Ethics and Industry Interactions: Impact on Specialty Training, Clinical Practice, and Research.

Physicians in training and their mentors must be cognizant of ethical concerns related to industry interactions. Mentors perceived to have conflicts of interest or to be engaging in misconduct can unconsciously and profoundly affect the learning and academic environment by implying certain values and expectations. Despite increased awareness of ethical concerns related to industry interactions in clinical practice and research, there remains a need for interventions to prevent ethical transgressions. Ethics education is essential and a move in the right direction, but it alone is likely inadequate in preventing unethical behavior. Education should be supplemented with ethical environments at institutions.

Evaluation of medical ethics competencies in rheumatology: local experience during national accreditation process.

INTRODUCTION: Rheumatologists are the primary healthcare professionals responsible for patients with rheumatic diseases and should acquire medical ethical competencies, such as the informed consent process (ICP). The objective clinical structured examination is a valuable tool for assessing clinical competencies. We report the performance of 90 rheumatologist trainees participating in a station designed to evaluate the ICP during the 2018 and 2019 national accreditations. METHODS: The station was validated and represented a medical encounter in which the rheumatologist informed a patient with systemic lupus erythematosus with clinically active nephritis about renal biopsy. A trained patient-actor and an evaluator were instructed to assess ICP skills (with a focus on kidney biopsy benefits, how the biopsy is done and potential complications) in obtaining formal informed consent, delivering bad news and overall communication with patients. The evaluator used a tailored checklist and form. RESULTS: Candidate performance varied with ICP content and was superior for potential benefit information (achieved by 98.9% of the candidates) but significantly reduced for potential complications (37.8%) and biopsy description (42.2%). Only 17.8% of the candidates mentioned the legal perspective of ICP. Death (as a potential complication) was omitted by the majority of the candidates (93.3%); after the patient-actor challenged candidates, only 57.1% of them gave a clear and positive answer. Evaluators frequently rated candidate communications skills as superior (≥80%), but ≥1 negative aspect was identified in 69% of the candidates. CONCLUSIONS: Ethical competencies are mandatory for professional rheumatologists. It seems necessary to include an ethics competency framework in the curriculum throughout the rheumatology residency.

Ethics and Professionalism 2016.

Whether a reaction to events in the clinical arena, a consequence of technological innovation, or the legitimization of the marked ethos in health care, the field of medical ethics has become a complex domain in our time. Indeed, the ubiquity of ethical dilemmas in the provision of health care is well documented with more than 99% of primary care physicians reporting ethical problems arising in the conduct of their practices (1-3). Although commentary relating to this domain has most often originated in the primary care setting, hospital-based medicine and its ethics committees are another fertile source, as is medical research. Yet when one examines subspecialty medicine, a remarkable dearth of analysis and discourse pertaining to medical ethics emerges. This discussion is an attempt to address this deficit, at least as it pertains to one subspecialty: rheumatology. Leading with a brief overview of medical ethics writ large, perceptions concerning the ethical challenges arising in current rheumatic disease practice will be presented, hopefully enhancing awareness and sensitivity to the ethical challenges arising in modern day medical practice.

Interface Management between General Practitioners and Rheumatologists-Results of a Survey Defining a Concept for Future Joint Recommendations.

OBJECTIVE: To measure the views of general practitioners (GPs) and rheumatologists in a nationwide evaluation, so as to optimise their cooperation in managing patients with inflammatory rheumatic diseases. METHODS: A questionnaire covering aspects of collaboration was sent, both by mail and/or by email, to all GPs and rheumatologists in Austria. Topics covered were (i) examinations and interventions to be performed before referral, (ii) the spectrum of diseases to be referred, and (iii) the role of GPs in follow-up and continuous management of patients. RESULTS: 1,229 GPs of the 4,016 GPs (31%) and 110 of the 180 rheumatologists (61%) responded to the questionnaire. In cases of suspected arthritis, 99% of the GPs and 92% of the rheumatologists recommended specific laboratory tests, and 92% and 70%, respectively, recommended X-rays of affected joints before referral. Rheumatoid arthritis and spondyloarthritis, psoriatic arthritis and connective tissue disease were unanimously seen as indications for referral to a rheumatologist. Only 12% of rheumatologists felt responsible for the treatment of hand osteoarthritis and fibromyalgia. 80% of GPs and 85% of rheumatologists were of the opinion that treatment with disease-modifying drugs should be initiated by a specialist. Subsequent drug prescription and administration by GPs was supported by a majority of GPs and rheumatologists, with a concomitant rheumatologist follow-up every three to six months. CONCLUSION: The considerable consensus between the two professional groups constitutes a solid base for future joint recommendations, with the aim to accelerate the diagnostic process and the initiation of adequate therapy.

Profesión médica, ética y reumatología: ¿hacia dónde vamos? / Medical profession, ethics and rheumatology: where are we going?

The progress of medicine in the past 25 years has been extraordinary, especially in what refers to the technology. This has allowed obtaining a better quality of life of a human being that ever increases over the average of this. However, raises doubt whether in this fast-paced technological progress the medical profession has lost the vocation and the true meaning of the medicine, to be replaced by another kind of interests. A look at current medicine allows observing balance has been lost and technology has moved to the person, the disease has moved to the sick and policies of management and goals have shifted to the quality and value. Medicine is immersed in a community market that most repairs on the thing that in the human being and in this environment develops rheumatology, which without renouncing the advance, trying to keep his gaze humanist to the sick person. It’s a look to evaluate what can be done, that many times is much, and what should be done, which is guided by the ethical education and the respect to the person...

El avance de la medicina en los últimos 25 años ha sido extraordinario, especialmente en lo que se refiere a la tecnología. Eso ha permitido obtener una mejor calidad de vida de un ser humano que cada vez aumenta más el promedio de ésta. Sin embargo, se plantea la duda si en este vertiginoso avance tecnológico la profesión médica ha perdido la vocación y el verdadero sentido de la medicina, para ser reemplazada por otra clase de intereses. Una mirada la medicina actual permite observar que se ha perdido el equilibrio y la tecnología ha desplazado a la persona, la enfermedad ha desplazado al enfermo y las políticas de gestión y de metas han desplazado a las de calidad y valor. La medicina está inmersa en una comunidad de mercado que repara más en la cosa que en el ser humano y en este medio se desarrolla la reumatología, que sin renunciar al avance, intenta mantener su mirada humanista hacia la persona enferma. Es una mirada hacia lo que se puede hacer, que muchas veces es mucho, y lo que se debe hacer, que es guiado por la formación ética y el respeto a la persona...

Ethical challenges in rheumatology: a survey of the American College of Rheumatology membership.

OBJECTIVE: Despite the frequency of ethical issues arising in patient care, ethical discourse in the rheumatology literature is negligible. To better understand the scope of ethical problems occurring in our specialty, the American College of Rheumatology (ACR) Committee on Ethics and Conflict of Interest surveyed ACR members. Specific objectives of the survey were 1) to learn the perceived frequency of ethical issues in rheumatology, 2) to identify activities that pose ethical problems in rheumatologic practice, 3) to determine the extent of education on, and self-perceived knowledge about, ethics among ACR members, and 4) to determine member interest in, and suggest content for, future ACR-sponsored educational activities related to bioethics. METHODS: The survey included 12 non-open-ended questions addressing 5 core areas: 1) ethical dilemmas in daily practice, 2) ethical concerns in basic and clinical research, 3) influence of industry, 4) ethics of regulatory policies, potential conflicts, and disclosure, and 5) personal education on and interest in ethics. Two open-ended questions were also included, asking respondents to list the ethical issues most relevant to rheumatology and to provide any comments. Data analysis was descriptive. RESULTS: Seven hundred seventy-one responses were received. Respondents believed that ethical issues arise most frequently in practice and in clinical research. The most common ethical issues cited were the high cost of treatment for patients (51% of respondents) and for society (48%), and the practice of defensive medicine (45%). CONCLUSION: The survey results suggest that ethical problems in rheumatology are of concern to the ACR membership. Further, there is a perceived need for educational programs targeted at helping members address such professional challenges.

Actualización 2011 del consenso Sociedad Española de Reumatología de osteoporosis / 2011 Up-date of the consensus statement of the Spanish Society of Rheumatology on osteoporosis

Objetivo. Dado el creciente avance en el diagnóstico como evaluación y tratamiento de la osteoporosis, y la incorporación de nuevas herramientas y medicamentos, desde la Sociedad Española de Reumatología (SER) se ha impulsado el desarrollo de recomendaciones basadas en la mejor evidencia posible. Estas deben de servir de referencia para reumatólogos y otros profesionales de la salud implicados en el tratamiento de pacientes con osteoporosis. Métodos. Las recomendaciones se emitieron siguiendo la metodología de grupos nominales. El nivel de evidencia y el grado de recomendación se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por técnica Delphi. Se utilizó toda la información de consensos previos y guías de práctica clínica disponibles. Resultados. Se realizan recomendaciones sobre el diagnóstico, la evaluación y el tratamiento en pacientes con osteoporosis. Estas recomendaciones incluyen la osteoporosis secundaria a glucocorticoides, la osteoporosis premenopáusica y la del varón. Conclusiones. Se presentan las recomendaciones SER sobre el diagnóstico, la evaluación y el manejo de pacientes con osteoporosis (AU)

Objective. Due to increasing improvement in the diagnosis, evaluation and management of osteoporosis and the development of new tools and drugs, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and other health professionals involved in the treatment of patients with osteoporosis. Methods. Recommendations were developed following a nominal group methodology and based on a systematic review. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Evidence from previous consensus and available clinical guidelines was used. Results. We have produced recommendations on diagnosis, evaluation and management of osteoporosis. These recommendations include the glucocorticoid-induced osteoporosis, premenopausal and male osteoporosis. Conclusions. We present the SER recommendations related to the biologic therapy risk management (AU)

Informed consent in rheumatology care practice.

Informed consent is a mandatory document in human subject research protocols. Its principles have been recently established in the history of Medicine, and the first official document to establish the need for an informed consent from the research subject was the Nuremberg Code (1947). All following documents confirmed that the informed consent is mandatory in human subject research. However, the informed consent, which represents patients' autonomy or self-determination regarding their relationship with their physicians, took a while to be included in medical care practice and medical deontology codes. The convenience of using the informed consent in medical practice is widely discussed today, especially in rheumatology. Our opinion is that the obligation of a signed informed consent provided by the patient for every medical procedure is neither reasonable nor practical. It should be used for more invasive or risky therapeutic procedures. We understand that the informed consent does not guarantee that the patient has been fully informed, which is an essential condition for the current rheumatological practice. Its adoption in routine medical care practice would make medical intervention bureaucratic, and, thus, quite different from the Hippocratic view, which considered the trustful physician-patient relationship fundamental for an adequate medical care practice.

Es necesario desarrollar el profesionalismo médico / It is necessary to develop medical professionalism

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Nuevos criterios de acreditación de unidades docentes de Reumatología / No disponible

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[Biomarkers collections: the future or a waste of resources?]. / Biomarkersammlungen: Zukunft oder Ressourcenverschwendung?

Disease biomarkers would aim at a more specific definition of diagnosis or subtype of a certain disease, as well as prognosis definition, including efficacy and side effects of certain therapeutics. Biomarkers could lead to a prognostically optimized definition of remission in the individual patient and thus to a more objective definition of therapeutic efficacy. Is this possible and does it make sense? Or would an extensive analysis of biomarkers to date lead to a costly overestimation of as yet not well established biologic parameters? Although we are currently unable to answer this question, many colleagues argue in favour of more in depth research for a better evaluation of biomarkers in many diseases. This could save money if we were able to predict the efficacy of expensive drugs such as immunobiologics. Biomarkers comprise cytometric information, data on protein expression and secretion, mRNA, microRNA or DNA, including epigenetic variants. Although much of these data already exist in the scientific literature, it is associated with problems in terms of feasibility (for cytometry and RNA analysis only on-site analysis is possible, while for DNA analysis central testing is also possible), costs and reproducibility (ethnic variability!). To date all biomarkers have only limited value in terms of the above-mentioned aims. The present review compiles "PROs and CONs" in a subjective way in order to provoke a discussion on the meaningfulness of biomarkers, while at the same time supporting and encouraging further research in this field.

El hombro y sus patologías en medicina del trabajo / Shoulder and their pathologies in occupational medicine

Las patologías del hombro son de las más frecuentes tanto en medicina del trabajo como en Atención Primaria, traumatología, reumatología y rehabilitación. Nos interesa estudiar con detalle los factores laborales y las actividades de riesgo dentro del mundo del trabajo que pudieran provocar o favorecer su aparición o bien agravar su evolución, haciendo especial hincapié en la legislación de aplicación en salud laboral y en las actividades preventivas relacionadas con la vigilancia periódica de la salud y en los protocolos que se aplican, así como en el Real Decreto de enfermedades profesionales en el que se encuentran incluidas las enfermedades del hombro, para los casos en los que pudiera establecerse un origen laboral. Se trata, en conclusión, de buscar una actuación profesional coordinada entre los médicos del trabajo, los de Atención Primaria y atención especializada en el manejo y control evolutivo de estas patologías (AU)

Shoulder pathologies are among the most common in both in occupational health and in primary care, traumatology, rheumatology and rehabilitation. In this paper, we examine in detail the risk factors and activities in the workplace that could provoke, aggravate or favor the appearance of shoulder pathologies. We emphasize the application of the laws on occupational health, preventive activities related to periodic vigilance and check-ups and the current protocols in effect as well as the Royal Decree on illnesses (including shoulder illnesses) which originate in the workplace. Our objective is to improve professional coordination among occupational, primary care and specialized health professionals in the management and care of these pathologies (AU)

Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

The concept of 'equipoise', or the 'uncertainty principle', has been represented as a central ethical principle, and holds that a subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology, to explore the reasons for any deviations from equipoise, to examine the concept of 'design bias', and to consider alternative ethical formulations that might improve subject safety and autonomy. We studied abstracts accepted for the 2001 American College of Rheumatology meetings that reported RCTs, acknowledged industry sponsorship, and had clinical end-points (n = 45), and examined the proportion of studies that favored the registration or marketing of the sponsor's drug. In every trial (45/45) results were favorable to the sponsor, indicating that results could have been predicted in advance solely by knowledge of sponsorship (P < 0.0001). Equipoise clearly was being systematically violated. Publication bias appeared to be an incomplete explanation for this dramatic result; this bias occurs after a study is completed. Rather, we hypothesize that 'design bias', in which extensive preliminary data are used to design studies with a high likelihood of being positive, is the major cause of the asymmetric results. Design 'bias' occurs before the trial is begun and is inconsistent with the equipoise principle. However, design bias increases scientific efficiency, decreases drug development costs, and limits the number of subjects required, probably reducing aggregate risks to participants. Conceptual and ethical issues were found with the equipoise principle, which encourages performance of negative studies; ignores patient values, patient autonomy, and social benefits; is applied at a conceptually inappropriate decision point (after randomization rather than before); and is in conflict with the Belmont, Nuremberg, and other sets of ethical principles, as well as with US Food and Drug Administration procedures. We propose a principle of 'positive expected outcomes', which informs the assessment that a trial is ethical, together with a restatement of the priority of personal autonomy.