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.
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 Blase
Disease Category: Other
Disease Name: Critical care
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Literature review
- Survey
Stakeholders:
Participants will consist of representatives from three categories: clinical researchers, ICU survivors and caregivers as well as healthcare professionals. We intend to gather a large panel of national and international professional society organisations, identified using the existing critical care networks.
Methods
The process will provide a COS of daily monitoring of GI function. The list will be divided into essential, recommended and suggested outcomes. Consensus will be reached via a two-stage process with each stage containing two to three rounds, and a final consensus meeting similar to previous studies.
In Stage 1, participants will score each suggested outcome according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) scale. In Stage 2, outcome definitions will be defined. All outcomes reaching consensus for ‘essential’, ‘recommended’ and ‘suggested’ inclusion will be entered into Stage 2. Patient representatives will not participate in Stage 2 due to the clinical nature of a monitoring set.
Sources
A recent systematic review, published in 2020, has identified 6 topics of monitoring and provides systematically identified literature. The results of this review will be used to provide initial outcomes. We will conduct an additional systematic search based on the same protocol to include relevant literature that was published beyond November 2019. For this systematic review, we will use the previously published search terms. The outcome list, e.g. outcomes that may be monitored daily, will be refined based on additional literature relevant to the topic. Identified monitoring will be reduced to a standard taxonomy for COS development.
Consensus Meeting
This will be held via web conference to ratify findings and deal with any uncertainty which may require additional voting.