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Healthcare professionals experience negative behaviors such as incivility from various sources within the hospital environment. However, little is known regarding the experience of unlicensed assistive personnel with these behaviors. Using a cross-sectional survey design, the research team aimed to examine the presence, sources, and impact of negative behaviors among registered nurses and unlicensed assistive personnel within a US hospital. Descriptive and inferential statistics were used to analyze quantitative data, while thematic analysis was used to analyze the qualitative responses. A total of 309 participants completed the survey, and 135 participants responded to three qualitative questions. Most respondents identified inadequate staffing/resources to handle workload (87%) and job stress leading to loss of control over behavior as contributing factors to lateral/vertical aggression in the work environment (71%). Impacts of negative behavior on job performance were related to both personal well-being and the work environment. Demoralization was identified as a common consequence of negative behaviors for individuals and within the work environment. The results suggested that registered nurses, unlicensed assistive personnel, and nursing leadership may benefit from system-wide approaches addressing negative behaviors such as incivility within the clinical environment. Specifically, efforts and policies aimed at aiding clinicians in responding to negative behaviors could potentially improve the clinical environment.

Introduction: SMARCA4/SMARCA2 deficiencies have been linked to a variety of neoplasms and have been mainly described in cases of thoracic non-small cell lung cancers. Case Presentation: Here we present a case of SMARCA4/SMARCA2-deficient undifferentiated metastatic malignant tumor with carcinoma of unknown primary. The staining on pathology as well as the unremarkable size of the lung masses raises the possibility of dedifferentiated tumor of unknown primary. Conclusion: This case highlights the need for more routine testing of SMARCA4/SMARCA2 deficiencies as well as the development of more targeted therapies as these mutations are often associated with an aggressive course and poor outcomes.

Abstract Background Integrating complex interventions within healthcare settings can be challenging. Mentoring can be embedded within a randomised controlled trial (RCT) to upskill and support those delivering the intervention. This study aimed to understand, from a realist perspective, how mentoring worked to support implementation fidelity for occupational therapists (OTs) delivering a vocational rehabilitation (VR) intervention within the context of an RCT. Methods A realist evaluation using secondary data (emails, mentoring record forms, interviews) collected as part of an RCT. Three researchers coded the data following content analysis, focused on refining or refuting an initial programme theory by exploring the interactions between context, mechanisms, and outcomes. The research team met to further refine the programme theories. Results Data from 584 emails, 184 mentoring record forms, and 25 interviews were analysed following a realist approach. We developed a programme theory consisting of two contexts (trial set-up, ongoing mentoring), nine mechanisms (collective understanding, monitoring, timely support, positive reinforcement, reflective practice, support data completeness, facilitation strategy, shared learning experience, management of research and clinical duties), and three outcomes (improved confidence, improved fidelity, reduced contamination). Conclusions Offering mentoring support to OTs delivering a VR intervention as part of an RCT improves intervention fidelity and reduces the risk of contamination. It improves OTs’ understanding of the differences between their clinical and research roles and increases their confidence and competence in trial paperwork completion and identification of potential contamination issues.

Introduction: Lemierre’s syndrome is septic thrombophlebitis of the internal jugular vein, most commonly associated with head and neck infections. While central catheters are associated with venous thromboembolism and catheter-associated bacterial infections, cases of Lemierre’s syndrome caused by central catheters are extraordinarily rare.Case Report: We detail a case of Lemierre’s syndrome resulting from a peripherally inserted central catheter in a pregnant female patient. Diagnosis of this rare and potentially life-threatening disease process was expedited using point-of-care ultrasound.  Conclusion: Diagnosis of rare but potentially life- or limb-threatening pathologies is paramount to the successful practice of emergency medicine. Identifying these rare disease processes requires a high index of suspicion and a work-up strategy that includes consideration of medical history in combination with lab and imaging findings to determine appropriate interventions.

This study investigated the association between psychological stamina (grit, mindset and hardiness) and thinking style preferences among South African university students. Data were collected from 369 first-year university students using measures of grit, mindset, hardiness and thinking style preferences. The results indicated that different thinking style preferences were related to grit, mindset and hardiness. We argue that thinking styles should be considered as an important variable when supporting first-year students. Additionally, the role of grit and hardiness in student success should be considered in conjunction with the thinking style preferences of students. Avenues for further research are considered.

