Navigating Ethical Practices in the Era of High Cost Hematology.

PURPOSE OF REVIEW: In this review article, we will highlight ethical issues faced by hematologists due to a growing constellation of expensive diagnostics and therapeutics in hematology. We outline the important issues surrounding this topic including stakeholders, cost considerations, and various ethical challenges surrounding access to care, communication about costs, and individual vs. societal responsibilities. We review available tools to navigate these ethical themes and offer potential solutions. RECENT FINDINGS: We identified several gaps in the literature on the topic of ethical issues in hematology treatment and supplement by non-hematological cancer and general medical literature. We propose proactive solutions to address these problems to include cost transparency, utilization of evidence-based decision making tools, application of the four quadrant approach to ethical care, and advanced systems-based practice curriculum for physician trainees.

When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges.

This study investigated the kinds of ethical challenges experienced by nurses in oncology and hematology when nursing care and research overlap in clinical trials, and how the nurses handle such challenges. Individual interviews with 39 nurses from Sweden, Denmark, and Finland indicated that all nurses were positive about research, considering it essential for developing the best care. Ethical challenges exist, however; the most difficult were associated with the end-of-life patients, no longer responsive to standard therapy, who eagerly volunteer for cutting-edge drug trials in the hope of gaining therapeutic benefit. Many nurses lacked systematic strategies for addressing such challenges but found support from their nursing colleagues and relied on the research protocols to guide them.

Ethical competence in DNR decisions -a qualitative study of Swedish physicians and nurses working in hematology and oncology care.

BACKGROUND: DNR decisions are frequently made in oncology and hematology care and physicians and nurses may face related ethical dilemmas. Ethics is considered a basic competence in health care and can be understood as a capacity to handle a task that involves an ethical dilemma in an adequate, ethically responsible manner. One model of ethical competence for healthcare staff includes three main aspects: being, doing and knowing, suggesting that ethical competence requires abilities of character, action and knowledge. Ethical competence can be developed through experience, communication and education, and a supportive environment is necessary for maintaining a high ethical competence. The aim of the present study was to investigate how nurses and physicians in oncology and hematology care understand the concept of ethical competence in order to make, or be involved in, DNR decisions and how such skills can be learned and developed. A further aim was to investigate the role of guidelines in relation to the development of ethical competence in DNR decisions. METHODS: Individual interviews were conducted with fifteen nurses and sixteen physicians. The interviews were analyzed using thematic content analysis. RESULTS: Physicians and nurses in the study reflected on their ethical competence in relation to DNR decisions, on what it should comprise and how it could be developed. The ethical competence described by the respondents related to the concepts being, doing and knowing. CONCLUSIONS: In order to make ethically sound DNR decisions in oncology and hematology care, physicians and nurses need to develop appropriate virtues, improve their knowledge of ethical theories and relevant clinical guidelines. Ethical competence also includes the ability to act upon ethical judgements. Continued ethical education and discussions for further development of a common ethical language and a good ethical working climate can improve ethical competence and help nurses and physicians cooperate better with regard to patients in relation to DNR decisions, in their efforts to act in the best interest of the patient.

Ética y protección radiológica en la medicina nuclear en hematología / Ethics and radiological protection in nuclear medicine in hematology

El campo de utilización cada vez más amplio de las sustancias radiactivas en la medicina exige el manejo y la aplicación de los principios de la ética en una relación muy estrecha con la protección radiológica (PR). Existe una necesidad insoslayable de llevar la perspectiva de la ética en el uso de las radiaciones ionizantes y de la PR del paciente a la práctica de la Medicina Nuclear en Hematología (MNH). Esto no debe asumirse como un proceso de simple adopción, sino como la aplicación creativa de sus principios. Será de gran utilidad continuar incluyendo en la docencia que se imparte a los profesionales de las diversas especialidades que emplean la medicina nuclear como herramienta diagnóstica o terapéutica, una formación científica basada en los principios de la ética sumados a elementos de la PR. El colectivo multidisciplinario dedicado a la MNH tiene una responsabilidad de índole moral y ética en la garantía del uso adecuado de las sustancias radiactivas en la técnica médica y el desarrollo científico de la especialidad. La siguiente revisión del tema pretende contribuir al fomento de principios éticos en los especialistas de hematología durante su quehacer diario. Con la aplicación de la ética en el contexto de la MNH, perfeccionaremos la gestión de PR en el manejo de los pacientes, contribuiremos a la mejor atención a estos y elevaremos la calidad de nuestro trabajo...

The increasingly width of the field of radioactive substances use in medicine demands the managing and the application of ethics principles in a very close relation to radiological protection. There is an unavoidable need to take ethics perspective in the use of ionizing radiations and the radiological protection of the patient to the practice of Nuclear Medicine in Hematology (NMH). This must not be assumed as a process of simple adoption, but as the creative application of his principles. It will be highly useful to continue including in the teaching programs aimed to professionals who use nuclear medicine as a diagnostic or therapeutic tool, a scientific formation based on the ethics principles including the elements of radiological protection. The multidisciplinary group dedicated to NMH has a moral and ethical responsibility to guarantee the appropriate use of radioactive substances in the medical technology and scientific development of this specialty. The following review on the subject wishes to contribute to the promotion of ethical principles in hematology specialists during their daily work. With the application of ethics in the context of NMH, we will also improve the radiological protection of our patients which will contribute to their best care and will increase the quality of our work...

Striving for good nursing care: nurses' experiences of do not resuscitate orders within oncology and hematology care.

BACKGROUND: Within oncology and hematology care, patients are sometimes considered to have such a poor prognosis that they can receive a do not resuscitate order from the physician responsible, stipulating that neither basic nor advanced coronary pulmonary rescue be performed in the event of a cardiac arrest. Studies on do not resuscitate decisions within oncology and hematology units, focusing on the specific role of the nurse in relation to these decisions, are scarce. OBJECTIVE: The aim of this study was to investigate hematology and oncology nurses' experiences and perceptions of do not resuscitate orders, in order to achieve a deeper understanding of the nurses' specific role in these decisions. RESEARCH DESIGN: A qualitative, descriptive methodology with individual semi-structured interviews was used. PARTICIPANTS AND RESEARCH CONTEXT: A total of 15 nurses from eight hematology/oncology wards in four hospitals in Sweden were interviewed individually. ETHICAL CONSIDERATIONS: In accordance with national regulations, an ethical review was not required for this study. The research followed international guidelines for empirical research, as outlined in the Helsinki Declaration. FINDINGS: The nurses strived for good nursing care through balancing harms and goods and observing integrity and quality of life as important values. Experienced hindrances for good care were unclear and poorly documented decisions, uninformed patients and relatives, and disagreements among the caregivers and family. The nurses expressed a need for an ongoing discussion on do not resuscitate decisions, including all concerned parties. CONCLUSION: In order to provide good nursing care, nurses need clear and well-documented do not resuscitate orders, and patients and relatives need to be well informed and included in the decisions. To increase the understanding for each other's opinions within the medical team, regular ethical discussions are required.

Applications of high-throughput DNA sequencing to benign hematology.

The development of novel technologies for high-throughput DNA sequencing is having a major impact on our ability to measure and define normal and pathologic variation in humans. This review discusses advances in DNA sequencing that have been applied to benign hematologic disorders, including those affecting the red blood cell, the neutrophil, and other white blood cell lineages. Relevant examples of how these approaches have been used for disease diagnosis, gene discovery, and studying complex traits are provided. High-throughput DNA sequencing technology holds significant promise for impacting clinical care. This includes development of improved disease detection and diagnosis, better understanding of disease progression and stratification of risk of disease-specific complications, and development of improved therapeutic strategies, particularly patient-specific pharmacogenomics-based therapy, with monitoring of therapy by genomic biomarkers.

Urgencias en Hematología: alteraciones metabólicas y leucocitarias / Emergencies in Hematology: metabolic and leukocyte alterations

Las urgencias que pueden surgir durante la evolución de las enfermedades hematológicas son diversas, tanto por el comportamiento de la enfermedad de base como por el momento en que se presentan. Pueden ser la primera manifestación de la enfermedad o aparecer en el curso de su evolución, y sus secuelas pueden ser menores si se diagnostican y tratan adecuadamente. Se hace una revisión de algunas de las alteraciones metabólicas y leucocitarias más frecuentes que se pueden presentar en el paciente oncohematológico

