Transcript New evidence on intervention efficacy & effectiveness

New evidence on intervention
efficacy & effectiveness
Betty Kirkwood
London School of Hygiene &
Tropical Medicine
Is there any major new evidence
concerning interventions to improve
newborn and child survival that adds
to or changes our current thinking?
Thanks to
Shams Arifeen
Ann Ashworth Hill
Rajiv Bahl
Zulfiqar Bhutta
Bob Black
Jennifer Bryce
Sandy Cairncross
Daniel Chandramohan
Anthony Costello
Simon Cousens
Gary Darmstadt
Joy Lawn
Jo Lines
Jose Martines
Liz Mason
Saul Morris
Kim Mulholland
David Osrin
Vinod Paul
Igor Rudan
Nancy Terreri
Ricardo Uauy
Cesar Victora
Peter Winch
Evidence-based Interventions
• Lancet Bellagio Child Survival Series 2003
23 interventions
– 15 preventive (9 child, 6 newborn)
– 8 case-management (6 child, 2 newborn)
• Lancet Neonatal Series 2005
8 additional “cost-effective” interventions
Is there new evidence:
• that significantly changes our
assessment about the potential impact
or delivery of any of the 31
interventions?
• for new intervention(s) to be added?
• about effective delivery strategies?
NEW evidence re
31 interventions:
ANTIBIOTICS FOR PNEUMONIA
 Current guidelines
 Non-severe pneumonia: treat at home with oral antibiotics
 Severe pneumonia: admit & give parenteral antibiotics
 Oral amoxycillin as effective as injectable penicillin:
multi-centre trial
 Potential benefits include decreases in:
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Risk of needle-borne infections
Need for referral or admission
Administration costs
Costs to the family
Addo-Yobo et al for the Amoxicillin Penicillin Pneumonia International Study (APPIS) Group,
Lancet 2004; 364: 1141–48
NEW evidence re
31 interventions:
EARLY INITIATION OF BREASTFEEDING
Ghana: Risk of Neonatal
Mortality after 1st day
Various measures taken to
address potential reverse
causality
POSTERS 20 & 21
BF initiated
Day 1, 1st hour
Day 1, later
Day 2
Day 3
After Day 3
Adj OR
1
1.45
2.70
3.01
4.42
Day 1 vs Later
2.40
NEW evidence re
31 interventions:
EARLY INITIATION OF BREASTFEEDING
MODEL A
99% babies
BF 1st hour
90% babies
BF 1st hour
60 priority countries
MODEL B
99% babies
Two intervention models:
BF 1st day
A: BF initiated within 1st hour
90% babies
B: BF initiated within 1st day BF 1st day
(but not necessarily 1st hour)
Newborn
lives
saved
Newborn
U5
1,117,032
31%
11%
972,917
27%
10%
Deaths prevented
Newborn
lives
saved
Newborn
U5
866,857
24%
9%
680,864
19%
7%
Deaths prevented
NEW evidence re
31 interventions:
HANDWASHING

Meta-analysis 11 studies:
37% reduction in diarrhoea (CI 23-48%)
(Fewtrell et al, Lancet Inf Dis 2005; 5: 42-52)

