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We describe a case of autochthonous human Babesia divergens infection in an immunocompetent woman in England. The patient had fever, hemolysis, multiorgan failure, and 18% parasitemia. We confirmed B. divergens by 18S rDNA PCR and sequencing. Clinicians should consider babesiosis as a differential diagnosis in patients with unexplained hemolysis.

Background: State-level leadership and conditions are instrumental to local and regional comprehensive school mental health system (CSMHS) quality, sustainability, and growth. However, systematic documentation of state-level school mental health (SMH) policy, infrastructure, funding, and practice is limited. Methods: Using a multi-phase, multi-method process, we developed the State School Mental Health Profile (State Profile) to offer a comprehensive landscape of state SMH efforts. State leaders in 25 states completed the State Profile once over a 3-year data collection period. Mixed methods results are reported in 8 domains. Results: State education agencies were reportedly most involved in SMH technical assistance, advocacy, leadership, funding, and service provision, with mental health agencies reported as second most involved. Nearly half of state respondents reported having a state-level SMH director or coordinator. Policies with the greatest perceived impact require implementation of and funding for SMH services and supports. Despite leveraging multiple sources of funding, most states emphasized lack of funding as a primary barrier to establishing CSMHSs. All states reported staffing shortages. Conclusion: The State Profile can assist multi-agency state leadership teams to self-assess policy, infrastructure, and resources to support CSMHSs statewide. Findings point to areas of opportunity to advance equity across resource allocation, service provision, and policy development.

Abstract The ability to remember unique past events (episodic memory) may be an evolutionarily conserved function, with accumulating evidence of episodic-(like) memory processing in rodents. In humans, it likely contributes to successful complex social networking. Rodents, arguably the most used laboratory models, are also rather social animals. However, many behavioural paradigms are devoid of sociality, and commonly-used social spontaneous recognition tasks (SRTs) are open to non-episodic strategies based upon familiarity. We address this gap by developing new SRT variants. Here, in object-in-context SRTs, we asked if context could be specified by the presence/absence of either a conspecific (experiment 1) or an additional local object (experiment 2). We show that mice readily used the conspecific as contextual information to distinguish unique episodes in memory. In contrast, no coherent behavioural response emerged when an additional object was used as a potential context specifier. Further, in a new social conspecific-in-context SRT (experiment 3) where environment-based change was the context specifier, mice preferably explored a more recently-seen familiar conspecific associated with contextual mismatch, over a less recently-seen familiar conspecific presented in the same context. The results argue that, in incidental SRT conditions, mice readily incorporate conspecific cue information into episodic-like memory. Thus, the tasks offer different ways to assess and further understand the mechanisms at work in social episodic-like memory processing.

El confinamiento por la pandemia del covid-19 causó estragos en el sistema educativo mexicano. El cierre de las escuelas llevó a la migración a la virtualidad; con ello modificó la forma tradicional de enseñanza y aprendizaje. A pesar del regreso a la presencialidad, en México se identifica un rezago educativo producto del confinamiento y afectaciones en la esfera psicosocial de los estudiantes que no han sido suficientemente atendidos. El objetivo de esta investigación fue caracterizar, desde la opinión de estudiantes de bachillerato, el clima del aula virtual, estrategias didácticas y la interacción social, para identificar las afectaciones psicoemocionales derivadas por el confinamiento. Se encuestó a 2927 estudiantes de seis bachilleratos mexicanos. Se trabajó un diseño mixto no experimental y transversal. El análisis de datos combinó estadística descriptiva y minería de textos cualitativos. Los resultados indicaron que el clima del aula virtual fue aburrido y con poca interacción social (43 %); que la modalidad virtual se basó principalmente en programas para videoconferencia (97 %); que el 61 % de los estudiantes sufrió ansiedad causada por la incertidumbre generada por el contexto pandémico; que al 50 %, el aislamiento le produjo soledad, y que el 49 % de ellos se sintió decepcionado porque no se cumplieron sus expectativas educativas. Esto coincide con la literatura, dado el contexto incierto caracterizado por una pandemia intermitente, se recomienda capacitar a los docentes mexicanos para la enseñanza en ambientes virtuales enfocados en mejorar el clima del aula y atender las afectaciones psicoemocionales en los estudiantes, factores que pueden limitar el logro de aprendizajes significativos futuros.

