Beattie 2000.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: 10 weeks. Location: single centre in the UK. |
|
Participants |
Inclusion criteria: adults resuming oral food intake after surgery with BMI < 20 kg/m², TSF or MAMC < 15th percentile or > 5% weight loss. All participants had an MNA score 20 or less. Exclusion criteria: requiring parenteral nutrition, pregnant or lactating, with terminal illness, decompensated liver or renal disease. Number randomised: 101 adults (both men and women). Gender split: 41 females, 60 males. Age: mean (SD); intervention group 54.4 (19.4) years; control group 62.4 (10.9) years. Nutritional status: on inclusion to study defined as mild (BMI <20 kg/m2), moderate (BMI <18 kg/m2), severe (BMI <16 kg/m2) normal (BMI 20‐25 kg/m2), overweight (BMI >25 kg/m2); intervention group severe 1, moderate 5, mild 29, normal 13, overweight 4; control group severe 2, moderate 9, mild 19, normal 16, overweight 3. nb. participants with normal or overweight BMI had weight loss >5% at inclusion. |
|
Interventions |
Intervention: participants received dietary advice and ONS in the form of routine nutritional management and 400 mL of a 1.5 kcal/mL nutritional supplement. Control: participants received dietary advice alone in the form of routine nutritional management. |
|
Outcomes | Survival*, weight*, BMI*, MAMC*, TSF*, handgrip strength*, complication rate, wound infection, chest infection, antibiotic use, QoL. | |
Publication details |
Language: English. Funding: this study was funded by Abbott Laboratories. Publication status: peer‐reviewed journal. |
|
Notes | Routine nutritional management provided by more than one dietitian and not described in the paper. Information on quality obtained from authors. Information on QoL not added to meta‐analyses as only scores for physical and mental QoL were provided in the manuscript ‐ global QoL missing. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using a computer‐generated list of random numbers. |
Allocation concealment (selection bias) | Low risk | The allocation was not concealed physically but the list of numbers was not consulted until the participant was recruited. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | The paper states that assessors were not blinded to treatment. However, it unlikely that morbidity is influenced by lack of blinding. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | No functional outcomes reported. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | The paper states that assessors were not blinded to treatment. Nutritional status and QoL outcomes can be influenced by assessors knowing group allocations. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judged to be unclear because low risk for clinical outcomes and high risk for nutritional and QoL outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8/101 (8%) attrition, 3 drop outs in intervention group (advice plus supplements) (transferred to intensive care unit n = 1, required artificial nutritional support n = 2) and 5 dropouts in control group (routine nutritional management group) (lost to follow‐up n = 2, required artificial nutritional support n = 3). |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. Data for analysis were extracted from the paper. Additional information on study quality obtained from authors. QoL data were not complete, only physical and mental health data provided |
Other bias | Unclear risk | Baseline variables provided, but groups not similar ‐ group receiving advice plus supplements was younger by almost 10 years than the advice only group. Routine nutritional management provided by more than one dietitian and not described in the paper. |