A cluster randomized controlled trial was conducted in Chad to evaluate the effectiveness and cost-effectiveness of ready-to-use supplementary food (RUSF) for preventing child wasting. The trial involved over 1,000 young children across 14 clusters in Abeche town. The primary outcome was the cumulative incidence of wasting, with secondary outcomes including anemia prevalence, growth, and morbidity. Results found no effect on wasting incidence but marginal benefits for growth, hemoglobin levels, and reducing diarrhea/fever episodes. A cost-effectiveness analysis found the cost per case averted for secondary outcomes was over 100 times more than common prevention programs, questioning the contexts where RUSF is most effective and cost-effective. Lessons
Whast goes up must come down: challenges of getting evidence back to the ground
RCT assessing effectiveness of RUSF for child wasting prevention in Chad
1. A cluster RCT to assess the effectiveness and cost
effectiveness of RUSF for the prevention of child
wasting in Chad: a successful collaboration
between a humanitarian aid organization and
academics
ALNAP conference Evidence & Knowledge in Humanitarian Action
March 6, 2013 - Washington, USA
Nutrition Research Advisor, Cécile Salpéteur
Research Officer, Chloe Puett
14 mars 2013
2. Context & rationale of Chad project
Humanitarian crisis expected in Sahel
Gap in evidence on how to prevent acute malnutrition
A Conducive environment ?
ACF providing support to CMAM programme
ACF internal funding & research policy since 2008
A strong scientific partner – Univ. of Ghent, Belgium
An impossible challenge
Timeframe very tight
High turnover of ACF key staff
Insecurity, floods, sandstorm …
A strong project set up
Specific governance of project
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3. Project set up & governance
A special coordinator directly under the Executive
Director
A big internal funding
A working group in HQ / weekly meetings
A steering committee
A Research Officer on the field
MoU with University of Ghent, Belgium
Univ. Of Gent responsible for research aspects
Ethical committee of Univ. of Ghent + local authorities
Registration on clinicaltrial.org
Research insurance
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4. Research question & outcomes
Main Objective:
• To measure the effectiveness of RUSF added to a food
ration in reducing incidence of wasting among
children aged 6 to 36 months living in Abeche town
during the hunger gap
Primary Outcome:
• Cumulative incidence of wasting
Secondary Outcomes:
• Anemia prevalence and hemoglobin level
• Linear growth
• Morbidity prevalence
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7. 45 neighborhoods
STUDY DESIGN
Abéché town
(N=110,000)
Inclusion based on
participatory approach
(ACF-France, 2010)
7 most vulnerable
neighborhoods
Listing of vulnerable
HH (n=3,000)
Listing checks
Division in 14 clusters and
localisation of HH in each cluster
Randomization of clusters
7 Clusters 7 clusters
Control Group Intervention Group
Food Assistance FA + RUSF
N=458 N=613
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9. Global timeframe
+ 1 year for scientific publication
2010 2011
Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Phase 1: Preparation 4.5 mo
8 mo
Phase 2 : Implementation
Acceptability Test RUSF
Inclusions + 5 distributions
Food intake Survey
KAP survey Mums’ knowledge
Follow up +1 mo & + 3 mo
Phase 3: data cleaning
and analyses >12 mo
Phase 4 : Dissemination
of results 6 mo
SMART surveys
SteerCo meetings
External Evaluation
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10. A key success factor: communication
to participants & partners
• Communication to
• authorities (MoH, CNNTA, DONG)
• partners at Nutrition Cluster meeting
• Abeche city authorities & chiefs of
neighborhoods
• Daily Radio Call-In about what is ACF doing, what
is research, what is RUSF, etc.
• Cartoon explaining research to population
• Scheme of circuit for participants - flyer
• Results presented to same audience in July 2011
in Chad
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20. RESULTS on RUSF effectiveness
No effect on wasting incidence
Marginal positive effect on length
Positive effect on hemoglobin
Positive effect on diarrhea/fever
episodes
Footer.ppt
21. CEA context & methods
CEA as part of ACF technical development
Methods for this study:
• Used secondary outcomes (diarrhea, anemia)
— Cost per case averted
• Retrospective analysis
• Societal perspective (community + institutions)
• Accounting records + interviews
— Community costs, in-kind donations, etc.
