Wooldridge Gavin, Murthy Srinivas, Kissoon Niranjan
Pediatric Critical Care, BC Children's Hospital, Vancouver, British Columbia, Canada
Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.
BMJ Open. 2020 Apr 6;10(4):e034960. doi: 10.1136/bmjopen-2019-034960.
Sepsis is the leading cause of death in children worldwide and has recently been declared a major global health issue. New interventions and a concerted effort to enhance our understanding of sepsis are required to address the huge burden of disease, especially in low- and middle-income countries (LMIC) where it is highest. An opportunity therefore exists to ensure that ongoing research in this area is relevant to all stakeholders and is of consistently high quality. One method to address these issues is through the development of a core outcome set (COS).
This study protocol outlines the phases in the development of a core outcome set for paediatric sepsis in LMIC. The first step involves performing a systematic review of all outcomes reported in the research of paediatric sepsis in low middle-income countries. A three-stage international Delphi process will then invite a broad range of participants to score each generated outcome for inclusion into the COS. This will include an initial two-step online survey and finally, a face-to-face consensus meeting where each outcome will be reviewed, voted on and ratified for inclusion into the COS.
No core outcome sets exist for clinical trials in paediatric sepsis. This COS will serve to not only highlight the heavy burden of paediatric sepsis in this setting and aid collaboration and participation between all stakeholders, but to promote ongoing essential high quality and relevant research into the topic. A COS in paediatric sepsis in LMIC will advocate for a common language and facilitate interpretation of findings from a variety of settings. A waiver for ethics approval has been granted by University of British Columbia Children's and Women's Research Ethics Board.
脓毒症是全球儿童死亡的主要原因，最近已被宣布为一个重大的全球健康问题。需要新的干预措施以及共同努力来加深我们对脓毒症的理解，以应对巨大的疾病负担，特别是在负担最重的低收入和中等收入国家（LMIC）。因此，有机会确保该领域正在进行的研究与所有利益相关者相关且质量始终很高。解决这些问题的一种方法是通过制定核心结局集（COS）。
本研究方案概述了在低收入和中等收入国家制定儿童脓毒症核心结局集的各个阶段。第一步是对低收入和中等收入国家儿童脓毒症研究中报告的所有结局进行系统评价。然后，一个三阶段的国际德尔菲过程将邀请广泛的参与者对每个生成的结局进行评分，以纳入核心结局集。这将包括最初的两步在线调查，最后是一次面对面的共识会议，在会上将对每个结局进行审查、投票并批准纳入核心结局集。
儿童脓毒症临床试验尚无核心结局集。这个核心结局集不仅将突出这种情况下儿童脓毒症的沉重负担，并有助于所有利益相关者之间的合作与参与，而且还将促进对该主题持续进行必要的高质量和相关研究。低收入和中等收入国家儿童脓毒症的核心结局集将倡导使用共同语言，并便于解释来自各种环境的研究结果。英属哥伦比亚大学儿童与妇女研究伦理委员会已批准豁免伦理审查。