IntroductionTongue weakness and atrophy can lead to deficits in the vital functions of breathing and swallowing in patients with motor neuron diseases (MNDs; e.g., amyotrophic lateral sclerosis (ALS) and pseudobulbar palsy), often resulting in aspiration pneumonia, respiratory failure, and death. Available treatments for patients with MNDs are largely palliative; thus, there is a critical need for therapies targeting preservation of upper airway function and suggesting a role for tongue exercise in patients with MNDs. Here, we leveraged our inducible rodent model of hypoglossal (XII) motor neuron degeneration to investigate the effects of a strength endurance tongue exercise program on upper airway structure and function. Our model was created through intralingual injection of cholera toxin B conjugated to saporin (CTB-SAP) into the genioglossus muscle of the tongue to induce targeted death of XII motor neurons.MethodsRats in this study were allocated to 4 experimental groups that received intralingual injection of either CTB-SAP or unconjugated CTB + SAP (i.e., control) +/- tongue exercise. Following tongue exercise exposure, we evaluated the effect on respiratory function (via plethysmography), macrostructure [via magnetic resonance imaging (MRI) of the upper airway and tongue], and ultrafine structure [via ex vivo magnetic resonance spectroscopy (MRS) of the tongue] with a focus on lipid profiles.ResultsResults showed that sham exercise-treated CTB-SAP rats have evidence of upper airway restriction (i.e., reduced airflow) and structural changes present in the upper airway (i.e., airway compression) when compared to CTB-SAP + exercise rats and control rats +/- tongue exercise, which was ameliorated with tongue exercise. Additionally, CTB-SAP + sham exercise rats have evidence of increased lipid expression in the tongue consistent with previously observed tongue hypertrophy when compared to CTB-SAP + exercise rats or control rats +/- tongue exercise.ConclusionThese findings provide further evidence that a strength endurance tongue exercise program may be a viable therapeutic treatment option in patients with XII motor neuron degeneration in MNDs such as ALS. Future directions will focus on investigating the underlying mechanism responsible for tongue exercise-induced plasticity in the hypoglossal-tongue axis, particularly inflammatory associated factors such as BDNF.

Based on theoretical frameworks of scientist stereotypes, possible selves, and science identity, written assignments were developed to teach science content through biographies and research of counter-stereotypical scientists--Scientist Spotlights (www.scientistspotlights.org). Previous studies on Scientist Spotlight assignments showed significant shifts in how college-level biology students relate to and describe scientists and in their performance in biology courses. However, the outcomes of Scientist Spotlight assignments in secondary schools were yet to be explored. In collaboration with 18 science teachers from 12 schools, this study assessed the impacts of Scientist Spotlight assignments for secondary school students. We used published assessment tools: Relatability prompt; Stereotypes prompt; and Performance/Competence, Interest, and Recognition (PCIR) instrument. Statistical analyses compared students' responses before and after receiving at least three Scientist Spotlight assignments. We observed significant shifts in students' relatability to and descriptions of scientists as well as other science identity measures. Importantly, disaggregating classes by implementation strategies revealed that students' relatability shifts were significant for teachers reporting in-class discussions and not significant for teachers reporting no discussions. Our findings raise questions about contextual and pedagogical influences shaping student outcomes with Scientist Spotlight assignments, like how noncontent Instructor Talk might foster student shifts in aspects of science identity.

