Objectives/Goals: The operation of a clinical trials unit involves multifaceted tasks and stakeholders. A competent information system is critical to daily operations while ensuring smooth conduct of clinical research. We share 15 years of experience in the design and implementation of such a system at Mayo Clinic to inform other institutions with similar interests. Methods/Study Population: The Informatics team collaborated closely with nurse leaders and elicited input from additional stakeholders including nurse unit coordinators, lab managers, schedulers, investigators, study coordinators, and regulatory specialists throughout the phases of system design, development and continuous enhancements, and expansion. The stakeholders offered insights on the corresponding requirements throughout the study life cycle, from engaging with the study sponsor, operational review for protocol execution, development of study budgets, human subject protection and risk mitigation, data management and integration, to outcome monitoring, and regulatory reporting. The activities were then translated into functional components and implemented as a seamless and effective solution. Results/Anticipated Results: Patient safety, scientific rigor, operation automation, efficiency, and regulatory requirements were all considered in developing an integrated system, or the clinical research trials unit (CRTU) Tools. Our institution has leveraged the system for essential tasks from the study start-up, visit scheduling and execution, specimen collection and tracking, to individual protocol metrics and billing. We adopted a measure-as-we-go methodology so that data such as visit census, resource usage, and protocol deviation are tracked and collected during routine use of the system. Specifically, an issues/concerns/exceptions (ICE) tool is used for quality control and patient safety. Moreover, data quality greatly benefits from a task dictionary, standardizing the study activities that can be ordered and executed. Discussion/Significance of Impact: The implementation of a well-rounded clinical trials unit information system not only improves the operation efficiency and team productivity but also ensures scientific rigor and contributes to patient safety. We believe the experience can be informative to other institutions. More details will be shared in the poster.

Although medical advancements have improved the mortality of CHD, morbidity still exists, impacting patient quality of life. Returning to baseline in the early surgical recovery phase is an area of potential improvement. This preliminary project aims to qualitatively understand CHD family perspectives concerning the immediate postoperative recovery phase. The participating patients enrolled in the Enhanced Recovery After Surgery program, a postsurgical symptom management tool utilised in adult centres and broadening into pediatrics. Twenty-three of 27 contacted families answered open-ended questions 1 to 3 months postoperatively regarding difficulties experienced during their first week home. They reviewed a list of symptoms including: difficulties with pain, nausea, activity, sleep, appetite, bowel or urinary systems, and taking medications. A qualitative thematic analysis was performed with the open responses, as well as a quantitative assessment of the types of issues that made recovery challenging. Participants struggled most with sleep (78%), returning to activity (70%), and pain (57%). Open-ended responses suggested that an inability to do daily activities, sleep (frequently impacted by pain), and inadequate resources most negatively impacted recovery. Given these findings, investigating postoperative sleep regimens and effective pain plan components may prove useful, in addition to the further development of early mobility programs. The positive and negative experiences highlighting the desire for readily available medical guidance enforce the need for open communication between families and team members, potentially aided by digital tools. Ultimately, further data could support the development of a standardised protocol to better the immediate postoperative quality of life for CHD families.

This essay is born of the belief that racial justice, social justice, and environmental justice are mutually entangled. Despite their shared commitments to justice, early modern ecocriticism and premodern critical race studies have rarely been in conversation with each other. We address this aporia here and ponder how such intersections can create pathways to more inclusive futures for early modern studies, and for literary studies more broadly. We begin with a brief reflection about how we came to these topics; we then turn to literary and critical works that illustrate the interconnectedness of these issues in premodern literature and explore how those connections persist and haunt our own thinking and writing. This essay is not argumentative in the traditional sense, but rather invites our scholarly communities to unlearn our way to different possibilities.

Post-traumatic stress disorder (PTSD) after traumatic birth can have a debilitating effect on parents already adapting to significant life changes during the post-partum period. Cognitive therapy for PTSD (CT-PTSD) is a highly effective psychological therapy for PTSD which is recommended in the NICE guidelines (National Institute for Health and Care Excellence, 2018) as a first-line intervention for PTSD. In this paper, we provide guidance on how to deliver CT-PTSD for birth-related trauma and baby loss and how to address common cognitive themes.

