Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates.

Importance: The US heart allocation system prioritizes medically urgent candidates with a high risk of dying without transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank ordering ability. Objective: To develop and validate a candidate risk score that incorporates current clinical, laboratory, and hemodynamic data. Design, Setting, and Participants: A registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between January 1, 2019, and December 31, 2022, split by center into training (70%) and test (30%) datasets. Adult candidates were listed between January 1, 2019, and December 31, 2022. Main Outcomes and Measures: A US candidate risk score (US-CRS) model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. Sensitivity analyses were performed, which included intra-aortic balloon pumps (IABP) and percutaneous ventricular assist devices (VAD) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS. Performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset was evaluated by time-dependent area under the receiver operating characteristic curve (AUC) for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC. Results: A total of 16 905 adult heart transplant candidates were listed (mean [SD] age, 53 [13] years; 73% male; 58% White); 796 patients (4.7%) died without a transplant. The final US-CRS contained time-varying short-term MCS (ventricular assist-extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device. In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79 (95% CI, 0.75-0.83), for the French-CRS model was 0.72 (95% CI, 0.67-0.76), and 6-status model was 0.68 (95% CI, 0.62-0.73). Overall c-index for the US-CRS model was 0.76 (95% CI, 0.73-0.80), for the French-CRS model was 0.69 (95% CI, 0.65-0.73), and 6-status model was 0.67 (95% CI, 0.63-0.71). Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%. Conclusions and Relevance: In this registry-based study of US heart transplant candidates, a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation.

Hospital Policy Variation in Addressing Decisions to Withhold and Withdraw Life-Sustaining Treatment.

BACKGROUND: Sociodemographic disparities in physician decisions to withhold and withdraw life-sustaining treatment exist. Little is known about the content of hospital policies that guide physicians involved in these decisions. RESEARCH QUESTION: What is the prevalence of US hospitals with policies that address withholding and withdrawing life-sustaining treatment; how do these policies approach ethically controversial scenarios; and how do these policies address sociodemographic disparities in decisions to withhold and withdraw life-sustaining treatment? STUDY DESIGN AND METHODS: This national cross-sectional survey assessed the content of hospital policies addressing decisions to withhold or withdraw life-sustaining treatment. We distributed the survey electronically to American Society for Bioethics and Humanities members between July and August 2023 and descriptively analyzed responses. RESULTS: Among 93 respondents from hospitals or hospital systems representing all 50 US states, Puerto Rico, and Washington, DC, 92% had policies addressing decisions to withhold or withdraw life-sustaining treatment. Hospitals varied in their stated guidance, permitting life-sustaining treatment to be withheld or withdrawn in cases of patient or surrogate request (82%), physiologic futility (81%), and potentially inappropriate treatment (64%). Of the 8% of hospitals with policies that addressed patient sociodemographic disparities in decisions to withhold or withdraw life-sustaining treatment, these policies provided opposing recommendations to either exclude sociodemographic factors in decision-making or actively acknowledge and incorporate these factors in decision-making. Only 3% of hospitals had policies that recommended collecting and maintaining information about patients for whom life-sustaining treatment was withheld or withdrawn that could be used to identify disparities in decision-making. INTERPRETATION: Although most surveyed US hospital policies addressed withholding or withdrawing life-sustaining treatment, these policies varied widely in criteria and processes. Surveyed policies also rarely addressed sociodemographic disparities in these decisions.

Do-Not-Resuscitate Orders by COVID-19 Status Throughout the First Year of the COVID-19 Pandemic.

BACKGROUND: At the beginning of the COVID-19 pandemic, whether performing CPR on patients with COVID-19 would be effective or increase COVID-19 transmission to health care workers was unclear. RESEARCH QUESTION: Did the prevalence of do-not-resuscitate (DNR) orders by COVID-19 status change over the first year of the pandemic as risks such as COVID-19 transmission to health care workers improved? STUDY DESIGN AND METHODS: This cross-sectional study assessed DNR orders for all adult patients admitted to ICUs at two academic medical centers in Chicago, IL, between April 2020 and April 2021. DNR orders by COVID-19 status were assessed using risk-adjusted mixed-effects logistic regression and propensity score matching by patient severity of illness. RESULTS: The study population of 3,070 critically ill patients were 46% Black, 53% male, with median age (interquartile range [IQR]) 63 (50-73) years. Eighteen percent were COVID-19 positive and 27% had a DNR order. Black and Latinx patients had higher absolute rates of DNR orders than White patients (30% vs 29% vs 23%; P = .006). After adjustment for patient characteristics, illness severity, and hospital location, DNR orders were more likely in patients with COVID-19 in the nonpropensity score-matched (n = 3,070; aOR, 2.01; 95% CI, 1.64-2.38) and propensity score-matched (n = 1,118; aOR, 1.91; 95% CI, 1.45-2.52) cohorts. The prevalence of DNR orders remained higher for patients with COVID-19 than patients without COVID-19 during all months of the study period (difference in prevalence over time, P = .751). INTERPRETATION: In this multihospital study, DNR orders remained persistently higher for patients with COVID-19 vs patients without COVID-19 with similar severity of illness during the first year of the pandemic. The specific reasons why DNR orders remained persistently elevated for patients with COVID-19 should be assessed in future studies, because these changes may continue to affect COVID-19 patient care and outcomes.

