The shared ethical framework to allocate scarce medical resources: a lesson from COVID-19.

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children.

Governing the Access to COVID-19 Tools Accelerator: towards greater participation, transparency, and accountability.

The Access to COVID-19 Tools Accelerator (ACT-A) is a multistakeholder initiative quickly constructed in the early months of the COVID-19 pandemic to respond to a catastrophic breakdown in global cooperation. ACT-A is now the largest international effort to achieve equitable access to COVID-19 health technologies, and its governance is a matter of broad public importance. We traced the evolution of ACT-A's governance through publicly available documents and analysed it against three principles embedded in the founding mission statement of ACT-A: participation, transparency, and accountability. We found three challenges to realising these principles. First, the roles of the various organisations in ACT-A decision making are unclear, obscuring who might be accountable to whom and for what. Second, the absence of a clearly defined decision making body; ACT-A instead has multiple centres of legally binding decision making and uneven arrangements for information transparency, inhibiting meaningful participation. Third, the nearly indiscernible role of governments in ACT-A, raising key questions about political legitimacy and channels for public accountability. With global public health and billions in public funding at stake, short-term improvements to governance arrangements can and should now be made. Efforts to strengthen pandemic preparedness for the future require attention to ethical, legitimate arrangements for governance.

Accurate long-term prediction of death for patients with cirrhosis.

BACKGROUND AND AIMS: Cirrhosis is a major cause of death and is associated with extensive health care use. Patients with cirrhosis have complex treatment choices due to risks of morbidity and mortality. To optimally counsel and treat patients with cirrhosis requires tools to predict their longer-term liver-related survival. We sought to develop and validate a risk score to predict longer-term survival of patients with cirrhosis. APPROACH AND RESULTS: We conducted a retrospective cohort study of adults with cirrhosis with no major life-limiting comorbidities. Adults with cirrhosis within the Veterans Health Administration were used for model training and internal validation, and external validation used the OneFlorida Clinical Research Consortium. We used four model-building approaches including variables predictive of cirrhosis-related mortality, focused on discrimination at key time points (1, 3, 5, and 10 years). Among 30,263 patients with cirrhosis ≤75 years old without major life-limiting comorbidities and complete laboratory data during the baseline period, the boosted survival tree models had the highest discrimination, with 1-year, 3-year, 5-year, and 10-year survival rates of 0.77, 0.81, 0.84, and 0.88, respectively. The 1-year, 3-year, and 5-year discrimination was nearly identical in external validation. Secondary analyses with imputation of missing data and subgroups by etiology of liver disease had similar results to the primary model. CONCLUSIONS: We developed and validated (internally and externally) a risk score to predict longer-term survival of patients with cirrhosis. This score would transform management of patients with cirrhosis in terms of referral to specialty care and treatment decision-making for non-liver-related care.

Ethical Responsibilities for Companies That Process Personal Data.

It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data Practices framework. The framework outlines six principles relevant to the collection and use of personal data-minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion-and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices.

Spillover Effects of Medicare's Voluntary Bundled Payments for Joint Replacement Surgery to Patients Insured by Commercial Health Plans.

BACKGROUND: Under the Bundled Payments for Care Improvement (BPCI) program, bundled paymtents for lower-extremity joint replacement (LEJR) are associated with 2% to 4% cost savings with stable quality among Medicare fee-for-service beneficiaries. However, BPCI may prompt practice changes that benefit all patients, not just fee-for-service beneficiaries. OBJECTIVE: To examine the association between hospital participation in BPCI and LEJR outcomes for patients with commercial insurance or Medicare Advantage (MA). DESIGN: Quasi-experimental study using Health Care Cost Institute claims from 2011 to 2016. SETTING: LEJR at 281 BPCI hospitals and 562 non-BPCI hospitals. PATIENTS: 184 922 patients with MA or commercial insurance. MEASUREMENTS: Differential changes in LEJR outcomes at BPCI hospitals versus at non-BPCI hospitals matched on propensity score were evaluated using a difference-in-differences (DID) method. Secondary analyses evaluated associations by patient MA status and hospital characteristics. Primary outcomes were changes in 90-day total spending on LEJR episodes and 90-day readmissions; secondary outcomes were postacute spending and discharge to postacute care providers. RESULTS: Average episode spending decreased more at BPCI versus non-BPCI hospitals (change, -2.2% [95% CI, -3.6% to -0.71%]; P = 0.004), but differences in changes in 90-day readmissions were not significant (adjusted DID, -0.47 percentage point [CI, -1.0 to 0.06 percentage point]; P = 0.084). Participation in BPCI was also associated with differences in decreases in postacute spending and discharge to institutional postacute care providers. Decreases in episode spending were larger for hospitals with high baseline spending but did not vary by MA status. LIMITATION: Nonrandomized studies are subject to residual confounding and selection. CONCLUSION: Participation in BPCI was associated with modest spillovers in episode savings. Bundled payments may prompt hospitals to implement broad care redesign that produces benefits regardless of insurance coverage. PRIMARY FUNDING SOURCE: Leonard Davis Institute of Health Economics at the University of Pennsylvania.