Recent arguments claim that behavioral science has focused – to its detriment – on the individual over the system when construing behavioral interventions. In this commentary, we argue that tackling economic inequality using both framings in tandem is invaluable. By studying individuals who have overcome inequality, “positive deviants,” and the system limitations they navigate, we offer potentially greater policy solutions.

Patients with social anxiety disorder (SAD) have a range of negative thoughts and beliefs about how they think they come across to others. These include specific fears about doing or saying something that will be judged negatively (e.g. ‘I’ll babble’, ‘I’ll have nothing to say’, ‘I’ll blush’, ‘I’ll sweat’, ‘I’ll shake’, etc.) and more persistent negative self-evaluative beliefs such as ‘I am unlikeable’, ‘I am foolish’, ‘I am inadequate’, ‘I am inferior’, ‘I am weird/different’ and ‘I am boring’. Some therapists may take the presence of such persistent negative self-evaluations as being a separate problem of ‘low self-esteem’, rather than seeing them as a core feature of SAD. This may lead to a delay in addressing the persistent negative self-evaluations until the last stages of treatment, as might be typically done in cognitive therapy for depression. It might also prompt therapist drift from the core interventions of NICE recommended cognitive therapy for social anxiety disorder (CT-SAD). Therapists may be tempted to devote considerable time to interventions for ‘low self-esteem’. Our experience from almost 30 years of treating SAD within the framework of the Clark and Wells (1995) model is that when these digressions are at the cost of core CT-SAD techniques, they have limited value. This article clarifies the role of persistent negative self-evaluations in SAD and shows how these beliefs can be more helpfully addressed from the start, and throughout the course of CT-SAD, using a range of experiential techniques.

Surveys are a powerful technique in cognitive behavioural therapy (CBT). A form of behavioural experiment, surveys can be used to test beliefs, normalise symptoms and experiences, and generate compassionate perspectives. In this article, we discuss why and when to use surveys in CBT interventions for a range of psychological disorders. We also present a step-by-step guide to collaboratively designing surveys with patients, selecting the appropriate recipients, sending out surveys, discussing responses and using key learning as a part of therapy. In doing so, we hope to demonstrate that surveys are a flexible, impactful, time-efficient, individualised technique which can be readily and effectively integrated into CBT interventions.

Therapist cognitions about trauma-focused psychological therapies can affect our implementation of evidence-based therapies for post-traumatic stress disorder (PTSD), potentially reducing their effectiveness. Based on observations gleaned from teaching and supervising one of these treatments, cognitive therapy for PTSD (CT-PTSD), ten common ‘misconceptions’ were identified. These included misconceptions about the suitability of the treatment for some types of trauma and/or emotions, the need for stabilisation prior to memory work, the danger of ‘retraumatising’ patients with memory-focused work, the risks of using memory-focused techniques with patients who dissociate, the remote use of trauma-focused techniques, and the perception of trauma-focused CBT as inflexible. In this article, these misconceptions are analysed in light of existing evidence and guidance is provided on using trauma-focused CT-PTSD with a broad range of presentations.

