Economic Evaluation of National Patient Blood Management Clinical Guidelines in Cardiac Surgery.

OBJECTIVES: To the best of our knowledge, no published clinical guidelines have ever undergone an economic evaluation to determine whether their implementation represented an efficient allocation of resources. Here, we perform an economic evaluation of national clinical guidelines designed to reduce unnecessary blood transfusions before, during, and after surgery published in 2012 by Australia's sole public blood provider, the National Blood Authority (NBA). METHODS: We performed a cost analysis from the government perspective, comparing the NBA's cost of implementing their perioperative patient blood management guidelines with the estimated resource savings in the years after publication. The impact on blood products, patient outcomes, and medication use were estimated for cardiac surgeries only using a large national registry. We adopted conservative counterfactual positions over a base-case 3-year time horizon with outcomes predicted from an interrupted time-series model controlling for differences in patient characteristics and hospitals. RESULTS: The estimated indexed cost of implementing the guidelines of A$1.5 million (2018-2019 financial year prices) was outweighed by the predicted blood products resource saving alone of A$5.1 million (95% confidence interval A$1.4 million-A$8.8 million) including savings of A$2.4 million, A$1.6 million, and A$1.2 million from reduced red blood cell, platelet, and fresh frozen plasma use, respectively. Estimated differences in patient outcomes were highly uncertain and estimated differences in medication were financially insignificant. CONCLUSIONS: Insofar as they led to a reduction in red blood cell, platelet, and fresh frozen plasma use during cardiac surgery, implementing the perioperative patient blood management guidelines represented an efficient use of the NBA's resources.

Rationing With Respect to Age During a Pandemic: A Comparative Analysis of State Pandemic Preparedness Plans.

BACKGROUND: Faced with possible shortages due to COVID-19, many states updated or rapidly developed crisis standards of care (CSCs) and other pandemic preparedness plans (PPPs) for rationing resources, particularly ventilators. RESEARCH QUESTION: How have US states incorporated the controversial standard of rationing by age and/or life-years into their pandemic preparedness plans? STUDY DESIGN AND METHODS: This was an investigator-initiated, textual analysis conducted from April to June 2020, querying online resources and in-state contacts to identify PPPs published by each of the 50 states and for Washington, DC. Analysis included the most recent versions of CSC documents and official state PPPs containing triage guidance as of June 2020. Plans were categorized as rationing by (A) short-term survival (≤ 1 year), (B) 1 to 5 expected life-years, (C) total life-years, (D) "fair innings," that is, specific age cutoffs, or (O) other. The primary measure was any use of age and/or life-years. Plans were further categorized on the basis of whether age/life-years was a primary consideration. RESULTS: Thirty-five states promulgated PPPs addressing the rationing of critical care resources. Seven states considered short-term prognosis, seven considered whether a patient had 1 to 5 expected life-years, 13 rationed by total life-years, and one used the fair innings principle. Seven states provided only general ethical considerations. Seventeen of the 21 plans considering age/life-years made it a primary consideration. Several plans borrowed heavily from a few common sources, although use of terminology was inconsistent. Many documents were modified in light of controversy. INTERPRETATION: Guidance with respect to rationing by age and/or life-years varied widely. More than one-half of PPPs, many following a few common models, included age/life-years as an explicit rationing criterion; the majority of these made it a primary consideration. Terminology was often vague, and many plans evolved in response to pushback. These findings have ethical implications for the care of older adults and other vulnerable populations during a pandemic.

Why enterprise resource planning initiatives do succeed in the long run: A case-based causal network.

Despite remarkable academic efforts, why Enterprise Resource Planning (ERP) post-implementation success occurs still remains elusive. A reason for this shortage may be the insufficient addressing of an ERP-specific interior boundary condition, i.e., the multi-stakeholder perspective, in explaining this phenomenon. This issue may entail a gap between how ERP success is supposed to occur and how ERP success may actually occur, leading to theoretical inconsistency when investigating its causal roots. Through a case-based, inductive approach, this manuscript presents an ERP success causal network that embeds the overlooked boundary condition and offers a theoretical explanation of why the most relevant observed causal relationships may occur. The results provide a deeper understanding of the ERP success causal mechanisms and informative managerial suggestions to steer ERP initiatives towards long-haul success.

Protocol to assess performance of crisis standards of care guidelines for clinical triage.

