Beck 2015.
Study characteristics | ||
Methods | RCT. Parallel design with 2 arms. Duration: 12 weeks, follow‐up at 6 months. Location: single centre in Denmark. |
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Participants |
Inclusion criteria: > 70 years of age, hospitalised at the wards of Geriatric Medicine and Orthopaedic Surgery, at nutritional risk according to the level 2 screening in NRS 2002 and planned to be discharged to their private home assisted by the discharge Liaison‐Team. Exclusion criteria: dementia or terminal disease, impaired renal function (GFR < 30 mL/min/1.73 m²), unable to understand the Danish language, nursing homes or rehabilitation homes, incapable of performing hand‐grip test, planning a weight‐reducing diet, no informed consent. Number randomised: 71 adults. Gender split: 23 males, 48 females. Age: data not reported (all greater than 70 years). Nutritional status: all at nutritional risk assessed using NRS 2002. |
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Interventions |
Intervention: participants received dietary advice plus ONS if required in the form of visits from the Liaison‐Team in cooperation with a dietician (who made 3 home visits over a period of 12 weeks). Control: participants received no dietary advice and no ONS in the form of visits from the Liaison‐Team without dietitian. |
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Outcomes | Nutritional status (weight*, and dietary intake*), muscle strength (hand‐grip strength*, chair stand), functional status (mobility, and activities of daily living), QoL (EQ‐5D), use of social services, rehospitalisation and mortality*, costs. The economic analysis of time spent by the dietitian, use of oral nutritional supplements and number of hospitalisation days was described by Pohju et al (2016). |
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Publication details |
Language: English. Funding: a grant from the Danish Regions and the Danish Health Cartel. Publication status: peer‐reviewed journal. |
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Notes | Outcomes were presented as median change scores in the article. In the review we used the mean change scores which were provided by the authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: Simple randomisation was used, i.e. each allocation was written on paper, concealed in an opaque envelope. The opaque envelopes were gathered in a jar from which the patients drew a lot after recruitment. |
Allocation concealment (selection bias) | Low risk | Quote: ... each allocation was written on paper, concealed in an opaque envelope. The opaque envelopes were gathered in a jar from which the patients drew a lot after recruitment. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | The study was unblinded. However, this is unlikely to influence clinical outcomes. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | The study was unblinded. Functional outcomes could have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | The study was unblinded. Nutritional outcomes could have been influenced by lack of blinding. |
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 functional and nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A total of 63 (89%) participants completed the second data collection; 8 participants died (2 (6%) in the intervention group and 6 (16%) in the control group). |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. |
Other bias | Low risk | Baseline characteristics were similar between groups. |