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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

Botella‐Carretero 2010.

Methods Randomised clinical trial, Spain
Participants 60 hospitalised adults with hip fractures, at nutritional risk due to hip surgery
Male:Female = 16:44
Mean age = 83.5 years
Exclusion criteria: "Patients with moderate–severe malnutrition (those with a weight loss of more than 5% in the previous month or more than 10% in the previous 6 months from their usual weight, and/or serum albumin concentrations below 2.7 g/dL) were automatically excluded from the study. All of these patients receive supplementation according to our Institution protocol, following current guidelines. Other exclusion criteria were acute and/or chronic renal failure, hepatic insufficiency or cirrhosis (Child B or C), severe heart failure with class III or IV of the New York Heart Association (NYHA), respiratory failure, and any gastrointestinal condition that may preclude from adequate oral nutritional intake. None of the patients had been on ONS from the previous 6 months, or had received any nutritional support by any other means.
Interventions Experimental group: Oral nutrition energy and protein support by means of commercial enteral nutrition for oral intake (Fortimel, 200 mL bricks, each provides 20 g protein and 200 kcal, Nutricia Advanced Medical Nutrition ‐ Danone Group) to aim at 40 g of protein and 400 kcal a day (2 bricks a day). The treatment was started at admission, before surgery and maintained until the day of hospital discharge. (n = 30)
Control group: No intervention (n = 30)
Co‐interventions: Every adult was prescribed a standard or texture‐adapted diet to meet their calculated metabolic rate.
Outcomes Mortality, serum proteins, BMI, postoperative complications, weight, postoperative hospital stay, time of immobilisation after surgery
Study dates May 2007 to September 2008
Notes We contacted the authors on 6th June 2015 by email: jbotella.hrc@salud.madrid.org about data on BMI, weight and complications, which could not be extracted from the full text.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Low risk The randomisation was concealed by means of sealed opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants were not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The procedure of blinding was insufficiently described.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Intention‐to‐treat analysis was performed with the last observation carried forward to evaluate data of all participants at hospital discharge. There were incomplete data for 32 participants.
Selective reporting (reporting bias) Low risk The protocol could not be obtained, but the study reported on mortality and complications.
For‐profit bias Low risk One of the Researchers, B.I. was supported by the Fundación para la Investigación Biomédica Hospital Ramón y Cajal (FIBio‐RyC), Madrid, Spain.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.