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Background There is a growing interest in practice-based implementation research, yet too often research prioritizes and is most successful in academic settings. During a national implementation trial to evaluate the effectiveness of Collaborative Care for co-occurring opioid use and mental health disorders, we lost three of our 11 participating implementation sites, all representing community sites. Method To better understand needed supports for implementation trial participation, we conducted exit interviews ( n = 5) with key staff at these community sites. Interview transcripts were double-coded and analyzed using Rapid Assessment Process. Qualitative themes were iteratively reviewed by the study team. Results Three themes emerged characterizing challenges for community sites, including that: (1) research threatens sites’ most precious resource—staff; (2) staff lack comfort with and skills for research; and (3) research participation in its current form does not offer a clear return on investment. Conclusions Learnings from this work illuminate some of the barriers community sites face when trying to participate in multisite implementation research. An undercurrent of participant perspectives was the belief that community sites like theirs are just not set up to successfully participate in clinical trial research, including population-based implementation trials. Future implementation trials should consider strategies that disrupt traditional approaches, increasing the equitable inclusion of diverse practice settings in implementation research.

Objective: Metastatic squamous cell carcinoma (SCC) of inguinal lymph node region with unknown origin is a rare condition. A patient was diagnosed to have vulvar SCC 7 years after the initial diagnosis of inguinal nodal metastatic SCC of unknown primary. Case report: A 59-year-old woman with metastatic SCC of unknown origin in the right inguinal lymph node underwent tumor resection and no evidence of residual disease or possible tumor origin was detected after the surgery and a comprehensive work-up. Seven years later, she was diagnosed to have invasive right vulvar SCC with right pelvic lymph node metastasis. We performed a series of tests to evaluate the relationship between these two events. Conclusion: According to our investigation, the possible relationship between the two events could not be ruled out. This case emphasizes the possibility of late recurrence and the importance of long-term follow up for patients with isolated nodal CUP.

Summary: Background: International distribution of contaminated foods can be a source of Salmonella infections in people and can contribute to the spread of antimicrobial-resistant bacteria across countries. We report an investigation led by the United States Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), and state governmental officials into a multistate outbreak of salmonellosis linked to pig ear pet treats. Methods: Pig ear treats and companion dogs were tested for Salmonella by state officials and the FDA. Products were traced back to the country of origin when possible. Cases were defined as outbreak illnesses in people associated with one of seven Salmonella serotypes genetically related to samples from pig ear pet treats, with isolation dates from June 2015 to September 2019. Whole genome sequencing (WGS) of isolates was used to predict antimicrobial resistance. Findings: The outbreak included 154 human cases in 34 states. Of these, 107 of 122 (88%) patients reported dog contact, and 65 of 97 (67%) reported contact with pig ear pet treats. Salmonella was isolated from 137 pig ear treats, including some imported from Argentina, Brazil, and Colombia, and from four dogs. WGS predicted 77% (105/137) of human and 43% (58/135) of pig ear treat isolates were resistant to ≥3 antimicrobial classes. Interpretation: This was the first documented United States multistate outbreak of Salmonella infections linked to pig ear pet treats. This multidrug-resistant outbreak highlights the interconnectedness of human health and companion animal ownership and the need for zoonotic pathogen surveillance to prevent human illness resulting from internationally transported pet food products. Funding: Animal Feed Regulatory Program Standards award. Animal and product testing conducted by FDA Vet-LIRN was funded by Vet-LIRN infrastructure grants (PAR-22-063).

Abstract Introduction Catholic hospitals' religious restrictions limit postpartum contraceptive care and reproductive counselling. This qualitative study explores opportunities for patients and providers to ensure access to desired postpartum contraception care. Methods We interviewed people who had obstetric experiences in Illinois Catholic hospitals: 21 patients and 23 providers, including clinicians, doulas, nurses, and maternal health home visitors. We transcribed interviews and coded transcripts then used a thematic content approach for analysis. To guide future interventions, we sought interviewees' perspectives on opportunities to improve postpartum contraceptive care for patients affected by these restrictions. Results Patients delivered in Catholic hospitals for varied reasons unrelated to religious affiliation and were generally unaware of limits on access to contraception. Some providers offered referrals or workarounds for some contraceptive methods. The majority of providers described the importance of initiating contraceptive counselling during the prenatal period, but few patients reported receiving comprehensive contraceptive counselling during this time. Patients who received contraceptive counselling often had these experiences with doulas and maternal health home visitors who were not affiliated with religious health centres. Conclusion Contraceptive counselling in the prenatal period can be a particularly helpful tool for patients delivering in hospitals that limit access to postpartum contraception, particularly in Catholic hospitals. Prenatal counselling can support advance planning if a patient needs to transfer or seek care outside their preferred health system. Where counselling and referrals are prohibited by religious restrictions, doulas and other maternal health home visitors can bridge gaps and support patient decision‐making and navigation to receive postpartum contraceptive care.

