Stage 1 of the COSMOGI Delphi study involved two questionnaires aimed at identifying the core outcomes that should be measured and reported daily in clinical trials assessing gastrointestinal function in ICU patients. Participants were asked to score the importance of various possible daily outcomes, which were categorized into specific domains of gastrointestinal function. The first questionnaire presented a list of these outcomes and asked for importance scores and suggestions for any additional items to be included in the core set. The second questionnaire showed the same list of outcomes with a summary of scores from the first round, allowing participants to see which items were considered more or less important by others.
Over 250 participants have identified 14 essential outcomes. We are proud to present you the raw data from the process:
| Outcome | Percentages of votes 7-9 (critical to include) | Recommendation | Group |
|---|---|---|---|
| Abdominal Distension | 86.9% | Essential | Clinical sign/symptom |
| Bowel Dilatation | 77.4% | Essential | Clinical sign/symptom |
| Lower GI Paralysis | 77.8% | Essential | Composite outcome |
| IAP | 74.2% | Essential | Clinical sign/symptom |
| Pain | 81.3% | Essential | Clinical sign/symptom |
| Prokinetics | 71.8% | Essential | Treatment outcome |
| Response to enteral nutrition | 89.7% | Essential | Composite outcome |
| Stool passage (frequency; aspect; volume) incl. Diarrhoea or Absence of stool | 85.7% | Essential | Clinical sign/symptom |
| Gastroparesis | 83.3% | Essential | Composite outcome |
| Postpyloric feeding due to gastroparesis | 79.4% | Essential | Treatment outcome |
| Vomiting | 88.5% | Essential | Clinical sign/symptom |
| Lower GI Bleeding (Haematochezia or Melaena) | 82.1% | Essential | Clinical sign/symptom |
| Upper GI Bleeding (Haematemesis or blood in gastric aspirate) | 77.4% | Essential | Clinical sign/symptom |
| Use of Parenteral Nutrition due to intolerance of EN | 82.9% | Essential | Treatment outcome |