Ventilation during COVID-19 in a school for students with intellectual and developmental disabilities (IDD).

BACKGROUND: This study examined the correlation of classroom ventilation (air exchanges per hour (ACH)) and exposure to CO2 ≥1,000 ppm with the incidence of SARS-CoV-2 over a 20-month period in a specialized school for students with intellectual and developmental disabilities (IDD). These students were at a higher risk of respiratory infection from SARS-CoV-2 due to challenges in tolerating mitigation measures (e.g. masking). One in-school measure proposed to help mitigate the risk of SARS-CoV-2 infection in schools is increased ventilation. METHODS: We established a community-engaged research partnership between the University of Rochester and the Mary Cariola Center school for students with IDD. Ambient CO2 levels were measured in 100 school rooms, and air changes per hour (ACH) were calculated. The number of SARS-CoV-2 cases for each room was collected over 20 months. RESULTS: 97% of rooms had an estimated ACH ≤4.0, with 7% having CO2 levels ≥2,000 ppm for up to 3 hours per school day. A statistically significant correlation was found between the time that a room had CO2 levels ≥1,000 ppm and SARS-CoV-2 PCR tests normalized to room occupancy, accounting for 43% of the variance. No statistically significant correlation was found for room ACH and per-room SARS-CoV-2 cases. Rooms with ventilation systems using MERV-13 filters had lower SARS-CoV-2-positive PCR counts. These findings led to ongoing efforts to upgrade the ventilation systems in this community-engaged research project. CONCLUSIONS: There was a statistically significant correlation between the total time of room CO2 concentrations ≥1,000 and SARS-CoV-2 cases in an IDD school. Merv-13 filters appear to decrease the incidence of SARS-CoV-2 infection. This research partnership identified areas for improving in-school ventilation.

Empowering the Participant Voice (EPV): Design and implementation of collaborative infrastructure to collect research participant experience feedback at scale.

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

Learning health system benefits: Development and initial validation of a framework.

Introduction: Implementation of research findings in clinical practice often is not realized or only partially achieved, and if so, with a significant delay. Learning health systems (LHSs) hold promise to overcome this problem by embedding clinical research and evidence-based best practices into care delivery, enabling innovation and continuous improvement. Implementing an LHS is a complex process that requires participation and resources of a wide range of stakeholders, including healthcare leaders, clinical providers, patients and families, payers, and researchers. Engaging these stakeholders requires communicating clear, tangible value propositions. Existing models identify broad categories of benefits but do not explicate the full range of benefits or ways they can manifest in different organizations. Methods: To develop such a framework, a working group with representatives from six Clinical and Translational Science Award (CTSA) hubs reviewed existing literature on LHS characteristics, models, and goals; solicited expert input; and applied the framework to their local LHS experiences. Results: The Framework of LHS Benefits includes six categories of benefits (quality, safety, equity, patient satisfaction, reputation, and value) relevant for a range of stakeholders and defines key concepts within each benefit. Applying the framework to five LHS case examples indicated preliminary face validity across varied LHS approaches and revealed three dimensions in which the framework is relevant: defining goals of individual LHS projects, facilitating collaboration based on shared values, and establishing guiding tenets of an LHS program or mission. Conclusion: The framework can be used to communicate the value of an LHS to different stakeholders across varied contexts and purposes, and to identify future organizational priorities. Further validation will contribute to the framework's evolution and support its potential to inform the development of tools to evaluate LHS impact.

Ventilation during COVID-19 in a school for students with intellectual and developmental disabilities (IDD).

Background: This study examined the correlation of classroom ventilation (air exchanges per hour (ACH)) and exposure to CO2 ≥1,000 ppm with the incidence of SARS-CoV-2 over a 20-month period in a specialized school for students with intellectual and developmental disabilities (IDD). These students were at a higher risk of respiratory infection from SARS-CoV-2 due to challenges in tolerating mitigation measures (e.g. masking). One in-school measure proposed to help mitigate the risk of SARS-CoV-2 infection in schools is increased ventilation. Methods: We established a community-engaged research partnership between the University of Rochester and the Mary Cariola Center school for students with IDD. Ambient CO2 levels were measured in 100 school rooms, and air changes per hour (ACH) were calculated. The number of SARS-CoV-2 cases for each room was collected over 20 months. Results: 97% of rooms had an estimated ACH ≤4.0, with 7% having CO2 levels ≥2,000 ppm for up to 3 hours per school day. A statistically significant correlation was found between the time that a room had CO2 levels ≥1,000 ppm and SARS-CoV-2 PCR tests normalized to room occupancy, accounting for 43% of the variance. No statistically significant correlation was found for room ACH and per-room SARS-CoV-2 cases. Rooms with ventilation systems using MERV-13 filters had lower SARS-CoV-2-positive PCR counts. These findings led to ongoing efforts to upgrade the ventilation systems in this community-engaged research project. Conclusions: There was a statistically significant correlation between the total time of room CO2 concentrations ≥1,000 and SARS-CoV-2 cases in an IDD school. Merv-13 filters appear to decrease the incidence of SARS-CoV-2 infection. This research partnership identified areas for improving in-school ventilation.

