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Purpose: There are a wide variety of intraoperative techniques available in breast surgery to achieve low rates for positive margins of excision. The objective of this systematic review was to determine the pooled diagnostic accuracy of intraoperative breast margin assessment techniques that have been evaluated in clinical practice. Methods: This study was performed in accordance with PRISMA guidelines. A systematic search of the literature was conducted to identify studies assessing the diagnostic accuracy of intraoperative margin assessment techniques. Only clinical studies with raw diagnostic accuracy data as compared with final permanent section histopathology were included in the meta-analysis. A bivariate model for diagnostic meta-analysis was used to determine overall pooled sensitivity and specificity. Results: Sixty-one studies were eligible for inclusion in this systematic review and meta-analysis. Cytology demonstrated the best diagnostic accuracy, with pooled sensitivity of 0.92 (95 % CI 0.77–0.98) and a pooled specificity of 0.95 (95 % CI 0.90–0.97). The findings also indicate good diagnostic accuracy for optical spectroscopy, with a pooled sensitivity of 0.86 (95 % CI 0.76–0.93) and a pooled specificity of 0.92 (95 % CI 0.82–0.97). Conclusion: Pooled data indicate that optical spectroscopy, cytology and frozen section have the greatest diagnostic accuracy of currently available intraoperative margin assessment techniques. However, long turnaround time for results and their resource intensive nature has prevented widespread adoption of these methods. The aim of emerging technologies is to compete with the diagnostic accuracy of these established techniques, while improving speed and usability.

AimThe overamplification of human epidermal growth factor (HER2) in breast cancer (BC) has been the subject of numerous research publications since its discovery in 1987. This is the first bibliometric analysis (BA) conducted on HER2-positive (HER2+) BC. The purpose of this BA is to analyze the published research on HER2+ BC from 1987 to 2024, highlighting the most significant scientific literature, as well as the main contributing authors and journals, and evaluating the impact of clinical and lab-based publications on HER2+ BC research.MethodsThe Web of Science Core Collection (WoSCC) was searched using the terms “Breast cancer” OR “Breast carcinoma” OR “Breast tumor” AND “HER2 positive” OR “HER2+”. The search was limited by publication year (1987–2024) and only full English articles were included. WoS returned 7,469 relevant results, and from this dataset, a bibliometric analysis was conducted using the “analyze results” and “journal citation report” functions in WoS and the VOSviewer 1.6.16 software to generate bibliographic coupling and co-citation analysis of authors.ResultsThe analysis encompassed a total of 7,469 publications, revealing a notable increase in the annual number of publications, particularly in recent years. The United States, China, Italy, Germany, and Spain were the top five most prolific countries. The top five significant institutions that published HER2+ research were the University of Texas System, Unicancer, UTMD Anderson Cancer Center, Harvard University, and University of California System. Breast Cancer Research and Treatment, Clinical Cancer Research, and Clinical Breast Cancer were the top three notable journals with the highest number of HER2+ BC publications. Dennis Slamon (Nc = 45,411, H-index = 51) and Jose Baselga (Nc = 32,592, H-index = 55) were the most prolific authors. Evolving research topics include anti-HER2 therapy in the neoadjuvant setting, treatment of metastatic HER2+ BC, and overcoming therapy resistance.ConclusionThis study provides an overview of HER2+ BC research published over the past three decades. It provides insight into the most cited papers and authors, and the core journals, and identifies new trends. These manuscripts have had the highest impact in the field and reflect the continued evolution of HER2 as a therapeutic target in BC.

Abstract Stream networks in Arctic and high-elevation regions underlain by frozen ground (i.e., permafrost) are expanding and developing in response to accelerating global warming, and intensifying summertime climate variability. The underlying processes governing landscape dissection in these environments are varied, complex and challenging to unravel due to air-temperature-regulated feedbacks and shifts to new erosional regimes as climate change progresses. Here we use multiple sources of environmental information and physical models to reconstruct and understand a 60-year history of landscape-scale channelization and evolution of the Muskox Valley, Axel Heiberg Island. A time series of air photographs indicates that freeze-thaw-related polygon fields can form rapidly, over decadal time scales. Supporting numerical simulations show that the presence of polygons can control how surface runoff is routed through the landscape, exerting a basic control on channelization, which is sensitive to the timing, duration and magnitude of hydrograph events, as well as seasonal air temperature trends. These results collectively highlight that the occurrence and dynamics of polygon fields modulate channel network establishment in permafrost-rich settings undergoing changes related to a warming climate.

Globally, the rapid retreat of coastal cliffs poses a profound risk to property, transport infrastructure, and public safety. To quantify and compare cliff top and cliff face retreat and identify erosion processes, this study combines historical (1842–2000) maps and orthophotos with contemporary UAV surveys (2019–2023) to quantify cliff top and cliff face retreat along a 240 m wide coastal drumlin in Galway Bay, Ireland. Retreat rates for the cliff top and cliff face were calculated using 2D mapping and 3D modelling, respectively. Critically, the choice of method has a significant impact on calculated rates of cliff top retreat, with output from the 2D mapping approach (0.14 +/− 0.02 m yr−1) being double that of the 3D modelling approach (0.08 +/− 0.02 m year−1). The aperiodic development of a talus cone, which temporarily protects the cliff from storm waves, also influences estimates of cliff retreat. The repeat cycles of talus slope formation and removal in this high wave energy environment suggest that the drumlin scarp transitions between a periodically transport-limited and supply-limited system over short- and long-time periods, respectively, on the continuum of cliff types. These results warrant further research to identify and quantify the rates, patterns, drivers (marine and subaerial processes), and timing of cliff retreat in response to climate change.

