Development of a core outcome set for pediatric critical care outcomes research.
Adolescent
Child
Child, Preschool
Critical Illness
/ therapy
Delphi Technique
Endpoint Determination
Female
Guidelines as Topic
Humans
Infant
Intensive Care Units, Pediatric
/ organization & administration
Male
Outcome Assessment, Health Care
/ organization & administration
Research Design
Stakeholder Participation
Clinical research
Core outcomes set
Critical illness
Morbidity
Pediatrics
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
22
11
2019
revised:
19
02
2020
accepted:
22
02
2020
pubmed:
10
3
2020
medline:
5
8
2021
entrez:
10
3
2020
Statut:
ppublish
Résumé
Pediatric 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. A 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. The 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. COMET database (http://www.comet-initiative.org/, Record ID 1131, 01/01/18).
Sections du résumé
BACKGROUND
Pediatric 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.
METHODS
A 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.
DISCUSSION
The 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 REGISTRATION
COMET database (http://www.comet-initiative.org/, Record ID 1131, 01/01/18).
Identifiants
pubmed: 32147572
pii: S1551-7144(20)30046-X
doi: 10.1016/j.cct.2020.105968
pmc: PMC7313715
mid: NIHMS1585821
pii:
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
105968Subventions
Organisme : NICHD NIH HHS
ID : RL1 HD107773
Pays : United States
Organisme : NHLBI NIH HHS
ID : L30 HL143674
Pays : United States
Organisme : NICHD NIH HHS
ID : U01 HD049934
Pays : United States
Organisme : NICHD NIH HHS
ID : K23 HD096018
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD050096
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare not competing interests.
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