| Methods |
Method of randomisation: Cluster randomised
Assessor blinding: no
Intention to treat: carried out
Lost to follow‐up: intervention 0; control 0
Timing of the intervention: 15 days or less if discharged
Length of follow‐up: 15 days |
| Participants |
Location: Bordeaux, France
672 patients
Inclusion criteria: Ward had >40% of patients >65years, patients in an acute phase of critical illness, unable to move by themselves, unable to eat independently at admission
Exclusion criteria: patients with pressure ulcers on admission
Sex: 437 female, 235 male
Age: 83.6 (SD7.3), 83.0 (7.1) |
| Interventions |
a: 2 x 200 kcal commercial supplements with breakfast and mid afternoon (400 kcal, 30g protein) and assistance with meals
b: usual nutritional care
Allocated: 295/377 (Cluster randomised)
Assessed: 295/377 |
| Outcomes |
Main outcomes: mortality, pressure ulcers
Additional outcomes: Measures of dietary intake ‐energy and protein intake |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