Summary: Background: A substantial proportion of attendances to ophthalmic emergency departments are for non-urgent presentations. We developed and evaluated a machine learning system (DemDx Ophthalmology Triage System: DOTS) to optimise triage, with the aim of reducing inappropriate emergency attendances and streamlining case referral when necessary. Methods: DOTS was built using retrospective tabular data from 11,315 attendances between July 1st, 2021, to June 15th, 2022 at Moorfields Eye Hospital Emergency Department (MEH) in London, UK. Demographic and clinical features were used as inputs and a triage recommendation was given (“see immediately”, “see within a week”, or “see electively”). DOTS was validated temporally and compared with triage nurses’ performance (1269 attendances at MEH) and validated externally (761 attendances at the Federal University of Minas Gerais - UFMG, Brazil). It was also tested for biases and robustness to variations in disease incidences. All attendances from patients aged at least 18 years with at least one confirmed diagnosis were included in the study. Findings: For identifying ophthalmic emergency attendances, on temporal validation, DOTS had a sensitivity of 94.5% [95% CI 92.3–96.1] and a specificity of 42.4% [38.8–46.1]. For comparison within the same dataset, triage nurses had a sensitivity of 96.4% [94.5–97.7] and a specificity of 25.1% [22.0–28.5]. On external validation at UFMG, DOTS had a sensitivity of 95.2% [92.5–97.0] and a specificity of 32.2% [27.4–37.0]. In simulated scenarios with varying disease incidences, the sensitivity was ≥92.2% and the specificity was ≥36.8%. No differences in sensitivity were found in subgroups of index of multiple deprivation, but the specificity was higher for Q2 when compared to Q4 (Q4 is less deprived than Q2). Interpretation: At MEH, DOTS had similar sensitivity to triage nurses in determining attendance priority; however, with a specificity of 17.3% higher, DOTS resulted in lower rates of patients triaged to be seen immediately at emergency. DOTS showed consistent performance in temporal and external validation, in social-demographic subgroups and was robust to varying relative disease incidences. Further trials are necessary to validate these findings. This system will be prospectively evaluated, considering human-computer interaction, in a clinical trial. Funding: The Artificial Intelligence in Health and Care Award (AI_AWARD01671) of the NHS AI Lab under National Institute for Health and Care Research (NIHR) and the Accelerated Access Collaborative (AAC).

We show that a Bose–Einstein Condensate illuminated by a far off-resonant optical pump field and its retroreflection from a feedback mirror can produce stable, localised structures known as optomechanical droplets. We show that these droplets could be used to measure the acceleration of a BEC via continuous monitoring of the position of the droplet via the optical intensity distribution.

Background The REHAB‐HF (Rehabilitation Therapy in Older Acute Heart Failure Patients) randomized trial demonstrated that a 3‐month transitional, tailored, progressive, multidomain physical rehabilitation intervention improves physical function, frailty, depression, and health‐related quality of life among older adults with acute decompensated heart failure. Whether there is differential intervention efficacy by race is unknown. Methods and Results In this prespecified analysis, differential intervention effects by race were explored at 3 months for physical function (Short Physical Performance Battery [primary outcome], 6‐Minute Walk Distance), cognition, depression, frailty, health‐related quality of life (Kansas City Cardiomyopathy Questionnaire, EuroQoL 5‐Dimension‐5‐Level Questionnaire) and at 6 months for hospitalizations and death. Significance level for interactions was P≤0.1. Participants (N=337, 97% of trial population) self‐identified in near equal proportions as either Black (48%) or White (52%). The Short Physical Performance Battery intervention effect size was large, with values of 1.3 (95% CI, 0.4–2.1; P=0.003]) and 1.6 (95% CI, 0.8–2.4; P

When seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration’s (FDA) Expanded Access (EA) pathway provides a mechanism for these patient’s physicians to pursue use of an investigational agent outside of a clinical trial when trial enrollment is not a feasible option. Though FDA has recently implemented processes to significantly streamline the regulatory portion of the process, the overall pathway has several time-consuming components including communication with the pharmaceutical company and the associated institutional requirements for EA use (contracting, Institutional Review Board [IRB], pharmacy, billing). Here, we present our experience building infrastructure at the Vanderbilt University Medical Center (VUMC) to support physicians and patients in pursuing EA, called the Access to Investigational Medicines (AIM) Platform, aligning the needs and responsibilities of institutional stakeholders and streamlining to ensure efficiency and regulatory compliance. Since its launch, the AIM team has experienced steady growth, supporting 40 EA cases for drugs/biologics, including both single patient cases and intermediate-size EA protocols in the emergent and non-emergent setting. As the EA pathway is a complex process that requires expert facilitation, we propose prioritizing EA support infrastructure at major academic medical centers as an essential regulatory knowledge function.

Direct modulation of the gut microbiota via rearing environments and fecal microbiota transplantation in a bleomycin-induced murine model suggests that a functional gut-lung axis modulates lung fibrosis.

Cognitive explanations raise epistemological problems not faced by accounts confined to observable variables. Many explanatory components of cognitive models are unobservable: beliefs, attitudes, and intentions, for instance, must be made empirically available to the researcher in the form of measures of observable behavior from which the latent variables are inferred. The explanatory variables are abstract and theoretical and rely, if they are to enter investigations and explanations, on reasoned agreement on how they can be captured by proxy variables derived from what people say and how they behave. Psychometrics must be founded upon a firm, intersubjective agreement among researchers and users of research on the relationship of behavioral measures to the intentional constructs to which they point and the latent variables they seek to operationalize. Only if these considerations are adequately addressed can we arrive at consistent interpretations of the data. This problem provides the substance of the intentional behaviorist research programme which seeks to provide a rationale for the cognitive explanation. Within this programme, two versions of the Behavioral Perspective Model (BPM), an extensional portrayal of socioeconomic behavior and a corresponding intentional approach, address the task of identifying where intentional explanation becomes necessary and the form it should take. This study explores a third version, based on neurophysiological substrates of consumer choice as a contributor to this task. The nature of “value” is closely related to the rationale for a neurophysiological model of consumer choice. The variables involved are operationally specified and measured with high intersubjective agreement. The intentional model (BPM-I), depicting consumer action in terms of mental processes such as perception, deliberation, and choice, extends the purview of the BPM to new situations and areas of explanation.