Background: Antimicrobial resistance (AMR) is an increasingly critical global public health challenge. An initial step in prevention is the understanding of resistance patterns with accurate surveillance. To improve accurate surveillance and good clinical care, we developed training materials to improve the appropriate collection of clinical culture samples in Ethiopia. Methods: Specimen-collection training materials were initially developed by a team of infectious diseases physicians, a clinical microbiologist, and a monitoring and evaluation specialist using a training of trainers (ToT) platform. Revisions after each training session were provided by Ethiopian attendees including the addition of regional and culturally relevant material. The training format involved didactic presentations, interactive practice sessions with participants providing feedback and training to each other and the entire group as well as assessments of all training activities. Results: Overall, 4 rounds of training were conducted from August 2017 to September 2019. The first 2 rounds of training were conducted by The Ohio State University (OSU) staff, and Ethiopian trainers conducted the last 2 rounds. Initial training was primarily in lecture format outlining use of microbiology laboratory findings in clinical practice and steps for collecting specimens correctly. Appropriate specimen collection was demonstrated and practiced. Essential feedback from this early audience provided input for the final development of the training manual and visual aids. The ToT for master trainers took place in July 2018 and was conducted by OSU staff. In sessions held in February and August 2019, these master trainers provided training to facility trainers, who provide training to personnel directly responsible for specimen collection. In total, 144 healthcare personnel (including physicians, nurses, and laboratory staff), from 12 representative Ethiopian public and academic hospitals participated in the trainings. Participants were satisfied with the quality of the training (typically ranked >4.5 of 5.0) and strongly agreed that the objectives were clearly defined and that the information was relevant to their work. Posttraining scores increased by 23%. Conclusions: Training materials for clinical specimen collection have been developed for use in low- and middle-resource settings and with initial pilot testing and adoption in Ethiopia. The trainings were well accepted, and Ethiopian personnel were able to successfully lead the trainings and improve their knowledge and skills regarding specimen collection. The materials are being finalized in an online format for easier open access dissemination. Further studies are planned to determine the effectiveness of the trainings in improving the quality of clinical specimen submissions to the microbiology laboratory.

Funding: None

Disclosures: None

Remote delivery of evidence-based psychological therapies via video conference has become particularly relevant following the COVID-19 pandemic, and is likely to be an on-going method of treatment delivery post-COVID. Remotely delivered therapy could be of particular benefit for people with social anxiety disorder (SAD), who tend to avoid or delay seeking face-to-face therapy, often due to anxiety about travelling to appointments and meeting mental health professionals in person. Individual cognitive therapy for SAD (CT-SAD), based on the Clark and Wells (1995) model, is a highly effective treatment that is recommended as a first-line intervention in NICE guidance (NICE, 2013). All of the key features of face-to-face CT-SAD (including video feedback, attention training, behavioural experiments and memory-focused techniques) can be adapted for remote delivery. In this paper, we provide guidance for clinicians on how to deliver CT-SAD remotely, and suggest novel ways for therapists and patients to overcome the challenges of carrying out a range of behavioural experiments during remote treatment delivery.

Around a quarter of patients treated in intensive care units (ICUs) will develop symptoms of post-traumatic stress disorder (PTSD). Given the dramatic increase in ICU admissions during the COVID-19 pandemic, clinicians are likely to see a rise in post-ICU PTSD cases in the coming months. Post-ICU PTSD can present various challenges to clinicians, and no clinical guidelines have been published for delivering trauma-focused cognitive behavioural therapy with this population. In this article, we describe how to use cognitive therapy for PTSD (CT-PTSD), a first line treatment for PTSD recommended by the National Institute for Health and Care Excellence. Using clinical case examples, we outline the key techniques involved in CT-PTSD, and describe their application to treating patients with PTSD following ICU.

Culturally linked family influences during adolescence are important predictors of health and well-being for Latino youth, yet few studies have examined whether these familial influences are associated with indicators of typical physiological stress processes. Following a cultural neurobiology framework, we examined the role of family in the everyday lives of Latino adolescents (N = 209; Mage = 18.10; 85.1% Mexican descent; 64.4% female) by investigating familism values and perceptions of parent support as well as daily family assistance behaviors in relation to hypothalamic–pituitary–adrenal axis diurnal patterns, indexed by salivary cortisol five times a day for 3 weekdays. Three-level growth curve analyses revealed that perceptions of parental support were associated with greater cortisol awakening responses, whereas familism values were not associated with diurnal cortisol patterns. In day-to-day analyses, assisting family during the day (compared to not assisting family) was associated with lower waking cortisol levels and flatter diurnal slopes the next day. Our findings highlight the dynamic associations and multiple time courses between cultural values and behaviors, daily experiences, and physiological stress processes for Latino adolescents. Further, we identified important cultural risk and promotive factors associated with physiological regulation in daily life and potential pathways toward health outcomes in adulthood.