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)

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.

Applying a Trauma-Informed Lens to Challenging Adolescent Encounters: A Faculty Development Session for Pediatricians.

Introduction: Patient encounters perceived to be challenging are common and contribute to both suboptimal patient health outcomes and provider burnout. A trauma-informed care (TIC) approach to these encounters is critical, as many of the characteristics associated with challenging patient encounters can be linked to a history of trauma exposure. Methods: Our team created and delivered a 1-hour synchronous virtual session intended to bolster provider knowledge of TIC principles and their application to challenging adolescent encounters. Participants were all faculty and staff engaged in pediatric primary care at an urban academic center, including physicians, nurse practitioners, psychologists, and social workers. The content was rooted in adult learning principles and included didactic components anchored to case-based learning with facilitated group discussions and opportunities for reflection. We used paired pre- and postsession self-assessments of provider knowledge, confidence, and practice related to TIC using Likert-scale and free-text questions. Descriptive statistics and a paired t test were used to determine the impact of the session on these metrics. Results: In 24 paired surveys, there were statistically significant increases (p ≤ .001) in participant perceived knowledge, confidence, and practice, with 100% of participants having a statistically significant improvement in one or more of these domains. There were also strongly positive Likert-scale and free-text responses regarding content relevance and delivery. Discussion: We demonstrate that a brief session can create improvement in pediatric providers' perceived knowledge about the application of TIC principles to challenging adolescent encounters as well as confidence in their ability to put these into practice.

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.

Advancing Late-Life Trauma-Informed Care Education: Development and Evaluation of an Educational Podcast.

Posttraumatic stress disorder (PTSD) may emerge in late life in the context of illness, role changes, and life review, leading to complications in disease management. The "Talking Later" podcast was developed as an accessible educational product to improve knowledge about late-life PTSD. We describe the process of systematically developing a ten-episode podcast following Kern's six-step curricular model. Following release, the podcast was evaluated via listenership analytics, external clinician feedback survey (N = 45), and internal team survey (N = 9). In 22 months since release, the podcast was played or downloaded 10,124 times across 45 countries. In the external survey, 97% of clinician experts reported the episodes as engaging and informational; 87% stated that no more than general knowledge of PTSD was required to enjoy the podcast. Qualitative analysis of open-ended feedback items found that participants were interested in learning about additional comorbidities and diversity issues related to late-life trauma reengagement. Both the external and internal survey identified discrete elements for improvement. Results suggest the podcast was engaging and informational to a diverse clinical audience. Podcasts represent a relatively new way to deliver educational content. Further consideration of their pedagogical value and limits is warranted.

Kinetic model-informed deep learning for multiplexed PET image separation.

BACKGROUND: Multiplexed positron emission tomography (mPET) imaging can measure physiological and pathological information from different tracers simultaneously in a single scan. Separation of the multiplexed PET signals within a single PET scan is challenging due to the fact that each tracer gives rise to indistinguishable 511 keV photon pairs, and thus no unique energy information for differentiating the source of each photon pair. METHODS: Recently, many applications of deep learning for mPET image separation have been concentrated on pure data-driven methods, e.g., training a neural network to separate mPET images into single-tracer dynamic/static images. These methods use over-parameterized networks with only a very weak inductive prior. In this work, we improve the inductive prior of the deep network by incorporating a general kinetic model based on spectral analysis. The model is incorporated, along with deep networks, into an unrolled image-space version of an iterative fully 4D PET reconstruction algorithm. RESULTS: The performance of the proposed method was evaluated on a simulated brain image dataset for dual-tracer [ 18 F]FDG+[ 11 C]MET PET image separation. The results demonstrate that the proposed method can achieve separation performance comparable to that obtained with single-tracer imaging. In addition, the proposed method outperformed the model-based separation methods (the conventional voxel-wise multi-tracer compartment modeling method (v-MTCM) and the image-space dual-tracer version of the fully 4D PET image reconstruction algorithm (IS-F4D)), as well as a pure data-driven separation [using a convolutional encoder-decoder (CED)], with fewer training examples. CONCLUSIONS: This work proposes a kinetic model-informed unrolled deep learning method for mPET image separation. In simulation studies, the method proved able to outperform both the conventional v-MTCM method and a pure data-driven CED with less training data.