Emergencies which may appear during the evolution of hemopathies are diverse due to their basic behavior as well as according to the moment the disease comes into view. They may be the first sign of the disease or could appear during the course of its evolution. Consequences might be milder if diagnosed and treated properly. A revision of some of the most frequent metabolic and leukocyte alterations that could arise in the patient with an oncohematological disease is shown

Diálogo de saberes sobre el bioanálisis en Venezuela / Dialogue of knowledge on Venezuela bioanalysis

La equidad de los servicios de salud es uno de los principios fundamentales del derecho a la salud de nuestra Carta Magna (Art. 84), es por ello que al hacer una revisión de la situación de los servicios de Bioanálisis, en Venezuela y en especial en las zonas de frontera con la población rural, indígena y dispersa, es donde se evidencia lo poco que se hace o hacemos como profesionales de la salud para cumplir con ese principio, plantearnos la necesidad de ejercer nuestra profesión donde más se necesite, zona donde por el ejemplo la sola realización de algún examen microscópico (baciloscopias, diagnóstico de malaria, recuento diferencial, contaje de blancos) marca la diferencia entre la vida y la muerte, y las acciones de salud pública que se puedan aplicar para el control de enfermedades endémica. Si bien es cierto, el profesinal del Bioanálisis posee la formación para desarrollar diferentes roles: analista, investigador, agente de cambio social y administrador, cuando hacemos una reflexión del papel que tradicionalmente se desarrolla, vemos que el mayor porcentaje de los egresados desempeña el rol de analista en cargos asistenciales, circunscribiéndose a ser ejecutores de técnicas y procedimientos analíticos, donde labora un técnico operador de equipos semiautomatizados o automatizados productos de resultados. Deja entonces de lado, los roles más humanos de nuestra profesión, y el rol de crítico protagonista del equipo de salud. Esto trae como consecuencia que frecuentemente, cuando se nombra a los miembros del equipo de salud, el Bioanalista no figura como tal y si se hace, sólo se hace referencia al "paramédico", pues el trabajo se traduce sólo en una hoja de resultado firmada. Hemos identificados algunos obstáculos que durante el ejercicio de nuestra profesión influyen en la generación de inequidades en salud, en particular en materia de acceso a los servicios de salud y a servicios de salud de igual calidad. Los hemos denomido FRONTERAS.

The equity of health services is one of the fundamental principles of the right to health of our Constitution (Art. 84), when we do a review of the situation of Bioanalysis servicies in Venezuela and especially in the border areas with rural, Indians and/or scattered population, we showed how little we do as health professionals to fullfill the need to accomplish our profession where most ist needed, areas for examples, where only doing a single microscopie examination (smear, malaria diagnosis, differential count, white count) makes the difference between life and death, and public health actions that can be applied for the control of endemic diseases. Although the professional trained like Bioanalysis has to develop different roles: analyst, researcher, social change agent and manager, when we see the role that we traditionally develop, we see that a highest percentage of bachelors play the role of technical operator of semi-automated or automated equipment just producing tests results, leaving aside the human role in our profession, and the role critical protagonist of the health team. The consequence is that often, when people refer to the members of the health team, the Bianalyst is not shown as such, referring only to "paramedic", as the work is translated only into a signature result sheet. We have identified some obstacles during the practice of our profession that influence the generation of health inequities, particularly in access to health services and health services of equal quality. We have called BORDERS.

[Benefit-risk evaluation of new drugs as a basis for decisions on prioritization in hematology/oncology: methodical challenges and problem-solving strategies]. / Nutzen-Risiko-Bewertung neuer Wirkstoffe als Grundlage für Priorisierungsentscheidungen in der Hämatologie/Onkologie: Methodische Herausforderungen und Lösungsansätze.

Innovations in the drug treatment of cancer patients pose several medical and ethical challenges. The increasing incidence and prevalence of cancer, in combination with the availability of new and usually highly expensive anticancer drugs, are associated with a significant increase in the general costs for the treatment of cancer patients. Therefore, the development of scientific strategies for judgments on benefits is indispensable. In this paper, the authors analyze the benefit assessment and the benefit-risk assessment as a foundation for decisions on prioritization in hematology and oncology. In a first step, regulatory aspects and shortcomings regarding the design of clinical trials in oncology before and after approval of anticancer drugs are identified as factors that contribute to difficulties in establishing the effectiveness of new drugs entering the health care market. The authors will conclude with suggestions for the improvement of benefit-risk analyses and the generation of scientific data necessary for such analyses.

[Role of multicenter study groups for clinical research in hematology and oncology]. / Bedeutung von Multicenterstudiengruppen für die klinische Forschung in der Hämatologie und Onkologie.

During the past 25 years a highly effective infrastructure for clinical trials was developed in hematology. Following initial funding by the BMFT (Ministry for Research and Technology) a number of large multicenter study groups for leukemia and lymphoma were developed. Treatment results from these studies often represent the"gold standard". However, since no standard therapy is defined for these diseases, the study groups aim to treat all patients within treatment optimization trials (TOT) to combine research and care. They contribute considerably to quality control in therapy and diagnostics, e.g., by establishing central reference laboratories. The regulatory requirements for clinical trials were extended considerably after the activation of the 12th drug law and TOTs now have to fulfill requirements similar to registration trials in the pharmaceutical industry. Due to the considerable bureaucratic effort and increased costs, only few large multicenter trials could thereafter be initiated and a substantial disadvantage for independent academic research becomes clearly evident.

Investment analysts and the American Society of Hematology.

Investment analysts are a growing presence at the Annual Meeting of the American Society of Hematology (ASH), and financial professionals frequently contact ASH members for information and perspective on drugs, devices, and scientific developments. Recent incidents have raised concerns about consulting relationships between physicians and the investment industry; the appropriate role of medical societies in influencing these relationships is unclear. In this essay, I summarize the current situation, discuss potential risks and benefits from interactions between physicians and investment analysts, and outline issues that all individuals involved in investment industry consulting should consider. I also propose changes in ASH policy that may help safeguard public trust as well as preserve the access of clinicians and scientists to clinically relevant data presented at the Annual Meeting.

Legal and ethical issues relating to use of complementary therapies in pediatric hematology/oncology.

Pediatricians increasingly are asked to advise pediatric patients and their families concerning integration into conventional care (including hematology and oncology) of complementary and alternative medical (CAM) therapies such as chiropractic, massage therapy, and herbal medicine. Inclusion of CAM therapies in pediatric oncology and hematology--as in any medical subspecialty--is not itself "unethical," clinically inadvisable, or legally risky; the danger comes from over-reliance on one or more CAM therapies (particularly those with evidence of danger and/or paltry evidence of success) to the exclusion of conventional care that is curative and imminently necessary. Pediatricians can help address potential malpractice liability issues by evaluating the level of clinical risk, engaging the patient in shared decision making and documenting this in the medical record, continuing to monitor conventionally, and being prepared to intervene conventionally when medically required.

Integrative medicine in hematology/oncology: benefits, ethical considerations, and controversies.

Integrative Medicine (IM), a newly emerging field, has evolved from Complementary and Alternative Medicine (CAM). CAM refers to diverse medical and health care systems, practices, and products that are not presently considered part of conventional medicine and generally have limited scientific evidence. In the US, CAM is a multi-billion dollar, unregulated industry with potential benefits and risks to consumers, including cancer patients, who are high utilizers of complementary therapies. Patients' CAM use often is unsupervised by physicians, yet patients need the advice and guidance of their hematologists/oncologists as part of total cancer care. Ethical and legal issues physicians need to address include inquiring about and educating patients regarding potential interactions (e.g., drug-herb, radiation-antioxidant) or product contaminants, while discussing other therapies that may alleviate symptoms and/or improve quality of life. Administratively, CAM offerings in medical settings require relevant policies and procedures, such as properly credentialing practitioners and providing financial assistance counseling for those who cannot afford fee-for-service. Unlike "Alternative Medicine," the goal of IM is to combine mainstream medical therapies and CAM therapies (e.g., acupuncture, meditation, music therapy) that have some high-quality scientific evidence of safety and effectiveness. The Society for Integrative Oncology (SIO), a new international organization of oncology professionals studying and integrating effective complementary therapies in cancer care, serves as a forum for presenting scientific data on these therapies while emphasizing the importance of developing infrastructure that promotes IM principles and practices. The ultimate goal is to develop multidisciplinary expertise and therapeutic synergy between conventional and complementary therapies.