Kjær Maj-Brit Nørregaard, Bruun Camilla Rahbek Lysholm, Granholm Anders, Møller Morten Hylander, Rasmussen Bodil Steen, Mortensen Camilla Bekker, Poulsen Lone Museaus, Strøm Thomas, Laerkner Eva, Brøchner Anne Craveiro, Haberlandt Trine, Bunzel Anne-Marie Gellert, Herløv Louise Stenbryggen, Holm Anna, Sivapalan Praleene, Estrup Stine, Cronhjort Maria, Schandl Anna, Laake Jon Henrik, Hofsø Kristin, Blokzijl Fredrike, Keus Frederik, Pfortmueller Carmen Andrea, Ostermann Marlies, Cole Jade M, Wise Matt P, Szczeklik Wojciech, Wludarczyk Anna, Jovaiša Tomas, Cecconi Maurizio, Sigurdsson Martin Ingi, Nalos Marek, Hästbacka Johanna, Mäkinen Marja, Hammond Naomi, Litton Edward, Haines Kimberley, Myatra Sheila Nainan, Vijayaraghavan Bharath Kumar Tirupakuzhi, Yadav Kavita, Jha Vivekanand, Venkatesh Balasubramanian, Egerod Ingrid, Perner Anders, Collet Marie O
Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Crit Care Med. 2025 Mar 1;53(3):e575-e589. doi: 10.1097/CCM.0000000000006556. Epub 2025 Jan 6.
Randomized clinical trials informing clinical practice (e.g., like large, pragmatic, and late-phase trials) should ideally mostly use harmonized outcomes that are important to patients, family members, clinicians, and researchers. Core outcome sets for specific subsets of ICU patients exist, for example, respiratory failure, delirium, and COVID-19, but not for ICU patients in general. Accordingly, we aimed to develop a core outcome set for adult general ICU patients.
We developed a core outcome set in Denmark following the Core Outcome Measures in Effectiveness Trials Handbook. We used a modified Delphi consensus process with multiple methods design, including literature review, survey, semi-structured interviews, and discussions with initially five Danish research panels. The core outcome set was internationally validated and revised based on feedback from research panels in all countries.
There were five Danish research panels and 17 panels in 13 other countries. Interviews and the three-round Delphi survey was conducted in Denmark, followed by validation of the core outcome set across 14 countries in Europe, Australasia, and India.
Adult ICU survivors, family members, clinicians, and researchers.
None.
We identified 329 published outcomes, of which 50 were included in the 264 participant Delphi survey. In semi-structured interviews of 82, no additional outcomes were added. The first Delphi survey round was completed by 249 (94%) participants, and 202 (82%) contributed to the third and final round. The initial core outcome set comprised six outcomes. International validation involved 217 research panel members and resulted in the final core outcome set comprising survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function.
We developed and internationally validated a core outcome set with six core outcomes to be used in research, specifically clinical trials involving adult general ICU patients.
为临床实践提供信息的随机临床试验（例如大型、务实的后期试验）理想情况下应大多使用对患者、家属、临床医生和研究人员都重要的统一结局指标。针对特定ICU患者亚组，如呼吸衰竭、谵妄和新冠肺炎患者，已有核心结局指标集，但一般ICU患者尚无。因此，我们旨在为成年综合性ICU患者制定一个核心结局指标集。
我们按照《有效性试验核心结局指标手册》在丹麦制定了一个核心结局指标集。我们采用了经过改进的德尔菲共识法，采用多种方法设计，包括文献综述、调查、半结构化访谈以及与最初的五个丹麦研究小组进行讨论。该核心结局指标集在国际上进行了验证，并根据所有国家研究小组的反馈进行了修订。
有五个丹麦研究小组以及其他13个国家的17个小组参与。在丹麦进行了访谈和三轮德尔菲调查，随后在欧洲、澳大拉西亚和印度的14个国家对核心结局指标集进行了验证。
成年ICU幸存者、家属、临床医生和研究人员。
无。
我们识别出329个已发表的结局指标，其中50个纳入了264名参与者的德尔菲调查。在对82人的半结构化访谈中，未增加其他结局指标。第一轮德尔菲调查由249名（94%）参与者完成，202名（82%）参与者参与了第三轮也是最后一轮调查。最初的核心结局指标集包含六个结局指标。国际验证涉及217名研究小组成员，最终的核心结局指标集包括生存、无需生命支持、无谵妄、出院、健康相关生活质量和认知功能。
我们制定并在国际上验证了一个包含六个核心结局指标的核心结局指标集，用于研究，特别是涉及成年综合性ICU患者的临床试验。
