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Objectives/Goals: In Fall 2024, we designed a collaborative scholar retreat model to create dialogue among our training programs. The purpose of the retreat was to foster collaboration and provide unique networking opportunity for our KL2, T32, and TL1 scholars to share their research across the translational spectrum and learn more about Clinical and Translational Science Institute (CTSI) resources and tools. Methods/Study Population: The CTSI Fall Scholar Retreat brought together a diverse group of 25 scholars who attended in-person a full-day program. The program included presentations on CTSI resources and Team Science on How to Become a Better Team Member in cross-disciplinary and cross-functional groups. The KL2 Scholars presented motivational talks on their career and professional development journeys. Mentoring roundtable included discussions on subthemes like characteristics of a good mentor/mentee, organizing your mentoring team, different mentor roles, and fears of approaching new mentor/mentee. TL1 and T32 scholars also presented posters describing their ongoing research project from the planning stages to initial observations to completed studies. Results/Anticipated Results: To measure the effectiveness and impact of the CTSI Fall Scholar Retreat, we conducted an evaluation using REDCap survey and received an 88% response rate. On the Likert scale of 1–5 (1 = not at all valuable, 2 = not very valuable, 3 = neutral, 4 = very valuable, and 5 = extremely valuable), 92% of the scholars found the sessions to be valuable. Net Promoter Score of 9.6 (scale of 1–10) was measured to collect the scholar feedback and most of them are likely to recommend the Scholar Retreat to other scholars. Discussion/Significance of Impact: The in-person retreat proved to be a unique platform to interact, collaborate, learn, and grow for all scholars at different levels of their career and research. Inclusion of HRSA-funded T32 post-doctoral program provided cross-level collaboration and helped promote a culture of continuous learning in clinical and translational science.
Medicare claims are frequently used to study Clostridioides difficile infection (CDI) epidemiology. However, they lack specimen collection and diagnosis dates to assign location of onset. Algorithms to classify CDI onset location using claims data have been published, but the degree of misclassification is unknown.
Methods:
We linked patients with laboratory-confirmed CDI reported to four Emerging Infections Program (EIP) sites from 2016–2021 to Medicare beneficiaries with fee-for-service Part A/B coverage. We calculated sensitivity of ICD-10-CM codes in claims within ±28 days of EIP specimen collection. CDI was categorized as hospital, long-term care facility, or community-onset using three different Medicare claims-based algorithms based on claim type, ICD-10-CM code position, duration of hospitalization, and ICD-10-CM diagnosis code presence-on-admission indicators. We assessed concordance of EIP case classifications, based on chart review and specimen collection date, with claims case classifications using Cohen’s kappa statistic.
Results:
Of 12,671 CDI cases eligible for linkage, 9,032 (71%) were linked to a single, unique Medicare beneficiary. Compared to EIP, sensitivity of CDI ICD-10-CM codes was 81%; codes were more likely to be present for hospitalized patients (93.0%) than those who were not (56.2%). Concordance between EIP and Medicare claims algorithms ranged from 68% to 75%, depending on the algorithm used (κ = 0.56–0.66).
Conclusion:
ICD-10-CM codes in Medicare claims data had high sensitivity compared to laboratory-confirmed CDI reported to EIP. Claims-based epidemiologic classification algorithms had moderate concordance with EIP classification of onset location. Misclassification of CDI onset location using Medicare algorithms may bias findings of claims-based CDI studies.
Background: Medicare claims are frequently used to study Clostridioides difficile infection (CDI) epidemiology. Categorizing CDI based on location of onset and potential exposure is critical in understanding transmission patterns and prevention strategies. While claims data are well-suited for identifying prior healthcare utilization exposures, they lack specimen collection and diagnosis dates to assign likely location of onset. Algorithms to classify CDI onset and healthcare association using claims data have been published, but the degree of misclassification is unknown. Methods: We linked patients with laboratory-confirmed CDI reported to four Emerging Infections Program (EIP) sites from 2016-2020 to Medicare beneficiaries using residence, birth date, sex, and hospitalization and/or healthcare exposure dates. Uniquely linked patients with fee-for-service Medicare A/B coverage and complete EIP case report forms were included. Patients with a claims CDI diagnosis code within ±28 days of a positive CDI test reported to EIP were categorized as hospital-onset (HO), long-term care facility onset (LTCFO), or community-onset (CO, either healthcare facility-associated [COHCFA] or community-associated [CA]) using a previously published algorithm based on claim type, ICD-10-CM code position, and duration of hospitalization (if applicable). EIP classifies CDI into these categories using positive specimen collection date and other information from chart review (e.g. admit/discharge dates). We assessed concordance of EIP and claims case classifications using Cohen’s kappa. Results: Of 10,002 eligible EIP-identified CDI cases, 7,064 were linked to a unique beneficiary; 3,451 met Medicare A/B fee-for-service coverage inclusion criteria. Of these, 650 (19%) did not have a claims diagnosis code ±28 days of the EIP specimen collection date (Table); 48% (313/650) of those without a claims diagnosis code were categorized by EIP as CA CDI. Among those with a CDI diagnosis code, concurrence of claims-based and EIP CDI classification was 68% (κ=0.56). Concurrence was highest for HO and lowest for COHCFA CDI. A substantial number of EIP-classified CO CDIs (30%, Figure) were misclassified as HO using the claims-based algorithm; half of these had a primary ICD-10 diagnosis code of sepsis (226/454; 50%). Conclusions: Evidence of CDI in claims data was found for 81% of EIP-reported CDI cases. Medicare classification algorithms concurred with the EIP classification in 68% of cases. Discordance was most common for community-onset CDI patients, many of whom were hospitalized with a primary diagnosis of sepsis. Misclassification of CO-CDI as HO may bias findings of claims-based CDI studies.
