Leslie 2012.
| Methods |
Cluster‐randomised controlled trial Randomisation ratio: 1:1 Superiority design |
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| Participants | 41 people living in residential care homes, 36 female, 5 male, mean age 91(SD 7) years Inclusion criteria: BMI < 18.5 kgm2, without acute disease Exclusion criteria: not described Diagnostic criteria: mixed diagnoses, people living in residential care homes |
|
| Interventions | Provision of energy enriched meals vs usual care Number of trial centres: 21 residential care homes Treatment before trial: not described |
|
| Outcomes | Outcomes reported in abstract of publication: energy intake, weight and BMI | |
| Study details |
Run‐in period: no Was trial terminated early: no |
|
| Publication details |
Language of publication: English Funding: commercial funding ‐ GlaxoSmithKline Publication status: peer review journal |
|
| Stated aim for study | Quote from publication: "To examine whether the nutritional status of aged undernourished residents in care could be improved through dietary modification to increase energy intake but not portion size" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "Random permuted block design, stratified by home type (dementia/no dementia) by a statistician who had no contact with the homes" Comment: insufficient detail of method provided |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "Allocation made post recruitment and baseline screening by a statistician who had no contact with the homes" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not mentioned. As energy enrichment was of usual meals it would have been possible to blind participants to the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not mentioned. Assessment of weight and food intake might have been influenced by knowing the study group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: the number of participants that dropped out and the reasons are given |
| Selective reporting (reporting bias) | Low risk | Comment: all specified outcomes are reported |
| Other bias | High risk |
Assessment of risk of bias in cluster‐randomised trials (1) Recruitment bias: no (2) Baseline imbalance: unclear (3) Loss of clusters: unclear (4) Incorrect analysis: no (5) Comparability with individually randomised trials/different types of clusters: different types of clusters |