Evaluation of modified fixed dose four-factor prothrombin complex concentrate for warfarin reversal.

Non-activated four-factor prothrombin complex concentrate (4 F-PCC) has emerged as the preferred reversal strategy for patients on warfarin with life-threatening bleeding. Current dosing recommendations for 4 F-PCC require pre-treatment international normalized ratio (INR) and bodyweight values, resulting in ordering and administration delays. Studies have shown that alternative dosing regimens are safe and efficacious. This retrospective, single-center, pre- and post-protocol analysis was conducted to assess the efficacy of a pharmacist driven modified fixed-dose 4 F-PCC regimen versus package insert weight- and INR-based dosing regimen for warfarin reversal. The primary outcome was achievement of INR less than two. Secondary outcomes included dose and cost of 4 F-PCC, a time analysis, incidence of concomitant vitamin K administration, and incidence of thrombosis within seven days of 4 F-PCC. There were 195 patients included in the analysis, with 74 in the pre-cohort and 121 in the post-cohort. Baseline characteristics were similar between cohorts with the most common indication for warfarin use being atrial fibrillation (48.6% versus 47.1%) and reversal being intracerebral hemorrhage (68.9% versus 43.0%). Achievement of the primary endpoint occurred in 92% versus 95% (p = 0.097) of patients. A statistically significant difference was seen between cohorts regarding median dose and cost of 4 F-PCC administered (p < 0.001). Eleven thromboembolic events occurred with three events in the pre-cohort and eight events in the post-cohort (p = 0.453). A fixed-dose of 1500IU of 4 F-PCC was effective in reversing INR to less than two in most patients regardless of reversal indication with minimal thrombotic risks.

Personal and situational factors that influence coaches' ability to care.

The purpose of this study was to explore how personal and situational factors may influence sport coaches' caring practices. 130 youth sport coaches completed an online survey including perceptions of caring, emotional intelligence, and leadership behaviours. Additionally, coaches were prompted to consider a situation when it was easy or hard to care while also identifying influencing factors. Results revealed coaches' awareness of others' emotions, coaches' ability to use their emotions, and coaches' lower use of autocratic behaviours significantly predicted their perceptions of caring on their teams. Open-ended findings revealed that having a core value/philosophy centred on caring, maintaining a collaborative and welcoming culture, engaging in relationship building, using empathy and listening skills, possessing personal experiences/expertise, encountering advantageous situations, or having positive athlete behaviour made it easier to care. It was more difficult for coaches to care when they experienced poor athlete or parent behaviour, unhelpful situational factors, lack of team culture, differing opinions among staff, or personal factors. These findings provide coaches insight into factors that may influence their ability to care.

Incarcerated workers: overlooked as essential workers.

OBJECTIVE: To use the example of COVID-19 vaccine prioritization for incarcerated workers to call attention to the need to prioritize incarcerated workers' health. METHODS: From November to December 2020, we searched publicly available information (e.g. Department Of Corrections websites and press releases) for 53 US prison systems, including all states, Immigration and Customs Enforcement, the Federal Bureau of Prisons, and Puerto Rico. Coders reviewed if states had prison labor policies, if states had COVID-19 specific prison labor policies, the location of work, industries both pre- and during the COVID-19 pandemic, the scope of work, and hourly wage. Findings were compared to the Centers for Disease Control and Prevention's occupational vaccine prioritization recommendations. RESULTS: Every facility has incarcerated individuals working in some capacity with some resuming prison labor operations to pre-pandemic levels. All but one prison system has off-site work locations for their incarcerated population and many incarcerated workers have resumed their off-site work release assignments. Additionally, every state has incarcerated workers whose job assignments are considered frontline essential workers (e.g. firefighters). In at least five states, incarcerated workers are participating in frontline health roles that put them at higher risk of acquiring COVID-19. Yet, no state followed the Centers for Disease Control and Prevention recommended vaccination plan for its incarcerated population given their incarcerated workers' essential worker status. CONCLUSION: The Centers for Disease Control and Prevention recommended that incarcerated people be prioritized for vaccination primarily due to the risk present in congregate style prison and jail facilities. Furthermore, our review found that many incarcerated people perform labor that should be considered "essential", which provides another reason why they should have been among the first in line for COVID-19 vaccine allocation. These findings also highlight the need for incarcerated workers' health to be prioritized beyond COVID-19.

Comparative effectiveness clinical trial of magnetic seizure therapy and electroconvulsive therapy in major depressive disorder.

BACKGROUND: Magnetic seizure therapy (MST) has demonstrated fewer cognitive side effects than electroconvulsive therapy (ECT) in antidepressant efficacy trials. However, there are no effectiveness trials examining antidepressant efficacy and cognitive side effects against ECT. The aims of this study were to evaluate the comparative effectiveness of MST vs ECT in major depressive disorder (MDD), and compare the cognitive side effects of MST and ECT. METHODS: In this open-label study, patients were assigned to either ECT or high-dose MST twice a week for 5 sessions based on the clinician's and the patient's decision-making. Efficacy was primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); cognitive side effects were assessed by time to reorientation (TRO) and cognitive battery. RESULTS: Sixty patients were enrolled. Efficacy was similar between those assigned to MST (n = 30) and ECT (n = 30). Post-treatment HAMD-21 mean scores were 12.33 after MST, 12.80 after bitemporal (BT) ECT (n = 15), and 27.93 after right unilateral (RUL) ECT (n = 15). Magnetic seizure therapy had a significantly faster TRO of 1.8 minutes (standard deviation [SD] = 0.37) compared with ECT (RUL: 18.9 minutes [SD = 8.25]; BT: 50.2 minutes [SD = 5.89]) and had fewer cognitive side effects. CONCLUSIONS: Magnetic seizure therapy was effective for the treatment of MDD in real-world clinical care, with fewer cognitive side effects than ECT. Future studies are warranted to replicate these findings.

Institutional distrust among gay, bisexual, and other men who have sex with men as a barrier to accessing pre-exposure prophylaxis (PrEP).

Populations at highest risk for acquiring HIV are more likely to pass through criminal justice (CJ) settings, and CJ-involved individuals are often at the intersection of multiple overlapping risk factors. The present study explored interest in, knowledge of, and barriers to PrEP uptake among gay, bisexual, and other men who have sex with men involved in the criminal justice system. Using semi-structured interviews, 26 participants who identified as MSM were asked about PrEP knowledge and interest, HIV risk, and incarceration experience. One theme that emerged across interviews was how institutional distrust in CJ settings may instill lack of trust in medical care after perceived mistreatment. Participants explained how lack of privacy fostered feelings that medical care was not confidential, care received was tied to status as an incarcerated person, and feelings of dehumanization led to distrust. Findings explore how distrust may hinder PrEP uptake and other HIV prevention efforts in CJ settings as well as after release. They highlight the need for greater privacy efforts and cultural humility, and explore how medical settings may function as spaces for people who are incarcerated to disclose HIV risk status. Few studies to our knowledge have examined the role of institutional distrust on men who have sex with men (MSM) in the context of pre-exposure prophylaxis (PrEP) interventions. The present study has implications for creating best practices to structure HIV prevention interventions in CJ settings.

Loss, liberation, and agency: Patient experiences of methadone treatment at opioid treatment programs during the COVID-19 pandemic.

BACKGROUND: Despite its safety and effectiveness, methadone treatment for opioid use disorder (OUD) remains highly stigmatized, and stringent opioid treatment program (OTP) attendance requirements create barriers to retention for many patients. The COVID-19 pandemic prompted a shift in federal regulations governing methadone, including a blanket exemption permitting increased take-home doses of methadone. We studied the impact of these changes upon established patients' experiences of OTP care. METHOD: We conducted semi-structured qualitative interviews with 18 OTP patients who met our criteria of having established OTP care (i.e., enrolled at the OTP for at least 12 weeks) and were administered methadone three to six days weekly prior to the March 2020 blanket exemption. Interviews centered on how COVID-19 had affected their experiences of receiving treatment at an OTP. RESULTS: We identified three interconnected themes relevant to transformation of OTP care by the COVID-19 pandemic. Participants described mourning therapeutic OTP relationships and structure (1. loss), yet feeling more satisfaction with fewer in-person OTP visits (2. liberation), and appreciating more opportunities to self-direct their OUD care (3. agency). DISCUSSION: Structural changes made to OTP care early in the COVID-19 pandemic resulted in loss of community and structure. Increasing the availability of take-home methadone also improved patient experience and sense of agency. Our findings join a diverse body of converging evidence in support of policy changes allowing for more flexible dosing and individualized OTP care.

Patient Education and Decision Support for Long-Acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing with Ryan White HIV/AIDS Program Medical Case Management Programs in New York.

