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.

Targeting of the diabetes prevention program leads to substantial benefits when capacity is constrained.

OBJECTIVE: Approximately 84 million people in the USA have pre-diabetes, but only a fraction of them receive proven effective therapies to prevent type 2 diabetes. We estimated the value of prioritizing individuals at highest risk of progression to diabetes for treatment, compared to non-targeted treatment of individuals meeting inclusion criteria for the Diabetes Prevention Program (DPP). METHODS: Using microsimulation to project outcomes in the DPP trial population, we compared two interventions to usual care: (1) lifestyle modification and (2) metformin administration. For each intervention, we compared targeted and non-targeted strategies, assuming either limited or unlimited program capacity. We modeled the individualized risk of developing diabetes and projected diabetic outcomes to yield lifetime costs and quality-adjusted life expectancy, from which we estimated net monetary benefits (NMB) for both lifestyle and metformin versus usual care. RESULTS: Compared to usual care, lifestyle modification conferred positive benefits and reduced lifetime costs for all eligible individuals. Metformin's NMB was negative for the lowest population risk quintile. By avoiding use when costs outweighed benefits, targeted administration of metformin conferred a benefit of $500 per person. If only 20% of the population could receive treatment, when prioritizing individuals based on diabetes risk, rather than treating a 20% random sample, the difference in NMB ranged from $14,000 to $20,000 per person. CONCLUSIONS: Targeting active diabetes prevention to patients at highest risk could improve health outcomes and reduce costs compared to providing the same intervention to a similar number of patients with pre-diabetes without targeted selection.

Pediatric Psychosocial Standards of Care in action: Research that bridges the gap from need to implementation.

OBJECTIVE: To describe innovative models of psychosocial care delivery that align with published Standards of Psychosocial Care of Children with Cancer and their Families, in efforts to bridge the divide between research and practice. METHODS: The Mattie Miracle Cancer Foundation, in partnership with the American Psychosocial Oncology Society reviewed 22 letters of intent and 13 full grants and awarded small grants to researchers with high quality projects that aimed to implement any of the published 15 Standards of Care. For three of the highest rated funded research projects, we describe the Standard implemented, the novel research design and implementation strategies, and how the research findings might inform the development, implementation, and dissemination of effective solutions for bridging Standard-to-practice gaps. RESULTS: The first study presented is an innovative eHealth intervention for parents of children with cancer designed to improve family functioning and decrease symptoms of acute distress, anxiety, and posttraumatic stress. The second study addresses the acceptability and feasibility of using daily text message assessments of oral chemotherapy adherence in adolescents and young adults with leukemia, and the third creates a blueprint for providing psychosocial services to siblings, including ways to overcome common implementation barriers. CONCLUSIONS: Several themes emerged from the studies presented, including (1) attention to barriers to previous attempts at implementation; (2) technology's role in delivering care; (3) the need for stakeholder involvement; and (4) consideration for multi-pronged solutions that address heterogeneity in care settings. Next steps for integrating the Standards of Psychosocial Care into clinical practice are discussed.

Our Next Pandemic Ethics Challenge? Allocating "Normal" Health Care Services.

The pandemic creates unprecedented challenges to society and to health care systems around the world. Like all crises, these provide a unique opportunity to rethink the fundamental limiting assumptions and institutional inertia of our established systems. These inertial assumptions have obscured deeply rooted problems in health care and deflected attempts to address them. As hospitals begin to welcome all patients back, they should resist the temptation to go back to business as usual. Instead, they should retain the more deliberative, explicit, and transparent ways of thinking that have informed the development of crisis standards of care. The key lesson to be learned from those exercises in rational deliberation is that justice must be the ethical foundation of all standards of care. Justice demands that hospitals take a safety-net approach to providing services that prioritizes the most vulnerable segments of society, continue to expand telemedicine in ways that improve access without exacerbating disparities, invest in community-based care, and fully staff hospitals and clinics on nights and weekends.

Comparison and analyses of therapeutic effects between metabolic management center (MMC) and conventional management modes.

