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)

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit.

BACKGROUND: Use of electronic methods to support informed consent ('eConsent') is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. MAIN TEXT: We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system's generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. CONCLUSIONS: We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.

Prevention of infective endocarditis in at-risk patients: how should dentists proceed in 2024?

National Institute for Health and Care Excellence (NICE) guidelines are ambiguous over the need for patients at increased risk of infective endocarditis (IE) to receive antibiotic prophylaxis (AP) prior to invasive dental procedures (IDPs), and this has caused confusion for patients and dentists alike. Moreover, the current law on consent requires clinicians to ensure that patients are made aware of any material risk they might be exposed to by any proposed dental treatment and what can be done to ameliorate this risk, so that the patient can decide for themselves how they wish to proceed. The aim of this article is to provide dentists with the latest information on the IE-risk posed by IDPs to different patient populations (the general population and those defined as being at moderate or high risk of IE), and data on the effectiveness of AP in reducing the IE risk in these populations. This provides the information dentists need to facilitate the informed consent discussions they are legally required to have with patients at increased risk of IE about the risks posed by IDPs and how this can be minimised. The article also provides practical information and advice for dentists on how to manage patients at increased IE risk who present for dental treatment.

Assessment of the knowledge, attitude and practices of the informed consent process in oral healthcare among dental students in Makerere University Dental Hospital, Uganda.

INTRODUCTION: Informed consent is an ethical and legal component of healthcare. It ensures patient autonomy and allows patients to make decisions regarding their treatment. In dental care, informed consent is particularly important because most dental procedures are invasive. Since dental students are future dentists, they need to learn about their ethical obligations and accountability through the informed consent process as this is critical to patients' well-being. This study aimed to determine dental students' knowledge, attitudes, and practices of the informed consent process for oral health care in Makerere University Dental Hospital, Uganda. STUDY METHODOLOGY: This was a descriptive cross-sectional study using quantitative methods. It was carried out at Makerere University Dental Hospital and third, fourth, and fifth-year students (n = 102) pursuing a Bachelor of Dental Surgery program took part in the survey. A self-administered structured questionnaire was used to assess their knowledge, attitudes, and practices of informed consent for oral health care. Collected data were entered into Epi-data version 3.1, where it was cleaned, coded, and imported to STATA version 14 software for statistical analysis. RESULTS: About two-thirds 67 (65.7%) of the participants were males. The mean age was 25 (SD = 3.21) years. The majority (90%) of the students had a high level of knowledge of the informed consent process. About (80%) had a positive attitude towards informed consent and (85%) most often practiced the informed consent process. Based on bi-variate analysis, training on informed consent, year of study, age, and sex were significantly associated with the informed consent process. However, there was no significant risk factor associated with informed consent in multiple logistic regression analysis. CONCLUSION: The study findings highlighted high levels of knowledge, positive attitude, and practice of the informed consent process among the clinical dental students. Continuous training is necessary to remind dental students about the importance of informed consent in healthcare, not only for complex procedures.

Closing the gaps: consent and preoperative assessment for children and young people.

The changing ethical and legal landscape in the UK means that anaesthetists should routinely be discussing the risk of death during the consent process. To do this effectively means expanding anaesthetic preassessment services for children and young people, something that has been recognised as a priority, but which still needs investment and an appreciation of its value at the trust level.

Patient Consent for Medical Student Pelvic Exams under Anesthesia: An Exploratory Retrospective Chart Review.

AbstractObjective: We performed this study to examine patients' choices to permit or refuse medical student pelvic examinations under anesthesia (EUAs) during planned gynecologic procedures. DESIGN: We conducted an exploratory retrospective chart review of electronic consent forms at a single academic medical center using contingency tables, logistic regression, and nonparametric tests to explore relationships between patient and physician characteristics and consent. RESULTS: We identified and downloaded electronic consent forms for a census of 4,000 patients undergoing gynecologic surgery from September 2020 through calendar year 2022. Forms were linked to anonymized medical record information. Of the 4,000 patients, 142 (3.6%) were removed from analysis because consent forms were incomplete. Of 3,858 patients, 308 (8.0%) were asked for EUA consent more than once, 46 of whom were not consistent. Overall, 3,308 (85.7%) patients consented every time asked, and 550 (14.2%) refused or limited EUA consent at least once. Nine patients limited their consent to female students, and two patients refused medical student participation at all. We performed exploratory multiple logistic regression analyses exploring differences in rates of consent across patient and physician demographic groups. CONCLUSIONS: We find that some patients are more likely than others to refuse a pelvic EUA, magnifying the dignitary harm from a nonconsensual invasion of intimate bodily integrity and perpetuating historic wrongs visited upon vulnerable people of color and religious minorities. Patients' rights to respect and control over their bodies require that physicians take seriously the ethical obligation to inform their patients and ask them for permission.