OBJECTIVES/GOALS: Our study explores the dose-related effects of THC on cardiovascular measures, self-reported effects, balance, and cognitive function among older adults. We also evaluate the acceptability and feasibility of study procedures, to inform future study designs employing this population. METHODS/STUDY POPULATION: Using a within-subject, double-blind, placebo-controlled design and standard behavioral pharmacology methods, reasonably healthy male and female adults aged 55-70 years undergo an eligibility screening, followed by a mock session and 3 experimental sessions (>7 days apart). During experimental sessions, participants are administered cannabis-infused brownies with varying THC doses. Prior to and at multiple intervals post- consumption, subjects complete assessments including self reports and observer ratings, psychomotor and cognitive performance measures, and vital signs. Follow-up interviews regarding the experience will be conducted one day after each session. RESULTS/ANTICIPATED RESULTS: We anticipate our results to mirror those of previously reported studies conducted in adults under 45 years old in that a dose-response relationship exists for subjective drug effects and vital signs with the caveat that this relationship may be exacerbated in our population. We additionally anticipate findings that indicate THC impairs balance and coordination, potentially increasing the risk of falls and accidents among this population, and cognitive function, affecting attention, memory, and executive functions. Feedback provided during the follow-up interviews will help refine procedures for future studies, ensuring that the methodology is acceptable and feasible for this population. DISCUSSION/SIGNIFICANCE: Prior work demonstrates the safety and efficacy of THC in conditions common among older adults, however, no conclusive data regarding tolerability and safety in this population exists. The presented work is vital groundwork for future research on THC as a potential therapeutic for older adults.
Patients tested for Clostridioides difficile infection (CDI) using a 2-step algorithm with a nucleic acid amplification test (NAAT) followed by toxin assay are not reported to the National Healthcare Safety Network as a laboratory-identified CDI event if they are NAAT positive (+)/toxin negative (−). We compared NAAT+/toxin− and NAAT+/toxin+ patients and identified factors associated with CDI treatment among NAAT+/toxin− patients.
Design:
Retrospective observational study.
Setting:
The study was conducted across 36 laboratories at 5 Emerging Infections Program sites.
Patients:
We defined a CDI case as a positive test detected by this 2-step algorithm during 2018–2020 in a patient aged ≥1 year with no positive test in the previous 8 weeks.
Methods:
We used multivariable logistic regression to compare CDI-related complications and recurrence between NAAT+/toxin− and NAAT+/toxin+ cases. We used a mixed-effects logistic model to identify factors associated with treatment in NAAT+/toxin− cases.
Results:
Of 1,801 cases, 1,252 were NAAT+/toxin−, and 549 were NAAT+/toxin+. CDI treatment was given to 866 (71.5%) of 1,212 NAAT+/toxin− cases versus 510 (95.9%) of 532 NAAT+/toxin+ cases (P < .0001). NAAT+/toxin− status was protective for recurrence (adjusted odds ratio [aOR], 0.65; 95% CI, 0.55–0.77) but not CDI-related complications (aOR, 1.05; 95% CI, 0.87–1.28). Among NAAT+/toxin− cases, white blood cell count ≥15,000/µL (aOR, 1.87; 95% CI, 1.28–2.74), ≥3 unformed stools for ≥1 day (aOR, 1.90; 95% CI, 1.40–2.59), and diagnosis by a laboratory that provided no or neutral interpretive comments (aOR, 3.23; 95% CI, 2.23–4.68) were predictors of CDI treatment.
