Background: The safe removal of personal protective equipment (PPE) can limit transmission of serious communicable diseases, but this process poses challenges to healthcare workers (HCWs). Methods: We observed 41 HCWs across 4 Ebola treatment centers in Georgia doffing PPE for simulated patients with serious communicable diseases. Using human factors methodologies, we obtained the details, sequences, and durations of doffing steps; identified the ways each step can fail (failure modes [FMs]); quantified the riskiness of FMs; and characterized the workload of doffing steps. Results: Eight doffing steps were common to all hospitals-removal of boot covers, gloves (outer and inner pairs), the outermost garment, the powered air purifying respirator (PAPR) hood, and the PAPR helmet assembly; repeated hand hygiene (eg, with hand sanitizer); and a final handwashing with soap and water. Across hospitals, we identified 256 FMs during the common doffing steps, 61 of which comprised 19 common FMs. Most of these common FMs were above average in their riskiness at each hospital. At all hospitals, hand hygiene, removal of the outermost garment, and removal of boot covers were above average in their overall riskiness. Measurements of workload revealed that doffing steps were often mentally demanding, and this facet of workload correlated most strongly with the effortfulness of a doffing step. Conclusions: We systematically identified common points of concern in protocols for doffing high-level PPE. Addressing FMs related to hand hygiene and the removal of the outermost garment, boot covers, and PAPR hood could improve HCW safety when doffing high-level PPE. We identified ways that doffing protocols for high-level personal protective equipment may fail to protect healthcare workers. Hand hygiene, removing the outermost garment, boot covers, and respirator hood harbored the greatest risk and failed in similar ways across different hospitals.

Background: Few data exist to guide the physical design of biocontainment units, particularly the doffing area. This can impact the contamination risk of healthcare workers (HCWs) during doffing of personal protective equipment (PPE). Methods: In phase I of our study, we analyzed simulations of a standard patient care task with 56 trained HCWs focusing on doffing of high-level PPE. In phase II, using a rapid cycle improvement approach, we tested different balance AIDS and redesigned doffing area layouts with 38 students. In phase III, we tested 1 redesigned layout with an additional 10 trained HCWs. We assessed the effectiveness of design changes on improving the HCW performance (measured by occurrence and number of risky behaviors) and reducing the physical and cognitive load by comparing the results from phase I and phase III. Results: The physical load was highest when participants were removing their shoe covers without any balance aid; the use of a chair required the lowest physical effort, followed by horizontal and vertical grab bars. In the revised design (phase III), the overall performance of participants improved. There was a significant decrease in the number of HCW risky behaviors (P =. 004); 5 risky behaviors were eliminated and 2 others increased. There was a significant decrease in physical load when removing disposable shoe covers (P =. 04), and participants reported a similar workload in the redesigned doffing layout (P =. 43). Conclusions: Through optimizing the design and layout of the doffing space, we reduced risky behaviors of HCWs during doffing of high-level PPE.

We observed 354 hand hygiene instances across 41 healthcare workers doffing personal protective equipment at 4 hospital-based biocontainment units. We measured the duration and thoroughness of each hand hygiene instance. Both parameters varied substantially, with systematic differences between hospitals and differences between healthcare workers accounting for much of the variance.

The heterogeneity of human clinical trials to assess the effectiveness of probiotics presents challenges regarding interpretation and comparison. Evidence obtained from clinical trials among a population with a disease or specific risk factors may not be generalizable to healthy individuals. The evaluation of interventions in healthy persons requires careful selection of outcomes due to the absence of health indicators and the low incidence of preventable conditions. Given the tremendous resources invested in such trials, development of consistent approaches to assessing the effectiveness of probiotics would be beneficial. Furthermore, the reporting, presentation and communication of results may also affect the validity of the scientific evidence obtained from a trial. This review outlines the challenges associated with the design, implementation, data analysis and interpretation of clinical trials in humans involving probiotics. Best practices related to their design are offered along with recommendations for enhanced collaboration to advance research in this emerging field.

In October 2001, four cases of inhalational anthrax occurred in workers in a Washington, D.C., mail facility that processed envelopes containing Bacillus anthracis spores. We reviewed the envelopes' paths and obtained exposure histories and nasal swab cultures from postal workers. Environmental sampling was performed. A sample of employees was assessed for antibody concentrations to B. anthracis protective antigen. Case-patients worked on nonoverlapping shifts throughout the facility, suggesting multiple aerosolization events. Environmental sampling showed diffuse contamination of the facility. Potential workplace exposures were similar for the case-patients and the sample of workers. All nasal swab cultures and serum antibody tests were negative. Available tools could not identify subgroups of employees at higher risk for exposure or disease. Prophylaxis was necessary for all employees. To protect postal workers against bioterrorism, measures to reduce the risk of occupational exposure are necessary.

BACKGROUND: Data are limited on the impact of methicillin-resistant Staphylococcus aureus (MRSA) on morbidity and mortality among very low birth weight (VLBW) infants with S aureus (SA) bacteremia and/or meningitis (B/M). METHODS: Neonatal data for VLBW infants (birth weight 401–1500 g) born January 1, 2006, to December 31, 2008, who received care at centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network were collected prospectively. Early-onset (≤72 hours after birth) and late-onset (>72 hours) infections were defined by blood or cerebrospinal fluid cultures and antibiotic treatment of ≥5 days (or death <5 days with intent to treat). Outcomes were compared for infants with MRSA versus methicillin-susceptible S aureus (MSSA) B/M. RESULTS: Of 8444 infants who survived >3 days, 316 (3.7%) had SA B/M. Eighty-eight had MRSA (1% of all infants, 28% of infants with SA); 228 had MSSA (2.7% of all infants, 72% of infants with SA). No infant had both MRSA and MSSA B/M. Ninety-nine percent of MRSA infections were late-onset. The percent of infants with MRSA varied by center (P < .001) with 9 of 20 centers reporting no cases. Need for mechanical ventilation, diagnosis of respiratory distress syndrome, necrotizing enterocolitis, and other morbidities did not differ between infants with MRSA and MSSA. Mortality was high with both MRSA (23 of 88, 26%) and MSSA (55 of 228, 24%). CONCLUSIONS: Few VLBW infants had SA B/M. The 1% with MRSA had morbidity and mortality rates similar to infants with MSSA. Practices should provide equal focus on prevention and management of both MRSA and MSSA infections among VLBW infants.

ABSTRACT: This is a summary from a workshop convened as part of the 13thannual meeting of the International Scientific Association for Probiotics and Prebiotics. A group of 24 stakeholders, including clinical experts, researchers, federal government officials, funding agencies, lawyers and industry experts met to review the challenges of the current regulatory approach to human research on probiotics in the USA and to discuss ways to move research forward. There was agreement that some of the current regulatory requirements imposed on probiotic research in the United States hindered research progress and increased cost without improving study subject safety. Many situations were outlined by clinical investigators demonstrating the impact of regulatory delays on research progress. Additionally, research is compromised when study designs and outcomes require manipulation so as to invoke less burdensome regulatory requirements. These responses by investigators to regulatory requirements have placed United States' researchers at a disadvantage. The public ultimately suffer when research to clarify the role of these products on health is stalled. Workshop participants concurred that regulatory oversight should balance study subject vulnerability with documented safety for the intended use for the probiotic strain, and that human research on foods and supplements should not be be regulated as drug research. Challenges and potential improvement strategies are discussed.

Rotavirus vaccines hold promise to decrease the burden of severe diarrhea in the poorest countries, where 85% of deaths due to rotavirus occur. However, the potency of live oral vaccines is lower in these challenging settings than in middle- and upper-income countries. Many hypotheses have been suggested to explain these differences that could provide clues to improve the ultimate success of these novel vaccines. Although introduction today of even moderately effective vaccines will decrease the morbidity and mortality associated with rotavirus in low-income settings, research is urgently needed to understand why these differences in efficacy occur and what could be done to improve vaccine performance to maximize the life-saving benefits of vaccination.

Background: Live oral rotavirus vaccines have been less immunogenic and efficacious among children in poor developing countries compared with middle income and industrialized countries for reasons that are not yet completely understood. We assessed whether the neutralizing activity of breast milk could lower the titer of vaccine virus and explain this difference in vitro. Methods: Breast milk samples were collected from mothers who were breast-feeding infants 4 to 29 weeks of age (ie, vaccine eligible age) in India (N = 40), Vietnam (N = 77), South Korea (N = 34), and the United States (N = 51). We examined breast milk for rotavirus-specific IgA and neutralizing activity against 3 rotavirus vaccine strains-RV1, RV5 G1, and 116E using enzyme immunoassays. The inhibitory effect of breast milk on RV1 was further examined by a plaque reduction assay. FINDINGS:: Breast milk from Indian women had the highest IgA and neutralizing titers against all 3 vaccine strains, while lower but comparable median IgA and neutralizing titers were detected in breast milk from Korean and Vietnamese women, and the lowest titers were seen in American women. Neutralizing activity was greatest against the 2 vaccine strains of human origin, RV1 and 116E. This neutralizing activity in one half of the breast milk specimens from Indian women could reduce the effective titer of RV1 by ∼2 logs, of 116E by 1.5 logs, and RV5 G1 strain by ∼1 log more than that of breast milk from American women. INTERPRETATION:: The lower immunogenicity and efficacy of rotavirus vaccines in poor developing countries could be explained, in part, by higher titers of IgA and neutralizing activity in breast milk consumed by their infants at the time of immunization that could effectively reduce the potency of the vaccine. Strategies to overcome this negative effect, such as delaying breast-feeding at the time of immunization, should be evaluated.

Invasive disease due to group B Streptococcus infection (Streptococcus agalactiae) results in a wide spectrum of clinical disease. In North America, serotypes Ia, Ib, II, III, and V are most frequently associated with invasive disease. Group B Streptococcus remains a continuing source of morbidity and mortality in high-risk populations, including pregnant women, neonates, and the elderly; an increasing incidence of invasive disease has been observed in nonpregnant adults. Group B Streptococcus remains the most common culture-confirmed neonatal bacterial infection in the United States and is a significant source of neonatal morbidity globally. Intrapartum antibiotic prophylaxis has reduced the incidence of early-onset neonatal disease without a notable impact on the incidence of late-onset neonatal disease. Penicillin G remains the mainstay of therapy, although reduced penicillin susceptibility has been observed in select isolates. Increased frequency of resistance to non-beta-lactam antibiotics, including clindamycin, erythromycin, and fluoroquinolones, has been observed, with some isolates demonstrating resistance to vancomycin. The development and implementation of strategies to identify hosts, treat judiciously with antimicrobials with the narrowest spectra, and prevent invasive disease, with vaccines, are essential to reduce the burden of group B Streptococcus disease.