Gray‐Donald 1995.
Methods | Randomised controlled trial.
Duration 12 weeks. Stratified randomisation according to gender and nutritional risk. |
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Participants | Elderly people living at home (n = 50, mean age 78 years) with involuntary weight loss of >5% in last month, >7.5% in last 3 months, >10% in last 6 months and BMI <27 or BMI <24. 4 deaths, 3 in the supplement group and 1 in the dietary counselling group. | |
Interventions | Weekly visits from a dietitian with dietary counselling (n = 25) versus weekly visits from a dietitian and 2 x 235 ml of a nutritional supplement (n = 25). | |
Outcomes | Survival*, body weight*, MAMC*, MUAC skinfold (triceps*, subscapular, suprailliac), energy intake*, handgrip strength*, perception of health, general well‐being score, number of falls. | |
Notes | Additional data and information on quality obtained from authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratified randomisation according to gender and nutritional risk. |
Allocation concealment (selection bias) | Low risk | Information from author indicates that sealed envelopes were used. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Clinical outcomes assessed blind. |
Blinding (performance bias and detection bias) Functional outcomes | Low risk | Functional outcomes assessed blind. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Nutritional outcomes not assessed blind. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 deaths, 3 in the supplement group and 1 in the dietary counselling group. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported and data on mortality, change in weight, TSF, MAMC were extracted from the paper. Data on energy intake are presented as mean change in daily intake averaged over 3 months, therefore mean change (SD) from baseline to 3 months has been obtained from the authors. Data on grip strength are presented as a mean (SD) at baseline and at end of intervention, therefore mean change (SD) obtained from the author. |
Other bias | Unclear risk | Baseline variables given, appetite was better in advice group than supplement group. |