Botella‐Carretero 2008b.
Methods | Randomised clinical trial, Spain | |
Participants | 90 hospitalised adults 65 years or older undergoing surgery for hip fracture, at nutritional risk due to frail elderly with hip fracture Male:Female = 71:19 Mean age = 83.5 years Exclusion criteria: Adults with moderate to severe malnutrition (those with a weight loss of > 5% in the previous month or > 10% in the previous 6 months from their usual weight or serum albumin concentrations < 2.7 g/dL, or both) acute or chronic renal failure, hepatic insufficiency or cirrhosis (Child B or C), severe heart failure defined as New York Heart Association class III or IV, respiratory failure, and any Gl condition which precluded adequate oral nutrition intake |
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Interventions | Experimental group: Group 3: Energy protein ONSs. Participants received energy and protein supplements by means of commercial enteral nutrition for oral intake (Resource Hiperproteico; Novartis Medical Nutrition, Barcelona, Spain; 200‐mL bricks, with each providing 18.8 g of protein and 250 kcal) to aim at 37.6 g of protein and 500 kcal a day (2 bricks a day). The ONS was started 48 hrs after operation and maintained after hospital discharge.(n = 30) Control group: No intervention(n = 15) Co‐intervention: All were prescribed a standard or texture‐adapted diet to meet the calculated metabolic rate. |
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Outcomes | Changes in serum albumin, prealbumin, retinol‐binding globulin (RBG), BMI, midbrachial circumference, and tricipital fold, tolerance to prescribed ONS, length of hospital stay, postoperative complications, the time from surgery to the start of mobilisation as included in the rehabilitation programme | |
Study dates | February 2006 to February 2007 | |
Notes | We contacted the authors on 6th June 2015 by email: jbotella.hrc@salud.madrid.org about details on data of BMI and complications and risk of bias (random sequence generation and blinding of outcome assessment). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Randomised using sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded, as the control group received no intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 participants did not complete the study and the trial did not use proper methodology to account for the missing data. |
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 | Low risk | The trial was financed by Fundación para la Investigación Biomédica, Hospital Ramón y Cajal Madrid, Spain. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |