Data collection and the importance of good follow-up
Transcript of Data collection and the importance of good follow-up
Data collection and the
importance of good
follow-up
Version 5, 13/07/16
Study overview
A multi-centre, randomised, placebo-controlled
trial to determine health and economic outcomes
of the treatment of a large Patent Ductus
Arteriosus (PDA)
in extremely preterm babies with ibuprofen within
72 hours of birth
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Research Question
Whether the pharmacological closure of a large
PDA (identified by echocardiography) with
ibuprofen within 72 hours of birth, improves short
and long term health and economic outcomes, in
extremely preterm babies.
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10 in total
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Description of DCFs…
• Form 1: Trial Entry
• Form 2: Trial Medication
• Form 3: ECHO Results around 3 weeks of age
• Form 4: 36 Week Form
• Form 5: Open Treatment of PDA*
• Form 6: Baby Outcomes
• Form 6a: Necrotising Enterocolitis Report Form *
• Form 7: Baby withdrawal *
• Form 8: Serious Adverse Event Report Form (CTIMP) *
• Form 9: Incident reporting *
* Optional – complete whenever appropriateVersion 5, 13/07/16
DCF completion (1)
Form 1: Trial Entry
Section A
Form 1: Trial Entry
Sections B - G
Form 2: Trial Medication
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DCF completion (2)
Form 6:
Baby
Outcomes
Form 6a: NEC
Report Form
Form 5: Open
Treatment of
PDA
Form 3:
ECHO
Results
around 3
weeks
Form 4: 36
Weeks
Form 7: Baby
withdrawal
Form 8: SAE
(CTIMP)
Form 9:
Incident
reporting
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Checklist
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Consent Forms
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• Consent Forms: If the father consents for the baby to
participate into the trial, ensure the mother countersigns
in the space provided
– we need her consent for some of the maternal data collected at
trial entry/randomisation.
Form 1: Trial Entry
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• Must be signed by a medically qualified doctor
• Do not state names, only list the ‘relationship’ to the infant:
• This questions forms part of calculating social deprivation:
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Form 2: Trial Medication
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• Completed 7 days after the last dose of trial medication.
• Culture proven sepsis?
– A blood/CSF culture proven sepsis ONLY
and
– does not require multiple samples
– We do not intend to include: ET tip/long line/UVC/UVC positive sepsis
– Record the results of the first culture proven sepsis
• Space to record test results, or tick if test was not done:
• Cerebral ultrasounds
Form 4: 36 Weeks Form
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• Complete at 36 weeks of postmenstrual age or at discharge
if discharged home earlier.
• If the infant dies before reaching 36 weeks, we would not
expect to receive a Form 4.
Form 6: Baby Outcomes (1)
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• Supplementary oxygen and respiratory support:
– When counting days use the highest level of support e.g. if a baby is
ventilated for 1 hour, then on CPAP for the rest of the day, both
would be counted.
• An infant might not be ‘screened’ for ROP at your hospital,
but ROP may be present; B12 and B13 are independent of
one another.
Form 6: Baby Outcomes (2)
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• There should only be one outcome selected as one form is
completed per admission/stay.
Form 6: Baby Outcomes (3)
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• When collecting the contact details of ‘Other family members’
– do not list names
– There is no space to record a person’s name (other than the mother)
– We only require recording the relationship to the infant
If a baby transfers…
• Phone the NPEU Co-ordinating Centre
01865 617 965
• Carry out 3 week ECHO scan and complete
Form 3 (if appropriate)
• Carry out 36 week ‘Oxygen Reduction Test’,
complete Form 4 (if appropriate) OR record on
transfer envelope date test due
• Complete Form 6: Baby Outcomes; in Section C,
complete tab B only
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If a baby dies…• Complete data collection forms as fully as
possible up to the time of death
– Including ‘Mothers contact details’
– We will be careful with the data, but may in very rare
incidences have a duty to contact them
• Health and Social Care Information Centre will
tell us about deaths that occur after discharge
however this may take several weeks
• If you become aware of a death that occurs after
discharge, please let us know
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Query prevention
• Please, write clearly!
• Answer all questions
• Avoid ambiguous answers
– ‘Not known’
– ‘Not available’
• NPEU must query missing data if no explanation
given.
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What to send to Baby-OSCAR
Co-ordinating Centre?All originals of completed forms
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Data Collection File
For your Data Collection File copy any completed
forms (1 – 9) plus a completed ‘Enrolment Log’
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Blinded endpoint review
• Given the subjective nature and complexity of diagnosis
for the outcomes listed below, a small number of
clinicians, as well as an independent radiologist, will
review all of the data relating to outcomes listed below
for the internal pilot phase and at least 10% for the main
trial.
– Severe intraventricular haemorrhage (IVH) (grade 3/4 with
ventricular dilation or intraparenchymal bleeding)
– Cystic periventricular leukomalacia (PVL)
– NEC definitive and/or complicated (Bell stage II and above)
confirmed by radiography and / or histopathology.
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The importance of good
follow-up
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What if the follow-rate is only 80%
overall?
• “80% is acceptable”
• What if the incidence of the primary outcome is
low?
− e.g. death, moderate or severe BPD at 36 weeks,
little outcome data at 36 weeks
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Does 100% follow-up make a
difference? (Cont’d 2)• 818 babies discharged from hospital after
being born at 32 weeks, outcome severe
disability
• Follow-up
− without difficulty (709, 87%) – 6.9% severe disability
− with some difficulty (40, 5%) – 17.5% severe disability
− with great difficulty (47, 6%) – 55.3% severe disability
Total disability changed from 6.9% to 11%
because of complete follow-up
Tin W, Fritz S, Wariyar U. Hey E. Outcomes of very preterm birth: children reviewed with ease at
2 years differ from those followed up with difficulty. Arch Dis Child Fetal Neonatal Ed.
1998;79(2):F83-7Version 5, 13/07/16
Protocol
• Assuming the risk of a child dying before 2 years of age is
10%
• The proportion of infants surviving to 2 years without
moderate or severe neurodevelopmental disability in the
control group is expected to be 55% [Mangham et al, 2009]
• 80% power to detect an increase in survival without
moderate or severe neurodevelopmental disability of 11%
from 55% to 66% and 90% to detect an increase of 13%
from 55% to 68%.
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• Increase rate of follow-up
• Other methods to get outcome data?
- Reminding parents; change of address
cards (spares are found in the
documentation box)
- Use of notes
- 2 year hospital visits; prompting parents
- Stressing the importance of follow-up
• Other suggestions..?
Solutions
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Contact details
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