Abstract Background Uncontrolled hypertension is a leading risk factor for cardiovascular disease. To ensure continuity of care, community health centers (CHCs) nationwide implemented virtual care (telehealth) during the pandemic. CHCs use the Centers for Medicare & Medicaid Services (CMS) 165v8 Controlling High Blood Pressure measure to report blood pressure (BP) control performance. CMS 165v8 specifications state that if no BP is documented during the measurement period, the patient’s BP is assumed uncontrolled. Methods To examine trends in BP documentation and control rates in CHCs as telehealth use increased during the pandemic compared with pre-pandemic period, we assessed documentation of BP measurement and BP control rates from December 2019 - October 2021 among persons ages 18-85 with a diagnosis of hypertension who had an in-person or telehealth encounter in 11 CHCs. Rates were compared between CHCs that did and did not implement self-measured BP monitoring (SMBP). Results The percent of patients with hypertension with no documented BP measurement was 0.5% in December 2019 and increased to 15.2% (overall), 25.6% (non-SMBP CHCs), and 11.2% (SMBP CHCs) by October 2021. BP control using CMS 165v8 was 63.5% in December 2019 and decreased to 54.9% (overall), 49.1% (non-SMBP), and 57.2% (SMBP) by October 2021. When assessing BP control only in patients with documented BP measurements, CHCs largely maintained BP control rates (63.8% in December 2019; 64.8% (overall), 66.0% (non-SMBP), and 64.4% (SMBP) by October 2021). Conclusions The transition away from in-person to telehealth visits during the pandemic likely increased the number of patients with hypertension lacking a documented BP measurement, subsequently negatively impacting BP control using CMS 165v8. There is an urgent need to enhance the flexibility of virtual care, improve EHR data capture capabilities for patient-generated data, and implement expanded policy and systems-level changes for SMBP, an evidence-based strategy that can build patient trust, increase healthcare engagement, and improve hypertension outcomes.

Abstract Background A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden. Main text While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure. There is an urgent need to optimise and standardise outcome measures for this important patient group both for clinical services and for research and to allow comparing and pooling of data. Conclusions A Core Outcome Set for post-COVID-19 condition should be developed in the shortest time frame possible, for improvement in data quality, harmonisation, and comparability between different geographical locations. We call for a global initiative, involving all relevant partners, including, but not limited to, healthcare professionals, researchers, methodologists, patients, and caregivers. We urge coordinated actions aiming to develop a Core Outcome Set (COS) for post-COVID-19 condition in both the adult and paediatric populations.

Abstract Background Routine evidence-based tobacco use treatment minimizes cancer-specific and all-cause mortality, reduces treatment-related toxicity, and improves quality of life among patients receiving cancer care. Few cancer centers employ mechanisms to systematically refer patients to evidence-based tobacco cessation services. Implementation strategies informed by behavioral economics can increase tobacco use treatment engagement within oncology care. Methods A four-arm cluster-randomized pragmatic trial will be conducted across nine clinical sites within the Implementation Science Center in Cancer Control Implementation Lab to compare the effect of behavioral economic implementation strategies delivered through embedded messages (or “nudges”) promoting patient engagement with the Tobacco Use Treatment Service (TUTS). Nudges are electronic medical record (EMR)-based messages delivered to patients, clinicians, or both, designed to counteract known patient and clinician biases that reduce treatment engagement. We used rapid cycle approaches (RCA) informed by relevant stakeholder experiences to refine and optimize our implementation strategies and methods prior to trial initiation. Data will be obtained via the EMR, clinician survey, and semi-structured interviews with a subset of clinicians and patients. The primary measure of implementation is penetration, defined as the TUTS referral rate. Secondary outcome measures of implementation include patient treatment engagement (defined as the number of patients who receive FDA-approved medication or behavioral counseling), quit attempts, and abstinence rates. The semi-structured interviews, guided by the Consolidated Framework for Implementation Research, will assess contextual factors and patient and clinician experiences with the nudges. Discussion This study will be the first in the oncology setting to compare the effectiveness of nudges to clinicians and patients, both head-to-head and in combination, as implementation strategies to improve TUTS referral and engagement. We expect the study to (1) yield insights into the effectiveness of nudges as an implementation strategy to improve uptake of evidence-based tobacco use treatment within cancer care, and (2) advance our understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how patients with cancer who smoke are best engaged in tobacco use treatment and may lead to future research focused on scaling this approach across diverse centers. Trial registration Clinicaltrials.gov, NCT04737031 . Registered 3 February 2021.

