Methods |
Method of randomisation: alternating number
Assessor blinding: blinded
Intention to treat: carried out
Lost to follow‐up: no losses to follow‐up
Timing of intervention: from second day of admission until discharge |
Participants |
Location: hospital, Ipswich, UK
10 patients
Inclusion criteria: thin (based on weight for height, triceps skinfold, mid‐arm circumference ‐ two out of three more than one standard deviation below reference mean), elderly, females with hip fracture
Exclusion criteria: malignant disease, mental illness, renal or hepatic failure, neurological disorder, stroke, diabetes
Sex: all female
Age: not given, but "elderly" |
Interventions |
a: Patient offered oral nutritional supplement Fresubin (Fresenius) calculated to make up deficit between intake from normal hospital diet and requirement. Fresubin provides 4.2 kJ or 1kcal/ml, as 15% protein energy, 30% fat energy and 55% carbohydrate energy
b: Normal hospital diet
Allocated: 5/5
Assessed: 5/5 |
Outcomes |
Main outcomes:
Mortality
Morbidity and complications ‐ pressure sore
Length of stay ‐ days to discharge from orthopaedic surgeon
Postoperative functional status ‐ two stage walking goals
Additional outcomes:
Measures of nutritional status ‐ percentage losses in weight, triceps skinfold, midarm circumference, arm muscle circumference
Measures of dietary intake |
Notes |
Author provided protocol of trial and information on method of randomisation and outcome assessment. Request for further details (other outcomes, period of follow‐up) sent 19/5/99, resent 3/2/00 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
High risk |
C ‐ Inadequate |