Reflections From School Communities in Underserved Populations on Childhood COVID-19 Vaccination.

OBJECTIVES: Outbreaks in vaccine-preventable diseases among children have increased, primarily among under- or unvaccinated subgroups. The influence and interaction of a child's school community on parental health care decisions, such as vaccination, has not been explored. Our study examined childhood coronavirus disease 2019 (COVID-19) vaccine hesitancy within the context of school communities. METHODS: This study combines data from 4 independent research studies funded by the National Institutes of Health Rapid Acceleration of Diagnostics Underserved Populations Return to School Initiative. We examined focus group data to better understand the apprehension surrounding parental and child COVID-19 vaccination among underserved school populations. RESULTS: Across all study sites, 7 main themes emerged with regard to COVID-19-related vaccination concerns for children: (1) potential side effects, (2) vaccine development, (3) misinformation (subthemes: content of vaccine and negative intent of the vaccine), (4) vaccine effectiveness, (5) timing of vaccine administration/availability for children, (6) fear of needles, and (7) mistrust. CONCLUSIONS: School settings offered unique access to youth and family perspectives in underserved communities. Our studies highlighted several factors contributing to COVID-19 vaccine hesitancy in school communities, which align with existing literature on vaccine hesitancy. These concerns centered primarily on potential harm of vaccines, as well as misinformation, mistrust, and timing of vaccines. Related recommendations for increasing vaccination rates are provided. Developing specific strategies that address parent and child concerns will be critical to reducing health inequities related to COVID-19 vaccination.

Common Data Element Collection in Underserved School Communities: Challenges and Recommendations.

OBJECTIVES: To provide recommendations for future common data element (CDE) development and collection that increases community partnership, harmonizes data interpretation, and continues to reduce barriers of mistrust between researchers and underserved communities. METHODS: We conducted a cross-sectional qualitative and quantitative evaluation of mandatory CDE collection among Rapid Acceleration of Diagnostics-Underserved Populations Return to School project teams with various priority populations and geographic locations in the United States to: (1) compare racial and ethnic representativeness of participants completing CDE questions relative to participants enrolled in project-level testing initiatives and (2) identify the amount of missing CDE data by CDE domain. Additionally, we conducted analyses stratified by aim-level variables characterizing CDE collection strategies. RESULTS: There were 15 study aims reported across the 13 participating Return to School projects, of which 7 (47%) were structured so that CDEs were fully uncoupled from the testing initiative, 4 (27%) were fully coupled, and 4 (27%) were partially coupled. In 9 (60%) study aims, participant incentives were provided in the form of monetary compensation. Most project teams modified CDE questions (8/13; 62%) to fit their population. Across all 13 projects, there was minimal variation in the racial and ethnic distribution of CDE survey participants from those who participated in testing; however, fully uncoupling CDE questions from testing increased the proportion of Black and Hispanic individuals participating in both initiatives. CONCLUSIONS: Collaboration with underrepresented populations from the early study design process may improve interest and participation in CDE collection efforts.

Trends and Non-Clinical Predictors of Respiratory Syncytial Virus (RSV) and Influenza Diagnosis in an Urban Pediatric Population.

