Anbar 2014.
Study characteristics | ||
Methods | Prospective RCT (unblinded). Parallel design. Duration: data collected up to 14 days or discharge (including pre‐op period). Location: single centre (Petah Tikva, Israel). |
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Participants |
Inclusion criteria: aged > 65 years and admitted within 48 hours of injury to an orthogeriatric unit following hip fracture; orthopedic surgery considered the treatment of choice. Exclusion criteria: presented to hospital > 48 hours after injury, receiving steroids and/or immunosuppression therapy; presence of active oncologic disease, multiple fractures, diagnosed dementia or in the event that participants required supplemental nasal oxygen which precludes the measurement of REE. Number randomised: 50 participants: intervention group n = 22; control group n = 28. Gender split: intervention group 6 (27%) male and 16 (73%) female; control group 11 (39%) male and 17 (61%) female. Age: mean (SD) intervention group 82.3 (6.1) years; control group 83.7 (6.4) years. Nutritional status: BMI, mean (SD): intervention group 25.2 (3.2) kg/m²; control group 24.7 (4.4) kg/m². |
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Interventions |
Intervention: participants received dietary advice plus ONS in the form of a hospital‐prepared diet plus ONS (355 kcal/237 mL and 13.5 g protein or 237 kcal/237 ml and 9.9 g protein/237 mL), adjusted to meet energy goals which were determined by repeated resting energy expenditure measurements using indirect calorimetry; participants, family and caregivers educated regarding the importance of nutritional support and more attention was given to personal food preferences. Control: participants received no dietary advice and no ONS in the form of usual hospital food (standard or texture adapted) and a fixed dose of oral nutritional supplement if already prescribed prior to hospitalisation. |
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Outcomes |
Primary outcomes Postoperative complications (i.e. surgical, infectious, cardio‐vascular, gastro‐intestinal, deep vein thrombosis and new pressure sores). Length of hospital stay. Secondary outcomes Energy intake. Calculated energy balance. |
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Publication details |
Language: English. Funding: not stated. Publication status: peer‐reviewed journal. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: Randomisation was performed using a concealed, computer‐generated program. |
Allocation concealment (selection bias) | Low risk | Quote: use of a consecutively numbered opaque envelope. |
Blinding (performance bias and detection bias) Clinical outcomes | High risk | Quote: Patients were examined daily by the research nurse and attending physician for the presence of postoperative complications. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | Not blinded and lack of blinding might have affected assessment of outcomes. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Quote: The nutrient intake of each patient was monitored by the research team on a daily basis. |
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 | Some outcome assessors were aware of group allocation and this might have affected assessment of some outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study with no drop‐outs. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. |
Other bias | Low risk | Baseline characteristics were similar in both groups. |