Mercer, MaryBeth

Abstract Background: Research biobanks collect biologic samples and health information. Previous work shows that biobank participants desire general study updates, but preferences about the method or frequency of these communications have not been explored. Thus, we surveyed participants in a long-standing research biobank. Methods: Eligible participants were drawn from a study of patients with personal/family history suggestive of Cowden syndrome, a poorly recognized inherited cancer syndrome. Participants gave blood samples and access to medical records and received individual results but had no other study interactions. The biobank had 3,618 participants at sampling. Survey eligibility included age ≥18 years, enrollment within the biobank's first 5 years, normal PTEN analysis, and contiguous U.S. address. Multivariate logistic regression analyses identified predictors of participant interest in Internet-based versus offline methods and methods allowing participant–researcher interaction versus one-way communication. Independent variables were narrowed by independent Pearson correlations by cutoff P < 0.2, with P < 0.02 considered significant. Results: Surveys were returned from 840 of 1,267 (66%) eligible subjects. Most (97%) wanted study updates, with 92% wanting updates at least once a year. Participants preferred paper (66%) or emailed (62%) newsletter methods, with 95% selecting one of these. Older, less-educated, and lower-income respondents strongly preferred offline approaches (P < 0.001). Most (93%) had no concerns about receiving updates and 97% were willing to provide health updates to researchers. Conclusion: Most participants were comfortable receiving and providing updated information. Demographic factors predicted communication preferences. Impact: Researchers should make plans for ongoing communication early in study development and funders should support the necessary infrastructure for these efforts. Cancer Epidemiol Biomarkers Prev; 24(4); 708–12. ©2015 AACR.

Abstract Background Although many probiotic products are currently available in yogurt or pill form in the United States ( US ), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population. Objective This study examined how patients with chronic gastrointestinal ( GI ) diseases view the regulation of probiotics. Design We conducted a multi‐site qualitative study consisting of focus groups of patients with chronic gastrointestinal diseases at three tertiary hospitals: at [institutions removed for blinded review]. Results We conducted 22 focus groups with 136 patients with major gastrointestinal ( GI ) diseases between March and August 2009. Participants were not familiar with the existing regulation of probiotic products but wanted assurances of accurate labelling of strain as well as safety. Participants raised concerns that regulation of probiotics might be accompanied by greater costs, reduced access and increased involvement of pharmaceutical companies. Although participants voiced significant doubt of government regulators, they felt that products containing genetically modified probiotic strains should have oversight comparable to that of pharmaceutical drugs. Discussion and conclusion If GI patient perspectives are indicative of public perceptions of therapeutic probiotics in the United States, consumers may expect more rigorous regulation in the future while simultaneously wanting low costs, easy access and low involvement of pharmaceutical companies. Manufacturers, translational scientists, clinicians and regulators should be sensitive to consumer attitudes when designing, testing and regulating new therapeutic probiotics.