Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial.

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

Legionella Infection in Pregnancy: The Forgotten Pathogen in Septic Shock.

BACKGROUND: Of eight cases of Legionella infection in pregnancy reported over 35 years, there was one case of maternal septic shock with poor outcome, one recovery with good outcome, and six with poor outcome. CASE: A 30-year-old woman, gravida 2 para 1, at 28 weeks of gestation presented with a high fever, cough, nausea, and vomiting. She deteriorated despite treatment for presumed urosepsis, was transferred to the intensive care unit, and remained intubated for 10 days receiving cardiovascular support, antivirals, antifungals, and multiple wide-spectrum antibiotics. Legionella infection antigen testing was performed on hospital day 1 and returned as positive. Azithromycin, started before the testing results became available, was continued for 14 days. The patient recovered, and the pregnancy progressed uneventfully to term. CONCLUSION: Legionella infection should be considered with maternal deterioration despite broad-spectrum antibiotic coverage. A favorable outcome is possible with early diagnosis and treatment.

Vulvodynia in Arkansas: a survey of Arkansas gynecologists' practice experience and management of vulvar pain.

The objective of this survey was to determine the level of experience OB/GYN (Obstetrics & Gynecology) physicians in the state of Arkansas have in seeing and managing patients with vulvar pain, commonly known as vulvodynia. The 8 question, anonymous survey was mailed to Arkansas OB/GYN physicians. The survey assessed the experience of the providers, the age range of their patients, and whether or not they treat and/or refer. Thirty of 182 surveys were returned for a rate of 16.4%. The survey revealed that physicians are moderately comfortable treating vulvodynia within their practice and refer mostly for treatment failure.