Aims To evaluate the myopia control efficacy of Diffusion Optics Technology (DOT) spectacle lenses in children over a 4-year treatment period.Methods CYPRESS Part 1 (NCT03623074) was a 3-year multicentre, randomised, controlled, double-masked trial comparing two investigational spectacle lens DOT designs (Test 1, Test 2) and standard single vision Control lenses in 256 North American children aged 6–10 years. Children completing Part 1 (n=200) were invited to enrol in CYPRESS Part 2 (NCT04947735) for an additional 1-year period. In Part 2, Test 1 (n=35) and Control groups (n=42) continued with their original lens assignment and the Test 2 group (n=21) were crossed over to Test 1 (DOT 0.2) lenses. The co-primary endpoints were change from baseline in axial length (AL) and cycloplegic spherical equivalent refraction (cSER).Results Test 1 spectacle lenses demonstrated superiority to the Control in both co-primary endpoints: with a difference between means (Test 1−Control) of −0.13 mm for AL (p=0.018) and 0.33 D for cSER (p=0.008) in Part 1 and −0.05 mm for AL (p=0.038) and 0.13 D for cSER (p=0.043) in Part 2. Comparing treatment effects in Part 1 and 2 suggests that COVID-19 public health restrictions negatively impacted treatment efficacy in study years 2 and 3.Conclusion DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear. These results support the hypothesis that a mild reduction in retinal contrast can slow myopia progression in young children. The unprecedented disruption in participant schooling and lifestyle during the COVID-19 pandemic may have depressed treatment efficacy in Part 1.

IntroductionElementary teachers face many challenges when including reform-based science instruction in their classrooms, and some teachers have chosen to enhance their science instruction by introducing students to citizen science (CS) projects. When CS projects are incorporated in formal school settings, students have an opportunity to engage in real-world projects as they collect and make sense of data, yet relatively few CS projects offer substantial guidance for teachers seeking to implement the projects, placing a heavy burden on teacher learning.MethodsFramed in theory on teacher relationships with curricula, we prepared science standards-aligned educative support materials for two CS projects. We present convergent mixed methods research that examines two teachers’ contrasting approaches to including school-based citizen science (SBCS) in their fifth-grade classrooms, each using support materials for one of the two CS projects. Both are veteran teachers at under-resourced Title 1 (an indicator of the high percentage of the students identified as economically disadvantaged) rural schools in the southeastern United States. We document the teachers’ interpretations and use of SBCS materials for the CS projects with data from classroom observations, instructional logs, teacher interviews, and student focus groups.ResultsOne teacher adapted the materials to include scaffolding to position students for success in data collection and analysis. In contrast, the second teacher adapted the SBCS support materials to maintain a teacher-centered approach to instruction, identifying perceptions of students’ limited abilities and limited instructional time as constraining factors.DiscussionWe discuss the intersection of CS projects in formal education and opportunities for engaging students in authentic science data collection, analysis, and sense-making. The two teachers’ stories identify the influences of school context and the need for teacher support to encourage elementary teachers’ use of SBCS instruction to supplement their science instruction.

