Nguyen, N.V.

Introduction: Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease without approved medical therapies. We examined the efficacy and safety of oral vancomycin (OV) in those with PSC. Methods: In this phase 3, 18-month, double-blind, placebo-controlled trial, we randomly assigned adults with PSC and a serum alkaline phosphatase (SAP) greater than 1.5 times the upper limit of normal to placebo or oral vancomycin (OV) with dosages ranging from 125-375 mg four times daily pending biochemical response. The primary endpoint was normalization of SAP. Results: Of the 82 patients who underwent randomization, 73 individuals had at least one outcome assessment. Individuals who withdrew early were less likely to rate their baseline health as excellent or very good (23.4% vs 54.5%, p<0.01) despite having similar PSC prognostic features to those who completed the study. SAP normalization rates were similar (5% placebo, 6.7% OV, p=1.00) after 18 months. Those who received OV had greater reduction in SAP (+1.2% placebo, -21.9% OV, p=0.03). There were no differences in the changes in either the Mayo PSC risk score (-0.1 placebo, -0.1 OV, p=0.88) or liver stiffness values (+0.1 kPa placebo, -4.0 kPa OV, p=0.15). Discoloration of the teeth and tongue was the most common side effect of OV (17.5%). Conclusions: OV was not associated with clinically significant reductions in markers of PSC disease severity. Impairments in quality of life may influence patient retention in clinical trials.

Abstract Rationale The United States has the highest per capita incarceration rate of any developed democracy. As the incarcerated population ages, medically complex and frail patients are increasingly hospitalized in the community, often arriving without decisional capacity and with limited family involvement. This is the first analysis of state laws and policies governing decision-making for incapacitated incarcerated patients. Methods Two team members independently conducted Westlaw and Internet searches for statutes, regulations and department of corrections (DOC) policies from 50 states and the District of Columbia, identifying language about medical decision-making for incapacitated incarcerated patients. These parallel searches were merged into a single database and reviewed by the analytic team, who created a codebook of inductively and deductively derived themes, guided by principles of grounded theory. The codebook was then systematically applied to the database by 2 independent coders; all data were double-coded. Disputes were resolved by consensus with the entire analytic team, in consultation with a legal scholar. Results Thirty-four of 51 jurisdictions have language addressing decision-making for incapacitated incarcerated patients. Data collected include the definition and determination of incapacity, language affirming incarcerated persons’ right to autonomy in medical decision-making, approaches to decision-making for patients with and without surrogate decision-makers, and whether treatment over patient/surrogate objection is authorized. Assertions about the importance of advance care planning (n = 25) are often undercut by procedural hurdles (n = 20), such as complex witnessing requirements for advance directive completion. Many jurisdictions (n = 26) allow family or friends to serve as legally recognized decision-makers. Thirteen jurisdictions exclude an incarcerated person from serving as decision-maker for another incarcerated person. Fourteen jurisdictions have provisions allowing for treatment over the objection of a patient or their surrogate. While approaches to unrepresented patients differ widely (Figure), 5 jurisdictions grant narrow decisional authority to treating physicians and 4 jurisdictions authorize correctional employees to make medical decisions. Conclusion A heterogeneous assortment of laws, policies and regulations govern the care of incapacitated incarcerated patients, with wide variation observed from jurisdiction to jurisdiction. One-third of jurisdictions lack policies or language regarding decision-making processes for incapacitated incarcerated patients. Even more troubling, 14 jurisdictions allow treatment over a patient or surrogate’s objection and 4 jurisdictions delegate authority over decisions for unrepresented patients to correctional employees, such as the prison medical director or the warden. These findings raise serious concerns about autonomy, beneficence and justice. National reform is needed to align correctional policies with established ethical standards for surrogate decision-making. This abstract is funded by: National Institute on Aging