The impact of vaccination on SARS-CoV-2 infectiousness is not well understood. We compared longitudinal viral shedding dynamics in unvaccinated and fully vaccinated adults. SARS-CoV-2-infected adults were enrolled within 5 days of symptom onset and nasal specimens were self-collected daily for two weeks and intermittently for an additional two weeks. SARS-CoV-2 RNA load and infectious virus were analyzed relative to symptom onset stratified by vaccination status. We tested 1080 nasal specimens from 52 unvaccinated adults enrolled in the pre-Delta period and 32 fully vaccinated adults with predominantly Delta infections. While we observed no differences by vaccination status in maximum RNA levels, maximum infectious titers and the median duration of viral RNA shedding, the rate of decay from the maximum RNA load was faster among vaccinated; maximum infectious titers and maximum RNA levels were highly correlated. Furthermore, amongst participants with infectious virus, median duration of infectious virus detection was reduced from 7.5 days (IQR: 6.0-9.0) in unvaccinated participants to 6 days (IQR: 5.0-8.0) in those vaccinated (P = 0.02). Accordingly, the odds of shedding infectious virus from days 6 to 12 post-onset were lower among vaccinated participants than unvaccinated participants (OR 0.42 95% CI 0.19-0.89). These results indicate that vaccination had reduced the probability of shedding infectious virus after 5 days from symptom onset.

Objectives: Our objectives were to identify Shigella isolates in the United States with decreased susceptibility to azithromycin (DSA) and characterize the genetic mechanisms responsible for this resistance. Methods: The National Antimicrobial Resistance Monitoring System (NARMS) at the US Centers for Disease Control and Prevention (CDC) collects and conducts broth microdilution antimicrobial susceptibility testing on Shigella to determine minimum inhibitory concentrations (MICs) for up to 15 drugs, including azithromycin. Isolates with decreased susceptibility to azithromycin were subjected to molecular methods (e.g., polymerase chain reaction [PCR], whole-genome sequencing, and plasmid typing/transformation) to identify the genetic mechanisms of resistance. Results: A total of 118 isolates with decreased susceptibility to azithromycin were tested—65 (55%) isolates contained only mphA, 1 (

Objective To examine how and to what extent medical devices using machine learning (ML) support clinician decision making.Methods We searched for medical devices that were (1) approved by the US Food and Drug Administration (FDA) up till February 2020; (2) intended for use by clinicians; (3) in clinical tasks or decisions and (4) used ML. Descriptive information about the clinical task, device task, device input and output, and ML method were extracted. The stage of human information processing automated by ML-based devices and level of autonomy were assessed.Results Of 137 candidates, 59 FDA approvals for 49 unique devices were included. Most approvals (n=51) were since 2018. Devices commonly assisted with diagnostic (n=35) and triage (n=10) tasks. Twenty-three devices were assistive, providing decision support but left clinicians to make important decisions including diagnosis. Twelve automated the provision of information (autonomous information), such as quantification of heart ejection fraction, while 14 automatically provided task decisions like triaging the reading of scans according to suspected findings of stroke (autonomous decisions). Stages of human information processing most automated by devices were information analysis, (n=14) providing information as an input into clinician decision making, and decision selection (n=29), where devices provide a decision.Conclusion Leveraging the benefits of ML algorithms to support clinicians while mitigating risks, requires a solid relationship between clinician and ML-based devices. Such relationships must be carefully designed, considering how algorithms are embedded in devices, the tasks supported, information provided and clinicians’ interactions with them.