Objective: To evaluate the demographic, maternal, and community-level predictors of pediatric respiratory syncytial virus (RSV) and influenza diagnosis among an urban population of children residing in Rochester, NY. Study design: A test-negative case-control design was used to investigate various non-clinical determinants of RSV and influenza diagnosis among 1,808 children aged 0-14 years who presented to the University of Rochester Medical Center (URMC) or an affiliated health clinic in Rochester, NY between 2012-2019. These children were all tested for RSV and influenza via polymerase-chain-reaction (PCR) method, including RSV and influenza diagnosis of all severity types. Test results were linked to medical records, birth certificates, questionnaires administered through the Statewide Perinatal Data System, and the US census by census tracts to obtain information on child, maternal, demographic, and socio-economic characteristics. Results: Overall the strongest predictor of RSV and influenza diagnosis was child's age, with every year increase in child's age, risk for RSV decreased (OR: 0.75; 95% CI: 0.71, 0.79) and risk for influenza increased (OR: 1.20; 95%: 1.16, 1.24). In addition to age, non-private insurance type was positively associated with influenza diagnosis. When considering the proportion of positive cases for RSV and influenza over all PCR tests by respiratory season, a spike in influenza cases was observed in 2018-2019. Conclusions: Age was a strong predictor of RSV and influenza diagnosis among this urban sample of children.

Diagnosis of Pregnancy Complications Using Blind Ultrasound Sweeps Performed by Individuals Without Prior Formal Ultrasound Training.

OBJECTIVE: To estimate the diagnostic accuracy of blind ultrasound sweeps performed with a low-cost, portable ultrasound system by individuals with no prior formal ultrasound training to diagnose common pregnancy complications. METHODS: This is a single-center, prospective cohort study conducted from October 2020 to January 2022 among people with second- and third-trimester pregnancies. Nonspecialists with no prior formal ultrasound training underwent a brief training on a simple eight-step approach to performing a limited obstetric ultrasound examination that uses blind sweeps of a portable ultrasound probe based on external body landmarks. The sweeps were interpreted by five blinded maternal-fetal medicine subspecialists. Sensitivity, specificity, and positive and negative predictive values for blinded ultrasound sweep identification of pregnancy complications (fetal malpresentation, multiple gestations, placenta previa, and abnormal amniotic fluid volume) were compared with a reference standard ultrasonogram as the primary analysis. Kappa for agreement was also assessed. RESULTS: Trainees performed 194 blinded ultrasound examinations on 168 unique pregnant people (248 fetuses) at a mean of 28±5.85 weeks of gestation for a total of 1,552 blinded sweep cine clips. There were 49 ultrasonograms with normal results (control group) and 145 ultrasonograms with abnormal results with known pregnancy complications. In this cohort, the sensitivity for detecting a prespecified pregnancy complication was 91.7% (95% CI 87.2-96.2%) overall, with the highest detection rate for multiple gestations (100%, 95% CI 100-100%) and noncephalic presentation (91.8%, 95% CI 86.4-97.3%). There was high negative predictive value for placenta previa (96.1%, 95% CI 93.5-98.8%) and abnormal amniotic fluid volume (89.5%, 95% CI 85.3-93.6%). There was also substantial to perfect mean agreement for these same outcomes (range 87-99.6% agreement, Cohen κ range 0.59-0.91, P<.001 for all). CONCLUSION: Blind ultrasound sweeps of the gravid abdomen guided by an eight-step protocol using only external anatomic landmarks and performed by previously untrained operators with a low-cost, portable, battery-powered device had excellent sensitivity and specificity for high-risk pregnancy complications such as malpresentation, placenta previa, multiple gestations, and abnormal amniotic fluid volume, similar to results of a diagnostic ultrasound examination using a trained ultrasonographer and standard-of-care ultrasound machine. This approach has the potential to improve access to obstetric ultrasonography globally.

Sustainable volume sweep imaging lung teleultrasound in Peru: Public health perspectives from a new frontier in expanding access to imaging.

Background: Pulmonary disease is a common cause of morbidity and mortality, but the majority of the people in the world lack access to diagnostic imaging for its assessment. We conducted an implementation assessment of a potentially sustainable and cost-effective model for delivery of volume sweep imaging (VSI) lung teleultrasound in Peru. This model allows image acquisition by individuals without prior ultrasound experience after only a few hours of training. Methods: Lung teleultrasound was implemented at 5 sites in rural Peru after a few hours of installation and staff training. Patients were offered free lung VSI teleultrasound examination for concerns of respiratory illness or research purposes. After ultrasound examination, patients were surveyed regarding their experience. Health staff and members of the implementation team also participated in separate interviews detailing their views of the teleultrasound system which were systematically analyzed for key themes. Results: Patients and staff rated their experience with lung teleultrasound as overwhelmingly positive. The lung teleultrasound system was viewed as a potential way to improve access to imaging and the health of rural communities. Detailed interviews with the implementation team revealed obstacles to implementation important for consideration such as gaps in lung ultrasound understanding. Conclusions: Lung VSI teleultrasound was successfully deployed to 5 health centers in rural Peru. Implementation assessment revealed enthusiasm for the system among members of the community along with important areas of consideration for future teleultrasound deployment. This system offers a potential means to increase access to imaging for pulmonary illness and improve the health of the global community.

Breast Ultrasound Volume Sweep Imaging: A New Horizon in Expanding Imaging Access for Breast Cancer Detection.

OBJECTIVE: The majority of people in the world lack basic access to breast diagnostic imaging resulting in delay to diagnosis of breast cancer. In this study, we tested a volume sweep imaging (VSI) ultrasound protocol for evaluation of palpable breast lumps that can be performed by operators after minimal training without prior ultrasound experience as a means to increase accessibility to breast ultrasound. METHODS: Medical students without prior ultrasound experience were trained for less than 2 hours on the VSI breast ultrasound protocol. Patients presenting with palpable breast lumps for standard of care ultrasound examination were scanned by a trained medical student with the VSI protocol using a Butterfly iQ handheld ultrasound probe. Video clips of the VSI scan imaging were later interpreted by an attending breast imager. Results of VSI scan interpretation were compared to the same-day standard of care ultrasound examination. RESULTS: Medical students scanned 170 palpable lumps with the VSI protocol. There was 97% sensitivity and 100% specificity for a breast mass on VSI corresponding to 97.6% agreement with standard of care (Cohen's κ = 0.95, P < .0001). There was a detection rate of 100% for all cancer presenting as a sonographic mass. High agreement for mass characteristics between VSI and standard of care was observed, including 87% agreement on Breast Imaging-Reporting and Data System assessments (Cohen's κ = 0.82, P < .0001). CONCLUSIONS: Breast ultrasound VSI for palpable lumps offers a promising means to increase access to diagnostic imaging in underserved areas. This approach could decrease delay to diagnosis for breast cancer, potentially improving morbidity and mortality.

Assessment of a Brief Standardized Obstetric Ultrasound Training Program for Individuals Without Prior Ultrasound Experience.

ABSTRACT: Obstetric volume sweep imaging (OB VSI) is a simple set of transducer movements guided by external body landmarks that can be taught to ultrasound-naive non-experts. This approach can increase access to ultrasound in rural/low-resources settings lacking trained sonographers. This study presents and evaluates a training program for OB VSI. Six trainees without previous formal ultrasound experience received a training program on the OB VSI protocol containing focused didactics and supervised live hands-on ultrasound scanning practice. Trainees then independently performed 194 OB VSI examinations on pregnancies >14 weeks with known prenatal ultrasound abnormalities. Images were reviewed by maternal-fetal medicine specialists for the primary outcome (protocol deviation rates) and secondary outcomes (examination quality and image quality). Protocol deviation was present in 25.8% of cases, but only 7.7% of these errors affected the diagnostic potential of the ultrasound. Error rate differences between trainees ranged from 8.6% to 53.8% ( P < 0.0001). Image quality was excellent or acceptable in 88.2%, and 96.4% had image quality capable of yielding a diagnostic interpretation. The frequency of protocol deviations decreased over time in the majority of trainees, demonstrating retention of training program over time. This brief OB VSI training program for ultrasound-naive non-experts yielded operators capable of producing high-quality images capable of diagnostic interpretation after 3 hours of training. This training program could be adapted for use by local community members in low-resource/rural settings to increase access to obstetric ultrasound.

Volume sweep imaging lung teleultrasound for detection of COVID-19 in Peru: a multicentre pilot study.

