Miller 2006b.
Methods | Randomised clinical trial, Australia | |
Participants | 100 hospitalised adults aged 70 or above and admitted with fall‐related lower limb fracture, at nutritional risk due to being frail elderly with lower limb fracture Male:female = 21:79 Mean age: 83 years Exclusion: Did not reside within southern Adelaide, unable to comprehend instructions relating to positioning of the upper arm for eligibility assessment, unable to fully weight‐bear on the side of the injury for more than 7 days post‐admission, not independently mobile prefracture, medically unstable/7 days post‐admission, suffering from cancer, chronic renal failure, unstable angina or unstable diabetes or were not classified as malnourished, (]/25th percentile for mid‐arm circumference of a large representative sample of older Australians/27.0 cm for men and 26.3 cm for women) |
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Interventions | Experimental group: Fortisip (Nutricia Australia Pty Ltd), a complete oral nutritional supplement (6.3 kJ (1.5 kcal)/mL, 16% protein, 35% fat and 49% carbohydrate). Between 580 ‐ 800 mL was given. (n = 24) Control: Attention control, with tri‐weekly visits (of equivalent duration) from weeks 1 to 6 and then weekly visits weeks 7 to 12, to match the home visits of the active intervention groups. (n = 25) Co‐intervention: usual clinical care (including general nutrition and exercise advice, usual dietetic and physiotherapy care, transfer to residential care, rehabilitation facility or directly home) and resistance training. |
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Outcomes | Mid‐arm circumference, quality of life, weight, quadriceps strength, mortality | |
Study dates | September 2000 and October 2002 | |
Notes | Groups attention control vs nutrition supplements | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated allocation sequence |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It was unclear if the trial was blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | it was unclear if the participants were blinded, and the trial reported quality of life. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was above 5% dropouts for weight data and the trial did not account for the missing data. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained. The trial reported all‐cause mortality but did not report serious adverse events. |
For‐profit bias | High risk | Supported by: NHMRC Public Health Postgraduate Research Scholarship, Flinders University‐Industry Collaborative Research Grant and Nutricia Australia Pty Ltd. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |