Aims to evaluate different feeding policies for stroke patients: Are oral supplements effective?

1. The FOOD Trial 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 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 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 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 Future plans • Expand numbers of centres • Accelerate accrual • Encourage co-enrolment

18. Progress 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