Academic Research Center Research Articles

Recycling photovoltaic modules within a circular economy approach and a snapshot for Türkiye

Solar energy has an important role for increasing renewable energy use and circularity options in the sector are increasing. This study analyses the advances in the scope of the Sustainable Development Goals that aim to create a more equitable and peaceful world and a more livable environment. Studies that are focused on life cycle perspectives, opportunities for end-of-life management, and multiple goals, including climate action as well as responsible consumption and production are compared. This is used to understand synergies between the circular economy and solar photovoltaic technologies in Türkiye. A need analysis survey is conducted with the participation of academic institutions and research centers, producers, and other stakeholders who operate in the solar photovoltaic sector in Türkiye. The results are analyzed across stakeholder categories and used to derive policy recommendations based on the top drivers, barriers, and enablers to increase circularity in the sector. The expected impacts on environmental, economic and social aspects are also questioned to obtain perspectives on possible pathways. For the first time, the realization of sustainable solar photovoltaic waste management in the context of the circular economy is discussed by stakeholders in Türkiye to establish consensus, increase collaboration, and support planning of future opportunities.

Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder

The human physiological sexual response is crucial for reward, satisfaction, and reproduction. Disruption of the associated neurophysiological pathways predisposes to low sexual desire; the most prevalent psychological form is hypoactive sexual desire disorder (HSDD), which affects 8% of men but currently has no effective pharmacological treatment options. The reproductive neuropeptide kisspeptin offers a putative therapeutic target, owing to emerging understanding of its role in reproductive behavior. To determine the physiological, behavioral, neural, and hormonal effects of kisspeptin administration in men with HSDD. This double-blind, 2-way crossover, placebo-controlled randomized clinical trial was performed at a single academic research center in the UK. Eligible participants were right-handed heterosexual men with HSDD. Physiological, behavioral, functional magnetic resonance imaging (fMRI), and hormonal analyses were used to investigate the clinical and mechanistic effects of kisspeptin administration in response to visual sexual stimuli (short and long video tasks). The trial was conducted between January 11 and September 15, 2021, and data analysis was performed between October and November 2021. Participants attended 2 study visits at least 7 days apart, in balanced random order, for intravenous infusion of kisspeptin-54 (1 nmol/kg/h) for 75 minutes or for administration of a rate-matched placebo. Changes in (1) brain activity on whole-brain analysis, as determined by fMRI blood oxygen level-dependent activity in response to visual sexual stimuli during kisspeptin administration compared with placebo, (2) physiological sexual arousal (penile tumescence), and (3) behavioral measures of sexual desire and arousal. Of the 37 men randomized, 32 completed the trial. Participants had a mean (SD) age of 37.9 (8.6) years and a mean (SD) body mass index of 24.9 (5.4). On viewing sexual videos, kisspeptin significantly modulated brain activity in key structures of the sexual-processing network on whole-brain analysis compared with placebo (mean absolute change [Cohen d] = 0.81 [95% CI, 0.41-1.21]; P = .003). Furthermore, improvements in several secondary analyses were observed, including significant increases in penile tumescence in response to sexual stimuli (by up to 56% more than placebo; mean difference = 0.28 units [95% CI, 0.04-0.52 units]; P = .02) and behavioral measures of sexual desire-most notably, increased happiness about sex (mean difference = 0.63 points [95% CI, 0.10-1.15 points]; P = .02). Collectively, this randomized clinical trial provides the first evidence to date showing that kisspeptin administration substantially modulates sexual brain processing in men with HSDD, with associated increases in penile tumescence and behavioral measures of sexual desire and arousal. These data suggest that kisspeptin has potential as the first pharmacological treatment for men with low sexual desire. isrctn.org Identifier: ISRCTN17271094.

Knowledge brokering organisations: a new way of governing evidence

Background:Government-funded knowledge brokering organisations (KBOs) are an increasingly prevalent yet under-researched area. Working in the space between knowledge and policy, yet framing themselves as different from think tanks and academic research centres, these organisations broker evidence into policy. Aims and objectives:This article examines how three organisations on different continents develop similar narratives and strategies to attempt to inform policymaking and build legitimacy. Methods:Using documentary analysis and semi-structured interviews, it shows how the organisations construct their credibility and legitimacy, and make sense of their emergence, activities and relationships with policymakers. Findings:The study responds to the lack of political focus on many existing studies, examining how KBOs make sense of their origins and roles, articulating notions of evidence, and mobilising different types of legitimacies to do so. The research also addresses an empirical gap surrounding the emergence and activities of KBOs (not individuals), analysing organisations on three different continents. Discussion and conclusions:KBOs developed similar narratives of origins and functions, despite emerging in different contexts. Furthermore, they build their legitimacy/ies in similar ways. Our research improves our understanding of how a new ‘tool’ in the evidence-informed policymaking (EIPM) arsenal – KBOs – is being mobilised by different governments in similar ways.

Orodispersible Films-Current State of the Art, Limitations, Advances and Future Perspectives.

Orodispersible Films (ODFs) are drug delivery systems manufactured with a wide range of methods on a big scale or for customized medicines and small-scale pharmacy. Both ODFs and their fabrication methods have certain limitations. Many pharmaceutical companies and academic research centers across the world cooperate in order to cope with these issues and also to find new formulations for a wide array of APIs what could make their work profitable for them and beneficial for patients as well. The number of pending patent applications and granted patents with their innovative approaches makes the progress in the manufacturing of ODFs unquestionable. The number of commercially available ODFs is still growing. However, some of them were discontinued and are no longer available on the markets. This review aims to summarize currently marketed ODFs and those withdrawn from sale and also provides an insight into recently published studies concerning orodispersible films, emphasizing of utilized APIs. The work also highlights the attempts of scientific communities to overcome ODF's manufacturing methods limitations.

Decentralized research technology use in multicenter clinical research studies based at U.S. academic research centers.

During the COVID-19 pandemic, research organizations accelerated adoption of technologies that enable remote participation. Now, there's a pressing need to evaluate current decentralization practices and develop appropriate research, education, and operations infrastructure. The purpose of this study was to examine current adoption of decentralization technologies in a sample of clinical research studies conducted by academic research organizations (AROs). The setting was three data coordinating centers in the U.S. These centers initiated coordination of 44 clinical research studies during or after 2020, with national recruitment and enrollment, and entailing coordination between one and one hundred sites. We determined the decentralization technologies used in these studies. We obtained data for 44/44 (100%) trials coordinated by the three centers. Three technologies have been adopted across nearly all studies (98-100%): eIRB, eSource, and Clinical Trial Management Systems. Commonly used technologies included e-Signature (32/44, 73%), Online Payments Portals (26/44, 59%), ePROs (23/44, 53%), Interactive Response Technology (22/44, 50%), Telemedicine (19/44, 43%), and eConsent (18/44, 41%). Wearables (7/44,16%) and Online Recruitment Portals (5/44,11%) were less common. Rarely utilized technologies included Direct-to-Patient Portals (1/44, 2%) and Home Health Nurse Portals (1/44, 2%). All studies incorporated some type of decentralization technology, with more extensive adoption than found in previous research. However, adoption may be strongly influenced by institution-specific IT and informatics infrastructure and support. There are inherent needs, responsibilities, and challenges when incorporating decentralization technology into a research study, and AROs must ensure that infrastructure and informatics staff are adequate.

ИССЛЕДОВАНИЯ ДЕТСКОЙ ЛИТЕРАТУРЫ В ПОРТУГАЛИИ: ОБЗОР ЖУРНАЛОВ И ПРОЕКТОВ

This paper provides an overview of the current state of research and critical reception of children’s literature in Portugal. It aims at listing and briefly describing academic journals, research centres, projects and other initiatives dedicated to children’s literature research that have emerged in Portugal since the beginning of the 21st century.

Hysterectomy for Non-Prolapsed Uterus in Elderly Patients: Predictors of Prolonged Hospital Stay

