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National survey of feasibility of NIV trials for management of children with bronchiolitis.关于无创通气试验用于毛细支气管炎患儿管理的可行性全国性调查。
BMJ Paediatr Open. 2020 Oct 27;4(1):e000780. doi: 10.1136/bmjpo-2020-000780. eCollection 2020.
2
Efficacy of High-Flow Nasal Cannula vs Standard Oxygen Therapy or Nasal Continuous Positive Airway Pressure in Children with Respiratory Distress: A Meta-Analysis.高流量鼻导管与标准氧疗或经鼻持续气道正压通气治疗儿童呼吸窘迫的疗效比较：一项荟萃分析。
J Pediatr. 2019 Dec;215:199-208.e8. doi: 10.1016/j.jpeds.2019.07.059. Epub 2019 Sep 27.
3
New therapies for acute RSV infections: where are we?急性 RSV 感染的新疗法：我们在哪里？
Eur J Pediatr. 2019 Feb;178(2):131-138. doi: 10.1007/s00431-018-03310-7. Epub 2019 Jan 4.
4
Higher number of items associated with significantly lower response rates in COS Delphi surveys.与 COS 德尔菲调查中较低的应答率显著相关的项目数量更多。
J Clin Epidemiol. 2019 Apr;108:110-120. doi: 10.1016/j.jclinepi.2018.12.010. Epub 2018 Dec 15.
5
Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol.无创通气治疗小儿细支气管炎（NOVEMBR）：一项可行性研究及核心结局指标集制定方案
Trials. 2018 Nov 14;19(1):627. doi: 10.1186/s13063-018-2969-9.
6
A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis.随机对照试验：高流量氧疗在毛细支气管炎患儿中的应用
N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.
7
Practice Variation in Acute Bronchiolitis: A Pediatric Emergency Research Networks Study.急性细支气管炎的实践差异：一项儿科急诊研究网络的研究
Pediatrics. 2017 Dec;140(6). doi: 10.1542/peds.2017-0842.
8
The COMET Handbook: version 1.0.《COMET手册：第1.0版》
Trials. 2017 Jun 20;18(Suppl 3):280. doi: 10.1186/s13063-017-1978-4.
9
High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): an open, phase 4, randomised controlled trial.高流量温湿氧疗对比标准低流量鼻导管氧疗治疗轻中度细支气管炎（HFWHO RCT）：一项开放标签、4 期、随机对照试验。
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10
Core Outcome Set-STAndards for Reporting: The COS-STAR Statement.核心结局集报告标准：COS-STAR声明
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未来的细支气管炎试验应采用哪些结果？通过系统评价、德尔菲调查和共识研讨会制定细支气管炎核心结局集。

Which outcomes should be used in future bronchiolitis trials? Developing a bronchiolitis core outcome set using a systematic review, Delphi survey and a consensus workshop.

作者信息

Rosala-Hallas A, Jones Ashley P, Williamson Paula R, Bedson Emma, Compton Vanessa, Fernandes Ricardo M, Lacy David, Lyttle Mark David, Peak Matthew, Thorburn Kentigern, Woolfall Kerry, Van Miert Clare, McNamara Paul S

机构信息

Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, Merseyside, UK.

Health Data Science, Institute of Population Health, University of Liverpool, Liverpool, UK.

出版信息

BMJ Open. 2022 Mar 9;12(3):e052943. doi: 10.1136/bmjopen-2021-052943.

DOI:10.1136/bmjopen-2021-052943
PMID:35264343
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8915376/
Abstract

OBJECTIVES

The objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are important to healthcare professionals (HCPs) and to parents and which outcomes should be prioritised for use in future clinical trials.

DESIGN AND SETTING

The study used a systematic review, workshops and interviews, a Delphi survey and a final consensus workshop.

RESULTS

Thirteen parents and 45 HCPs took part in 5 workshops; 15 other parents were also separately interviewed. Fifty-six items were identified from the systematic review, workshops and interviews. Rounds one and two of the Delphi survey involved 299 and 194 participants, respectively. Sixteen outcomes met the criteria for inclusion within the COS. The consensus meeting was attended by 10 participants, with representation from all three stakeholder groups. Nine outcomes were added, totalling 25 outcomes to be included in the COS.

CONCLUSION

We have developed the first parent and HCP consensus on a COS for bronchiolitis in a hospital setting. The use of this COS will ensure outcomes in future bronchiolitis trials are important and relevant, and will enable the trial results to be compared and combined.

TRIAL REGISTRATION NUMBER

ISRCTN75766048.

摘要

目的

本研究的目的是制定一套核心结局集（COS），供未来用于毛细支气管炎的临床试验。我们想了解哪些结局对医疗保健专业人员（HCP）和家长而言很重要，以及哪些结局应在未来的临床试验中优先使用。

设计与背景

本研究采用了系统评价、研讨会与访谈、德尔菲调查以及最终的共识研讨会。

结果

13名家长和45名HCP参加了5次研讨会；另外还分别采访了15名家长。通过系统评价、研讨会和访谈确定了56项内容。德尔菲调查的第一轮和第二轮分别有299名和194名参与者。16项结局符合纳入COS的标准。10名参与者参加了共识会议，三个利益相关者群体均有代表出席。又增加了9项结局，COS总共纳入25项结局。

结论

我们已就医院环境中毛细支气管炎的COS达成了家长和HCP的首个共识。使用该COS将确保未来毛细支气管炎试验的结局具有重要意义且相关，并能使试验结果进行比较和汇总。

试验注册号

ISRCTN75766048。