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.

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.

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.

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.

[Evaluation of Pharmacy Students' Understanding of Clinical Trials and Research through Questionnaires Before and After the Hospital Practical Training].

A questionnaire survey was conducted to evaluate practical training and improve education on clinical trial and research. This survey was based on the results of questionnaire before and after the practical training undertaken by 240 pharmaceutical students (Kanto region; 1 university, Tokai region; 2 university, Kinki region; 9 university) at Mie University Hospital between 2011 and 2022. In the questionnaire before practical training, lectures in university (n=219, 91%) were the main source of information on clinical trials and research. Fifty-two students (22%) correctly answered the contents of phase 1-4 trials. As an occupation that can perform clinical research coordinator (CRC)'s work, only 7 students (3%) answered that "all medical and non-medical professionals" can perform the CRC's duties. Regarding the understanding of terms related to clinical trials and research, more than 90% of the students understood the meaning of "subjects," "informed consent," and "placebo" even before practical training. Otherwise, even after practical training, students' understanding of "reimbursement," "follow-up period," "audit," or "direct access" was less than 80%. Practical training improved the understanding of terms such as clinical trial (Wilcoxon signed-rank test, p<0.001), clinical research phase 1-4 trials (Wilcoxon signed-rank test, p<0.001), interest in clinical trials and research (McNemar-Bowker test, p<0.001), and understanding of CRC's work (McNemar-Bowker test, p<0.001). We will improve the content of practical training and bequeath the knowledge and importance of drug discovery and development to the next generation.

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.

Envisioning the Future of Personalized Medicine: Role and Realities of Digital Twins.

Digital twins have emerged as a groundbreaking concept in personalized medicine, offering immense potential to transform health care delivery and improve patient outcomes. It is important to highlight the impact of digital twins on personalized medicine across the understanding of patient health, risk assessment, clinical trials and drug development, and patient monitoring. By mirroring individual health profiles, digital twins offer unparalleled insights into patient-specific conditions, enabling more accurate risk assessments and tailored interventions. However, their application extends beyond clinical benefits, prompting significant ethical debates over data privacy, consent, and potential biases in health care. The rapid evolution of this technology necessitates a careful balancing act between innovation and ethical responsibility. As the field of personalized medicine continues to evolve, digital twins hold tremendous promise in transforming health care delivery and revolutionizing patient care. While challenges exist, the continued development and integration of digital twins hold the potential to revolutionize personalized medicine, ushering in an era of tailored treatments and improved patient well-being. Digital twins can assist in recognizing trends and indicators that might signal the presence of diseases or forecast the likelihood of developing specific medical conditions, along with the progression of such diseases. Nevertheless, the use of human digital twins gives rise to ethical dilemmas related to informed consent, data ownership, and the potential for discrimination based on health profiles. There is a critical need for robust guidelines and regulations to navigate these challenges, ensuring that the pursuit of advanced health care solutions does not compromise patient rights and well-being. This viewpoint aims to ignite a comprehensive dialogue on the responsible integration of digital twins in medicine, advocating for a future where technology serves as a cornerstone for personalized, ethical, and effective patient care.

Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.

[Ethics of care: Assessment of the ethical issues in the protocols or consensuses on mechanical restraint in force in Spain]. / Ética de los cuidados: valoración de los contenidos éticos en los protocolos o consensos de contención mecánica vigentes en España.

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.

Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study.

OBJECTIVE: Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or 'lost in translation'. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages. DESIGN: We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data. SETTING: The study was based in Lusaka, Zambia. RESULTS: The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood. CONCLUSION: Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Are Psychedelic Experiences Transformative? Can We Consent to Them?

Psychedelic substances have great promise for the treatment of many conditions, and they are the subject of intensive research. As with other medical treatments, both research and clinical use of psychedelics depend on our ability to ensure informed consent by patients and research participants. However, some have argued that informed consent for psychedelic use may be impossible, because psychedelic experiences can be transformative in the sense articulated by L. A. Paul (2014). For Paul, transformative experiences involve either the acquisition of knowledge that cannot be obtained in any other way or changes in the self. Either of these characteristics may appear to undermine informed consent. This article argues, however, that there is limited evidence that psychedelic experiences are transformative in Paul's sense, and that they may not differ in their transformative features from other common medical experiences for which informed consent is clearly possible. Further, even if psychedelic experiences can be transformative, informed consent is still possible. Because psychedelic experiences are importantly different in several respects from other medical experiences, this article closes with recommendations for how these differences should be reflected in informed consent processes.