[Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment]. / National standardisierter Broad Consent in der Praxis: erste Erfahrungen, aktuelle Entwicklungen und kritische Betrachtungen.

BACKGROUND: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites. METHODS: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from a large number of stakeholders were evaluated. RESULTS: The online surveys showed that 27 of the 32 sites have gradually introduced the consent documents productively, with a current total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials. DISCUSSION: The introduction of the MII consent documents at the university hospitals creates a uniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete.

Opioid prescription and postoperative outcomes in pediatric patients.

OBJECTIVES/HYPOTHESIS: To determine if the amount of opioid prescribed and postoperative outcomes after adenotonsillectomy changed following implementation of mandated opioid consent forms. STUDY DESIGN: Retrospective cohort study. METHODS: Patients undergoing adenotonsillectomy 6 months before and after implementation of mandated opioid consent forms at a tertiary-care pediatric hospital were studied. Demographics, operative data, weight-based opioid dosage, and postoperative outcome measures, including nursing calls, emergency department (ED) visits, hospital readmission, and bleed rates, were collected and analyzed. RESULTS: Of 300 patients, opioid prescription was provided for 211 patients (70.3%), 112 preconsent (74.7%) and 99 postconsent (66.0%). Mean (standard deviation) total opioid prescribed (milligrams/kilogram) was significantly higher preconsent 4.8 (5.6) than postconsent 3.2 (4.7), (P = .003). There were no differences between number of nursing calls (P = .134) or ED visits (P = .083). Interestingly, preconsent patients had more hospital readmission for pain/dehydration (odds ratio OR: 368, P = .016) and bleeding concerns (OR: 244, P = .003). CONCLUSIONS: A mandated consent form prior to opioid prescription was associated with decreased overall opioid prescription without resultant increase in postoperative complications in pediatric patients. These data provide support for minimizing opioid prescription on a systems-based level. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:1477-1481, 2019.

The Medical Legal Aspects of Surgery First and a New Model of Consent Form.

The introduction of "surgery first" has resulted in a new requirement to compare and resolve medical legal problems which previously did not exist in traditional orthognathic surgery. The first issue relates to the relationship between the doctor and the patient and, in particular, the need to create a new informed consent form for surgery first. The second problem that has arisen with the arrival of surgery first concerns the relationship between health workers, namely the surgeon, and the orthodontist. The authors of this article propose a new template for informed consent specifically created for surgery first and also a model for the new working relationship between surgeons and orthodontists which will facilitate and improve co-operation between them. This will improve results, and guarantee a greater level of protection for the surgeon. It will also enable the identification the individual responsibilities of each person.

Adding injury to injury: ethical implications of the Medicaid sterilization consent regulations.

The need for contraceptive and family planning services is often unmet, especially among lower-income women. However, the history of the provision of these services is fraught with coercion and mistrust: in 1979, in response to forced sterilization practices among doctors working with poor and minority populations, the U.S. Department of Health, Education, and Welfare imposed regulations on the informed consent process for Medicaid recipients requesting sterilization. The government mandated, among other requirements, a 30-day waiting period between consent and surgery and proscribed laboring women from providing consent. Initially intended to prevent the exploitation of poor women, these rules have instead become a barrier to many women receiving strongly desired, effective, permanent contraception. More critically, the regulations are ethically flawed: by preventing women from accessing needed family planning services, the Medicaid consent rules violate the standards of beneficence and nonmaleficence; by treating publically insured women differently from privately insured women, they fail the justice standard; and by placing constraints on women's free choice of contraceptive methods, they run afoul of the autonomy standard. The current federal sterilization consent regulations warrant revising. The new rules must simultaneously reduce barriers to tubal ligation while safeguarding the rights of women who have historically suffered mistreatment at the hands of the medical profession. These goals could best be obtained through a combined approach of improved clinician ethics education and a new standardized sterilization consent policy, which applies to all women and which abolishes the 30-day waiting period and the prohibition on obtaining consent in labor.

Aspectos éticos e jurídicos dos exames complementares / Ethical and legal aspects of supplementary tests

Dentro do processo de decisão médica em cardiologia, em especial na doença arterial coronária, com a necessidade de avaliar o paciente individualmente dentro do binômio diagnóstico-prognóstico, estão incluídos os exames complementares não invasivos. Quando indicados nas populações classificadas como probabilidade pré-teste intermediária de doença, alcançam habitualmente sua máxima eficiência, mas envolvem riscos inerentes aos métodos empregados, que devem ser abordados no sentido de fornecer a máxima segurança ao paciente dentro da melhor relação custo-efetividade. No caso das provas de estresse físico como o teste ergo métrico (TE), a despeito de ser considerado um procedimento seguro, há relatos de eventos de natureza grave como infarto do miocárdio (lM) e morte, com estudos sugerindo de zero a seis mortes ou paradas cardíacas e dois a 10 IM por 10.000 testes realizados. Ressalta-se, no entanto, que as estimativas variam de modo significativo de acordo à prevalência e gravidade da doença cardíaca de base na população testada, sendo tais dados corroborados em diretrizes nacionais da especialidade. Destacados tais fatos, toma-se obrigatório o conhecimento pelo médico das implicações médico-legais do procedimento, abordadas nos Códigos de Proteção ao Consumidor, Civil Brasileiro e de Ética Médica e que são passíveis de aplicação. Há considerações adicionais quando exames complementares que empregam estresse físico, estímulo ou estresse farmacológico associam-se com a injeção de radiofármacos para o estudo da perfusão do miocárdio, como o tálio 201 ou isonitrilas (MIEI ou tetrofosmin) marcadas com tecnécio 99m, considerando-se a exposição à radiação e intercorrências possíveis relacionadas ao estresse, documentados em TCLE apropriado...

Within the cardiology medica I decision-rnaking, especially in coronary artery disease, and the need to evaluate the individual patient in binomial diagnosis-prognosis, as well as meet the conceptuation of incremental prognostic value, the complementary non-invasive examinations are included: when indicated in populations classified as intermediate pretest probability of illness they usually reach their maximum efficiency, but involve risks inherent in methods, which must be addressed in order to provide maximum safety to the patient within the best cost effectiveness ratio. In case of evidence of physical stress such as exercise testing (EXT), in spite of being considered a safe procedure, there are reports of serious nature, such as myocardial infarction (MI) and death, with studies suggesting from zero to six deaths or cardiac arrest and two to ten MI for 10.000 tests performed. It should be noted however, that estimates vary significantly according to the prevalence and the severity of heart disease based on the population tested, being such data supported by national specialty guidelines. Highlighted such facts, it becomes rnandatory the doctor's knowledge about the medical-legal implications of the procedure, consumer protection codes, Brazilian civil and medical ethics that can be applied. There are other considerations when additional tests that emply physical stress, stimulation or pharmacological stress associated with the injection of radio pharmaceuticals for the study of myocardiaI perfusion, as thallium 201 or isonitriles (MIBI or tetrofosrnin) labeled with technetium 99 m, considering the radiation exposure and possible complications related to stress, documented in appropriate free informed consent statement...

La obligación de informar al paciente: Cuestiones sobre el derecho a ser informado / The obligation to inform the patient: Issues on the right to be informed

This article aims to analyze, from a legal perspective, the boundaries of the obligation imposed on health care providers to inform the patient. This requirement originated and was developed as an ethical issue. However, with the newly approved law regulating the rights and duties of patients, the obligation to inform can be viewed from prisms and principles that differ from those governing medical ethics. With this purpose, we will focus on the comparative experience, which will allow us to evaluate the responsibility of health care providers when this duty is breached. We will try to answer the following questions: Which medical information must be informed to the patient? When should the doctor inform the patient? In which form should this information be provided?.

Physicians' explanatory behaviours and legal liability in decided medical malpractice litigation cases in Japan.

BACKGROUND: A physician's duty to provide an adequate explanation to the patient is derived from the doctrine of informed consent and the physician's duty of disclosure. However, findings are extremely limited with respect to physicians' specific explanatory behaviours and what might be regarded as a breach of the physicians' duty to explain in an actual medical setting. This study sought to identify physicians' explanatory behaviours that may be related to the physicians' legal liability. METHODS: We analysed legal decisions of medical malpractice cases between 1990 and 2009 in which the pivotal issue was the physician's duty to explain (366 cases). To identify factors related to the breach of the physician's duty to explain, an analysis was undertaken based on acknowledged breaches with regard to the physician's duty to explain to the patient according to court decisions. Additionally, to identify predictors of physicians' behaviours in breach of the duty to explain, logistic regression analysis was performed. RESULTS: When the physician's explanation was given before treatment or surgery (p = 0.006), when it was relevant or specific (p = 0.000), and when the patient's consent was obtained (p = 0.002), the explanation was less likely to be deemed inadequate or a breach of the physician's duty to explain. Patient factors related to physicians' legally problematic explanations were patient age and gender. One physician factor was related to legally problematic physician explanations, namely the number of physicians involved in the patient's treatment. CONCLUSION: These findings may be useful in improving physician-patient communication in the medical setting.

Documentos médicos / Medical documents

O artigo ressalta os aspectos jurídicos dos documentos médicos, privilegiando a sua vocação como meios de prova em processos judiciais. Procurase trazer uma abordagem prática da questão dos documentos médicos, com vistas ao exercício profissional cotidiano e sem que se pretenda minimizar a importância da investigação aprofundada da matéria, e muito menos desvalorizar a finalidade principal desses documentos que decorre da sua natureza médica. Os principais instrumentos que retratam os cuidados prestados ao paciente, quais sejam Prontuário Médico, Termo de Consentimento Informado, Atestados e Receituário, são comentados sob o enfoque legal, buscando-se apontar quais características lhe conferem legitimidade jurídica

This article emphasizes the legal aspects of medical documents, giving priority to their potential use as evidence in legal proceedings. It seeks to provide a practical approach to the issue of medical documents, which is addressed to everyday professional practice but has no intention of minimizing the importance of a thorough investigation of the matter, and much less underestimating the main purpose of these documents arising from its medical nature. The main instruments that reflect the care delivered to the patient, namely, Medical Chart, Informed Consent Form, Certificates and Prescriptions, are discussed under the legal point of view, aiming to point out which features grant them legal legitimacy

Photography consent and related legal issues.

The use of photography is an integral part of any plastic surgery practice. Photographs are part of the patient's medical record and thus are covered by both federal and state privacy laws. Liability issues may arise when patients are photographed without their knowledge and consent. With proper written consent, practices may use "before" and "after" photographs of patients. However, some states have specific requirements as to the manner in which these photographs are taken and what claims may appear as text with the photographs. This article seeks to discuss legal issues associated with the use of photography in plastic surgery practices, and provides sample agreements to serve as a basis for addressing these issues.

Evaluating the quality of information about alternatives to research participation in oncology consent forms.

A careful consideration of the alternatives to research participation is an essential element of making an informed choice to enroll in a biomedical research study. While there is general agreement on the importance of informing prospective subjects about alternatives to research participation, little is known about how investigators communicate this information. The purpose of this study was to attempt to assess the quality of information about alternatives contained in informed consent documents in oncology randomized controlled trials. Our study indicates that there is room for improvement concerning the discussion of alternatives to research participation in informed consent documents in oncology randomized controlled trials. Though most of the documents in our study met the minimal disclosure standard found in the U.S. federal regulations, less than a third met the reasonable person standard, a widely accepted principle endorsed by the common law and various ethics guidelines and documents. There was a statistically significant difference between the alternative discussions in local and model forms (P<0.0014). The alternatives discussions in local informed consent documents were more likely to receive higher scores than those in model consent documents, with an odds-ratio of 3.5 to 1.

Adhesion-related complications are common, but rarely discussed in preoperative consent: a multicenter study.

BACKGROUND: Peritoneal adhesions are recognized as an important cause for patient morbidity, but complications related to adhesions occur relatively late after the original operation. Therefore preoperative consent may not adequately reflect the proportions of the problem. METHODS: A total of 200 patients admitted for intraperitoneal operations at six hospitals were prospectively reviewed to identify whether adhesion-related complications were documented as possible adverse events in their respective consent forms. RESULTS: Adhesion-related complications were documented in 8.5% (n=17) of consent forms (bowel obstruction n=8, requirement for further operations n=5, difficult reoperation n=1, pain n=3). A direct relationship with adhesions was noted in n=9 of these consent forms. CONCLUSIONS: Preoperative informed consent does not adequately reflect the magnitude of adhesion-related problems. These findings have immediate implications for clinical practice.

Do-not-resuscitate. Orders in surgery: decreasing the confusion.

Patients have the right to make decisions regarding their medical care, including the right to refuse treatment or to issue do-not-resuscitate orders as part of an advance directive. Health care providers must comply with the patient's wishes regarding care. Automatic suspension or continuation of a do-not-resuscitate order for a patient undergoing surgery cannot be justified. Surgical team members should consult with the patient and, if necessary, with an ethics expert or committee to determine whether the do-not-resuscitate order is to be maintained or completely or partially suspended during anesthesia and surgery. All surgical departments should have a written policy and procedure concerning the treatment of patients with do-not-resuscitate orders.

Informing patients of risks inherent in treatment.

Consent to treatment lies at the heart of autonomous decision making by patients who are entitled to make a free choice about whether to accept or refuse treatment. To help patients arrive at their decision district nurses must ensure that they give sufficient information about the nature and risks inherent in the treatment to allow an informed choice to be made. This article considers how much information regarding risks needs to be disclosed. It discusses how the law requires a different level of disclosure for patients who ask no questions about risks, those who make general enquiries about risks and those who ask specific questions about the risks inherent in treatment.

Ethical issues arising from the requirement to sign a consent form in palliative care.

French healthcare networks aim to help healthcare workers to take care of patients by improving cooperation, coordination and the continuity of care. When applied to palliative care in the home, they facilitate overall care including medical, social and psychological aspects. French legislation in 2002 required that an information document explaining the functioning of the network should be given to patients when they enter a healthcare network. The law requires that this document be signed. Ethical issues arise from this legislation with regard to the validity of the signature of dying patients. Signature of the consent form by a guardian or trustee, a designated person--the Person of Trust--transforms the doctor-patient relationship into a triangular doctor-patient-third-party relationship.