Predicting survival after liver transplantation in patients with hepatocellular carcinoma using the LiTES-HCC score.

BACKGROUND & AIMS: Liver transplant priority in the US and Europe follows the 'sickest-first' principle. However, for patients with hepatocellular carcinoma (HCC), priority is based on binary tumor criteria to expedite transplant for patients with 'acceptable' post-transplant outcomes. Newer risk scores developed to overcome limitations of these binary criteria are insufficient to be used for waitlist priority as they focus solely on HCC-related pre-transplant variables. We sought to develop a risk score to predict post-transplant survival for patients using HCC- and non-HCC-related variables. METHODS: We performed a retrospective cohort study using national registry data on adult deceased-donor liver transplant (DDLT) recipients with HCC from 2/27/02-12/31/18. We fit Cox regression models focused on 5- and 10-year survival to estimate beta coefficients for a risk score using manual variable selection. We then calculated absolute predicted survival time and compared it to available risk scores. RESULTS: Among 6,502 adult DDLT recipients with HCC, 11 variables were selected in the final model. The AUCs at 5- and 10-years were: 0.62, 95% CI 0.57-0.67 and 0.65, 95% CI 0.58-0.72, which was not statistically significantly different to the Metroticket and HALT-HCC scores. The LiTES-HCC score was able to discriminate patients based on post-transplant survival among those meeting Milan and UCSF criteria. CONCLUSION: We developed and validated a risk score to predict post-transplant survival for patients with HCC. By including HCC- and non-HCC-related variables (e.g., age, chronic kidney disease), this score could allow transplant professionals to prioritize patients with HCC in terms of predicted survival. In the future, this score could be integrated into survival benefit-based models to lead to meaningful improvements in life-years at the population level. LAY SUMMARY: We created a risk score to predict how long patients with liver cancer will live if they get a liver transplant. In the future, this could be used to decide which waitlisted patients should get the next transplant.

Development and Validation of a Model to Predict Long-Term Survival After Liver Transplantation.

Patients are prioritized for liver transplantation (LT) under an "urgency-based" system using the Model for End-Stage Liver Disease score. This system focuses solely on waitlist mortality, without considerations of posttransplant morbidity, mortality, and health care use. We sought to develop and internally validate a continuous posttransplant risk score during 5-year and 10-year time horizons. This retrospective cohort study used national registry data of adult deceased donor LT (DDLT) recipients with ≥90 days of pretransplant waiting time from February 27, 2002 to December 31, 2018. We fit Cox regression models at 5 and 10 years to estimate beta coefficients for a risk score using manual variable selection and calculated the absolute predicted survival time. Among 21,103 adult DDLT recipients, 11 variables were selected for the final model. The area under the curves at 5 and 10 years were 0.63 (95% confidence interval [CI], 0.60-0.66) and 0.67 (95% CI, 0.64-0.70), respectively. The group with the highest ("best") scores had 5-year and 10-year survivals of 89.4% and 85.4%, respectively, compared with 45.9% and 22.2% for those with the lowest ("worst") scores. Our score was significantly better at predicting long-term survival compared with the existing scores. We developed and validated a risk score using nearly 17 years of data to prioritize patients with end-stage liver disease based on projected posttransplant survival. This score can serve as the building block by which the transplant field can change the entire approach to prioritizing patients to an approach that is based on considerations of maximizing benefits (ie, survival benefit-based allocation) rather than simply waitlist mortality.

Immunity certification for COVID-19: ethical considerations.

Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights.