Evidence for the beneficial role of impacts in the creation of urable or habitable environments on Earth prompts the question of whether meteorite impacts could play a similar role at other potentially urable/habitable worlds like Enceladus, Europa, and Titan. In this work, we demonstrate that to first order, impact conditions on these worlds are likely to have been consistent with the survival of organic compounds and/or sufficient for promoting synthesis in impact melt. We also calculate melt production and freezing times for crater sizes found at Enceladus, Europa, and Titan and find that even the smallest craters at these worlds offer the potential to study the evolution of chemical pathways within impact melt. These first-order calculations point to a critical need to investigate these processes at higher fidelity with lab experiments, sophisticated thermodynamic and chemical modeling, and, eventually, in situ investigations by missions.

ObjectiveThis study provides a first approach to the use of the Multiple-Choice Procedure in social media networks use, as well as empirical evidence for the application of the Behavioral Perspective Model to digital consumption behavior in young users in conjunction with a methodology based on behavioral economics.Participants/methodsThe participants were part of a large university in Bogotá, Colombia, and they received an academic credit once they completed the online questionnaire. A total of 311 participants completed the experiment. Of the participants, 49% were men with a mean age of 20.6 years (SD = 3.10, Range = 15–30); 51% were women with a mean age of 20.2 years (SD = 2.84, Range = 15–29).ResultsAmong the total participants, 40% reported that they used social networks between 1 and 2 h a day, 38% between 2 and 3 h, 16% for 4 h or more, and the remaining 9% used them for 1 h or less per day. The factorial analysis of variance (ANOVA) allowed us to identify a statistically significant effect of the delay of the alternative reinforcer, that is, the average crossover points were higher when the monetary reinforcer was delayed 1 week, compared to the immediate delivery of the monetary reinforcer. There was no statistically significant effect of the interaction between the magnitude of the reinforcer and the delay time of the alternative reinforcer.ConclusionsThis study supports the relative reinforcing value of an informational reinforcement consequence such as social media use, which is sensitive to both the magnitude of reinforcement and the delay in delivery as individual factors. The findings on reinforcer magnitude and delay effects are consistent with previous research that have applied behavioral economics to the study of non-substance-related addictions.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.

Contracting delays remain a challenge to the successful initiation of multisite clinical research in the US. The Clinical and Translational Science Awards (CTSA) Contracts Processing Study showed average contract negotiation duration of > 100 days for industry-sponsored or investigator-initiated contracts. Such delays create enormous costs to sponsors and to patients waiting to use new evidence-based treatments. With support from the National Institutes of Health’s National Center for Advancing Translational Sciences, the Accelerated Clinical Trial Agreement (ACTA) was developed by 25 major academic institutions and medical centers engaged in clinical research in collaboration with the University-Industry Demonstration Partnership and with input from pharmaceutical companies. The ACTA also informed the development of subsequent agreements, including the Federal Demonstration Partnership Clinical Trial Subaward Agreement (FDP-CTSA); both ACTA and the FDP-CTSA are largely non-negotiable agreements that represent pre-negotiated compromises in contract terms agreed upon by industry and/or medical center stakeholders. When the involved parties agree to use the CTSA-developed and supported standard agreement templates as a starting point for negotiations, there can be significant time savings for trials. Use of the ACTA resulted in an average savings of 48 days and use of the FDP-CTSA saved an average of 57 days of negotiation duration.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.

PurposeThe development of human epidermal growth factor receptor 2 (HER2)-directed therapies has revolutionized the treatment of HER2-positive breast cancer. The aim of this article is to review the continually evolving treatment strategies in the neoadjuvant setting of HER2-positive breast cancer, as well as the current challenges and future perspectives.MethodsSearches were undertaken on PubMed and Clinicaltrials.gov for relevant publications and trials.FindingsThe current standard of care in high-risk HER2-positive breast cancer is to combine chemotherapy with dual anti-HER2 therapy, for a synergistic anti-tumor effect. We discuss the pivotal trials which led to the adoption of this approach, as well as the benefit of these neoadjuvant strategies for guiding appropriate adjuvant therapy. De-escalation strategies are currently being investigated to avoid over treatment, and aim to safely reduce chemotherapy, while optimizing HER2-targeted therapies. The development and validation of a reliable biomarker is essential to enable these de-escalation strategies and personalization of treatment. In addition, promising novel therapies are currently being explored to further improve outcomes in HER2-positive breast cancer.

Background Whether the composition of intravenous crystalloid solutions affects outcomes in adults with aneurysmal subarachnoid hemorrhage (aSAH) remains unknown. Therefore, we determined whether the use of saline is associated with a lower risk of disability and death in patients with aSAH compared with balanced crystalloids. Methods We conducted a post hoc subgroup analysis of SMART (Isotonic Solutions and Major Adverse Renal Events Trial), a pragmatic, unblinded, cluster‐randomized, multiple‐crossover clinical trial that enrolled 15 802 adults between June 2015 and April 2017. We compared IV administration of saline to balanced crystalloids in consecutively enrolled patients with aSAH aged 18 years or older whose ruptured aneurysm was procedurally secured at a single academic center in the United States. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms]–6 [death]) at 90 days obtained from a prospective institutional stroke registry. Secondary outcome included death by 90 days. Logistic or proportional odds regression models were used to test for between‐group differences adjusted for age, hypertension, aSAH grade, and procedure type. Results Of the 79 patients with aSAH procedurally treated during the Isotonic Solutions and Major Adverse Renal Events Trial study period, 78 were enrolled (median age, 58 years; interquartile range, 49–64.5; 64% female), with 41 (53%) assigned to saline and 37 (47%) to balanced crystalloids. Plasma‐Lyte was the primary balanced crystalloid used. Among 72 patients with 90‐day modified Rankin scale assessment, the adjusted common odds ratio, for the modified Rankin scale was 0.68 (95% CI, 0.28–1.63; P=0.39), with values

