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COVID-19 大流行对低收入、中等收入和高收入国家儿童癌症患者的影响:一项多中心、国际、观察性队列研究方案。

Impact of the COVID-19 pandemic on paediatric patients with cancer in low-income, middle-income and high-income countries: protocol for a multicentre, international, observational cohort study.

机构信息

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.

出版信息

BMJ Open. 2021 Jun 2;11(6):e045679. doi: 10.1136/bmjopen-2020-045679.

DOI:10.1136/bmjopen-2020-045679
PMID:34083337
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8182746/
Abstract

INTRODUCTION

Childhood cancers are a leading cause of non-communicable disease deaths for children around the world. The COVID-19 pandemic may have impacted on global children's cancer services, which can have consequences for childhood cancer outcomes. The Global Health Research Group on Children's Non-Communicable Diseases is currently undertaking the first international cohort study to determine the variation in paediatric cancer management during the COVID-19 pandemic, and the short-term to medium-term impacts on childhood cancer outcomes.

METHODS AND ANALYSIS

This is a multicentre, international cohort study that will use routinely collected hospital data in a deidentified and anonymised form. Patients will be recruited consecutively into the study, with a 12-month follow-up period. Patients will be included if they are below the age of 18 years and undergoing anticancer treatment for the following cancers: acute lymphoblastic leukaemia, Burkitt lymphoma, Hodgkin lymphoma, Wilms tumour, sarcoma, retinoblastoma, gliomas, medulloblastomas and neuroblastomas. Patients must be newly presented or must be undergoing active anticancer treatment from 12 March 2020 to 12 December 2020. The primary objective of the study was to determine all-cause mortality rates of 30 days, 90 days and 12 months. This study will examine the factors that influenced these outcomes. χ analysis will be used to compare mortality between low-income and middle-income countries and high-income countries. Multilevel, multivariable logistic regression analysis will be undertaken to identify patient-level and hospital-level factors affecting outcomes with adjustment for confounding factors.

ETHICS AND DISSEMINATION

At the host centre, this study was deemed to be exempt from ethical committee approval due to the use of anonymised registry data. At other centres, participating collaborators have gained local approvals in accordance with their institutional ethical regulations. Collaborators will be encouraged to present the results locally, nationally and internationally. The results will be submitted for publication in a peer-reviewed journal.

摘要

简介

儿童癌症是全球儿童非传染性疾病死亡的主要原因。COVID-19 大流行可能对全球儿童癌症服务产生影响,这可能对儿童癌症结局产生影响。全球儿童非传染性疾病健康研究小组目前正在进行第一项国际队列研究,以确定 COVID-19 大流行期间儿科癌症管理的变化,以及对儿童癌症结局的短期至中期影响。

方法和分析

这是一项多中心国际队列研究,将使用匿名和匿名形式的常规收集的医院数据。患者将连续招募入组,随访期为 12 个月。如果患者年龄在 18 岁以下,并且正在接受以下癌症的抗癌治疗,将纳入本研究:急性淋巴细胞白血病、伯基特淋巴瘤、霍奇金淋巴瘤、肾母细胞瘤、肉瘤、视网膜母细胞瘤、神经胶质瘤、髓母细胞瘤和神经母细胞瘤。患者必须是新出现的,或者必须在 2020 年 3 月 12 日至 2020 年 12 月 12 日期间接受积极的抗癌治疗。本研究的主要目的是确定 30 天、90 天和 12 个月的全因死亡率。本研究将研究影响这些结果的因素。χ 分析将用于比较低收入和中等收入国家与高收入国家的死亡率。将进行多水平、多变量逻辑回归分析,以确定影响结局的患者水平和医院水平因素,并对混杂因素进行调整。

伦理和传播

在主办中心,由于使用匿名登记数据,该研究被认为免于伦理委员会批准。在其他中心,参与的合作者已根据其机构伦理法规获得了当地批准。合作者将被鼓励在当地、国家和国际上介绍研究结果。研究结果将提交给同行评议的期刊发表。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f52/8182746/45bd8efb61b1/bmjopen-2020-045679f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f52/8182746/b698442f96a4/bmjopen-2020-045679f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f52/8182746/45bd8efb61b1/bmjopen-2020-045679f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f52/8182746/b698442f96a4/bmjopen-2020-045679f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f52/8182746/45bd8efb61b1/bmjopen-2020-045679f02.jpg

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