학술논문
Development of a core outcome set for pediatric critical care outcomes research
Document Type
article
Author
Fink, Ericka L; Jarvis, Jessica M; Maddux, Aline B; Pinto, Neethi; Galyean, Patrick; Olson, Lenora M; Zickmund, Susan; Ringwood, Melissa; Sorenson, Samuel; Dean, J Michael; Carcillo, Joseph A; Berg, Robert A; Zuppa, Athena; Pollack, Murray M; Meert, Kathleen L; Hall, Mark W; Sapru, Anil; McQuillen, Patrick S; Mourani, Peter M; Watson, R Scott; Investigators, and the Pediatric Acute Lung Injury and Sepsis Investigators Long-term Outcomes Subgroup; Network, the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research
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Subject
Language
Abstract
BackgroundPediatric Intensive Care Unit (PICU) teams provide care for critically ill children with diverse and often complex medical and surgical conditions. Researchers often lack guidance on an approach to select the best outcomes when evaluating this critically ill population. Studies would be enhanced by incorporating multi-stakeholder preferences to better evaluate clinical care. This manuscript outlines the methodology currently being used to develop a PICU Core Outcome Set (COS). This PICU COS utilizes mixed methods, an inclusive stakeholder approach, and a modified Delphi consensus process that will serve as a resource for PICU research programs.MethodsA Scoping Review of the PICU literature evaluating outcomes after pediatric critical illness, a qualitative study interviewing PICU survivors and their parents, and other relevant literature will serve to inform a modified, international Delphi consensus process. The Delphi process will derive a set of minimum domains for evaluation of outcomes of critically ill children and their families. Delphi respondents include researchers, multidisciplinary clinicians, families and former patients, research funding agencies, payors, and advocates. Consensus meetings will refine and finalize the domains of the COS, outline a battery instruments for use in future studies, and prepare for extensive dissemination for broad implementation.DiscussionThe PICU COS will be a guideline resource for investigators to assure that outcomes most important to all stakeholders are considered in PICU clinical research in addition to those deemed most important to individual scientists.Trial registrationCOMET database (http://www.comet-initiative.org/, Record ID 1131, 01/01/18).