Core outcome set in paediatric sepsis in low- and middle-income countries: a study protocol

Abstract

IntroductionSepsis 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 analysisThis 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 disseminationNo 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.

A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study

“…Another limitation in our study is that, although we sought to recruit participants internationally, a majority of the respondents were from Europe and North America, similar to other COSs 93 . Although this has not been formally evaluated, others have suggested translating surveys into different languages and having a facilitator engage with stakeholders (particularly patients) during the eDelphi process to improve engagement with low-and middleincome country (LMIC) participants 94 . However, the outcomes listed in the final COS (table 1) are for the most part easily measured and recorded globally.…”

Core outcome sets in intensive care–what are they and why do we need them? An example for delirium

“…14 Most recently published are a COS for paediatric critical care 15 and two for COVID-19 trials. 16,17 Several other protocols of COS have been published that are relevant to adult and paediatric critical care 18,19 including our own protocol for a delirium COS. 20 This COS is now complete and published in Critical Care Medicine. 21 In this special issue of the journal, there are three research studies, one integrative review, and a quality improvement project focused on delirium, emphasizing the importance of this topic among the journal's readership.…”

“…Most recently published are a COS for paediatric critical care 15 and two for COVID‐19 trials 16,17 . Several other protocols of COS have been published that are relevant to adult and paediatric critical care 18,19 including our own protocol for a delirium COS 20 . This COS is now complete and published in Critical Care Medicine 21 …”

Common data elements for predictors of pediatric sepsis: A framework to standardize data collection

“…The Pediatric Sepsis Predictor Standardization (PS2) working group, a subgroup within the Pediatric Sepsis CoLab, has collaborated to develop a set of common data elements for predictors of pediatric sepsis at the point of triage in resource-limited settings. Standardized outcomes are being addressed by a related working group [ 9 , 10 ]. Routine use of the framework within the pediatric sepsis research community would promote an environment of collaboration, improve compatibility of datasets across studies, and yield robust, high quality sources of data that can be used to develop powerful risk prediction algorithms and support clinical decision making.…”