BACKGROUND: Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people living with HIV and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence and thus can clinically benefit from alternative treatment modalities. Ryan White HIV/AIDS Program Part A medical case management (MCM) programs provide an array of services to address barriers to HIV care and treatment among economically and socially marginalized people living with HIV. These programs have demonstrated effectiveness in improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence. OBJECTIVE: This study aims to adapt and expand Ryan White MCM service strategies to integrate LAI ART regimen options, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens. METHODS: In 3 phases of work involving patient and provider participants, this study uses role-specific focus groups to elicit perceptions of LAI versus daily oral ART; discrete choice experiment (DCE) surveys to quantify preferences for different ART delivery options and related supports; and a nonrandomized trial to assess the implementation and utility of newly developed tools at 6 partnering Ryan White HIV/AIDS Program Part A MCM programs based in urban, suburban, and semirural areas of New York. Findings from the focus groups and DCEs, as well as feedback from advisory board meetings, informed the design and selection of the tools: a patient-facing, 2-page fact sheet, including frequently asked questions and a side-by-side comparison of LAI with daily oral ART; a patient-facing informational video available on YouTube (Google Inc); and a patient-provider decision aid. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide further specification of strategies to integrate LAI ART options into MCM program workflows. RESULTS: The study was funded in late April 2021 and received approval from the institutional review board in May 2021 under protocol 20-096. Focus groups were conducted in late 2021 (n=21), DCEs ran from June 2022 to January 2023 (n=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024) has enrolled >200 patients. CONCLUSIONS: This study is designed to provide evidence regarding the acceptability, feasibility, appropriateness, and utility of a package of patient-oriented tools for comparing and deciding between LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed methods approach, and the testing of tools in real-world safety-net service settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56892.

Novel compstatin family peptides inhibit complement activation by drusen-like deposits in human retinal pigmented epithelial cell cultures.

We have used a novel human retinal pigmented epithelial (RPE) cell-based model that mimics drusen biogenesis and the pathobiology of age-related macular degeneration to evaluate the efficacy of newly designed peptide inhibitors of the complement system. The peptides belong to the compstatin family and, compared to existing compstatin analogs, have been optimized to promote binding to their target, complement protein C3, and to enhance solubility by improving their polarity/hydrophobicity ratios. Based on analysis of molecular dynamics simulation data of peptide-C3 complexes, novel binding features were designed by introducing intermolecular salt bridge-forming arginines at the N-terminus and at position -1 of N-terminal dipeptide extensions. Our study demonstrates that the RPE cell assay has discriminatory capability for measuring the efficacy and potency of inhibitory peptides in a macular disease environment.

Connections between caring climate, self-compassion, self-pity, and reactions to an emotionally difficult sport situation.

Multiple variables influence athletes' ability to cope with the challenges of sport participation including self-compassion, self-pity, and emotional regulation. Yet, the role of coach and teammates in nurturing self-compassion (SC), reducing self-pity (SP), and helping to regulate emotions (RESE) has not been fully investigated. Therefore, this study explored the interrelationships between perceptions of the caring climate (CC), SC, SP, RESE, and reactions to an emotionally difficult sport scenario (REs) and specific ways coaches and teammates helped or hindered SC. 224 predominately White (79%), female (69%), male (30%), and non-binary (1%) undergraduate students (Mage = 18.44, SD = 0.66) involved in a high school sport the previous year, participated in an online survey. The survey included measures of CC, SC, SP, RESE, and REs along with four open-ended questions asking participants to reflect on how coaches and teammates helped or hindered development of SC. Correlations revealed CC was positively related to RESE and SC and negatively related to SP. Further, CC was positively associated with constructive REs and negatively associated with deconstructive REs. To test whether RESE, SC, and SP mediated the relationship between the CC and REs, a path analysis was conducted. A partially mediated model emerged, ꭓ2(11) = 22.10, p = .02, CFI = 0.99, TLI = 0.93, RMSEA = 0.07 (CI = 0.02-0.11), SRMR = 0.04, with CC positively predicting positive and negative RESE, positive RESE positively predicting SC, and negative RESE positively predicting SC and negatively predicting SP. Additionally, SC, SP, and RESE differentially predicted REs. Thematic analysis of the open-ended questions revealed higher order themes of emotional, esteem, informational, and conditional support with a variety of supports being used by coaches and teammates. These findings provide insight into how coaches may be able to support athletes' SC and RESE to navigate challenges within sport.

Suicides in state prisons in the United States: Highlighting gaps in data.