Objective: The objective of this study was to investigate surgical outcomes and complications of hysterectomy for benign conditions other than prolapse in elderly patients and to define predictors of prolonged hospitalization. Design: Retrospective analysis of prospectively collected data. Setting: This study was conducted in an academic research center. Patients: We utilized our institution surgical database to identify patients aged 60 years or more (“elderly”) who underwent hysterectomy for benign conditions other than pelvic organ prolapse during a 20-year period (January 2000–December 2019). Methods: Length of stay (LOS) of more than 2 days (90th percentile of LOS) was defined as prolonged hospitalization. Patient demographics, comorbid conditions, and surgical approach (vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), and abdominal hysterectomy (AH)) were identified. Patients treated via LH or VH were also grouped as minimally invasive surgery (MIS). Multivariable logistic regression was used to identify factors associated with prolonged LOS. Results: Overall, 334 patients were included in this study, 262 (78.4%) of whom underwent LH, 42 (12.6%) VH, and 30 (9.0%) AH. Median LOS was 2 days (1–8), and 63 (18.8%) patients required prolonged LOS. Compared to AH, median hospital stay was shorter in MIS group (2 days vs. 3 days, p < 0.001). No admission variables were associated with prolonged LOS. The only independent predictors of prolonged LOS were AH (odds ratio 24.82, 95% CI 4.84–127.16) and operative time (odds ratio for 30 mins increased 11.34, 95% CI 1.63–78.78). Compared to those who underwent VH, patients having LH had a higher rate of concomitant salpingo-oophorectomy (96.6% vs. 61.9%, p < 0.001). Limitations: Retrospective single-center study design, number of patients with prolonged hospitalization, and the setting (tertiary minimally invasive gynecology referral center), which might have reduced the generalizability of our results are the limitations of this study. Conclusions: The abdominal route of hysterectomy was found as the main driver of prolonged hospitalization, reinforcing the benefits of MIS for benign hysterectomy in elderly patients with non-prolapsed uteri; the higher chance of performing concomitant salpingo-oophorectomy supports the laparoscopic approach as the first option for these patients.

Global Trend for Waste Lithium-Ion Battery Recycling from 1984 to 2021: A Bibliometric Analysis

With the massive use of lithium-ion batteries in electric vehicles and energy storage, the environmental and resource problems faced by used lithium-ion batteries are becoming more and more prominent. In order to better resource utilization and environmental protection, this paper employs bibliometric and data analysis methods to explore publications related to waste lithium-ion battery recycling from 1984 to 2021. The Web of Science core set from the SCIE online database was used for this article. These findings demonstrate a considerable increase trend in the number of publications published in the subject of recycling used lithium-ion batteries, with a natural-sciences-centric focus. Argonne National Lab, Chinese Academy of Sciences, and China Academic and Scientific Research Center are the top three institutions in terms of quantity of papers published. The affiliated journals corresponding to these three institutions also have high impact factors, which are 106.47, 44.85, and 58.69, respectively. In comparison to comparable institutes in other nations, the American Argonne National Laboratory supports 223 research articles in this area. China and the US make up the majority of the research’s funding. The two key aspects of current lithium-ion battery recycling research are material structure research and environmentally friendly recycling. Nevertheless, high-capacity lithium-ion batteries, waste lithium-ion integrated structures, and gentle recycling of spent lithium-ion batteries will be the major aspects of study in the future. It is hoped that the above analysis can bring new ideas and methods to the field of waste lithium-ion battery recycling and provide a basis for the subsequent research and application of waste lithium-ion battery recycling.

Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe.

Important discoveries by academic drug developers hold the promise of bringing innovative treatments that address unmet medical needs to the market. However, the drug development process has proved to be challenging and demanding for academic researchers, and regulatory challenges are an important barrier to implementing academic findings in clinical practice. European regulators offer varying degrees of support services to help drug developers meet regulatory standards and requirements. "Strengthening Training of Academia in Regulatory Sciences and Supporting Regulatory Scientific Advice" (STARS) is a European Commission-funded consortium aiming to strengthen the training of academics in regulatory science and requirements. Here, we report the results of four surveys that investigated the awareness and utilization of support tools offered by European regulators and identified the regulatory challenges and support needs of researchers. The surveys targeted four main European stakeholders in academic medicines research: academic research groups (706 respondents), academic research centers (99), funding organizations (49), and regulators (22). The results show that while European regulators provide various regulatory support tools, less than half of the responding academic researchers were aware of these tools and many experienced challenges in reaching a sufficient level of regulatory knowledge. There was a general lack of understanding of the regulatory environment that was aggravated by poor communication between stakeholders. The results of this study form a foundation for an improved European medicines regulatory network, in which regulatory challenges faced by academia are tackled.

