Norman 2008b.
| Methods | Randomised controlled trial. Duration 3 months. | |
| Participants | Adults (n = 101) with benign gastrointestinal disorders (gender not stated). Intervention group mean age 52.2 (SD 16.5), control group mean age 53.6 (SD 16.8). All malnourished according to SGA (grade B or C). 21 dropouts, 10 intervention group (withdrew before baseline) and 11 lost to follow‐up in the control group. |
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| Interventions | Dietary counselling from a dietitian to increase energy and protein intake from food and up to 3 x 200 ml Fresubin protein energy drinks (n = 48) versus dietary counselling to increase energy and protein intake from food (n = 48). | |
| Outcomes | Energy intake*, weight*, height, BMI*, TSF*, MUAC*, body composition (BIA), handgrip strength*, length of stay, number of readmissions*, number of prescribed drugs on discharge, peak expiratory flow. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated list. |
| Allocation concealment (selection bias) | Low risk | Operated by co‐worker not involved in the study. |
| Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 21 dropouts:
Dietary counselling and supplement group: 10 withdrew before baseline;
Dietary counselling alone: 11 lost to follow‐up. Also, in the dietary counselling and supplement group 8 known to not take the supplement, but included in the ITT analysis. In the dietary counselling group, 4 reported consuming nutritional supplements during the study period. |
| Selective reporting (reporting bias) | Low risk | All specified outcomes reported but not all in a format usable for meta‐analysis. Data on mean change (SD) for weight and grip strength were extracted from the paper. Data on TSF and MUAC were not presented but were assessed and so have been obtained from author. Details of hospital admissions are not reported clearly and therefore have been clarified with the authors. |
| Other bias | Low risk | Baseline characteristics described in text as not different and data given for some variables. |