Rabeneck 1998.

Study characteristics
Methods	RCT. Parallel design with 2 treatment arms. Duration: 6 weeks. Location: multicentre trial in the USA.
Participants	Inclusion criteria: adults with HIV infection who were < 90% ideal weight or who had > 10% weight loss in previous 6 months. Exclusion criteria: dysphagia, severe diarrhoea, cytomegalovirus, or mycobacterium avium complex infection, suspected untreated infection, or a diagnosis of infection or hospitalisation within the previous 2 weeks. Number randomised: 118 participants (intervention group, n = 50; control group, n = 52). Attrition: 28 dropouts (intervention group, n = 16; control group, n = 12). Gender split: all males. Age: mean (SD), intervention group 39.3 (8.8) years; control group 41.1 (9.7) years. Nutritional status: mean (SD) BMI, intervention 20.6 (3.0) kg/m2; control 21.0 (2.6) kg/m2.
Interventions	Intervention: participants received dietary advice and ONS in the form of nutritional counselling to achieve target and an oral nutritional supplement. Control: participants received dietary advice alone in the form of nutritional counselling to achieve specific energy target.
Outcomes	Weight*, MUAC*, skinfold measurements at all sites*, body composition (BIA)*, grip strength*, cognitive function, QoL, energy intake*.
Publication details	Language: English. Funding: the study was supported by Mead Johnson. Publication status: peer‐reviewed journal.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised, but method not stated.
Allocation concealment (selection bias)	Unclear risk	Method not reported.
Blinding (performance bias and detection bias) Clinical outcomes	Unclear risk	No objective clinical outcomes measured.
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	High risk	The study was unblinded. Functional and nutritional outcomes could have been influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	16 dropouts in intervention group (dietary counselling and supplements) and 12 dropouts in control group (dietary counselling); reasons for dropouts reported for the 19 participants who failed to complete at least 4 weeks of the 6‐week treatment period.
Selective reporting (reporting bias)	Unclear risk	No study protocol identified, thus unable to judge whether all planned outcomes were reported. Specified outcomes extracted from paper. No data obtained from the author.
Other bias	Low risk	Baseline variables given, groups similar at baseline.