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

Akpele 2004.

Study characteristics
Methods Pilot RCT.
Duration: mean 7.5 months (longest follow‐up 14 months).
Location: USA.
Participants Inclusion criteria: adults (> 18 years), receiving haemodialysis three times weekly for a minimum of 6 months, serum albumin < 3.5g/dL, MNA score < 23.5.
Exclusioncriteria: co‐morbidities or medical illness that reduced life expectancy to less than 6 months.
Number randomised: 40; attrition: none described.
Diagnosis: CKD receiving haemodialysis.
Age (mean): dietary advice group 61.5 years; supplement group 66.6 years.
Gender split: not reported.
Nutritional status: serum albumin <3.5g/dL, MNA score <23.5.
Interventions Intervention (intervention group 1): participants received dietary advice in the form of intensive dietary counselling.
Intervention (intervention group 2): particpants received ONS in the form of 1 ‐ 2 cans of Nepro daily in addition to usual diet.
Outcomes Rate of change of serum albumin.
Publication details Language: English.
Funding: not declared.
Publication status: peer‐reviewed journal.
Notes No outcomes usable for this review reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information/detail.
Quote: "subjects were randomised".
Allocation concealment (selection bias) Unclear risk Insufficient information/detail.
Quote: "subjects were randomised".
Blinding (performance bias and detection bias)
Clinical outcomes Low risk Not described but unlikely that assessment of clinical outcomes would be influenced by lack of blinding.
Blinding (performance bias and detection bias)
Functional outcomes Unclear risk No functional outcomes assessed.
Blinding (performance bias and detection bias)
Nutritional outcomes High risk Not reported but likely that assessment of nutritional outcomes would be influenced by lack of blinding.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described 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 were influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described and likely that assessment of some outcomes would be influenced by lack of blinding.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No attrition reported.
Selective reporting (reporting bias) High risk No protocol identified. Some outcomes described in the methods not reported (nutritional intake, hospital admissions, missed treatments and weight).
Other bias Low risk Baseline characteristics compared and Chi² tests used for difference. No statistically significant differences between groups.