Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol
Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol
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DOI：
10.1183/23120541.00193-2020
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发表时间：
2020-07-01
影响因子：
4.6
通讯作者：
Jensen, Jens-Ulrik
中科院分区：
文献类型：
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作者：
Mathioudakis, Alexander G.;Abroug, Fekri;Jensen, Jens-Ulrik
关于慢性阻塞性肺病恶化管理的随机对照试验（RCTs）评估的是异质性结果，往往忽略了那些具有临床重要性和患者相关性的结果。这限制了它们的可用性和可比性。核心结果集（COS）是基于共识的最低临床重要结果集，应在卫生保健特定领域的所有随机对照试验中进行评估。我们提出了COS- aecopd ERS工作组的研究方案，旨在开发COPD恶化管理的COS，以弥补这些局限性。对于这个COS的开发，我们遵循COMET倡议推荐的标准方法。通过对相关随机对照试验中报告的结果进行方法学系统评价，汇总了一份全面的结果清单。还将对COPD患者进行定性研究，旨在确定可能对患者重要的其他结果，但目前尚未在临床研究中得到解决。将通过广泛的、覆盖全球的多利益攸关方德尔菲调查，促进核心成果的优先排序。遴选将在一次国际多方利益相关者会议上最终确定。对于每一个核心成果，我们将推荐一个具体的测量工具和标准化的时间点进行评估。工具的选择将基于循证共识。我们的工作将提高未来COPD恶化管理的随机对照试验的质量、可用性和可比性，并最终提高COPD患者的护理。欧洲呼吸学会的多方利益相关者参与和社会支持将提高认识并促进COS的实施。
Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations.For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus.Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.