Effect of a Lifestyle Intervention on Cardiometabolic Health Among Emerging Adults

The prevalence of obesity has increased substantially among emerging adults, yet no previous large-scale behavioral weight loss trials have been conducted among this age group. To test the effect of 2 theory-based motivational enhancements on weight loss within a primarily digital lifestyle intervention designed for emerging adults. In this randomized clinical trial conducted at an academic medical research center, 382 participants aged 18 to 25 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45 were enrolled between February 2, 2016, and February 6, 2019. Data collection was completed February 8, 2020. Analysis was performed on an intention-to-treat basis. Participants were randomized to 1 of 3 groups: developmentally adapted behavioral weight loss (aBWL), aBWL plus behavioral economics (aBWL + BE), or aBWL plus self-determination theory (aBWL + SDT). All groups received a 6-month intervention with 1 group session, 1 individual session, and a digital platform (digital tools for self-monitoring, weekly lessons, tailored feedback, text messages, and optional social media). The aBWL + BE group received modest financial incentives for self-monitoring and weight loss; the aBWL + SDT group received optional experiential classes. Coaching and message framing varied by group. The primary outcome was mean (SE) weight change (in kilograms) at 6 months. Secondary outcomes included proportion of participants achieving weight loss of 5% or more, percentage weight change, waist circumference, body composition, and blood pressure. Among the 382 participants (mean [SD] age, 21.9 [2.2] years), 316 (82.7%) were female, mean (SD) BMI was 33.5 (4.9), 222 (58.1%) were of underrepresented race and/or ethnicity, and 320 (83.8%) were retained at the primary end point. There was a significant time effect for mean (SE) weight loss (-3.22 [0.55] kg in the aBWL group; -3.47 [0.55] kg in the aBWL + BE group; and -3.40 [0.53] kg in the aBWL + SDT group; all P < .001), but no between-group differences were observed (aBWL vs aBWL + BE: difference, -0.25 kg [95% CI, -1.79 to 1.29 kg]; P = .75; aBWL vs aBWL + SDT: difference, -0.18 kg [95% CI, -1.67 to 1.31 kg]; P = .81; and aBWL + SDT vs aBWL + BE: difference, 0.07 kg [95% CI, -1.45 to 1.59 kg]; P = .93). The proportion of participants achieving a weight loss of 5% or more was 40.0% in the aBWL group (50 of 125), 39.8% in the aBWL + BE group (51 of 128), and 44.2% in the aBWL + SDT group (57 of 129), which was not statistically different across groups (aBWL vs aBWL + BE, P = .89; aBWL vs aBWL + SDT, P = .45; aBWL + SDT vs aBWL + BE, P = .54). Parallel findings were observed for all secondary outcomes-clinically and statistically significant improvements with no differences between groups. In this randomized clinical trial, all interventions produced clinically significant benefit, but neither of the motivational enhancements promoted greater reductions in adiposity compared with the developmentally adapted standard group. Continued efforts are needed to optimize lifestyle interventions for this high-risk population and determine which intervention works best for specific individuals based on sociodemographic and/or psychosocial characteristics. ClinicalTrials.gov Identifier: NCT02736981.

The Repeatable Battery for the Assessment of Neuropsychological Status, While Useful for Measuring Cognitive Changes in Manifest Huntington Disease, May Show Limited Utility in Premanifest Disease.

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, standardized neuropsychological test that assesses several areas of cognitive function. Recent studies, although sparse, have examined the use of the RBANS to detect cognitive deficits in individuals with manifest Huntington disease (HD); however, no studies have investigated its utility to detect cognitive deficits in individuals with premanifest HD (PreHD), where cognitive symptoms are thought to be more subtle. To assess cognitive deficits in individuals with HD, particularly in individuals with PreHD, using an easily administered, brief but comprehensive, neuropsychological test. We administered the RBANS to 31 individuals with HD, 29 individuals with PreHD, and 22 healthy controls (HC) at an academic HD clinical research center and collected RBANS Total, Index, and subtest scores for group comparisons. The HD group had significantly lower RBANS Total, Index, and subtest scores than the HC. The PreHD group had significantly lower RBANS Total scores and Coding subtest scores than the HC, but no other significant group differences were identified. Our results substantiate previous findings of significant impairment on the RBANS in individuals with HD. In addition, we are the first to demonstrate that, although the RBANS can identify deficits in psychomotor speed and information processing in individuals with PreHD, it does not appear to have the ability to detect impairment in any additional cognitive domains in individuals with PreHD.

Libraries and Archives in the Digital Age

Libraries and Archives in the Digital Age

Addressing leadership communication, parenting demands and mental health challenges: a mixed-methods case study of clinical and translational scientists during COVID-19

BackgroundIn March 2020, academic research centres in Colorado were closed to prevent the spread of COVID-19. Scientists and research staff were required to continue their work remotely with little time...