During the COVID-19 pandemic, US states developed Crisis Standards of Care (CSC) algorithms to triage allocation of scarce resources to maximize population-wide benefit. While CSC algorithms were developed by ethical debate, this protocol guides their quantitative assessment. For CSC algorithms, this protocol addresses (1) adapting algorithms for empirical study, (2) quantifying predictive accuracy, and (3) simulating clinical decision-making. This protocol provides a framework for healthcare systems and governments to test the performance of CSC algorithms to ensure they meet their stated ethical goals. For complete details on the use and execution of this protocol, please refer to Jezmir et al. (2021).

Association of COVID-19 Hospitalization Volume and Case Growth at US Hospitals with Patient Outcomes.

BACKGROUND: Whether the volume of coronavirus disease 2019 (COVID-19) hospitalizations is associated with outcomes has important implications for the organization of hospital care both during this pandemic and future novel and rapidly evolving high-volume conditions. METHODS: We identified COVID-19 hospitalizations at US hospitals in the American Heart Association COVID-19 Cardiovascular Disease Registry with ≥10 cases between January and August 2020. We evaluated the association of COVID-19 hospitalization volume and weekly case growth indexed to hospital bed capacity, with hospital risk-standardized in-hospital case-fatality rate (rsCFR). RESULTS: There were 85 hospitals with 15,329 COVID-19 hospitalizations, with a median hospital case volume was 118 (interquartile range, 57, 252) and median growth rate of 2 cases per 100 beds per week but varied widely (interquartile range: 0.9 to 4.5). There was no significant association between overall hospital COVID-19 case volume and rsCFR (rho, 0.18, P = .09). However, hospitals with more rapid COVID-19 case-growth had higher rsCFR (rho, 0.22, P = 0.047), increasing across case growth quartiles (P trend = .03). Although there were no differences in medical treatments or intensive care unit therapies (mechanical ventilation, vasopressors), the highest case growth quartile had 4-fold higher odds of above median rsCFR, compared with the lowest quartile (odds ratio, 4.00; 1.15 to 13.8, P = .03). CONCLUSIONS: An accelerated case growth trajectory is a marker of hospitals at risk of poor COVID-19 outcomes, identifying sites that may be targets for influx of additional resources or triage strategies. Early identification of such hospital signatures is essential as our health system prepares for future health challenges.

[Consensus of the Genetics Branch of the Chilean Society of Pediatrics on the prioritization of people with Down syndrome and rare diseases for vaccination against SARS-CoV-2]. / Consenso de la Rama de Genética de la Sociedad Chilena de Pediatría sobre priorización de personas con Síndrome de Down y otras condiciones poco frecuentes en la Campaña de Vacunación COVID-19.

In the framework of the vaccination campaign against the SARS-CoV-2 virus, the Chilean Ministry of Health requested advice from the Genetics Branch of the Chilean Society of Pediatrics, to define the level of prioritization for people with Down Syndrome . A panel of geneticists worked on the development of this consensus, in which not only patients with Down syndrome were included, but the search was extended to patients with other types of disabilities, in both pediatric and adult ages in or der to contribute to the development of public health measures against the COVID-19 pandemic. The consensus concludes that, given the prevalence of comorbidities associated with Down syndrome, the higher incidence of cases with severe COVID-19 in this population group and a higher mortality, individuals with trisomy 21 should be considered as a high-risk population, and therefore, vaccina tion against SARS-CoV-2 should have a high priority for all people with Down syndrome regardless of their age (except for the age limit established by the clinical trials of each vaccine), and should be preceded only by the groups of health personnel and adults aged > 60-65 years. Likewise, this group of experts urges health authorities to include people with intellectual disabilities and related conditions as a priority population (other chromosomal abnormalities other than Down syndrome, intellectual disability, congenital anomalies and conditions that cause disability with microcephaly), as well as the caregivers of people with this type of conditions. Vaccination in children with this type of disorders should be considered as part of the first priority group, once safe vaccines against SARS-CoV-2 are available for use in children and adolescents.

COVID-19 vaccine prioritization of incarcerated people relative to other vulnerable groups: An analysis of state plans.