Abstract Background Aerophagia (ingestion of air), is a functional aerodigestive disorder in people. Criteria for diagnosis of aerophagia in dogs are >1/3 of bolus volume containing air or ingested air resulting in gastric distention (>1/3 of end gastric volume). Aerophagia is highlighted during eating and drinking. Videofluoroscopic swallow studies (VFSS) document aerophagia in dogs, but the incidence, clinical signs (CS), and associated disorders are unknown. Objectives Identify the incidence of aerophagia, compare CS between dogs with and without aerophagia, and identify associated and predisposing disorders using VFSS. Animals A total of 120 client‐owned dogs. Methods Sequential VFSS and associated medical records from dogs presenting to veterinary teaching hospitals at Auburn University and the University of Missouri were retrospectively reviewed. Statistical comparisons were made using Mann‐Whitney and chi‐squared tests, odds ratios (OR), and multiple logistic regression (P

Abstract Complex systems ranging from societies to ecological communities and power grids may be viewed as networks of connected elements. Such systems can go through critical transitions driven by an avalanche of contagious change. Here we ask, where in a complex network such a systemic shift is most likely to start. Intuitively, a central node seems the most likely source of such change. Indeed, topological studies suggest that central nodes can be the Achilles heel for attacks. We argue that the opposite is true for the class of networks in which all nodes tend to follow the state of their neighbors, a category we call two-way pull networks. In this case, a well-connected central node is an unlikely starting point of a systemic shift due to the buffering effect of connected neighbors. As a result, change is most likely to cascade through the network if it spreads first among relatively poorly connected nodes in the periphery. The probability of such initial spread is highest when the perturbation starts from intermediately connected nodes at the periphery, or more specifically, nodes with intermediate degree and relatively low closeness centrality. Our finding is consistent with empirical observations on social innovation, and may be relevant to topics as different as the sources of originality of art, collapse of financial and ecological networks and the onset of psychiatric disorders.

Persistence of HIV-1 in cellular reservoirs results in lifelong infection, with cure achieved only in rare cases through ablation of marrow-derived cells. We report on optimization of an approach that could potentially be aimed at eliminating these reservoirs, hijacking the HIV-1 alternative splicing process to functionalize the herpes simplex virus thymidine kinase (HSVtk)/ganciclovir (GCV) cell suicide system through targeted RNA trans-splicing at the HIV-1 D4 donor site. AUG1-deficient HSVtk therapeutic pre-mRNA was designed to gain an in-frame start codon from HIV-1 tat1. D4-targeting lentiviral vectors were produced and used to transduce HIV-1-expressing cells, where trans-spliced HIV-1 tat/HSVtk mRNA was successfully detected. However, translation of catalytically active HSVtk polypeptides from internal AUGs in HSVtkΔAUG1 caused GCV-mediated cytotoxicity in uninfected cells. Modifying these sites in the D4 opt 2 lentiviral vector effectively mitigated this major off-target effect. Promoter choice was optimized for increased transgene expression. Affinity for HIV-1 RNA predicted in silico correlated with the propensity of opt 2 payloads to induce HIV-1 RNA trans-splicing and killing of HIV-1-expressing cells with no significant effect on uninfected cells. Following latency reversing agent (LRA) optimization and treatment, 45% of lymphocytes in an HIV-1-infected latency model could be eliminated with D4 opt 2/GCV. Further development would be warranted to exploit this approach.

Autism spectrum disorders (ASD) are complex human neurodiversities increasing in prevalence within the human population. In search of therapeutics to improve quality-of-life for ASD patients, the gut microbiome (GM) has become a promising target as a growing body of work supports roles for the complex community of microorganisms in influencing host behavior via the gut-brain-axis. However, whether naturally-occurring microbial diversity within the host GM affects these behaviors is often overlooked. Here, we applied a model of population-level differences in the GM to a classic ASD model – the BTBR T+ Itpr3tf/J mouse – to assess how complex GMs affect host behavior. Leveraging the naturally occurring differences between supplier-origin GMs, our data demonstrate that differing, complex GMs selectively effect host ASD-related behavior – especially neonatal ultrasonic communication – and reveal a male-specific effect on behavior not typically observed in this strain. We then identified that the body weight of BTBR mice is influenced by the postnatal GM which was potentially mediated by microbiome-dependent effects on energy harvest in the gut. These data provide insight into how variability within the GM affects host behavior and growth, thereby emphasizing the need to incorporate microbial diversity within the host GM as an experimental factor in biomedical research.