OBJECTIVES: Pulmonary disease is a significant cause of morbidity and mortality in adults and children, but most of the world lacks diagnostic imaging for its assessment. Lung ultrasound is a portable, low-cost, and highly accurate imaging modality for assessment of pulmonary pathology including pneumonia, but its deployment is limited secondary to a lack of trained sonographers. In this study, we piloted a low-cost lung teleultrasound system in rural Peru during the COVID-19 pandemic using lung ultrasound volume sweep imaging (VSI) that can be operated by an individual without prior ultrasound training circumventing many obstacles to ultrasound deployment. DESIGN: Pilot study. SETTING: Study activities took place in five health centres in rural Peru. PARTICIPANTS: There were 213 participants presenting to rural health clinics. INTERVENTIONS: Individuals without prior ultrasound experience in rural Peru underwent brief training on how to use the teleultrasound system and perform lung ultrasound VSI. Subsequently, patients attending clinic were scanned by these previously ultrasound-naïve operators with the teleultrasound system. PRIMARY AND SECONDARY OUTCOME MEASURES: Radiologists examined the ultrasound imaging to assess its diagnostic value and identify any pathology. A random subset of 20% of the scans were analysed for inter-reader reliability. RESULTS: Lung VSI teleultrasound examinations underwent detailed analysis by two cardiothoracic attending radiologists. Of the examinations, 202 were rated of diagnostic image quality (94.8%, 95% CI 90.9% to 97.4%). There was 91% agreement between radiologists on lung ultrasound interpretation among a 20% sample of all examinations (κ=0.76, 95% CI 0.53 to 0.98). Radiologists were able to identify sequelae of COVID-19 with the predominant finding being B-lines. CONCLUSION: Lung VSI teleultrasound performed by individuals without prior training allowed diagnostic imaging of the lungs and identification of sequelae of COVID-19 infection. Deployment of lung VSI teleultrasound holds potential as a low-cost means to improve access to imaging around the world.

From insights to action: Enriching the clinical and translational research workforce by developing diverse and inclusive career programs.

Diversification of the Translational Science workforce is a strategic goal for the National Center for the Advancement of Translational Science (NCATS) program. NCATS has identified the development of translational science education, training, and support for a diverse translational science workforce as key to advancing the growing field of translational science. An annual mixed-methods assessment has been conducted on Common Metrics data submitted by over 60 Clinical & Translational Science Awards (CTSA) programs nationwide and includes metrics addressing recruitment and retention of scientists with particular attention to underrepresented persons and women. This article describes a methodology for the development of From Insights to Action, a resource for guiding program implementation and strategic planning to develop a diverse clinical and translational science workforce. This was informed by the Common Metrics Initiative process and constituted of findings from qualitative interviews of a subset of CTSAs that participated. The dissemination of this guide had several impacts, including providing structural foci for the CTSA Fall 2020 program meeting centered on Diversity, Equity, and Inclusion in translational science; addressing NCATS' goal of workforce diversity; and understanding the number of diverse graduates still engaged in research.

How to overcome hesitancy for COVID-19 and other vaccines.

These evidence-based strategies (and list of do's and don'ts) can help you to increase the likelihood of vaccine uptake in hesitant patients.

Moving beyond annual data reports: A blueprint for communicating and disseminating actionable intelligence.

Identifying and disseminating actionable intelligence is a challenging task that requires thoughtful planning. The National Center for Advancing Translational Sciences instituted the Common Metrics Initiative with the goal of evaluating the Clinical and Translational Science Awards (CTSA) Programs using a standard set of metrics. Initially managed by Tufts University, the Center for Leading Innovation and Collaboration (CLIC) at the University of Rochester began leading this initiative in 2017. In directing this work, CLIC created a framework for communicating and disseminating data insights. Insights to Inspire emerged from the need to share strategies and lessons learned to improve metric performance at the local level to a network of 60+ academic research institutions. Insights to Inspire employs a mixed methods approach for translating data into actionable intelligence. A series of blogs, webinars, and webcasts were designed to communicate metric-specific strategies used by individual sites to the broader CTSA consortium. A dissemination plan to expand the reach beyond metric stakeholders utilized focused communications including social media channels, network newsletters, and presentations at national meetings. This framework serves as a blueprint for other national evaluation programs interested in a systematic approach to using data insights for continuous improvement.

A Community Collaborative for the Exploration of Local Factors Affecting Black Mothers' Experiences with Perinatal Care.