BackgroundChild and Family Health Nursing (CFHN) services provide universal care to families during the first 2000 days (conception: 5 years) to support optimal health and developmental outcomes of children in New South Wales, Australia. The use of technology represents a promising means to encourage family engagement with CFHN services and enable universal access to evidenced-based age and stage information. Currently, there is little evidence exploring the acceptability of various models of technology-based support provided during the first 2000 days, as well as the maternal characteristics that may influence this. ObjectiveThis study aims to describe (1) the acceptability of technology-based models of CFHN support to families in the first 6 months, and (2) the association between the acceptability of technology-based support and maternal characteristics. MethodsA cross-sectional survey was undertaken between September and November 2021 with women who were 6-8 months post partum within the Hunter New England Local Health District of New South Wales, Australia. Survey questions collected information on maternal demographics and pregnancy characteristics, perceived stress, access to CFHN services, as well as preferences and acceptability of technology-based support. Descriptive statistics were used to describe the characteristics of the sample, the proportion of women accessing CFHN services, maternal acceptability of technology-based support from CFHN services, and the appropriateness of timing of support. Multivariable logistic regression models were conducted to assess the association between maternal characteristics and the acceptability of technology-based CFHN support. ResultsA total of 365 women participated in the study, most were 25 to 34 years old (n=242, 68%), had completed tertiary level education or higher (n=250, 71%), and were employed or on maternity leave (n=280, 78%). Almost all (n=305, 89%) women reported accessing CFHN services in the first 6 months following their child’s birth. The majority of women (n=282-315, 82%-92%) “strongly agreed or agreed” that receiving information from CFHN via technology would be acceptable, and most (n=308) women “strongly agreed or agreed” with being provided information on a variety of relevant health topics. Acceptability of receiving information via websites was significantly associated with maternal employment status (P=.01). The acceptability of receiving support via telephone and email was significantly associated with maternal education level (adjusted odds ratio 2.64, 95% CI 1.07-6.51; P=.03 and adjusted odds ratio 2.90, 95% CI 1.20-7.00; P=.02, respectively). Maternal age was also associated with the acceptability of email support (P=.04). ConclusionsTechnology-based CFHN support is generally acceptable to mothers. Maternal characteristics, including employment status, education level, and age, were found to modify the acceptability of specific technology modalities. The findings of this research should be considered when designing technology-based solutions to providing universal age and stage child health and developmental support for families during the first 2000 days.

Gestational thrombocytopenia, preeclampsia, and immune thrombocytopenia are commonly recognized etiologies of low platelet counts representing the vast majority of encountered gestational cases (86-100%). However, there are many other rare causes. The following case details a patient with three prior pregnancies, each remarkable for profound unexplained thrombocytopenia, which promptly normalized following delivery. It further details her fourth pregnancy, similar thrombocytopenia, an investigation into the causes, balancing platelet transfusion against the risk of alloimmunization, in-hospital treatment, and her eventual anesthetic, resuscitation, and delivery.

BackgroundCommon, operational definitions are crucial to assess interventions and outcomes related to pediatric mechanical ventilation. These definitions can reduce unnecessary variability among research and quality improvement efforts, to ensure findings are generalizable, and can be pooled to establish best practices.Research questionCan we establish operational definitions for key elements related to pediatric ventilator liberation using a combination of detailed literature review and consensus-based approaches?Study design and methodsA panel of 26 international experts in pediatric ventilator liberation, two methodologists, and two librarians conducted systematic reviews on eight topic areas related to pediatric ventilator liberation. Through a series of virtual meetings, we established draft definitions that were voted upon using an anonymous web-based process. Definitions were revised by incorporating extracted data gathered during the systematic review and discussed in another consensus meeting. A second round of voting was conducted to confirm the final definitions.ResultsIn eight topic areas identified by the experts, 16 preliminary definitions were established. Based on initial discussion and the first round of voting, modifications were suggested for 11 of the 16 definitions. There was significant variability in how these items were defined in the literature reviewed. The final round of voting achieved ≥ 80% agreement for all 16 definitions in the following areas: what constitutes respiratory support (invasive mechanical ventilation and noninvasive respiratory support), liberation and failed attempts to liberate from invasive mechanical ventilation, liberation from respiratory support, duration of noninvasive respiratory support, total duration of invasive mechanical ventilation, spontaneous breathing trials, extubation readiness testing, 28 ventilator-free days, and planned vs rescue use of post-extubation noninvasive respiratory support.InterpretationWe propose that these consensus-based definitions for elements of pediatric ventilator liberation, informed by evidence, be used for future quality improvement initiatives and research studies to improve generalizability and facilitate comparison.

