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制定支气管扩张长期管理临床试验的核心结局集。

Development of a core outcome set for trials investigating the long-term management of bronchiectasis.

机构信息

1 School of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland.

2 The School of Pharmacy & Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, Dublin, Ireland.

出版信息

Chron Respir Dis. 2019 Jan-Dec;16:1479972318804167. doi: 10.1177/1479972318804167. Epub 2018 Oct 3.

DOI:10.1177/1479972318804167
PMID:30278785
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6301837/
Abstract

Heterogeneity in outcomes measured in trials limits accurate comparison of bronchiectasis studies. A core outcome set (COS) is an agreed, standardized set of outcomes that should be measured in trials for specific clinical areas. A COS for bronchiectasis could encourage consistency in future studies. An overview of systematic reviews and qualitative study on outcome selection in bronchiectasis informed an initial list of outcomes. A Delphi panel ( n = 86) rated the importance of each outcome from 1 to 9 in 3 sequential questionnaires, as a means to achieve consensus: 1-3 = 'of limited importance'; 4-6 = 'important, but not critical'; and 7-9 = 'critical'. Outcomes rated 'critical' by ≥70% of the panel were added to the COS. Eighty-two participants responded to the first questionnaire. Attrition between each questionnaire was 5%. After 3 rounds of questioning, 18 outcomes exceeded the threshold for consensus and were included in the COS. This study has achieved consensus on 18 outcomes that should be measured in trials of interventions for bronchiectasis. Selection of the highest ranked outcomes may represent a pragmatic means for comparison. Further research is required to condense the number of outcomes selected and to determine its relevance to interventions.

摘要

在临床试验中,由于测量结果的异质性,限制了对支气管扩张症研究的准确比较。核心结局集(COS)是一种在特定临床领域的临床试验中应测量的商定的、标准化的结局集。支气管扩张症的 COS 可以鼓励未来研究的一致性。系统评价和支气管扩张症结局选择的定性研究概述为初始结局清单提供了信息。德尔菲小组(n=86)在 3 轮顺序问卷调查中对每个结局的重要性进行了 1 到 9 的评分,以达成共识:1-3=“重要性有限”;4-6=“重要,但不是关键”;7-9=“关键”。小组中≥70%的人认为“关键”的结局被添加到 COS 中。82 名参与者回答了第一轮问卷。每份问卷之间的流失率为 5%。经过 3 轮提问,有 18 个结果超过了共识的阈值,并被纳入 COS。本研究就支气管扩张症干预试验中应测量的 18 个结局达成了共识。选择排名最高的结局可能是一种实用的比较方法。需要进一步研究来减少所选结局的数量,并确定其对干预措施的相关性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/24ff271b6770/10.1177_1479972318804167-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/1d38cf8b270d/10.1177_1479972318804167-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/9c734378389c/10.1177_1479972318804167-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/24ff271b6770/10.1177_1479972318804167-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/1d38cf8b270d/10.1177_1479972318804167-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/9c734378389c/10.1177_1479972318804167-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3714/6301837/24ff271b6770/10.1177_1479972318804167-fig3.jpg

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