Division of Pediatric Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, 4401 Penn Avenue, Faculty Pavilion, 2nd floor, Pittsburgh, PA 15224, United States of America.
Department of Physical Medicine and Rehabilitation, University of Pittsburgh, Kaufmann Medical Building, Suite 910, 3471 Fifth Avenue, Pittsburgh, PA, United States of America.
Contemp Clin Trials. 2020 Apr;91:105968. doi: 10.1016/j.cct.2020.105968. Epub 2020 Mar 5.
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).
儿科重症监护病房（PICU）团队为患有各种复杂疾病的重症儿童提供治疗。研究人员在评估这一重症患者群体时，往往缺乏选择最佳结果的方法指导。如果在研究中纳入多利益相关者的偏好，将会提高研究水平，从而更好地评估临床护理。本文概述了目前正在用于制定儿科重症监护病房核心结局集（COS）的方法。该 PICU COS 采用混合方法、包容性利益相关者方法和经过修改的 Delphi 共识流程，将作为儿科重症监护病房研究计划的资源。
对评估儿科危重病后结局的儿科重症监护病房文献进行了范围综述，对儿科重症监护病房幸存者及其父母进行了定性研究访谈，并对其他相关文献进行了研究，为经过修改的国际 Delphi 共识流程提供了信息。Delphi 流程将得出一组用于评估重症儿童及其家庭结局的最小评估领域。Delphi 调查对象包括研究人员、多学科临床医生、患者及其家属、研究资助机构、支付方和倡导者。共识会议将完善和敲定 COS 的领域，概述一套用于未来研究的工具包，并为广泛实施做好广泛传播的准备。
PICU COS 将成为研究人员的指南资源，以确保在儿科重症监护病房的临床研究中考虑到所有利益相关者认为最重要的结果，而不仅仅是个别科学家认为最重要的结果。
COMET 数据库（http://www.comet-initiative.org/，记录 ID 1131，01/01/18）。