Listeria monocytogenes is a foodborne pathogen with a highly clonal population structure comprising multiple phylogenetic sub-groups that can persist within food processing environments and contaminate food. The epidemiology of L. monocytogenes is well-described in some developed countries; however, little is known about the prevalence and population structure of this pathogen in food and food processing environments located in less developed regions. The aim of this study was to determine the genetic characteristics and clonal relatedness of L. monocytogenes that were isolated from two Jamaican meat processing facilities. Of the 37 isolates collected between 2011 and 2015, only a single lineage II isolate was recovered (serotype 1/2c), and the remaining were lineage I isolates representing serotypes 4b, 1/2b, 3b, and two untypeable isolates. Pulsed-field gel electrophoresis (PFGE) delineated isolates into seven pulsotypes, and whole-genome sequencing (WGS) categorized most isolates within one of three clonal complexes (CC): CC2 (N = 12), CC5 (N = 11), and CC288 (N = 11). Isolates representing CC1 (N = 2) and CC9 (N = 1) were also recovered. Virulence-associated genes such as inlA and the LIPI-3 cluster were detected in multiple isolates, along with the stress survival islet cluster-1 (SSI-1), and benzalkonium (bcrABC) and cadmium (cad1, cad2, cad4) resistance cassettes. Multiple isolates that belong to the same CC and matching PFGE patterns were isolated from food and the environment from both facilities across multiple years, suggesting the presence of persistent strains of L. monocytogenes, and/or constant re-entry of the pathogens into the facilities from common sources. These findings highlight the ability of lineage I isolates of L. monocytogenes to colonize, persist, and predominate within two meat-producing environments, and underscores the need for robust surveillance strategies to monitor and mitigate against these important foodborne pathogens.

The biodiversity of the bycatch community in tuna longline fisheries has historically been under-studied. In this study, observer data from 9744 sets of Chinese tuna longline fisheries were used to estimate the biodiversity of the bycatch by applying alpha diversity measures, and their habitat preference was predicted with the Generalized Additive Model. A total of 98 bycatch species were observed, mainly consisting of bony fishes and elasmobranchs. We found that there was a similar species composition in the ALB (Thunnus alalunga) and BET (Thunnus obesus) sets that was different in abundance assemblages. Regarding the entire study area, biodiversity in the tropical Pacific was higher than that in the temperate Pacific, and it was highest in the eastern tropical Pacific. In the western Pacific, higher pelagic biodiversity was noted between 15° and 20° latitude. The species richness and diversity were largely influenced by geographical positions, sea surface temperature and fishing depth. The indicators of species richness and density performed well in identifying the hotspots of biodiversity. This study helps to understand the predator biodiversity in pelagic ecosystems and identify, for conservation purposes, critical habitats for the bycatch community in tuna longline fisheries.

Antibiotic resistance (AR) phenotypes and acquired resistance determinants (ARDs) detected by in silico analysis of genome sequences were examined in 55 Shiga toxin-producing Escherichia coli (STEC) isolates representing diverse serotypes recovered from surfaces waters and sediments in a mixed use urban/agricultural landscape in British Columbia, Canada. The isolates displayed decreased susceptibility to florfenicol (65.5%), chloramphenicol (7.3%), tetracycline (52.7%), ampicillin (49.1%), streptomycin (34.5%), kanamycin (20.0%), gentamycin (10.9%), amikacin (1.8%), amoxicillin/clavulanic acid (21.8%), ceftiofur (18.2%), ceftriaxone (3.6%), trimethoprim-sulfamethoxazole (12.7%), and cefoxitin (3.6%). All surface water and sediment isolates were susceptible to ciprofloxacin, nalidixic acid, ertapenem, imipenem and meropenem. Eight isolates (14.6%) were multidrug resistant. ARDs conferring resistance to phenicols (floR), trimethoprim (dfrA), sulfonamides (sul1/2), tetracyclines (tetA/B), and aminoglycosides (aadA and aph) were detected. Additionally, narrow-spectrum β-lactamase blaTEM-1b and extended-spectrum AmpC β-lactamase (cephalosporinase) blaCMY-2 were detected in the genomes, as were replicons from plasmid incompatibility groups IncFII, IncB/O/K/Z, IncQ1, IncX1, IncY and Col156. A comparison with surveillance data revealed that AR phenotypes and ARDs were comparable to those reported in generic E. coli from food animals. Aquatic environments in the region are potential reservoirs for the maintenance and transmission of antibiotic resistant STEC, associated ARDs and their plasmids.

