Abstract

Standardized collection of predictors of pediatric sepsis has enormous potential to increase data compatibility across research studies. The Pediatric Sepsis Predictor Standardization Working Group collaborated to define common data elements for pediatric sepsis predictors at the point of triage to serve as a standardized framework for data collection in resource-limited settings. A preliminary list of pediatric sepsis predictor variables was compiled through a systematic literature review and examination of global guideline documents. A 5-round modified Delphi that involved independent voting and active group discussions was conducted to select, standardize, and prioritize predictors. Considerations included the perceived predictive value of the candidate predictor at the point of triage, intra- and inter-rater measurement reliability, and the amount of time and material resources required to reliably collect the predictor in resource-limited settings. We generated 116 common data elements for implementation in future studies. Each common data element includes a standardized prompt, suggested response values, and prioritization as tier 1 (essential), tier 2 (important), or tier 3 (exploratory). Branching logic was added to the predictors list to facilitate the design of efficient data collection methods, such as low-cost electronic case report forms on a mobile application. The set of common data elements are freely available on the Pediatric Sepsis CoLab Dataverse and a web-based feedback survey is available through the Pediatric Sepsis CoLab. Updated iterations will continuously be released based on feedback from the pediatric sepsis research community and emergence of new information. Routine use of the common data elements in future studies can allow data sharing between studies and contribute to development of powerful risk prediction algorithms. These algorithms may then be used to support clinical decision making at triage in resource-limited settings. Continued collaboration, engagement, and feedback from the pediatric sepsis research community will be important to ensure the common data elements remain applicable across a broad range of geographical and sociocultural settings.

Highlights

  • Sepsis is life-threatening organ dysfunction due to a dysregulated host response to infection [1]

  • Routine use of the common data elements in future studies can allow data sharing between studies and contribute to development of powerful risk prediction algorithms. These algorithms may be used to support clinical decision making at triage in resource-limited settings

  • Engagement, and feedback from the pediatric sepsis research community will be important to ensure the common data elements remain applicable across a broad range of geographical and sociocultural settings

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Summary

Introduction

Sepsis is life-threatening organ dysfunction due to a dysregulated host response to infection [1]. In recognizing the enormity of the global burden of sepsis in terms of mortality, morbidity, and social and economic consequences, the World Health Assembly, the decisionmaking body for the World Health Organization highlighted the urgent need for strengthened efforts to identify, prevent, and treat sepsis [3]. Coordination, and timely identification of critically ill (or at risk of becoming critically ill) children has been recognized as cornerstone in the efforts to improve sepsis outcomes [4,5]. The importance of powerful data driven prediction algorithms is underlined by the fact that they can be used by healthcare workers with less experience and training, a common scenario in resource-limited settings where the burden of sepsis is highest. The Pediatric Sepsis Predictor Standardization Working Group collaborated to define common data elements for pediatric sepsis predictors at the point of triage to serve as a standardized framework for data collection in resourcelimited settings

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