Les restrictions imposées dans le cadre de la lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) ont eu de lourdes conséquences économiques, sociales et sanitaires. Certains pays ont envisagé la mise en place d'une stratégie visant à alléger ces restrictions pour les individus guéris en leur octroyant un document communément appelé «passeport d'immunité¼. Ce document atteste qu'ils ont développé une immunité protectrice contre le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2), le virus à l'origine de la COVID-19. L'Organisation mondiale de la Santé a déconseillé l'usage du certificat d'immunité pour l'instant, car l'incertitude demeure quant à l'existence réelle d'une immunité à long terme pour ceux qui se sont remis de la COVID-19. En outre, la fiabilité des tests sérologiques censés déterminer si l'individu est immunisé n'est pas avérée. Un tel certificat ne peut être instauré que si les seuils scientifiques en matière d'immunité sont respectés, qu'ils soient fondés sur les anticorps ou sur d'autres critères. Néanmoins, même si le certificat d'immunité est désormais bien accepté par la science, il s'accompagne de nombreuses questions d'ordre éthique en ce qui concerne la limitation des libertés individuelles et la mise en œuvre. Dans le présent document, nous examinons les principales considérations à prendre en compte pour garantir l'acceptabilité éthique du certificat d'immunité visant à lever les mesures de restriction pour certaines personnes durant la pandémie de COVID-19. Cette acceptabilité éthique dépend non seulement de son degré de conformité à des critères scientifiques stricts, mais aussi de son usage, des objectifs politiques ainsi que des mesures mises en place pour atténuer les préjudices potentiels et éviter d'imposer une charge disproportionnée sur les individus dépourvus de certificat, ou de bafouer les droits et libertés de tout un chacun.

Las medidas restrictivas impuestas a causa de la pandemia de la enfermedad coronavirus de 2019 (COVID-19) han tenido graves efectos sociales, económicos y sanitarios. Algunos países han considerado la posibilidad de utilizar la certificación de inmunidad como estrategia para flexibilizar dichas medidas para las personas que se han recuperado de la infección mediante la expedición a dichas personas de un documento, comúnmente denominado pasaporte de inmunidad. Este documento certifica que han desarrollado inmunidad protectora contra el coronavirus-2 del síndrome respiratorio agudo severo (SARS-CoV-2), el virus que causa la COVID-19. La Organización Mundial de la Salud ha desaconsejado la aplicación de la certificación de la inmunidad en la actualidad debido a la incertidumbre sobre si existe realmente una inmunidad a largo plazo para quienes se han recuperado de la COVID-19 y a las preocupaciones sobre la fiabilidad del método de prueba serológica propuesto para determinar la inmunidad. La certificación de la inmunidad solo puede considerarse si se cumplen los umbrales científicos para asegurar la inmunidad, ya sea que se basen en anticuerpos o en otros criterios. Sin embargo, incluso si la certificación de la inmunidad llegara a estar bien respaldada por la ciencia, tiene muchas cuestiones éticas en cuanto a las diferentes restricciones de las libertades individuales y su proceso de aplicación. Examinamos las principales consideraciones sobre la aceptabilidad ética de la certificación de la inmunidad para eximir a los individuos de las medidas restrictivas durante la pandemia de la COVID-19. Además de necesitar cumplir criterios científicos sólidos, la aceptabilidad ética de la certificación de inmunidad depende de sus usos y objetivos de política y de las medidas que se apliquen para reducir los posibles daños y evitar que se impongan cargas desproporcionadas a las personas que no cuenten con dicha certificación y se violen las libertades y derechos individuales.

Publication Ethics During Public Health Emergencies Such as the COVID-19 Pandemic.

Public health emergencies require real-time, accurate information to guide effective responses. Rapid publication of information can, therefore, advance both the scientific validity and the social value of research conducted in these contexts. Consequently, medical journals place a high priority on rapidly publishing reports on these emergencies, which the media often report on to the public. Today, the focus is on the rapid publication of research related to the COVID-19 outbreak. Tomorrow, it might be an influenza pandemic or a crisis related to a vaping-related illness. (Am J Public Health. Published online ahead of print May 14, 2020: e1-e2. doi:10.2105/AJPH.2020.305686).

Real-time Feedback in Pay-for-Performance: Does More Information Lead to Improvement?

BACKGROUND: Pay-for-performance (P4P) has been used expansively to improve quality of care delivered by physicians. However, to what extent P4P works through the provision of information versus financial incentives is poorly understood. OBJECTIVE: To determine whether an increase in information feedback without changes to financial incentives resulted in improved physician performance within an existing P4P program. INTERVENTION/EXPOSURE: Implementation of a new registry enabling real-time feedback to physicians on quality measure performance. DESIGN: Observational, predictive piecewise model at the physician-measure level to examine whether registry introduction associated with performance changes. We used detailed physician quality measure data 3 years prior to registry implementation (2010-2012) and 2 years after implementation (2014-2015). We also linked physician-level data including age, gender, and board certification; group-level data including registry click rates; and patient panel data including chronic conditions. PARTICIPANTS: Four hundred thirty-four physicians continuously affiliated with Advocate from 2010 to 2015. MAIN MEASURES: Physician performance on ten quality metrics. KEY RESULTS: We found no consistent pattern of improvement associated with the availability of real-time information across ten measures. Relative to predicted performance without the registry, average performance increased for two measures (childhood immunization status-rotavirus (p < 0.001) and diabetes care-medical attention for nephropathy (p = 0.024)) and decreased for three measures (childhood immunization status-influenza (p < 0.001) and diabetes care-HbA1c testing (p < 0.001) and poor HbA1c control (p < 0.001)). Results were consistent for subgroup analysis on those most able to improve, i.e., physicians in the bottom tertile of performance prior to registry introduction. Physicians who improved most were in groups that accessed the registry more than those who improved least (8.0 vs 10.0 times per week, p = 0.010). CONCLUSIONS: More frequent provision of information, provided in real-time, was insufficient to improve physician performance in an existing P4P program with high baseline performance. Results suggest that electronic registries may not themselves drive performance improvement. Future work should consider testing information feedback enhancements with financial incentives.

