Dear participants
We would like to cordially thank you for all the additional outcomes that were suggested by you. The steering committe has evaluated these outcomes and has accepted a suggestion made by the study team on how to proceed (> 70% acceptance rate by the steering committee).
Below you can find a summary of the suggested outcomes as well as the plan of action and rationale behind them.
We have evaluated the additional outcomes using the following criteria / questions:
- Is the outcome new? If it is already represented by one or more existing outcomes, the additional outcome was rejected.
- Is the outcome specific for GI function / does it represent GI function? We have evaluated this using the framework of domains (https://cosmogi.site/information-sheets/). If the additional outcome does not fit into any domain of GI function and thus does not represent GI function, it was rejected.
- If there is no evidence linking the outcome to critically ill patients and GI function, we would generally suggest rejecting, although recognizing that evidence level for some of the outcomes already in COSMOGI is also low. Rationale: if there is no evidence, then it is unlikely that this outcome could be selected for daily monitoring.
| Outcome | Action | Terminology | Domain | Comment / Rationale |
| APPETITE (WILLINGNESS TO INGEST FOODS AND DRINKS) | Reject | Critical care patients are often intubated and appetite cannot be assessed within that specific population. It is therefore not an appropriate outcome to monitor GI function in the setting of critically ill patients and does not fit into a domain. | ||
| NAUSEA | Reject | Vomiting is a suggested outcome that is more objective and potentially specific for GI function. Nausea is not GI specific and cannot be assessed in an intubated population. | ||
| NEED FOR ANTIEMETIC MEDICATIONS | Reject | Antiemetics are often given to patients either prophylactically or because of other pathologies, such us neurological problems. It therefore does not represent GI function. | ||
| ABDOMINAL CIRCUMFERENCE | Reject | Abdominal distension is a suggested outcome. Measuring abdominal circumference is a question of definition, which we will do in stage 2 should abdominal distension be voted as critical to include. | ||
| ASPIRATION OF GI CONTENTS | Reject | Vomiting and GRV are already a suggested outcome. Aspiration then defines a pulmonary complication of impaired GI function, but does not primarily monitor GI function. | ||
| BIOIMPEDENCE ( BODY COMPOSITION: TOTAL BODY WATER; ECW/ICW, PHASE ANGLE, BCM ) THAT HIGHLIGHT FLUID SHIFT IN CRITICAL ILL PATIENT AND MESURES CELLULAR INTEGRITY | Reject | Body composition is impacted by many factors, particularly fluid balance. It therefore is not a specific measure of GI function and does not fit into a domain. | ||
| FOOD OR ENTERAL NUTRITION ASPIRATION-RELATED PNEUMONIA | Reject | Vomiting and GRV are already a suggested outcome. Aspiration then defines a pulmonary complication of impaired GI function, but does not primarily monitor GI function. | ||
| BODY SURFACE GASTRIC MAPPING BY ALIMETRY – NOT FULLY EVALUATED IN CCM, BUT WE ARE DOING THAT NOW AND IT IS PROMISING AND IS AVAILABLE COMMERCIALLY. | Accept | Body Surface Gastric Mapping | Upper GI Motility | Info Text: Gastric Alimetry body surface gastric mapping (BSGM) is a non-invasive diagnostic test that measures gastric motility. BSGM uses a stretchable high-resolution array of electrodes and a wearable reader to evaluate gastric function |
| FLUID OVERLOAD – AMOUT OF FLUIDS | Reject | This outcome is not GI specific (e.g. does not fit into a domain) and is not able to monitor GI function. We agree that fluid status might be interesting for this population, but this is true for almost any other disorder as well. | ||
| WEIGHT | Reject | Weight in the ICU is primarily driven by fluid resuscitation and deresuscitation and is therefore not a marker of GI function and does not fit into a domain. | ||
| MUSCLE MASS | Reject | This is not a marker of GI function specifically and may be affected by many factors outside of GI funciton. It does not fit into a domain. | ||
| PERIPHERAL PERFUSION – USUALLY, WE EVALUATE ABDOMINAL DISSENSION AND MOVEMENTS TOGETHER WITH PERIPHERAL PERFUSION (AS USED IN SEPTIC SHOCK) TO GET AN INDIRECT PERSPECTIVE OF THE INTESTINAL CIRCULATION | Reject | This is a monitoring of cardiovascular function and not GI function and does not fit into a domain. Altough impaired cardiovascular function may impair GI function, we are looking for outcomes that are GI specific. | ||
| SERIAL ABDOMINAL GIRTH MEASUREMENT | Reject | See abdominal circumference | ||
| SERUM PHOSPHATE (AS A MARKER OF REFEEDING) | Reject | Refeeding is an important aspect of ICU management, but phosphate is not a specific marker and thus does not allow monitoring of GI funciton (e.g. does not fit into a domain). | ||
| HYPOGLYCAEMIA | Reject | Glycemic control is affected by many processes (including applied insulin dosage) and does therefore not represent GI function. It does not fit into a domain of GI function. | ||
| C. DIFF TESTING | Reject | We would suggest to reject due to the following reasons: 1) It does not fit well into the framework of GI function. 2) Positive C. difficile does not necessarily carry any disease burden. 3) It monitors the presence of a specific bacteria within the GI tract. The impact on GI function of any function will be monitored by the outcomes in the consensus process; monitoring directly for bacteria does not add value and is rather an underlying pathology than GI function. In the same sense we do not monitor for sepsis or heart failure. | ||
| REGURGITATION | Reject | This outcome is already represented by either vomiting or GRV. | ||
| HICCUP | Reject | There is not any evidence linking hiccup to a relevant outcomes of mortality or morbidity, nor is it associated with GI function per se and does not fit into a domain. | ||
| TYPE FORMULA ENTERAL NUTRITION | Accept | Use of peptide based formula for enteral nutrition | Nutrient Absorption, nutrient digestion | Info Text: Enteral nutrition formula may be changed to peptide base formula based on feeding tubes, malabsorption or digestion. |
| START DAY ENTERAL NUTRITION | Reject | Start of enteral nutrition is already represented by the outcome: response to enteral nutrition. Which parameters we will assess in detail will be defined during the definitions stage of COSMOGI (Stage 2). | ||
| PROGRESSIVE INCREASE ENTERAL NUTRITION | Reject | Start of enteral nutrition is already represented by the outcome: response to enteral nutrition. Which parameters we will assess in detail will be defined during the definitions stage of COSMOGI (Stage 2). | ||
| NEED TO STOP ENTERAL NUTRITION | Reject | Need to stop is already represented by the outcome: response to enteral nutrition as well as use of parenteral nutrition. Which parameters we will assess in detail will be defined during the definitions stage of COSMOGI (Stage 2). | ||
| CLINICAL STABILITY BEFORE STARTING ENTERAL NUTRITION | Reject | This outcome does not fit into a domain of GI function and does not represent a monitoring of GI function but of overall clinical picture and stability. | ||
| CITRULLINE GENERATION TEST (USING GLUTAMINE) | Reject | This outcome is already represented by citrulline testing. If Citrulline testing is included in stage 2, we will bring up the question of which test exactly should be used. |