Dose optimisation and scarce resource allocation: two sides of the same coin.

OBJECTIVE: A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute a supply-constrained drug along these lines. SUMMARY OF KEY DATA: The vast majority of drug development and repurposing during the COVID-19 pandemic - an event that has made clear the ever-present scarcity in healthcare systems -has been ignorant of scarcity and dose optimisation's ability to help address it. CONCLUSIONS: Future pandemic clinical trials systems should obtain dose optimisation data, as these appear necessary to enable appropriate scarce resource allocation according to societal values.

Variation in COVID-19 Resource Allocation Protocols and Potential Implementation in the Chicago Metropolitan Area.

BACKGROUND: Scarce resource allocation policies vary across the United States. Little is known about regional variation in resource allocation protocols and variation in their application. We sought to evaluate how Covid-19 scarce resource allocation policies vary throughout the Chicago metropolitan area and whether there are differences in policy application within hospitals when prioritizing hypothetical patients who need critical care resources. METHODS: Two cross-sectional surveys were distributed to Chicago metropolitan area hospital representatives and triage officers. Survey responses and categorical variables are described by frequency of occurrence. Intra- and interhospital variation in ranking of hypothetical patients was assessed using Fleiss's Kappa coefficients. RESULTS: Eight Chicago-area hospitals responded to the survey assessing scarce resource allocation protocols (N = 8/18, response rate 44%). For hospitals willing to describe their ventilator allocation protocol (N = 7), most used the sequential organ failure assessment (SOFA) score (N = 6/7, 86%) and medical comorbidities (N = 4/7, 57%) for initial scoring of patients. A majority gave priority in initial scoring to pre-defined groups (N = 5/7, 71%), all discussed withdrawal of mechanical ventilation for adult patients (N = 7/7, 100%), and a minority had exclusion criteria (N = 3/7, 43%). Forty-nine triage officers from nine hospitals responded to the second survey (N = 9/10 hospitals, response rate 90%). Their rankings of hypothetical patients showed only slight agreement amongst all hospitals (Kappa 0.158) and fair agreement within two hospitals with the most respondents (Kappa 0.21 and 0.25). Almost half used tiebreakers to rank patients (N = 23/49, 47%). CONCLUSIONS: Although most respondents from Chicago-area hospitals described policies for resource allocation during the COVID-19 pandemic, the substance and application of these protocols varied. There was little agreement when prioritizing hypothetical patients to receive scarce resources, even among people from the same hospital. Variations in resource allocation protocols and their application could lead to inequitable distribution of resources, further exacerbating community distrust and disparities in health.Supplemental data for this article is available online at https://doi.org/10.1080/23294515.2021.1983667.

Accuracy of the Sequential Organ Failure Assessment Score for In-Hospital Mortality by Race and Relevance to Crisis Standards of Care.