Natural gas distribution systems within municipalities supply a substantial fraction of energy consumed in the United States. As decarbonization of the natural gas system necessitates new modes of operation outside original design purposes, for example, increased hydrogen or biogas blending, it becomes increasingly important to understand in advance how existing infrastructure will respond to these changes. Such an analysis will require detailed information about the existing asset base, such as local soil composition, plastic type, and other characteristics that are not systematically tracked at present or have substantial missing data. Opportunistic sampling, for example, collecting measurements at assets that are already undergoing maintenance, has the potential to substantially reduce the cost of gathering such data but only if the results are representative of the full asset base. To assess prospects for such an approach, we employ a dataset including the entire service line and leak database from a large natural gas distribution utility (∼66,700 km of service pipelines and over 530,000 leaks over decades of observations). This dataset shows that service lines affected by excavation damage produce an approximately random sample of plastic and steel service lines, with similar distributions of component age, operating pressure, and pipeline diameter, as well as a relatively uniform spatial distribution. This means that opportunistic measurements at these locations will produce a first-order estimate of the relative prevalence of key characteristics across the utility's full asset base of service lines. We employ this approach to estimate the plastic type, which is unknown for roughly 80% of plastic service lines in the database. We also find that while 32% of leaks across all components occur in threaded steel junctions, excavation damage accounts for 75% of hazardous grade 1 leaks in plastic service lines and corrosion accounts for 47% in steel service lines. Insights from this sampling approach can thus help natural gas utilities collect the data they need to ensure a safe and reliable transition to a lower-emission system.

Abstract Sedimentary basins are valuable archives of tectonic processes involved in continental rifting. The northern Rocky Mountains preserve the Belt Supergroup, one of the most complete records of Mesoproterozoic strata on Earth; however, debate remains about its tectonic origin. We investigated a recently identified package of Mesoproterozoic strata at Leaton Gulch near Challis, Idaho, using a combination of traditional and newer sedimentological tools. Results suggest that the Leaton Gulch stratigraphic section was deposited in a fluvial setting ca. 1,380–1,317 Ma, spanning the poorly documented interval between late Belt Supergroup deposition at ∼1,370 Ma and recently characterized Deer Trail Group strata that are less than 1,300 Ma. Detrital zircon age distributions from Leaton Gulch demonstrate a similar provenance signature to Missoula Group rocks of the upper Belt Supergroup; however, Leaton Gulch strata are up to ∼70 Ma younger than most prior age constraints on Belt Supergroup rocks. Regional metabentonites (interpreted as metamorphosed reworked tuffs) found within Leaton Gulch and Missoula Group strata show dominantly radiogenic εHf(t), with a range of −8 to +15, interpreted as a mix of primary mantle and remelted metasedimentary sources. Zircon trace element data of the metabentonite from Leaton Gulch suggest a 1,450–1,300 Ma geochemically consistent and moderate–high silica melt source. Collectively, the strata of Leaton Gulch record basin sedimentation during a critical window of Mesoproterozoic time. We speculate that sedimentation during late‐stage Belt Supergroup deposition thickened and stepped westward, abandoning the main Belt basin, culminating with breakup of the Nuna Supercontinent.

Multidisciplinary teams of school- and community-employed mental health, health, and educational staff work together in schools to offer a full continuum of mental health promotion, prevention, early intervention, and treatment services and supports. Intentional teaming structures and practices are essential to ensure teams deliver effective, coordinated services and supports. The current study investigated the extent to which continuous quality improvement strategies improved school mental health team performance during a 15-month national learning collaborative for 24 school district teams. All teams significantly improved their average teaming performance from baseline to the end of the collaborative (t(20) = -5.20, p < 0.001). Plan-Do-Study-Act (PDSA) cycles allowed teams to rapidly evaluate specific quality improvement changes to improve their performance. Teams with the most improvement focused on increasing multidisciplinary team membership, avoiding duplication and promoting efficiency, and connecting to community mental health providers/resources.

