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. 2016 Dec 20;2016(12):CD009840. doi: 10.1002/14651858.CD009840.pub2

Larsson 1990.

Methods Parallel randomised controlled clinical trial
Randomisation ratio: 1:1
Superiority design
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
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
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
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
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)