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)

Pass the tissue: restoring researcher access to legal human donations.

The sensitivity of human tissue and previous instances of misuse have, rightfully, led to the introduction of far-reaching oversight and regulatory mechanisms for accessing, storing and sharing samples. However, these restrictions, in tandem with more broad-based privacy regulations, have had the unintended consequence of obstructing legitimate requests for medical materials. This is of real detriment to ambitions for biomedical research, most notably the precision medicine agenda. As such, this paper makes the case for facilitating authorised researcher access to human tissue and associated data along practical medical ethics lines, detailing how liberating samples from unfit regulations, re-evaluating biobanks, diversifying considerations for donor benefit-risk, future proofing donor consent and flattening hierarchies of donation acceptability equate to a more cohesive and respectful means of managing biological samples and information than is achieved at present.

Clinical Informed Consent and ABA.

The practice of clinical informed consent in America is governed by over 100 years of case law. Although predominant ethics resources for behavior analysts offer some guidance regarding the provision of clinical informed consent, such guidance remains limited. The goal of this article is thus to expand the contemporary literature on clinical informed consent in behavior analysis by providing a historical and contemporary guide to relevant case law. The article will highlight seminal moments in the history of case law regarding clinical informed consent, discuss their applicability to the process of clinical informed consent in behavior analysis, and provide an enhanced understanding of the ethical and legal obligations related to informed consent in the therapeutic context. Supplementary Information: The online version contains supplementary material available at 10.1007/s40617-023-00902-0.

Caesarean section on request - a controversial request or the patient's right?

Caesarean section on request, a request that we have been encountering more and more recently. This can be interpreted as a primary caesarean section performed as a request of the mother without any relevant obstetrical or other medical indications in order to avoid vaginal delivery. The most common reason for mothers' requests for caesarean section is the fear of childbirth and the associated pain. Currently, medicine recognises the patient's right to actively participate in the choice of treatment procedures, including methods of delivery. We have accepted patients' claim for various aesthetic surgical interventions, in case they provide informed consent. The same principle should be maintained for caesarean sections on request.

Human Brain Organoid Research and Applications: Where and How to Meet Legal Challenges?

An ethical and legal framework is needed to regulate the rapidly developing human brain organoid research field properly. However, considering the legal issues involved in human brain organoid research remains underdeveloped and scattered. This article reviews the legal issues of human brain organoid research, grouping them into the following five broad themes: (1) consciousness, (2) legal status, (3) consent, (4) ownership, and (5) transplantation. The issues in each topic include both the urgent (e.g., appropriate forms of consent) and the speculative (e.g., protection of conscious human brain organoids). Therefore, we have attempted to be as explicit as possible about the timescale within which each issue will be realized and to prioritize each. Examining these issues has revealed legal issues specific to human brain organoid research and issues common to research in other fields. Further discussion of human brain organoid research from a legal perspective is needed in the future, considering discussions in related fields.

Psychodynamic psychotherapy for gender dysphoria is not conversion therapy.

Over the last ten years, there has been a substantial increase in the number of children and adolescents referred to gender clinics for possible gender dysphoria. The gender affirming model of care, a dominant treatment approach in Canada, is based on low quality evidence. Other countries are realizing this and making psychosocial treatments and/or exploratory psychotherapy a first line of treatment for gender related distress in young patients. Psychodynamic (exploratory) psychotherapy has established efficacy for a range of conditions, and has been used in youth and adults with gender dysphoria. In Canada, the adoption of psychodynamic psychotherapy for gender dysphoria is impeded by some academics who argue that it may violate laws against conversion therapy. Psychodynamic psychotherapy is not conversion therapy and should be made available in Canada as a treatment modality for gender dysphoria.

Disclosing the undisclosed: are radiographers and healthcare scientists required to communicate a provisional diagnosis when asked?

Patients need to be given the relevant information to be able to give informed consent, which might require the disclosure of a provisional diagnosis. Yet, there is no duty to give information to a patient if that patient is aware that this information exists but chooses not to request it. Diagnostic radiographers and healthcare scientists are often responsible for ensuring that patients have given informed consent for the investigations they undertake, but which were requested by other clinicians. Here we examine if they have a duty to disclose a patient's provisional diagnosis made by a referring clinician if the patient asks for this information as part of the informed consent process to a diagnostic investigation. We first consider aspects of UK law, professional guidance and salient ethical principles, emphasising that while professional codes of practice highlight the need to act in the patient's best interest, they do not require giving patients information they do not require for the examination or have not requested. We then propose that diagnostic radiographers and healthcare scientists placed in such a position use a 'minimally necessary disclosure' framework. This framework fulfils their commitment to their patient and the principle of veracity, while respecting the boundaries of their professional duties. The framework ensures that enough detail is given to the patient for them to be able to give informed consent, while shouldering the diagnostic professional from making a full disclosure, which is the duty of the referring clinician.

