| Two scoring systems are used to identify severe rotavirus gastroenteritis in rotavirus vaccine efficacy trials, Vesikari and Clark. These scoring systems were originally developed for use in developed country clinical trials. No evidence exists regarding the validity of their use in developing country clinical trials where health care seeking behaviors are different and literacy rates lower than in developed countries. The purpose of this quasi-experimental, concurrent, mixed-methods study was to compare the two scoring systems, better understand their similarities and differences, determine which factors are most associated with severe rotavirus gastroenteritis, and determine whether a single, simplified scoring system could be optimized for use among developing country populations under 2 years of age in Africa and Asia. In order to answer these questions, qualitative interviews of rotavirus experts and a secondary logistic regression and accuracy analysis of an existing rotavirus vaccine trial dataset containing items in both scoring systems were conducted. Conclusions were (a) the Vesikari and Clark scoring systems classified severe disease differently because of the severity cutoffs chosen and differences in items and item scoring, and (b) an optimized scoring system using a truncated duration of symptom collection and containing a reduced number of items was identified for use in developing country study settings. Implications for positive social change include use of a single, simplified scoring system that reduces the resources required to accurately collect severity data. This can encourage additional developing country rotavirus vaccine research thereby providing evidence supporting rotavirus vaccine introduction which can lead to lower mortality from rotavirus gastroenteritis in developing countries in Africa and Asia. |
