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Objectives/Goals: Mayo Clinic’s Clinical Trials Beyond Walls™ (CTBW) program collaborates with study teams to implement decentralized elements in clinical trials, enabling participation from home or local settings. In cancer treatment trials, traditional paper pill diaries are replaced with real-time digital tracking solutions to monitor chemotherapy adherence. Methods/Study Population: The CTBW team developed a solution to deliver electronic pill diaries to research participants using the electronic health record (EHR) system Epic and patient portal MyChart1. The solution includes a portal message to remind participants to take chemotherapy. Medication dose, date taken, and reasons for missed doses (e.g., “I forgot” or “side effects were bothersome”) are captured. An automated in-basket notification system alerts the study team when predefined conditions are met. Configurable medication schedules ensure diaries are sent according to the prescribed frequency. Reports were generated to allow study teams to monitor all participant diaries. Results/Anticipated Results: The CTBW team implemented this digital pill diary in neuro-oncology trial NCT066250472. We anticipate the pill diary in the patient portal will enhance chemotherapy adherence by capturing real-time data in a platform widely used by Mayo Clinic patients. This patient-reported data is stored in the EHR, where it is accessible to providers and study teams. This allows for continuous monitoring, which facilitates a streamlined review of potential adverse events, improved compliance visibility, and timely treatment adjustments compared to paper-based or external solutions. The system also streamlines data entry, reducing human error and eliminating manual transcription. The created language and workflow templates allow the CTBW to scale this approach to future cancer trials Discussion/Significance of Impact: Decentralized clinical trial participants may never visit Mayo Clinic, making digital recording essential. The EHR-based digital pill diary enables continuous monitoring within a familiar system for providers and patients, increasing study team visibility, and allowing for earlier intervention in cases of non-compliance or adverse events.
Hallucinations are common and distressing symptoms in Parkinson’s disease (PD). Treatment response in clinical trials is measured using validated questionnaires, including the Scale for Assessment of Positive Symptoms-Hallucinations (SAPS-H) and University of Miami PD Hallucinations Questionnaire (UM-PDHQ). The minimum clinically important difference (MCID) has not been determined for either scale. This study aimed to estimate a range of MCIDs for SAPS-H and UM-PDHQ using both consensus-based and statistical approaches.
Methods
A Delphi survey was used to seek opinions of researchers, clinicians, and people with lived experience. We defined consensus as agreement ≥75%. Statistical approaches used blinded data from the first 100 PD participants in the Trial for Ondansetron as Parkinson’s Hallucinations Treatment (TOP HAT, NCT04167813). The distribution-based approach defined the MCID as 0.5 of the standard deviation of change in scores from baseline at 12 weeks. The anchor-based approach defined the MCID as the average change in scores corresponding to a 1-point improvement in clinical global impression-severity scale (CGI-S).
Results
Fifty-one researchers and clinicians contributed to three rounds of the Delphi survey and reached consensus that the MCID was 2 points on both scales. Sixteen experts with lived experience reached the same consensus. Distribution-defined MCIDs were 2.6 points for SAPS-H and 1.3 points for UM-PDHQ, whereas anchor-based MCIDs were 2.1 and 1.3 points, respectively.
Conclusions
We used triangulation from multiple methodologies to derive the range of MCID estimates for the two rating scales, which was between 2 and 2.7 points for SAPS-H and 1.3 and 2 points for UM-PDHQ.
The relevance of education and outreach (E&O) activities about the Antarctic Treaty has been recognized at the Antarctic Treaty Consultative Meetings (ATCM) and at the Committee for Environmental Protection (CEP). This study examines the key topics and the target audiences detailed in papers submitted to the ATCM on E&O. Since the Antarctic Treaty entered into force in 1961, a total of 216 ATCM papers on E&O have been produced. The number of papers has increased substantially since the mid-1990s. ‘Science’ (76.9%) and ‘Wildlife/Biodiversity/Environment’ (75.5%) were the most addressed topics in these papers, while the ‘Public’ (81.0%) and those attending ‘Schools’ (69.0%) are the main target audiences. ‘Science’ in ATCM papers increased ~120-fold from 1961–1997 to 2015–2023, while ATCM papers discussing engagement with the ‘Public’ increased ~40-fold during the same period. ‘Climate change’ was first mentioned in 2006, and the number of papers per year increased fourfold by 2015–2023. This study shows the increasing interest in E&O through time, addressing key topics to relevant audiences related to the Antarctic region. From an educational perspective, attention should be paid to emerging topics (e.g. equity, diversity and inclusion), and the engagement of early-career professionals and educators should be made a priority.
To evaluate the design of I-Corps@NCATS as a translational scientist training program, we mapped specific elements of the program’s content and pedagogy to the characteristics of a translational scientist, as first defined by Gilliland et al. []: systems thinker, process innovator, boundary spanner, team player, and skilled communicator. Using a mixed-methods evaluation, we examined how the I-Corps@NCATS training program, delivered across twenty-two Clinical and Translational Science Award Hubs, impacted the development of these key translational scientist characteristics.
Methods:
We developed survey items to assess the characteristics of systems thinker, process innovator, boundary spanner, team player, and skilled communicator. Data were collected from a national sample of 281 participants in the I-Corps@NCATS program. Using post-then-retrospective-pre survey items, participants self-reported their ability to perform skills associated with each of the translational scientist characteristics. Additionally, two open-ended survey questions explored how the program shifted participants’ translational orientation, generating 211 comments. These comments were coded through a team-based, iterative process.
Results:
Respondents reported the greatest increases in self-assessed abilities related to systems thinking and skilled communication. Participants indicated the highest levels of abilities related to team player and boundary crosser. From the coding of open-ended comments, we identified two additional characteristics of translational scientists: intellectual humility and cognitive flexibility.
Conclusions:
Participation in I-Corps@NCATS accelerates translational science in two ways: 1) by teaching the process of scientific translation from research ideas to real-world solutions, and 2) by encouraging growth in the mindset and characteristics of a translational scientist.
Background: Feedback reports summarizing clinician performance are effective tools to improve antibiotic stewardship in the ambulatory setting, but few studies have evaluated their effectiveness for pediatric inpatients. We developed and implemented feedback reports reflecting electronically-derived measures of appropriate antibiotic choice and duration for community acquired pneumonia (CAP) and measured their impact on appropriate antibiotic use in children hospitalized for CAP. Methods: We performed a single center quasi-experimental study including children 6 months to 17 years hospitalized for CAP between 12/1/2021-11/30/2023. Children with chronic medical conditions, ICU stays >48 hours, and outside transfers were excluded. The intervention occurred in 11/2022 and included clinician education, a monthly group-level feedback report disseminated by email (Figure 1), and a monthly review of clinician performance during a virtual quality improvement meeting. Patient characteristics were compared using chi-square or Wilcoxon rank sum tests. Interrupted time series analysis (ITSA) was used to measure the immediate change in the proportion of CAP encounters receiving both the appropriate antibiotic choice and duration, as well as the change in slope from the preintervention to the postintervention periods. Choice and duration were analyzed separately using ITSA as a secondary analysis. Results: There were 817 CAP encounters, including 420 preintervention and 397 postintervention. Patients admitted in the postintervention period were older (median age 2 years vs 3 years, P=0.03), but otherwise there were no differences in race, ethnicity, sex, ICU admission, or complicated pneumonia. Preintervention, 52% of encounters received both the appropriate antibiotic choice and duration; 96% of encounters received the appropriate antibiotic choice and 54% received the appropriate duration. The ITSA demonstrated an immediate 16% increase in the proportion of patients receiving both appropriate antibiotic choice and duration (95% confidence interval, 1-31%; P = 0.047) and no significant further increase over time following the intervention (P = 0.84) (Figure 2). When antibiotic choice was analyzed separately by ITSA, there was no immediate change or change over time in the proportion of patients receiving the appropriate antibiotic choice. In the ITSA of duration alone, there was an immediate 17% increase in the proportion receiving the appropriate duration (95% confidence interval, 2-33%; P = 0.03) and no change over time. Conclusion: Feedback reports generated from electronically-derived metrics of antibiotic choice and duration, combined with ongoing clinician education, increased the proportion of children with CAP treated with the appropriate antibiotic duration. Electronic feedback reports are a scalable and impactful intervention to improve antibiotic use in children hospitalized with CAP.
Changing practice patterns caused by the pandemic have created an urgent need for guidance in prescribing stimulants using telepsychiatry for attention-deficit hyperactivity disorder (ADHD). A notable spike in the prescribing of stimulants accompanied the suspension of the Ryan Haight Act, allowing the prescribing of stimulants without a face-to-face meeting. Competing forces both for and against prescribing ADHD stimulants by telepsychiatry have emerged, requiring guidelines to balance these factors. On the one hand, factors weighing in favor of increasing the availability of treatment for ADHD via telepsychiatry include enhanced access to care, reduction in the large number of untreated cases, and prevention of the known adverse outcomes of untreated ADHD. On the other hand, factors in favor of limiting telepsychiatry for ADHD include mitigating the possibility of exploiting telepsychiatry for profit or for misuse, abuse, and diversion of stimulants. This Expert Consensus Group has developed numerous specific guidelines and advocates for some flexibility in allowing telepsychiatry evaluations and treatment without an in-person evaluation to continue. These guidelines also recognize the need to give greater scrutiny to certain subpopulations, such as young adults without a prior diagnosis or treatment of ADHD who request immediate-release stimulants, which should increase the suspicion of possible medication diversion, misuse, or abuse. In such cases, nonstimulants, controlled-release stimulants, or psychosocial interventions should be prioritized. We encourage the use of outside informants to support the history, the use of rating scales, and having access to a hybrid model of both in-person and remote treatment.
