Terp 2018.

Study characteristics
Methods	RCT. Parallel design with 2 arms. Duration: 3 months. Location: Denmark.
Participants	Inclusion criteria: geriatric patients in a university hospital and in the primary healthcare sector in Copenhagen, > 65 years, at nutritional risk at admission (NRS‐2002), BMI < 20.5 kg/m2 and/or weight loss within the last three months and/or a reduced dietary intake in the previous week and/or severely ill). Exclusion criteria: terminal illness, active cancer diagnosis, permanently living in a nursing home, and not willing or able to give an informed consent. Number randomised: 144 participants. Gender split: 32 males, 112 females. Age: mean (SD), intervention group 87 (6) years; control group 88 (6) years. Nutritional status: mean (SD) BMI, intervention group 19.6 (2.0) kg/m2; control group 19.7 (2.8) kg/m2.
Interventions	Intervention: participants received dietary advice plus ONS if required in the form of an individual dietary plan, based on everyday food, if relevant combined with oral nutritional supplements, by a dietitian for each participant including advice on nutritional intake after discharge. After discharge, participants received a prescription for oral nutritional supplements, funded by the participants and 3 follow‐up visits conducted by a district nurse or a healthcare assistant were scheduled at 1, 4, and 8 weeks after discharge. Control: participants received no dietary advice and no ONS in the form of usual care i.e. weekly monitoring of nutritional status. The nursing staff completed the screening for nutrition risk at admission and the clinical dietician was involved in the process if the participant had specific needs and gave dietary advice and prepared a dietary plan for nutrition intake while they were hospitalized. At discharge, any nutritional problems were documented in the discharge summary, but no follow‐up on those who were at nutritional risk was planned.
Outcomes	Change in body weight*, Barthel Index, handgrip strength* and self‐rated health from baseline (discharge) to 3 months after discharge, readmission*, and mortality* (90 and 120 days).
Publication details	Language: English. Funding: work was supported by the Capital Region of Denmark. Publication status: peer‐reviewed journal.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: Randomization was performed using a computer‐generated randomization table. An equal distribution among intervention and control was achieved by blocks.
Allocation concealment (selection bias)	Low risk	Quote: The treatment allocation was written and stored in sequentially numbered opaque envelopes and was opened by a study personnel immediately after the participant had given informed consent. The randomization was performed before collection of baseline data.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	Comment: Not blinded, clinical outcomes were unlikely to have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Functional outcomes	High risk	Comment: Not blinded, functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	Comment: Not blinded, 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 103 (72%) participants completed the 2nd data collection; 21 participants died (12 in the intervention group and 9 in the control group); 8 participants withdrew (4 in the intervention group and 4 in the control group); 12 participants were unable to participate (6 in the intervention group and 6 in the control group). Numbers and reasons for attrition balanced between groups.
Selective reporting (reporting bias)	Low risk	Study protocol identified CliniclTrials NCT03131856 all planned outcomes were reported.
Other bias	Low risk	Baseline characteristics were similar between groups.