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. |