International Neonatal Immunotherapy Study Westmead Hospital Drugs Committee 6'11'2000

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
Whats 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 babys 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 (n300)
• Aust all INIS babies at some centres only
  (n300)
• 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