Bachmann Kaspar F, Jenkins Bethan, Asrani Varsha, Bear Danielle E, Bolondi Giuliano, Boraso Sabrina, Casaer Michael P, Chang Zhigang, Coopersmith Craig M, Cotoia Antonella, Davies Thomas, De Man Angelique, Elke Gunnar, Gundogan Kursat, Gunst Jan, Kvolik Slavica, Laube Marcus, Lindner Matthias, Lopez-Delgado Juan Carlos, Loudet Cecilia, Matsa Ram, Pardo Emmanuel, Piva Simone, Puthucheary Zudin, Rice Todd W, Ruiz-Santana Sergio, Schaller Stefan J, Starkopf Joel, Stoppe Christian, Van Zanten Arthur, Reintam Blaser Annika
Department of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia.
Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Crit Care. 2024 Dec 18;28(1):420. doi: 10.1186/s13054-024-05192-8.
Gastrointestinal (GI) dysfunction is common in critically ill patients and associated with poor outcomes. There is a lack of standardised methods for daily monitoring of GI function. COSMOGI aimed to develop a Core Outcome Set (COS) for daily monitoring of GI function to improve consistency and comparability in future studies in critically ill patients.
A modified Delphi consensus process engaging healthcare providers, clinical researchers, and patient representatives was performed. A systematic review identified existing parameters to monitor GI function, informing the development of potential outcomes. In Stage 1, participants rated outcomes (i.e., variables used for daily monitoring). In Stage 2, they refined and agreed on the definitions for the selected outcomes. The COS was ratified through consensus meetings.
368 individuals registered for the Delphi process. 285 participants (77.4%) completed Stage 1, and 181 participants (63.5%) completed Stage 2. From 77 potential outcomes, 13 essential outcomes for daily monitoring of GI function in studies, each with an agreed-upon definition, were established: abdominal distension, bowel dilatation, intra-abdominal pressure, abdominal pain, stool passage, vomiting, GI bleeding (upper and lower), use of parenteral nutrition due to intolerance of enteral nutrition, prokinetics, postpyloric feeding due to gastroparesis, lower GI paralysis, gastroparesis, intolerance to enteral nutrition.
Using a modified Delphi consensus process, COSMOGI established a COS for monitoring GI function in critically ill patients in research. This COS and definitions provide a framework to guide future research, enabling comparability across studies and allowing for future definitions of GI dysfunction.
This project was registered at ( www.comet-initiative.org ) on 27.03.2023 (number 2609) and was an ESICM-endorsed research project.
胃肠道(GI)功能障碍在重症患者中很常见,且与不良预后相关。目前缺乏用于日常监测GI功能的标准化方法。COSMOGI旨在制定一个用于日常监测GI功能的核心结局集(COS),以提高未来重症患者研究的一致性和可比性。
开展了一项经过改进的德尔菲共识流程,参与人员包括医疗保健提供者、临床研究人员和患者代表。进行了一项系统综述,确定了用于监测GI功能的现有参数,为潜在结局的制定提供参考。在第一阶段,参与者对结局(即用于日常监测的变量)进行评分。在第二阶段,他们对所选结局的定义进行完善并达成一致。通过共识会议批准了该COS。
368人登记参与德尔菲流程。285名参与者(77.4%)完成了第一阶段,181名参与者(63.5%)完成了第二阶段。从77个潜在结局中,确定了13个研究中用于日常监测GI功能的关键结局,每个结局都有商定的定义:腹胀、肠扩张、腹内压、腹痛、排便、呕吐、GI出血(上消化道和下消化道)、因肠内营养不耐受而使用肠外营养、促动力药、因胃轻瘫进行幽门后喂养、下消化道麻痹、胃轻瘫、肠内营养不耐受。
通过改进的德尔菲共识流程,COSMOGI制定了一个用于研究中监测重症患者GI功能的COS。该COS及其定义提供了一个框架,以指导未来的研究,实现研究间的可比性,并为未来GI功能障碍的定义提供依据。
该项目于2023年3月27日在(www.comet-initiative.org)注册(编号2609),是一项得到欧洲重症监护医学学会认可的研究项目。