Termo de consentimento livre e esclarecido e sua relação com os procedimentos de preenchimento labial / Free and informed consent terms and its relationship with lip filling procedures

Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)

Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)

Simplifying informed consent as a universal precaution.

One barrier to participating in clinical research is that patients with low literacy skills (1 in 5 US adults) may struggle to understand the informed consent document (ICD). Writing consents using health literacy and plain language guidelines including simplified syntax and semantics can increase understandability and facilitate inclusivity of research populations with literacy challenges. Our study aim was to evaluate a simplified ICD for understandability while considering factors known to relate to comprehension (reading skills and working memory). We performed an on-line survey of 192 adults ages 18-77 in Georgia. Participants performed significantly better on the simplified ICD test. We built an additional model with all version x measure interactions (i.e., age, sex, race, urbanicity, GMVT, WM). This model did not significantly improve model fit, F < 1.00, suggesting that individual differences did not moderate the effect of simplification. Our findings suggest that using plain language and simplified syntax and semantics in ICD as a universal precaution may reduce cognitive reading burden for adults regardless of differences in reading skill or working memory. Increasing understandability in ICD may help improve targets for clinical trial enrollment.

Ethical and Equity Guidance for Transplant Programs Considering Thoracoabdominal Normothermic Regional Perfusion (TA-NRP) for Procurement of Hearts.

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical "authorization," for cadaveric organ donation using TA-NRP.

Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement.

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group. Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified. Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

Future-proofing genomic data and consent management: a comprehensive review of technology innovations.

Genomic information is increasingly used to inform medical treatments and manage future disease risks. However, any personal and societal gains must be carefully balanced against the risk to individuals contributing their genomic data. Expanding our understanding of actionable genomic insights requires researchers to access large global datasets to capture the complexity of genomic contribution to diseases. Similarly, clinicians need efficient access to a patient's genome as well as population-representative historical records for evidence-based decisions. Both researchers and clinicians hence rely on participants to consent to the use of their genomic data, which in turn requires trust in the professional and ethical handling of this information. Here, we review existing and emerging solutions for secure and effective genomic information management, including storage, encryption, consent, and authorization that are needed to build participant trust. We discuss recent innovations in cloud computing, quantum-computing-proof encryption, and self-sovereign identity. These innovations can augment key developments from within the genomics community, notably GA4GH Passports and the Crypt4GH file container standard. We also explore how decentralized storage as well as the digital consenting process can offer culturally acceptable processes to encourage data contributions from ethnic minorities. We conclude that the individual and their right for self-determination needs to be put at the center of any genomics framework, because only on an individual level can the received benefits be accurately balanced against the risk of exposing private information.

Better Conversations for Better Informed Consent: Talking with Surgical Patients.

For more than sixty years, surgeons have used bioethical strategies to promote patient self-determination, many of these now collectively described as "informed consent." Yet the core framework-understanding, risks, benefits, and alternatives-fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will "fix" the problem. They omit critical information about the goals and downsides of surgery and present untenable options as a matter of patient choice. We propose a novel framework called "better conversations." Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

BACKGROUND: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs). METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third. RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas. CONCLUSION: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Informed consent of the patient for medical intervention for conducting biomedical research.

OBJECTIVE: Aim: is to find out the peculiarities of informed consent of the patient for medical intervention during biomedical research. PATIENTS AND METHODS: Materials and Methods: The dialectical method was used as a universal and general scientific method, which made it possible to consider the peculiarities of the content of the patient's informed consent. Using the logico-semantic method, the essence and features of biomedical research with the patient's participation were determined. The formal-legal method is used to analyze adaptation processes of biomedical research. System-structural method were applied when comparing the content of the patient's informed consent in separate legislation. The work also used such methods of cognition as comparative-legal, systemic-logical, and logical-legal. CONCLUSION: Conclusions: "Informed consent" includes not only the concept of consent itself, i.e. the free decision of a person, but also an explanation of a specific case or research procedure. And it largely depends on the specialist. Will he be able to convey and explain the patient's problem, illness, actions correctly, fully and in an accessible form? Yes, free consent is given by a person, but the doctor also influences this decision to some extent. Patients' freedom in choosing medical care methods is somewhat limited.

