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Core outcome set of daily monitoring of gastrointestinal function in adult critically ill patients: a modified Delphi consensus process (COSMOGI)
Critical Care ( IF 8.8 ) Pub Date : 2024-12-18 , DOI: 10.1186/s13054-024-05192-8 Kaspar F. Bachmann, Bethan Jenkins, Varsha Asrani, Danielle E. Bear, Giuliano Bolondi, Sabrina Boraso, Michael P. Casaer, Zhigang Chang, Craig M. Coopersmith, Antonella Cotoia, Thomas Davies, Angelique De Man, Gunnar Elke, Kursat Gundogan, Jan Gunst, Slavica Kvolik, Marcus Laube, Matthias Lindner, Juan Carlos Lopez-Delgado, Cecilia Loudet, Ram Matsa, Emmanuel Pardo, Simone Piva, Zudin Puthucheary, Todd W. Rice, Sergio Ruiz-Santana, Stefan J. Schaller, Joel Starkopf, Christian Stoppe, Arthur Van Zanten, Annika Reintam Blaser
Critical Care ( IF 8.8 ) Pub Date : 2024-12-18 , DOI: 10.1186/s13054-024-05192-8 Kaspar F. Bachmann, Bethan Jenkins, Varsha Asrani, Danielle E. Bear, Giuliano Bolondi, Sabrina Boraso, Michael P. Casaer, Zhigang Chang, Craig M. Coopersmith, Antonella Cotoia, Thomas Davies, Angelique De Man, Gunnar Elke, Kursat Gundogan, Jan Gunst, Slavica Kvolik, Marcus Laube, Matthias Lindner, Juan Carlos Lopez-Delgado, Cecilia Loudet, Ram Matsa, Emmanuel Pardo, Simone Piva, Zudin Puthucheary, Todd W. Rice, Sergio Ruiz-Santana, Stefan J. Schaller, Joel Starkopf, Christian Stoppe, Arthur Van Zanten, Annika Reintam Blaser
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. Trial registration: This project was registered at ( www.comet-initiative.org ) on 27.03.2023 (number 2609) and was an ESICM-endorsed research project.
中文翻译:
成年危重患者胃肠道功能日常监测的核心结果集:改良的德尔菲共识过程 (COSMOGI)
胃肠道 (GI) 功能障碍在危重患者中很常见,并与不良结局相关。缺乏日常监测胃肠道功能的标准化方法。COSMOGI 旨在开发一个核心结果集 (COS),用于胃肠道功能的日常监测,以提高未来危重患者研究的一致性和可比性。执行了涉及医疗保健提供者、临床研究人员和患者代表的修改后的 Delphi 共识过程。一项系统评价确定了监测 GI 功能的现有参数,为潜在结果的开发提供信息。在第 1 阶段,参与者对结果(即用于日常监测的变量)进行评分。在第 2 阶段,他们完善并就所选结果的定义达成一致。COS 是通过共识会议批准的。368 人注册了 Delphi 流程。285 名参与者 (77.4%) 完成了第 1 阶段,181 名参与者 (63.5%) 完成了第 2 阶段。从 77 个潜在结局中,确定了研究中每日监测胃肠道功能的 13 个基本结局,每个结局都有一个商定的定义:腹胀、肠道扩张、腹内压、腹痛、大便排出、呕吐、胃肠道出血(上下消化道出血)、由于肠内营养不耐受而使用肠外营养、促动力药、胃轻瘫引起的幽门后喂养、下消化道麻痹、 胃轻瘫,对肠内营养不耐受。使用改进的 Delphi 共有过程,COSMOGI 建立了一个 COS,用于监测研究中危重患者的胃肠道功能。该 COS 和定义提供了一个指导未来研究的框架,使研究之间的可比性成为可能,并允许未来对胃肠道功能障碍的定义。 试用注册:该项目于 2023 年 3 月 27 日(第 2609 www.comet-initiative.org)注册,是 ESICM 认可的研究项目。
更新日期:2024-12-18
中文翻译:
成年危重患者胃肠道功能日常监测的核心结果集:改良的德尔菲共识过程 (COSMOGI)
胃肠道 (GI) 功能障碍在危重患者中很常见,并与不良结局相关。缺乏日常监测胃肠道功能的标准化方法。COSMOGI 旨在开发一个核心结果集 (COS),用于胃肠道功能的日常监测,以提高未来危重患者研究的一致性和可比性。执行了涉及医疗保健提供者、临床研究人员和患者代表的修改后的 Delphi 共识过程。一项系统评价确定了监测 GI 功能的现有参数,为潜在结果的开发提供信息。在第 1 阶段,参与者对结果(即用于日常监测的变量)进行评分。在第 2 阶段,他们完善并就所选结果的定义达成一致。COS 是通过共识会议批准的。368 人注册了 Delphi 流程。285 名参与者 (77.4%) 完成了第 1 阶段,181 名参与者 (63.5%) 完成了第 2 阶段。从 77 个潜在结局中,确定了研究中每日监测胃肠道功能的 13 个基本结局,每个结局都有一个商定的定义:腹胀、肠道扩张、腹内压、腹痛、大便排出、呕吐、胃肠道出血(上下消化道出血)、由于肠内营养不耐受而使用肠外营养、促动力药、胃轻瘫引起的幽门后喂养、下消化道麻痹、 胃轻瘫,对肠内营养不耐受。使用改进的 Delphi 共有过程,COSMOGI 建立了一个 COS,用于监测研究中危重患者的胃肠道功能。该 COS 和定义提供了一个指导未来研究的框架,使研究之间的可比性成为可能,并允许未来对胃肠道功能障碍的定义。 试用注册:该项目于 2023 年 3 月 27 日(第 2609 www.comet-initiative.org)注册,是 ESICM 认可的研究项目。