Importance: Crisis Standards of Care (CSC) are guidelines for rationing health care resources during public health emergencies. The CSC adopted by US states ration intensive care unit (ICU) admission using the Sequential Organ Failure Assessment (SOFA) score, which is used to compare expected in-hospital mortality among eligible patients. However, it is unknown if Black and White patients with equivalent SOFA scores have equivalent in-hospital mortality. Objective: To investigate whether reliance on SOFA is associated with bias against Black patients in CSC. Design, Setting, and Participants: This cohort study was conducted using data from the eICU Collaborative Research Database of patients admitted to 233 US ICUs in 2014 to 2015. Included individuals were Black and White adult patients in the ICU, who were followed up to hospital discharge. Data were analyzed from May 2020 through April 2021. Exposure: SOFA scores at ICU admission. Main Outcomes and Measures: Hierarchical logistic regression with hospital fixed effects was used to measure the interaction between race and SOFA as a factor associated with in-hospital mortality, as well as the odds of death among Black and White patients with equivalent priority for resource allocation according to the SOFA-based ranking rules of 3 statewide CSC (denoted A, B, and C) under shortage conditions that were severe (ie, only patients with the highest priority would be eligible for allocation), intermediate (ie, patients in the highest 2 tiers would be eligible for allocation), or low (ie, only patients with the lowest priority would be at risk of exclusion). Results: Among 111 885 ICU encounters representing 95 549 patients, there were 16 688 encounters with Black patients (14.9%) and 51 464 (46.0%) encounters with women and the mean (SD) age was 63.3 (16.9) years. The median (interquartile range) SOFA score was not statistically significantly different between Black and White patients (4 [2-6] for both groups; P = .19), but mortality was lower among Black individuals compared with White individuals with equivalent SOFA scores (odds ratio [OR], 0.98; 95% CI, 0.97-0.99; P < .001). This was associated with lower mortality among Black patients compared with White patients prioritized for resource allocation in 3 CSC under shortage conditions that were severe (system A: OR, 0.65; 95% CI, 0.58-0.74; P < .001; system B: OR, 0.70; 95% CI, 0.64-0.78; P < .001; system C: OR, 0.73; 95% CI, 0.67-0.80; P < .001), intermediate (system A: OR, 0.73; 95% CI, 0.67-0.80; P < .001; system B: OR, 0.83; 95% CI, 0.77-0.89; P < .001; system C: OR, 0.82; 95% CI, 0.77-0.89; P < .001), and low (system A: OR, 0.83; 95% CI, 0.77-0.89; P < .001; system C: OR, 0.86; 95% CI, 0.81-0.92; P < .001; not applicable for system B, which had fewer tiers). When SOFA-based ranking rules were adjusted for Black patients to simulate equitable allocation based on observed mortality, the proportion upgraded to higher priority ranged from 379 Black patient encounters (2.3%) in low shortage conditions to 2601 Black patient encounters (15.6%) in severe shortage conditions. Conclusions and Relevance: This study found that SOFA scores were associated with overestimated mortality among Black patients compared with White patients, and this was associated with a structural disadvantage for Black patients in CSC allocation systems. These findings suggest that guidelines should be revised to correct this inequity and alternative methods should be developed for more equitable triage.

COVID-19 Among African Americans: An Action Plan for Mitigating Disparities.

As the COVID-19 pandemic has unfolded across the United States, troubling disparities in mortality have emerged between different racial groups, particularly African Americans and Whites. Media reports, a growing body of COVID-19-related literature, and long-standing knowledge of structural racism and its myriad effects on the African American community provide important lenses for understanding and addressing these disparities.However, troubling gaps in knowledge remain, as does a need to act. Using the best available evidence, we present risk- and place-based recommendations for how to effectively address these disparities in the areas of data collection, COVID-19 exposure and testing, health systems collaboration, human capital repurposing, and scarce resource allocation.Our recommendations are supported by an analysis of relevant bioethical principles and public health practices. Additionally, we provide information on the efforts of Chicago, Illinois' mayoral Racial Equity Rapid Response Team to reduce these disparities in a major urban US setting.

Variation in Ventilator Allocation Guidelines by US State During the Coronavirus Disease 2019 Pandemic: A Systematic Review.

Importance: During the coronavirus disease 2019 pandemic, there may be too few ventilators to meet medical demands. It is unknown how many US states have ventilator allocation guidelines and how these state guidelines compare with one another. Objective: To evaluate the number of publicly available US state guidelines for ventilator allocation and the variation in state recommendations for how ventilator allocation decisions should occur and to assess whether unique criteria exist for pediatric patients. Evidence Review: This systematic review evaluated publicly available guidelines about ventilator allocation for all states in the US and in the District of Columbia using department of health websites for each state and internet searches. Documents with any discussion of a process to triage mechanical ventilatory support during a public health emergency were screened for inclusion. Articles were excluded if they did not include specific ventilator allocation recommendations, were in draft status, did not include their state department of health, or were not the most up-to-date guideline. All documents were individually assessed and reassessed by 2 independent reviewers from March 30 to April 2 and May 8 to 10, 2020. Findings: As of May 10, 2020, 26 states had publicly available ventilator guidelines, and 14 states had pediatric guidelines. Use of the Sequential Organ Failure Assessment score in the initial rank of adult patients was recommended in 15 state guidelines (58%), and assessment of limited life expectancy from underlying conditions or comorbidities was included in 6 state guidelines (23%). Priority was recommended for specific groups in the initial evaluation of patients in 6 states (23%) (ie, Illinois, Maryland, Massachusetts, Michigan, Pennsylvania, and Utah). Many states recommended exclusion criteria in adult (11 of 26 states [42%]) and pediatric (10 of 14 states [71%]) ventilator allocation. Withdrawal of mechanical ventilation from a patient to give to another if a shortage occurs was discussed in 22 of 26 adult guidelines (85%) and 9 of 14 pediatric guidelines (64%). Conclusions and Relevance: These findings suggest that although allocation guidelines for mechanical ventilatory support are essential in a public health emergency, only 26 US states provided public guidance on how this allocation should occur. Guidelines among states, including adjacent states, varied significantly and could cause inequity in the allocation of mechanical ventilatory support during a public health emergency, such as the coronavirus disease 2019 pandemic.