Interactive Health Technology Tool for Kidney Living Donor Assessment to Standardize the Informed Consent Process: Usability and Qualitative Content Analysis.

BACKGROUND: Kidney living donation carries risks, yet standardized information provision regarding nephrectomy risks and psychological impacts for candidates remains lacking. OBJECTIVE: This study assesses the benefit of interactive health technology in improving the informed consent process for kidney living donation. METHODS: The Kidney Hub institutional open portal offers comprehensive information on kidney disease and donation. Individuals willing to start the kidney living donation process at Helsinki University Hospital (January 2019-January 2022) were invited to use the patient-tailored digital care path (Living Donor Digital Care Path) included in the Kidney Hub. This platform provides detailed donation process information and facilitates communication between health care professionals and patients. eHealth literacy was evaluated via the eHealth Literacy Scale (eHEALS), usability with the System Usability Scale (SUS), and system utility through Likert-scale surveys with scores of 1-5. Qualitative content analysis addressed an open-ended question. RESULTS: The Kidney Hub portal received over 8000 monthly visits, including to its sections on donation benefits (n=1629 views) and impact on donors' lives (n=4850 views). Of 127 living kidney donation candidates, 7 did not use Living Donor Digital Care Path. Users' ages ranged from 20 to 79 years, and they exchanged over 3500 messages. A total of 74 living donor candidates participated in the survey. Female candidates more commonly searched the internet about kidney donation (n=79 female candidates vs n=48 male candidates; P=.04). The mean eHEALS score correlated with internet use for health decisions (r=0.45; P<.001) and its importance (r=0.40; P=.01). Participants found that the Living Donor Digital Care Path was technically satisfactory (mean SUS score 4.4, SD 0.54) and useful but not pivotal in donation decision-making. Concerns focused on postsurgery coping for donors and recipients. CONCLUSIONS: Telemedicine effectively educates living kidney donor candidates on the donation process. The Living Donor Digital Care Path serves as a valuable eHealth tool, aiding clinicians in standardizing steps toward informed consent. TRIAL REGISTRATION: ClinicalTrials.gov NCT04791670; https://clinicaltrials.gov/study/NCT04791670. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-051166.

It's a spiral staircase, not just two steps: An iterative approach to assessing patient capacity for medical decision-making.

The assessment of medical decision-making capacity as part of the process of clinical informed consent has been considered a bioethical housekeeping matter for decades. Yet in practice, the reality bears little resemblance to what is described in the medical literature and professed in medical education. Most literature on informed consent refers to medical decision-making capacity as a precondition to the consent process. That is, a clinician must first determine if a patient has capacity, and only then may the clinician engage with the patient for the rest of informed consent. The problem with this two-step approach is that it makes no sense in actual practice. We see the assessment of medical decision-making capacity within the process of informed consent as a spiral staircase, not just two steps, requiring clinicians to keep circling up and around, making progress, until they get to where they need to be: 1. Clinicians start with a general presumption of capacity for most adults, sometimes having a provisional appraisal of capacity based on prior patient contact. 2. Then, they begin performing informed consent for the current situation and intervention options. 3. Next, they must reassess capacity during this process. 4. After that, they continue with informed consent. 5. If capacity is not yet clear, they repeat 1-4.

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.

BACKGROUND: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals. OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure. METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses. RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group. CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

Corrigendum: Are face transplant candidates choosing autonomously? A preliminary method to evaluate autonomous choosing in psychosocial and bioethical assessments.

[This corrects the article DOI: 10.3389/frtra.2024.1346667.].

A qualitative study on the effect of a decision aid on knowledge of cataract surgery in patients in developing countries.

BACKGROUND: Despite cataract surgery being a safe procedure with a low incidence of perioperative complications rates, poor knowledge, concerns about the effectiveness of treatment and cost-benefit analysis of the procedure significantly hinder cataract surgery uptake rates in Africa. This study describes the effect of a decision aid on knowledge and decision conflict on cataract patients in Africa. METHODS AND ANALYSIS: 120 patients with cataracts reporting to a tertiary hospital in Ghana were randomly assigned to receive a decision aid containing information on the possible outcomes of cataract surgery or a control booklet containing general knowledge about cataracts without information about cataract surgery. The primary outcome measured was the effect of the decision aid on their knowledge of cataract surgery. A score greater than 6/12 (50%) was deemed adequate knowledge. The secondary outcome was the decision conflict experienced by the participants assessed using the Decision Conflict Scale. RESULTS: Compared to the control group, the participants in the intervention group scored higher marks across all sections of the questionnaire (2.92 vs 2.7, p = 0.042 in section "Background"; 2.62 vs 1.77, p < 0.001 in section "Materials"; 1.87 vs 1.55, p = 0.03 in section "Results"). The average total score was higher in the intervention group than in the control (36.7% difference; p < 0.001). Participants in the intervention group also demonstrated lower decision conflict scores than those in the control group (13.00 vs 37.17; p < 0.001). CONCLUSION: The decision aid increased knowledge of cataract surgery and reduced decision conflict among patients in a developing country.

Association of Language Preference with Therapeutic Care for Hospitalized COVID-19 Patients.

INTRODUCTION: There is a paucity of research investigating disparities in utilization of inpatient therapeutics for COVID-19 by language preference. The primary aim of this study was to assess if the likelihood of treatment with novel COVID-19 therapies differed for patients using a language other than English (LOE) relative to English-speaking patients. METHODS: This was a retrospective observational cohort study of COVID-19 patients hospitalized between March 1, 2020, and June 30, 2022, across 11 hospitals within a single not-for-profit health system. Multivariable relative risks were estimated for the impact of preferred language on the receipt of novel COVID-19 therapies: baricitinib, remdesivir, tocilizumab, and convalescent plasma. RESULTS: This study included 12,510 hospitalized adults with English as the most common preferred language (92.3%) followed by Spanish (3.1%), Somali (1.3%), Russian (0.9%), and Hmong (0.6%). Spanish speakers were more likely to receive any of the novel COVID-19 therapies compared to English speakers (RR 1.45; CI 1.32-1.59). Estimates for Hmong, Somali, Russian, and Other language groups were not statistically significant and closer to the null (aRR range, 0.89-1.12). CONCLUSION: Linguistic patterns in health outcomes expose inherent heterogeneity within racial and ethnic groups. Our study found that Spanish speakers were nearly 1.5 times more likely to receive any of the four novel inpatient COVID-19 therapeutics in comparison to English speakers. Future research is needed to explore the reasons for the heterogeneous findings including temporal influence, cultural factors, informed consent comprehension, and therapeutic hesitancy in all groups.

Informed Consent and the Duty to Warn: More than the Mere Provision of Information.

Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that may not be readily apparent. Such risks include risks that threaten the patient's values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring.

Through Patients' Eyes: Evaluating the Consent Process in Elective Orthopedic Surgery at a Tertiary Referral Center in Ireland.

BACKGROUND: Informed consent is a critical component of ethical clinical practice, particularly in elective orthopedic procedures. It ensures that patients understand the nature, benefits, and risks of the medical procedures they agree to undergo. This study aims to evaluate the informed consent process at Merlin Park University Hospital from the patient's perspective. METHODS: This cross-sectional observational study included 140 participants undergoing elective orthopedic procedures. Data were collected via a questionnaire focusing on socio-demographic information and the informed consent process, including details on who provided the information, where and when the consent was signed, and patient understanding and satisfaction. Responses were analyzed using SPSS version 26 (IBM Corp., Armonk, NY). RESULTS: The majority of participants were females, with 80 (57.1%) women and 60 (42.9%) men. The average age of the participants was 60.86 years. Most participants were employed, constituting 75 (53.6%) of the sample, and 55 (39.3%) had attained university or higher education. The most common procedures were total hip replacement, with 30 (21.4%) participants, and total knee replacement, with 20 (14.3%) participants. Information during the consent process was primarily provided by consultants in 80 (57.1%) cases. High satisfaction levels were reported, with 139 (99.3%) participants expressing satisfaction. Significant correlations were found between satisfaction and the type of healthcare provider, type of operation, and educational level. CONCLUSION: The informed consent process at Merlin Park University Hospital is generally effective, with high patient satisfaction and understanding. However, there is a preference for concise information delivery. Enhancing the process through personalized information delivery could further improve patient satisfaction and comprehension. These findings contribute valuable insights into patient-centered care and informed consent in elective orthopedic surgeries.

Strategies to promote treatment compliance: a grounded theory study with relatives of people with a serious mental health condition.

BACKGROUND: Treatment pressures encompass communicative strategies that influence mental healthcare service users' decision-making to increase their compliance with recommended treatment. Persuasion, interpersonal leverage, inducements, and threats have been described as examples of treatment pressures. Research indicates that treatment pressures are exerted not only by mental healthcare professionals but also by relatives. While relatives play a crucial role in their family member's pathway to care, research on the use of treatment pressures by relatives is still scarce. Likewise, little is known about other strategies relatives may use to promote the treatment compliance of their family member with a serious mental health condition. In particular, no study to date has investigated this from the perspective of relatives of people with a serious mental health condition. AIM: The aim of this study was to answer the following research questions: Which types of treatment pressures do relatives use? Which other strategies do relatives use to promote the treatment compliance of their family member with a serious mental health condition? How do treatment pressures relate to these other strategies? METHODS: Eleven semi-structured interviews were conducted with relatives of people with a serious mental health condition in Germany. Participants were approached via relatives' self-help groups and flyers in a local psychiatric hospital. Inclusion criteria were having a family member with a psychiatric diagnosis and the family member having experienced formal coercion. The data were analyzed using grounded theory methodology. RESULTS: Relatives use a variety of strategies to promote the treatment compliance of their family member with a serious mental health condition. These strategies can be categorized into three general approaches: influencing the decision-making of the family member; not leaving the family member with a choice; and changing the social or legal context of the decision-making process. Our results show that the strategies that relatives use to promote their family member's treatment compliance go beyond the treatment pressures thus far described in the literature. CONCLUSION: This qualitative study supports and conceptually expands prior findings that treatment pressures are not only frequently used within mental healthcare services but also by relatives in the home setting. Mental healthcare professionals should acknowledge the difficulties faced and efforts undertaken by relatives in seeking treatment for their family member. At the same time, they should recognize that a service user's consent to treatment may be affected and limited by strategies to promote treatment compliance employed by relatives.

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.

The European Medicines Agency's conditional marketing authorization (CMA) aims to expedite patient access to medicines for unmet medical needs by shifting a part of the drug development process post-authorization. We highlight ethical issues surrounding CMA, comprising (i) the complexity of defining unmet medical need; (ii) poor understanding of CMA and its impact on informed consent; (iii) hope versus unrealistic optimism; (iv) implications of prolonged post-authorization studies and potential patient harm; (v) rights and duties of patients surrounding participation in post-authorization studies; (vi) access to previously authorized CMA medicines; and (vii) the "benefit slippage" phenomenon, defined as the gradual shift of strict criteria to less strict criteria. We propose a comprehensive research agenda to address these ethical issues, and stress the need for multi-stakeholder engagement to ensure patient-centered use of CMA.

Modifications to consent documentation with adults with communication disorders following brain injury: An exploratory study.

Consent documentation for research studies is often inaccessible to people with neurogenic communication disorders following brain injury and there is limited literature on specific modifications for informed consent. This exploratory study aimed to identify effective strategies and modifications to consent processes for adults with brain injury. Using a fictitious research study, we developed a set of Participant Information Sheets (PISs) varying in complexity, presentation format, and communication modality. Evaluations were conducted with eight participants. Findings indicated diverse participant preferences for PIS modifications, suggesting simplified vocabulary, reduced text, carefully selected images, and an interactive presentation modality as helpful strategies. Building on previous literature, we present refined guidelines for consent modifications for adults with neurogenic communication disorder after brain injury. These guidelines can promote more appropriate inclusion of communicatively impaired populations in research and assist ethics committees and researchers in preparing modified consent documents.

Are face transplant candidates choosing autonomously? A preliminary method to evaluate autonomous choosing in psychosocial and bioethical assessments.

This report proposes a framework for evaluating the validity of informed consent and autonomy in face transplant candidates, taking into account the risk of depression and non-compliance. Traditional factors like decisional capacity, disclosure, comprehension, voluntariness, and agreement are insufficient for assessing valid informed consent in individuals whose self-worth relies on public perception, potentially leading to self-harm if societal worth is undermined. Reliance on self-esteem, rather than inherent personal value, poses risks of depression, poor treatment adherence, and deferential vulnerability. We suggest a qualitative analysis of self-worth, self-esteem, self-trust, and self-respect to better assess the autonomy of face transplant candidates in their decision-making process.