En el caso de México, educar en contextos de vulnerabilidad y afectaciones sociales ha llevado a buscar otras formas de aproximarse al estudiantado para mejorar las relaciones interpersonales en el aula. Así, la Pedagogía de la alteridad, en el ejercicio de la docencia, reconoce la individualidad del estudiantado y busca atender sus necesidades desde una perspectiva ética y antropológica. Las cualidades docentes que destaca esta propuesta, como categorías son la responsabilidad, la acogida, la esperanza, el testimonio y la compasión hacia el estudiantado. En esta investigación de corte cualitativo, diseñada como un estudio de caso biográfico, se entrevistó a 11 miembros del profesorado, quienes trabajan en el sistema educativo mexicano en el nivel de educación básica, con el objetivo de identificar elementos de la Pedagogía de la alteridad en su práctica docente. Las entrevistas se analizaron a partir de la técnica de análisis de contenido. Los resultados arrojaron la presencia de todas las categorías de la Pedagogía de la alteridad en el discurso, especialmente sobresalieron la responsabilidad, la acogida y la esperanza. De igual manera, en las unidades de análisis, se vieron reflejadas intenciones y acciones enfocadas en el fortalecimiento de la relación entre el personal docente y el estudiantado en su contexto social, personal y académico. Se concluyó que la práctica de la Pedagogía de la alteridad puede considerarse como una alternativa que impacte positivamente en la disminución de problemáticas relacionales en el aula.

Abstract Objective Increasing evidence over the last decade suggests that many cases of unexplained chronic cough (UCC) have a neurogenic etiology, with laryngeal hypersensitivity (LH) being identified as a key mechanism. Official guidelines since 2015 have adopted use of neuromodulators and adjuvant speech therapy as a result, but historically implementation of guidelines is slow. Our survey aimed to investigate gaps in diagnosis and management practices of otolaryngology providers in caring for patients with UCC. Study Design Cross‐sectional study. Setting Survey. Methods 12‐item survey was distributed to 110 otolaryngology practitioners experienced in diagnosis and treatment of chronic cough at a regional otolaryngology continuing education conference. Statistical analysis included Kendall's Tau Rank Correlation to measure the ordinal association between responses to questions, and Fisher's exact test to determine if there were associations between responses and years of career experience. Results Forty eligible respondents underwent subsequent analysis. There was no association between frequency of identifying LH as a primary etiology and use of neuromodulators (τ = 0.23, P = .10). However, there was a significant correlation between LH and referrals to speech therapy (τ = 0.27, P = .05). Fisher's exact test did not reveal any significant differences among any responses based on practitioner experience. Conclusion Our results indicate a possible disparity in treatment of UCC with neuromodulators and the utilization of speech therapy despite guideline recommendations advocating for neuromodulators with adjuvant speech therapy. Further research with larger sample sizes and more specific inquiries is necessary to elucidate this association and control for any regional differences.

Background Women with complex health needs are more at risk of having children’s social care involvement with their newborns than other mothers. Around the time of pregnancy, there are opportunities for health services to support women with these needs and mitigate the risk of mother–baby separation. Yet little is known about healthcare professionals’ experiences of providing this support.Methods We administered an online survey to perinatal healthcare professionals across England (n=70 responders), including midwives, obstetricians, perinatal psychologists/psychiatrists and health visitors. We asked about their experiences of providing care for pregnant women with chronic physical conditions, mental health needs, intellectual/developmental disabilities and substance use disorders, who might be at risk of children’s social care involvement. We conducted a framework analysis.Results We constructed five themes from participant data. These include (1) inaccessible healthcare for women with complex needs, (2) the challenges and importance of restoring trust, (3) services focusing on individuals, not families, (4) the necessity and caution around multidisciplinary support and (5) underfunded services inhibiting good practice.Conclusions Women who are at risk of children’s social care involvement will likely experience perinatal healthcare inequities. Our findings suggest that current perinatal healthcare provision for this population is inadequate and national guidelines need updated to inform support.

