Breedveld‐Peters.
Methods | Randomised clinical trial, the Netherlands | |
Participants | 152 hospitalised adults admitted for hip fracture surgery and aged > 55 years, at nutritional risk due to being frail elderly Male:Female = 44:108 Mean age = 78.5 years Exclusion criteria: Pathological or periprosthetic fracture; a disease of bone metabolism (e.g. M Paget, M Kahler, hyperparathyroidism); an estimated life expectancy < 1 year due to underlying disease; if they used an ONS before hospital admission; if they were unable to speak Dutch, lived outside the region or had been bedridden before their hip fracture, had dementia or were cognitively impaired, defined as a score of < 7 on the Abbreviated Mental Test, as assessed before inclusion |
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Interventions | Experimental group: frequent dietetic counselling and multinutrient ONSs until 3 months after hip fracture surgery (n = 73) Control group: standard dietetic counselling and diet (n = 79) |
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Outcomes | Cost, cost effectiveness, mortality, weight, quality of life | |
Study dates | ||
Notes | The trial had both an inpatient and an outpatient phase. We contacted the authors on 16th December 2015 by email: c.wyers@maastrichtuniversity.nl. We received no reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random‐number sequence list |
Allocation concealment (selection bias) | Unclear risk | The allocation was described as being concealed, but it was unclear how it was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | More than 5% dropouts, and the trial did not allow proper intention‐to‐treat methodology. |
Selective reporting (reporting bias) | High risk | The trial did not report length of stay or rate of complications, which were stated in the protocol. |
For‐profit bias | High risk | The oral nutritional supplements were provided by at nutrition company (Nutricia Advanced Medical Nutrition). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |