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Background: Standardized patients (SPs) are essential stakeholders in the multiple mini interviews (MMIs) that are increasingly used to assess medical school applicants' interpersonal skills. However, there is little evidence for their inclusion in the development of instruments. Objective: This study aimed to describe the process and evaluate the impact of having SPs co-design and cocreate a global measurement question that assesses medical school applicants' readiness for medical school and acceptance status. Methods: This study used an exploratory, sequential, and mixed methods study design. First, we evaluated the initial MMI program and determined the next quality improvement steps. Second, we held a collaborative workshop with SPs to codevelop the assessment question and response options. Third, we evaluated the created question and the additional MMI rubric items through statistical tests based on 1084 applicants' data from 3 cohorts of applicants starting in the 2018-2019 academic year. The internal reliability of the MMI was measured using a Cronbach a test, and its prediction of admission status was tested using a forward stepwise binary logistic regression. Results: Program evaluation indicated the need for an additional quantitative question to assess applicant readiness for medical school. In total, 3 simulation specialists, 2 researchers, and 21 SPs participated in a workshop leading to a final global assessment question and responses. The Cronbach a's were >0.8 overall and in each cohort year. The final stepwise logistic model for all cohorts combined was statistically significant (P<.001), explained 9.2% (R2) of the variance in acceptance status, and correctly classified 65.5% (637/972) of cases. The final model consisted of 3 variables: empathy, rank of readiness, and opening the encounter. Conclusions: The collaborative nature of this project between stakeholders, including nonacademics and researchers, was vital for the success of this project. The SP-created question had a significant impact on the final model predicting acceptance to medical school. This finding indicates that SPs bring a critical perspective that can improve the process of evaluating medical school applicants. [ABSTRACT FROM AUTHOR]

Background: Patient and Public Involvement (PPI) in research is increasingly being utilized to better connect patients and researchers. The Patient Engagement Studio (PES) supports PPI in research by working directly with researchers throughout various stages of their projects. Recently, two researchers presented to the PES for assistance with their project, Embryo+™. The purpose of Embryo+™ is to decrease miscarriage rates using RNA sequencing technology that screens for the most viable embryos. To date, no examples of PPI directly in the planning or implementation of bench research concerning in vitro fertilization and embryo transfer have been identified. Main body: Embryo+™ researchers met in-person with the PES two times (fall 2019; each meeting had 9 PES members in attendance) for initial feedback and protocol development. After these meetings, PES leadership and Embryo+™ researchers decided that the unique nature of the project merited a PPI evaluation. Subsequent evaluation of engagement efforts occurred by reviewing the PES reports for the Embryo+™ researchers, conducting two recorded web-based discussion meetings with the PES (summer 2020; meeting 1 n = 7; meeting 2 n = 6), and a brief survey (n = 13). The discussion meetings provided an opportunity for the PES members to define engagement themes through consensus via verbal agreement to the studio director's periodic summaries during the discussions. Combining survey results and PES themes allowed for a broad discussion for meaningful engagement. The Embryo+™ researchers established trust with the patients by changing some of their language in response to patient suggestions, allowing for unintended ethical conversations, and implementing the patient developed protocols. Overall, the patient experts thought this project was very meaningful and valuable, quantified by a mean loyalty score 89.43 (s.d. 10.29). Conclusion: Bench science researchers may need additional PPI training prior to engaging with patient groups. PPI in this project was successful in large part due to this training, where the director emphasized the importance of gaining trust with the patients. The researchers applied what they learned and several examples of how to develop trust with patients are discussed. If trust is established, PPI in an ethically charged, basic science research study can be both valuable and successful. Plain English summary: Patients are increasingly becoming involved in all stages of the research process. Patient and public involvement has been shown to answer questions that matter to patients, increase enrollment in studies, and improve the spread of research results to the public. However, there are limited evaluations of patient engagement in basic science research (research performed in a laboratory setting in various fields). Here, we provide an example of patients effectively involved in the planning and implementation of an ethically complex study in the field of Assistive Reproductive Technology. A Patient Engagement Studio, affiliated with an academic health center, directly connects patients and researchers through bi-monthly meetings. Recently, two researchers presented their project, Embryo+™, to the studio during the planning stage of their study. This project aims to use a new testing technology to reduce miscarriage rates. The researchers presented to the studio twice (fall 2019), and two follow-up meetings were conducted with the patients (summer 2020). Also, the patients completed a survey evaluating how engaged they felt with the project. Through the meetings, the researchers changed their language in response to patient feedback, and patients developed project protocols. Survey results showed that the patients thought this project was very meaningful and valuable. Overall, this evaluation shows that patients can add value to contentious bench science projects, particularly in the field of Assistive Reproductive Technology. [ABSTRACT FROM AUTHOR]