A randomised controlled trial of handwashing on child health in
Karachi, Pakistan
Reduction compared to Controls
Intervention Group
Pneumonia
Diarrhoea
Antibacterial Soap
45% (26%-64%)
50% (37%-64%)
Plain Soap
50% (34%-65%)
53% (41%-65%)
Luby et al, Lancet 2005; 366: 225–33
New intervention to
add?
RUTF (highly fortified Ready to Use Therapeutic
Foods) for community-based management of
SEVERE MALNUTRITION
ISSUE:
• 10 million children severely malnourished, High risk of mortality
• Usual recommendation: refer to hospital or specialised treatment unit
• Coverage low
CONSULTATION (WHO, UNICEF, SCF; Geneva 21-23 Nov 2005):
• Community based approach with RUTF feasible & effective
– Very low case fatality rate
– Only a small proportion of severely malnourised children needed to be
referred to hospital
• Potential to save 100,000’s child deaths
• YES: STRONG EVIDENCE
New intervention
to add?
Cotrimoxazole prophylaxis for children
with clinical signs of HIV
CHAP trial, Zambia:
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RCT, 541 Children aged 1-14 with clinical signs of HIV
Primary outcomes: Mortality & adverse events
DSMC recommended trial should be stopped early
43% lower mortality in cotrimoxazole group (CI 23-57%,
P=0.0002)
Chintu et al, Lancet 2004; 364: 1865-71
New intervention
to add?
Chlorhexidine Cleansing: Nepal
 A single cleansing of newborn skin as
soon as possible after delivery
(median 6 h):
–28% reduction in mortality among
LBW infants
 Cleansing umbilical cord with 4%
chlorhexidine on days 0,1,2,3,5,7,9:
–24% reduction in overall neonatal
mortality (Lancet in press)
POSTERS 39 & 41
Courtesy Darmstadt & colleagues
New VACCINES
to add?
TO CONSIDER:
 Pneumococcal conjugate vaccine (3 doses):
The Gambia: 16% reduction in mortality (CI 3-28%)
Cutts et al, The Lancet 2005; 365: 1139-46
Issues: Affordability, Availability, Composition
NOT YET:
 Rotavirus:
 High efficacy LA/US
 Trials needed in less developed countries
 Malaria RTS,S/AS02A vaccine:
The Gambia: 58% reduction in severe malaria (CI 1681%) Alonso et al, Lancet 2004; 364: 1411–20
NEW evidence re
effective delivery
WOMEN’S GROUPS: Makwanpur
Effect of a participatory intervention with women’s groups on
birth outcomes in Nepal: cluster RCT (Manandhar et al, Lancet 2004)
0·70 [95% CI 0·53–0·94])
>6000 deliveries
12 pairs
NEW evidence re
effective delivery
NEWBORN CARE HOME VISITS: Shivgarh
Shivgarh (India): Impact of 4 home visits by CHWs to
PROMOTE ESSENTIAL NEWBORN CARE* through
Community Mobilization & Behavior Change
Communications
POSTER
Mortality rate/
1000 livebirths
Perinatal
Early neonatal
Neonatal
Control
Area
114.5
62.0
84.3
Intervention Intervention
Area 1
Area 2
70.8
73.2
34.8
33.1
42.0
44.2
*As defined in Lancet Neonatal Survival Series paper 2: Lancet 2005;365:977-88.
NEW evidence re
effective delivery
COMPLEMENTARY FEEDING PERU: Educational
intervention delivered through health services
• RCT: Government health
facilities (6 intervention, 6
control)
• Aim of intervention: enhance
quality & coverage of
existing nutrition education &
introduce accrediation
system
• Evaluation: Birth cohort, 187
infants
OR 3.04 (CI 1.21-7.64)
Intervention to
reconsider?
PROPHYLACTIC IRON SUPPLEMENTS IN
MALARIA ENDEMIC AREAS
Zanzibar: Pemba RCT (IFA, IFA+zinc, Zinc, Placebo)
 IFA arms stopped because adverse effects
– Adverse events: 12% higher, CI=2 to 23%, P=0.02
– Deaths: 15% higher, CI=-7 to 41%, P=0.19
 “Current guidelines for universal IFA supplementation
should be reconsidered”
Sazawal et al, Lancet in press
Coming soon
 Impact of routine zinc supplements on child
mortality
 RESULTS from 2 trials in Pemba & Nepal
 Next 6 months
NEW evidence:
IMPLICATIONS
 ADD IMMEDIATELY
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RUTF for severely malnourished children
Oral amoxycillin for pneumonia
Cotrimoxazole prophylaxis for HIV+ children
Indicator for handwashing
 CONSIDER
 Newborn skin/cord cleansing
 Pneumococcal vaccine
 GET MORE EVIDENCE
 Early initiation of BF & neonatal mortality
 IF Ghana findings replicated, ADD to list
NEW evidence:
IMPLICATIONS
 Reconsider Iron Guidelines
 EVALUATING INTERVENTIONS IS
ESSENTIAL, as is monitoring outcomes after
implementation
 Evidence supports increased emphasis on
community-based involvement
 NEED: Evidence on scaling up