OBJECTIVES: Black women face disparities in maternal morbidity and mortality when compared to White women. Multiple factors contribute to these disparities. This study examines the perspectives of Black women who have given birth in the last 5 years, to understand their pregnancy and birth experiences as a means of ascertaining factors that may be contributing to these disparities. METHODS: The Consortium to End Black Maternal Mortality was established as a collaborative table of cross-sector stakeholders and Black mothers to effectively conduct community-based participatory research focused on Black maternal health. Between January and March 2020, Black mothers who had given birth in the last 5 years facilitated Listening Sessions (LS) with other Black mothers in Rochester, NY. Participants reported on details of their pregnancy and delivery, including interaction with providers, personal relationships and their individual experience. The qualitative data captured during these sessions were coded to draw out key themes which were validated with LS participants and the Consortium. RESULTS: The key themes that emerged clustered into four groups, including: (1) Mother-Provider Communication; (2) Social Support; (3) Systemic factors and (4) Maternal Emotional & Mental Health. Mother-provider communication was the most salient factor affecting the maternal experience and was found to be influenced primarily by maternal health literacy and provider discriminatory attitudes and behaviors. CONCLUSIONS FOR PRACTICE: As a result of the Listening Sessions conducted with Black women, we identified mother-provider communication as the most important factor influencing the maternal experience.

Implementation of Teleophthalmology to Improve Diabetic Retinopathy Surveillance: Qualitative Interview Study of Clinical Staff Informed by Implementation Science Frameworks.

BACKGROUND: The store-and-forward camera-based evaluation of the eye, or teleophthalmology, is an effective way to identify diabetic retinopathy, the leading cause of blindness in the United States, but uptake has been slow. Understanding the barriers to and facilitators of implementing teleophthalmology programs from those actively adopting, running, and sustaining such programs is important for widespread adoption. OBJECTIVE: This study aims to understand the factors that are important in introducing teleophthalmology to improve access to diagnostic eye care for patients with diabetes in primary care clinics by using implementation science. METHODS: This qualitative study in 3 urban, low-income, largely racial and ethnic minority-serving safety-net primary care clinics in Rochester, New York, interviewed nurses and physicians on implementing a teleophthalmology program by using questions informed by the Practical, Robust Implementation and Sustainability Model and the Consolidated Framework for Implementation Research. RESULTS: Primary care nurses operationalizing the program in their clinics saw increased work burden and a lack of self-efficacy as barriers. Continuous training on the teleophthalmology process for nurses, physicians, and administrative staff through in-service and peer training by champions and superusers were identified by interviewees as needs. Facilitators included the perceived convenience for the patient and a perceived educational advantage to the program, as it gave an opportunity for providers to discuss the importance of eye care with patients. Concerns in making and tracking referrals to ophthalmology because of challenges related to care coordination were highlighted. The financial aspects of the program (eg, patient coverage and care provider reimbursement) were unclear to many staff members, influencing adoption and sustainability. CONCLUSIONS: Streamlining processes and workflows, training and assigning adequate staff, effectively coordinating care between primary care and eye care to improve follow-ups, and ensuring financial viability can all help streamline the adoption of teleophthalmology.

No sonographer, no radiologist: New system for automatic prenatal detection of fetal biometry, fetal presentation, and placental location.

Ultrasound imaging is a vital component of high-quality Obstetric care. In rural and under-resourced communities, the scarcity of ultrasound imaging results in a considerable gap in the healthcare of pregnant mothers. To increase access to ultrasound in these communities, we developed a new automated diagnostic framework operated without an experienced sonographer or interpreting provider for assessment of fetal biometric measurements, fetal presentation, and placental position. This approach involves the use of a standardized volume sweep imaging (VSI) protocol based solely on external body landmarks to obtain imaging without an experienced sonographer and application of a deep learning algorithm (U-Net) for diagnostic assessment without a radiologist. Obstetric VSI ultrasound examinations were performed in Peru by an ultrasound operator with no previous ultrasound experience who underwent 8 hours of training on a standard protocol. The U-Net was trained to automatically segment the fetal head and placental location from the VSI ultrasound acquisitions to subsequently evaluate fetal biometry, fetal presentation, and placental position. In comparison to diagnostic interpretation of VSI acquisitions by a specialist, the U-Net model showed 100% agreement for fetal presentation (Cohen's κ 1 (p<0.0001)) and 76.7% agreement for placental location (Cohen's κ 0.59 (p<0.0001)). This corresponded to 100% sensitivity and specificity for fetal presentation and 87.5% sensitivity and 85.7% specificity for anterior placental location. The method also achieved a low relative error of 5.6% for biparietal diameter and 7.9% for head circumference. Biometry measurements corresponded to estimated gestational age within 2 weeks of those assigned by standard of care examination with up to 89% accuracy. This system could be deployed in rural and underserved areas to provide vital information about a pregnancy without a trained sonographer or interpreting provider. The resulting increased access to ultrasound imaging and diagnosis could improve disparities in healthcare delivery in under-resourced areas.