Usage of immunotherapy in Merkel cell carcinoma from 2004 to 2016: A National Cancer Database (NCDB) analysis.

e21576 Background: Merkel Cell Carcinoma (MCC) is a rare and aggressive skin malignancy with increasing incidence, likely due to an aging population. MCC has been shown to have an increased prevalence in immunosuppressed patients, and current clinical trials are investigating the potential for immunotherapy treatments. As the understanding of the underlying pathogenesis of MCC progresses, the ability to implement specific immunotherapy targets is being investigated and showing promise. Methods: Using the NCDB, we identified 6,918 patients diagnosed with Merkel Cell Carcinoma between 2004-2016 using ICD-O-3 histology code 8247. The cohort was analyzed to identify differences in survival outcomes among patients who received immunotherapy, chemotherapy, a combination of chemotherapy and immunotherapy, and neither chemotherapy nor immunotherapy. We performed univariate analysis to assess median length of survival for each of these specific treatment modality cohorts, in addition to descriptive statistics. Data were analyzed using SPSS and statistical significance was set at α = 0.05. Results: Between 2004 and 2016, 118 patients in the NCDB received immunotherapy. From 2004-14, 21 patients received immunotherapy (1.9 patients per year). The usage of immunotherapy increased drastically in 2015 and 2016 with 18 patients and 79 patients being treated with immunotherapy, respectively. Most immunotherapy patients (59%) received treatment at an academic research center while the remaining patients received immunotherapy at a comprehensive community cancer program (24.8%), an integrated cancer network (12%), or a community cancer program (4.3%). 41.7% of MCC immunotherapy patients were between 33 and 69 years of age, whereas 59.3% ranged from 70-90 years of age. Of the 118 MCC patients who received some form of immunotherapy, 39% had stage IV MCC, 38.1% had stage III MCC, 5.9% had stage II MCC, and 9.3% had stage I MCC. Conclusions: As the use of immunotherapy in MCC continues to rise, especially at academic research centers, future studies should investigate the trends of its usage, its effects on patient survival, and the stage of MCC in which immunotherapy is most often used. We found that patients that received both chemotherapy and immunotherapy had a significantly lower median survival than all other treatment combinations. We hypothesize that the poorer survival rates in the patients that received some form of immunotherapy is due to a later stage of treatment, but this will become clearer as the sample size of MCC patients receiving immunotherapy continues to grow.[Table: see text]

Effects of Spermidine Supplementation on Cognition and Biomarkers in Older Adults With Subjective Cognitive Decline

Developing interventions against age-related memory decline and for older adults experiencing neurodegenerative disease is one of the greatest challenges of our generation. Spermidine supplementation has shown beneficial effects on brain and cognitive health in animal models, and there has been preliminary evidence of memory improvement in individuals with subjective cognitive decline. To determine the effect of longer-term spermidine supplementation on memory performance and biomarkers in this at-risk group. This 12-month randomized, double-masked, placebo-controlled phase 2b trial (the SmartAge trial) was conducted between January 2017 and May 2020. The study was a monocenter trial carried out at an academic clinical research center in Germany. Eligible individuals were aged 60 to 90 years with subjective cognitive decline who were recruited from health care facilities as well as through advertisements in the general population. Data analysis was conducted between January and March 2021. One hundred participants were randomly assigned (1:1 ratio) to 12 months of dietary supplementation with either a spermidine-rich dietary supplement extracted from wheat germ (0.9 mg spermidine/d) or placebo (microcrystalline cellulose). Eighty-nine participants (89%) successfully completed the trial intervention. Primary outcome was change in memory performance from baseline to 12-month postintervention assessment (intention-to-treat analysis), operationalized by mnemonic discrimination performance assessed by the Mnemonic Similarity Task. Secondary outcomes included additional neuropsychological, behavioral, and physiological parameters. Safety was assessed in all participants and exploratory per-protocol, as well as subgroup, analyses were performed. A total of 100 participants (51 in the spermidine group and 49 in the placebo group) were included in the analysis (mean [SD] age, 69 [5] years; 49 female participants [49%]). Over 12 months, no significant changes were observed in mnemonic discrimination performance (between-group difference, -0.03; 95% CI, -0.11 to 0.05; P = .47) and secondary outcomes. Exploratory analyses indicated possible beneficial effects of the intervention on inflammation and verbal memory. Adverse events were balanced between groups. In this randomized clinical trial, longer-term spermidine supplementation in participants with subjective cognitive decline did not modify memory and biomarkers compared with placebo. Exploratory analyses indicated possible beneficial effects on verbal memory and inflammation that need to be validated in future studies at higher dosage. ClinicalTrials.gov Identifier: NCT03094546.

