| Methods |
Method of randomisation: sealed opaque envelopes, prepared independently from recruitment
Intention‐to‐treat analysis: unclear
Lost to follow‐up: details given |
| Participants |
Location: Hospital Ramon y Cajal, Madrid, Spain
Period of study: February 2006‐February 2007
90 participants
Inclusion criteria: > 65 years, surgery for hip fracture, written informed consent
Exclusion criteria: weight loss > 5% in previous month or > 10% in previous 6 months, and/or albumin < 27 g/dL. Acute or chronic renal failure, hepatic insufficiency or cirrhosis (Child B or C), severe heart failure (New York heart classification III or IV), respiratory failure, gastrointestinal condition precluding adequate oral intake. Also: previous oral nutrition supplements or nutrition support in previous 6 months.
Sex: 71 female, 19 male
Age: mean age 84 years
Fracture type: 58% gamma nail surgery (presumed extracapsular fractures), 42% total hip replacement (presumed intracapsular fractures) |
| Interventions |
Timing of intervention: started 48 h after operation, until hospital discharge
(a) Four 10 g packets a day of Vegenat‐med Proteina (Vegenat SA, Badajoz, Spain) each providing 9 g protein and 38 kcal, dissolved in water, milk or soup from diet
(b) Two 200 ml bricks a day (Resource Hiperproteico, Novartis Medical Nutrition, Barcelona) providing total of 37.6 g protein and 500 kcal
(c) no oral nutrition supplements
Allocated: 30/30/30
Assessed: 28/30/27 |
| Outcomes |
Length of follow‐up: up to hospital discharge
Main outcomes:
Mortality
Complications: urinary, respiratory, wound infection; pressure ulcer, dysphagia, ischaemic heart disease; severe hyponatraemia; anaphylaxis; vomiting and/or diarrhoea
Length of acute hospital stay
Level of care: time to mobilisation
Other outcomes:
Energy and protein intake |
| Notes |
Emailed 22 January 2009 requesting mortality information. Author replied 23 January confirming no participants had died during the trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States "randomized" only. No further details provided |
| Allocation concealment (selection bias) |
Low risk |
States used of "sealed opaque envelopes". Independent preparation of envelopes: "The investigator recruiting the patients ....had no role in the randomisation process" |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No placebo provided |
| Blinding of outcome assessment (detection bias)
Primary outcomes |
Low risk |
No details provided on blinding of outcome assessment, but outcome assessment unlikely to have been influenced by unblinding. |
| Blinding of outcome assessment (detection bias)
Secondary and other outcomes |
Unclear risk |
No details provided on blinding of outcome assessment, and outcome assessment may have been influenced by unblinding |
| Incomplete outcome data (attrition bias)
Primary outcomes |
Low risk |
All participants accounted for in analysis |
| Incomplete outcome data (attrition bias)
Secondary and other outcomes |
Unclear risk |
Denominators unclear for length of hospital stay, length of immobilisation and supplement intake |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient details provided |
| Other bias |
Unclear risk |
Funding source (Fundacion para la Investigacion Biomedica, Hospital Ramon y Cajal, Madrid, Spain) and source of supplemental nutrition (Hospital Ramon y Cajal) do not appear related to manufacturer of the supplements. |
