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1.
Bone Joint J ; 102-B(5): 550-555, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32349593

RESUMEN

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of "failure to warn", i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on "failure to warn" and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550-555.


Asunto(s)
Consentimiento Informado/legislación & jurisprudencia , Mala Praxis/legislación & jurisprudencia , Procedimientos Ortopédicos/legislación & jurisprudencia , Medicina Estatal/legislación & jurisprudencia , Australia , Alemania , Humanos , Consentimiento Informado/ética , Medicina Estatal/ética , Decisiones de la Corte Suprema , Reino Unido , Estados Unidos
2.
Recenti Prog Med ; 111(4): 184-185, 2020 04.
Artículo en Italiano | MEDLINE | ID: mdl-32319435

RESUMEN

A position statement published by the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) is fostering a vibrant debate, crossed by deep fears. These are recommendations addressed to ICU doctors who must decide whether to implement intensive treatments for patients who need them to survive. Specifically, the reference is to the patients to whom the CoViD-19 epidemic has compromised respiratory capacity. We still do not have clear what positive criteria can help make clinical decisions in contexts of insufficient resources that force us to make choices.


Asunto(s)
Infecciones por Coronavirus , Toma de Decisiones , Recursos en Salud , Pandemias , Neumonía Viral , Betacoronavirus , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/terapia , Toma de Decisiones/ética , Recursos en Salud/provisión & distribución , Hospitales de Práctica de Grupo , Humanos , Consentimiento Informado , Derechos del Paciente , Médicos , Neumonía Viral/complicaciones , Neumonía Viral/terapia , Índice de Severidad de la Enfermedad
3.
J Korean Med Sci ; 35(13): e94, 2020 Apr 06.
Artículo en Inglés | MEDLINE | ID: mdl-32242345

RESUMEN

BACKGROUND: In 1999, the Organ Transplantation Act legalized organ donation from brain-dead patients. As a result of the government's continued efforts, the number of brain-dead donors steadily increased from 2002 through 2016. However, the number has declined since 2017. This paper examined the possible reasons behind the decline in brain-dead organ donation. METHODS: This investigation was an analysis of published data from the Korea Organ Donation Agency annual reports from 2013 to 2018. RESULTS: The number of brain-dead organ donors in Korea rose steadily until 2016, declined in 2017 for the first time since 2002, and then dropped sharply in 2018. Although the number of brain-dead potential organ donors increased between 2017 and 2018, the number of eligible donors decreased, suggesting that patient families rejected the brain-death determination process and brain-dead organ donation. Statistics gathered during identification of brain-dead potential donors and actual donations confirm that rejection or withdrawal of consent by the family has increased. During the same period when donation from brain- dead patients decreased, five events occurred: 1) compensation for donor families was abolished; 2) an incident of mistreatment of a brain-dead donor's remains occurred; 3) the Life-Sustaining Treatment Act was enacted, providing a legal procedure whereby families of brain-dead patients could forgo life-sustaining treatment; 4) residents' work week was limited to 80 hours; and 5) the Labor Standards Law was amended. CONCLUSION: Fewer eligible donors in spite of an increase in brain-dead potential organ donors suggests that reduction in these donations resulted mainly from factors associated with family consent. Among such factors, implementation of the Life-sustaining Treatment Act appears to be most important. Abolition of family compensation and the incident in which a brain-dead donor's remains were mistreated may also have influenced family consent.


Asunto(s)
Familia , Consentimiento Informado , Trasplante de Órganos , Donantes de Tejidos , Obtención de Tejidos y Órganos , Muerte Encefálica , Determinación de la Elegibilidad , Humanos , República de Corea , Obtención de Tejidos y Órganos/tendencias
4.
Monaldi Arch Chest Dis ; 90(1)2020 Apr 08.
Artículo en Inglés | MEDLINE | ID: mdl-32268719

RESUMEN

Severe COVID-19 illness is characterised by the development of Acute Respiratory Distress Syndrome (ARDS), for which the mainstay of treatment is represented by mechanical ventilation. Mortality associated with ARDS due to other causes is in the range of 40-60%, but currently available data are not yet sufficient to draw safe conclusions on the prognosis of COVID-19 patients who require mechanical ventilation. Based on data from cohorts of the related coronavirus-associated illnesses, that is to say Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), prognosis would seem to be worse than ARDS due to other causes such as trauma and other infections. Discussion of prognosis is central to obtaining informed consent for intubation, but in the absence of definitive data it is not clear exactly what this discussion should entail.


Asunto(s)
Toma de Decisiones Clínicas/ética , Infecciones por Coronavirus/terapia , Pandemias , Neumonía Viral/terapia , Respiración Artificial/ética , Síndrome Respiratorio Agudo Grave/terapia , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/mortalidad , Humanos , Consentimiento Informado/ética , Intubación Intratraqueal , Pandemias/ética , Neumonía Viral/epidemiología , Neumonía Viral/mortalidad , Pronóstico , Respiración Artificial/mortalidad , Síndrome Respiratorio Agudo Grave/etiología , Síndrome Respiratorio Agudo Grave/mortalidad
6.
Ophthalmologe ; 117(4): 313-319, 2020 Apr.
Artículo en Alemán | MEDLINE | ID: mdl-32215676

RESUMEN

BACKGROUND: In the legal evaluation of medical treatments it is important to know which legal and contractual regulations apply. OBJECTIVE: This article discusses in which context treatment errors play a role and are identified as such. MATERIAL AND METHODS: Relevant German legal framework conditions are discussed and examples with reference to intravitreal injection therapy are given. RESULTS: The civil law treatment contract between physician and patient results in the medical obligations of a service contract. As a consequence, the physician is obliged to provide the patient with treatment according to the current generally accepted professional standard, including information obligations, the certainty of a diagnosis, the execution of treatment and aftercare. Before claims for compensation and damages for pain and suffering can be enforced, proof of a treatment error and the causal connection must be provided. In court, mostly expert opinions are used to assess what the professional standard is and whether the physician was sufficiently qualified, whether informed consent and documentation met the legal requirements and whether a (gross) treatment error must be assumed. The Patients' Rights Act emphasizes the importance of an open error culture by requiring a practitioner to inform patients of third party/own treatment errors on request or in order to avert health risks, if circumstances are discernible to the practitioner that justify the assumption of a treatment error. CONCLUSION: Although ophthalmologists cannot guarantee healing or success but only the treatment, there are many medical obligations for intravitreal therapy. Increased standards of quality assurance can be implemented within the framework of selective contracts.


Asunto(s)
Responsabilidad Legal , Testimonio de Experto , Humanos , Consentimiento Informado , Inyecciones Intravítreas , Derechos del Paciente , Garantía de la Calidad de Atención de Salud
11.
Clin Ter ; 171(2): e94-e96, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32141477

RESUMEN

End-of-life decisions are an emergent issue for bioethical debates and practical concerns among health professionals. On December 2017, Italy enacted a new law named "Rules about informed consent and advance directives", which promotes the relationship of care in a fiduciary sense through the implementation of a correct and exhaustive information. It is also prescribed to record in writing all the patients' decisions about consent or refusal. Furthermore, the law explicitly forbids unreasonable therapeutic obstinacy for terminal patient, legitimizing deep palliative sedation. Finally, the law establishes the use of "advance directives" as a written document by which adults and capable people can express their wishes regarding health treatments and diagnostic tests in anticipation of a possible future incapacity. The law provides that doctors must comply with these directives, unless they appear clearly incongruous or not corresponding to the patient's current clinical condition.


Asunto(s)
Directivas Anticipadas/legislación & jurisprudencia , Consentimiento Informado/legislación & jurisprudencia , Cuidado Terminal/legislación & jurisprudencia , Adulto , Toma de Decisiones , Humanos , Italia
13.
G Ital Cardiol (Rome) ; 21(4): 306-308, 2020 Apr.
Artículo en Italiano | MEDLINE | ID: mdl-32202564

RESUMEN

The Italian law 219/2017, enacted on January 31, 2018, regulates patients' informed consent, personalized care planning and advance directives. The law provides for patient's self-determination in all phases of life. This also applies to patients suffering from chronic, progressive, terminal disease such as heart failure. In fact, the clinical and psychosocial trajectory for heart failure patients demands an interdisciplinary, systemic approach. Advance directives should be tailor-made to patient's needs and dynamically updated through the course of the disease according to patient's and family informed and shared decision-making. Healthcare professionals will require education and training to stay up to the task both clinically, psychologically and emotionally.


Asunto(s)
Directivas Anticipadas/legislación & jurisprudencia , Cuidadores , Consentimiento Informado/legislación & jurisprudencia , Órdenes de Resucitación , Toma de Decisiones , Humanos , Italia , Autonomía Personal , Cuidado Terminal
14.
G Ital Cardiol (Rome) ; 21(4): 309-314, 2020 Apr.
Artículo en Italiano | MEDLINE | ID: mdl-32202565

RESUMEN

BACKGROUND: The request for informed consent to join a clinical trial often creates mistrust and hesitation in the patient who should be enrolled. In our study, we evaluated the reasons for refusing to participate in a clinical trial. METHODS: In the last 10 years of cardiovascular clinical research, we asked an informed consent to 2586 patients for intervention studies. Overall, 59% agreed to join clinical trials, 40% refused. The 1% initially accepted and then withdrew the consent. Those who refused were more frequently women, relatively younger (mean age 62 ± 5 vs 74 ± 9 years) and had a higher level of education and income. We asked all these patients who refused to answer a brief questionnaire about the reasons for rejection. RESULTS: Of 1031 patients, 629 (61%), accepted to answer the interview; 176 (28%) answered they refused on relatives', friends' or other doctors' advices, or after Internet searches; 157 (25%) answered they did not agree about how the trials were carried out (double-blind control procedure, use of placebo); 126 (20%) did not trust official medicine; 63 (10%) could not guarantee their presence at the follow-up visits; 69 (11%) did not want to undergo additional medical examinations; 31 (5%) had previous bad research experiences (feeling like a guinea pig); 7 (about 1%) refused for other reasons. CONCLUSIONS: Recruitment into clinical research studies is still a major challenge. Patients, due to a prevailing humanistic culture, are not fully aware of the importance of participation in clinical research, which is sometimes considered as exclusive economic or prestige interest. In our experience, people who refused participation in the trials were younger, with a high level of education and income, more frequently women. The researcher's task is to motivate the patient by emphasizing that participating in a study means being the actors of a treatment choice and that one is a guinea pig when taking untested therapies.


Asunto(s)
Ensayos Clínicos como Asunto , Consentimiento Informado , Participación del Paciente , Adulto , Toma de Decisiones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Motivación , Participación del Paciente/psicología , Selección de Paciente , Sujetos de Investigación , Encuestas y Cuestionarios , Confianza
15.
Soins Gerontol ; 25(141): 31-37, 2020.
Artículo en Francés | MEDLINE | ID: mdl-32200988

RESUMEN

We wonder about the patient's perception relating to a request for informed and express free consent. We report interviews conducted with sixteen seniors who responded to a consent request while they were hospitalized in a geriatric department. Those patients had to give their opinion on the quality of the information received, their feeling of freedom and the perception of their consent or not. Making a qualitative study of the verbatim by an analysis using anchored theorization, we show the major influence of the freedom with the act of choice and the importance of supporting the patients to whom it is asked to consent.


Asunto(s)
Emociones , Consentimiento Informado/psicología , Anciano , Servicios de Salud para Ancianos , Hospitalización , Humanos , Investigación Cualitativa
16.
J Clin Ethics ; 31(1): 60-67, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32213692

RESUMEN

An accurate determination of an individual's decision-making capacity is fundamental to obtaining informed consent for medical treatment, as it allows clinicians to balance respect for patients' autonomy with the best interests of patients. Despite the increasing demand for assessments of patients' capacity, healthcare professionals find this task complex and challenging. Currently, assessments are largely based on patients' cognitive ability and do not sufficiently take into account other factors that influence patients' judgment. Furthermore, it is important to assess for and treat modifiable factors that impair decision-making capabilities, and to have guidance on when it is appropriate to delay treatment-related decisions. This article will review current methods for assessing capacity, highlight other factors to consider in the decision-making process, and propose an enhanced framework to guide clinicians in making timely and prudent treatment-related decisions for patients with impaired capacity.


Asunto(s)
Toma de Decisiones , Personal de Salud , Competencia Mental , Autonomía Personal , Humanos , Consentimiento Informado
17.
Zhonghua Yi Xue Yi Chuan Xue Za Zhi ; 37(3): 352-357, 2020 Mar 10.
Artículo en Chino | MEDLINE | ID: mdl-32128757

RESUMEN

Clinical genetic testing results are compiled into a standardized report by genetic specialists and provided to clinicians and patients (Should the patient be intellectually disabled or under 18, the report will be provided to his/her parents or legal guardians). The content of genetic testing report should conform to relevant guidelines, industry standards and consensus. The decisions of clinicians will be made based on the report and clinical indications. Genetic counselors should provide post-test counseling to clinicians and patients or their authorized family members. A mechanism of follow-up visit after the genetic testing should be established with informed consent. Data should be shared by clinical institutions and genome sequencing institutions. As findings upon follow-up visit can help with further evaluation of the results, genome sequencing institutions should regularly re-analyze historical and follow-up data, and the updated results should be shared with clinical institutions. All activities involving reporting, genetic counselling, follow-up visiting, and re-analyzing should follow the relevant guidelines and regulations.


Asunto(s)
Asesoramiento Genético , Enfermedades Genéticas Congénitas/diagnóstico , Pruebas Genéticas/normas , Secuenciación de Nucleótidos de Alto Rendimiento/normas , Consenso , Humanos , Consentimiento Informado
20.
Z Gastroenterol ; 58(2): 127-132, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32050283

RESUMEN

BACKGROUND: In 1978 and 1979, contaminated anti-D immunoglobulin was used in the German Democratic Republic (GDR). As a result, several thousand women were, in the end, infected with hepatitis C. These women received medical attention, part of which was research on hepatitis C. Up to now, results of the research and data are being published in international journals. It remains unclear whether the affected women were asked to be subjects of the clinical research. METHODS: The authors analyzed historical sources and conducted interviews with contemporary witnesses. RESULTS: In the GDR, these women were compulsorily treated by physicians without sufficient information about the disease, diagnostics, and therapy. If the women refused medical care, they were coerced into it by the physicians. Medical care and research were inseparable. Without the knowledge of the women and without their consent, research was carried out on the blood samples and liver biopsies acquired from them.After the German reunification, the same physicians continued to conduct research on the same group of patients. Beginning in 1990, interferon therapy was offered to the women. Parallel to the medication with interferon, studies on the effects of the therapy were carried out. In this case as well, the women were not informed about the use of collected data, nor did they agree to it. CONCLUSIONS: Physicians should clearly define the border between medical care and scientific interest. Exclusively, data obtained from studies performed correctly under ethical point of view should be accepted for publication.


Asunto(s)
Contaminación de Medicamentos , Hepatitis C Crónica/tratamiento farmacológico , Globulina Inmune rho(D)/efectos adversos , Prestación de Atención de Salud , Femenino , Alemania Oriental , Hepatitis C Crónica/virología , Experimentación Humana , Humanos , Consentimiento Informado
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