School victimization issues remain largely unresolved due to over-reliance on unidimensional conceptions of victimization and data from a few developed OECD countries. Thus, support for cross-national generalizability over multiple victimization components (relational, verbal, and physical) is weak. Our substantive-methodological synergy tests the cross-national generalizability of a three-component model (594,196 fifteen-year-olds; nationally-representative samples from 77 countries) compared to competing (unidimensional and two-component) victimization models. We demonstrate the superior explanatory power of the three-component model--goodness-of-fit, component differentiation, and discriminant validity of the three components concerning gender differences, paradoxical anti-bullying attitudes (the Pro-Bully Paradox) whereby victims are more supportive of bullies than of other victims, and multiple indicators of well-being. For example, gender differences varied significantly across the three components, and all 13 well-being indicators were more strongly related to verbal and particularly relational victimization than physical victimization. Collapsing the three components into one or two components undermined discriminant validity. Cross-nationally, systematic differences emerged across the three victimization components regarding country-level means, gender differences, national development, and cultural values. These findings across countries support a tripartite model in which the three components of victimization--relational, verbal, and physical--relate differently to key outcomes. Thus, these findings advance victimization theory and have implications for policy, practice, and intervention. We also discuss directions for further research: the need for simultaneous evaluation of multiple, parallel components of victimization and bullying, theoretical definitions of bullying and victimization and their implications for measurement, conceptual bases of global victimization indices, cyberbullying, anti-bullying policies, and capitalizing on anti-bullying attitudes.

Abstract Background Prognostic indicators for equine multinodular pulmonary fibrosis (EMPF), an interstitial fibrosing lung disease, are poorly described. Hypothesis/Objectives Describe diagnostic findings and outcome predictors for EMPF. Animals Forty‐six adult horses with EMPF. Methods Retrospective multicenter case series from 2009 to 2019. Radiographic (n = 27) and ultrasonographic studies (n = 19) from EMPF horses and bronchoalveolar lavage fluid (BALF) cytology from 6 EMPF and 13 asthma cases were independently reviewed and blinded to diagnosis and outcome. Associations between predictor variables and survival were assessed by predictor screening followed by Fisher's exact and Wilcoxon rank sum tests. Results Primary clinical findings were weight loss (36/46, 78%), increased respiratory effort (33/46, 72%), tachypnea (32/46, 70%), and fever (18/46, 39%). Macrophage atypia was seen in more EMPF than asthmatic horse BALF (67% vs. 8%; P = .02). Equine herpesvirus 5 (EHV‐5) was detected in 24 of 30 (80%) and hyperfibrinogenemia in 25 of 28 (89%) cases. Twenty‐seven of 46 horses (59%) and 11 of 45 (24%) survived to discharge and to 3 months, respectively. Three‐month survival was associated with lower median (range) respiratory rates (30 [24‐36] vs. 41 [30‐60] breaths per minute; P = .04), and higher BALF lymphocyte:neutrophil ratios (4.7 [1.4‐22] vs. 0.47 [0.11‐1.9]; P = .01) and blood lymphocyte counts (1.25 [0.93‐2.55] vs. 0.90 [0.70‐1.24] × 109/L; P = .03). Imaging findings, EHV‐5 detection, and corticosteroid treatment were not associated with survival. Conclusions and Clinical Importance Fever is not a sensitive clinical sign of EMPF. Diagnostic testing should be pursued for horses with increased respiratory rate and effort and weight loss. The prognosis for EMPF horses is poor. Corticosteroid treatment does not improve 3‐month survival.

Abstract Background Exoskeletons are increasingly applied during overground gait and balance rehabilitation following neurological impairment, although optimal parameters for specific indications are yet to be established. Objective This systematic review aimed to identify dose and dosage of exoskeleton-based therapy protocols for overground locomotor training in spinal cord injury/disease. Methods A systematic review was conducted in accordance with the Preferred Reporting Items Systematic Reviews and Meta-Analyses guidelines. A literature search was performed using the CINAHL Complete, Embase, Emcare Nursing, Medline ALL, and Web of Science databases. Studies in adults with subacute and/or chronic spinal cord injury/disease were included if they reported (1) dose (e.g., single session duration and total number of sessions) and dosage (e.g., frequency of sessions/week and total duration of intervention) parameters, and (2) at least one gait and/or balance outcome measure. Results Of 2,108 studies identified, after removing duplicates and filtering for inclusion, 19 were selected and dose, dosage and efficacy were abstracted. Data revealed a great heterogeneity in dose, dosage, and indications, with overall recommendation of 60-min sessions delivered 3 times a week, for 9 weeks in 27 sessions. Specific protocols were also identified for functional restoration (60-min, 3 times a week, for 8 weeks/24 sessions) and cardiorespiratory rehabilitation (60-min, 3 times a week, for 12 weeks/36 sessions). Conclusion This review provides evidence-based best practice recommendations for overground exoskeleton training among individuals with spinal cord injury/disease based on individual therapeutic goals – functional restoration or cardiorespiratory rehabilitation. There is a need for structured exoskeleton clinical translation studies based on standardized methods and common therapeutic outcomes.

