Department of Intensive Care, Amsterdam UMC, Amsterdam, The Netherlands
Department of Critical Care Medicine, NMC Specialty Hospital, Dubai, UAE.
BMJ Open. 2024 Apr 25;14(4):e082986. doi: 10.1136/bmjopen-2023-082986.
Acute respiratory distress syndrome (ARDS), marked by acute hypoxemia and bilateral pulmonary infiltrates, has been defined in multiple ways since its first description. This Delphi study aims to collect global opinions on the conceptual framework of ARDS, assess the usefulness of components within current and past definitions and investigate the role of subphenotyping. The varied expertise of the panel will provide valuable insights for refining future ARDS definitions and improving clinical management.
A diverse panel of 35-40 experts will be selected based on predefined criteria. Multiple choice questions (MCQs) or 7-point Likert-scale statements will be used in the iterative Delphi rounds to achieve consensus on key aspects related to the utility of definitions and subphenotyping. The Delphi rounds will be continued until a stable agreement or disagreement is achieved for all statements.
Consensus will be considered as reached when a choice in MCQs or Likert-scale statement achieved ≥80% of votes for agreement or disagreement. The stability will be checked by non-parametric χ tests or Kruskal Wallis test starting from the second round of Delphi process. A p-value ≥0.05 will be used to define stability.
The study will be conducted in full concordance with the principles of the Declaration of Helsinki and will be reported according to CREDES guidance. This study has been granted an ethical approval waiver by the NMC Healthcare Regional Research Ethics Committee, Dubai (NMCHC/CR/DXB/REC/APP/002), owing to the nature of the research. Informed consent will be obtained from all panellists before the start of the Delphi process. The study will be published in a peer-review journal with the authorship agreed as per requirements.
NCT06159465.
急性呼吸窘迫综合征（ARDS）以急性低氧血症和双侧肺部浸润为特征，自首次描述以来，已经有多种定义方法。本德尔菲研究旨在收集全球对 ARDS 概念框架的意见，评估当前和过去定义中各组成部分的有用性，并研究亚表型的作用。专家小组的多样化专业知识将为完善未来 ARDS 定义和改善临床管理提供有价值的见解。
将根据预先确定的标准选择 35-40 名不同领域的专家组成小组。在迭代德尔菲轮次中，将使用多项选择题（MCQ）或 7 分李克特量表陈述来就与定义和亚表型实用性相关的关键方面达成共识。只有在所有陈述都达成稳定的一致或不一致意见时，德尔菲轮次才会结束。
当 MCQ 或李克特量表陈述中的选择获得≥80%的同意或不同意票数时，将认为达成共识。从德尔菲过程的第二轮开始，将通过非参数 χ 检验或 Kruskal Wallis 检验来检查稳定性。使用 p 值≥0.05 来定义稳定性。
本研究将完全遵循《赫尔辛基宣言》的原则进行，并按照 CREDES 指南进行报告。由于研究的性质，本研究已获得 NMC Healthcare Regional Research Ethics Committee，Dubai（NMCHC/CR/DXB/REC/APP/002）的伦理豁免批准。在德尔菲过程开始之前，将获得所有小组成员的知情同意。该研究将在同行评议期刊上发表，并根据要求确定作者身份。
NCT06159465。