Epistemic Authority and Trust in Shared Decision Making About Organ Transplantation.

Patient epistemic authority acknowledges respect for a patient's knowledge claims, an important manifestation of patient autonomy that facilitates shared decision making in medicine. Given the scarcity of deceased donor organs, transplantation programs state that patient promises of compliance cannot be taken at face value and exclude candidates deemed untrustworthy. This article argues that transplant programs frequently lack the data to make this utilitarian calculation accurately, with the result that, in practice, the psychosocial evaluation of potential transplant candidates is discriminatory and unfair. Historically excluded candidates, such as patients suffering from alcohol use, have turned out to benefit highly from transplantation. Transplant programs should tend to trust patients when they claim to be good potential organ stewards, thereby respecting patient autonomy, advancing justice, and saving more lives.

Association of Transplant Center With Survival Benefit Among Adults Undergoing Heart Transplant in the United States.

Importance: In the United States, the number of deceased donor hearts available for transplant is limited. As a proxy for medical urgency, the US heart allocation system ranks heart transplant candidates largely according to the supportive therapy prescribed by transplant centers. Objective: To determine if there is a significant association between transplant center and survival benefit in the US heart allocation system. Design, Setting, and Participants: Observational study of 29 199 adult candidates for heart transplant listed on the national transplant registry from January 2006 through December 2015 with follow-up complete through August 2018. Exposures: Transplant center. Main Outcomes and Measures: The survival benefit associated with heart transplant as defined by the difference between survival after heart transplant and waiting list survival without transplant at 5 years. Each transplant center's mean survival benefit was estimated using a mixed-effects proportional hazards model with transplant as a time-dependent covariate, adjusted for year of transplant, donor quality, ischemic time, and candidate status. Results: Of 29 199 candidates (mean age, 52 years; 26% women) on the transplant waiting list at 113 centers, 19 815 (68%) underwent heart transplant. Among heart transplant recipients, 5389 (27%) died or underwent another transplant operation during the study period. Of the 9384 candidates who did not undergo heart transplant, 5669 (60%) died (2644 while on the waiting list and 3025 after being delisted). Estimated 5-year survival was 77% (interquartile range [IQR], 74% to 80%) among transplant recipients and 33% (IQR, 17% to 51%) among those who did not undergo heart transplant, which is a survival benefit of 44% (IQR, 27% to 59%). Survival benefit ranged from 30% to 55% across centers and 31 centers (27%) had significantly higher survival benefit than the mean and 30 centers (27%) had significantly lower survival benefit than the mean. Compared with low survival benefit centers, high survival benefit centers performed heart transplant for patients with lower estimated expected waiting list survival without transplant (29% at high survival benefit centers vs 39% at low survival benefit centers; survival difference, -10% [95% CI, -12% to -8.1%]), although the adjusted 5-year survival after transplant was not significantly different between high and low survival benefit centers (77.6% vs 77.1%, respectively; survival difference, 0.5% [95% CI, -1.3% to 2.3%]). Overall, for every 10% decrease in estimated transplant candidate waiting list survival at a given center, there was an increase of 6.2% (95% CI, 5.2% to 7.3%) in the 5-year survival benefit associated with heart transplant. Conclusions and Relevance: In this registry-based study of US heart transplant candidates, transplant center was associated with the survival benefit of transplant. Although the adjusted 5-year survival after transplant was not significantly different between high and low survival benefit centers, compared with centers with survival benefit significantly below the mean, centers with survival benefit significantly above the mean performed heart transplant for recipients who had significantly lower estimated expected 5-year waiting list survival without transplant.