Identifying the critically ill paediatric oncology patient: a study protocol for a prospective observational cohort study for validation of a modified Bedside Paediatric Early Warning System score in hospitalised paediatric oncology patients
Soeteman, Marijn; Kappen, Teus H; van Engelen, Martine; Kilsdonk, Ellen; Koomen, Erik; Nieuwenhuis, Edward E S; Tissing, Wim J E; Fiocco, Marta; van den Heuvel-Eibrink, Marry; Wösten-van Asperen, Roelie M
(2021) BMJ Open, volume 11, issue 5
(Article)
Abstract
INTRODUCTION: Hospitalised paediatric oncology patients are at risk to develop acute complications. Early identification of clinical deterioration enabling adequate escalation of care remains challenging. Various Paediatric Early Warning Systems (PEWSs) have been evaluated, also in paediatric oncology patients but mostly in retrospective or case-control study designs. This study protocol encompasses
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the first prospective cohort with the aim of evaluating the predictive performance of a modified Bedside PEWS score for non-elective paediatric intensive care unit (PICU) admission or cardiopulmonary resuscitation in hospitalised paediatric oncology patients. METHODS AND ANALYSIS: A prospective cohort study will be conducted at the 80-bed Dutch paediatric oncology hospital, where all national paediatric oncology care has been centralised, directly connected to a shared 22-bed PICU. All patients between 1 February 2019 and 1 February 2021 admitted to the inpatient nursing wards, aged 0-18 years, with an International Classification of Diseases for Oncology (ICD-O) diagnosis of paediatric malignancy will be eligible. A Cox proportional hazard regression model will be used to estimate the association between the modified Bedside PEWS and time to non-elective PICU transfer or cardiopulmonary arrest. Predictive performance (discrimination and calibration) will be assessed internally using resampling validation. To account for multiple occurrences of the event of interest within each patient, the unit of study is a single uninterrupted ward admission (a clinical episode). ETHICS AND DISSEMINATION: The study protocol has been approved by the institutional ethical review board of our hospital (MEC protocol number 16-572/C). We adapted our enrolment procedure to General Data Protection Regulation compliance. Results will be disseminated at scientific conferences, regional educational sessions and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NL8957).
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Keywords: paediatric intensive & critical care, paediatric oncology, risk management, General Medicine, Journal Article
ISSN: 2044-6055
Publisher: BMJ Publishing Group
Note: Funding Information: Contributors MvE, RMW-vA and THK: designed the study concept. MS, MvE, MvdH-E, THK, EKi, EKo and RMW-vA: major contributors in writing the clinical protocol, related documents and the set-up of the study. MS, EESN, WJET, THK, MF, MvdH-E and RMW-vA: contributed to the manuscript drafting and manuscript revision for important intellectual content. All authors read and approved the final manuscript. Funding This study is supported by KiKa, grant number 287. Competing interests None declared. Publisher Copyright: © 2020 American Society of Mechanical Engineers (ASME). All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
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