Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.
Pediatr Res. 2024 Jul;96(1):81-88. doi: 10.1038/s41390-024-03094-7. Epub 2024 Mar 6.
Clinical and analytical information on laboratory data of neonates in scientific publications is sparse and incomplete. Furthermore, interpreting neonatal laboratory data can be complex due to their time-dependent and developmental physiology, and paucity of well-established age-appropriate reference ranges for neonates. This study aims to develop publication recommendations to report laboratory data of neonates to enhance the quality of these data in research and clinical care.
A modified Delphi approach was used to develop recommendations in cooperation with the International Neonatal Consortium. A Core Group, including different stakeholders, was responsible for developing the recommendations, in collaboration with a Reflection Group, responsible for providing additional input.
The recommendations were classified into three categories: 'Clinical Characteristics', 'Bio-analytical Information' and 'Data-analytical Information'. These were each divided into 'Core Data' (always to be reported) and 'Supplemental Considerations' (to be reported when considered relevant to the study).
Our recommendations provide guidance on standardization of neonatal laboratory data in publications. This will enhance the comparison, replication, and application of study results in research initiatives and clinical practice. Furthermore, these recommendations also serve as foundational work to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts.
Standardized reporting of neonatal laboratory data in scientific publications will enhance the comparison, replication, and application of study results in research initiatives and clinical practice, as well as improve reporting to regulatory agencies. To integrate multistakeholder perspectives, a modified Delphi approach was used to develop publication recommendations which strengthens the applicability of the recommendations. Implementation of standardization will likely improve the overall quality of neonatal clinical research and neonatal healthcare. In addition, these recommendations are foundational to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts.
科学出版物中关于新生儿实验室数据的临床和分析信息很少且不完整。此外，由于新生儿具有时间依赖性和发育生理学特点，且尚未建立完善的适用于各年龄段的参考范围，因此解读新生儿实验室数据可能较为复杂。本研究旨在制定报告新生儿实验室数据的发表建议，以提高这些数据在研究和临床护理中的质量。
采用改良 Delphi 法与国际新生儿联合会合作制定建议。核心小组由不同利益相关者组成，负责与负责提供额外意见的反思小组合作制定建议。
建议分为“临床特征”、“生物分析信息”和“数据分析信息”三类。每类又分为“核心数据”（必须报告）和“补充考虑因素”（认为与研究相关时报告）。
我们的建议为出版物中新生儿实验室数据的标准化提供了指导。这将增强研究计划和临床实践中研究结果的比较、复制和应用。此外，这些建议还为通过标准化此类工作所需的信息质量来制定新生儿实验室值参考范围奠定了基础。
科学出版物中新生儿实验室数据的标准化报告将增强研究计划和临床实践中研究结果的比较、复制和应用，同时也将改善向监管机构的报告。为了整合多利益相关者的观点，采用改良 Delphi 法制定发表建议，从而增强建议的适用性。标准化的实施可能会提高新生儿临床研究和新生儿保健的整体质量。此外，这些建议是通过标准化此类工作所需的信息质量来制定新生儿实验室值参考范围的基础。
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