Many people who generally receive standard recommended inoculations refuse to partake of COVID-19 vaccines, preventatives that are effective, safe, and life-saving amidst the current pandemic. Our quest is to understand this puzzling and dangerous phenomenon, as it exists among US and UK citizens, whom in other respects would be regarded as quite regular. We will discuss Vaccine Refusal compared with two better understood phenomena: addiction, and akrasia, along with the related matters of human action, intention, agency, will, and identity. Vaccine Refusal, we will argue, appears to be rewarded by “informational reinforcement” leading to heightened arousal, along with increases in self-esteem resulting from “bucking the trend,” asserting one's “superior” understanding, and “tribal identity” in acting against social norms. These factors provide an overall reward amounting to satisfaction that outweighs the well-known consequences of COVID-19 infections. Our investigations will also lead us to a pair of epistemological hypotheses about two subtypes of the Vaccine Refusers under consideration here.

Background The REHAB‐HF (Rehabilitation Therapy in Older Acute Heart Failure Patients) trial showed that a novel, early, transitional, tailored, progressive, multidomain physical rehabilitation intervention improved physical function and quality of life in older, frail patients hospitalized for acute decompensated heart failure. This analysis examined the relationship between intervention adherence and outcomes. Methods and Results Adherence was defined as percent of sessions attended and percent of sessions attended adjusted for missed sessions for medical reasons. Baseline characteristics were examined to identify predictors of session attendance. Associations of session attendance with change in physical function (Short Physical Performance Battery [primary outcome], 6‐minute walk distance, quality of life [Kansas City Cardiomyopathy Questionnaire], depression, and clinical events [landmarked postintervention]) were examined in multivariate analyses. Adherence was 67%±34%, and adherence adjusted for missed sessions for medical reasons was 78%±34%. Independent predictors of higher session attendance were the following: nonsmoking, absence of myocardial infarction history and depression, and higher baseline Short Physical Performance Battery. After adjustment for predictors, adherence was significantly associated with larger increases in Short Physical Performance Battery (parameter estimate: β=0.06[0.03–0.10], P=0.001), 6‐minute walk distance (β=1.8[0.2–3.5], P=0.032), and Kansas City Cardiomyopathy Questionnaire score (β=0.62[0.26–0.98], P=0.001), and reduction in depression (β=−0.08[−0.12 to 0.04], P

Abstract Background Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). However, the clinical efficacy of COVID-19 convalescent plasma is unclear. Methods The Passive Immunity Trial for Our Nation (PassITON) is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the USA to provide high-quality evidence on the efficacy of COVID-19 convalescent plasma as a treatment for adults hospitalized with symptomatic disease. Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days are eligible. Enrolled patients are randomized in a 1:1 ratio to 1 unit (200–399 mL) of COVID-19 convalescent plasma that has demonstrated neutralizing function using a SARS-CoV-2 chimeric virus neutralization assay. Study treatments are administered in a blinded fashion and patients are followed for 28 days. The primary outcome is clinical status 14 days after study treatment as measured on a 7-category ordinal scale assessing mortality, respiratory support, and return to normal activities of daily living. Key secondary outcomes include mortality and oxygen-free days. The trial is projected to enroll 1000 patients and is designed to detect an odds ratio ≤ 0.73 for the primary outcome. Discussion This trial will provide the most robust data available to date on the efficacy of COVID-19 convalescent plasma for the treatment of adults hospitalized with acute moderate to severe COVID-19. These data will be useful to guide the treatment of COVID-19 patients in the current pandemic and for informing decisions about whether developing a standardized infrastructure for collecting and disseminating convalescent plasma to prepare for future viral pandemics is indicated. Trial registration ClinicalTrials.gov NCT04362176 . Registered on 24 April 2020.

Abstract Background Recent trials have suggested use of balanced crystalloids may decrease the incidence of major adverse kidney events compared to saline in critically ill adults. The effect of crystalloid composition on biomarkers of early acute kidney injury remains unknown. Methods From February 15 to July 15, 2016, we conducted an ancillary study to the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) comparing the effect of balanced crystalloids versus saline on urinary levels of neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) among 261 consecutively-enrolled critically ill adults admitted from the emergency department to the medical ICU. After informed consent, we collected urine 36 ± 12 h after hospital admission and measured NGAL and KIM-1 levels using commercially available ELISAs. Levels of NGAL and KIM-1 at 36 ± 12 h were compared between patients assigned to balanced crystalloids versus saline using a Mann-Whitney U test. Results The 131 patients (50.2%) assigned to the balanced crystalloid group and the 130 patients (49.8%) assigned to the saline group were similar at baseline. Urinary NGAL levels were significantly lower in the balanced crystalloid group (median, 39.4 ng/mg [IQR 9.9 to 133.2]) compared with the saline group (median, 64.4 ng/mg [IQR 27.6 to 339.9]) (P