Conclusion:
Use of this 2-step algorithm likely results in underreporting of some NAAT+/toxin− cases with clinically relevant CDI. Disease severity and laboratory interpretive comments influence treatment decisions for NAAT+/toxin− cases.
Pseudomonas aeruginosa bloodstream infection (PA-BSI) and COVID-19 are independently associated with high mortality. We sought to demonstrate the impact of COVID-19 coinfection on patients with PA-BSI.
Design:
Retrospective cohort study.
Setting:
Veterans Health Administration.
Patients:
Hospitalized patients with PA-BSI in pre-COVID-19 (January 2009 to December 2019) and COVID-19 (January 2020 to June 2022) periods. Patients in the COVID-19 period were further stratified by the presence or absence of concomitant COVID-19 infection.
Methods:
We characterized trends in resistance, treatment, and mortality over the study period. Multivariable logistic regression and modified Poisson analyses were used to determine the association between COVID-19 and mortality among patients with PA-BSI. Additional predictors included demographics, comorbidities, disease severity, antimicrobial susceptibility, and treatment.
Results:
A total of 6,714 patients with PA-BSI were identified. Throughout the study period, PA resistance rates decreased. Mortality decreased during the pre-COVID-19 period and increased during the COVID-19 period. Mortality was not significantly different between pre-COVID-19 (24.5%, 95% confidence interval [CI] 23.3–28.6) and COVID-19 period/COVID-negative (26.0%, 95% CI 23.5–28.6) patients, but it was significantly higher in COVID-19 period/COVID-positive patients (47.2%, 35.3–59.3). In the modified Poisson analysis, COVID-19 coinfection was associated with higher mortality (relative risk 1.44, 95% CI 1.01–2.06). Higher Charlson Comorbidity Index, higher modified Acute Physiology and Chronic Health Evaluation score, and no targeted PA-BSI treatment within 48 h were also predictors of higher mortality.
Conclusions:
Higher mortality was observed in patients with COVID-19 coinfection among patients with PA-BSI. Future studies should explore this relationship in other settings and investigate potential SARS-CoV-2 and PA synergy.
Real-world data, such as administrative claims and electronic health records, are increasingly used for safety monitoring and to help guide regulatory decision-making. In these settings, it is important to document analytic decisions transparently and objectively to assess and ensure that analyses meet their intended goals.
Methods:
The Causal Roadmap is an established framework that can guide and document analytic decisions through each step of the analytic pipeline, which will help investigators generate high-quality real-world evidence.
Results:
In this paper, we illustrate the utility of the Causal Roadmap using two case studies previously led by workgroups sponsored by the Sentinel Initiative – a program for actively monitoring the safety of regulated medical products. Each case example focuses on different aspects of the analytic pipeline for drug safety monitoring. The first case study shows how the Causal Roadmap encourages transparency, reproducibility, and objective decision-making for causal analyses. The second case study highlights how this framework can guide analytic decisions beyond inference on causal parameters, improving outcome ascertainment in clinical phenotyping.
Conclusion:
These examples provide a structured framework for implementing the Causal Roadmap in safety surveillance and guide transparent, reproducible, and objective analysis.
A unique and accessible guide to contemporary psychodynamic therapy and its applications. Introduced with a foreword by Nancy McWilliams, an author line-up of experienced educators guide the reader through the breadth of psychodynamic concepts in a digestible and engaging way. The key applications of psychodynamic psychotherapy to a range of presentations are explored, including anxiety, depression, problematic narcissism as well as the dynamics of 'borderline' states. Specific chapters cover the dynamics of anger and aggression, and working with people experiencing homelessness. A valuable resource for novice and experienced therapists, presenting a clear, comprehensive review of contemporary psychodynamic theory and clinical practice. Highly relevant for general clinicians, third-sector staff and therapists alike, the authors also examine staff-client dynamics and the development of psychologically-informed services underpinned by reflective practice. Part of the Cambridge Guides to the Psychological Therapies series, offering all the latest scientifically rigorous, and practical information on a range of key, evidence-based psychological interventions for clinicians.
This chapter provides an introduction to psychodynamic theory as applied to settings outwith the specialist psychotherapy clinic, paving the way for the chapters that follow in Part 4. An individual’s internal world affects how they relate to others. Others may be unconsciously invited into playing old roles that are familiar to the individual (such as rejecting, not listening, criticising), even though these roles bring difficulty and distress to both sides. This chapter explores how these powerful but sometimes ‘invisible’ interpersonal dynamics may play out between service users and staff in settings where the human relationship is at the fore (such as schools, social service agencies, and hospitals). We also discuss splitting within a clinical team and other system dynamics. In circumstances where services and professionals can sustain a good-enough therapeutic environment in the face of unconscious invitations to repeat a problematic relationship, trust may develop between service user and service and many people are able to discover new ways of forming relationships. This depends partly on the capacities and current state of the person using a service, but also, crucially, on the capacity of the professionals and services to observe and be reflective about both sides of the relationship.
