Kendell 1982.
Study characteristics | ||
Methods | RCT. Parallel design with 2 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 n = 12; control group n = 12). Attrition: 100% follow‐up. Gender split: 5 males and 19 females. Age: mean (SD) 25 (8.1) years. Nutritional status: 12 out of 24 participants had a weight below IBW at inclusion. |
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Interventions |
Intervention group: 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 calculated energy requirements. Control group: participants received dietary advice alone in the form of dietary instruction given verbally and in writing. |
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Outcomes | Survival*, body weight*, MAUC, MAMC*, TSF*, serum chemistry and creatinine height index, macro and micronutrient intake, length of hospital stay. | |
Publication details |
Language: English Funding: Publication status: peer‐reviewed journal |
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Notes | Data not available from authors. | |
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 | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not reported |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not reported. |
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 was influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% follow‐up. |
Selective reporting (reporting bias) | High risk | All outcomes reported but using general statements e.g. 'at each time interval, there were no statistically significant differences in body weight, MAC, TSF and creatinine height index between the experimental and control groups'. Data presented in table as % deficit and data not available from the authors, therefore risk of bias due to partial reporting. |
Other bias | Unclear risk | Baseline variables not given, no information available from authors, not sure if groups similar at baseline. |