inis – the australian experience oxford - 12-13 september 2005 priya duggal-beri
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INIS – the Australian Experience
Oxford - 12-13 September 2005
Priya Duggal-Beri
The ANZ Team
The ANZ Way
• Australia (680)–17 active centres
• NZ (172)–7 active centres
Sites in ANZ
*Monash Medical Centre
*Royal Children’s Hospital
*Mercy Hospital for Women
*Royal Women’s Melbourne
*Royal Hobart Hospital
*Royal Women’s Brisbane
*Women’s and Children’s
*Flinders Medical Centre
*Canberra Hospital
*National Women’s *Middlemore Hospital
*Christchurch Women’s Hospital
*Wellington Women’s Hospital
*Dunedin Hospital
*Waikato Hospital
*Palmerston North
*John Hunter Hospital
*Westmead Hospital
*Liverpool Hospital
*Royal Hospital For Women
*Royal North Shore
*RPA Women and Babies
*The Children’s Westmead
*Nepean
ANZ and UK Recruitment
Australia and New Zealand Recruitment
0
5
10
15
20
25
30
35
40
F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A
Year/Month
Num
ber o
f bab
ies
recr
uite
d/m
onth
NZ Aus
Targets for centres
• Each site has a set target to recruit to – based on the number of hospital beds
• Based on estimates at the start of the study
• Have changed the target for some centres that recruited more or less than the initial set target
Actual/Target
Data as at 22/8/05
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
120.0%
102 201 202 203 205 213 222 255 279 331 341 343 344 401 504 515 701 901 902 903 911 915 922 927
Site
Eligibility Log
Actual recruitment /Eligible babies
0.00%
20.00%
40.00%
60.00%
80.00%
100.00%
102 201 202 203 205 213 222 255 279 331 341 343 344 401 504 515 701 901 902 903 911 915 922 927
Site
Data as at 22/8/05
Reasons why families may not participate
1 - Eligible, not approached for consent, open label IVIG was given - Doctor's decision
2 - Eligible, not approached for consent, open label IVIG was not given - Doctor's decision
3 - Eligible, consent refused by parents, open label IVIG was given
4 - Eligible, consent refused by parents, open label IVIG was not given
Of 647 families that said no…
0.0%
25.0%
50.0%
1 2 3 4 Diff icult torecruit
Not eligible Unknow n
Reason for not participating
% o
f p
eo
ple
sa
yin
g n
o in
ca
teg
ory
% Families that say yes when approached
Families were approached but chose not to participate, did not give a reason for not participating are compared with families who chose to participate.
0.0
20.0
40.0
60.0
80.0
100.0
102 201 202 203 205 213 222 255 279 331 341 343 344 401 504 515 701 901 902 903 911 915 922 927
Site
% f
am
ilie
s t
ha
t s
aid
ye
s w
he
n
ap
pro
ac
he
d.
Baby Birthweight
0
100
200
300
400
300-400
401-500
501-600
601-700
701-800
801-900
901-1000
1001-1250
1251-1500
1501-2000
2001-3000
3001-4000
4001-5000
Birthweight (gm)
No
. b
abie
s el
igib
le
Baby Gestational Age
0
50
100
150
200
250
20 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43
Gestational Age (Wks)
INIS in ANZ
• Recruitment to discharge – similar to UK
• Follow Up–1 year follow up
• Helps sites stay in touch with families
• Economic evaluation
–2 year follow up• Parent and Paediatrician Questionnaires
• Bayley Scales of Assessment II
ANZ status
• Completed 2 year follow Up: 97% (completed or booked appts)
• Completed 1 year follow Up: 96%• >1 year old: 413 babies• Babies older than 2 years: Staying in
touch using Christmas cards/ newsletters.
• TOTAL RECRUITMENT: 870
Babies/NICUs by region
• Total births per NICU are greater in ANZ than the UK.• Proportionately fewer NICUs in ANZ than in UK.• ANZ Nurses have relatively greater funding and
supportAnnual Births in UK vs. ANZ
UK ANZ
Annual Births ~ 700,000 ~310,000
Number of NICUs 220 28
Total births/ NICU ~3,200 11,000
ANZ Recruits
• We encourage a wide spectrum of illness severity babies to be recruited
• Relatively lower overall mortality rate
ANZ Whole Trial
Number of babies 870 1596
Mortality rate (%) 12.8 14.6
Parent Newsletters
• Includes –Parents story
–Recipe
–Games
– INIS news
–Stay in touch
–“Clinical trials” information
Letters from Parents
• Letters from parents about the recipes
• Letters thanking us for staying in touch
• A mother asked for her second baby to be recruited to INIS, and he/ she was!
Common Link?
• Enthusiasm of everyone across both hemispheres
• We applaud our collaborators and nurses, in Europe and ANZ, for the hard work they do.
• Thank you!
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