Background Prior observational studies indicate that lower systolic blood pressure (SBP) after successful endovascular treatment (EVT) is associated with better functional outcomes in patients with acute ischemic stroke. However, whether targeting SBP to levels below the guideline‐recommended target of ≤180 mm Hg is safe and efficacious remains to be determined. Methods The BEST (Blood Pressure After Endovascular Stroke Therapy)‐II trial (NCT04116112) is a pragmatic, phase 2, multisite, prospective, randomized, open‐label trial with blinded end‐point assessment designed to (1) compare the safety of lower SBP targets with higher SBP targets in successfully EVT‐treated patients with stroke and (2) inform the design and estimate the probability of success of a future phase 3 trial. A total of 120 patients with acute ischemic stroke who undergo successful EVT (final modified Thrombolysis in Cerebral Infarction score ≥2b) for intracranial internal carotid artery or M1 or M2 segment of the middle cerebral artery will be randomized to the SBP targets of ≤180,

Surface displacement measurements collected using continuous Global Positioning System (cGPS) stations include the contribution of both endogenic processes (e.g., plate tectonics, isostasy) and exogenic processes that show seasonal variation (e.g., climate). These seasonal variations distort the tectonic signals and limit the usefulness of short-term investigations. This paper explores cGPS and meteorological time series collected in southern Africa and investigates whether the usefulness of cGPS time series can be improved by accounting for the seasonal effects of the dominant meteorological processes. The study is carried out using time, frequency, and time-frequency domain signal processing (inferential) analysis techniques. It was found that from the considered atmospheric processes, thermally-induced effects, which are not corrected for in the cGPS data, are the most prominent meteorological contributors in the vertical annual deformation component observed in cGPS time series. The effects of heave action (due to seasonal subsurface water infiltration and absorption, as well as changes in the water table) and changes of water mass distribution (caused by infiltration, transportation, extractions, and evaporation) on the displacement time series are much smaller. This suggests that correcting for thermal expansion, contraction, and thermal-induced errors could reduce the annual seasonal deformation component observed in cGPS position measurements in southern Africa and, most probably, in other parts of the world subjected to large seasonal variations in atmospheric temperatures. Reducing the magnitude of the seasonal components would increase the usefulness of short-term cGPS campaigns.

Abstract Classical Hodgkin lymphoma (HL) patients achieve excellent outcomes; therefore, treatment de‐escalation strategies to spare toxicity have been prioritized. In a large randomized trial of early‐stage HL patients, omission of chemotherapeutic agents including bleomycin from the standard ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) regimen was not found to be noninferior; however, the effect of partial omission is unknown. We investigated the effect of bleomycin omission on outcome for 150 early‐stage HL patients. At 8 years, freedom from relapse was 99% for both patients who received complete or incomplete bleomycin, which is reassuring for patients requiring bleomycin omission due to toxicity.

This study presents a modified semi-empirical radar scattering model for weathered rough rock surfaces. Weathered rocks generally have dry surfaces except for a few hours after heavy rain due to their rapid drainage compared to bare soils. We find that the dielectric properties of the rocks themselves and the moisture content of a marginal amount of soil patches in and around the rock surfaces have a negligible effect on radar backscattering. Therefore, radar backscattering from rock surfaces is mainly controlled by surface roughness. Here, we modified the cross-polarization ratio model developed by Oh, which is formulated by only surface roughness parameters with no dependence on soil moisture. Based on LiDAR surface topography data collected from weathered rock surfaces in the Canadian Arctic and corresponding quad-polarimetric RADARSAT-2 synthetic aperture radar (SAR) data, we determined the best fit radar backscattering model for weathered rock surfaces. The modified model was successfully applied to estimate the surface roughness of weathered rock surfaces up to approximately ks = 7 where k is the radar wavenumber (= 2π/λ) and s is the root mean square (RMS) height. This approach avoids the rapid saturation feature observed at ks > 3 in other models.

For decades, the research community called for streamlined Institutional Review Board (IRB) review processes for multisite studies. Department of Health and Human Services and National Institutes of Health (NIH) recognized this need and implemented single IRB (sIRB) of record mandates. However, announcing mandates without sufficient operational guidance and tools is insufficient to foster the desired change. Nearly 4 years into implementation of the NIH’s sIRB mandate, operational challenges remain. Fortunately, NIH supports a web-based sIRB platform, the IRB Reliance Exchange (IREx), to facilitate sIRB communication and documentation. IREx has received continuous NIH funding supporting its evolution since 2011 and is now used by over 5,000 Human Research Protection Program and research personnel, 35 sIRBs, and 415 participating sites to operationalize sIRB review and approval on over 400 studies. IREx supports over 2300 reliance relationships with an average of 7 sites per study. The platform is continually used by sIRBs and relying sites, providing a valuable centralized portal for promoting a harmonized sIRB review process. IREx can promote transparency, standardize practice, minimize workflow variation, and mitigate the need for sIRBs to implement significant technical changes to their local electronic systems. IREx has proven to be nimble and adaptable with practice and policy changes over the past decade, as evidenced by continually increasing platform utilization.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

Abstract Introduction: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring. Methods: The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed. Results: Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial’s DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report. Conclusion: It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.

Summary: The COVID-19 pandemic revealed an urgent need for rapid profiling of neutralizing antibody responses and development of antibody therapeutics. The current Food and Drug Administration-approved serological tests do not measure antibody-mediated viral neutralization, and there is a need for standardized quantitative neutralization assays. We report a high-throughput two-step profiling approach for identifying neutralizing convalescent plasma. Screening and downselection for serum antibody binding to the receptor-binding domain are followed by quantitative neutralization testing using a chimeric vesicular stomatitis virus expressing spike protein of SARS-CoV-2 in a real-time cell analysis assay. This approach enables a predictive screening process for identifying plasma units that neutralize SARS-CoV-2. To calibrate antibody neutralizing activity in serum from convalescent plasma donors, we introduce a neutralizing antibody standard reagent composed of two human antibodies that neutralize SARS-CoV strains, including SARS-CoV-2 variants of concern. Our results provide a framework for establishing a standardized assessment of antibody-based interventions against COVID-19.

