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1.
PLoS One ; 15(10): e0239610, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33048952

RESUMO

Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.


Assuntos
Conflito de Interesses/economia , Dermatologia/economia , Revelação , Indústria Farmacêutica/economia , Guias de Prática Clínica como Assunto , Autoria , Dermatologia/ética , Revelação/ética , Indústria Farmacêutica/ética , Feminino , Apoio Financeiro/ética , Humanos , Japão , Masculino , Preparações Farmacêuticas/economia , Sociedades Médicas/economia , Sociedades Médicas/ética
4.
J Med Ethics ; 46(9): 565-568, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32522812

RESUMO

The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.


Assuntos
Infecções por Coronavirus , Revelação/ética , Ética Médica , Alocação de Recursos para a Atenção à Saúde , Consentimento Livre e Esclarecido/ética , Pandemias , Pneumonia Viral , Beneficência , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Humanos , Autonomia Pessoal , Médicos , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Justiça Social , Padrão de Cuidado
6.
Med Sci (Paris) ; 36(5): 515-520, 2020 May.
Artigo em Francês | MEDLINE | ID: mdl-32452374

RESUMO

The genetic tests for "non-rare thrombophilias" (TNR) were introduced into clinical setting immediately after the identification of genetic variants in the mid-90s to predict and prevent venous thromboembolism (VTE). Although being a rare example of a genetic test of susceptibility for complex diseases that has been integrated in medical routine, it is the most widespread post-natal genetics inquiry in France nowadays. Yet, determining whom to test and how to use the results is still controversial. This article outlines the trajectory of its clinical regulation and illustrates the importance of the context of use to understand its diffusion. This analysis is intended to feed a more general reflection on the issues raised by the clinical integration of genetic surveys for common diseases, particularly with regard to the clinical utility of a test (statistical vs. biological), the subjects to be tested (the case index and/or her/his relatives), and the criteria underlying access to these tests (modalities of medico-economic assessment).


Assuntos
Testes Genéticos , Trombofilia/diagnóstico , Trombofilia/genética , Acesso à Informação/legislação & jurisprudência , Revelação/ética , Revelação/legislação & jurisprudência , França/epidemiologia , Predisposição Genética para Doença , Testes Genéticos/ética , Testes Genéticos/legislação & jurisprudência , Testes Genéticos/métodos , Acesso aos Serviços de Saúde/ética , Acesso aos Serviços de Saúde/legislação & jurisprudência , História do Século XXI , Humanos , Recém-Nascido , Legislação Médica , Futilidade Médica/ética , Futilidade Médica/legislação & jurisprudência , Triagem Neonatal/ética , Triagem Neonatal/legislação & jurisprudência , Triagem Neonatal/métodos , Padrões de Prática Médica/ética , Padrões de Prática Médica/legislação & jurisprudência , Padrões de Prática Médica/tendências , Valor Preditivo dos Testes , Trombofilia/epidemiologia
7.
Neurology ; 94(19): e2037-e2044, 2020 05 12.
Artigo em Inglês | MEDLINE | ID: mdl-32291296

RESUMO

OBJECTIVE: To evaluate the point of view of patients with Parkinson disease (PD) on early detection and risk disclosure in the prodromal phase of PD and to derive recommendations for an ethical framework for the recruitment of prodromal PD cohorts. METHODS: A standardized questionnaire to evaluate the patients' perception on early diagnosis in PD was designed by an interdisciplinary study group. After testing in a preliminary feasibility study (n = 20), the survey was performed retrospectively with patients from our clinic. RESULTS: A total of 101 patients with PD answered the questions. The majority of patients reported that time from onset of motor symptoms to diagnosis was burdensome, including false diagnoses and many consultations of various medical specialists. However, most of the patients evaluated early risk disclosure with skepticism. Freedom of choice and the potential of changes in lifestyle were rated as important. CONCLUSION: Although patients with PD reported the time to diagnosis retrospectively as burdensome, the majority was skeptical regarding early disclosure of risk, especially with regard to the lack of pharmacologic options. Circumstances under which early detection and disclosure would have been approved by the majority of patients were (1) advice on lifestyle changes (exercise, nutrition) as potentially disease course-modifying therapy; (2) the establishment of an early diagnosis "culture," including early clarification of the patients' wish to know; and (3) regular support and follow-up of individuals after risk disclosure.


Assuntos
Atitude , Revelação/ética , Diagnóstico Precoce , Doença de Parkinson/diagnóstico , Pacientes/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários/normas
8.
Hastings Cent Rep ; 50(3): 25-27, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32279318

RESUMO

Prestigious University is a large, private educational institution with a medical school, a university hospital, a law school, and graduate and undergraduate colleges all on a single campus. In the face of the Covid-19 pandemic, students were told during spring break to return to campus only briefly to retrieve their belongings. Classes then went online. On March 23, 2020, the faculty, students, and staff were emailed the following by the university's director of infection control and public health: We have become aware that a Prestigious University staff member has tested positive for the virus that causes Covid-19. The individual, who was last on campus on March 16, is now in isolation at their permanent residence and is doing well clinically. The university has already identified those members of our community who may have been in close contact with this individual, and we are working to notify them. Further, this individual's local health department has a protocol for identifying people who have been in direct contact with anyone testing positive for Covid-19 (such as this Prestigious University staff member) so that they can self-quarantine and watch for COVID-19 symptoms for a period of 14 days from their last contact with the infected individual. A professor in the Philosophy Department has asked the ethicists at the medical school whether such contact tracing suffices. "Don't the members of the community deserve to know who this is? Isn't there a mandate to identify this person in order to maximize public health benefits and slow the spread of this deadly virus?"


Assuntos
Infecções por Coronavirus/epidemiologia , Revelação/ética , Controle de Infecções/organização & administração , Pneumonia Viral/epidemiologia , Centros Médicos Acadêmicos/organização & administração , Betacoronavirus , Humanos , Controle de Infecções/normas , Pandemias
9.
BMC Med Ethics ; 21(1): 11, 2020 01 31.
Artigo em Inglês | MEDLINE | ID: mdl-32005225

RESUMO

BACKGROUND: Genomic research can reveal 'unsolicited' or 'incidental' findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings (for example, by conducting additional analyses to search for findings outside the scope of the research question). MAIN TEXT: This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. CONCLUSIONS: We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve.


Assuntos
Revelação/ética , Pesquisa em Genética/ética , Obrigações Morais , Pesquisadores/ética , Conflito Psicológico , Ética em Pesquisa , Genoma Humano , Humanos , Achados Incidentais , Relações Pesquisador-Sujeito/ética , Responsabilidade Social
10.
BMC Med Ethics ; 21(1): 9, 2020 01 30.
Artigo em Inglês | MEDLINE | ID: mdl-32000764

RESUMO

BACKGROUND: Incidental findings (IFs) and secondary findings (SFs), being results that are unrelated to the diagnostic question, are the subject of an important debate in the practice of clinical genomic medicine. Arguments for reporting these results or not doing so typically relate to the principles of autonomy, non-maleficence and beneficence. However, these principles frequently conflict and are insufficient by themselves to come to a conclusion. This study investigates empirically how ethical principles are considered when actually reporting IFs or SFs and how value conflicts are weighed. METHODS: A qualitative focus group study has been undertaken, including a multidisciplinary group of professionals from Belgian centres for medical genetics. The data were analysed thematically. RESULTS: All eight Belgian centres participated in this study. Ethical values were frequently referred to for disclosure policies on IFs and SFs. Participants invoked respect for patient autonomy to support the disclosure of IFs and opt-out options for IFs and SFs, non-maleficence for the professional delineation of reportable IFs and opt-out options for IFs and SFs and (the particular scope of) beneficence for the mandatory reporting of actionable IFs, the delineation of reportable IFs and a current decline of actively pursued SFs. Professional assumptions about patients' genetic literacy were an important factor in the weighing of values. CONCLUSIONS: In line with the traditional bioethical discourse, the mandatory reporting of actionable IFs might be interpreted as a "technological, soft paternalism". Restricting patients' choices might be acceptable, but then its motives should be valid and its beneficent outcomes highly plausible. Hence, the presuppositions of technological, soft paternalism - patients' inability to make informed decisions, normative rationality, the efficacy of beneficent outcomes and the delineated spectrum of beneficence - should be approached critically. Moreover, distributive justice should be considered an important value in the delineation of the current scope of the ethical debate on IFs and SFs. This study of guiding values may stimulate the debate on the ethical grounds for a solid policy on IFs and SFs internationally.


Assuntos
Atitude do Pessoal de Saúde , Revelação/ética , Genômica/ética , Bélgica , Grupos Focais , Humanos , Achados Incidentais , Entrevistas como Assunto , Autonomia Pessoal , Pesquisa Qualitativa
11.
BMC Med Ethics ; 21(1): 13, 2020 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-32019532

RESUMO

BACKGROUND: When a genetic mutation is identified in a family member (proband), internationally, it is usually the proband's or another responsible family member's role to disclose the information to at-risk relatives. However, both active and passive non-disclosure in families occurs: choosing not to communicate the information or failing to communicate the information despite intention to do so, respectively. The ethical obligations to prevent harm to at-risk relatives and promote the duty of care by genetic health professionals (GHPs) is in conflict with Privacy laws and professional regulations that prohibits disclosure of information to a third party without the consent of the proband (duty of confidentiality). In New South Wales (NSW), Australia, amendments to Privacy legislation permits such disclosure to living genetic relatives with the process defined under guidelines although there is no legal duty to warn. This study assessed NSW GHP's awareness and experience of the legislation and guidelines. METHODS: An online survey collected demographics; theoretical knowledge; clinical scenarios to assess application knowledge; attitudes; confidence; experience with active non-disclosure. A link to correct answers was provided after completion. Knowledge scores above the median for non-parametric data or above the mean for parametric data were classified as 'good' or 'poor'. Chi square tests assessed associations between confidence and knowledge scores. RESULTS: While many of the 37 participants reported reading the guidelines, there was limited awareness of their scope and clinical application; that there is no legal duty to warn; and that the threat does not need to be imminent to warrant disclosure. No association between confidence and 'good' theoretical or applied clinical knowledge was identified. Uncertainty of their professional responsibility was identified and in the several case examples of active non-disclosure that were reported this uncertainty reflected the need for further understanding of the guidelines in regard to the processes required before disclosure was initiated. CONCLUSIONS: There is a need for further education and training about the guidelines associated with the legislation that would be relevant to support disclosure. The findings may inform future strategies to support introduction of policy changes in other jurisdictions where similar regulatory regimes are introduced.


Assuntos
Revelação/ética , Revelação/legislação & jurisprudência , Família , Privacidade Genética/ética , Privacidade Genética/legislação & jurisprudência , Conscientização , Responsabilidade pela Informação/ética , Responsabilidade pela Informação/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido , Obrigações Morais , New South Wales
14.
Am J Nurs ; 120(3): 14, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32079781

RESUMO

One study's pediatric protocol sparks ethical debate.


Assuntos
Revelação/ética , Genômica/ética , Predisposição Genética para Doença , Humanos , Programas de Rastreamento/ética
15.
Metas enferm ; 23(1): 25-32, feb. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-189186

RESUMO

OBJETIVO: examinar las barreras comunicativas que tienen los profesionales sanitarios cuando se enfrentan a un efecto adverso. MÉTODO: estudio cualitativo de orientación fenomenológica, desarrollado en el Servicio de Urgencias del Hospital de Tortosa Virgen de la Cinta (Tarragona), entre octubre y diciembre de 2018. Muestreo por conveniencia. Se llevaron a cabo dos grupos focales formados por seis-siete profesionales sanitarios que se agrupan en función del tiempo de experiencia profesional (mayor o menor a tres años). Los candidatos a participar se diferencian por edad, sexo y categoría profesional. Se usa el programa Atlas.Ti para el análisis. Se identifican tres categorías analíticas y 14 subcategorías. RESULTADOS: participaron 13 profesionales en dos grupos focales. Categorías que emergen del discurso: definición de efecto adverso, información y mejoras. Se normaliza la frecuencia de los errores. Hablan de errores leves y graves, diferenciando su actuación y los sentimientos. Refieren que parte de su aprendizaje es debido al ensayo-error de la práctica. Expresan miedo a informar en situaciones de gravedad. Hay una infrautilización del sistema de registro. Coinciden en dar la información en equipo, previo consenso, y expresan desprotección institucional. Proponen la implantación de los debriefings, identificación positiva, comunicación entre servicios, informatización y un cambio de turno estructurado. CONCLUSIÓN: el miedo a las respuestas, la pérdida de reputación y la falta de apoyo institucional aparecen como las principales barreras a la hora de admitir y comunicar los incidentes. Hay un amplio consenso sobre la falta de responsabilidad en la comunicación y disculpa de los eventos adversos y sobre la necesidad de aportar soporte y formación a los profesionales


OBJECTIVE: to review the communication barriers in healthcare professionals when faced with an adverse event. METHOD: a qualitative phenomenological study conducted at the Emergency Unit from the Hospital de Tortosa Virgen de la Cinta (Tarragona) between October and December, 2018, through convenience sampling. Two focus groups were set up, with six-seven healthcare professionals grouped by time of professional experience (over or below three years). The participants were differentiated by age, gender and professional category. The Atlas.Ti program was used for analysis. Three analytical categories and 14 subcategories were identified. RESULTS: the study included 13 professionals in two focus groups. The categories emerging from their speech were: definition of adverse event, information and improvements. The frequency of errors was normalized. They mentioned mild and severe mistakes, differentiating their action and feelings. They reported that part of their learning consists in trial-error during practice. They expressed fear to report in severe situations. The recording system is underused. They coincided in reporting as a team, after consensus, and they expressed lack of institutional protection. They proposed implementing debriefings, positive identification, communication between hospital units, information technologies, and a structured change of shift. CONCLUSION: fear of answers, loss of reputation, and lack of institutional support appeared as the main barriers at the time of acknowledging and reporting incidents. There was wide consensus about lack of responsibiility in communication and excuse for adverse events, and about the need to provide support and training to professionals


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Barreiras de Comunicação , Comunicação Interdisciplinar , Erros Médicos , Revelação/ética , Serviços Médicos de Emergência/ética , Serviços Médicos de Emergência/estatística & dados numéricos , Denúncia de Irregularidades/ética , Pesquisa Qualitativa , Segurança do Paciente , Grupos Focais
17.
BMJ ; 368: l6925, 2020 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-31969320

RESUMO

OBJECTIVE: To investigate pharmaceutical or medical device industry funding of patient groups. DESIGN: Systematic review with meta-analysis. DATA SOURCES: Ovid Medline, Embase, Web of Science, Scopus, and Google Scholar from inception to January 2018; reference lists of eligible studies and experts in the field. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Observational studies including cross sectional, cohort, case-control, interrupted time series, and before-after studies of patient groups reporting at least one of the following outcomes: prevalence of industry funding; proportion of industry funded patient groups that disclosed information about this funding; and association between industry funding and organisational positions on health and policy issues. Studies were included irrespective of language or publication type. REVIEW METHODS: Reviewers carried out duplicate independent data extraction and assessment of study quality. An amended version of the checklist for prevalence studies developed by the Joanna Briggs Institute was used to assess study quality. A DerSimonian-Laird estimate of single proportions with Freeman-Tukey arcsine transformation was used for meta-analyses of prevalence. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of the evidence for each outcome. RESULTS: 26 cross sectional studies met the inclusion criteria. Of these, 15 studies estimated the prevalence of industry funding, which ranged from 20% (12/61) to 83% (86/104). Among patient organisations that received industry funding, 27% (175/642; 95% confidence interval 24% to 31%) disclosed this information on their websites. In submissions to consultations, two studies showed very different disclosure rates (0% and 91%), which appeared to reflect differences in the relevant government agency's disclosure requirements. Prevalence estimates of organisational policies that govern corporate sponsorship ranged from 2% (2/125) to 64% (175/274). Four studies analysed the relationship between industry funding and organisational positions on a range of highly controversial issues. Industry funded groups generally supported sponsors' interests. CONCLUSION: In general, industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship. Transparency about corporate funding is also inadequate. Among the few studies that examined associations between industry funding and organisational positions, industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of sponsors above those of the public. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017079265.


Assuntos
Associações de Consumidores/economia , Indústria Farmacêutica/economia , Administração Financeira/legislação & jurisprudência , Associações de Consumidores/ética , Associações de Consumidores/legislação & jurisprudência , Revelação/ética , Revelação/legislação & jurisprudência , Indústria Farmacêutica/ética , Administração Financeira/ética , Estudos Observacionais como Assunto , Política Organizacional
18.
Am J Bioeth ; 20(1): 6-18, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31896322

RESUMO

Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as ?pragmatic clinical trial collateral findings,? or ?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice.


Assuntos
Tomada de Decisões , Revelação/ética , Análise Ética , Achados Incidentais , Ensaios Clínicos Pragmáticos como Assunto/ética , Melhoria de Qualidade/ética , Humanos , Projetos de Pesquisa/normas , Relações Pesquisador-Sujeito
20.
Midwifery ; 80: 102568, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31698295

RESUMO

OBJECTIVE: Rwanda amended its abortions law in 2012 to allow for induced abortion under certain circumstances. We explore how Rwandan health care providers (HCP) understand the law and implement it in their clinical practice. DESIGN: Fifty-two HCPs involved in post-abortion care in Kigali were interviewed by qualitative individual in-depth interviews (n =32) and in focus group discussions (n =5) in year 2013, 2014, and 2016. All data were analyzed using thematic analysis. FINDINGS: HCPs express ambiguities on their rights and responsibilities when providing abortion care. A prominent finding was the uncertainties about the legal status of abortion, indicating that HCPs may rely on outdated regulations. A reluctance to be identified as an abortion provider was noticeable due to fear of occupational stigma. The dilemma of liability and litigation was present, and particularly care providers' legal responsibility on whether to report a woman who discloses an illegal abortion. CONCLUSION: The lack of professional consensus is creating barriers to the realization of safe abortion care within the legal framework, and challenge patients right for confidentiality. This bring consequences on girl's and women's reproductive health in the setting. IMPLICATIONS FOR PRACTICE: To implement the amended abortion law and to provide equitable maternal care, the clinical and ethical guidelines for HCPs need to be revisited.


Assuntos
Aborto Induzido/legislação & jurisprudência , Atitude do Pessoal de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde/psicologia , Adulto , Confidencialidade/ética , Confidencialidade/psicologia , Revelação/ética , Revelação/legislação & jurisprudência , Feminino , Grupos Focais , Humanos , Entrevistas como Assunto , Legislação como Assunto , Responsabilidade Legal , Masculino , Pessoa de Meia-Idade , Gravidez , Pesquisa Qualitativa , Ruanda/epidemiologia , Estigma Social , Adulto Jovem
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