Neethi P Pinto1,2, Aline B Maddux3, Leslie A Dervan4, Alan G Woodruff5, Jessica M Jarvis6, Sholeen Nett7, Elizabeth Y Killien4, Robert J Graham8, Karen Choong9, Peter M Luckett10,11, Julia A Heneghan12, Katherine Biagas13, Erin F Carlton14,15, Mary E Hartman16, Lauren Yagiela17,18, Kelly N Michelson19,20, Joseph C Manning21,22, Debbie A Long23, Jan Hau Lee24, Beth S Slomine25,26, Sue R Beers27, Trevor Hall28, Brenda M Morrow29, Kathleen Meert17,18, Maria Del Pilar Arias Lopez30, Hennie Knoester31, Amy Houtrow32, Lenora Olson33, Lisa Steele34, Luregn J Schlapbach35,36, Randall S Burd37, Ruth Grosskreuz38, Warwick Butt39, Ericka L Fink40, R Scott Watson4. 1. Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA. 2. Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA. 3. Department of Pediatrics, Section of Critical Care Medicine, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO. 4. Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Washington and Seattle Children's, Seattle, WA. 5. Department of Anesthesiology, Section of Pediatric Critical Care Medicine, Wake Forest School of Medicine, Winston Salem, NC. 6. Department of Physical Medicine and Rehabilitation, Division of Pediatric Rehabilitation Medicine, University of Pittsburgh, Pittsburgh, PA. 7. Department of Pediatrics, Section of Critical Care Medicine, Dartmouth Hitchcock Medical Center, Lebanon, NH. 8. Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA. 9. Departments of Pediatrics, Critical Care, Health Evidence and Impact, McMaster University, Hamilton, ON, Canada. 10. Department of Pediatrics, UT Southwestern Medical Center, Dallas, TX. 11. Division of Pediatric Critical Care Medicine, Children's Health, Dallas, TX. 12. Division of Critical Care, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis, MN. 13. Department of Pediatrics, Division of Pediatric Critical Care Medicine, The Renaissance School of Medicine at Stony Brook University and the Stony Brook Children's Hospital, Stony Brook, NY. 14. Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI. 15. Susan B. Meister Child Health Evaluation and Research Center, Department of Pediatrics, University of Michigan, Ann Arbor, MI. 16. Division of Pediatric Critical Care Medicine, Department of Pediatrics, Washington University in St. Louis, St. Louis, MO. 17. Division of Critical Care, Department of Pediatrics, Children's Hospital of Michigan, Detroit, MI. 18. Department of Pediatrics, Central Michigan University, Mount Pleasant, MI. 19. Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL. 20. Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL. 21. Centre for Children and Young People Health Research, School of Health Sciences, University of Nottingham, Nottingham, United Kingdom. 22. Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom. 23. School of Nursing, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, QLD, Australia. 24. Children's Intensive Care Unit, KK Women's and Children's Hospital, Singapore. 25. Department of Neuropsychology, Kennedy Krieger Institute, Baltimore, MD. 26. Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD. 27. Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA. 28. Department of Pediatrics, Division of Pediatric Psychology, Pediatric Critical Care and Neurotrauma Recovery Program, Oregon Health & Science University, Portland, OR. 29. Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa. 30. Department of Pediatric Critical Care, Hospital de Niños Ricardo Gutierrez, SATI-Q Program, Argentine Society of Intensive Care, Buenos Aires, Argentina. 31. Pediatric Intensive Care Unit, Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, The Netherlands. 32. Department of Physical Medicine & Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA. 33. Department of Pediatrics, University of Utah, Salt Lake City, UT. 34. Research Institute, Nationwide Children's Hospital, Columbus, OH. 35. Department of Intensive Care and Neonatology, Children`s Research Center, University Children`s Hospital Zurich, Zurich, Switzerland. 36. Department of Intensive Care and Neonatology, Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia. 37. Division of Trauma and Burn Surgery, Center for Surgical Care, Children's National Hospital, Washington, DC. 38. Research Institute, Children's Hospital Colorado, Aurora, CO. 39. Intensive Care Unit, Royal Children's Hospital Melbourne, Melbourne, VIC, Australia. 40. Department of Critical Care Medicine, Division of Pediatric Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.
Abstract
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.
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.