Perceived benefits and risks of participation in a clinical trial for Ugandan children with sickle cell anemia.

INTRODUCTION: Understanding factors that affect the decisions of caregivers of African children to enroll their children in clinical trials would lead to more fully informed consent. METHODS: During the NOHARM study (NCT01976416), a placebo-controlled clinical trial of hydroxyurea for Ugandan children with sickle cell anemia (SCA), 206 caregivers were given a semistructured questionnaire about factors that influenced participation in the study and their perceptions of study benefits and risks. Factors were further assessed with focus group discussions. RESULTS: Caregivers identified education provided during the recruitment process (44%), the child's current poor state of health (35%), and the possibility of improvement in the child's health (16%) as their primary initial reasons for deciding to participate in the NOHARM trial. Concerns regarding the drug or participation in a research study, including the stated concern of death by several caregivers, were outweighed by the possibility of improvement in the child's health. During the study, 72% of caregivers cited improved health as an advantage of study participation, while disadvantages cited included the potential side effects of hydroxyurea, most of which did not occur during the trial. DISCUSSION: Our study findings highlight the generally poor state of health of Ugandan children with SCA, the desperation by caregivers for anything that could improve the child's health, and the inevitable improvements in care that result from strict adherence to a study protocol, even a protocol based on local guidelines. Studies in this vulnerable population must be careful not to portray improved care as a primary incentive for participation.

The Benjamin H. Kean Travel Fellowship in Tropical Medicine: Assessment of Impact at 15 Years.

The Benjamin H. Kean Fellowship in Tropical Medicine is an American Society of Tropical Medicine and Hygiene initiative that provides medical students with funding for international clinical or research experiences lasting at least 1 month. Of the 175 Kean fellows from 1998 to 2013, 140 had current available e-mails, and 70 of the 140 (50%) responded to a survey about their fellowship experience. Alumni indicated that the Kean Fellowship had a high impact on their career plans with regard to preparation for (N = 65, 94.2%) and inspiration to pursue (N = 59, 88.1%) a career in tropical medicine and global health. Continued involvement in tropical medicine and global health was common: 52 alumni (74.3%) were currently working in tropical medicine or global health, 49 (71.0%) had done so in the interim between the Kean fellowship and their current position; and 17 of 19 Kean fellows (89.4%) who had completed all medical training and were now in professional practice continued to work in tropical medicine and global health. Alumni had been highly productive academically, publishing a total of 831 PubMed-indexed manuscripts, almost all on tropical medicine or global health topics, in the period between their fellowship year and 2013. Alumni reported strengths of the fellowship including funding, networking, and flexibility, and suggested that more networking and career mentoring would enhance the program. The Benjamin H. Kean fellowship program has been highly successful at inspiring and fostering ongoing work by trainees in tropical medicine and global health.

Perceptions of personal belief vaccine exemption policy: a survey of Arizona vaccine providers.

BACKGROUND: As exemptions to school-entry requirements rise, vaccination rates in Arizona school children are approaching levels that may threaten public health. Understanding the interactions physicians have with vaccine-hesitant parents, as well as the opinions physicians hold regarding vaccination, exemption, and exemption policies, are critical to our understanding of, and ability to affect, vaccination exemption rates among children. METHODS: Survey responses were elicited from practitioners listed in The Arizona Partnership for Immunization and the Arizona Medical Association databases using a multi-pronged recruitment approach. Respondents provided data regarding their practice, comfort with parental refusal of individual vaccines, opinions about the beliefs held by parents that seek exemptions, parent education strategies, issues regarding providing care to unvaccinated children, and potential changes to Arizona policy. RESULTS: A total of 152 practitioners providing care to a wide geographic and economic population of Arizona responded to the survey. Respondents were generally strong advocates of all immunizations but were more accepting of parents' desires to refuse hepatitis B and rotavirus vaccines. Almost all providers indicated that they see patients whose parents request to refuse or delay from vaccinations at least occasionally (88% and 97%, respectively). Only 37% of respondents indicated that they would be supportive of a policy requiring them to sign off on a parent's decision to refuse vaccination. CONCLUSIONS: Vaccination providers in Arizona are generally very supportive of childhood immunizations but have varying comfort with exemption from individual vaccines. Responding providers tended to not support a requirement for a physician's signature for vaccine exemptions due to varying concerns regarding the implementation of such a practice.