Abstract Background Observational research suggests that combined therapy with Vitamin C, thiamine and hydrocortisone may reduce mortality in patients with septic shock. Methods and design The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a multicenter, double-blind, adaptive sample size, randomized, placebo-controlled trial designed to test the efficacy of combination therapy with vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) given every 6 h for up to 16 doses in patients with respiratory or circulatory dysfunction (or both) resulting from sepsis. The primary outcome is ventilator- and vasopressor-free days with mortality as the key secondary outcome. Recruitment began in August 2018 and is ongoing; 501 participants have been enrolled to date, with a planned maximum sample size of 2000. The Data and Safety Monitoring Board reviewed interim results at N = 200, 300, 400 and 500, and has recommended continuing recruitment. The next interim analysis will occur when N = 1000. This update presents the statistical analysis plan. Specifically, we provide definitions for key treatment and outcome variables, and for intent-to-treat, per-protocol, and safety analysis datasets. We describe the planned descriptive analyses, the main analysis of the primary end point, our approach to secondary and exploratory analyses, and handling of missing data. Our goal is to provide enough detail that our approach could be replicated by an independent study group, thereby enhancing the transparency of the study. Trial registration ClinicalTrials.gov, NCT03509350 . Registered on 26 April 2018.

Background: There is wide heterogeneity in sepsis in causative pathogens, host response, organ dysfunction, and outcomes. Clinical and biologic phenotypes of sepsis are proposed, but the role of pathogen data on sepsis classification is unknown.Methods: We conducted a secondary analysis of the Recombinant Human Activated Protein C (rhAPC) Worldwide Evaluation in Severe Sepsis (PROWESS) Study. We used latent class analysis (LCA) to identify sepsis phenotypes using, (i) only clinical variables (“host model”) and, (ii) combining clinical with microbiology variables (e.g., site of infection, culture-derived pathogen type, and anti-microbial resistance characteristics, “host-pathogen model”). We describe clinical characteristics, serum biomarkers, and outcomes of host and host-pathogen models. We tested the treatment effects of rhAPC by phenotype using Kaplan-Meier curves.Results: Among 1,690 subjects with severe sepsis, latent class modeling derived a 4-class host model and a 4-class host-pathogen model. In the host model, alpha type (N = 327, 19%) was younger and had less shock; beta type (N=518, 31%) was older with more comorbidities; gamma type (N = 532, 32%) had more pulmonary dysfunction; delta type (N = 313, 19%) had more liver, renal and hematologic dysfunction and shock. After the addition of microbiologic variables, 772 (46%) patients changed phenotype membership, and the median probability of phenotype membership increased from 0.95 to 0.97 (P < 0.01). When microbiology data were added, the contribution of individual variables to phenotypes showed greater change for beta and gamma types. In beta type, the proportion of abdominal infections (from 20 to 40%) increased, while gamma type patients had an increased rate of lung infections (from 50 to 78%) with worsening pulmonary function. Markers of coagulation such as d-dimer and plasminogen activator inhibitor (PAI)-1 were greater in the beta type and lower in the gamma type. The 28 day mortality was significantly different for individual phenotypes in host and host-pathogen models (both P < 0.01). The treatment effect of rhAPC obviously changed in gamma type when microbiology data were added (P-values of log rank test changed from 0.047 to 0.780).Conclusions: Sepsis host phenotype assignment was significantly modified when microbiology data were added to clinical variables, increasing cluster cohesiveness and homogeneity.

We report on the effect of the end-Cretaceous impact event on the present-day deep microbial biosphere at the impact site. IODP-ICDP Expedition 364 drilled into the peak ring of the Chicxulub crater, México, allowing us to investigate the microbial communities within this structure. Increased cell biomass was found in the impact suevite, which was deposited within the first few hours of the Cenozoic, demonstrating that the impact produced a new lithological horizon that caused a long-term improvement in deep subsurface colonization potential. In the biologically impoverished granitic rocks, we observed increased cell abundances at impact-induced geological interfaces, that can be attributed to the nutritionally diverse substrates and/or elevated fluid flow. 16S rRNA gene amplicon sequencing revealed taxonomically distinct microbial communities in each crater lithology. These observations show that the impact caused geological deformation that continues to shape the deep subsurface biosphere at Chicxulub in the present day.

The geography of deep-ocean mixing driven by internal tides is poorly constrained in ocean models. Here the authors unveil the global variability of energetic small-scale internal tides, combining an analytical model with satellite and in situ observations, paving the way to future parameterisations.

Abstract Background Sepsis accounts for 30% to 50% of all in-hospital deaths in the United States. Other than antibiotics and source control, management strategies are largely supportive with fluid resuscitation and respiratory, renal, and circulatory support. Intravenous vitamin C in conjunction with thiamine and hydrocortisone has recently been suggested to improve outcomes in patients with sepsis in a single-center before-and-after study. However, before this therapeutic strategy is adopted, a rigorous assessment of its efficacy is needed. Methods The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled trial. It will enroll patients with sepsis causing respiratory or circulatory compromise or both. Patients will be randomly assigned (1:1) to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 h or matching placebos until a total of 16 administrations have been completed or intensive care unit discharge occurs (whichever is first). Patients randomly assigned to the comparator group are permitted to receive open-label stress-dose steroids at the discretion of the treating clinical team. The primary outcome is consecutive days free of ventilator and vasopressor support (VVFDs) in the 30 days following randomization. The key secondary outcome is mortality at 30 days. Sample size will be determined adaptively by using interim analyses with pre-stated stopping rules to allow the early recognition of a large mortality benefit if one exists and to refocus on the more sensitive outcome of VVFDs if an early large mortality benefit is not observed. Discussion VICTAS is a large, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled trial that will test the efficacy of vitamin C, thiamine, and hydrocortisone as a combined therapy in patients with respiratory or circulatory dysfunction (or both) resulting from sepsis. Because the components of this therapy are inexpensive and readily available and have very favorable risk profiles, demonstrated efficacy would have immediate implications for the management of sepsis worldwide. Trial registration ClinicalTrials.gov Identifier: NCT03509350. First registered on April 26, 2018, and last verified on December 20, 2018. Protocol version: 1.4, January 9, 2019