Abstract Effects of plant diversity on grassland productivity, or overyielding, are found to be robust to nutrient enrichment. However, the impact of cumulative nitrogen (N) addition (total N added over time) on overyielding and its drivers are underexplored. Synthesizing data from 15 multi-year grassland biodiversity experiments with N addition, we found that N addition decreases complementarity effects and increases selection effects proportionately, resulting in no overall change in overyielding regardless of N addition rate. However, we observed a convex relationship between overyielding and cumulative N addition, driven by a shift from complementarity to selection effects. This shift suggests diminishing positive interactions and an increasing contribution of a few dominant species with increasing N accumulation. Recognizing the importance of cumulative N addition is vital for understanding its impacts on grassland overyielding, contributing essential insights for biodiversity conservation and ecosystem resilience in the face of increasing N deposition.

Abstract Plant diversity effects on community productivity often increase over time. Whether the strengthening of diversity effects is caused by temporal shifts in species-level overyielding (i.e., higher species-level productivity in diverse communities compared with monocultures) remains unclear. Here, using data from 65 grassland and forest biodiversity experiments, we show that the temporal strength of diversity effects at the community scale is underpinned by temporal changes in the species that yield. These temporal trends of species-level overyielding are shaped by plant ecological strategies, which can be quantitatively delimited by functional traits. In grasslands, the temporal strengthening of biodiversity effects on community productivity was associated with increasing biomass overyielding of resource-conservative species increasing over time, and with overyielding of species characterized by fast resource acquisition either decreasing or increasing. In forests, temporal trends in species overyielding differ when considering above- versus belowground resource acquisition strategies. Overyielding in stem growth decreased for species with high light capture capacity but increased for those with high soil resource acquisition capacity. Our results imply that a diversity of species with different, and potentially complementary, ecological strategies is beneficial for maintaining community productivity over time in both grassland and forest ecosystems.

Rationale: Pediatric-specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients readiness for extubation. Methods: Twenty-six international experts comprised a multiprofessional panel to establish pediatrics-specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. A systematic review was conducted for questions that did not meet an a priori threshold of ⩾80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence and drafted and voted on the recommendations. Measurements and Main Results: Three questions related to systematic screening using an extubation readiness testing bundle and a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ⩾80% agreement. For the remaining eight questions, five systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials, measures of respiratory muscle strength, assessment of risk of postextubation upper airway obstruction and its prevention, use of postextubation noninvasive respiratory support, and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. Conclusions: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.

Drought disrupts soil microbial activity and many biogeochemical processes. Although plant-associated fungi can support plant performance and nutrient cycling during drought, their effects on nearby drought-exposed soil microbial communities are not well resolved. We used H218O quantitative stable isotope probing (qSIP) and 16S rRNA gene profiling to investigate bacterial community dynamics following water limitation in the hyphospheres of two distinct fungal lineages (Rhizophagus irregularis and Serendipita bescii) grown with the bioenergy model grass Panicum hallii. In uninoculated soil, a history of water limitation resulted in significantly lower bacterial growth potential and growth efficiency, as well as lower diversity in the actively growing bacterial community. In contrast, both fungal lineages had a protective effect on hyphosphere bacterial communities exposed to water limitation: bacterial growth potential, growth efficiency, and the diversity of the actively growing bacterial community were not suppressed by a history of water limitation in soils inoculated with either fungus. Despite their similar effects at the community level, the two fungal lineages did elicit different taxon-specific responses, and bacterial growth potential was greater in R. irregularis compared to S. bescii-inoculated soils. Several of the bacterial taxa that responded positively to fungal inocula belong to lineages that are considered drought susceptible. Overall, H218O qSIP highlighted treatment effects on bacterial community structure that were less pronounced using traditional 16S rRNA gene profiling. Together, these results indicate that fungal-bacterial synergies may support bacterial resilience to moisture limitation.

