Abstract

.In 2010, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) began the design of randomized controlled trials to compare different strategies for praziquantel mass drug administration, whether for gaining or sustaining control of schistosomiasis or for approaching local elimination of Schistosoma transmission. The goal of this operational research was to expand the evidence base for policy-making for regional and national control of schistosomiasis in sub-Saharan Africa. Over the 10-year period of its research programs, as SCORE operational research projects were implemented, their scope and scale posed important challenges in terms of research performance and the final interpretation of their results. The SCORE projects yielded valuable data on program-level effectiveness and strengths and weaknesses in performance, but in most of the trials, a greater-than-expected variation in community-level responses to assigned schedules of mass drug administration meant that identification of a dominant control strategy was not possible. This article critically reviews the impact of SCORE’s cluster randomized study design on performance and interpretation of large-scale operational research such as ours.

Highlights

  • In performing its mission to inform program managers and policy-makers working in schistosomiasis control, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) project confronted a number of opportunities and challenges in the design, performance, and analysis of its large field research studies that were meant to determine implementation effectiveness in real-world settings.[1]

  • The target questions identified at these development meetings were as follows: 1) Is there different mass drug administration (MDA) impact with different frequencies of treatment implementation? 2) Is there a different MDA impact based on the population targeted for participation in MDA? 3) What is the impact of non-adherence to MDA? In addition to these objectives, collection of non-research–related program cost and performance data were planned to estimate the incremental cost-effectiveness of more intensive interventions

  • An important finding that did emerge from the SCORE trials included the fact that all interventions significantly reduced mean infection prevalence and intensity, the wide variability in community responses poses a clear challenge to the effectiveness of a blanket application of the current WHO schistosomiasis control recommendations.[34,35]

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Summary

KING AND OTHERS

Other factors that arose during the operational trials were those that could modify local participation of community residents or the timing of drug delivery and follow-up surveys for prevalence and intensity of infection These included local and national elections and election-related violence, extreme weather events (2015 EL Niño rains in East Africa), intercurrent bacterial epidemics, and annual periods of food scarcity before harvest or sporadic food shortages due to drought, which. Niger Kenya and Tanzania gaining control studies Mozambique gaining control study All

Randomization by region and not by community
MDA coverage was suboptimal in many communities
Findings
SUMMARY
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