Schools are the most common venue in which children and youth receive mental health services. To organize delivery of mental health care to such a large number of children, use of school teams is often recommended. Yet, there is limited empirical literature about the composition of school mental health teams or teams' relations to service provision. This study investigated team composition, including team multidisciplinarity (number of different types of professionals) and the presence of a community provider, and the relations of these two variables to service provision at Tier 1 (mental health promotion), Tier 2 (early intervention) and Tier 3 (intensive treatment) for 386 schools representing different school sizes, locations, and urbanicity. Results suggested team multidisciplinarity and the presence of a community provider were related to more frequent endorsement of service provision at schools. Practice and research implications are discussed including possible application to hiring decisions and further research with longitudinal data and information on service quality.

Schools are well positioned to facilitate early identification and intervention for youth with emerging mental health needs through universal mental health screening. Early identification of mental health concerns via screening can improve long-term student development and success, but schools face logistical challenges and lack of pragmatic guidance to develop local screening policies and practices. This study summarizes mental health screening practices tested by six school districts participating in a 15-month learning collaborative. Qualitative analysis of 42 Plan-Do-Study-Act cycles revealed that districts tested quality improvement changes across seven screening practice areas, with all teams conducting at least one test to (1) build a foundation and (2) identify resources, logistics, and administration processes. Quantitative data indicated that the average percentage of total students screened increased from 0% to 22% (range = 270-4850 students screened at follow-up). Together, these results demonstrate how school districts not currently engaged in mental health screening can apply small, specific tests of change to develop a locally-tailored, practical, and scalable process to screen for student mental health concerns. Lessons learned are provided to inform future directions for school-based teams.

Taking as its inspiration Joanne Entwistle’s understanding of the “power-dressing” phenomenon that took over the United States from the late 1970s as a discourse on the body, sexuality, gender performance, and power, this paper considers the implications of power-dressing when applied to another iteration of gendered performance; one which instead of carefully negotiating between masculine and feminine traits, instead presents a hyper-feminine, hyper-sexualised professional appearance to the ends of power and professional success. However, the professional backdrop of this research is not of the office but of sex-work (defined in the Dictionary as “a person employed in the sex industry, as a prostitute, pornographic film actor, stripper, nude model, or creator of sexually explicit online content”), and celebrity. This paper uses the case studies of two women who employ exaggerated feminine performance, and explicitly harness, rather than “manage” their sexuality, in their professional careers during the 90s and early 2000s – writer, filmmaker and ex sex-worker Virginie Despentes, and media personality (and sex-tape star) Paris Hilton. My aim is to explore how hyper-feminine dress and presentation, synonymous with unacceptable female sexuality, might interact with questions of power and agency, and subvert historic theories on the subject.

BackgroundThe perinatal period is known as time of transition and anticipation. For women with social risk factors, child protection services may become involved during the perinatal period and this might complicate their interactions with healthcare providers.AimTo systematically review and synthesise the existing qualitative evidence of healthcare experiences of women and healthcare professionals during the perinatal period while facing child protection involvement.MethodsA systematic search of databases (Web of Science, MEDLINE, EMBASE, PsychINFO, CINAHL, ASSIA, MIDIRS, Social Policy and Practice and Global Health) was carried out in January 2023, and updated in February 2024. Quality of studies was assessed using the Critical Appraisal Skills Programme. A Critical Interpretative Synthesis was used alongside the PRISMA reporting guideline.ResultsA total of 41 studies were included in this qualitative evidence synthesis. We identified three types of healthcare interactions: Relational care, Surveillance and Avoidance. Healthcare interactions can fluctuate between these types, and elements of different types can coexist simultaneously, indicating the complexity and reciprocal nature of healthcare interactions during the perinatal period when child protection processes are at play.ConclusionsOur findings provide a novel interpretation of the reciprocal interactions in healthcare encounters when child protection agencies are involved. Trust and transparency are key to facilitate relational care. Secure and appropriate information-sharing between agencies and professionals is required to strengthen healthcare systems. Healthcare professionals should have access to relevant training and supervision in order to confidently yet sensitively safeguard women and babies, while upholding principles of trauma-informed care. In addition, systemic racism in child protection processes exacerbate healthcare inequalities and has to be urgently addressed. Providing a clear framework of mutual expectations between families and healthcare professionals can increase engagement, trust and accountability and advance equity.

