Follow-up of INIS participants: practicalities

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

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)

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

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

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

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

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

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.

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

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

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