OBJECTIVES: Our objectives were to document data availability and reporting on suicide mortality in state prison systems. The United States leads the world in mass incarceration, a structural determinant of health, but lacks real-time reporting of prison health statistics. This absence is particularly notable in suicides, a leading cause of death that carceral policies play a key role in mitigating. METHODS: Suicide data for each state prison system from 2017-2021 were gathered through statistical reports, press releases, and Freedom of Information Act requests. We graded states based on data availability. RESULTS: Only sixteen states provide updated, frequent, granular, freely provided suicide data. An additional thirteen states provided frequently updated data but that had little granularity, was incomplete, or was not freely provided. Eight states provided sparse, infrequent, or outdated data, and thirteen provided no data at all. CONCLUSIONS: The 2000 Death in Custody Reporting Act requires that states provide these data freely, yet the majority of states do not. There is a need for reliable, real-time data on suicides, suicide attempts, and conditions of confinement to better understand the harms of the carceral system and to advocate for change.

Study protocol for data to suppression (D2S): a cluster-randomised, stepped-wedge effectiveness trial of a reporting and capacity-building intervention to improve HIV viral suppression in housing and behavioural health programmes in New York City.

INTRODUCTION: With progress in the 'diagnose', 'link' and 'retain' stages of the HIV care continuum, viral suppression (VS) gains increasingly hinge on antiretroviral adherence among people with HIV (PWH) retained in care. The Centers for Disease Control and Prevention estimate that unsuppressed viral load among PWH in care accounts for 20% of onward transmission. HIV intervention strategies include 'data to care' (D2C)-using surveillance to identify out-of-care PWH for follow-up. However, most D2C efforts target care linkage, not antiretroviral adherence, and limit client-level data sharing to medical (versus support-service) providers. Drawing on lessons learnt in D2C and successful local pilots, we designed a 'data-to-suppression' intervention that offers HIV support-service programmes surveillance-based reports listing their virally unsuppressed clients and capacity-building assistance for quality-improvement activities. We aimed to scale and test the intervention in agencies delivering Ryan White HIV/AIDS Programme-funded behavioural health and housing services. METHODS AND ANALYSIS: To estimate intervention effects, this study applies a cross-sectional, stepped-wedge design to the intervention's rollout to 27 agencies randomised within matched pairs to early or delayed implementation. Data from three 12-month periods (pre-implementation, partial implementation and full implementation) will be examined to assess intervention effects on timely VS (within 6 months of a report listing the client as needing follow-up for VS). Based on projected enrolment (n=1619) and a pre-implementation outcome probability of 0.40-0.45, the detectable effect size with 80% power is an OR of 2.12 (relative risk: 1.41-1.46). ETHICS AND DISSEMINATION: This study was approved by the New York City Department of Health and Mental Hygiene's institutional review board (protocol: 21-036) with a waiver of informed consent. Findings will be disseminated via publications, conferences and meetings including provider-agency representatives. TRIAL REGISTRATION NUMBER: NCT05140421.

Comprehensive Reform Urgently Needed in Hospital Shackling Policy for Incarcerated Patients in the United States.

Approximately 2.2 million people are incarcerated in the United States. The carceral population is aging due to strict sentencing laws, which has increased the frequency and acuity of off-site medical care. Inpatient providers must follow departments of correction procedures when treating incarcerated patients, which often prevents adherence to standards of care and puts the health of patients at risk. Shackling is a common requirement during hospitalization and is associated with increased risk for complications. Current state and federal policies regarding shackling lack specifics to prevent patient harm. Incarcerated people have a constitutionally protected right to health care, but with current policy, we are not meeting this essential responsibility. Updates to policy are needed to ensure that patients receive compassionate, safe, and constitutionally mandated health care.

Overlapping Crises: Climate Disaster Susceptibility and Incarceration.

Climate-related disasters are becoming more frequent all over the world; however, there is significant variability in the impact of disasters, including which specific communities are the most vulnerable. The objective of this descriptive study was to examine how climate disaster susceptibility is related to the density of incarceration at the county level in the United States. Percent of the population incarcerated in the 2010 census and the Expected Annual Loss (EAL) from natural hazards were broken into tertiles and mapped bivariately to examine the overlap of areas with high incarceration and susceptibility to climate disasters. Over 13% of counties were in the highest tertile for both incarceration and EAL, with four states containing over 30% of these counties. The density of incarceration and climate disaster susceptibility are overlapping threats that must be addressed concurrently through (1) decarceration, (2) developing standardized guidance on evacuated incarcerated individuals during disasters, and (3) more deeply understanding how the health of everyone in these counties is jeopardized when prisons suffer from climate disasters.

COVID-19 community spread and consequences for prison case rates.

