Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola

The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) was a randomized, controlled trial of rVSVΔG-ZEBOV-GP vaccine in healthcare and frontline workers during the 2014-2016 Ebola epidemic. Overall safety findings have been previously reported; there were no vaccine-related serious adverse events (SAEs). Here we describe the safety monitoring system established for STRIVE and the health conditions that resulted in reported SAEs, as well as factors affecting SAE incidence. Participants were randomized to immediate (≤7 days) or deferred (18-24 weeks later) vaccination and were monitored for safety for 6 months (immediate-vaccinated group) or until vaccination (deferred [unvaccinated] group). Once vaccinated, the latter group was termed crossover-vaccinated and monitored for 6 additional months. Of the 8577 STRIVE participants with safety follow-up data, 4172 were in the immediate-vaccinated group and 4398 were in the unvaccinated group, of whom 3787 received crossover vaccination. Overall, 143 SAEs were reported among 132 participants. Of the 143 SAEs, 130 (90.9%) resulted in hospitalization, and 24 (18.2%) participants with an SAE died. Infections were the most common SAEs; malaria was the most common single diagnosis and the most common cause of death. STRIVE built local capacity for vaccine safety monitoring in future clinical trials and research and in the national immunization program. This information about serious health conditions that resulted in hospitalization or death among a population of relatively young, healthy adults in Sierra Leone could help inform improved delivery of preventive and therapeutic health services

Confidence of UK Ophthalmology Registrars in Managing Posterior Capsular Rupture: Results from a National Trainee Survey

IntroductionTo establish the level of confidence amongst UK ophthalmology specialist registrars (residents) in managing posterior capsule rupture (PCR) during cataract surgery. Methods: An online nine-item questionnaire was distributed to all registrars, recruited nationwide via regional representatives. Data collected included stage of training, number of completed cataract operations, cumulative PCR rate, number of PCRs independently managed, understanding of vitrectomy settings and fluidic parameters and access to simulation. Respondents self-evaluated their confidence in managing PCR with vitreous loss. ResultsComplete responses were obtained from 248 registrars (35% response rate). Mean number of phacoemulsification procedures performed was 386. For senior registrars (OST 6–7), 35 out of 70 (50%) felt confident to manage PCR independently and 55 out of 70 (78.6%) were either quite confident or very confident at deciding when to implant an intraocular lens during PCR management. Lower confidence levels were noted for junior trainees (OST 1–2). Over 65% of survey respondents had access to relevant simulation. ConclusionsOur results represent the largest UK survey analysing the confidence of PCR management amongst registrars. Confidence improves with duration of training and increased exposure to management of PCR. However, 50% of senior registrars still lacked confidence to independently manage PCR and vitreous loss. A specific competency-based framework, potentially using a simulator or simulating a PCR event, incorporated into the curriculum may be desirable.</div