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Core outcome set in paediatric sepsis in low- and middle-income countries: a study protocol
Gavin Wooldridge1, Srinivas Murthy2, Niranjan Kissoon2
1Pediatric Critical Care, BC Children's Hospital, Vancouver, British Columbia, Canada gfwooldridge@gmail.com.
Insights
Developing a core outcome set (COS) for pediatric sepsis in low- and middle-income countries (LMIC) is crucial. This standardized approach will improve research quality and collaboration for this leading cause of child mortality.
Area of Science:
- Global Health
- Pediatric Critical Care
- Clinical Trial Methodology
Background:
- Sepsis is the leading cause of mortality in children globally, disproportionately affecting low- and middle-income countries (LMIC).
- There is a critical need for enhanced understanding and improved interventions for pediatric sepsis, particularly in resource-limited settings.
- A standardized approach is required to ensure research quality and relevance for all stakeholders involved in pediatric sepsis.
Purpose of the Study:
- To outline the protocol for developing a core outcome set (COS) for pediatric sepsis research in LMIC.
- To establish a consensus on essential outcomes for clinical trials involving pediatric sepsis in LMIC.
- To promote high-quality, relevant research and facilitate interpretation of findings across diverse settings.
Main Methods:
- Conducting a systematic review of outcomes reported in pediatric sepsis research in LMIC.
- Implementing a three-stage international Delphi process involving a broad range of stakeholders.
- Utilizing a two-step online survey followed by a face-to-face consensus meeting for outcome ratification.
Main Results:
- The study protocol details the systematic development of a COS for pediatric sepsis in LMIC.
- A multi-stage Delphi process will be employed to achieve consensus on core outcomes.
- Ethical approval waiver granted by the University of British Columbia Children's and Women's Research Ethics Board.
Conclusions:
- The developed COS will provide a common language for pediatric sepsis research in LMIC.
- This initiative aims to improve the quality, relevance, and comparability of clinical trials.
- The COS will support collaboration and enhance the interpretation of research findings in global child health settings.
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.
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