Language barriers during vaccination practice, the point of view of healthcare providers.

Background: Language barriers are one of the main obstacles faced by migrants in accessing healthcare services. A compromised communication between migrants and Healthcare Providers in vaccination setting can result in increased vaccine hesitancy and decreased vaccine uptake. The objective of the current study is to investigate Healthcare Providers' perceptions about linguistic barriers faced during both routinary vaccination practice and the extraordinary vaccination program for Ukrainian refugees in the Local Health Authorities of Bologna and Romagna (Italy). Methods: A cross-sectional study was conducted through the administration of a questionnaire examining Healthcare Providers' perceptions. A descriptive analysis and a multiple logistic regression model were adopted to analyze the collected data. Results: Language barriers resulted as an obstacle to informed consent and to doctor-patient relationship. The strategies adopted were perceived as helpful in increasing vaccination adherence, despite communication difficulties were still experienced during refugees' vaccinations. Results suggest that the implementation of translated material and the use of professional interpreters may represent important strategies to overcome linguistic barriers, along with Healthcare Providers' training. Healthcare Providers' opinions could assist the implementation of new tools capable of countering language barriers. Conclusions: The current study represents an example of providers' involvement in understanding the complexities behind the issue of language barriers in vaccination practice.

Ethical Challenges and Guidance Related to Adolescent Pregnancy.

An emergency team was challenged with ethical issues while managing an unmarried adolescent girl who presented with an acute abdomen wherein a ruptured ectopic pregnancy was suspected. Consent remained at the center of this dilemma given the age of the patient and the nature of the issues. Herein, we deliberate upon the challenges faced by the treating team in accessing the reproductive history, obtaining consent for performing pregnancy tests and for therapeutic interventions.

Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021.

INTRODUCTION: Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence. METHODS: We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico's cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations. RESULTS: The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care. CONCLUSION: While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

[Placebo procedures in the operating room: necessary or an unnecessary risk for the patient?] / Placeboprocedures in de operatiekamer.

Sham surgeries, surgical procedures without actually carrying out the intended surgical intervention, are rarely used in research concerning a new surgical or invasive technique. The conflicting needs of minimizing operational risks and maximizing simulation present challenges in designing placebo-controlled surgical trials. It is important to thoroughly consider ethical considerations in the design of studies involving sham surgeries, including the importance of a transparent research design, objective reporting of results, challenges related to the informed consent procedure, and the inherent risks associated with surgical procedures. Furthermore, there exists a societal need to offer patients the most cost-effective intervention. Responsible sham surgeries are therefore crucial for understanding the potential and cost-effectiveness of surgical interventions compared to less invasive placebo conditions. Clinically high-quality studies involving placebo-based interventions can provide clarity regarding the balance between doing good and avoiding harm through surgical interventions.

Strategies to address recruitment to a randomised trial of surgical and non-surgical treatment for cancer: results from a complex recruitment intervention within the Mesothelioma and Radical Surgery 2 (MARS 2) study.

OBJECTIVES: Recruiting to randomised trials is often challenging particularly when the intervention arms are markedly different. The Mesothelioma and Radical Surgery 2 randomised controlled trial (RCT) compared standard chemotherapy with or without (extended) pleurectomy decortication surgery for malignant pleural mesothelioma. Anticipating recruitment difficulties, a QuinteT Recruitment Intervention was embedded in the main trial phase to unearth and address barriers. The trial achieved recruitment to target with a 4-month COVID-19 pandemic-related extension. This paper presents the key recruitment challenges, and the strategies delivered to optimise recruitment and informed consent. DESIGN: A multifaceted, flexible, mixed-method approach to investigate recruitment obstacles drawing on data from staff/patient interviews, audio recorded study recruitment consultations and screening logs. Key findings were translated into strategies targeting identified issues. Data collection, analysis, feedback and strategy implementation continued cyclically throughout the recruitment period. SETTING: Secondary thoracic cancer care. RESULTS: Respiratory physicians, oncologists, surgeons and nursing specialists supported the trial, but recruitment challenges were evident. The study had to fit within a framework of a thoracic cancer service considered overstretched where patients encountered multiple healthcare professionals and treatment views, all of which challenged recruitment. Clinician treatment biases, shaped in part by the wider clinical and research context alongside experience, adversely impacted several aspects of the recruitment process by restricting referrals for study consideration, impacting eligibility decisions, affecting the neutrality in which the study and treatment was presented and shaping patient treatment expectations and preferences. Individual and group recruiter feedback and training raised awareness of key equipoise issues, offered support and shared good practice to safeguard informed consent and optimise recruitment. CONCLUSIONS: With bespoke support to overcome identified issues, recruitment to a challenging RCT of surgery versus no surgery in a thoracic cancer setting with a complex recruitment pathway and multiple health professional involvement is possible. TRIAL REGISTRATION NUMBER: ISRCTN ISRCTN44351742, Clinical Trials.gov NCT02040272.

