McMurdo 2009.
Study characteristics | ||
Methods | RCT (2 centres) | |
Participants | Setting: Dundee and Glasgow, Scotland, United Kingdom N = 253 Sample: people admitted to hospital with acute illness who appeared undernourished (61% women) Age (years): mean 82 (SD 62) Inclusion criteria: consenting; community‐dwelling; aged ≥ 70; admitted to the hospital with an acute illness; BMI < 24.0 kg/m2 and mid‐arm muscle circumference below the 10th centile or weight loss of 5% or more during the hospital stay Exclusion criteria: Barthel Index > 8, chronic liver disease or renal failure (serum creatinine 43.39 mg/dL); residence in a care home; cognitive impairment precluding informed consent; dysphagia; metastatic carcinoma or other terminal illness; acute inflammatory arthritis; stroke affecting both hands; major surgery within the preceding month |
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Interventions | 1. Oral nutritional supplementation (400 mL/day of Fresubin, Fresenius Kabi Ltd, Runcorn, Cheshire, UK: 600 kcal, 2520 kJ, 40 g protein, a nutritionally complete liquid protein and energy supplement) 2. Control: matching control supplement (based on skim milk containing minimal energy: 200 kcal, 840 kJ, 12.4 g protein content) in identical packaging |
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Outcomes | 1. Number of people falling Falls are a secondary outcome in this study. Other outcomes reported but not included in this review | |
Duration of the study | 4 months | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was stratified according to site, in random permuted blocks of 4. An individual not involved in the study prepared the randomization schedule from computer‐generated random number tables." |
Allocation concealment (selection bias) | Low risk | Quote: "Participants were allocated to oral nutritional supplementation ... or to a matching control supplement ... Both preparations were packaged in identical 200‐mL plain white rectangular cartons and labeled using one of two randomization codes." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both preparations were packaged in identical 200‐mL plain white rectangular cartons and labeled using one of two randomization codes." |
Blinding of outcome assessment (detection bias) Falls and fallers | Low risk | Likely to be low given that the participants were blinded to contents of supplement and "... observations were recorded blind to treatment allocation" |
Incomplete outcome data (attrition bias) Falls | Unclear risk | SeeAppendix 3 for method of assessment |
Incomplete outcome data (attrition bias) Fallers | Low risk | SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls | Unclear risk | Quote: "Falls were recorded prospectively using the validated daily diary method." But no mention of telephone contact or frequency of return. |