Here we provide the 'Global Spectrum of Plant Form and Function Dataset', containing species mean values for six vascular plant traits. Together, these traits -plant height, stem specific density, leaf area, leaf mass per area, leaf nitrogen content per dry mass, and diaspore (seed or spore) mass - define the primary axes of variation in plant form and function. The dataset is based on ca. 1 million trait records received via the TRY database (representing ca. 2,500 original publications) and additional unpublished data. It provides 92,159 species mean values for the six traits, covering 46,047 species. The data are complemented by higher-level taxonomic classification and six categorical traits (woodiness, growth form, succulence, adaptation to terrestrial or aquatic habitats, nutrition type and leaf type). Data quality management is based on a probabilistic approach combined with comprehensive validation against expert knowledge and external information. Intense data acquisition and thorough quality control produced the largest and, to our knowledge, most accurate compilation of empirically observed vascular plant species mean traits to date.

BackgroundApplied behavior analysis (ABA) is an evidence-based approach to autism spectrum disorder that has been shown in clinical trials to improve child functional status. There is substantial focus in ABA on setting and tracking individualized goals that are patient-centered, but limited research on how to measure progress on such patient-centered outcomes.PurposeThe purpose of this investigation was to assess concordance between patient-centered and standard outcome measures of treatment progress in a real-world clinical sample of children receiving ABA for autism spectrum disorder.MethodsThis observational study used a clinical sample of children ages 3 to 16 years (N = 154) who received 24 months of ABA from an integrated health system. Concordance between three outcome measures after ABA was assessed using a correlation matrix: (1) patient-centered measures of progress on individualized treatment goals, (2) caregiver-centered measure of progress on treatment participation goals, and (3) the Vineland Adaptive Behavior Scales adaptive behavior composite.ResultsThere was limited concordance among measures at both 12 and 24 months of ABA. None of the patient-centered measures showed significant positive correlation with adaptive behavior composite difference scores at either 12 or 24 months, nor did the caregiver measure. The percentage of children achieving clinically meaningful gain on patient-centered goal measures increased between 12 and 24 months of ABA, while the percentage of children achieving clinically meaningful gains in adaptive behavior declined during the same time period.ConclusionsIn a health system implementation of ABA, there was limited concordance between patient-centered and standard measures of clinically meaningful treatment progress for children with ASD. Clinicians should have ongoing dialogue with patients and parents/caregivers to ensure that interventions for ASD are resulting in progress towards outcomes that are meaningful to patients and families.

The objective of the study was to validate adapted versions of the Glasgow Anxiety Scale for people with Intellectual Disabilities (GAS-ID) simultaneously developed in English and French. A sample of 361 youth with mild to moderate intellectual disability (ID) (M = 15.78 years) from Australia (English-speaking) and Canada (French-speaking) participated in this study. The results supported the factor validity and reliability, measurement invariance (between English and French versions), a lack of differential items functioning (as a function of youth's age and ID level, but not sex in the English-Australian sample), temporal stability (over one year interval), and convergent validity (with global self-esteem and school loneliness) of a bi-factor exploratory structural equation modeling representation of the GAS-ID. The present study supports the psychometric properties of the English-Australian and French-Canadian versions of the adapted GAS-ID.

