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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Beck 2015.

Study characteristics
Methods RCT.
Parallel design with 2 arms.
Duration: 12 weeks, follow‐up at 6 months.
Location: single centre in Denmark.
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.
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.
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).
Publication details Language: English.
Funding: a grant from the Danish Regions and the Danish Health Cartel.
Publication status: peer‐reviewed journal.
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.