Bourdel‐Marchasson 2000.
| Methods |
Cluster‐randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants | 672 critically ill elderly participants; N = 295 intervention (199 female, 96 male); N = 377 control (238 female, 139 male). Mean age in intervention group = 83.6 yrs (SD 7.3) and mean age in the intervention group = 83.0 yrs (SD 7.1) Inclusion criteria: wards inclusion: > 40% of participants over age 65 yrs and nurses able to guarantee significant involvement in the trial. Older than 65 yrs, in acute phase of a critical illness, unable to move by themselves, unable to eat independently on admission Exclusion criteria: pressure ulcers at admission Diagnostic criteria: critically ill inpatients |
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| Interventions | Intervention group received standard diet of 1800 kcal/day plus 2 oral nutritional supplements of 200 kcal each, one with breakfast and the other mid afternoon. Control group received standard diet of 1800 kcal/day Number of trial centres: unclear Treatment before trial: none |
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| Outcomes | Outcomes reported in abstract of publication: energy and protein intakes; incidence of pressure ulcers; serum albumin; Kuntzmann score; Norton score; lower limb fracture | |
| Study details |
Run‐in period: none Was trial terminated early: no |
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| Publication details |
Language of publication: English Funding: non‐commercial/other funding ‐ Projet Hospitalier de Recherche Clinique, Ministere de la Sante et de l'Action Humanitaire, Direction Generale de la Sante and the Direction des Hopitaux Publication status: peer review journal |
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| Stated aim for study | Quote from publication: "The purpose of the present study was to assess the effects of nutritional supplementation (400 kcal/day) for 15 days on dietary intake and on pressure ulcer development in critically ill older patients; 672 subjects older than 65 years were included" | |
| Notes | ‐ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from paper: "Nineteen wards were then selected and stratified according their speciality....These wards were then randomised in two groups according to the nutritional intervention Comment: insufficient detail of method provided |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 25 deaths in intervention group and 22 in the usual care. Other attrition not described |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |
| Other bias | High risk |
Assessment of risk of bias in cluster‐randomised trials (1) Recruitment bias: unclear (2) Baseline imbalance: yes (serum albumin at baseline, weight, Norton score, Kuntzmann mean score) (3) Loss of clusters: unclear (4) Incorrect analysis: no (5) Comparability with individually randomised trials/different types of clusters: different types of clusters |