The efficacy of the adaptive humoral immune response likely requires diverse, yet focused regional B cell antibody production throughout the body. Here we address, in the first study of its kind, the B cell repertoire in the bronchial mucosa, an important barrier to antigens inhaled from the atmosphere. To accomplish this, we have applied high-throughput Adaptive Immune Receptor Repertoire Sequencing (AIRR-Seq) to 10 bronchial biopsies from altogether four different sites in the right lungs from an asthmatic patient and a healthy subject. While the majority of identified B cell clones were restricted to a single site, many were disseminated in multiple sites. Members of a clone were shared more between adjacent biopsies than between distal biopsies, suggesting local mucosal migration and/or a homing mechanism for B cells through the blood or lymph. A smaller fraction of clones spanned the bronchial mucosa and peripheral blood, suggesting ongoing trafficking between these compartments. The bronchial mucosal B cell repertoire in the asthmatic patient was geographically more variable but less diverse compared to that of the healthy subject, suggesting an ongoing, antigen-driven humoral immune response in atopic asthma. Whether this is a feature of atopy or disease status remains to be clarified in future studies. We observed a subset of highly mutated and antigen-selected IgD-only cells in the bronchial mucosa. These cells were found in relative high abundance in the asthmatic individual but also, albeit at lower abundance, in the healthy subject. This novel finding merits further exploration using a larger cohort of subjects.

The human pathogen Listeria monocytogenes continues to pose a challenge in the food industry, where it is known to contaminate ready-to-eat foods and grow during refrigerated storage. Increased knowledge of the cold-stress response of this pathogen will enhance the ability to control it in the food-supply-chain. This study utilized strand-specific RNA sequencing and whole cell fatty acid (FA) profiling to characterize the bacterium's cold stress response. RNA and FAs were extracted from a cold-tolerant strain at five time points between early lag phase and late stationary-phase, both at 4°C and 20°C. Overall, more genes (1.3×) were suppressed than induced at 4°C. Late stationary-phase cells exhibited the greatest number (n = 1,431) and magnitude (>1,000-fold) of differentially expressed genes (>2-fold, p

Computer-Aided Biomimetics (CAB) tools aim to support the integration of relevant biological knowledge into biomimetic problem-solving processes. Specific steps of biomimetic processes that require support include the identification, selection and abstraction of relevant biological analogies. Existing CAB tools usually aim to support these steps by describing biological systems in terms of functions, although engineering functions do not map naturally to biological functions. Consequentially, the resulting static, functional view provides an incomplete understanding of biological processes, which are dynamic, cyclic and self-organizing. This paper proposes an alternative approach that revolves around the concept of trade-offs. The aim is to include the biological context, such as environmental characteristics, that may provide information crucial to the transfer of biological information to an engineering application. The proposed design process is exemplified by an illustrative case study.

BACKGROUND:Community interactions can produce complex dynamics with counterintuitive responses. Synanthropic community members are of increasing practical interest for their effects on biodiversity and public health. Most studies incorporating introduced species have been performed on islands where they may pose a risk to the native fauna. Few have examined their interactions in urban environments where they represent the majority of species. We characterized house cat (Felis catus) predation on wild Norway rats (Rattus norvegicus), and its population effects in an urban area as a model system. Three aspects of predation likely to influence population dynamics were examined; the stratum of the prey population killed by predators, the intensity of the predation, and the size of the predator population. METHODOLOGY/PRINCIPAL FINDINGS:Predation pressure was estimated from the sizes of the rat and cat populations, and the characteristics of rats killed in 20 alleys. Short and long term responses of rat population to perturbations were examined by removal trapping. Perturbations removed an average of 56% of the rats/alley but had no negative long-term impact on the size of the rat population (49.6+/-12.5 rats/alley and 123.8+/-42.2 rats/alley over two years). The sizes of the cat population during two years (3.5 animals/alley and 2.7 animals/alley) also were unaffected by rat population perturbations. Predation by cats occurred in 9/20 alleys. Predated rats were predominantly juveniles and significantly smaller (144.6 g+/-17.8 g) than the trapped rats (385.0 g+/-135.6 g). Cats rarely preyed on the larger, older portion of the rat population. CONCLUSIONS/SIGNIFICANCE:The rat population appears resilient to perturbation from even substantial population reduction using targeted removal. In this area there is a relatively low population density of cats and they only occasionally prey on the rat population. This occasional predation primarily removes the juvenile proportion of the rat population. The top predator in this urban ecosystem appears to have little impact on the size of the prey population, and similarly, reduction in rat populations doesn't impact the size of the cat population. However, the selected targeting of small rats may locally influence the size structure of the population which may have consequences for patterns of pathogen transmission.