BACKGROUND: Carceral facilities are epicenters of the COVID-19 pandemic, placing incarcerated people at an elevated risk of COVID-19 infection. Due to the initial limited availability of COVID-19 vaccines in the United States, all states have developed allocation plans that outline a phased distribution. This study uses document analysis to compare the relative prioritization of incarcerated people, correctional staff, and other groups at increased risk of COVID-19 infection and morbidity. METHODS AND FINDINGS: We conducted a document analysis of the vaccine dissemination plans of all 50 US states and the District of Columbia using a triple-coding method. Documents included state COVID-19 vaccination plans and supplemental materials on vaccine prioritization from state health department websites as of December 31, 2020. We found that 22% of states prioritized incarcerated people in Phase 1, 29% of states in Phase 2, and 2% in Phase 3, while 47% of states did not explicitly specify in which phase people who are incarcerated will be eligible for vaccination. Incarcerated people were consistently not prioritized in Phase 1, while other vulnerable groups who shared similar environmental risk received this early prioritization. States' plans prioritized in Phase 1: prison and jail workers (49%), law enforcement (63%), seniors (65+ years, 59%), and long-term care facility residents (100%). CONCLUSIONS: This study demonstrates that states' COVID-19 vaccine allocation plans do not prioritize incarcerated people and provide little to no guidance on vaccination protocols if they fall under other high-risk categories that receive earlier priority. Deprioritizing incarcerated people for vaccination misses a crucial opportunity for COVID-19 mitigation. It also raises ethical and equity concerns. As states move forward with their vaccine distribution, further work must be done to prioritize ethical allocation and distribution of COVID-19 vaccines to incarcerated people.

What Has Covid-19 Exposed in Bioethics? Four Myths.

The Covid-19 pandemic has exposed four myths in bioethics. First, the flood of bioethics publications on how to allocate scarce resources in crisis conditions has assumed authorities would declare the onset of crisis standards of care, yet few have done so. This leaves guidelines in limbo and patients unprotected. Second, the pandemic's realities have exploded traditional boundaries between clinical, research, and public health ethics, requiring bioethics to face the interdigitation of learning, doing, and allocating. Third, without empirical research, the success or failure of ethics guidelines remains unknown, demonstrating that crafting ethics guidance is only the start. And fourth, the pandemic's glaring health inequities require new commitment to learn from communities facing extraordinary challenges. Without that new learning, bioethics methods cannot succeed. The pandemic is a wake-up call, and bioethics must rise to the challenge.

Out of Africa: A Solidarity-Based Approach to Vaccine Allocation.

This article sets forth a solidaristic approach to global distribution of vaccines against the SARS-CoV-2 virus. Our approach draws inspiration from African ethics and from the characterization of the Covid-19 crisis as a syndemic, a convergence of biosocial forces that interact with one another to produce and exacerbate clinical disease and prognosis. The first section elaborates the twin ideas of syndemic and solidarity. The second section argues that these ideas lend support to global health alliances to distribute vaccines beyond national borders. The third section introduces ethical criteria to guide global distribution, emphasizing priority to low- and middle-income countries, which have the least ability to obtain vaccines on their own. It also justifies giving priority to people at high risk of infection and high risk of severe disease and death.

Dutifully Defying Death: A Right to Life-saving Emergency Treatment.

Article 12 of the International Covenant on Economic, Social and Cultural Rights provides for the right to health. Two questions are considered in this article. Does this right entail a more specific right to life-saving emergency treatment? And if so, should the latter right become justiciable in the domestic courts? Two propositions will be made in this article. First, the right to life-saving emergency treatment is a necessary component of the right to health. Second, the conventional arguments against the justiciability of socio-economic rights do not apply to the right to life-saving emergency treatment. Such a right should be justiciable at the domestic level.

Addressing the maldistribution of health resources in Sichuan Province, China: A county-level analysis.

INTRODUCTION: The equity of health resource allocation geographically is a contested topic. Sichuan Province, located in Southwest China, has varied topography, providing us with natural materials to explore the determinants of health resource distribution. MATERIALS AND METHODS: Spatial panel econometric models were constructed to explore the relationship between health resources and factors such as health care service demand and socioeconomic and demographic perspectives using data from Sichuan Province for eight consecutive years (2010-2017). RESULTS: Health care service demands were found to be a major driving force behind the distribution of health resources, showing that an increase in health care service demands draws health resources to specific counties and surrounding areas. From a socioeconomic perspective, gross domestic product per capita and the average wage show a positive association with health resources. In addition, the total population and proportion of the urban population have diverse effects in regard to health-related human resources but have the same effects on material and financial health resources. CONCLUSIONS: Our results provide the Chinese government with evidence needed to formulate and promulgate effective policies, especially those aiming to tackle inequity among different regions.

[Vaccine against covid-19: an open question.] / Vaccino contro la covid-19: una questione aperta.

For covid-19, a disease that has proved fatal in many cases, a specific therapy has not yet been found, but the vaccine. This has triggered a further series of issues. Who to vaccinate first, how to achieve the so-called "herd immunity", especially if it is right, as it is being done, start with the medical staff and immediately after safeguard the elderly which also involve the problem of a clear explanation and acceptance, through informed consent, which it can be particularly difficult to illustrate.