Objective Parkwood VIP4SCI platform is a virtual e-health solution adapted from a version created for Spinal Cord Injury Ontario (SCIO) that focused on self-management skill development for persons with spinal cord injury (SCI) transitioning between stages of care, in partnership with caregivers and clinicians. This evaluation of the platform informs the usability and feasibility of a model to facilitate service care aims postrehabilitation. Design Participants: Inpatients and outpatients admitted to the SCI Rehabilitation Program (n = 31), and a mix of interdisciplinary clinicians on the Rehabilitation Team (n = 20). Caregivers participated at the discretion of the patient. Interventions: Inpatients were randomized into two groups (Platform or Standard Care (i.e., delayed access)). Outpatients were given access at enrollment. Pre–post assessments were completed using surveys, and platform analytics were collected. Weekly check-ins were introduced to increase engagement. Focus groups were held with a subset of participants near study completion. Results VIP4SCI was viewed as usable and feasible. Platform satisfaction assessed on a −3 to +3 scale ranged from +0.9 to 2.5, demonstrating positive agreement. Self-efficacy related to self-management ranged from 5.4 to 7.6 out of 10. The educational resource hub was identified as the most beneficial feature. Lack of clinician uptake was a barrier to integration into day-to-day practice. Conclusions Platform usage was low among all groups despite the perceived need for facilitating care coordination with consistent and intentional self-management programming. Despite the lack of uptake, partly due to challenges associated with the pandemic, conclusions on platform features and barriers to implementation will help to inform future programming.

In silico clinical trials (ISCTs) are an emerging method in modeling and simulation where medical interventions are evaluated using computational models of patients. ISCTs have the potential to provide cost-effective, time-efficient, and ethically favorable alternatives for evaluating the safety and effectiveness of medical devices. However, ensuring the credibility of ISCT results is a significant challenge. This paper aims to identify unique considerations for assessing the credibility of ISCTs and proposes an ISCT credibility assessment workflow based on recently published model assessment frameworks. First, we review various ISCTs described in the literature, carefully selected to showcase the range of methodological options available. These studies cover a wide variety of devices, reasons for conducting ISCTs, patient model generation approaches including subject-specific versus 'synthetic' virtual patients, complexity levels of devices and patient models, incorporation of clinician or clinical outcome models, and methods for integrating ISCT results with real-world clinical trials. We next discuss how verification, validation, and uncertainty quantification apply to ISCTs, considering the range of ISCT approaches identified. Based on our analysis, we then present a hierarchical workflow for assessing ISCT credibility, using a general credibility assessment framework recently published by the FDA's Center for Devices and Radiological Health. Overall, this work aims to promote standardization in ISCTs and contribute to the wider adoption and acceptance of ISCTs as a reliable tool for evaluating medical devices.

Computational models of patients and medical devices can be combined to perform an in silico clinical trial (ISCT) to investigate questions related to device safety and/or effectiveness across the total product life cycle. ISCTs can potentially accelerate product development by more quickly informing device design and testing or they could be used to refine, reduce, or in some cases to completely replace human subjects in a clinical trial. There are numerous potential benefits of ISCTs. An important caveat, however, is that an ISCT is a virtual representation of the real world that has to be shown to be credible before being relied upon to make decisions that have the potential to cause patient harm. There are many challenges to establishing ISCT credibility. ISCTs can integrate many different submodels that potentially use different modeling types (e.g., physics-based, data-driven, rule-based) that necessitate different strategies and approaches for generating credibility evidence. ISCT submodels can include those for the medical device, the patient, the interaction of the device and patient, generating virtual patients, clinical decision making and simulating an intervention (e.g., device implantation), and translating acute physics-based simulation outputs to health-related clinical outcomes (e.g., device safety and/or effectiveness endpoints). Establishing the credibility of each ISCT submodel is challenging, but is nonetheless important because inaccurate output from a single submodel could potentially compromise the credibility of the entire ISCT. The objective of this study is to begin addressing some of these challenges and to identify general strategies for establishing ISCT credibility. Most notably, we propose a hierarchical approach for assessing the credibility of an ISCT that involves systematically gathering credibility evidence for each ISCT submodel in isolation before demonstrating credibility of the full ISCT. Also, following FDA Guidance for assessing computational model credibility, we provide suggestions for ways to clearly describe each of the ISCT submodels and the full ISCT, discuss considerations for performing an ISCT model risk assessment, identify common challenges to demonstrating ISCT credibility, and present strategies for addressing these challenges using our proposed hierarchical approach. Finally, in the Appendix we illustrate the many concepts described here using a hypothetical ISCT example.