No sonographer, no radiologist: Assessing accuracy of artificial intelligence on breast ultrasound volume sweep imaging scans.

Breast ultrasound provides a first-line evaluation for breast masses, but the majority of the world lacks access to any form of diagnostic imaging. In this pilot study, we assessed the combination of artificial intelligence (Samsung S-Detect for Breast) with volume sweep imaging (VSI) ultrasound scans to evaluate the possibility of inexpensive, fully automated breast ultrasound acquisition and preliminary interpretation without an experienced sonographer or radiologist. This study was conducted using examinations from a curated data set from a previously published clinical study of breast VSI. Examinations in this data set were obtained by medical students without prior ultrasound experience who performed VSI using a portable Butterfly iQ ultrasound probe. Standard of care ultrasound exams were performed concurrently by an experienced sonographer using a high-end ultrasound machine. Expert-selected VSI images and standard of care images were input into S-Detect which output mass features and classification as "possibly benign" and "possibly malignant." Subsequent comparison of the S-Detect VSI report was made between 1) the standard of care ultrasound report by an expert radiologist, 2) the standard of care ultrasound S-Detect report, 3) the VSI report by an expert radiologist, and 4) the pathological diagnosis. There were 115 masses analyzed by S-Detect from the curated data set. There was substantial agreement of the S-Detect interpretation of VSI among cancers, cysts, fibroadenomas, and lipomas to the expert standard of care ultrasound report (Cohen's κ = 0.73 (0.57-0.9 95% CI), p<0.0001), the standard of care ultrasound S-Detect interpretation (Cohen's κ = 0.79 (0.65-0.94 95% CI), p<0.0001), the expert VSI ultrasound report (Cohen's κ = 0.73 (0.57-0.9 95% CI), p<0.0001), and the pathological diagnosis (Cohen's κ = 0.80 (0.64-0.95 95% CI), p<0.0001). All pathologically proven cancers (n = 20) were designated as "possibly malignant" by S-Detect with a sensitivity of 100% and specificity of 86%. Integration of artificial intelligence and VSI could allow both acquisition and interpretation of ultrasound images without a sonographer and radiologist. This approach holds potential for increasing access to ultrasound imaging and therefore improving outcomes related to breast cancer in low- and middle- income countries.

Preterm prelabor rupture of membranes: evaluating latency and neonatal morbidity for pregnancies with expectant management ≥34 weeks.

OBJECTIVE: To evaluate the association between latency and neonatal morbidity for pregnancies with expectant management of PPROM ≥34 w. MATERIALS AND METHODS: A retrospective cohort of singletons with PPROM from 2011 to 2016. Exposure was defined as latency (period from diagnosis of PPROM to delivery) and was analyzed as a count variable (i.e. number of days) and binary variable (≥7 days and <7 days; ≥21 days and <21 days). Primary outcome was composite neonatal morbidity defined as need for respiratory support, culture positive neonatal sepsis, and/or neonatal antibiotics >72 h. Fisher's exact test, chi-square test, Mann-Whitney U and binary logistic regression tests were performed with p<.05 considered significant. RESULTS: Of 813 pregnancies, 104 met inclusion criteria: 73 (70.2%) pregnancies with PPROM diagnosed at <34 weeks and 31 (29.8%) pregnancies with PPROM diagnosed ≥34 weeks. A total of 58 (55.8%) pregnancies had a latency of ≥7 days and 46 (44.2%) had a latency <7 days. There was no difference in composite neonatal morbidity for latency ≥7 d versus <7 d (aOR 0.92; 95% CI 0.30-2.82) or latency as a count variable (aOR 0.70; 95% CI 0.23-2.13). However, a latency ≥21 d was associated with increased composite neonatal morbidity (aOR 10.24, 95% CI 1.42-73.99). CONCLUSION: In pregnancies with PPROM expectantly managed ≥34 w, a latency of ≥7 d is not associated with significant differences in neonatal morbidity. However, different latency thresholds may be more clinically relevant for late preterm pregnancies. The increase in composite neonatal morbidity associated with a latency >21 days should be an area of future investigation and may suggest there is a population of pregnancies with PPROM which may not benefit from expectant management past 34 weeks.