Follow-up of INIS participants: practicalities

1. Follow-up of INIS participants: practicalities

2. Who gets long-term follow-up? • ALL BABIES enrolled in INIS, who are still alive • We need full follow-up even if babies are not appropriately randomised or do not receive the full INIS treatment

3. What’s involved for follow-up? • At 1 yr of age: • 1st year parent questionnaire – simple, 2 pages • At 2 years of age (corrected for gestation) : • parent questionnaire (~20 mins to complete) • paediatrician questionnaire • Bayley II Scales at some Aust centres & all NZ centres (but not at European/UK centres)

4. Coordination of follow-up • INIS Coordinating Centre sends materials and monthly follow-up reminders to INIS research nurse • Site INIS research nurse & follow-up team coordinate the follow-up for their INIS babies, including sending out questionnaires, newsletters, cards, booking appointments

5. 1 yr follow-up procedures • Around 1 year of age: • send the family the 1st year questionnaire together with the baby’s 1st Birthday card, change of address slip and reply paid envelope • Follow-up non-responders by resending the questionnaire and/or a phone call • Can be completed over the phone if necessary

6. Follow-up at 2 yrs corrected age • 3 months before 2yr date: Book paediatrician appointment with family • 8 weeks before 2yr date: Send a reminder letter to parents (with a copy of latest parent newsletter if appropriate) • 2-4 weeks before 2yr date : Send questionnaire to parent with Reply Paid envelope (could send with appointment letter), plus phone reminder • Parents to send back questionnaire, or bring with them to appointment (check it is filled in completely) • Follow-up non-responders with a phone call and resending the questionnaire

7. 2 yr follow-up - Bayley II Scales • In addition to parent and paediatrician questionnaires: • Bayley Scales at 2 yrs corrected, for: • NZ: all INIS babies (n~300) • Aust: all INIS babies at some centres only (n~300) • Administered by certified paediatrician or psychologist • Australian centres with established follow-up programs, demonstrated excellent rates of follow-up, suitable resources, & who are interested • Funding available

8. 2 yr follow-up - Bayley II Scales • The Bayley assessments will: • allow a sensitivity analysis within the economic evaluation by reliably classifying the subset of 600 surviving infants into major, moderate, mild or no disability at 2 years of age • allow validation of the PARCA parental and paediatrician questionnaires in Australia, which may provide justification for their use to assess major disability in future large-scale perinatal trials in ANZ • enable evaluation of whether IVIG has subtle beneficial effects on cognitive and psychomotor development, by comparing the mean scores on the MDI and PDI in pre-specified subgroups

9. Follow-up FAQs • Who can complete the 2 year paediatrician questionnaire? • Preferably a paediatrician at hospital where enrolled in INIS (or another INIS hospital) but a community paediatrician locally is also fine. • Who can complete the Parent questionnaire? • Preferably a primary caregiver, e.g. mother or father or other caregiver. • This can be completed by the research nurse over the phone if necessary, or with the help of a, family member, friend or GP if necessary.

10. Follow-up FAQs Flexibility regarding the 2 year timeline: • Can the 2 yr assessment be done earlier or later to accommodate other trials (e.g. CAP trial follow-up is at 18 months so would 21 months be OK)? • Paediatrician and parent questionnaire: aim for follow up as near to 2 years corrected age as possible • Bayleys: a compromise of 21 months would be OK if necessary, but not preferred

11. Maintaining contact with families • In the unit: meet the parents • Before discharge: Thank you letter (with contact numbers), change of address slip, Reply Paid envelope, fridge magnet, parent newsletter • Parent newsletters every 6-12 months • Birthday cards at 1 year and 2 years

12. Minimising loss to follow-up • Collect maximum contact details on the Contact Details case report form (full names, mobile phone, email) • Emphasise to parents the importance of follow-up and updating contact details. Send change of address slips with any mailouts to parents. • Add your return address to any mailouts so that mail can be returned automatically. Chase-up any un-returned parent questionnaires or returned-to-sender envelopes • Check hospital database(s), medical records, other hospitals, white pages • Inform the INIS Coordinating Centre ASAP if families are considered ‘lost’ so that we can help track them if needed