Association between Environmental Tobacco Smoke Exposure and Adaptive Behavior in Individuals with Autism Spectrum Disorder.

The study focuses on current issues of adaptive behavior in individuals with autism spectrum disorder (ASD) and on the possible risk factor of environmental tobacco smoke (ETS). Children examined at the Academic Research Center for Autism (ARCA) in Bratislava were involved in the study. The study sample included 84 children (71 boys) with ASD (average age 5.35 years) and a non-ASD group of 24 children (20 boys; average age 8.10 years). The “ETS Questionnaire” focused on the detection of parental smoking habits and other ETS exposures. The concentrations of cotinine in urine were measured by ELISA kit. A significant delay in adaptive behavior of children with ASD in comparison with the non-ASD group was identified. The significant differences were in adaptive behavior, communication, and everyday skills. Children with ASD were more likely to be exposed to ETS, especially in the household. Good agreement was found between objective and subjective ETS exposure indicators (kappa = 0.613). Self-reported exposure to ETS corresponded significantly with the median levels of urinary cotinine. In addition to evaluation and assessment of the quality of adaptive behavior, an important goal of further research should be to identify, investigate, and eliminate environmental factors that interfere with adaptive behavior.

Rethinking Clinical Trial Radiology Workflows and Student Training: Integrated Virtual Student Shadowing Experience, Education, and Evaluation.

There is consistent demand for clinical exposure from students interested in radiology; however, the COVID-19 pandemic resulted in fewer available options and limited student access to radiology departments. Additionally, there is increased demand for radiologists to manage more complex quantification in reports on patients enrolled in clinical trials. We present an online educational curriculum that addresses both of these gaps by virtually immersing students (radiology preprocessors, or RPs) into radiologists’ workflows where they identify and measure target lesions in advance of radiologists, streamlining report quantification. RPs switched to remote work at the beginning of the COVID-19 pandemic in our National Institutes of Health (NIH). We accommodated them by transitioning our curriculum on cross-sectional anatomy and advanced PACS tools to a publicly available online curriculum. We describe collaborations between multiple academic research centers and industry through contributions of academic content to this curriculum. Further, we describe how we objectively assess educational effectiveness with cross-sectional anatomical quizzes and decreasing RP miss rates as they gain experience. Our RP curriculum generated significant interest evidenced by a dozen academic and research institutes providing online presentations including radiology modality basics and quantification in clinical trials. We report a decrease in RP miss rate percentage, including one virtual RP over a period of 1 year. Results reflect training effectiveness through decreased discrepancies with radiologist reports and improved tumor identification over time. We present our RP curriculum and multicenter experience as a pilot experience in a clinical trial research setting. Students are able to obtain useful clinical radiology experience in a virtual learning environment by immersing themselves into a clinical radiologist’s workflow. At the same time, they help radiologists improve patient care with more valuable quantitative reports, previously shown to improve radiologist efficiency. Students identify and measure lesions in clinical trials before radiologists, and then review their reports for self-evaluation based on included measurements from the radiologists. We consider our virtual approach as a supplement to student education while providing a model for how artificial intelligence will improve patient care with more consistent quantification while improving radiologist efficiency.

Abstract PO-113: Overall survival in ovarian cancer patients seeking care at more than one treatment facility

