Crit Care Resusc
-
Observational Study
Faecal diversion system usage in an adult intensive care unit.
To determine the frequency, indications and complications associated with the use of faecal diversion systems (rectal tubes) in critically ill patients. ⋯ Rectal tubes appear to be frequently inserted and can lead to major adverse events in critically ill patients.
-
Comparative effectiveness research can help guide the use of common, routine medical practices. However, to be safe and informative, such trials must include at least one treatment arm that accurately portrays current practices. While comparative effectiveness research is widely perceived as safe and to involve no or only minimal risks, these assumptions may not hold true if unrecognised deviations from usual care exist in one or more study arms. ⋯ Furthermore, unrecognised unusual care seems likely to corrupt informed consent documents, with underappreciated risks shrouded under the reassuring "comparative effectiveness" research label. At present, oversight measures are inadequate to ensure that research subjects enrolled in comparative effectiveness trials are actually receiving usual and not unusual care. Oversight by governmental and non-governmental entities with appropriate expertise, empowered to ensure that current clinical practice has been properly represented, could help prevent occurrences in clinical trials of unusual care masquerading as usual care.