D: The FOOD trials: feeding policies in hospitalised stroke patients influence patient outcomes
Submitting InstitutionUniversity of Edinburgh
Unit of AssessmentPsychology, Psychiatry and Neuroscience
Summary Impact TypeHealth
Research Subject Area(s)
Medical and Health Sciences: Clinical Sciences, Neurosciences, Public Health and Health Services
Summary of the impact
Impact: Health and wellbeing; improvement in mortality and
morbidity; changes in policy and guidelines.
Significance: Clinical trial findings have led to 1160 fewer
deaths and 780 fewer severely disabled patients each year in the UK;
rationalising feeding policies saves over £12M annually.
Beneficiaries: Stroke patients, the NHS and healthcare delivery
organisations, the economy.
Attribution: Trials were designed and led by Professor M Dennis,
Reach: Worldwide: revised national guidelines in UK, Europe, North
America, South Africa, Singapore, Australasia.
Professor Martin Dennis (Professor of Stroke Medicine, UoE, 1990-present)
demonstrated that stroke patients, of which there are 15 million new cases
worldwide per year, are frequently elderly and under-nourished and about
half have difficulties with swallowing caused by the stroke. He
demonstrated that patients with poor nutrition are about twice as likely
to die after stroke as well-nourished patients [3.1]. In the 1990s,
surveys of practice indicated wide variations in the use of oral
nutritional supplements, and in the timing and type of enteral tube
feeding. Small trials and systematic reviews suggested that routine oral
supplementation of the hospital diet may improve outcomes among elderly
patients admitted to hospital, and that early feeding via percutaneous
endoscopic gastrostomy (PEG), rather than a nasogastric tube, results in
With £940K funding from the NHS Research and Development Health
Technology Assessment Programme, the Stroke Association and Chest Heart
& Stroke Scotland, Dennis, Professor Charles Warlow (Professor of
Neurology, now Emeritus, UoE, 1987-2008), Dr Steff Lewis (Lecturer in
Statistics, UoE, 1997-present) and Dr John Forbes (Reader in Health
Economics, UoE, 1987-2013) established the Feed Or Ordinary Diet (FOOD)
trials — three multicentre randomised controlled trials to evaluate
feeding policies in hospitalised stroke patients. Trials 1-3 comprised
4023, 859 and 321 patients from 15, 15 and 11 countries, respectively. The
trials ran between 1996 and 2004 and were reported in 2005 and 2006
Trial 1 compared a normal hospital diet with oral supplementation. The
supplemented diet was associated with an absolute reduction in the risk of
death of only 0.7% and a 0.7% increased risk of death or poor outcome. The
data did not support routine supplementation for unselected stroke
patients who are well nourished on admission.
Trial 2 compared early tube feeding with avoiding tube feeding. Early
tube feeding was associated with an absolute reduction in the risk of
death of 5.8% and a reduction in death or poor outcome of 1.2%. In other
words, a policy of early tube feeding may substantially reduce the risk of
dying after stroke, and it is very unlikely that the alternative policy of
avoiding early tube feeding would significantly improve survival. Improved
survival may be at the expense of increasing the proportion of patients
surviving with poor outcome. These data might usefully inform the
difficult discussions about whether to feed a patient with a severe
Trial 3 compared PEG with nasogastric tube feeding. PEG was associated
with an increase in the absolute risk of death of 1.0% and an increased
risk of death or poor outcome of 7.8%. The data suggested that better
functional outcomes result from feeding via nasogastric tube than PEG,
although there was no major difference in survival. The data do not
support the policy of early initiation of PEG feeding in dysphagic stroke
patients that had been promulgated by previous small studies.
References to the research
3.1 The FOOD Trial Collaboration. Poor nutritional status on admission
predicts poor outcomes after stroke: observational data from the FOOD
trial. Stroke. 2003;34:1450-6. DOI: 10.1161/01.STR.0000074037.49197.8C.
3.2 The FOOD Trial Collaboration. Routine oral nutritional
supplementation for stroke patients in hospital (FOOD): a multicentre
randomised controlled trial. Lancet. 2005;365:755-63. DOI:
3.3 The FOOD Trial Collaboration. Effect of timing and method of enteral
tube feeding for dysphagic stroke patients (FOOD): a multicentre
randomised controlled trial. Lancet. 2005;365:764-72. DOI:
3.4 Dennis M, Lewis S, Cranswick G, Forbes J, FOOD Trial Collaboration.
FOOD: a multicentre randomised trial evaluating feeding policies in
patients admitted to hospital with a recent stroke. Health Technol Assess.
