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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
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
14/03/2013                    Footer.ppt                    2
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
14/03/2013                           Footer.ppt                        3
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

14/03/2013                     Footer.ppt                     4
©ACF, F.Houngbe 2010




14/03/2013             Footer.ppt   5
©ACF, F.Houngbe 2010

14/03/2013             Footer.ppt   6
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
                         Footer.ppt                                      7
©ACF, F.Houngbe 2010
14/03/2013             Footer.ppt   8
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

14 mars 2013                                       Footer.ppt                                           9
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

14/03/2013                       Footer.ppt                   10
©ACF, F.Houngbe 2010
14/03/2013             Footer.ppt   11
©ACF, F.Houngbe 2010   Footer.ppt   12
©ACF, F.Houngbe 2010
                       Footer.ppt   13
©ACF, F.Houngbe 2010
                       Footer.ppt   14
©ACF, F.Houngbe 2010

                       Footer.ppt   15
©ACF, F.Houngbe 2010
                       Footer.ppt   16
©ACF, F.Houngbe 2010
14/03/2013             Footer.ppt   17
©ACF, F.Houngbe 2010
                       Footer.ppt   18
Footer.ppt
             ©ACF, F.Houngbe 2010   19
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
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


3/14/2013                                Footer.ppt                  21
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 €




3/14/2013                       Footer.ppt                     22
Cost components

                             Community, 5%
            Local office, 2%

                                                              Personnel, 27%
             Logistics, 8%




                                                             Program
                                                          activities, 58%


3/14/2013                                    Footer.ppt                        23
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



3/14/2013                            Footer.ppt                       24
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

3/14/2013                               Footer.ppt                    25
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




14/03/2013                           Footer.ppt                   26
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




14/03/2013                      Footer.ppt                      27
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

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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 14/03/2013 Footer.ppt 2
  • 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 14/03/2013 Footer.ppt 3
  • 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 14/03/2013 Footer.ppt 4
  • 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 Footer.ppt 7
  • 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 14 mars 2013 Footer.ppt 9
  • 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 14/03/2013 Footer.ppt 10
  • 12. ©ACF, F.Houngbe 2010 Footer.ppt 12
  • 13. ©ACF, F.Houngbe 2010 Footer.ppt 13
  • 14. ©ACF, F.Houngbe 2010 Footer.ppt 14
  • 15. ©ACF, F.Houngbe 2010 Footer.ppt 15
  • 16. ©ACF, F.Houngbe 2010 Footer.ppt 16
  • 18. ©ACF, F.Houngbe 2010 Footer.ppt 18
  • 19. Footer.ppt ©ACF, F.Houngbe 2010 19
  • 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 3/14/2013 Footer.ppt 21
  • 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 € 3/14/2013 Footer.ppt 22
  • 23. Cost components Community, 5% Local office, 2% Personnel, 27% Logistics, 8% Program activities, 58% 3/14/2013 Footer.ppt 23
  • 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 3/14/2013 Footer.ppt 24
  • 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 3/14/2013 Footer.ppt 25
  • 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 14/03/2013 Footer.ppt 26
  • 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 14/03/2013 Footer.ppt 27
  • 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

  1. 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
  2. Discuss ICERs more generally/compared to other interventions in following slides
  3. 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.
  4. 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