Abstract Purpose: Ovarian cancer is the most lethal gynecological cancer and despite advances in treatment, most patients are diagnosed at an advanced stage with poor prognosis. Black women have a lower 5 year survival than White women when diagnosed at the same stage, and while there are a number of contributing factors, quality of treatment center may play a significant role. Choice in treatment facility may be limited by insurance coverage, availability of high-volume hospitals or specialists, or ability to access high-quality facilities, and it is unclear how a change in treatment facility may impact ovarian cancer survival. Methods: Participant usage files from the National Cancer Database were used to interrogate the characteristics of patients that seek treatment at more than one Commission on Cancer accredited facility in the United States to determine the effect on overall survival. Multivariable Cox regression analysis models were used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CI) to determine risk of mortality for patients receiving all of their first course treatment at one facility vs those receiving first course treatment at more than one facility. The fully-adjusted model was then stratified by race/ethnicity (Non-Hispanic White, Non-Hispanic Black, Hispanic) and by facility type (Community, Comprehensive Community, Academic/Research, Integrative Network). Results: A total of 211,937 women were included in the analysis. Patients were more likely to receive all of their first course treatment at one facility (81%). Patents treated at more than one facility had a 26% increase in ovarian cancer mortality compared with those treated at a single facility (HR: 1.26, 95% CI: 1.24-1.28). When stratified by race, NH-Black patients had the lowest increase in overall survival (HR: 1.08, 95% CI: 1.03-1.14) when compared with NH-White (HR: 1.27, 95% CI: 1.25-1.29) and Hispanic (HR: 1.33, 95% CI: 1.28-1.39) patients. Stratification by facility type showed that among women receiving treatment at more than one facility, those switching to an academic research center had the highest mortality (HR: 1.31, 95% CI: 1.28-1.34). Conclusions: Ovarian cancer patients that received treatment at more than one facility had a higher rate of mortality than those who were treated at a single center. Our findings suggest the need for further investigation into the effects of continuity of care, including how race, facility type, and other socioeconomic factors may modulate those effects. Citation Format: April Deveaux, Jessica Islam, Tomi Akinyemiju. Overall survival in ovarian cancer patients seeking care at more than one treatment facility [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-113.

Reimagining Doctrinal Orientations of English Health Care Law Scholarship Since 1980

Defining a legal field has functional importance and a legitimising usefulness for the field. There is no doubt that health care law (HCL) has emerged as a field of law and a discrete academic discipline in England and Wales with indicators that gradually became identifiable post-1980. Increasingly, patients aggrieved by their clinical experiences have sought redress in the courts. Doctors have also resorted to the courts for declarations as to the legality of proposed procedures that are ethically sensitive. The burgeoning litigation in healthcare has not only generated an avalanche of case law for academic study, but has also exposed the inadequacy of the common law in resolving the specific bioethical and legal challenges raised by healthcare. Specific legislation was enacted for the first time to address issues raised by medical advances. Concomitant with the evolution of this field of law was the emergence of its academic discipline. It entered the curriculum of legal education as many universities began to teach HCL. This eventually triggered a proliferation of textbooks and journals. The proliferation of literature was accompanied by the creation of academic research centres. Active scholarship in this field has manifested itself in four different doctrinal orientations, namely medical ethics, human rights, and multidisciplinary and socio-legal approaches.

Managing Human Subjects Research During a Global Pandemic at an Academic Center: Lessons Learned From COVID-19.

By March 2020, New York City became the early epicenter of the COVID-19 pandemic in the United States. Consequently, Columbia University, with its large portfolio of human subjects research, had to address the challenges of protecting thousands of research participants and research staff from potential exposure to COVID-19 while facilitating essential biomedical research, especially pandemic-related studies. The authors describe, from the perspective of Columbia’s research administration leadership, how the University and its primary teaching hospital ramped down—and later ramped up—human subjects research and reflect on lessons learned.As the pandemic unfolded, only studies offering the prospect of direct benefit to subjects were permitted to continue with in-person contact. New in-person participant enrollment ceased, except for COVID-19 prevention or treatment studies. Centralized, frequently updated communication about policies and procedures was disseminated to the Columbia research community. Procedural efficiencies were rapidly developed and implemented for review and oversight of human subjects research and contractual agreements for clinical trials. More frequent institutional review board meetings and 24-hour support markedly reduced turnaround time for COVID-19 studies, without delaying approvals of non–COVID-19 research. Research administration worked closely with relevant principal federal agencies, whose regulatory flexibility facilitated the efficient implementation of COVID-19–related research.Overall, the ramp-down and ramp-up of the majority of human subjects research, with specified priorities and accelerated processes, worked well. Adjustments were made to handle the increase in administrative tasks, the need to respond rapidly to added oversight responsibilities, and the management of the many new COVID-19–related research protocols. Timely, centralized communication, support for staff needs, prioritization, and collaboration were critical to successful research oversight at a large-scale academic setting in the midst of a pandemic. These perspectives may be useful to academic research centers addressing the current and future pandemics.