Access to medically-assisted procreation: the withdrawal of paternal consent in the maze of law n. 40/2004.

Abstract: The law (No.40/2004) stipulates that consent to Medically Assisted Procreation (MAP) remains irrevocable post ovum fertilization. Cryo-preservation introduces complexities, enabling embryo implantation requests after a couple's separation and the dissolution of the original parenthood plan. Constitutional Court Ruling No.161 in 2023 affirmed that the prohibition of revoking consent to MAP aligns with the Italian Constitution and the jurisprudence of the European Court of Human Rights. This delicate equilibrium of conflicting interests upholds human freedom, allowing consent revocation prior to ovocyte fertilization. Permitting revocation until implantation could inflict more significant harm: the infertile woman can in fact miss the opportunity to become a mother, impacting her psychophysical well-being and freedom of self-determination. Moreover, the embryo loses the chance to live, remaining in cryopreservation, which violates its dignity. Addressing this issue requires thorough communication by medical profession-als to inform couples about the limitations on consent revocation. An element of objectivity in terms of standards and evidence-based guidelines, from which norms must originate, is of utmost importance. Relying on broadly shared rules, especially at the international level, is vital in light of the unremitting scientific advances in MAP, as in other areas of medicine, which will open up new opportunities for which current legal/regulatory frameworks are inadequate.

[The Italian law 219/2017: informed consent and advance directives. When the patient-doctor communication time is law, but it is forgotten]. / Legge 219/2017: consenso informato e disposizioni anticipate di trattamento. Quando il tempo della comunicazione medico-paziente è legge, ma viene dimenticato.

The Italian law 217/2019 on "Informed consent and advance directives" is an important step forward in the redefinition of patient-doctor relationships. The law points out the principles of the decisional autonomy and freedom of the patient to choose the treatment options. However, it is underestimated and largely unapplied by the Italian cardiologists. The main elements of patient-doctor communication are present in the law. The most important is the time devoted to the patient-doctor relationship, necessary to ease the disease awareness. This time is clearly emphasized in the law, but the healthcare institutions did not arrange for the appropriate organizational procedures. Through the advance directives (ADs) the patients may express their own wishes about healthcare treatments, as well as their consent or refusal regarding the diagnostic or therapeutical doctors' suggestions, allowing their respect in case they become incompetent. This right is supported by the patients' designation of a healthcare proxy, who can interact for them with the healthcare team. However, after 6 years since the law enactment, only 0.4% of the Italian citizens signed ADs, due to insufficient information and organization by the healthcare authorities. In the Law, the advance care planning is closely related to ADs. In this process, the adults can understand and share their personal values, life goals and preferences, in order to define the potential future medical care and to discuss all the issues with family and physicians. These processes can be integrated in a broader shared decision-making, a strong tool of the patient-doctor alliance.

Ethical guidance for conducting health research with online communities: A scoping review of existing guidance.

