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。