BACKGROUND: COVID-19 and mass incarceration are closely intertwined with prisons having COVID-19 case rates much higher than the general population. COVID-19 has highlighted the relationship between incarceration and health, but prior work has not explored how COVID-19 spread in communities have influenced case rates in prisons. Our objective was to understand the relationship between COVID-19 case rates in the general population and prisons located in the same county. METHODS: Using North Carolina's (NC) Department of Health and Human Services data, this analysis examines all COVID-19 tests conducted in NC from June-August 2020. Using interrupted time series analysis, we assessed the relationship between substantial community spread (50/100,000 detected in the last seven days) and active COVID-19 case rates (cases detected in the past 14 days/100,000) within prisons. RESULTS: From June-August 2020, NC ordered 29,605 tests from prisons and detected 1,639 cases. The mean case rates were 215 and 427 per 100,000 in the general and incarcerated population, respectively. Once counties reached substantial COVID-19 spread, the COVID-19 prison case rate increased by 118.55 cases per 100,000 (95% CI: -3.71, 240.81). CONCLUSIONS: Community COVID-19 spread contributes to COVID-19 case rates in prisons. In counties with prisons, community spread should be closely monitored. Stringent measures within prisons (e.g., vaccination) and decarceration should be prioritized to prevent COVID-19 outbreaks.

Carceral epidemiology: mass incarceration and structural racism during the COVID-19 pandemic.

The COVID-19 pandemic and the ongoing epidemic of mass incarceration are closely intertwined, as COVID-19 entered US prisons and jails at astounding rates. Although observers warned of the swiftness with which COVID-19 could devastate people who are held and work in prisons and jails, their warnings were not heeded quickly enough. Incarcerated populations were deprioritised, and COVID-19 infected and killed those in jails and prisons at rates that outpaced the rates among the general population. The COVID-19 pandemic highlighted what has been long-known: mass incarceration is a key component of structural racism that creates and exacerbates health inequities. It is imperative that the public health, particularly epidemiology, public policy, advocacy, and medical communities, are catalysed by the COVID-19 pandemic to drastically rethink the USA's criminal legal system and the public health emergency that it has created and to push for progressive reform.

The impact of menthol cigarette use on quit attempts and abstinence among smokers with opioid use disorder.

An exceedingly high proportion of persons with opioid use disorder (OUD) smoke cigarettes. Smokers with OUD face multiple barriers to smoking cessation. While menthol cigarette use has been associated with low cessation rates, research has not explored the impact of menthol cigarette use on tobacco use outcomes among smokers with OUD. Participants were current smokers, in methadone treatment for OUD, participating in randomized controlled trials of smoking cessation therapies. We examined the use of menthol cigarettes, and the association between menthol cigarette use and achieving 24-hour quit attempts and seven-day point prevalence abstinence. Of 268 participants, 237 (88.4%) reported menthol use. A similar proportion of menthol and non-menthol smokers achieved a 24-hour quit attempt (83.1% vs. 83.8%, p = 0.92). Though fewer menthol smokers (vs. non-menthol smokers) achieved abstinence (12.7% vs. 22.6%), this did not reach statistical significance (p = 0.14). In this sample of smokers with OUD, menthol smoking was nearly ubiquitous. Menthol smoking was not associated with differences in quit attempts, but was associated with differences in cessation that were not statistically significant. Menthol smoking may contribute to the challenges in achieving abstinence among smokers with OUD.

Fentanyl-related overdose during incarceration: a comprehensive review.

BACKGROUND: Fentanyl and related compounds have recently saturated the illicit drug supply in the United States, leading to unprecedented rates of fatal overdose. Individuals who are incarcerated are particularly vulnerable, as the burden of opioid use disorder is disproportionately higher in this population, and tolerance generally decreases during incarceration. METHODS: We conduct a systematic search for publications about fentanyl overdoses during incarceration in PubMed and PsycINFO, as well as lay press articles in Google, from January 1, 2013 through March 30th, 2021. RESULTS: Not a single fentanyl overdose was identified in the medical literature, but 90 overdose events, comprising of 76 fatal and 103 nonfatal fentanyl overdoses, were identified in the lay press. Among the 179 overdoses, 138 occurred in jails and 41 occurred in prisons, across the country. CONCLUSIONS: Fentanyl-related overdoses are occurring in correctional facilities with unknown but likely increasing frequency. In addition to the need for improved detection and reporting, immediate efforts to 1) increase understanding of the risks of fentanyl and how to prevent and treat overdose among correctional staff and residents, 2) ensure widespread prompt availability of naloxone and 3) expand the availability of medications to treat opioid use disorder for people who are incarcerated will save lives.