Online research methods have grown in popularity due in part to the globalised and far-reaching nature of the internet but also linked to the Covid-19 pandemic whereby restrictions to travel and face to face contact necessitated a shift in methods of research recruitment and data collection. Ethical guidance exists to support researchers in conducting online research, however this is lacking within health fields. This scoping review aims to synthesise formal ethical guidance for applying online methods within health research as well as provide examples of where guidance has been used. A systematic search of literature was conducted, restricted to English language records between 2013 and 2022. Eligibility focused on whether the records were providing ethical guidance or recommendations, were situated or relevant to health disciplines, and involved the use or discussion of online research methods. Following exclusion of ineligible records and duplicate removal, three organisational ethical guidance and 24 research papers were charted and thematically analysed. Four key themes were identified within the guidance documents, 1) consent, 2) confidentiality and privacy, 3) protecting participants from harm and 4) protecting researchers from harm with the research papers describing additional context and understanding around these issues. The review identified that there are currently no specific guidelines aimed at health researchers, with the most cited guidance coming from broader methodological perspectives and disciplines or auxiliary fields. All guidance discussed each of the four key themes within the wider context of sensitive topics and vulnerable populations, areas and issues which are often prominent within health research thus highlighting the need for unifying guidance specific for health researchers. Further research should aim to understand better how online health studies apply ethical principles, to support in informing gaps across both research and guidance.

Capacity to Consent in Healthcare: A Systematic Review and Meta-Analysis Comparing Patients with Bipolar Disorders and Schizophrenia Spectrum Disorders.

Background: Mental capacity is a fundamental aspect that enables patients to fully participate in various healthcare procedures. To assist healthcare professionals (HCPs) in assessing patients' capacity, especially in the mental health field, several standardized tools have been developed. These tools include the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), and the Competence Assessment Tool for Psychiatric Advance Directives (CAT-PAD). The core dimensions explored by these tools include Understanding, Appreciation, Reasoning, and Expression of a choice. Objective: This meta-analysis aimed to investigate potential differences in decision-making capacity within the healthcare context among groups of patients with bipolar disorders (BD) and schizophrenia spectrum disorders (SSD). Methods: A systematic search was conducted on Medline/Pubmed, and Scopus. Additionally, Google Scholar was manually inspected, and a manual search of emerging reviews and reference lists of the retrieved papers was performed. Eligible studies were specifically cross-sectional, utilizing standardized assessment tools, and involving patients diagnosed with BD and SSD. Data from the studies were independently extracted and pooled using random-effect models. Hedges' g was used as a measure for outcomes. Results: Six studies were identified, with three studies using the MacCAT-CR, two studies the MacCAT-T, and one the CAT-PAD. The participants included 189 individuals with BD and 324 individuals with SSD. The meta-analysis revealed that patients with BD performed slightly better compared to patients with SSD, with the difference being statistically significant in the domain of Appreciation (ES = 0.23, 95% CI: 0.01 to 0.04, p = 0.037). There was no statistically significant difference between the two groups for Understanding (ES = 0.09, 95% CI:-0.10 to 0.27, p = 0.352), Reasoning (ES = 0.18, 95% CI: -0.12 to 0.47, p = 0.074), and Expression of a choice (ES = 0.23, 95% CI: -0.01 to 0.48, p = 0.60). In the sensitivity analysis, furthermore, when considering only studies involving patients in symptomatic remission, the difference for Appreciation also resulted in non-significant (ES = 0.21, 95% CI: -0.04 to 0.46, p = 0.102). Conclusions: These findings indicate that there are no significant differences between patients with BD and SSD during remission phases, while differences are minimal during acute phases. The usefulness of standardized assessment of capacity at any stage of the illness should be considered, both for diagnostic-therapeutic phases and for research and advance directives. Further studies are necessary to understand the reasons for the overlap in capacity between the two diagnostic categories compared in this study.

Implant maintenance in general dental practice: dento-legal considerations for the general dental practitioner.

Before implants are placed, the patient, as part of the consent process, should understand the risks of the treatment but also the importance of a lifelong maintenance programme. This is particularly important if the patient is at risk of periodontitis. There should be arrangements in place for the patient's ongoing care and general dental practitioners who look after the patient need to appreciate their duty of care in monitoring the implants. Excellent record-keeping and valid consent are important factors in delivering care and can also very much help assist a defence in the event of a civil claim or a regulatory investigation.