Abstract Introduction The COVID-19 pandemic exposed underrecognized structural deficiencies in pandemic preparedness across the US, particularly impacting marginalized and medically vulnerable populations. State leaders who were developing policies to allocate critical care resources, often called crisis standards of care (CSC), confronted challenges such as whether and how to incorporate age and chronic conditions into triage protocols, how to contend with imperfect illness acuity scores such as the sequential organ failure assessment (SOFA), and whether essential worker status or area deprivation index (ADI) ought to confer an advantage during triage. To our knowledge, this is the first analysis to highlight CSC writers’ approach to ethical challenges, including from states whose policies provoked corrective action from the Office of Civil Rights (OCR). This study explores how state leaders navigated ethical controversies underlying states’ CSC policies, including whether those controversies were satisfactorily resolved. Methods Between February-September 2022 we conducted semi-structured interviews of public health leaders tasked with developing their states’ (CSC) policies. Interviews were transcribed verbatim and a codebook was developed iteratively, using inductively and deductively derived themes based on principles of grounded theory. The codebook was systematically applied to transcripts; disputes were resolved by consensus discussion among analytic team members. Results Leaders from 34 states were interviewed. Participants described how their states’ CSC policy writing committees considered the role of age in triage, some proposing age as a tiebreaker, or considering age only if coupled with measures of frailty or chronic illness, with others proposing age as an “exclusion criterion.” Many leaders acknowledged a controversial approach to disability in early versions of their policies, some describing how they responded to civil rights complaints. Participants described debates over whether pandemic triage decisions should advantage patients from underserved populations or affirmatively consider essential worker status or pregnancy. While most leaders regretted that early iterations of their policies stood to exacerbate health disparities, others described a less conciliatory response to civil rights complaints. In particular, triage exclusion criteria, whereby certain patients would be excluded outright from certain resources, provoked intense debate. Conclusion We describe ethical controversies that stymied CSC policy writing committees during the COVID-19 pandemic. Leaders described spirited debate around how age, disability, and justice ought to factor into triage; few described satisfactory resolution to those debates. Improved community engagement and adherence to civil rights protections in CSC are imperative to protect marginalized populations as we prepare for future calamites, whether global or local. This abstract is funded by: R03 AG73987; K76 AG88403

ABSTRACT Background The COVID‐19 pandemic presented unprecedented challenges to hospital system and critical care resources, leading to significant changes to operations and patient care. There are limited national data on these changes and instances of unsanctioned deviations from patient care, yet understanding the COVID response is key to future preparedness efforts. We sought to understand how hospitals and states navigated scarcity during COVID‐19, particularly in the absence of a declaration of crisis standards of care. Methods Between February 2022 and September 2022 we conducted 34 interviews with 36 leaders of U.S. states' COVID‐19 planning and response efforts. Interviews were transcribed verbatim and verified. We analyzed interviews using iterative inductive thematic analysis for descriptions of resource scarcity and changes to policies and procedures to prevent rationing lifesaving care. Results Nearly all participants described equipment and personnel scarcity in their home institution or state during COVID‐19. Hospitals across regions and states developed formal and informal coordination processes for load and resource sharing in response to influxes of high‐acuity patients, avoiding formal rationing of lifesaving resources in many regions. Participants also described unsanctioned patient triage, early discharge, and patients counseled to accept less aggressive care (e.g., premature transition to hospice) in states that had not declared crisis standards of care. Conclusions Extending limited resources and inter‐institutional collaboration helped avoid formal rationing. Yet, patient care was unquestionably impacted due to scarcity, both real and perceived. Reports of using hospital triage protocols to deny patients lifesaving care outside of formally recognized crisis conditions and attempts to nudge patients to accept less‐resource‐intensive care are concerning. This may have had disproportionate effects on older adults, individuals with disabilities, and racial and ethnic minoritized groups. To avoid unsanctioned deviations from standard practice in future health emergencies, we recommend that transparent and equitable triage protocols are implemented with robust oversight.