AIMS: The past 3 decades witnessed the rapid growth of diabetes in China. To better serve large numbers of patients, the Chinese Medical Doctor Association launched metabolic management center (MMC) program which is featured with a one-stop and comprehensive diabetes management mode in 2016. It is worth exploring whether MMC model is better than conventional models in management. METHODS: In this study, 228 patients with type 2 diabetes were recruited, and 193 patients completed the study. Therapeutic effects and health care costs were analyzed. RESULTS AND CONCLUSIONS: Our results showed that decreases in HbA1C and TG/HDL-C values were significantly greater in the MMC group than in the control group. The increase in HDL-C was significantly higher in the MMC group than in the control group. The percentage of patients whose HbA1C lower than 7% was significantly higher in the MMC group. The results of the UKPDS model simulation showed that within 30 years, with the slight increases in treatment costs, the average life expectancy and total QALE of the MMC group are higher than those of the control group by 0.61 and 0.51 year, respectively. Further study showed that the drug intervention in the MMC group was significantly stronger. In addition, the questionnaires revealed that MMC group performed better in diabetes knowledge tests and have higher patient satisfaction rates of medical services. More patients in the MMC group adopted a more favorable diet strategy. These advantages enable MMC to achieve more short-term and long-term benefits in diabetes treatment than conventional mode.

Usual Care for Emergency Department Patients Who Present with Suicide Risk: A Survey of Hospital Procedures in Washington State.

Hospital emergency departments (EDs) are important settings for the implementation of effective suicide-specific care. Usual care for suicidal patients who present to EDs remains understudied. This study surveyed EDs in Washington State to assess the adoption of written procedures for recommended standards of care for treating suicidality. Most (N = 79, 84.9%) of the 93 EDs in Washington State participated. Most (n = 58, 73.4%) hospitals had a written protocol for suicide risk assessment, but half (n = 42, 53.2%) did not include documentation of access to lethal means. There was evidence of an association between patient volume and the adoption of suicide-specific protocols and procedures. Our findings suggest the need to enhance the adoption and implementation of recommended standard care in this setting.

Program-wide review and follow-up of erythema Induratum of Bazin and tuberculosis-associated ocular inflammation management in a TB low-incidence setting: need for improved treatment candidate selection, therapy standardization, and care collaboration.

BACKGROUND: Erythema induratum of Bazin (EIB) - nodular vasculitis associated with Mycobacterium tuberculosis (TB) - and Tuberculosis-Associated Ocular Inflammation (TB-AOI) represent uncommon manifestations of TB. There is limited data and a lack of diagnostic and treatment standards for these conditions. METHODS: Eleven-year retrospective review of EIB and TB-AOI cases managed in a provincial TB program with prospective phone-based follow-up of anti-tubercular therapy (ATT) recipients. Presumptive TB-AOI and EIB diagnoses were determined by ophthalmologist or dermatologist assessments correlated with positive tuberculin skin test and/or QuantiFERON-TB Gold, along with pathologic criteria in EIB cases. RESULTS: Of 21 EIB and 20 TB-AOI cases that received ATT, 13 and 11, respectively, were reached for follow-up. The majority of EIB and TB-AOI cases were female and immigrated from TB high-burden countries. Median durations of pre-diagnosis symptoms were 2 and 0.8 years (IQR 2.5 & 1.1) for EIB and TB-AOI cases, respectively. Overall, 14 different ATT regimens were used for a median duration of 6 months (range 5-9). ATT related adverse events resulting in treatment discontinuation occurred in 14% of EIB and 10% of TB-AOI cases. On last follow-up, 76% of EIB and 42% of TB-AOI had improvement or resolution of disease. CONCLUSION: EIB and TB-AOI were uncommon presentations receiving variable therapy. While treatment response was modest for EIB cases, TB-AOI cases had sub-optimal treatment outcomes. The unique diagnostic and management challenges presented by these conditions in TB low-incidence settings highlight a need for improved treatment candidate selection, therapy standardization, and cross-specialty medical collaboration.

Routine HIV Screening as a Standard of Care: Implementing HIV Screening in General Medical Settings, 2013-2015.

