Olejko 1984.
Study characteristics | ||
Methods | RCT. Parallel design with 3 treatment arms. Duration: 6 weeks. Location: single centre in the USA. |
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Participants |
Inclusion criteria: adults awaiting elective orthognathic surgery. Exclusion criteria: not specified. Number randomised: 24 participants (intervention group 1, n = 8; intervention group 2, n = 8; control group, n = 8). 100% follow‐up. Gender split: 12 males, 12 females. Age: mean (SD), 22.8 (6.1) years. Nutritional status: 12 of 24 participants had a weight below IBW at study inclusion. Mean BMI can be calculated from individual participant data (mean BMI 22). |
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Interventions |
Intervention (intervention group 1): participants received dietary advice and ONS in the form of dietary instruction and an oral nutritional supplement (1.5 kcal/mL) to provide 50% of energy requirements. Intervention (intervention group 2): participants received dietary advice and ONS in the form of dietary instruction, an oral nutritional supplement (1.5 kcal/mL) to provide 50% of energy requirements and a nutritional supplement to take preoperatively. Control: participants received dietary advice alone in the form of dietary instruction given verbally and in writing. |
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Outcomes | Survival*, body weight*, MUAC*, MAMC*, TSF*, serum chemistry and creatinine height index, macro and micronutrient intake. | |
Publication details |
Language: English. Funding: not reported. Publication status: peer‐reviewed journal. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, method not reported. |
Allocation concealment (selection bias) | Unclear risk | Method not reported. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Not reported, but the nature of the study suggests that the study was unblinded. However, it is unlikely that knowing groups assignment would have influenced clinical outcomes. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Not reported, but the nature of the study suggests that the study was unblinded. Functional outcomes could have been influenced by lack of blinding. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Not reported, but the nature of the study suggests that 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 | Unclear risk | Judged to be unclear because of low risk for clinical outcomes and high risk for functional and nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% follow‐up. |
Selective reporting (reporting bias) | High risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. All outcomes were reported but using general statements about change rather than numerical presentation e.g. 'the pre‐load group reported an average weight gain of 3.1% during the one month pre‐operative period, which was significantly greater (P < 0.05) than that of the other two groups'. No data are available from the authors therefore unclear risk of bias due to partial reporting. |
Other bias | Unclear risk | Baseline variables not given, not sure if groups similar at baseline. |