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Criteria and definitions for the radiological and clinical diagnosis of bronchiectasis in adults for use in clinical trials: international consensus recommendations
The Lancet Respiratory Medicine ( IF 76.2 ) Pub Date : 2021-09-24 , DOI: 10.1016/s2213-2600(21)00277-0
Stefano Aliberti 1 , Pieter C Goeminne 2 , Anne E O'Donnell 3 , Timothy R Aksamit 4 , Hamdan Al-Jahdali 5 , Alan F Barker 6 , Francesco Blasi 7 , Wim G Boersma 8 , Megan L Crichton 9 , Anthony De Soyza 10 , Katerina E Dimakou 11 , Stuart J Elborn 12 , Charles Feldman 13 , Harm Tiddens 14 , Charles S Haworth 15 , Adam T Hill 16 , Michael R Loebinger 17 , Miguel Angel Martinez-Garcia 18 , Jennifer J Meerburg 14 , Rosario Menendez 18 , Lucy C Morgan 19 , Marlene S Murris 20 , Eva Polverino 21 , Felix C Ringshausen 22 , Michal Shteinberg 23 , Nicola Sverzellati 24 , Gregory Tino 25 , Antoni Torres 26 , Thomas Vandendriessche 27 , Montserrat Vendrell 28 , Tobias Welte 22 , Robert Wilson 17 , Conroy A Wong 29 , James D Chalmers 9
Affiliation  

Bronchiectasis refers to both a clinical disease and a radiological appearance that has multiple causes and can be associated with a range of conditions. Disease heterogeneity and the absence of standardised definitions have hampered clinical trials of treatments for bronchiectasis and are important challenges in clinical practice. In view of the need for new therapies for non-cystic fibrosis bronchiectasis to reduce the disease burden, we established an international taskforce of experts to develop recommendations and definitions for clinically significant bronchiectasis in adults to facilitate the standardisation of terminology for clinical trials. Systematic reviews were used to inform discussions, and Delphi processes were used to achieve expert consensus. We prioritised criteria for the radiological diagnosis of bronchiectasis and suggest recommendations on the use and central reading of chest CT scans to confirm the presence of bronchiectasis for clinical trials. Furthermore, we developed a set of consensus statements concerning the definitions of clinical bronchiectasis and its specific signs and symptoms, as well as definitions for chronic bacterial infection and sustained culture conversion. The diagnosis of clinically significant bronchiectasis requires both clinical and radiological criteria, and these expert recommendations and proposals should help to optimise patient recruitment into clinical trials and allow reliable comparisons of treatment effects among different interventions for bronchiectasis. Our consensus proposals should also provide a framework for future research to further refine definitions and establish definitive guidance on the diagnosis of bronchiectasis.



中文翻译:

用于临床试验的成人支气管扩张的放射学和临床诊断的标准和定义:国际共识建议

支气管扩张是指一种临床疾病和放射学表现,其原因有多种,并且可能与一系列病症相关。疾病异质性和缺乏标准化定义阻碍了支气管扩张治疗的临床试验,也是临床实践中的重要挑战。鉴于非囊性纤维化支气管扩张症需要新疗法以减轻疾病负担,我们成立了一个国际专家工作组,为成人临床上显着的支气管扩张症制定建议和定义,以促进临床试验术语的标准化。系统评审用于为讨论提供信息,德尔菲流程用于达成专家共识。我们优先考虑了支气管扩张的放射学诊断标准,并提出了关于胸部 CT 扫描的使用和中心阅读的建议,以确认临床试验中是否存在支气管扩张。此外,我们还制定了一套关于临床支气管扩张的定义及其具体体征和症状,以及慢性细菌感染和持续培养转化的定义的共识声明。临床上显着的支气管扩张症的诊断需要临床和放射学标准,这些专家的建议和建议应有助于优化临床试验的患者招募,并可以对支气管扩张症的不同干预措施之间的治疗效果进行可靠的比较。我们的共识提案还应为未来的研究提供一个框架,以进一步完善定义并为支气管扩张的诊断建立明确的指导。

更新日期:2021-09-24
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