Culturally Tailored Cancer Communication, Education, and Research: The Highways and Back Roads of Appalachia

We have varying experiences with Appalachia, yet we all agree that there is a unique relationship between Appalachians and cancer. Two of us are nurses who have worked with various communities. Two of us grew up here; 1 watched several of her relatives battle cancer in their Appalachian homes. All of us are scholars who want to talk with practitioners and researchers who are developing culturally tailored cancer control interventions. This goal to have a dialogue emerged after we had a series of discussions about cancer in Appalachia, discussions resulting in our developing a list of cultural traits that seem to be related to this region’s high cancer morbidity and morality (Table). For example, in one of our previous publications we describe the association between the traditional Appalachian oral culture and the cancer experience, finding that cancer stories appeared to pass from 1 generation to the next (1). In turn, these stories seem to affect some community members\u27 willingness to be screened. Our essay\u27s purpose is not to justify the elements presented in the Table. Rather, we write to consider the following: What are the advantages and disadvantages of making generalizations about a culture that has already been marginalized by overgeneralizations

Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial

Background Effective treatment options for recurrent Clostridioides difficile infection (rCDI) are limited, with high recurrence rates associated with the current standard of care. Herein we report results from an open-label Phase 2 trial to evaluate the safety, efficacy, and durability of RBX2660—a standardized microbiota-based investigational live biotherapeutic—and a closely-matched historical control cohort. Methods This prospective, multicenter, open-label Phase 2 study enrolled patients who had experienced either ≥ 2 recurrences of CDI, treated by standard-of-care antibiotic therapy, after a primary CDI episode, or ≥ 2 episodes of severe CDI requiring hospitalization. Participants received up to 2 doses of RBX2660 rectally administered with doses 7 days apart. Treatment success was defined as the absence of CDI diarrhea without the need for retreatment for 8 weeks after completing study treatment. A historical control group with matched inclusion and exclusion criteria was identified from a retrospective chart review of participants treated with standard-of-care antibiotics for recurrent CDI who matched key criteria for the study. The primary objective was to compare treatment success of RBX2660 to the historical control group. A key secondary outcome was the safety profile of RBX2660, including adverse events and CDI occurrence through 24 months after treatment. In addition, fecal samples from RBX2660-treated participants were sequenced to evaluate microbiome composition and functional changes from before to after treatment. Results In this Phase 2 open-label clinical trial, RBX2660 demonstrated a 78.9% (112/142) treatment success rate compared to a 30.7% (23/75) for the historical control group (p < 0.0001; Chi-square test). Post-hoc analysis indicated that 91% (88/97) of evaluable RBX2660 responders remained CDI occurrence-free to 24 months after treatment demonstrating durability. RBX2660 was well-tolerated with mostly mild to moderate adverse events. The composition and diversity of RBX2660 responders’ fecal microbiome significantly changed from before to after treatment to become more similar to RBX2660, and these changes were durable to 24 months after treatment. Conclusions In this Phase 2 trial, RBX2660 was safe and effective for reducing rCDI recurrence as compared to a historical control group. Microbiome changes are consistent with restorative changes implicated in resisting C. difficile recurrence. Clinical Trials Registration NCT02589847 (10/28/2015)Medicine, Faculty ofNon UBCPathology and Laboratory Medicine, Department ofReviewedFacultyResearche