Abstract Background Finding the optimal treatment for a chronic condition can be a complex and lengthy endeavor for both the patient and the clinician. To address this challenge, we developed an “N-of-1” quality improvement infrastructure to aid providers and patients in personalized treatment decision-making using systematic assessment of patient-reported outcomes during routine care. Methods Using the REDCap data management infrastructure, we implemented three pediatric pilots of the Treatment Assessments in the Individual Leading to Optimal Regimens (TAILOR) tool, including children receiving early intervention, children with attention deficit hyperactivity disorder, and children with challenging behaviors in the classroom setting. This retrospective review of data summarizes utilization and satisfaction data during our pilot experience with the tool. Results The three pilots included a combined total of 109 children and 39 healthcare providers, with 67 parents and 77 teachers invited to share data using brief surveys administered using TAILOR. Overall survey response rates ranged from 38% to 84% across the three pilots, with response rates notably higher among teachers as compared with parents. Satisfaction data indicated positive impressions of the tool’s utility. Discussion These experiences show the utility of the TAILOR framework for supporting collection and incorporation of patient-reported outcomes into the care of individuals with chronic conditions.

Remote sensing has revolutionized resource exploration by enabling quick surveillance of large areas. Quad-polarimetric synthetic aperture radar (SAR) is useful for assessing surface roughness, but few studies have applied it for geological mapping. Located in the Canadian Arctic, Axel Heiberg Island is a suitable site for exploring remote predictive geologic mapping techniques that combine quad-polarimetric SAR and multispectral datasets. The island has extensive rock exposure, with little interference from vegetation and snow in late summer. Axel Heiberg Island has the second highest concentration of salt diapirs globally. As a result, it also hosts extensive secondary salt deposits that have been weathered and precipitated away from their source. Because diapirs frequently provide structural traps for petroleum reservoirs, it is important to distinguish between diapiric and non-diapiric salt during early exploration. This study maps diapirs and secondary salts using multispectral data and characterizes them in polarimetric SAR. Diapirs appear rough in C-Band and L-Band radar, whereas the secondary salts appear smooth at both (cm–dm) scales. Field observations confirm salt diapirs are rough at the millimeter–meter scales, whereas secondary salts precipitate on smoother surfaces. These results show that radar can help differentiate between diapiric and secondary salt exposures, which will assist in future resource exploration.

Background: the need for social distancing midst the COVID-19 pandemic has forced ophthalmologists to innovate with telemedicine. The novel process of triaging emergency ophthalmology patients via videoconsultations should reduce hospital attendances. However, the safety profile of such services were unknown. Methods: in this retrospective cohort study, we reviewed case notes of 404 adults who used our videoconsultation service from 20/04/2020 to 03/05/2020. We compared these to 451 patient who attended eye casualty in person at the same time who were deemed not to require same day ophthalmic examination. Findings: patients seen by videoconsultations tended to be younger (Median = 43 years, Inter-quartile range = 27 vs Median= 49 years, Inter-quartile range = 28)'. More males used the face-to-face triage (55%) while more females used videoconsultation (54%)%. Fewer patients seen by videoconsultations required specialist review compared to face-face triage [X2 (1, N = 854) = 128.02, p

Summary: A detailed understanding of the adaptive host response to SARS-CoV-2 infection in humans is urgently needed. We developed a sensitive, high-throughput, and efficient assay using liquid bead array technology. We observed advantages over traditional ELISA for the detection and quantification of binding IgG against the receptor binding domain (RBD) of SARS-CoV-2. To determine whether COVID-19 symptom severity correlates with SARS-CoV-2 IgG, we measured anti-RBD IgG levels from 67 subjects recovered from PCR-confirmed COVID-19. We found that COVID-19 symptom severity strongly correlated with RBD IgG level (p < 0.001). These findings have substantial implications for public policy surrounding assessments of antibody responses and possible immunity, as not all cases of COVID-19 can be assumed to generate a protective antibody response, and mild disease in particular is capable of generating very low-level anti-RBD IgG levels. These findings also have important implications for the selection of donors for convalescent plasma to be used therapeutically.

Abstract Objective From the perspective of percutaneous coronary intervention (PCI) centers, locations of ST‐segment elevation myocardial infarction (STEMI) diagnosis can include a referring facility, emergency medical services (EMS) transporting to a PCI center, or the PCI center's emergency department (ED). This challenges the use of door‐to‐balloon‐time as the primary evaluative measure of STEMI treatment pathways. Our objective was to identify opportunities to improve care by quantifying differences in the timeliness of STEMI treatment mobilization based on the location of the diagnostic ECG. Methods This 3‐year, single‐center, retrospective cohort study classified patients by diagnostic ECG location: referring facility, EMS, or PCI center ED. We quantified door‐to‐balloon‐time and diagnosis‐to‐balloon‐time with its care subintervals. Results Of 207 ED STEMI patients, 180 (87%) received PCI. Median diagnosis‐to‐balloon‐times were shortest among the ED‐diagnosed (78 minutes [interquartile range (IQR), 61‐92]), followed by EMS‐identified patients (89 minutes [IQR, 78‐122]), and longest among those referred (140 minutes [IQR, 119‐160]), reflecting time for transport to the PCI center. Conversely, referred patients had the shortest median door‐to‐balloon‐times (38 minutes [IQR, 34‐43]), followed by the EMS‐identified (64 minutes [IQR, 47‐77]), whereas ED‐diagnosed patients had the longest (89 minutes [IQR, 70‐114]), reflecting diagnosis and catheterization lab activation frequently occurring before PCI center ED arrival for referred and EMS‐identified patients. Conclusions Diagnosis‐to‐balloon‐time and its care subintervals are complementary to the traditional door‐to‐balloon‐times as measures of the STEMI treatment process. Together, they highlight opportunities to improve timely identification among ED‐diagnosed patients, use of out‐of‐hospital cath lab activation for EMS‐identified patients, and encourage pathways for referred patients to bypass PCI center EDs.