OBJECTIVE: We implemented routine HIV screening as part of the 4-year Care and Prevention in the United States Demonstration Project, whose aim was to reduce HIV/AIDS-related morbidity and mortality among racial/ethnic minority groups in the United States. We describe the capacity-building efforts to implement routine HIV screening and provide lessons learned and implications for practice. METHODS: From January 2013 through September 2015, the Public Health Institute of Metropolitan Chicago (PHIMC) implemented routine HIV screening in 7 health care systems in Illinois by providing capacity-building assistance focused on systems and operational infrastructure, staff member skills and organizational structure, and clinic culture. Each site received funding to integrate routine HIV screening into the existing clinic flow, engage the entire health care team in the process, and transform the system and shift clinic culture to sustain HIV screening. RESULTS: All 7 systems established policies and procedures to implement routine screening, 5 systems integrated HIV test ordering and documentation into their electronic health records, and 4 systems established a third-party billing and reimbursement process for testing. The 7 systems conducted a total of 49 285 tests and identified 160 people living with HIV. The number of tests increased by more than 40% each year. CONCLUSIONS: PHIMC identified the following practices for consideration when implementing routine HIV screening in general medical settings: create a culture that supports HIV screening, use champions in clinics, integrate HIV screening into clinic flow and electronic health records, and train clinic staff members on HIV messaging. Incorporating these practices can help other clinical settings build capacity to make routine HIV screening a standard of care.

The Suspected CANcer (SCAN) pathway: protocol for evaluating a new standard of care for patients with non-specific symptoms of cancer.

INTRODUCTION: Cancer survival in England lags behind most European countries, due partly to lower rates of early stage diagnosis. We report the protocol for the evaluation of a multidisciplinary diagnostic centre-based pathway for the investigation of 'low-risk but not no-risk' cancer symptoms called the Suspected CANcer (SCAN) pathway. SCAN is a new standard of care being implemented in Oxfordshire; one of a number of pathways implemented during the second wave of the Accelerate, Coordinate, Evaluate (ACE) programme, an initiative which aims to improve England's cancer survival rates through establishing effective routes to early diagnosis. METHODS AND ANALYSIS: To evaluate SCAN, we are collating a prospective database of patients referred onto the pathway by their general practitioner (GP). Patients aged over 40 years, with non-specific symptoms such as weight loss or fatigue, who do not meet urgent cancer referral criteria or for whom symptom causation remains unclear after investigation via other existing pathways, can be referred to SCAN. SCAN provides rapid CT scanning, laboratory testing and clinic review within 2 weeks. We will follow all patients in the primary and secondary care record for at least 2 years. The data will be used to understand the diagnostic yield of the SCAN pathway in the short term (28 days) and the long term (2 years). Routinely collected primary and secondary care data from patients not referred to SCAN but with similar symptoms will also be used to evaluate SCAN. We will map the routes to diagnosis for patients referred to SCAN to assess cost-effectiveness. Acceptability will be evaluated using patient and GP surveys. ETHICS AND DISSEMINATION: The Oxford Joint Research Office Study Classification Group has judged this to be a service evaluation and so outside of research governance. The results of this project will be disseminated by peer-reviewed publication and presentation at conferences.

Probable Standards of Care for Suicide Risk Assessment.

The legal standard of care for assessing and responding to suicide risk has historically been ambiguous, creating inconsistency in the testimony of forensic experts and uncertainty about clinical responsibilities among practitioners. In this article, I rigorously apply the legal concept of reasonable care to identify clinical activities that courts could collectively consider as evidence of reasonably careful suicide risk assessments. I derived six clinical activities, which I refer to as probable standards, from a review of legal scholarship in tort law, court cases involving suicidal behavior, and forensic papers on suicide risk assessment. I discuss the basis for each probable standard and offer commentary to aid in their interpretation. My intention is not to define the legal standard of care for suicide risk assessments (only courts can do so) or to create a clinical practice guideline, but to establish legally informed reference points to assist forensic experts in providing objective, consistent, and compelling testimony.

Challenging logics of complex intervention trials: community perspectives of a health care improvement intervention in rural Uganda.

Health systems in many African countries are failing to provide populations with access to good quality health care. Morbidity and mortality from curable diseases such as malaria remain high. The PRIME trial in Tororo, rural Uganda, designed and tested an intervention to improve care at health centres, with the aim of reducing ill-health due to malaria in surrounding communities. This paper presents the impact and context of this trial from the perspective of community members in the study area. Fieldwork was carried out for a year from the start of the intervention in June 2011, and involved informal observation and discussions as well as 13 focus group discussions with community members, 10 in-depth interviews with local stakeholders, and 162 context descriptions recorded through quarterly interviews with community members, health workers and district officials. Community members observed a small improvement in quality of care at most, but not all, intervention health centres. However, this was diluted by other shortfalls in health services beyond the scope of the intervention. Patients continued to seek care at health centres they considered inadequate as well as positioning themselves and their children to access care through other sources such as research and nongovernmental organization (NGO) projects. These findings point to challenges of designing and delivering interventions within a paradigm that requires factorial (reduced to predictable factors) problem definition with easily actionable and evaluable solutions by small-scale projects. Such requirements mean that interventions often work on the periphery of a health system rather than tackling the murky political and economic realities that shape access to care but are harder to change or evaluate with randomized controlled trials. Highly projectified settings further reduce the ability to genuinely 'control' for different health care access scenarios. We argue for a raised consciousness of how evaluation paradigms impact on intervention choices.

