[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.

Obstetrician-Gynecologists' Practices in Postpartum Sterilization Without a Valid Medicaid Consent Form.

OBJECTIVE: To explore the practices of obstetrician-gynecologists (ob-gyns) in the United States surrounding postpartum sterilization when the Medicaid consent form was not valid. METHODS: Using the American College of Obstetricians and Gynecologists' online directory, we conducted a qualitative study where we recruited ob-gyns practicing in 10 geographically diverse U.S. states for a qualitative study using semi-structured interviews conducted by telephone. We analyzed interview transcripts using the constant comparative method and principles of grounded theory. RESULTS: Thirty ob-gyns (63% women, 77% nonsubspecialized, and 53% academic setting) were interviewed. Although most physicians stated that they did not perform sterilizations without a valid Medicaid sterilization form, others noted that they sometimes did due to a sense of ethical obligation toward their patient's health, being in a role with more authority or seniority, interpreting the emergency justification section of the form more broadly, or backdating the form. The physicians who said that they never went ahead without a signed form tended to work at large institutions and were concerned with losing funding and engaging in potentially illegal or fraudulent behavior. CONCLUSION: Physicians' varied behaviors related to providing postpartum sterilization without a valid Medicaid consent form demonstrate that the policy is in need of revision. Unclear terminology and ramifications of the Medicaid sterilization policy need to be addressed to ensure equitable care.

COVID-19 highlights the policy barriers and complexities of postpartum sterilization.

Multiple barriers exist to sterilization in the postpartum period. One such barrier, the Medicaid Title XIX sterilization policy, requires publicly insured patients to complete a sterilization consent form at least 30 days prior to their scheduled procedure. While this policy was set in place in the 1970s to address the practice of coerced sterilization among marginalized women, it has served as a significant barrier to obtaining the procedure in the contemporary period. The COVID-19 pandemic has highlighted specific complexities surrounding postpartum sterilization and created additional barriers for women desiring this contraceptive method. Despite the time constraints to perform postpartum sterilization, some hospital administrators, elective officials, and state Medicaid offices deemed sterilization as "elective." Additionally, as the Center for Medicare and Medicaid Services (CMS) has revised telemedicine reimbursement and encouraged its increased use, it has provided no guidance for the sterilization consent form, use of oral consents, and change to the sterilization consent form expiration date. This leaves individual states to create policies and recommended procedures that may not be accepted or recognized by CMS. These barriers put significant strain on patients attempting to obtain postpartum sterilization, specifically for patients with lower incomes and women of color. CMS can support reproductive health for vulnerable populations by providing clear guidance to state Medicaid offices, extending the 180-day expiration of a sterilization consent form signed prior to the pandemic, and allowing for telemedicine oral consents with witnesses or electronic signatures.

Legal policies of organ transplantation in India: Basics and beyond.

The Organ Transplantation Act issued by the Government of India 1994 has undergone major and minor changes in the form of addition of rules and amendments in order to improve the Act to make it much acceptable legally. Over a period of time, with an increase in cadaver organ donations, the rules and policies with regard to the same have been defined and redefined over the years. In this article, the Act, the rules, the amendments, the quick essentials of approach, and the forms are reviewed.

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales.

BACKGROUND: Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capacity. The role of the 'proxy' (or 'surrogate') is to advise researchers about the person's wishes and feelings or to provide consent on the person's behalf for a clinical trial of a medicine. Information about the study is usually provided to the proxy; however, little information is available to proxies about their role, or the appropriate legal and ethical basis for their decision, to help inform their decision-making. The aim of this study was to analyse the written information that is provided to consultees and legal representatives. METHODS: Studies including adults lacking capacity to consent which utilised consultees or legal representatives were identified using the UK Clinical Trials Gateway database. A representative sample (n = 30) were randomly selected. Information sheets and other study documents provided to proxies were obtained, and relevant content was extracted. Content analysis was conducted through four stages: decontextualisation of the unit of analysis, recontextualisation, categorisation, and compilation. The data were summarised narratively according to each theme and category. RESULTS: Considerable variation was found in the written information sheets provided to proxies. Most directed proxies to consider the wishes and feelings of the person who lacked capacity and to consult with others during the decision-making process. However, a small number of studies extended the scope of the proxy's role to consider the person's suitability or eligibility for the study. Particular discrepancies were found in information provided to those acting as consultees or legal representatives in a professional, as opposed to a personal, capacity. Incorrect uses of terminology were frequently found, and a small number of studies inaccurately interpreted the law. CONCLUSIONS: Despite undergoing ethical review, study documents lacked essential information, incorrectly used terminology, and conflated professionals' clinical and representation roles. Future recommendations include ensuring proxies are provided with adequate and accurate information which complies with the legal frameworks. Further research is needed to explore the information and decision-making needs of those acting as consultees and legal representatives.

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.

[Medical prescription and informed consent for the use of physical restraints in nursing homes in the Canary Islands (Spain)]. / Prescripción facultativa y consentimiento informado ante el uso de restricciones físicas en centros geriátricos de las Islas Canarias.

OBJECTIVE: To identify the frequency of completion of informed consent and medical prescription in the clinical records of older patients subject to physical restraint, and to analyse the association between patient characteristics and the absence of such documentation. METHODS: A cross-sectional and descriptive multicentre study with direct observation and review of clinical records was conducted in nine public nursing homes, comprising 1,058 beds. RESULTS: 274 residents were physically restrained. Informed consent was not included in 82.5% of cases and was incomplete in a further 13.9%. There was no medical prescription in 68.3% of cases and it was incomplete in a further 12.0%. The only statistical association found was between the lack of prescription and the patients' advanced age (PR=1.03; p <0.005). CONCLUSIONS: Failure to produce this documentation contravenes the law. Organisational characteristics, ignorance of the legal requirements or the fact that some professionals may consider physical restraint to be a risk-free procedure may explain these results.

Negative impact of litigation procedures on patient outcomes four years after severe traumatic brain injury: results from the PariS-traumatic brain injury study.

PURPOSE: To analyze the effect of litigation procedures on long-term outcomes in severe traumatic brain injury. MATERIALS AND METHODS: Prospective observational follow-up of an inception cohort including 504 adults with severe traumatic brain injury recruited in 2005-2007 in the Parisian area, France, with initial, one- and four-year outcomes measures. RESULTS: Four years after the traumatic brain injury, 147 patients, out of 257 who survived the acute phase, were assessed. Among these patients, 53 patients declared being litigants and 78 nonlitigants (litigation status was unknown in 16 cases). Sociodemographic characteristics, type of injury and initial severity did not differ significantly between litigants and nonlitigants, except for Injury Severity Score (worse in litigants) and the proportion of road traffic accidents (higher in litigants). One- and four-year outcomes were significantly worse in litigants for autonomy, participation, psychiatric and cognitive function but not quality of life (measured with the Glasgow Outcome Scale-Extended, the working activity status, the Brain Injury Community Rehabilitation Outcome, the Hospital Anxiety and Depression scale, the Neurobehavioral Rating Scale-revised and the Quality of Life after Brain Injury, respectively). Multivariate analyses highlighted litigation procedure as an independent significant predictor of lower autonomy, participation and psychiatric function and tended to predict lower cognitive function, but not lower quality of life, after adjustment for pretrauma characteristics, Injury Severity Score, road traffic accidents and work-related accident status. CONCLUSIONS: Patients with severe traumatic brain injury have a worse prognosis when involved in a litigation procedure and require special attention in clinical practice. Implications for rehabilitation The influence of litigation procedure on health and social outcomes in severe traumatic brain injury is a major issue that entail numerous levels of complexities. A wide range of interactions and factors related to the prolonged process of litigation against a third party may influence recovery. Results from the PariS-Traumatic Brain Injury study suggest that patients with a severe Traumatic Brain Injury who are involved in a litigation procedure within French jurisdiction compensation scheme have a worse prognosis than patients who do not. Health professionals should be aware of the potential adverse effects of litigation procedures on recovery, and provide appropriate interventions and information to patients and families in such cases.

[Advance directives in clinical practice : Living will, healthcare power of attorney and care directive]. / Vorausverfügungen im klinischen Alltag : Patientenverfügung, Vorsorgevollmacht und Betreuungsverfügung.

In clinical practice, situations continuously occur in which medical professionals and family members are confronted with decisions on whether to extend or limit treatment for severely ill patients in end of life treatment decisions. In these situations, advance directives are helpful tools in decision making according to the wishes of the patient; however, not every patient has made an advance directive and in our experience medical staff as well as patients are often not familiar with these documents. The purpose of this article is therefore to explain the currently available documents (e.g. living will, healthcare power of attorney and care directive) and the possible (legal) applications and limitations in the routine clinical practice.

Autonomía, consentimiento y responsabilidad. Parte II. El consentimiento informado en la medicina asistencial y en la jurisprudencia / Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law

La consolidación legislativa de los derechos del paciente introdujo modificaciones en la relación clínica y en la lex artis, pero su implantación progresa con dificultades en un entorno sanitario muy condicionado por la escasez de los recursos y la abundancia de las normas. Desde hace algunos años, la autonomía, el consentimiento y la responsabilidad forman uno de los ejes vertebradores de la profesión médica. Sin embargo, son objeto de controversia y causan malestar profesional. En la primera parte de este artículo examinamos las limitaciones conceptuales y normativas del principio de autonomía como fundamento del consentimiento informado, abordadas desde una perspectiva filosófica, histórico-jurídica, bioética, legal, deontológica y profesional. En la segunda parte analizamos la viabilidad del consentimiento informado en la medicina asistencial y su relación con la responsabilidad jurídica (AU)

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility (AU)

Consentimiento informado en endoscopia digestiva: información para el paciente, protección para el endoscopista / No disponible

No disponible

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.

Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.

BACKGROUND: Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles. AIM: We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. METHODS: We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. RESULTS: We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. CONCLUSION: We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.