Core outcome set of daily monitoring of gastrointestinal function in adult critically ill patients: a modified Delphi consensus process (COSMOGI)
Kaspar F. Bachmann, Bethan Jenkins, Varsha Asrani, Danielle E. Bear, Giuliano Bolondi, Sabrina Boraso, Michaël P. Casaer, Zhigang Chang, Craig M. Coopersmith, Antonella Cotoia, Thomas Davies, A. Man, Gunnar Elke, Kürşat Gündoğan, Jan Gunst, Slavica Kvolik, Marcus Laube, Matthias Lindner, Juan Carlos Lopez‐Delgado, Cecilia Loudet, Ramprasad Matsa, Emmanuel Pardo, Simone Piva, Zudin Puthucheary, Todd W. Rice, Sergio Ruiz‐Santana, Stefan J. Schaller, Joel Starkopf, Christian Stoppe, Arthur R. H. van Zanten, Annika Reintam Blaser
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.