Simmons 2008.

Methods	Cluster‐ and cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: long‐stay residents in a care home; free of feeding tube, not receiving palliative care, not on planned weight loss diet Exclusion criteria: not explicitly stated Diagnostic criteria: not stated
Interventions	Number of trial centres: 4 care homes Treatment before trial: not stated
Outcomes	Outcomes reported in abstract of publication: energy intake, weight change; staff time to provide interventions
Study details	At baseline all eligible participants were assessed for responsiveness (15% increase in energy intake) to one of 2 interventions (i.e. feeding assistance or between‐meal snacks). This was a 2‐phase cross‐over trial where residents not eligible in the first phase were re‐evaluated for possible inclusion in the second phase and residents included in the first phase were re‐evaluated and could become ineligible for the second phase (based on adequacy of energy intake) Run‐in period: not stated Was trial terminated early: no
Publication details	Language of publication: English Funding: non‐commercial funding ‐ National Institute of Aging and National Institute of Health, University of California, LA Publication status: peer review journal
Stated aim for study	Quote from publication: "To evaluate the effect of two feeding assistance interventions (meal time assistants and between meal snack delivery) on residents oral food and fluid intake, BMI and weight status when maintained by research staff for 24 weeks"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "Participants were randomised at the facility level..., the four nursing homes were identified as intervention or control (in pairs of two) using a toss of the coin...."
Allocation concealment (selection bias)	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no blinding and outcome likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: no blinding and outcome likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: numbers are described in text and appendix. Mortality given as a reason for most dropouts (58%), but the remaining reasons are not described.
Selective reporting (reporting bias)	Unclear risk	Comment: insufficient information to judge
Other bias	High risk	Comment: baseline characteristics presented for total numbers of participants in each group (phase 1 and 2 combined) Assessment of risk of bias in cluster‐randomised trials (1) Recruitment bias: no (2) Baseline imbalance: frail status (3) Loss of clusters: no (4) Incorrect analysis: no (5) Comparability with individually randomised trials/different types of clusters: different types of clusters