• Incremental cost effectiveness: comparing additional
effects with additional costs of RUSF component
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22. Program costs
Cost outcome €
Total program costs (FA+RUSF) 1,009,106 €
Incremental cost of RUSF Component 229,017 € (23%)
Incremental cost per child 374 €
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23. Cost components
Community, 5%
Local office, 2%
Personnel, 27%
Logistics, 8%
Program
activities, 58%
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24. CEA Results & Interpretation
Cost per case averted was >100x more than
other common programs preventing diarrhea,
anemia, e.g.:
• Water, sanitation, hygiene infrastructure
• School-based helminth control
These programs not comparable with our results
different cost structure, i.e. food = 50% of costs in
Chad
emergency context
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25. CEA Lessons & Recommendations
Use of secondary outcomes (anemia, diarrhea)
Relevant for RUSF component
Less relevant for general food distributions
Doesn’t reflect effectiveness of the global operation
RUSF can address multiple outcomes in emergency
contexts in the short-term, where other infrastructure is
unavailable, but…
Further research needed to determine the contexts in
which RUSF is most effective & cost-effective
C-E data in ACF decision-making is a work in progress,
will take time to perfect
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26. RCT lessons
Plan adequate timeframe
• Continue communication around the project to all
audiences (pop, authorities, partners)
• Plan a feasibility trial 2-3 months
• Better Roles & Resp btw Field HQ
• Cheaper procurement
• Renewal of contract with WFP in the middle of
intervention > risk for research
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27. Conclusions
RUSF added to food rations did not prevent wasting
during hunger gap
RCT not a « routine » method
Relevant for ACF when need to generate evidence on a
strategic key question to influence policy
Need for more scientific approaches to measure better
effectiveness
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28. Thank you !
Reference
Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, et al.
(2012) The Effect of Adding Ready-to-Use Supplementary Food to a
General Food Distribution on Child Nutritional Status and Morbidity:
A Cluster-Randomized Controlled Trial. PLoS Med 9(9): e1001313.
doi:10.1371/journal.pmed.1001313
Contact for more information:
- Cécile Salpéteur, Nutrition Research Advisor, Paris -
csalpeteur@actioncontrelafaim.org
- Chloe Puett, Cost Effectiveness Expert, NY – cpuett@actionagainsthunger.org
- Lieven Huybregts, Principal Investigator, Gent - lieven.huybregts@ugent.be
14/03/2013 Footer.ppt 28
Notas del editor
Retrospective CEA:Important for the implementers to have this retrospective analysis on the costs in order to get recommendations and information for future programming in the field
Discuss ICERs more generally/compared to other interventions in following slides
The addition of RUSF to a staple ration distribution prevented cases of diarrhea and anemia in young children, however the cost-effectiveness of this approach was poor when compared to other common intervention strategies. While food-based programs, such as ration distribution or supplementary feeding with RUSF, may not be among the most cost-effective solutions to child morbidity, these interventions play an important role in preserving food security, livelihoods and nutritional status among vulnerable adults and children. Further, RUSF holds the potential to address multiple health and nutrition outcomes in emergency contexts, making it a promising short-term option to protect child health and nutrition in settings where diets are poor and public health infrastructure is weak. Given inconclusive evidence, further research is needed to determine the contexts in which RUSF is most effective and cost-effective to address various child health and nutrition outcomes, compared to other alternatives.
Retrospective CEA:Important for the implementers to have this retrospective analysis on the costs in order to get recommendations and information for future programming in the fieldTHE POINT IS THAT, EVEN GIVEN THESE COST-INEFFECTIVE OUTCOMES, THESE PROGRAMS ARE IMPORTANT FOR PROTECTING LIVELIHOOD AND NUTRIITON OUTCOMES ESPECIALLY IN EMERGENCY CONTEXTS.THE FACT THAT RUSF CAN ADDRESS MANY OUTCOMES, FROM WASTING TO DIARRHEA, ANEMIA, ETC, SUGGESTS THAT IT IS A GOOD TOOL TO USE IN THE SHORT-TERM, IN SETTINGS THAT LACK THE PUBLIC HEALTH INFRASTRUCTURE NEEDED FOR THE OTHER PROGRAMS.NEED TO BALANCE ECON CONSIDERATIONS WITH ETHICAL ONES, AND CONSIDER THE EMERGENCY CONTEXT OF THE PROGRAM.Limitations of external validity of RCTs (Wikipedia)The extent to which RCTs' results are applicable outside the RCTs varies; that is, RCTs' external validity may be limited. Factors that can affect RCTs' external validity include: Where the RCT was performed (e.g., what works in one country may not work in another) Characteristics of the patients (e.g., an RCT may include patients whose prognosis is better than average, or may exclude "women, children, the elderly, and those with common medical conditions") Study procedures (e.g., in an RCT patients may receive intensive diagnostic procedures and follow-up care difficult to achieve in the "real world") Outcome measures (e.g., RCTs may use composite measures infrequently used in clinical practice) Incomplete reporting of adverse effects of interventions