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. 2020 May 12;103(1 Suppl):36–41. doi: 10.4269/ajtmh.19-0805

Table 1.

Examples of potentially influential protocol deviations experienced during SCORE study implementation

Location Challenge Impact
Niger Randomization by region and not by community This prompted complete revision of the Niger study protocols; exclusion from main SCORE analysis
Kenya and Tanzania gaining control studies Decision not to use schools as a venue within community-based treatment arms in years 1 and 2 Lower than desired coverage of school-age children in enrolled villages receiving community-wide treatment in Kenya and Tanzania in years 1 and 2
Mozambique gaining control study Allocation of community drug distributors was not done based on the size of the population that needed to be reached, and supervision was minimal MDA coverage was suboptimal in many communities
All Delays in data inputs and data cleaning, uneven formats for reporting Late detection of implementation problems; inability to provide well-timed correction of coverage errors
Tanzania, Mozambique, Niger, Cote d’Ivoire Difficulty categorizing costs and separating MDA costs from other costs; nonuniform reporting of program vs. research costs Inability to develop summary estimates of programmatic cost-effectiveness across all SCORE studies, except for Kenya’s gaining control study

MDA = mass drug administration; SCORE = Schistosomiasis Consortium for Operational Research and Evaluation.