Cystic fibrosis (CF) is one of the most common genetic diseases with around 70,000 affected patients worldwide. CF is a multisystem disease caused by a mutation in the CF transmembrane conductance regulator gene, which has led to a significant decrease in life expectancy and a marked impairment in the quality of life for people with CF (pwCF). In recent years, the use of highly effective CFTR modulator therapy (HEMT) has led to improved pulmonary function, fewer CF exacerbations, lower symptom burden, and increased weight. This has coincided with an increased life expectancy for pwCF, with mean age of survival being now in the 50s. This being a major breakthrough, which the CF population has hoped for, pwCF are now facing new challenges by growing old with a chronic respiratory disease. In this mini review, we are attempting to summarize the current knowledge of the aging process and its effect on CF disease and its manifestations including new developments, the current research gaps and potential future developments in the field to allow healthy aging for the CF community.

The accurate monitoring of metabolic syndrome in older adults is relevant in terms of its early detection, and its management. This study aimed at proposing a novel semiparametric modeling for a cardiometabolic risk index (CMRI) and individual risk factors in older adults.MethodsMultivariate semiparametric regression models were used to study the association between the CMRI with the individual risk factors, which was achieved using secondary analysis the data from the SABE study (Survey on Health, Well-Being, and Aging in Colombia, 2015).ResultsThe risk factors were selected through a stepwise procedure. The covariates included showed evidence of non-linear relationships with the CMRI, revealing non-linear interactions between: BMI and age (p< 0.00); arm and calf circumferences (pConclusionsSemiparametric modeling explained 24.5% of the observed deviance, which was higher than the 18.2% explained by the linear model.

IntroductionRespiratory diseases such as chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, and COVID-19 may cause a decrease in arterial oxygen saturation (SaO2). The continuous monitoring of oxygen levels may be beneficial for the early detection of hypoxemia and timely intervention. Wearable non-invasive pulse oximetry devices measuring peripheral oxygen saturation (SpO2) have been garnering increasing popularity. However, there is still a strong need for extended and robust clinical validation of such devices, especially to address topical concerns about disparities in performances across racial groups. This prospective clinical validation aimed to assess the accuracy of the reflective pulse oximeter function of the EmbracePlus wristband during a controlled hypoxia study in accordance with the ISO 80601-2-61:2017 standard and the Food & Drug Administration (FDA) guidance.MethodsHealthy adult participants were recruited in a controlled desaturation protocol to reproduce mild, moderate, and severe hypoxic conditions with SaO2 ranging from 100% to 70% (ClinicalTrials.gov registration #NCT04964609). The SpO2 level was estimated with an EmbracePlus device placed on the participant's wrist and the reference SaO2 was obtained from blood samples analyzed with a multiwavelength co-oximeter.ResultsThe controlled hypoxia study yielded 373 conclusive measurements on 15 subjects, including 30% of participants with dark skin pigmentation (V–VI on the Fitzpatrick scale). The accuracy root mean square (Arms) error was found to be 2.4%, within the 3.5% limit recommended by the FDA. A strong positive correlation between the wristband SpO2 and the reference SaO2 was observed (r = 0.96, P