This chapter explores the complex area of working with patients who experience relational difficulties and who may function predominantly at a borderline level of psychological organization. These patients are influenced by early traumatic experiences, which can shape the therapeutic encounter. They often don’t have the kind of early experience that enables them to develop the capacity to recognise feelings and to know that they are not dangerous, that they are bearable, and will pass. Acts of self-harm are frequently a response to manage unbearable feelings. These and the experience of suicidal thoughts can be understood as a wish to get rid of these feelings. The nature of self-harm and what it evokes in the clinician are discussed. Individuals with these difficulties have often experienced a lack of a consistent and containing other and can enter crisis in response to experiences of rejection or threats of abandonment. This is important both during therapy but particularly when ending the therapy. If we understand what underpins the relational difficulties that these patients have, we can take them into account in the therapeutic work. Some adaptations of technique when working with patients with borderline level difficulties are considered.
This chapter provides a brief introduction to the relational dynamics underlying ‘multiple exclusion homelessness’ and an approach to working in this area. Adults experiencing multiple exclusion homelessness have often, during their developmental years, experienced multiple homes, disrupted attachments, un-forecasted endings, multiple and short-lived figures of support – all experiences that can lead a person to develop an understandable anxiety about trusting anyone to remain stable in their life. These dynamics may inadvertently be recreated in the person’s adult life through the impermanency of different organisations they are involved with. Multiple exclusion homelessness can be understood as a late emerging symptom of underlying difficulties in someone’s relationships with care. A psychologically informed approach for staff working in the homeless sector is outlined. The staff-service user relationship, while often viewed as important within mainstream services, is commonly seen as a vehicle through which treatments can be completed rather than as the treatment itself. By contrast, a psychologically informed service for people experiencing multiple exclusion homelessness understands that the reverse is often more accurate: that the tasks and activities are really just the vehicle through which a relationship can develop that carries the possibility of developing a sense of safety, trust, and continuity.
There are many ways of becoming depressed. In this chapter we highlight common developmental themes and therapeutic situations amongst people who experience depressing/depressed states. In particular, we expand on two common clinical constellations in some detail: the first a pattern to do with dynamics of loss and abandonment; and the second a tendency to harsh self-criticism, which leads to a devaluing of oneself and others. We use the phrase ‘depressing/depressed’ state to capture the dynamic nature of depression, as opposed to conceptualising depression as a passive state of affairs when someone ‘just is’ depressed. From a psychodynamic view, this is an active and dynamic situation, where an aspect of someone’s internal world is depressing in some way to that person, leaving them feeling depressed. This chapter approaches the external manifestations of depressing/depressed states not as a discrete ‘disorder’, but more as a ‘basic emotional response’ that signals that something is amiss in an individual’s world which requires attending to and addressing.
Psychoanalytic work is always under threat of degradation; for example, understanding is replaced by education, or subtle pressure on the patient to function in a different way (that is getting him to think or behave differently, give up his symptoms etc.). One of the most important locations of this degradation of growth-promoting thought takes place at the site of the transmission of knowledge from one generation to the next. The supervisee is on the one hand being taught and at the same time needs to discover for herself a way of doing things that truly belongs to her. This chapter discusses these tensions giving illustrative examples suggesting that supervising must join the list of the impossible professions.
A psychodynamic approach to anxiety is not disorder specific; anxiety can and usually is present to varying degrees in all patients that are seen for psychodynamic psychotherapy. This chapter aims to shed some light on some psychodynamic approaches to thinking about anxieties. Using theory and clinical examples we think about how difficulties in containing processes between caregiver and infant early in the infant’s life may predispose to the persistence of archaic anxieties. We go on to explore the nature of separation and loss in relation to anxiety and finally, we reflect on how internal conflict and the role of a critical internal object can bring about anxiety. The clinical examples illustrate how wider variation in anxieties may present in therapy and the last section focuses on how the therapist may experience and respond to these different anxieties.
This chapter is a summary of psychodynamic psychotherapy and includes elements of the theory and technique of psychodynamic psychotherapy. It starts with a brief description of what it is and drawing on work by Blagys and Hilsenroth. Seven key features of psychodynamic psychotherapy are described. There is a very brief outline of the various schools of psychotherapy in order to orient the reader. This is followed by brief practical sections explaining the differences between brief and long-term therapy, and between open-ended and closed therapy. Practicalities involved in combining therapy with psychotropic medication are discussed.