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低危发热性中性粒细胞减少症患儿治疗减量的系统评价方案

Protocol for a systematic review of reductions in therapy for children with low-risk febrile neutropenia.

作者信息

Morgan Jessica E, Stewart Lesley, Phillips Robert S

机构信息

Centre for Reviews and Dissemination, University of York, York, UK.

出版信息

Syst Rev. 2014 Oct 21;3:119. doi: 10.1186/2046-4053-3-119.

DOI:10.1186/2046-4053-3-119
PMID:25336249
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4234526/
Abstract

BACKGROUND

Febrile neutropenia is a common complication of therapy in children with cancer. Some patients are at low risk of complications, and research has considered reduction in therapy for these patients. A previous systematic review broadly considered whether outpatient treatment and oral antibiotics were safe in this context and concluded that this was likely to be the case. Since that review, there has been further research in this area. Therefore, we aim to provide a more robust answer to these questions and to additionally explore whether the exact timing of discharge, including entirely outpatient treatment, has an impact on outcomes.

METHODS/DESIGN: The search will cover MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, CDSR, CENTRAL, LILACS, HTA and DARE. A full search strategy is provided. Key conference proceedings and reference lists of included papers will be hand searched. Prominent authors/clinicians in the field will be contacted. We will include randomised and quasi-randomised controlled trials along with prospective single-arm studies that examine the location of therapy and/or the route of administration of antibiotics in children or young adults (aged less than 18 years) who attend paediatric services with fever and neutropenia due to treatment for cancer and are assessed to be at low risk of medical complications. Studies will be screened and data extracted by one researcher and independently checked by a second. All studies will be critically appraised using tools appropriate to the study design. Data from randomised controlled trials (RCTs) will be combined to provide comparative estimates of treatment failure, safety and adequacy. Information from quasi-randomised trials and single-arm studies will provide further data on the safety and adequacy of regimes. Random effects meta-analysis will be used to combine studies. A detailed analysis plan, including assessment of heterogeneity and publication bias, is provided.

DISCUSSION

This study will aim to specifically define the features of a low-risk strategy that will maintain levels of safety and adequacy equivalent to those of traditional treatments. This will both inform the development of services and provide patients and families with data to help them make an informed decision about care.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42014005817.

摘要

背景

发热性中性粒细胞减少是癌症患儿治疗中常见的并发症。一些患者发生并发症的风险较低,已有研究考虑减少对这些患者的治疗。之前的一项系统评价广泛探讨了在这种情况下门诊治疗和口服抗生素是否安全,并得出这可能可行的结论。自该评价以来,该领域有了进一步的研究。因此,我们旨在更有力地回答这些问题,并额外探讨出院的确切时间,包括完全门诊治疗,是否会对治疗结果产生影响。

方法/设计:检索将涵盖MEDLINE、MEDLINE在研及其他非索引引文、EMBASE、CDSR、CENTRAL、LILACS、HTA和DARE。提供了完整的检索策略。将手工检索关键会议论文集和纳入论文的参考文献列表。将联系该领域的知名作者/临床医生。我们将纳入随机和半随机对照试验以及前瞻性单臂研究,这些研究考察了因癌症治疗而出现发热和中性粒细胞减少且被评估为发生医疗并发症风险较低的儿童或青少年(年龄小于18岁)的治疗地点和/或抗生素给药途径。研究将由一名研究人员进行筛选和数据提取,并由另一名研究人员独立检查。所有研究将使用适合研究设计的工具进行严格评价。将合并随机对照试验(RCT)的数据,以提供治疗失败、安全性和充分性的比较估计值。来自半随机试验和单臂研究的信息将提供关于治疗方案安全性和充分性的进一步数据。将使用随机效应荟萃分析来合并研究。提供了详细的分析计划,包括异质性评估和发表偏倚评估。

讨论

本研究旨在明确低风险策略的特征,该策略将维持与传统治疗相当的安全性和充分性水平。这将为服务的发展提供信息,并为患者及其家庭提供数据,帮助他们就护理做出明智的决定。

系统评价注册

PROSPERO CRD42014005817。

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