Cluster RCTs in Chad (Cecile Salpeteur, ACF)


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A cluster Randomised Control Trial to assess the effectiveness and cost effectiveness of RUSF for the prevention of child wasting in Chad.

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  • 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
  • Cluster RCTs in Chad (Cecile Salpeteur, ACF)

    1. 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 Puett14 mars 2013
    2. 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 project14/03/2013 Footer.ppt 2
    3. 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  Research insurance14/03/2013 Footer.ppt 3
    4. 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 prevalence14/03/2013 Footer.ppt 4
    5. 5. ©ACF, F.Houngbe 201014/03/2013 Footer.ppt 5
    6. 6. ©ACF, F.Houngbe 201014/03/2013 Footer.ppt 6
    7. 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 GroupFood Assistance FA + RUSF N=458 N=613 Footer.ppt 7
    8. 8. ©ACF, F.Houngbe 201014/03/2013 Footer.ppt 8
    9. 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 Evaluation14 mars 2013 Footer.ppt 9
    10. 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 Chad14/03/2013 Footer.ppt 10
    11. 11. ©ACF, F.Houngbe 201014/03/2013 Footer.ppt 11
    12. 12. ©ACF, F.Houngbe 2010 Footer.ppt 12
    13. 13. ©ACF, F.Houngbe 2010 Footer.ppt 13
    14. 14. ©ACF, F.Houngbe 2010 Footer.ppt 14
    15. 15. ©ACF, F.Houngbe 2010 Footer.ppt 15
    16. 16. ©ACF, F.Houngbe 2010 Footer.ppt 16
    17. 17. ©ACF, F.Houngbe 201014/03/2013 Footer.ppt 17
    18. 18. ©ACF, F.Houngbe 2010 Footer.ppt 18
    19. 19. Footer.ppt ©ACF, F.Houngbe 2010 19
    20. 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. 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 component3/14/2013 Footer.ppt 21
    22. 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. 23. Cost components Community, 5% Local office, 2% Personnel, 27% Logistics, 8% Program activities, 58%3/14/2013 Footer.ppt 23
    24. 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 context3/14/2013 Footer.ppt 24
    25. 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 perfect3/14/2013 Footer.ppt 25
    26. 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 research14/03/2013 Footer.ppt 26
    27. 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 effectiveness14/03/2013 Footer.ppt 27
    28. 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 - - Chloe Puett, Cost Effectiveness Expert, NY – - Lieven Huybregts, Principal Investigator, Gent - lieven.huybregts@ugent.be14/03/2013 Footer.ppt 28