Purpose: Problematic smartphone use has been associated with negative effects in work and school environments. This study proposes the application of a behavioural economics perspective to establish whether heavy smartphone users show a tendency to devalue the consequences of their behaviour in the long term. To address this proposition, the study sought to establish how an objective measurement of usage time of smartphones and apps might help to predict, firstly, participants’ choice behaviour and, secondly, their perceived dependence levels. Design/methodology/approach: An objective measurement of the usage time of smartphones and apps was conducted over four weeks (N = 560 data points), and a computer-based intertemporal choice task and the Spanish version of the Smartphone Addiction Inventory (SPAI) were applied. The participants were twenty undergraduate college students. Findings: Although the usage time of devices and apps failed to predict the choice behaviour, a correlation was found between the total usage time of smartphones and WhatsApp and Facebook apps and users’ dependence level. On the other hand, dependence had a positive effect on the average selection of the impulsive choice. Originality/value: This paper proposes the application of a behavioural economics perspective to explore the relationship between objectively measured usage time of smartphone and apps, choice behaviours in an intertemporal task and users’ perceived dependence levels. This allows us to consider an alternative to the traditional psychiatric approach in an environment of increasing access to and use of mobile digital platforms.

Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC’s goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.

Pistachios have been implicated in two salmonellosis outbreaks and multiple recalls in the U.S. This study performed an in-depth retrospective data analysis of Salmonella associated with pistachios as well as a storage study to evaluate the survivability of Salmonella on inoculated inshell pistachios to further understand the genetics and microbiological dynamics of this commodity-pathogen pair. The retrospective data analysis on isolates associated with pistachios was performed utilizing short-read and long-read sequencing technologies. The sequence data were analyzed using two methods: the FDA’s Center for Food Safety and Applied Nutrition Single Nucleotide Polymorphism (SNP) analysis and Whole Genome Multilocus Sequence Typing (wgMLST). The year-long storage study evaluated the survival of five strains of Salmonella on pistachios stored at 25 °C at 35% and 54% relative humidity (RH). Our results demonstrate: i) evidence of persistent Salmonella Senftenberg and Salmonella Montevideo strains in pistachio environments, some of which may be due to clonal resident strains and some of which may be due to preharvest contamination; ii) presence of the Copper Homeostasis and Silver Resistance Island (CHASRI) in Salmonella Senftenberg and Montevideo strains in the pistachio supply chain; and iii) the use of metagenomic analysis is a novel tool for determining the composition of serovar survival in a cocktail inoculated storage study.

Background The COVID-19 crisis forced hospitals in the UK dramatically to reduce outpatient activity. To provide continuity of care and to assist patients reluctant or unable to leave their homes, video consultations were rapidly implemented across routine and emergency ophthalmology services.Objective To describe the deployment and scaling to a large volume of teleophthalmology using a video consultation platform ‘Attend Anywhere’ in Moorfields Eye Hospital’s accident and emergency (A&E) department (London, UK).Method Patient satisfaction, waiting time, consultation duration, outcome and management were audited following the launch of the new virtual A&E service.Results In the 12 days following the service launch, 331 patients were seen by video consultation. 78.6% of patients (n=260) were determined not to need hospital A&E review and were managed with advice (n=126), remote prescription (n=57), general practitioner referral (n=27), direct referral to hospital subspecialty services (n=26) or diversion to a local eye unit (n=24). Mean patient satisfaction was 4.9 of 5.0 (n=62). The mean consultation duration was 12 min (range 5–31 min) and the wait time was 6 min (range 0–37 min).Conclusion Video consultations showed greater than expected usefulness in the remote management of eye disease and supported a substantial reduction in the number of people visiting the hospital.

The 28-km diameter Tunnunik impact structure in northern Victoria Island, Arctic Canada, was mapped using ASTER, Landsat 8, RADARSAT-2 polarimetric synthetic aperture radar (SAR), and Quickbird data. Multispectral analysis was accomplished through band ratios, MNF transform, and spectral matching algorithms, from which 4 distinct spectral units were defined. Polarimetric SAR decompositions also showed different scattering mechanisms for these 4 units indicating different surface roughness properties. These multispectral and polarimetric SAR observations were combined with detailed surface textures and morphological features as visible in very high-resolution Quickbird imagery (61 cm/pixel). Remote sensing parameters and their thresholds for characterizing each unit were implemented into a decision-tree algorithm and a remote predictive geological map was produced. Subsequent field and follow-up laboratory investigations enabled the ground-truthing of these predictions. The geological units were defined as follows: (i) (smooth) fluvioglacial deposits, (ii) (moderately rough) chert-bearing dolostone, (iii) (rough) dolostone, and (iv) (rough) dolostone covered by silicified surfaces. The rough surfaces characterized by multiple scattering in the polarimetric SAR decomposition correspond to the occurrences of weathered carbonate rocks, which are relatively resistant to weathering and form blocky surfaces. This shows that SAR-derived surface roughness properties can greatly contribute to defining geological units by combining with lithological mapping.

Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.