Standards of practice for the adult mental health workforce: meeting the needs of families where a parent has a mental illness.

This article outlines the development of practice standards for the adult mental health workforce for addressing the needs of families where a parent has a mental illness (FaPMI). The practice standards recommended here were formulated using a modified cooperative inquiry process with a group of senior clinical leaders in adult mental health services in Australia, following consultation with the available literature and policy documents. The aim of the project was to generate, align, and operationalize family-inclusive practice standards within the core activities of the adult mental health workforce and integrate into the continuum of care and recovery for service users who are parents of dependent children. As part of a modified Delphi method, the standards were also ranked by the senior clinical leaders to determine what they believe to be essential and recommended practices for the adult mental health workforce they manage. We argue that developing practice standards that provide practical and realistic expectations of the adult mental health service workforce enable services and workers to better adapt practice to respond to FaPMI.

Lineamientos generales del sistema de referencia y contrareferencia / General guidelines of the referral and counter-referral system

Contiene un listado de siglas y acrónimos, mayormente de departamentos/unidades del Ministerio de Salud Pública y Asistencia Social. El documento hace la propuesta de esquematizar el SRCR [Sistema de Referencia y Contrarreferencia], puesto que: "En muchos países las urgencias hospitalarias se encuentran saturadas, en la mayoría por pacientes que no presentan afecciones que requieran atención hospitalaria urgente (2). Esto ha ocasionado que los hospitales sobrepasen su capacidad de respuesta, por el aumento en la demanda, ya sea por consulta externa o por emergencias menores, que pueden resolverse en los servicios del primero y segundo nivel de atención, teniendo en cuenta que el uso de los servicios sanitarios de Atención Primaria en Salud (APS) reduce las hospitalizaciones inadecuadas." Específicamente propone que: "El SRCR comprende todos los elementos que se necesitan para coordinar el envío de pacientes entre establecimientos de atención dentro de la red de servicios, de acuerdo con la complejidad del caso, la capacidad resolutiva, los recursos del establecimiento y la cartera de servicios. Establece que el proceso de referencia se debe realizar cuando la atención requerida por el paciente no está comprendida dentro de la cartera de servicios del establecimiento y/o no se cuenta con los recursos necesarios para su atención, debiéndose realizar el traslado hacia otro establecimiento de mayor o menor complejidad dependiendo del caso." El presente documento establece lineamientos de carácter general y obligatorio para las unidades médicas y es aplicable para todos los niveles de atención. Representa una guía para el traslado de pacientes, tanto al servicio que refiere como al que recibe, estableciendo la obligatoriedad de registrar y analizar la información de las referencias y contrarreerencias, datos que deben integrarse en la sala situacional de cada establecimiento de salud de los distintos niveles de atención, como parte de una red articulada de servicios de salud.

Building a network of ADPKD reference centres across Europe: the EuroCYST initiative.

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic inherited kidney disease, affecting an estimated 600 000 individuals in Europe. The disease is characterized by age-dependent development of a multiple cysts in the kidneys, ultimately leading to end-stage renal failure and the need of renal replacement therapy in the majority of patients, typically by the fifth or sixth decade of life. The variable disease course, even within the same family, remains largely unexplained. Similarly, assessing disease severity and prognosis in an individual with ADPKD remains difficult. Epidemiological studies are limited due to the fragmentation of ADPKD research in Europe. METHODS: The EuroCYST initiative aims: (i) to harmonize and develop common standards for ADPKD research by starting a collaborative effort to build a network of ADPKD reference centres across Europe and (ii) to establish a multicentric observational cohort of ADPKD patients. This cohort will be used to study factors influencing the rate of disease progression, disease modifiers, disease stage-specific morbidity and mortality, health economic issues and to identify predictive disease progression markers. Overall, 1100 patients will be enrolled in 14 study sites across Europe. Patients will be prospectively followed for at least 3 years. Eligible patients will not have participated in a pharmaceutical clinical trial 1 year before enrollment, have clinically proven ADPKD, an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m(2) and above, and be able to provide written informed consent. The baseline visit will include a physical examination and collection of blood, urine and DNA for biomarker and genetic studies. In addition, all participants will be asked to complete questionnaires detailing self-reported health status, quality of life, socioeconomic status, health-care use and reproductive planning. All subjects will undergo annual follow-up. A magnetic resonance imaging (MRI) scan will be carried out at baseline, and patients are encouraged to undergo a second MRI at 3-year follow-up for qualitative and quantitative kidney and liver assessments. CONCLUSIONS: The ADPKD reference centre network across Europe and the observational cohort study will enable European ADPKD researchers to gain insights into the natural history, heterogeneity and associated complications of the disease as well as how it affects the lives of patients across Europe.

