Espaulella 2000.
Methods | Randomised, placebo‐controlled clinical trial, Spain. | |
Participants | 171 hospitalised adults hospitalised due to hip fracture, at nutritional risk due to being frail elderly Male:Female = 36:135 Mean age = 82.5 years Exclusion criteria: Younger than 70, advanced dementia, need for IVN, those with pathological fractures or fractures not due to accidental falls |
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Interventions | Experimental group: Oral supplement of 20g protein and 800 mg calcium for 60 days(n = 85) Control group: Placebo (n = 86) Co‐interventions: Normal diet |
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Outcomes | Mortality, complications, functional recovery, use of walking aids | |
Study dates | Not stated | |
Notes | We contacted the authors by email: hguyer@umich.edu. We received no reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated in blocks of 4 |
Allocation concealment (selection bias) | Low risk | Allocation concealment with sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | An independent pharmacist assigned the study number, and prepared the appropriate nutritional supplement. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was unclear how the outcome assessment was blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The pattern of dropouts was not clearly stated, and exceeded 5%. The trial did not use multiple imputation. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report all‐cause mortality or serious adverse events. |
For‐profit bias | High risk | The trial was funded by Clinical Nutrition SA. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |