Larsson 1990.
Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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Participants |
Inclusion criteria: people with an expected hospital stay of more than 3 weeks, admitted consecutively to a long‐term medical care clinic Exclusion criteria: not stated Diagnostic criteria: diagnosis of participants included: malignancy, endocrine, neurological, heart, vascular, respiratory, musculoskeletal, fracture |
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Interventions | Intervention group received nutritional supplementation (400 kcal) in the morning and afternoon between meals, when all patients on the ward were routinely supplied with drinks, as well as standard hospital diet. The usual care received standard hospital diet alone Number of trial centres: 1 Treatment before trial: none described |
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Outcomes | Outcomes reported in abstract of publication: anthropometry, serum protein analysis, delayed hypersensitivity skin test, mobility, general physical condition, food intake | |
Study details |
Run‐in period: none Was trial terminated early: no |
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Publication details |
Language of publication: English Funding: commercial/other funding ‐ Swedish Medical Research Council, Research Fund of the County of Ostergotland, Kabi Nutrition Publication status: peer review journal |
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Stated aim for study | Quote from publication: "to investigate the relationship between nutritional state and the development and healing of pressure sores in patients in a long term care clinic" (page 245). Larsson: "to evaluate the effect of dietary supplements on clinical outcome and nutritional status in a large group of geriatric patients" (Ek 1991) | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "Randomisation was carried out by means of sealed envelopes containing group designation". Comment: insufficient information provided about the sequence generation process |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: number of study dropouts presented in figure but unclear which group they belong to and the reason |
Selective reporting (reporting bias) | Low risk | Comment: data not reported at all time points for all outcomes |
Other bias | High risk | Comment: significant differences between groups at baseline in TSF and weight index in men, and AMC in women were significantly lower in experimental than the usual care. The supplemented group also had a significantly lower mental score on admission (Unosson 1992) |