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Rev. bioét. derecho ; (50): 189-203, nov. 2020.
Artigo em Espanhol | IBECS | ID: ibc-191353


La actual pandemia por la COVID-19 está ocasionado serias amenazas para la salud pública a nivel mundial, especialmente para los grupos de población más vulnerables. Los casos más graves de la enfermedad han sido primeramente atendidos por los profesionales de urgencias y emergencias, los cuales han tenido que tomar decisiones en contextos altamente complejos donde la priorización en la asignación de los recursos sanitarios disponibles les ha generado situaciones éticamente conflictivas. El objetivo del presente artículo es analizar la importancia de implantar la PDA en los servicios de urgencias y emergencias como herramienta de consulta en la resolución de los problemas éticos surgidos durante la pandemia por COVID-19, concretamente, en la atención al paciente crónico complejo o con enfermedad crónica avanzada

The events of the present CoVID-19 pandemic are causing serious threats to Public Health worldwide, specifically at the most vulnerable population groups. Emergency professionals have served as the first responders for the most serious cases of this disease. At the same time, they have made decisions in highly complex contexts where the prioritization of allocated care resources has generated ethically conflictive situations. The aim of this article is to analyze the importance of implementing the ACP as a tool in the emergency services to solve ethical problems that have arisen during the COVID-19 pandemic, particularly in the care of complex chronic patients or those with advanced chronic disease

L'actual pandèmia per la COVID-19 està ocasionat serioses amenaces a la salut pública a nivell mundial, especialment als grups de població més vulnerables. Els casos més greus de la malaltia han estat primerament atesos pels professionals d'urgències I emergències, els quals han hagut de prendre decisions en contextos altament complexos on la priorització en l'assignació dels recursos sanitaris disponibles els ha generat situacions èticament conflictives. L'objectiu d'aquest article va ser analitzar la importància d'implantar la PDA en els serveis d'urgències I emergències com a eina de consulta a la resolució dels problemes ètics sorgits durant la pandèmia per COVID-19, concretament, en l'atenció al pacient crònic complex o amb malaltia crònica avançada

Humanos , Prioridades em Saúde/ética , Prioridades em Saúde/organização & administração , Planejamento de Assistência ao Paciente , Tomada de Decisões/ética , Conflito de Interesses , Serviços Médicos de Emergência/ética , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Pandemias , Doença Crônica
Cochrane Database Syst Rev ; 8: CD013461, 2020 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-32841367


BACKGROUND: Depression is common in people with non-communicable diseases (NCDs) such as cardiovascular disease, diabetes, cancer, and chronic respiratory conditions. The co-existence of depression and NCDs may affect health behaviours, compliance with treatment, physiological factors, and quality of life. This in turn is associated with worse outcomes for both conditions. Behavioural activation is not currently indicated for the treatment of depression in this population in the UK, but is increasingly being used to treat depression in adults. OBJECTIVES: To examine the effects of behavioural activation compared with any control group for the treatment of depression in adults with NCDs. To examine the effects of behavioural activation compared with each control group separately (no treatment, waiting list, other psychological therapy, pharmacological treatment, or any other type of treatment as usual) for the treatment of depression in adults with NCDs. SEARCH METHODS: We searched CCMD-CTR, CENTRAL, Ovid MEDLINE, Embase, four other databases, and two trial registers on 4 October 2019 to identify randomised controlled trials (RCTs) of behavioural activation for depression in participants with NCDs, together with grey literature and reference checking. We applied no restrictions on date, language, or publication status to the searches. SELECTION CRITERIA: We included RCTs of behavioural activation for the treatment of depression in adults with one of four NCDs: cardiovascular disease, diabetes, cancer, and chronic respiratory conditions. Only participants with a formal diagnosis of both depression and an NCD were eligible. Studies were included if behavioural activation was the main component of the intervention. We included studies with any comparator that was not behavioural activation, and regardless of reported outcomes. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane, including independent screening of titles/abstracts and full-text manuscripts, data extraction, and risk of bias assessments in duplicate. Where necessary, we contacted study authors for more information. MAIN RESULTS: We included two studies, contributing data from 181 participants to the analyses. Both studies recruited participants from US hospital clinics; one included people who were recovering from a stroke and the other women with breast cancer. For both studies, the intervention consisted of eight weeks of face-to-face behavioural therapy, with one study comparing to poststroke treatment as usual and the other comparing to problem-solving therapy. Both studies were at risk of performance bias and potential conflict of interest arising from author involvement in the development of the intervention. For one study, risks of selection bias and reporting bias were unclear and the study was judged at high risk of attrition bias. Treatment efficacy (remission) was greater for behavioural activation than for comparators in the short term (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.98 to 2.38; low-certainty evidence) and medium term (RR 1.76, 95% CI 1.01 to 3.08; moderate-certainty evidence), but these estimates lacked precision and effects were reduced in the long term (RR 1.42, 95% CI 0.91 to 2.23; moderate-certainty evidence). We found no evidence of a difference in treatment acceptability in the short term (RR 1.81, 95% CI 0.68 to 4.82) and medium term (RR 0.88, 95% CI 0.25 to 3.10) (low-certainty evidence). There was no evidence of a difference in depression symptoms between behavioural activation and comparators (short term: MD -1.15, 95% CI -2.71 to 0.41; low-certainty evidence). One study found no difference for quality of life (short term: MD 0.40, 95% CI -0.16 to 0.96; low-certainty evidence), functioning (short term: MD 2.70, 95% CI -6.99 to 12.39; low-certainty evidence), and anxiety symptoms (short term: MD -1.70, 95% CI -4.50 to 1.10; low-certainty evidence). Neither study reported data on adverse effects. AUTHORS' CONCLUSIONS: Evidence from this review was not sufficient to draw conclusions on the efficacy and acceptability of behavioural activation for the treatment of depression in adults with NCDs. A future review may wish to include, or focus on, studies of people with subthreshold depression or depression symptoms without a formal diagnosis, as this may inform whether behavioural activation could be used to treat mild or undiagnosed (or both) depressive symptoms in people with NCDs. Evidence from low-resource settings including low- and middle-income countries, for which behavioural activation may offer a feasible alternative to other treatments for depression, would be of interest.

Terapia Comportamental/métodos , Neoplasias da Mama/psicologia , Depressão/terapia , Doenças não Transmissíveis/psicologia , Acidente Vascular Cerebral/psicologia , Adulto , Viés , Conflito de Interesses , Feminino , Humanos , Masculino , Aceitação pelo Paciente de Cuidados de Saúde , Resolução de Problemas , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
Am J Law Med ; 46(2-3): 275-296, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32659196


Corporate influence is one of the most pressing issues in public health. It cuts across many of our most intractable problems-from obesity to the opioid epidemic. Companies develop close relationships with public health agencies, research universities, academic medical centers, professional societies, and patient advocacy organizations-often funding medical research and public health interventions intended to address the very challenges these corporations are creating or exacerbating. How we view relationships with industry, including how these relationships are framed in ethical discourse, shapes our legal and policy responses to them. In recent years, fueled in part by the opioid epidemic, the ethical framing of industry relationships has begun to evolve in significant ways. But legal and policy responses have not yet caught up. In this article, I develop a temporal account of corporate influence, and legal and policy responses to corporate influence. This account clarifies the limitations and adverse effects of conflicts of interest disclosure, especially when implemented as the sole legal or policy response. Disclosure can illuminate corporate influence-but policymakers cannot and should not rely on disclosure to eliminate corporate influence or its effects. Nor should we allow disclosure to crowd out structural and systemic responses to corporate influence-including sequestration of and separation from private-sector entities.

Pesquisa Biomédica/legislação & jurisprudência , Revelação/legislação & jurisprudência , Ética nos Negócios , Formulação de Políticas , Saúde Pública/legislação & jurisprudência , Conflito de Interesses , Humanos , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Estados Unidos
S Afr Med J ; 110(4): 262-264, 2020 03 30.
Artigo em Inglês | MEDLINE | ID: mdl-32657734


Letters by Van Niekerk and Khan on article by Lake et al. (Lake L, Kroon M, Sanders D, et al. Child health, infant formula funding and South African health professionals: Eliminating conflict of interest. S Afr Med J 2019;109(12):902-906.; and response by Lake et al.

Saúde da Criança , Fórmulas Infantis , Grupo com Ancestrais do Continente Africano , Criança , Conflito de Interesses , Pessoal de Saúde , Humanos , Lactente
S Afr Med J ; 110(4): 12895, 2020 03 30.
Artigo em Inglês | MEDLINE | ID: mdl-32657735


Letter by Ntsie on the responses of Van Niekerk (Van Niekerk A. Child health, infant formula funding and South African health professionals: Eliminating conflict of interest. S Afr Med J 2020;110(4):262-264. and Khan (Khan N. Child health, infant formula funding and South African health professionals: Eliminating conflict of interest. S Afr Med J 2020;110(4):262-264. to the article by Lake et al. (Lake L, Kroon M, Sanders D, et al. Child health, infant formula funding and South African health professionals: Eliminating conflict of interest. S Afr Med J 2019;109(12):902-906.

Saúde da Criança , Fórmulas Infantis , Criança , Pré-Escolar , Conflito de Interesses , Pessoal de Saúde , Humanos , Lactente
PLoS One ; 15(7): e0236166, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32706798


Recently, concerns have been raised over the potential impacts of commercial relationships on editorial practices in biomedical publishing. Specifically, it has been suggested that certain commercial relationships may make editors more open to publishing articles with author conflicts of interest (aCOI). Using a data set of 128,781 articles published in 159 journals, we evaluated the relationships among commercial publishing practices and reported author conflicts of interest. The 159 journals were grouped according to commercial biases (reprint services, advertising revenue, and ownership by a large commercial publishing firm). 30.6% (39,440) of articles were published in journals showing no evidence of evaluated commercial publishing relationships. 33.9% (43,630) were published in journals accepting advertising and reprint fees; 31.7% (40,887) in journals owned by large publishing firms; 1.2% (1,589) in journals accepting reprint fees only; and 2.5% (3,235) in journals accepting only advertising fees. Journals with commercial relationships were more likely to publish articles with aCOI (9.2% (92/1000) vs. 6.4% (64/1000), p = 0.024). In the multivariate analysis, only a journal's acceptance of reprint fees served as a significant predictor (OR = 2.81 at 95% CI, 1.5 to 8.6). Shared control estimation was used to evaluate the relationships between commercial publishing practices and aCOI frequency in total and by type. BCa-corrected mean difference effect sizes ranged from -1.0 to 6.1, and confirm findings indicating that accepting reprint fees may constitute the most significant commercial bias. The findings indicate that concerns over the influence of industry advertising in medical journals may be overstated, and that accepting fees for reprints may constitute the largest risk of bias for editorial decision-making.

Pesquisa Biomédica , Conflito de Interesses , Políticas Editoriais , Propriedade , Viés de Publicação , Publicidade , Humanos
PLoS One ; 15(6): e0235021, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32579571


BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.

Indústria Farmacêutica/economia , Apoio Financeiro , Defesa do Paciente/economia , Preparações Farmacêuticas/economia , Conflito de Interesses , Estudos Transversais , Custos de Medicamentos , Humanos , Marketing/economia , Organizações/economia , Organizações/ética , Defesa do Paciente/ética , Suécia
Z Evid Fortbild Qual Gesundhwes ; 153-154: 39-43, 2020 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-32553895


INTRODUCTION: Evidence-based clinical practice guidelines are one of the most important sources to inform clinical decision-making. They contain recommendations to support treatment decisions. These recommendations should be free from bias and should only aim to increase patient benefit. To ensure this, recommendations should be free from bias caused by conflicts of interest. When conflicts of interest exist, they should be completely transparent. The aim of this study was to analyze the payments from pharmaceutical and medical device industry to clinical practice guideline panel members (GPM). In addition, we assessed the completeness and accuracy of the GPMs' conflict of interest statements. METHODS: A manual search for international guidelines was conducted on the website of the National Guideline Clearinghouse. We included all available clinical practice guidelines published in 2017. We extracted the names of all guideline group members and identified the payments they had received from industry over the four years preceding the publication using the "open payments" database. RESULTS: In total, 81 guidelines were identified. We found data on payments for 543 out of 659 GPMs. For 34% of the GPMs, there was no declaration of individual conflicts of interest in either the guideline or related documents. The sum of payments across all guidelines to all GPMs was 10,844,938 USD. The average payment amounted to 19,972 USD and the median 1,227 USD. Sixty two percent of GPMs received at least 500 USD. Of these, 17% stated that they had no conflict of interest to declare. DISCUSSION: The amount of industrial payments in some subject areas raises doubt about the independence of guideline recommendations. Stricter rules are needed to avoid and manage conflicts of interest of guideline authors. The analysis carried out indicates that conflict of interest involving GPMs is a considerable problem. CONCLUSION: GPMs receive sizeable payments from industry. The payments are often inadequately disclosed or not disclosed at all. This threatens the objectivity of the recommendations in clinical practice guidelines.

Conflito de Interesses , Doações , Revelação , Indústria Farmacêutica , Apoio Financeiro , Alemanha , Humanos , Indústrias
Clin Dermatol ; 38(2): 254-256, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32513405


With the increasing costs of health care, clinical practice guidelines (CPGs) have gained a crucial role in standardizing care, protecting health resources, and assuring their accurate distribution by improving health outcomes. Influencing the outcome of a guideline (by one of the authors, members of the specialty board, or an influential member of the specialty) could result in inappropriate expense to the health care system and profits to investors of the medications/tests/devices that were recommended. CPGs are statements based on a systematic review of the existing scientific evidence, developed by knowledgeable experts, that have the potential to reduce inappropriate practice variation, enhance research, and improve health care quality and safety.1.

Conflito de Interesses , Guias de Prática Clínica como Assunto , Garantia da Qualidade dos Cuidados de Saúde , Qualidade da Assistência à Saúde , Confiança , Assistência à Saúde/economia , Assistência à Saúde/normas , Custos de Cuidados de Saúde , Recursos em Saúde , Humanos , Avaliação de Resultados em Cuidados de Saúde , Procedimentos Desnecessários/economia