Table 3.
COSMOGI Definitions and documentation practice with information as to how the definition was created
| Essential outcome | Definition | Documented daily as | How the definition was created | Consensus at final meeting (> 70% needed) (%) | Subjectivity rating |
|---|---|---|---|---|---|
| Abdominal distension | Abdominal distension is defined as a visibly enlarged abdomen that appears expanded at palpation and/or percussion | Yes/No | Based on the essential definitions found in the Delphi rounds | 94.7 | High (Estimation) |
| Abdominal pain | Abdominal pain should be assessed by numeric rating scale (NRS) or visual analogue scale (VAS) scale for patients who are able to communicate. For patients who are unable to communicate, behavioural pain scale (BPS) should be used during clinical examination of the abdomen to provoke an abdominal response. Pain should be documented as no pain, mild pain, moderate pain or severe pain. Assessment is only necessary in patients with suspected abdominal pain as defined in the study protocol | Yes (with a pain intensity)/No/Not applicable. Independent of the scale (NRS/VAS/BPS), pain intensity should be documented as "mild", "moderate" or "severe" pain |
Based on the essential and recommended definitions found in the Delphi rounds. To ensure that patients who are unable to communicate can also be assessed, the BPS was included Based on the consensus meeting, assessment was limited to the relevant population as defined per study protocol |
100 | Moderate (Subjective measure, but clear scaling available) |
| Bowel dilatation | Bowel dilatation is defined as small bowel diameter > 3 cm or large bowel diameter > 6 cm (caecum > 9 cm) measured by any imaging modality; and associated with symptoms referring to bowel distension (pain; nausea; vomiting; IAH) and/or GI paralysis. Bowel dilatation is only assessed in patients at risk as defined in the study protocol of each study | Yes/No/Not applicable | Based on the essential definitions (combining both large and small bowels) and consensus meeting, where assessment was only deemed necessary as per study protocol and not in every patient | 92.5 | Low (Imaging measures) |
| Gastroparesis | Gastroparesis is defined by high gastric residual volumes (GRV) (i.e. > 500mL; measured or estimated by ultrasound) or vomiting due to delayed gastric emptying in the absence of mechanical obstruction. Indication for GRV measurement,GRV cut-off and measurement frequency need to be defined in the study protocol and reported in the manuscript | Yes/No | Based on the essential definitions. Based on the consensus meeting, GRV measurement only needs to be assessed as per study protocol | 92.7 | High (GRV is quantifiable, but cut-offs may vary and interpretation of signs and symptoms may be subjective) |
| Gastrointestinal bleeding | Gastrointestinal bleeding is defined as the loss of blood from any location within the gastrointestinal tract, evidenced by the macroscopic presence of blood in vomited fluids, gastric aspirate, or stools, and/or by evidence of active bleeding on CT scan, angiography, or endoscopy. Clinically important GI bleeding is defined as overt bleeding associated with significant hemodynamic changes, the need for blood transfusions (two or more units of blood over a 24h period), significant changes in hemoglobin level (at least 2g/dl), or the necessity for surgical, endoscopic or endovascular intervention to control bleeding | Yes (specify if any bleeding or clinically important GI bleeding)/No | Based on the essential definitions from the Delphi rounds | 92.7 | Low (Evidence of bleeding) |
| Intraabdominal pressure | Intra-abdominal hypertension (IAH) is defined as a sustained or repeated pathologic elevation of intra-abdominal pressure (IAP) ≥ 12 mmHg. The severity of IAH is graded into four categories based on maximum daily IAP values: Grade I (12–15 mmHg), Grade II (16–20 mmHg), Grade III (21–25 mmHg), and Grade IV (> 25 mmHg). IAP only needs to be measured in patients at risk as defined in the study protocol of each study | Yes (specify grade)/No/Not applicable | Based on the essential definitions and consensus meeting, where assessment was only deemed necessary as per study protocol and not in every patient | 100 | Low in paralysed patients (quantifiable). Moderate in spontaneously breathing patients (interpretation may depend on experience) |
| Stool passage | Documentation of daily frequency and stool consistency using Bristol stool form scale. Absence of stool passage used as a part of definition of lower GI paralysis is the absence of stool for 3 days or longer despite current administration of laxatives and/or prokinetics | Yes (specify times per day with Bristol scale)/No | Essential and recommended definitions were combined | 88.6 | Low (Quantifiable, clear scaling) |
| Lower GI paralysis | Paralysis of lower GI tract (paralytic ileus) is defined as the inability of the bowel to pass stool due to impaired peristalsis. Clinical signs include the absence of stool for three or more consecutive days without mechanical obstruction and despite current administration of laxatives and/or prokinetics. Bowel sounds may or may not be present | Yes/No/Not applicable (cannot be measured in the first two days) | Based on the definition of absence of stool, medication was added to the definition | 100 | Moderate (Stool passage is quantifiable, but associated symptom interpretation may vary) |
| Prokinetics | Prokinetic therapy is defined as use of any prokinetics alone or in combination in case of feeding intolerance | Yes/No | Based on essential definitions. A full list of medication is provided in supplement (Supplementary Content 4) | 100 | Moderate (Indication depends on clinical judgement) |
| Intolerance to enteral nutrition | Intolerance is defined as the occurrence of GI symptoms (e.g. abdominal distension, vomiting/regurgitation, pain, diarrhoea or elevated GRV or IAP), leading to discontinuation or reduction of enteral feeding to the extent that nutritional targets cannot be met via the enteral route | Yes/No | Based on the essential definitions. Additionally, discontinuation or reduction of EN due to clinical signs & symptoms clinically defines feeding intolerance, | 100 | High (Decision to interrupt EN depends on clinical judgement) |
| Use of parenteral nutrition | Parenteral nutrition is defined as artificial nutrition administered through a venous access due to absolute contraindications for receiving enteral nutrition or due to enteral nutrition intolerance. It can be total or supplementary | Yes (specify 1: reason (contraindication or feeding intolerance) and 2: full or supplemental)/No | All essential definitions were combined. Specific list of contraindications can be found in the supplement (Supplementary Content 4) | 97.5 | Moderate (Definition for EFI as indication for parenteral nutrition may vary) |
| Vomiting | Vomiting or emesis is defined as the occurrence of any visible regurgitation of gastric content irrespective of the amount | Yes (independent if either vomiting or regurgitation)/No | All essential definitions were combined | 97.3 | Low (Observable) |
| Postpyloric feeding | Postpyloric feeding is defined as enteral feeding delivered distal to the stomach due to gastroparesis, obstruction or oesophageal or gastric surgery | Yes/No | Based on the essential definition | 92.1 | Moderate (Indication depends on clinical judgement) |
The authors rated the subjectivity of each outcome/definition: The subjectivity scale assesses the potential bias from assessor dependency, categorized as low (objective and reproducible), moderate (some interpretation or variability), or high (heavily reliant on subjective judgment). Outcomes with moderate or high subjectivity may require further exploration and refinement through additional consensus processes to improve standardization and reliability