Multidimensional Grief Therapy (MGT) provides counselors, social workers, psychologists, and psychiatrists (as well as students in these fields) with a flexible program for assessing and supporting children and adolescents who have experienced bereavement. MGT is a strength-based intervention, designed to reduce unhelpful grief reactions that prevent adjustment, and promote adaptive grief reactions that enable children to cope better after a death. It also reduces associated symptoms of psychological distress and helps bereaved children and adolescents lead healthy, happy, productive lives. As young people grieve in different ways and “one-size-fits-all” treatments often lack effectiveness, MGT uses an assessment-driven, two-phased approach to effectively address the unique mental health needs of diverse youth. This manual provides a wealth of activities and handouts designed specifically to engage and empower youth after experiencing a death, including under traumatic circumstances.
Methicillin-resistant Staphylococcus aureus (MRSA) is a common etiology of hospital-acquired infections (HAIs). One strategy to reduce HAIs due to MRSA involves a multistep decolonization process. This often involves nasal application of mupirocin 2% ointment. In our institution, when individuals meet criteria for decolonization, we recommend 5 days of treatment given twice daily. High levels of mupirocin resistance have been reported in some hospital systems, with >80% of tested isolates being resistant. To better understand our resistance levels, we selected 238 MRSA isolates from blood cultures to be tested for mupirocin resistance to correlate the presence of resistance and use of mupirocin for decolonization. We choose to assess MRSA blood isolates rather than nasal swabs given that we aim to prevent invasive MRSA infections, including blood stream infections, with decolonization. The blood cultures were collected from 11 acute-care facilities within our system from March 2021 through June 2022. High-level resistance was defined as an MIC >1,024 μg/mL according to Clinical and Laboratory Standards Institute guidelines. Of those, 7.14% showed high level resistance, and 76.47% occurred in those who were exposed to mupirocin and 23.53% occurred in those without mupirocin exposure (P = .0094). On average, those with high-level resistance had had more recent exposure to mupirocin compared to those without resistance, which was statistically significant. Also, those with high resistance, on average, received more doses of mupirocin, although this was not statistically significant. Conclusions: More recent and higher number of doses of mupirocin were associated with the development of resistance, which is consistent with what we know from pharmacodynamics of antibiotic resistance with other agents. These findings may be particularly important for those patients who have frequent hospitalizations and often require decolonization. Understanding baseline mupirocin resistance levels in an institution can assist with determining decolonization strategies.
Both multidimensional grief theory and multidimensional grief therapy (MGT) draw upon a rich history of the clinical and scientific study of child and adolescent (hereafter youth) bereavement. This history offers a diverse array of conceptual lenses and therapeutic tools that support a broad, integrative approach to understanding, assessing, and intervening with bereaved youth and families. As a theory derived from decades of field study and clinical practice, multidimensional grief theory is both practical and powerful in its ability to describe, explain, predict, and therapeutically address a broad range of grief reactions. As we will discuss, the theory is an outgrowth of three major streams of clinical research, theory, and practice: attachment theory, existential philosophy, and disaster mental health (Layne, 2021b).
It is not surprising that parents and caregivers play a critical role in helping their child adjust to a “new normal” following the death of a loved one. One of the most challenging aspects of assisting a child after a death is that the caregivers themselves are usually grappling with their own personal grief reactions at the same time. The reality is that observing one’s own child in emotional distress is extremely painful under most circumstances, but bearing witness to this emotional pain within the context of a death can greatly add to the sorrow and devastation that a bereaved caregiver is likely already experiencing. In addition, it is often hard for caregivers to separate their own intense emotions from those of their child. This tendency can predispose caregivers to believe that their child’s experiences are similar to their own. However, members of the same family can grieve in very different ways as a result of many contributing factors.
Multidimensional Grief Therapy (MGT) is a strength-based intervention designed to carry out a range of important therapeutic tasks with bereaved children and adolescents. These tasks include (1) reducing unhelpful grief reactions (grief that keeps kids “stuck” and unable to adjust); (2) promoting adaptive grief reactions (grief that helps kids to feel and cope better after a death); (3) reducing associated symptoms of psychological distress (e.g., posttraumatic stress and depressive symptoms), and (4) helping bereaved children and adolescents to lead healthy, happy, productive lives. Consistent with its assessment-driven, flexibly tailored design, MGT is divided into a pretreatment assessment interview and an assessment feedback interview, followed by a two-phased treatment approach.
Note: The pretreatment assessment interview is usually conducted on an individual basis between a MGT clinician who will be facilitating the individual sessions and a prospective client. Primary aims of this interview include (1) gathering information needed to determine whether MGT is an appropriate treatment for this particular youth, or whether a referral for other services is appropriate; if MGT is indicated, (2) gathering information regarding losses and (in cases of multiple deaths) ranking them according to their severity/current impact to decide which should be a primary focus of treatment; (3) beginning to build a shared vocabulary for describing losses, grief reactions, and their consequences; and (4) building trust and therapeutic rapport, which you will draw on in subsequent sessions.