1. The FOOD Trial Are oral supplements effective?
Aims to evaluate different feeding policies for stroke patients:
Are oral supplements effective?
When should we start tube feeding?
Is PEG better than NG?

2. The FOOD Trial Is a “Family” of 3 trials which:
share the same randomisation system
share data collection forms
share the same follow up system
allows co-enrolment into the 3 trials

3. Variations in Practice
Feeding policies vary greatly
If feeding practices influences outcome
Variation in practice is unacceptable
We need RCTs to identify best practice
The RCT and systematic review are the “gold standards” for judging whether a treatment does more good than harm.
(NHS R& D Centre for Evidence based Medicine)

4. Trial 1
Trial 1
Within 1st month of admission

5. Trial 2
Within 1st week of admission

6. Trial 3
In 1st month of admission

7. Co-enrolment
This means patients can be entered into more than one of these 3 trials
Allows randomisation whenever you are uncertain about the best policy
Increases number of eligible patients
Increases rate of accrual
Mimics everyday clinical practice
Provides information on interactions

8. Sequential Co-enrolment in Trials 2 Then 3

9. Sequential Co-enrolment in Trials 2 Then 1

10. Sequential Co-enrolment in Trials 3 Then 1

11. Delayed Tube Feeding For At Least One Week (Hydrate with Parenteral Fluids)
IV or S/C according to local protocols
Does not preclude oral diet or fluids
If oral intake adequate clinician may stop parenteral fluids
If regime becomes impractical or another regime is definitely indicated clinician may switch.

12. Immediate Tube Feeding
PEG or NG
Initiate feeding within 72 hours of phone call to randomisation service
Recommend using a nutritionally complete feed, according to local policy
Prescribe in consultation with Dietitian
Does not preclude oral diet or fluids
If regime becomes impractical or another regime is definitely indicated clinician may switch.

13. The randomisation system
This all might seem complicated but:
Our computerised randomisation system sorts it out
You simply fill in a one page randomisation form
Telephone our 24 hour freefone number
The patient will be allocated to a feeding regime which reflects your uncertainties

14. Follow Up Report serious adverse events in hospital using report card
A simple form at hospital discharge or death in hospital
Centralised follow up at 6 months by telephone or postal questionnaire

15. Follow Up Six months after first randomisation To establish:
Independence in everyday activities
Type of residence
Modified Rankin and EUROQoLScore
If patient still being fed via a tube

16. Targets We currently hope to randomise at least:
6000 in Trial 1 (Normal diet vs. Supps)
2000 in Trial 2 (Early vs. delay tube)
1000 in Trial 3 (NG vs. PEG)

17. Future Plans Expand numbers of centres Accelerate accrual
Encourage co-enrolment

18. Progress We have already randomised over 2500 patients
129 centres in 18 countries are already taking part
We need to randomise over 9000 patients by 2002
We would like your help !

19. The Practicalities Everything you need is in the FOOD Manual
Freephone number to the randomisation service
24 hour helpline

20. The Practicalities 1. Identify a patient 2. Get consent 3. Randomise
4. Prescribe treatment allocation
5. Complete Hospital Discharge Form