2006;10:1-120. DOI: 10.3310/hta10020.
Details of the impact
The FOOD trials showed that (i) routine oral supplements had little
effect on outcomes, (ii) that in patients who could not swallow, early
tube feeding showed a trend towards improved survival, and (iii) that
early use of PEG was associated with worse functional outcomes.
Pathways to impact
The trial team conducted a substantial programme of dissemination
activities beyond the three primary results publications. These included
many local, national and international conference presentations; materials
posted on the FOOD website (www.dcn.ed.ac.uk/food/);
co-authorship of a Cochrane review and secondary publications; and
engagement with guideline committees, including the National Institute for
Health and Care Excellence (NICE), Royal College of Physicians and
Scottish Intercollegiate Guidelines Network (SIGN).
Impact on public policy
The results of the FOOD trials have had direct implications for the
management of at least 100,000 stroke patients admitted to hospital each
year in the UK, and many of the 15 million patients with stroke each year
The results of the FOOD trials have been used as the basis for national
guidelines in the UK, Canada, Italy, Australia, Singapore and South Africa
The third edition of the UK National Clinical Guidelines for Stroke
(2008) references the FOOD trials 2 and 3 and recommends that a
nasogastric tube is used after 24-48 hours. PEG may be considered within 4
weeks if the patient cannot tolerate nasogastric feeding, but otherwise
not until 4 weeks. These guidelines were revised since the first edition
on the basis of the FOOD trials data.
Impact on health and welfare
1160 deaths prevented per year
Based on the estimates of effect seen in the FOOD trial 2 (a 5.8% absolute
reduction in death at 6 months — 58 deaths avoided/1000 patients) and
assumptions based on Dennis' 2003 survey of UK clinicians [3.4], 1160
additional patients would survive compared with a policy of avoiding tube
feeding for at least a week, which was common prior to publication of the
780 severe disabilities avoided per year
Based on the effect sizes seen in the FOOD trial 3 (7.8% absolute
difference in severe disability — 78 severely disabled patients/1000
treated with early PEG) and assumptions based on Dennis' 2003 survey
[3.4], 780 patients might avoid poor outcomes (severe disability) in the
UK each year by avoiding an early PEG tube insertion, with no effect on
Improved hospital experience for up to 40,000 patients per year
Based on the estimates of effect seen in the FOOD trial 1 and assumptions
based on Dennis' 2003 survey [3.4], up to 40,000 patients may now be
avoiding unnecessary supplements each year in the UK without a detriment
to their clinical outcome. Many of those patients would have found the
supplement unpalatable, which would have had a detrimental effect on their
Impact on the economy
As a result of FOOD trial 1, an estimated 40,000 patients in the UK each
year will avoid receiving routine oral supplements (£10 per day). Based on
an average hospital stay of 25 days, this amounts to a saving to the NHS
of £250 per patient and £10M per year.
According to a survey conducted by Dennis in 2003, 84% would, if
resources allowed, insert a PEG within the first 4 weeks. Given the
prevalence of prolonged dysphagia, this is estimated to translate into
10,000 PEG insertions per year. Avoiding these PEG insertions by using
nasogastric tube feeding will save the NHS approximately £2M each year
(£200 per PEG insertion).
In addition, the trials' findings suggested that early PEG insertion
might increase severe disability (78/1000 patients), resulting in 780 more
severely disabled patients per year; the associated costs of this are
possibly as much as £40M if the total cost of caring for a severely
disabled stroke patient is estimated at about £50K.
Sources to corroborate the impact
5.1 Intercollegiate Stroke Working Party National clinical guideline for
stroke, third edition (2008). http://bookshop.rcplondon.ac.uk/contents/6ad05aab-8400-494c-8cf4-9772d1d5301b.pdf.
5.2 SIGN Guideline 118 (2010). Management of patients with stroke:
rehabilitation, prevention and management of complications, and discharge
5.3 Canadian Best Practice statement, fourth edition (2013).
5.4 Clinical Guidelines for Stroke Management (2010).
5.5 Stroke and Transient Ischaemic Attacks. MOH Clinical Practice
5.6 South African guideline for management of ischaemic stroke and
transient ischaemic attack (2010): A guideline from the South African
Stroke Society (SASS) and the SASS Writing Committee. S Afr Med J.
[South African guidelines.]