Abstract Rationale: The US prison population carries a high burden of chronic disease and disability, with older adults constituting the fastest growing subpopulation. When medical needs exceed a prison's healthcare service capabilities, incarcerated patients are transported to clinics and hospitals in surrounding communities. The influence of prison policies on off-site medical care of incarcerated patients is poorly understood. This study aims to identify and classify correctional policies regulating the care of incarcerated patients in community hospitals. Methods: Between 6/2024-10/2024 we searched the Internet for policies from states’ Departments of Corrections (DOC) pertaining to healthcare of incarcerated patients. We compiled, reconciled and organized those policies according to date, jurisdiction and relevance to hospital care. We then developed a preliminary thematic coding scheme and, using mixed inductive and deductive content analysis, two coders independently applied our codebook to each policy. Any coding discrepancies were resolved by consensus, and when necessary, with adjudication by a third team member. Results: Forty-eight state DOCs and the District of Columbia (totaling 49 “states”) have publicly available policies pertaining to healthcare. Among these, 20/49 (41%) have policies pertaining to the protection of bodily privacy during healthcare encounters. Separately, 31 (63%) have policies regarding the confidentiality of incarcerated patients’ medical encounters and records. Thirty-four (69%) maintain policies regarding incarcerated individuals’ right to select and consent to treatment. Thirty-three (67%) include language about the right to refuse treatment. Twenty-six states (53%) direct that incarcerated individuals be informed of their right to access healthcare either in writing (22/49; 45%), verbally (20/49; 41%), or through posted signage (5/49; 10%). Twenty-one states (43%) address shackling during off-site medical care, but only 15 (31%) address responding to requests from off-site clinicians to minimize or remove patients’ restraints. Just 4/49 states (8%) use person-centered language (avoiding terms like “offender” and “inmate”). Policy excerpts addressing key domains are depicted in the Table. Conclusions: Correctional policies regarding the care of incarcerated patients in community hospitals vary significantly in scope and content across states. While incarcerated people have a Constitutionally protected right to accept or refuse healthcare, including making their own treatment decisions, many state policies do not explicitly mandate how these disclosures must be communicated to patients or their healthcare providers. These silences, when combined with security measures like shackling and the ubiquitous presence of officers, countermand person-centered care and undermine the ability of hospital healthcare professionals to uphold the rights and dignity of incarcerated patients.

Importance During the COVID-19 pandemic, many US states issued or revised pandemic preparedness plans guiding allocation of critical care resources during crises. State plans vary in the factors used to triage patients and have faced criticism from advocacy groups due to the potential for discrimination. Objective To analyze the role of comorbidities and long-term prognosis in state triage procedures. Design, Setting, and Participants This cross-sectional study used data gathered from parallel internet searches for state-endorsed pandemic preparedness plans for the 50 US states, District of Columbia, and Puerto Rico (hereafter referred to as states), which were conducted between November 25, 2021, and June 16, 2023. Plans available on June 16, 2023, that provided step-by-step instructions for triaging critically ill patients were categorized for use of comorbidities and prognostication. Main Outcomes and Measures Prevalence and contents of lists of comorbidities and their stated function in triage and instructions to predict duration of postdischarge survival. Results Overall, 32 state-promulgated pandemic preparedness plans included triage procedures specific enough to guide triage in clinical practice. Twenty of these (63%) included lists of comorbidities that excluded (11 of 20 [55%]) or deprioritized (8 of 20 [40%]) patients during triage; one state’s list was formulated to resolve ties between patients with equal triage scores. Most states with triage procedures (21 of 32 [66%]) considered predicted survival beyond hospital discharge. These states proposed different prognostic time horizons; 15 of 21 (71%) were numeric (ranging from 6 months to 5 years after hospital discharge), with the remaining 6 (29%) using descriptive terms, such as long-term. Conclusions and Relevance In this cross-sectional study of state-promulgated critical care triage policies, most plans restricted access to scarce critical care resources for patients with listed comorbidities and/or for patients with less-than-average expected postdischarge survival. This analysis raises concerns about access to care during a public health crisis for populations with high burdens of chronic illness, such as individuals with disabilities and minoritized racial and ethnic groups.