Core outcome set in paediatric sepsis in low- and middle-income countries: a study protocol
Core outcome set in paediatric sepsis in low- and middle-income countries: a study protocol
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DOI：
10.1136/bmjopen-2019-034960
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发表时间：
2020-04-01
期刊：
影响因子：
2.9
通讯作者：
Kissoon, Niranjan
中科院分区：
文献类型：
--
作者：
Wooldridge, Gavin;Murthy, Srinivas;Kissoon, Niranjan
脓毒症是全球儿童死亡的主要原因，最近已被宣布为一个主要的全球健康问题。需要新的干预措施和协调一致的努力来提高我们对脓毒症的理解，以解决疾病的巨大负担，特别是在低收入和中等收入国家（LMIC），这是最高的。因此，有机会确保这一领域正在进行的研究与所有利益攸关方相关，并始终保持高质量。解决这些问题的一种方法是通过开发一个核心结果集（COS）。方法和分析本研究方案概述了在LMIC的儿科败血症的核心结果集的发展阶段。第一步是对中低收入国家儿科败血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产生的结果进行评分，以纳入COS。这将包括最初的两步在线调查，最后是面对面的共识会议，每个结果将被审查，投票并批准纳入COS。伦理和传播儿科败血症临床试验没有核心结果集。该COS不仅将突出儿童脓毒症在这种情况下的沉重负担，并帮助所有利益相关者之间的合作和参与，而且将促进对该主题进行持续的高质量和相关研究。LMIC儿科败血症的COS将倡导一种共同的语言，并促进对各种情况下发现的解释。不列颠哥伦比亚省儿童和妇女研究伦理委员会已批准豁免伦理审批。
Introduction 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).Methods and analysis 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.Ethics and dissemination 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.