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?

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

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)

Trial 1 Trial 1 Within 1st month of admission

Trial 2 Within 1st week of admission

Trial 3 In 1st month of admission

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

Sequential Co-enrolment in Trials 2 Then 3

Sequential Co-enrolment in Trials 2 Then 1

Sequential Co-enrolment in Trials 3 Then 1

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.

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.

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

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

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

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)

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

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 !

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

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