Dennis 2006.
Methods | Randomised clinical trial, UK | |
Participants | 859 hospitalised adults who were 1. either admitted to hospital with a stroke (1st or recurrent stroke) within 7 days of onset OR 2. suffering a stroke whilst already in hospital AND 3. randomising clinician uncertain about the best feeding policy AND 4. consent or assent from close relatives obtained and 5. did not pass shallow screen. The participants were at nutritional risk due to having had a stroke. Exclusion: Subarachnoid haemorrhage |
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Interventions | Experimental group: early enteral tube‐feeding. (n = 429) Control group: no tube‐feeding for > 7 days (early versus avoid)(n = 430) |
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Outcomes | Death or poor outcome and overall survival, proportion of participants who were dead at 6 months, health‐related QoL among survivors, time to hospital discharge, length of stay in hospital (which will provide a surrogate outcome for analysis of cost), number of days of tube‐feeding, adverse effects of feeding regimens, premature cessation of feeding regimens and reasons | |
Study dates | Nov 1996 to August 2003 | |
Notes | We contacted the authors on 12th November 2015 by email: martin.dennis@ed.ac.uk. We received data on quality of life. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Locked computer |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded. Participants knew their allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Only a blinded assessment at 6 months follow‐up. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All clinically relevant outcomes were reported, as stated in the protocol. |
For‐profit bias | Low risk | FOOD was funded by the NHS R&D Health Technology Assessment Programme (Reference 96/29/01), The Stroke Association (Reference 17/98) and Chest Heart and Stroke Scotland (Reference 97/4). The Singapore Medical Research Council supported the trial in Singapore. The Royal Australasian College of Physicians supported the trial in Hawkes Bay, New Zealand. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |