Nancy Olivieri: Sometimes, truth has only one face.

Nancy Olivieri is a senior haematologist and professor at the University of Toronto, Canada. In the early 1990s, she was conducting investigator-initiated research of an experimental drug, deferiprone, in children with thalassaemia, for which a pharmaceutical company, Apotex, started giving some supplemental support. In the course of her work, Dr Olivieri found that deferiprone might not be very effective and was also possibly toxic. When she signalled her intent to disclose the risks to participants, the trials were immediately shut down and she was threatened with "all legal remedies" should she disclose her concerns. This led to 18 years of attacks from the CEO of Apotex as well as fabricated charges and harassment from the University and the Hospital for Sick Children where she worked.

Disclosure of Adverse Events and Medical Errors: A Framework for Anesthesiologists.

Ethical disclosure of adverse events (AE) presents opportunities and challenges for physicians and has unique ramifications for anesthesiologists. AE disclosure is supported by patients, regulatory organizations, and physicians. Disclosure is part of a physician's ethical duty toward patients, supports fully informed patient decision making, and is a critical component of root cause analysis. Barriers to AE disclosure include disruption of the doctor-patient relationship, fear of litigation, and inadequate training. Apology laws intended to support disclosure and mitigate concern for adverse legal consequences have not fulfilled that initial promise. Training and institutional communication programs support physicians in providing competent, ethical AE disclosure.

Revealing misattributed parentage through the integration of genetic information into the electronic health record.

The integration of genetic information (GI) into the electronic health record (EHR) seems inevitable as the mainstreaming of genomics continues. Such newly provided accessibility to GI could be beneficial for improving health care, as well as for supporting clinical decision-making and health management. Notwithstanding these promising benefits, the automatic integration of GI into the EHR, allowing unrestricted access to one's GI through patient portals, carries various knowledge-related risks for patients. This article is focused on the potential case of inadvertently revealing misattributed parentage through such practice. The article aims to identify key clinical and ethical implications of such revelation for adult patients. Clinical implications include, for example, altering the physician-patient interaction and the need to enhance physician's genetic literacy to improve genetic-information-specific communication skills. Ethical implications yield arguments supporting disclosure of MP, such as autonomy, individuals' right to know medical information pertaining to them, and the right to know one's genetic origins. Arguments opposing disclosure of MP centre on the right not to know GI and concerns for post-disclosure family relationships. Following the clinical and ethical analyses of these respective implications, we consider how such integration of GI into the EHR ought to be carried out, ethically. We therefore suggest a solution, featuring an autonomy-based approach, built around EHR users' right not to know. Our solution of nuanced consent options (including a 'genetic ignorance option') is designed to enable patients' informed exposure to GI through the EHR, allowing them some control over their self- and familial narrative.

Difficulties experienced by dentists and orthodontists regarding ethical issues when announcing the diagnosis of a rare oral disease: a qualitative study in Marseille, France.

PURPOSE: It is traditionally considered that breaking bad news to patients does not represent a cause for concern for dental professionals. However, there are situations where they will be confronted with this task, as in the case of rare dental diseases. Little information is available regarding the feelings of healthcare professionals on this subject. There are no qualitative studies that explore how a diagnosis of oligodontia is announced to patients by dentists and orthodontists. The aim of our study is to explore the difficulties and ethical issues experienced by dental health professionals when they have to announce a diagnosis of oligodontia to a patient and their family. METHODS: This study relied on a qualitative research method using focus groups of dentists and orthodontists and a thematic analysis procedure. RESULTS: The difficulties experienced could be summarised within five topics: organisational difficulties, difficulties with the management of dental treatment and with the administrative management associated with this anomaly, difficulties with the content of the announcement, and relational difficulties. These could be grouped in two categories: practical difficulties and ethical difficulties. CONCLUSION: This survey allowed us to understand the difficulties encountered by dentists and orthodontists when announcing oligodontia. The participants felt uncomfortable with this task and were under stress. They reported difficulties in delivering the medical information and in adapting to the message. It is essential that dental professionals develop skills in medical communication.

Truth-telling to the seriously ill child - Nurses' experiences, attitudes, and beliefs.

BACKGROUND: Nurses play an integral role in the care of children hospitalised with a serious illness. Although information about diagnostics, treatments, and prognosis are generally conveyed to parents and caregivers of seriously ill children by physicians, nurses spend a significant amount of time at the child's bedside and have an acknowledged role in helping patients and families understand the information that they have been given by a doctor. Hence, the ethical role of the nurse in truth disclosure to children is worth exploring. METHODS: A systematic academic database and grey literature search strategy was conducted using CINAHL, Medline Psych Info, and Google Scholar. Keywords used included truth, children, nurse, disclosure, serious illness, and communication. A total of 17 publications of varying types were included in the final data set. ETHICAL CONSIDERATIONS: As this was a review of the literature, there were no direct human participants. Empirical studies included in the review had received ethics approval. RESULTS: Of the 17 articles included in the review, only one directly reported on the experiences of nurses asked to withhold the truth from patients. Empirical studies were limited to HIV-positive children and children diagnosed with cancer and the dying child. CONCLUSION: A paucity of literature exploring the experiences, attitudes, and beliefs of nurses with regard to truth-telling to seriously ill children is evident. Little consideration has been given to the role nurses play in communicating medical information to children in a hospital setting. The 17 articles included in the review focused on cancer, and HIV, diagnosis, and end-of-life care. Further research should be undertaken to explore the experiences and attitudes of nurses to clinical information sharing to children hospitalised with a wide range of serious illnesses and in diverse clinical scenarios.

Estratégias e dificuldades encontradas na comunicação de notícias difíceis em um hospital universitário / Strategies and difficulties found in communicating difficult news in a university hospital / Estrategias y dificultades encontradas para comunicar noticias difíciles en un hospital universitario

O trabalho teve como objetivo apresentar estratégias e dificuldades que influenciam o processo de Comunicação de Notícias Difíceis por médicos em um hospital universitário. Trata-se de um estudo descritivo-exploratório, de orientação qualitativa, sobre as estratégias e dificuldades encontradas por residentes (R1, R2 ou R3) e staffs, dos quatro programas da área médica: Ginecologia e Obstetrícia (GO), Pediatria, Cirurgia Geral (CG) e Clínica Médica (CM). A partir de uma entrevista semiestruturada para a análise dos dados foi utilizado o método do Discurso do Sujeito Coletivo (DSC), que mostrou como é importante utilizar protocolos para subsidiar a melhor abordagem com o paciente. Além da formação profissional, para realizar a comunicação de notícias difíceis, foi citado o protocolo SPIKES, seus pontos estratégicos e como ele pode auxiliar o profissional a realizar a melhor conduta. No que tange às dificuldades, a falta de preparo foi um dos destaques, bem como a ausência de um local adequado para a comunicação e os aspectos emocionais envolvidos, tanto por parte dos pacientes quanto dos profissionais de saúde. (AU)

The aim of this study was to present the strategies and difficulties that influence the process of communicating difficult news by doctors in a university hospital. This is a descriptive-exploratory study with a qualitative orientation on the strategies and difficulties encountered by residents (R1, R2 or R3) and staff from the four medical programs: Obstetrics and Gynecology (O&G), Pediatrics, General Surgery (GS) and Internal Medicine (IM). Based on a semi-structured interview, the Collective Subject Discourse (CSD) method was used for data analysis, which showed the importance of using protocols to support the best approach to the patient. In addition to professional training for communicating difficult news, the SPIKES protocol and its strategic points were mentioned, as well as how it can help professionals to conduct themselves effectively. The lack of preparation was one of the main difficulties reported, as well as the absence of an appropriate location for communication and the emotional aspects involved for both patients and health professionals. (AU)

El objetivo de este trabajo fue presentar estrategias y dificultades que influyen en el proceso de Comunicación de Noticias Difíciles por parte de médicos en un hospital universitario. Se trata de un estudio descriptivo-exploratorio, con orientación cualitativa, sobre las estrategias y dificultades encontradas por los residentes (R1, R2 o R3) y personal, de los cuatro programas del área médica: Ginecología y Obstetricia (GO), Pediatría, General Cirugía (CG) y Medicina Interna (CM). A partir de una entrevista semiestructurada para el análisis de los datos, se utilizó el método del Discurso del Sujeto Colectivo (CSD), que mostró cuán importante es el uso de protocolos para apoyar el mejor abordaje del paciente. Además de la formación profesional, para comunicar noticias difíciles, se mencionó el protocolo SPIKES, sus puntos estratégicos y cómo puede ayudar a los profesionales a llevar a cabo la mejor conducta. En cuanto a las dificultades, la falta de preparación fue uno de los destaques, así como la ausencia de un lugar adecuado para la comunicación y los aspectos emocionales involucrados, tanto por parte de los pacientes como de los profe-sionales de la salud. (AU)

Truthfulness and Deceit in Dementia Care: An argument for truthful regard as a morally significant human bond.

This paper presents a challenge to the view that benign 'white lies' may be therapeutic in dementia care and preferable to more truthful alternatives. Drawing on Sissela Bok and Bernard Williams, the paper develops three key points: first, that another person's dementia is not a reason to suspend one's customary reluctance to deceive others; second, that the commonly drawn contrast between benign deceit and blunt disclosure is too simple to frame arguments for the acceptability of deceit in dementia care; and third, truthful regard-regard for a person living with dementia as one for whom truth matters, as it does for oneself-is a foundation for beneficent concern that is neither infantilizing nor condescending. The paper proposes that a morally significant human bond is established through regard for another person as one for whom truth matters, just as it does for oneself, irrespective of another's dementia, and that within dementia care, the commission of deceit should be seen as an unsettling exception to a general principle of truthfulness.

Analysis of the reliability of patient COVID-19 screening data compared against their actual test data.

OBJECTIVES: This study aimed to evaluate the truthfulness of patients about their pre-appointment COVID-19 screening tests at a dental clinic. METHODS: A total of 613 patients were recruited for the study from the dental clinic at the Faculty of Dentistry, Najran University, Saudi Arabia. The data collection was done in three parts from the patients who visited the hospital to receive dental treatment. The first part included the socio-demographic characteristics of the patients and the COVID-19 swab tests performed within the past 14 days. The second part was the clinical examination, and the third part was a confirmation of the swab test taken by the patient by checking the Hesen website using the patient ID. After data collection, statistical analysis was carried out using SPSS 26.0. Descriptive analysis was done and expressed as mean, standard deviation, frequency, and percentage (%). A cross-tabulation, also described as a contingency table, was used to identify trends and patterns across data and explain the correlation between different variables. RESULTS: It was seen from the status of the swab test within 14 days of the patient's arrival at the hospital for the dental treatment that 18 (2.9%) patients lied about the pre-treatment swab test within 14 days, and 595 (97.1%) were truthful. The observed and expected counts showed across genders and diagnosis a statistically significant difference (p < 0.001), and there was no significant difference seen across different age groups (p = 0.064) of the patients. CONCLUSIONS: Dental healthcare workers are worried and assume a high risk of COVID-19 infection as the patients are not truthful about the pre-treatment COVID-19 swab test. Routine rapid tests on patients and the healthcare staff are a feasible option for lowering overall risks.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Consentimiento informado en las prestaciones de salud / Informed consent in health care services / Consentimento informado nas prestações de saúde

Resumen: Por regla general, las prestaciones de salud requieren el consentimiento informado del paciente. Los fundamentos éticos detrás de esta exigencia son la autonomía del paciente para decidir sobre su propio cuerpo y el respeto a su dignidad, que impide instrumentalizarlo. La manera en que el ordenamiento jurídico materializa estos fines es consagrando deberes de información y de consejo, y disciplinando las condiciones bajo las cuales debe prestarse el consentimiento. Jurídicamente, estos deberes delimitan la relación médico-paciente y ayudan a definir hipótesis de responsabilidad civil. En este artículo se revisan las condiciones para la satisfacción de estos deberes, así como los supuestos en que su infracción pueden dar lugar a responsabilidad civil.

Abstract: As a general rule, medical interventions require to be informingly consented by the patient. This requirement is ethically founded in the autonomy of the patient to decide on his own body and the respect for his dignity that prevent to instrumentalise it. The way in which the law materialises those ends is by implementing duties to inform and duties to advise, and regulating the conditions under which the consent must be given. Legally, those duties delimit the relation physician-patient and give guidance to define hypothesis of civil liability. In this article, we revise the conditions for the satisfaction of those duties and the cases in which their breach give rise to civil liability.

Resumo: Por regra general, as prestações de saúde requerem o consentimento informado do paciente. Os fundamentos éticos por trás dessa exigência são a autonomia do paciente para decidir sobre seu próprio corpo e o respeito à sua dignidade, que impede instrumentalizálo. A maneira em que o ordenamento jurídico materializa estes fins é consagrando deveres de informação e de aconselhamento, e disciplinando as condições sob as quais deve prestar-se o consentimento. Juridicamente, estes deveres delimitam a relação médico-paciente e ajudam a definir hipóteses de responsabilidade civil. Neste artigo se revisam as condições para a satisfação destes deveres, assim como os pressupostos em que sua infração podem dar lugar à responsabilidade civil.

The right to be forgotten and COVID-19: privacy versus public interest / El derecho al olvido y el COVID-19: privacidad frente a interés público / O direito ao esquecimento e COVID-19: privacidade versus interesse público

Abstract: Recent studies highlight the importance of digital surveillance to gather individual health information due to the global pandemic caused by the new COVID-19 disease. This paper analyses its legal and ethical implications at the interface between the individual right to privacy and the collective interests of public health. We framed the discussion in law, deontology and utilitarianism. The lasted theories and human rights, especially privacy, are crucial in our argument. Health-derived dilemmas and efforts to solve them, especially by information technologies, bioethics and law, exist at these perspectives' interface. In particular, we analysed the intersection between autonomy, the right to privacy, and the so-called 'right to be forgotten' in the public health context. In other words, we studied the right to obtain from the controller the erasure of health data - a radical means of control over personal data established in Article 17 of the General Data Protection Regulation (GDPR). Given the lack of specifics regarding collection and re-use of such data under the broad scope of public health purposes, implied consent does not address the issue of proportionality. We highlight legal safeguards' insufficiency, suggesting applying the 'right to be forgotten' according to an ethical interpretation.

Resumen: Estudios recientes destacan la importancia de la vigilancia digital para recoger información sanitaria individual debido a la pandemia mundial causada por la nueva enfermedad COVID-19. Este artículo analiza sus implicaciones legales y éticas en la interfaz entre el derecho individual a la privacidad y los intereses colectivos de la salud pública. Enmarcamos la discusión en el derecho, la deontología y el utilitarismo. Estas últimas teorías y los derechos humanos, especialmente la privacidad, son cruciales en nuestro argumento. Los dilemas relacionados con la salud y los esfuerzos por resolverlos, especialmente a través de la tecnología de la información, la bioética y el derecho, se encuentran en la interfaz de estas perspectivas. En particular, analizamos la intersección entre la autonomía, el derecho a la privacidad y el llamado "derecho al olvido" en el contexto de la salud pública. Es decir, estudiamos el derecho a obtener del responsable del tratamiento la supresión de los datos de salud, un medio radical de control sobre los datos personales establecido en el artículo 17 del Reglamento general de protección de datos (RGPD). Dada la falta de especificidades en cuanto a la recogida y reutilización de dichos datos dentro del amplio ámbito de los objetivos de salud pública, el consentimiento implícito no aborda la cuestión de la proporcionalidad. Destacamos la insuficiencia de las garantías legales, sugiriendo la aplicación del "derecho al olvido" según una interpretación ética.

Resumo: Estudos recentes salientam a importância da vigilância digital para recolher informações individuais de saúde devido à pandemia global causada pela nova doença COVID-19. Este artigo analisa as suas implicações legais e éticas na interface entre o direito individual à privacidade e os interesses coletivos da saúde pública. Enquadramos a discussão no direito, na deontologia e no utilitarismo. As últimas teorias e os direitos humanos, especialmente a privacidade, são cruciais na nossa argumentação. Dilemas derivados da saúde e esforços para os resolver, especialmente através das tecnologias da informação, da bioética e do direito, existem na interface destas perspetivas. Em particular, analisámos a intersecção entre autonomia, direito à privacidade, e o chamado "direito ao esquecimento" no contexto da saúde pública. Por outras palavras, estudámos o direito de obter do responsável pelo tratamento o apagamento dos dados de saúde, um meio radical de controlo dos dados pessoais estabelecido no artigo 17º do Regulamento Geral de Proteção de Dados (RGPD). Dada a falta de especificidades em relação à recolha e reutilização de tais dados no âmbito alargado dos objetivos de saúde pública, o consentimento implícito não aborda a questão da proporcionalidade. Destacamos a insuficiência de salvaguardas jurídicas, sugerindo a aplicação do "direito ao esquecimento" de acordo com uma interpretação ética.

Quality of end-of-life communication in 2 high-risk ICU cohorts: a retrospective cohort study.

BACKGROUND: Factors influencing the quality of end-of-life communication are relevant to improving end-of-life care. We assessed the quality of end-of-life communication and influencing factors in 2 intensive care unit (ICU) cohorts at high risk of death: patients living in nursing homes and those on extracorporeal membrane oxygenation (ECMO). METHODS: This retrospective cohort study included admissions to 4 ICUs in Winnipeg, Manitoba, from 2000 to 2017. We identified cohorts and influencing factors from the Winnipeg ICU database and by manual chart review. We assessed quality of end-of-life communication using 18 validated, binary quality indicators to calculate a weighted, scaled, composite score (range 0-100). We used median regression to identify factors associated with the composite score. RESULTS: The ECMO cohort (n = 109) was younger than the nursing home cohort (n = 230), with longer hospital stays and higher disease severity. Mean composite scores of end-of-life communication were extremely low in both cohorts (mean 48.5 [standard error of the mean (SEM) 1.7] for the nursing home cohort, 49.1 [SEM 2.5] for the ECMO cohort). Patient characteristics associated with higher median composite scores were older age (5.0 per decade, 95% confidence interval [CI] 2.1-7.8) and lower (worse) Glasgow Coma Scale (GCS) scores (1.8 per GCS point, 95% CI 0.5-3.2). The median composite score rose significantly over time (1.7 per year, 95% CI 0.5-2.8). INTERPRETATION: The quality of end-of-life communication in ICUs is poor, and factors associated with better prognosis are also associated with worse communication. Direct and early communication should occur with all patients in the ICU and their surrogates, not just those who are believed most likely to die.