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Core outcomes and definitions for pediatric fever and neutropenia research: a consensus statement from an
Gabrielle M Haeusler1, Robert S Phillips, Thomas Lehrnbecher
1Department of Infectious Diseases and Infection Control, Peter MacCallum Cancer Centre, Melbourne, Australia; Department of Infectious Diseases, Monash Children's Hospital, Monash Health, Melbourne, Australia; Paediatric Integrated Cancer Service, Victoria, Australia.
Insights
Researchers established core variables and outcomes for pediatric fever and neutropenia (FN) studies. This consensus aims to standardize reporting, improving data comparability and collaboration in clinical research.
Area of Science:
- Pediatric Oncology
- Infectious Diseases
- Clinical Research Methodology
Background:
- Lack of standardized reporting in pediatric fever and neutropenia (FN) studies leads to heterogeneity.
- Inconsistent variables and outcomes hinder research comparison and data synthesis.
- Emerging definitions further complicate the landscape of pediatric FN research.
Purpose of the Study:
- To achieve expert consensus on essential variables and outcomes for pediatric FN studies.
- To establish a minimum standard for data collection and reporting in this field.
- To address the heterogeneity in current research designs and reporting practices.
Main Methods:
- Utilized the Delphi method with an international expert panel.
- Administered four electronic surveys to gather input on variables, outcomes, and definitions.
- Achieved consensus based on over 80% agreement on survey statements.
Main Results:
- Forty-five participants contributed, with response rates between 84-96%.
- Consensus was reached on eight core variables and 10 core outcomes for pediatric FN studies.
- Consensus definitions were established for all identified core outcomes.
Conclusions:
- Expert consensus was achieved on a core set of variables, outcomes, and definitions for pediatric FN studies.
- These core elements represent the minimum standard for data collection and reporting.
- Implementation will enhance collaboration, consistency, and comparability across studies.
Background:
There are no specific recommendations for the design and reporting of studies of children with fever and neutropenia (FN). As a result, there is marked heterogeneity in the variables and outcomes that are reported and new definitions continue to emerge. These inconsistencies hinder the ability of researchers and clinicians to compare, contrast and combine results. The objective was to achieve expert consensus on a core set of variables and outcomes that should be measured and reported, as a minimum, in pediatric FN studies.
Procedure:
The Delphi method was used to achieve consensus among an international group of clinicians, pharmacists, researchers, and patient representatives. Four surveys focusing on (i) the identification of a core set of variables and outcomes; and (ii) definitions of these variables and outcomes, were administered electronically. Consensus was predefined as more than 80% agreement on any statement.
Results:
There were forty-five survey participants and the response rate ranged between 84 and 96%. There was consensus on eight core variables and 10 core outcomes that should be collected and reported in all studies of children with FN. Consensus definitions were identified for all of the core outcomes.
Conclusion:
Using the Delphi method, expert consensus on a set of core variables and outcomes, and their corresponding definitions, was achieved. These core sets represent the minimum that should be collected and reported in all studies of children with FN. This will promote collaboration and ensure consistency and comparability between studies.