We describe the structural characterization of the capsular polysaccharides (CPSs) of Pasteurella multocida serotypes B and E. CPS was isolated following organic solvent precipitation of the supernatant from flask grown cells. Structural analysis utilizing nuclear magnetic resonance spectroscopy enabled the determination of the CPS structures and revealed significant structural similarities between the two serotypes, but also provided an explanation for the serological distinction. This observation was extended by the development of polyclonal sera to the glycoconjugate of serotype B CPS that corroborated the structural likenesses and differences. Finally, identification of these structures enabled a more comprehensive interrogation of the genetic loci and prediction of roles for some of the encoded proteins in repeat unit biosynthesis. [ABSTRACT FROM AUTHOR]

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Dental caries remains a major health issue and the Gram-positive bacterium Streptococcus mutans is considered as the major pathogen causing caries. More recently, S. mutans has been recognised as a cause of endocarditis, ulcerative colitis and fatty acid liver disease along with the likelihood of increased cerebral hemorrhage following a stroke if S. mutans is present systemically. We initiated this study to examine the vaccine candidacy of the serotype specific polysaccharides elaborated by S. mutans. We have confirmed the carbohydrate structures for the serotype specific rhamnan containing polysaccharides from serotypes c, f and k. We have prepared glycoconjugate vaccines using the rhamnan containing polymers from serotypes f and k and immunised mice and rabbits. We consistently obtained a robust immune response to the glycoconjugates with cross-reactivity consistent with the structural similarities of the polymers from the different serotypes. We developed an opsonophagocytic assay which illustrated the ability of the post-immune sera to facilitate opsonophagocytic killing of the homologous and heterologous serotypes at titers consistent with the structural homologies. We conclude that glycoconjugates of the rhamnan polymers of S. mutans are a potential vaccine candidate to target dental caries and other sequelae following the escape of S. mutans from the oral cavity. [ABSTRACT FROM AUTHOR]

Research Objective: Patient engagement in research involves patients and caregivers as experts and collaborators who impactfully contribute to the research continuum. Traditionally, most patient engagement activities were facilitated in‐person. Little is known about methods and effectiveness of virtual engagement. This project aims to build capacity for and implement a diabetes‐focused VIrtual Patient (VIP) Engagement Studio, with emphasis on geographically dispersed and hard‐to‐reach patients, to facilitate engagement efforts along the diabetes continuum of comparative effectiveness research and patient‐centered outcomes research (CER/PCOR). Study Design: This engagement project realizes its objectives through: (1) Building a diverse network of geographically dispersed VIP Studio patient experts (VIPs) who can serve as experts with lived experiences of diabetes and can be meaningfully involved in the VIP Studio; (2) Training recruited VIPs and implement the VIP Studio activities by engaging VIPs in ongoing and new CER/PCOR research opportunities; (3) Evaluating the virtual experience and disseminate the capacity‐building plan to expand and replicate the VIP Studio among other PCOR partners. Population Studied: South Carolina (SC) ranks fifth highest in the US in the percentage of population with diabetes, with major racial & geographic disparities. While over one‐third of SC population are minorities or live in rural areas, engagement of patients and stakeholders from these communities in CER/PCOR remains limited partly because of transportation and other access issues. The VIP Studio can support efforts relating to the engagement of hard‐to‐reach population groups. VIP Expert eligibility includes being 18 years‐old or older, have diabetes or be the caregiver to someone with diabetes, and live in South Carolina, North Carolina, or Georgia. Principal Findings: 51 individuals attended (out of 93 who signed up) one of 23 informational sessions held over two months; of which, 46 completed the application for the 25 VIP spots available. The selection of VIPs was an iterative process that ensured diversity, in terms of gender, rurality, race and ethnicity, educational attainment, age, caregiver status, and county. Seven virtual training sessions were conducted to build trust, generate patient‐centered questions, and establish basic premises of research and how to partner in research. The sessions included training on virtual platforms used, an overview of the 10‐Step Framework of Continuous Patient Engagement, understanding diabetes, introduction to research with emphasis on CER/PCOR, formulating research "wonderings" into research questions, and communicating with researchers. Various trust‐building and team‐building activities were incorporated in all sessions. At least five research 'review' sessions are planned for the remainder of the project. The process, methods, key learnings and experiences from the VIP Studio will be presented. Conclusions: The VIP Engagement Studio has potential to expand the participation of diverse patient groups, providing a patient perspective of health issues that is more representative of the patient population afflicted with diabetes. Implications for Policy or Practice: This project demonstrates the feasibility of expanding the VIP Studio as an infrastructure model that can be scaled‐up to a regional and national levels. Ultimately, this virtual model can be useful in nation‐wide, multi‐site studies where each site may be enrolling patients from geographic areas that may have unique concerns to that region or area. Primary Funding Source: Patient‐Centered Outcomes Research Institute. [ABSTRACT FROM AUTHOR]

