The publication quality of laboratory values in clinical studies in neonates

Allegaert, Karel; Hildebrand, Heidrun; Singh, Kanwaljit; Turner, Mark A.

doi:10.1038/s41390-022-02385-1

Cited by 5 publications

(4 citation statements)

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“…Specifically, AEs based on laboratory values are considered an important gap of the current version of INC NAESS. As recently reported, there are however no generally accepted, actionable reference values for commonly used laboratory values in neonates, while published information on lab values in neonates is sparse, not systematic and incomplete ( Allegaert et al, 2022 ). Data driven approaches are needed to define normality and levels of abnormality (severity grades) in the term and preterm neonatal population.…”

Section: Discussionmentioning

confidence: 99%

“…The generic criteria on the other hand are on purpose very broad and require some interpretation. The current and first version of INC NAESS contains specific severity criteria for 35 common neonatal adverse events, which were chosen based on a stakeholder survey (Salaets et al, 2019) (Allegaert et al, 2022). Data driven approaches are needed to define normality and levels of abnormality (severity grades) in the term and preterm neonatal population.…”

Section: Figurementioning

confidence: 99%

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Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale

Salaets,

Lacaze-Masmonteil,

Hokuto

et al. 2023

Front. Pharmacol.

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Introduction: To ensure the quality of clinical trial safety data, universal data standards are required. In 2019 the International Neonatal Consortium (INC) published a neonatal adverse event severity scale (NAESS) to standardize the reporting of adverse event (AE) severity. In this study the reliability of AE severity grading with INC NAESS was prospectively assessed in a real-world setting.Methods: Severity of AEs was assessed by two independent observers at each of four centers across the world. In each center two series of 30 neonatal adverse events were assessed by both observers: in a first phase with a generic (Common Terminology Criteria for Adverse Events, CTCAE) severity scale not specific to neonates, and in a second phase with INC NAESS (after a structured training). Intraclass correlation coefficients (ICC) were calculated to express inter-rater agreement in both phases, and bootstrap sampling was used to compare them.Results: 120 AEs were included in each of both phases. The ICC with the use of INC NAESS in phase 2 was 0.69. This represents a significant but modest improvement in comparison to the initial ICC of 0.66 in phase 1 (confidence interval of ratio of ICC in phase 2 to phase 1 = 1.005–1.146; excludes 1). The ICC was higher for those AEs for which a diagnosis specific AE severity table was available in INC NAESS (ICC 0.80).Discussion: Good inter-rater reliability of the INC NAESS was demonstrated in four neonatal intensive care units (NICUs) across the globe. The ICC is comparable to what is reported for scales with similar purposes in different populations. There is a modest, but significant, improvement in inter-rater agreement in comparison to the naïve phase without INC NAESS. The better performance when reviewers use AE-specific NAESS tables highlights the need to expand the number of AEs that are covered by specific criteria in the current version of INC NAESS.

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Section: Discussionmentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale

Salaets,

Lacaze-Masmonteil,

Hokuto

et al. 2023

Front. Pharmacol.

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“…Furthermore, the scale also has a generic neonatal AE severity grading table that uses criteria relevant to neonates to define severity of any other possible AE. Laboratory values were not considered in this initial tool, as reference or normal values are still poorly described, another area in need for further development ( 8 ).…”

Section: Steps Taken To Develop the Neonatal Adverse Event Severity (...mentioning

confidence: 99%

“…This is because lab values in other populations are commonly assessed during severity scoring. However, there is no standards for reporting laboratory values in neonates and the publication quality of laboratory values in clinical studies in neonates turned out to be sparse, not systematic and incomplete ( 8 ). Once a standard reference range for lab values is available, then we intend to apply this standard to large pooled real world datasets of laboratory values collected by the INC. To involve the users in the prioritization, requests to add a new AE or to adapt some of the scales in this NAEES document can therefore be filed through a Thesaurus link ( https://ncitermform.nci.nih.gov/ncitermform/?dictionary=NCI%20Thesaurus ).…”

Section: Future Perspectivesmentioning

confidence: 99%

The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives

Allegaert,

Salaets,

Wade

et al. 2024

Front. Pediatr.

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To support informed decisions on drug registration and prescription, clinical trials need tools to assess the efficacy and safety signals related to a given therapeutic intervention. Standardized assessment facilitates reproducibility of results. Furthermore, it enables weighted comparison between different interventions, instrumental to facilitate shared decisions. When focused on adverse events in clinical trials, tools are needed to assess seriousness, causality and severity. As part of such a toolbox, the international Neonatal Consortium (INC) developed a first version of the neonatal adverse event severity scale (NAESS). This version underwent subsequent validation in retro-and prospective trials to assess its applicability and impact on the inter-observer variability. Regulators, sponsors and academic researchers also reported on the use of the NAESS in regulatory documents, trial protocols and study reports. In this paper, we aim to report on the trajectory, current status and impact of the NAESS score, on how stakeholders within INC assess its relevance, and on perspectives to further develop this tool.

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Publication Recommendations to Report Laboratory Data of Neonates – a Modified Delphi Approach

Vander Elst,

Hildebrand,

Short

et al. 2024

Pediatr Res

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Background 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. Methods 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. Results 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). Conclusion 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. Impact 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.

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The publication quality of laboratory values in clinical studies in neonates

Cited by 5 publications

References 5 publications

Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale

Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale

The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives

Publication Recommendations to Report Laboratory Data of Neonates – a Modified Delphi Approach

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