Vivanti 2015.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: starting at the emergency department with follow‐up at 12 weeks. Location: Australia. |
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Participants |
Inclusion criteria: malnourished adults (MST, confirmed with SGA) aged 60 years or over, presenting to the emergency department. Exclusion criteria: unable to provide informed consent, triage category 1 (highest priority), already receiving dietetic care, admitted from a healthcare facility (including nursing home). Number randomised: 24 participants (intervention group, n = 10, control group, n = 14). Attrition: 5 participants (intervention group, n = 1; control group, n = 4). Gender split: 10 males, 14 females. Age: mean (SD) 79.0 (7.7) years. Nutritional status: assessed using the MST and confirmed with SGA, 21/24 (88 %) participants diagnosed with malnutrition. |
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Interventions |
Intervention: participants received dietary advice plus ONS if required in the form of individualised dietary counselling at baseline when nutrition goals and strategies were made in collaboration with the dietitian in the emergency department following standard medical nutrition therapy practice; follow‐up at a minimum of weeks 4 and 8, by telephone review or home visit or both. Strategies included both food‐based advice and use of ONS depending on the needs of the patient*. Control: participants received no dietary advice and no ONS in the form of regular treatment through community hospital interface programme nursing staff and community support. |
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Outcomes | Weight change, length of stay, QoL (EQ‐5D), depression, further decline in nutritional status, number of falls (self‐recorded). | |
Publication details |
Language: English. Funding: Queensland Health allied health grants. Publication status: peer‐reviewed journal. |
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Notes | *information on nutrition strategies obtained from the authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A statistician‐generated randomised sequence. |
Allocation concealment (selection bias) | Low risk | Sealed in sequentially numbered opaque envelopes. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | The intervention group received usual care + individualised dietary care. This suggests that both treating dietitians and participants were aware of group allocation. The emergency department dietitian provided dietary counselling to the participants in the intervention groups and performed the following follow‐up measurements in both groups: malnutrition screening tool and subjective global assessment. Data on death, malnutrition diagnosis, number of presentations to the emergency department, days of unplanned hospital admissions and pressure ulcers were recorded from health information management and emergency department information systems. Clinical outcomes were unlike to be influenced by knowing group assignment. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Blinding of assessment of depression not described and the outcome might have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional 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 participants and personnel (performance bias) All outcomes | High risk | Participants and the treating dietitian were aware of group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judged to be unclear, as low risk for clinical outcomes and high risk for nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition: intervention group n = 1; control group n = 4, due to withdrawal and death. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. |
Other bias | Unclear risk | No description of baseline characteristics. |