TY - JOUR
T1 - Identifying the critically ill paediatric oncology patient
T2 - 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
AU - Soeteman, Marijn
AU - Kappen, Teus H
AU - van Engelen, Martine
AU - Kilsdonk, Ellen
AU - Koomen, Erik
AU - Nieuwenhuis, Edward E S
AU - Tissing, Wim J E
AU - Fiocco, Marta
AU - van den Heuvel-Eibrink, Marry
AU - Wösten-van Asperen, Roelie M
N1 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021/5/19
Y1 - 2021/5/19
N2 - 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 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).
AB - 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 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).
KW - Case-Control Studies
KW - Child
KW - Cohort Studies
KW - Critical Illness
KW - Humans
KW - Intensive Care Units, Pediatric
KW - Neoplasms/diagnosis
KW - Netherlands
KW - Observational Studies as Topic
KW - Prospective Studies
KW - Retrospective Studies
UR - http://www.scopus.com/inward/record.url?scp=85106555493&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-046360
DO - 10.1136/bmjopen-2020-046360
M3 - Article
C2 - 34011596
SN - 2044-6055
VL - 11
SP - e046360
JO - BMJ open
JF - BMJ open
IS - 5
M1 - e046360
ER -