Allocating scarce intensive care resources during the COVID-19 pandemic: practical challenges to theoretical frameworks.

The COVID-19 pandemic strained health-care systems throughout the world. For some, available medical resources could not meet the increased demand and rationing was ultimately required. Hospitals and governments often sought to establish triage committees to assist with allocation decisions. However, for institutions operating under crisis standards of care (during times when standards of care must be substantially lowered in the setting of crisis), relying on these committees for rationing decisions was impractical-circumstances were changing too rapidly, occurring in too many diverse locations within hospitals, and the available information for decision making was notably scarce. Furthermore, a utilitarian approach to decision making based on an analysis of outcomes is problematic due to uncertainty regarding outcomes of different therapeutic options. We propose that triage committees could be involved in providing policies and guidance for clinicians to help ensure equity in the application of rationing under crisis standards of care. An approach guided by egalitarian principles, integrated with utilitarian principles, can support physicians at the bedside when they must ration scarce resources.

Servicio profesional farmacéutico de indicación farmacéutica en sequedad ocular utilizando el programa 'I-VALOR' / Minor ailment service for dry eye syndromes: I-VALOR programme

INTRODUCCIÓN: la labor del farmacéutico comunitario en el Servicio de Indicación Farmacéutica (SIF) es muy importante como primera línea de asistencia a la población, aunque no está suficientemente documentada. OBJETIVOS: evaluar la intervención del farmacéutico comunitario en el SIF ante una consulta sobre enfermedad de ojo seco (EOS) con el uso de protocolos. MATERIAL Y MÉTODOS: estudio descriptivo, observacional realizado dentro del programa I-VALOR (enero-junio 2015). Los participantes fueron farmacéuticos voluntarios y pacientes que solicitaron algún remedio para aliviar la EOS. Se utilizó el protocolo del SIF del Foro de Atención Farmacéutica en Farmacia Comunitaria, un consenso para EOS realizado entre sociedades científicas, una hoja de derivación, un informe para el paciente y una hoja de recomendaciones. RESULTADOS: participaron 6.350 pacientes. 62,7 % consultas fueron realizadas por mujeres (24,3 % 46-65 años). El 60 % de los pacientes no presentaba ningún criterio de derivación. Se detectaron 3.887 criterios de derivación en 2.537 pacientes. Se decidió no derivar al 15,4 %, y del resto, 87,3 % aceptó la derivación. La dispensación de algún tratamiento tuvo lugar en el 80 % de los pacientes: 3.157 con tratamiento farmacológico (89,2 % un único medicamento) y 2.403 con tratamiento no farmacológico. El 35 % recibió consejos higiénico-dietéticos y consejo farmacéutico. Se detectaron 25 reacciones adversas a medicamentos (0,4 %). El 70,5 % de todas las consultas realizadas fueron resueltas sin necesidad de derivar al médico. CONCLUSIONES: el programa I-VALOR para EOS ha permitido evaluar la intervención protocolizada del farmacéutico en EOS mediante el registro de las actuaciones farmacéuticas para demostrar la labor desarrollada desde la farmacia comunitaria

BACKGROUND: Minor ailment service offered in community pharmacist is a key element in patient care. Thought in Spain the service is not properly documented. AIMS: The main objective was to evaluate community pharmacists' interventions through an agreed minor ailment service for dry eye syndromes (DES). METHOD: Descriptive study undertaken alongside I-VALOR programme (January-June 2015). Participants were pharmacists from SEFAC who voluntarily decided to do, and patients were those who consulted about DES in community pharmacy. Pharmacists used the Pharmaceutical Care Forum guideline for the Minor Ailment Service and an agreed consensus between pharmaceutical and medical societies. A patient's form and a referral's form were designed. RESULTS: There were 6,350 patients involved. 62.7% consultations were made by women 24.3% of 46-65 years old). No referral criteria were detected in 60% of patients. The pharmacist detected 3,887 referral criteria in 2,537 patients. Pharmacists decided not to refer 15.4% of those patients. 87.3% of the patients referred accepted the referral. Treatments were dispensed in 80% of patients: 3,157 pharmacological treatment (89.2% a single medication) and 2,403 non-pharmacological treatment (medical device, food supplement or eye cleaning product). 35% received hygienic-dietary advice and pharmaceutical advice. Twenty-five adverse drug reactions were detected (0.4%). 70.5% of all consultations made were managed with no referral to a general practitioner (GP). CONCLUSIONS: I-VALOR programme allowed to evaluate an agreed intervention for DES in community pharmacy through the record of MAS to demonstrate CP contribution to manage minor ailments