Association Between the Implementation of a Population-Based Primary Care Payment System and Achievement on Quality Measures in Hawaii.

Importance: Hawaii Medical Service Association (HMSA), the Blue Cross Blue Shield of Hawaii, introduced Population-based Payments for Primary Care (3PC), a new capitation-based primary care payment system, in 2016. The effect of this system on quality measures has not been evaluated. Objective: To evaluate whether the 3PC system was associated with changes in quality, utilization, or spending in its first year. Design, Setting, and Participants: Observational study using HMSA claims and clinical registry data from January 1, 2012, to December 31, 2016, and a propensity-weighted difference-in-differences method to compare 77 225 HMSA members in Hawaii attributed to 107 primary care physicians (PCPs) and 4 physician organizations participating in the first wave of the 3PC and 222 233 members attributed to 312 PCPs and 14 physician organizations that continued in a fee-for-service model in 2016 but had 3PC start dates thereafter. Exposures: Participation in the 3PC system. Main Outcomes and Measures: The primary outcome was the change in a composite measure score reflecting the probability that a member achieved an eligible measure out of 13 pooled Healthcare Effectiveness Data and Information Set quality measures. Primary care visits and total cost of care were among 15 secondary outcomes. Results: In total, the study included 299 458 HMSA members (mean age, 42.1 years; 51.5% women) and 419 primary care physicians (mean age, 54.9 years; 34.8% women). The risk-standardized composite measure scores for 2012 to 2016 changed from 75.1% to 86.6% (+11.5 percentage points) in the 3PC group and 74.3% to 83.5% (+9.2 percentage points) in the non-3PC group (differential change, 2.3 percentage points [95% CI, 2.1 to 2.6 percentage points]; P < .001). Of 15 prespecified secondary end points for utilization and spending, 11 showed no significant difference. Compared with the non-3PC group, the 3PC system was associated with a significant reduction in the mean number of primary care visits (3.3 to 3.0 visits vs 3.3 to 3.1 visits; adjusted differential change, -3.9 percentage points [95% CI, -4.6 to -3.2 percentage points]; P < .001), but there was no significant difference in mean total cost of care ($3344 to $4087 vs $2977 to $3564; adjusted differential change, 1.0% [95% CI, -1.3% to 3.4%]; P = .39). Conclusions and Relevance: In its first year, the 3PC population-based primary care payment system in Hawaii was associated with small improvements in quality and a reduction in PCP visits but no significant difference in the total cost of care. Additional research is needed to assess longer-term outcomes as the program is more fully implemented and to determine whether results are generalizable to other health care markets.

Outcomes for individuals turned down for living kidney donation.

BACKGROUND: A better understanding of the consequences of being turned down for living kidney donation could help transplant professionals to counsel individuals considering donation. METHODS: In this exploratory study, we used survey instruments and qualitative interviews to characterize nonmedical outcomes among individuals turned down for living kidney donation between July 1, 2010 and December 31, 2013. We assembled a comparator group of kidney donors. RESULTS: Among 83 turned-down donors with contact information at a single center, 43 (52%) participated in the study (median age 53 years; 53% female; 19% black). Quality of life, depression, financial stress, and provider empathy scores were similar between individuals turned down for donation (n = 43) and donors (n = 128). Participants selected a discrete choice response to a statement about the overall quality of their lives; 32% of turned-down donors versus 7% of donors (P < 0.01) assessed that their lives were worse after the center's decision about whether they could donate a kidney. Among turned-down donors who reported that life had worsened, 77% had an intended recipient who was never transplanted, versus 36% among individuals who assessed life as the same or better (P = 0.02). In interviews, the majority of turned-down donors reported emotional impact, including empathy, stress, and other challenges, related to having someone in their lives with end-stage kidney disease. CONCLUSIONS: Generic instruments measuring quality of life, depression, financial stress, and provider empathy revealed no significant differences between kidney donors and turned-down donors. However, qualitative interviews revealed preliminary evidence that some turned-down donors experienced emotional consequences. These findings warrant confirmation in larger studies.