; Julius O Jacobsen; Saumya S Jamuar; Elizabeth L Janes; Francis Jeanson; Aina Jené; Amber L Johns; Yann Joly; Steven J M Jones; Alexander Kanitz; Kazuto Kato; Thomas M Keane; Kristina Kekesi-Lafrance; Jerome Kelleher; Giselle Kerry; Seik-Soon Khor; Bartha M Knoppers; Melissa A Konopko; Kenjiro Kosaki; Martin Kuba; Jonathan Lawson; Rasko Leinonen; Stephanie Li; Michael F Lin; Mikael Linden; Xianglin Liu; Isuru Udara Liyanage; Javier Lopez; Anneke M Lucassen; Michael Lukowski; Alice L Mann; John Marshall; Michele Mattioni; Alejandro Metke-Jimenez; Anna Middleton; Richard J Milne; Fruzsina Molnár-Gábor; Nicola Mulder; Monica C Munoz-Torres; Rishi Nag; Hidewaki Nakagawa; Jamal Nasir; Arcadi Navarro; Tristan H Nelson; Ania Niewielska; Amy Nisselle; Jeffrey Niu; Tommi H Nyrönen; Brian D O'Connor; Sabine Oesterle; Soichi Ogishima; Vivian Ota Wang; Laura A D Paglione; Emilio Palumbo; Helen E Parkinson; Anthony A Philippakis; Angel D Pizarro; Andreas Prlic; Jordi Rambla; Augusto Rendon; Renee A Rider; Peter N Robinson; Kurt W Rodarmer; Laura Lyman Rodriguez; Alan F Rubin; Manuel Rueda; Gregory A Rushton; Rosalyn S Ryan; Gary I Saunders; Helen Schuilenburg; Torsten Schwede; Serena Scollen; Alexander Senf; Nathan C Sheffield; Neerjah Skantharajah; Albert V Smith; Heidi J Sofia; Dylan Spalding; Amanda B Spurdle; Zornitza Stark; Lincoln D Stein; Makoto Suematsu; Patrick Tan; Jonathan A Tedds; Alastair A Thomson; Adrian Thorogood; Timothy L Tickle; Katsushi Tokunaga; Juha Törnroos; David Torrents; Sean Upchurch; Alfonso Valencia; Roman Valls Guimera; Jessica Vamathevan; Susheel Varma; Danya F Vears; Coby Viner; Craig Voisin; Alex H Wagner; Susan E Wallace; Brian P Walsh; Marc S Williams; Eva C Winkler; Barbara J Wold; Grant M Wood; J Patrick Woolley; Chisato Yamasaki; Andrew D Yates; Christina K Yung; Lyndon J Zass; Ksenia Zaytseva; Junjun Zhang; Peter Goodhand; Kathryn North; Ewan Birney
Journal:  Cell Genom       Date:  2021-11-10
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