Research Objective: Patient engagement in research involves patients and caregivers as experts and collaborators who impactfully contribute to the research continuum. Traditionally, most patient engagement activities were facilitated in‐person. Little is known about methods and effectiveness of virtual engagement. This project aims to build capacity for and implement a diabetes‐focused VIrtual Patient (VIP) Engagement Studio, with emphasis on geographically dispersed and hard‐to‐reach patients, to facilitate engagement efforts along the diabetes continuum of comparative effectiveness research and patient‐centered outcomes research (CER/PCOR). Study Design: This engagement project realizes its objectives through: (1) Building a diverse network of geographically dispersed VIP Studio patient experts (VIPs) who can serve as experts with lived experiences of diabetes and can be meaningfully involved in the VIP Studio; (2) Training recruited VIPs and implement the VIP Studio activities by engaging VIPs in ongoing and new CER/PCOR research opportunities; (3) Evaluating the virtual experience and disseminate the capacity‐building plan to expand and replicate the VIP Studio among other PCOR partners. Population Studied: South Carolina (SC) ranks fifth highest in the US in the percentage of population with diabetes, with major racial & geographic disparities. While over one‐third of SC population are minorities or live in rural areas, engagement of patients and stakeholders from these communities in CER/PCOR remains limited partly because of transportation and other access issues. The VIP Studio can support efforts relating to the engagement of hard‐to‐reach population groups. VIP Expert eligibility includes being 18 years‐old or older, have diabetes or be the caregiver to someone with diabetes, and live in South Carolina, North Carolina, or Georgia. Principal Findings: 51 individuals attended (out of 93 who signed up) one of 23 informational sessions held over two months; of which, 46 completed the application for the 25 VIP spots available. The selection of VIPs was an iterative process that ensured diversity, in terms of gender, rurality, race and ethnicity, educational attainment, age, caregiver status, and county. Seven virtual training sessions were conducted to build trust, generate patient‐centered questions, and establish basic premises of research and how to partner in research. The sessions included training on virtual platforms used, an overview of the 10‐Step Framework of Continuous Patient Engagement, understanding diabetes, introduction to research with emphasis on CER/PCOR, formulating research "wonderings" into research questions, and communicating with researchers. Various trust‐building and team‐building activities were incorporated in all sessions. At least five research 'review' sessions are planned for the remainder of the project. The process, methods, key learnings and experiences from the VIP Studio will be presented. Conclusions: The VIP Engagement Studio has potential to expand the participation of diverse patient groups, providing a patient perspective of health issues that is more representative of the patient population afflicted with diabetes. Implications for Policy or Practice: This project demonstrates the feasibility of expanding the VIP Studio as an infrastructure model that can be scaled‐up to a regional and national levels. Ultimately, this virtual model can be useful in nation‐wide, multi‐site studies where each site may be enrolling patients from geographic areas that may have unique concerns to that region or area. Primary Funding Source: Patient‐Centered Outcomes Research Institute. [ABSTRACT FROM AUTHOR]

Inhalation of small numbers of Francisella tularensis subspecies tularensis (Ftt) in the form of small particle aerosols causes severe morbidity and mortality in people and many animal species. For this reason, Ftt was developed into a bona fide biological weapon by the USA, by the former USSR, and their respective allies during the previous century. Although such weapons were never deployed, the 9/11 attack quickly followed by the Amerithrax attack led the U.S. government to seek novel countermeasures against a select group of pathogens, including Ftt. Between 2005–2009, we pursued a novel live vaccine against Ftt by deleting putative virulence genes from a fully virulent strain of the pathogen, SCHU S4. These mutants were screened in a mouse model, in which the vaccine candidates were first administered intradermally (ID) to determine their degree of attenuation. Subsequently, mice that survived a high dose ID inoculation were challenged by aerosol or intranasally (IN) with virulent strains of Ftt. We used the current unlicensed live vaccine strain (LVS), first discovered over 70 years ago, as a comparator in the same model. After screening 60 mutants, we found only one, SCHU S4 ΔclpB, that outperformed LVS in the mouse ID vaccination-respiratory-challenge model. Currently, SCHU S4 ΔclpB has been manufactured under current good manufacturing practice conditions, and tested for safety and efficacy in mice, rats, and macaques. The steps necessary for advancing SCHU S4 ΔclpB to this late stage of development are detailed herein. These include developing a body of data supporting the attenuation of SCHU S4 ΔclpB to a degree sufficient for removal from the U.S. Select Agent list and for human use; optimizing SCHU S4 ΔclpB vaccine production, scale up, and long-term storage; and developing appropriate quality control testing approaches. [ABSTRACT FROM AUTHOR]