European Cystic Fibrosis Society Standards of Care: Best Practice guidelines.

Specialised CF care has led to a dramatic improvement in survival in CF: in the last four decades, well above what was seen in the general population over the same period. With the implementation of newborn screening in many European countries, centres are increasingly caring for a cohort of patients who have minimal lung disease at diagnosis and therefore have the potential to enjoy an excellent quality of life and an even greater life expectancy than was seen previously. To allow high quality care to be delivered throughout Europe, a landmark document was published in 2005 that sets standards of care. Our current document builds on this work, setting standards for best practice in key aspects of CF care. The objective of our document is to give a broad overview of the standards expected for screening, diagnosis, pre-emptive treatment of lung disease, nutrition, complications, transplant/end of life care and psychological support. For comprehensive details of clinical care of CF, references to the most up to date European Consensus Statements, Guidelines or Position Papers are provided in Table 1. We hope that this best practice document will be useful to clinical teams both in countries where CF care is developing and those with established CF centres.

Can Italian healthcare administrative databases be used to compare regions with respect to compliance with standards of care for chronic diseases?

BACKGROUND: Italy has a population of 60 million and a universal coverage single-payer healthcare system, which mandates collection of healthcare administrative data in a uniform fashion throughout the country. On the other hand, organization of the health system takes place at the regional level, and local initiatives generate natural experiments. This is happening in particular in primary care, due to the need to face the growing burden of chronic diseases. Health services research can compare and evaluate local initiatives on the basis of the common healthcare administrative data.However reliability of such data in this context needs to be assessed, especially when comparing different regions of the country. In this paper we investigated the validity of healthcare administrative databases to compute indicators of compliance with standards of care for diabetes, ischaemic heart disease (IHD) and heart failure (HF). METHODS: We compared indicators estimated from healthcare administrative data collected by Local Health Authorities in five Italian regions with corresponding estimates from clinical data collected by General Practitioners (GPs). Four indicators of diagnostic follow-up (two for diabetes, one for IHD and one for HF) and four indicators of appropriate therapy (two each for IHD and HF) were considered. RESULTS: Agreement between the two data sources was very good, except for indicators of laboratory diagnostic follow-up in one region and for the indicator of bioimaging diagnostic follow-up in all regions, where measurement with administrative data underestimated quality. CONCLUSION: According to evidence presented in this study, estimating compliance with standards of care for diabetes, ischaemic heart disease and heart failure from healthcare databases is likely to produce reliable results, even though completeness of data on diagnostic procedures should be assessed first. Performing studies comparing regions using such indicators as outcomes is a promising development with potential to improve quality governance in the Italian healthcare system.

Equity in cancer care: pathways, protocols, and guidelines.

The quality of patient care varies based on numerous factors, such as health care setting, geographic location, access to medications, insurance coverage, and treatment protocols. Recently, the issue of whether use of clinical pathways can reduce costs and inappropriate variability in care has been the subject of much debate. As clinical treatment guidelines and pathways are increasingly deployed in oncology practice, they have a growing impact on the quality of treatment and how it is delivered. To fulfill the current need to discuss the use of pathways and clinical treatment guidelines in oncology and to address how patient care is impacted by their use, the National Comprehensive Cancer Network convened the NCCN Oncology Policy Summit: Equity in Cancer Care-Pathways, Protocols, and Guidelines. The summit was a forum to discuss the use and implementation of pathways, including how much flexibility pathways should allow in care, pathways' impact on public and private health insurance benefit design, what data is used to select pathway regimens and protocols, and ultimately what impact pathways may have on variation in care. The use and implementation of clinical treatment guidelines in practice was also explored from a variety of perspectives.