Simmons 2010.
Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Superiority design |
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Participants |
Inclusion criteria: long stay residents; free of feeding tube; not receiving hospice care; identified for nutritional supplementation Exclusion criteria: not stated Diagnostic criteria: |
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Interventions |
Number of trial centres: 3 Treatment before trial: not stated |
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Outcomes | Outcomes reported in abstract of publication: energy intake, staff time and costs | |
Study details |
Run‐in period: not stated Was trial terminated early: no |
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Publication details |
Language of publication: English Funding: non‐commercial funding ‐ National Alzheimer's Association and National Institute for Aging Publication status: peer review journal |
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Stated aim for study | Quote from publication: "To determine the cost effectiveness of supplements relative to offering residents snack foods and fluids between meals to increase caloric intake" | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote from paper: "Participants....were randomised into one of three groups" Comment: insufficient detail of method provided |
Allocation concealment (selection bias) | Unclear risk | Comment: no detail provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: insufficient detail |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient detail |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: fully reported |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient detail to judge |
Other bias | Unclear risk | Comment: baseline characteristics reported for whole study population and not according to group allocation |