#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research.

INTRODUCTION: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries. MATERIALS AND METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability. RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented. CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.

Erratum: Trauma in the lives of parents experiencing severe perinatal mental illness.

[This corrects the article DOI: 10.3389/fpsyt.2024.1380146.].

Quantifying local and global mass balance errors in physics-informed neural networks.

Physics-informed neural networks (PINN) have recently become attractive for solving partial differential equations (PDEs) that describe physics laws. By including PDE-based loss functions, physics laws such as mass balance are enforced softly in PINN. This paper investigates how mass balance constraints are satisfied when PINN is used to solve the resulting PDEs. We investigate PINN's ability to solve the 1D saturated groundwater flow equations (diffusion equations) for homogeneous and heterogeneous media and evaluate the local and global mass balance errors. We compare the obtained PINN's solution and associated mass balance errors against a two-point finite volume numerical method and the corresponding analytical solution. We also evaluate the accuracy of PINN in solving the 1D saturated groundwater flow equation with and without incorporating hydraulic heads as training data. We demonstrate that PINN's local and global mass balance errors are significant compared to the finite volume approach. Tuning the PINN's hyperparameters, such as the number of collocation points, training data, hidden layers, nodes, epochs, and learning rate, did not improve the solution accuracy or the mass balance errors compared to the finite volume solution. Mass balance errors could considerably challenge the utility of PINN in applications where ensuring compliance with physical and mathematical properties is crucial.

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.

A prediction method for the individual serum concentration and therapeutic effect for optimizing adalimumab therapy in inflammatory bowel disease.

OBJECTIVES: Adalimumab (ADM) therapy is effective for inflammatory bowel disease (IBD), but a significant number of IBD patients lose response to ADM. Thus, it is crucial to devise methods to enhance ADM's effectiveness. This study introduces a strategy to predict individual serum concentrations and therapeutic effects to optimize ADM therapy for IBD during the induction phase. METHODS: We predicted the individual serum concentration and therapeutic effect of ADM during the induction phase based on pharmacokinetic and pharmacodynamic (PK/PD) parameters calculated using the empirical Bayesian method. We then examined whether the predicted therapeutic effect, defined as clinical remission or treatment failure, matched the observed effect. RESULTS: Data were obtained from 11 IBD patients. The therapeutic effect during maintenance therapy was successfully predicted at 40 of 47 time points. Moreover, the predicted effects at each patient's final time point matched the observed effects in 9 of the 11 patients. CONCLUSION: This is the inaugural report predicting the individual serum concentration and therapeutic effect of ADM using the Bayesian method and PK/PD modelling during the induction phase. This strategy may aid in optimizing ADM therapy for IBD.

Breast Cancer Patient's Outcomes after Neoadjuvant Chemotherapy and Surgery at 5 and 10 Years for Stage II-III Disease.

Introduction: Neoadjuvant chemotherapy in breast cancer offers the possibility to facilitate breast and axillary surgery; it is a test of chemosensibility in vivo with significant prognostic value and may be used to tailor adjuvant treatment according to the response. Material and Methods: A retrospective single-institution cohort of 482 stage II and III breast cancer patients treated with neoadjuvant chemotherapy based on anthracycline and taxans, plus antiHEr2 in Her2-positive cases, was studied. Survival was calculated at 5 and 10 years. Kaplan-Meier curves with a log-rank test were calculated for differences according to age, BRCA status, menopausal status, TNM, pathological and molecular surrogate subtype, 20% TIL cut-off, surgical procedure, response to chemotherapy and the presence of vascular invasion. Results: The pCR rate was 25.3% and was greater in HER2 (51.3%) and TNBC (31.7%) and in BRCA carriers (41.9%). The factors independently related to patient survival were pathology and molecular surrogate subtype, type of surgery, response to NACT and vascular invasion. BRCA status was a protective prognostic factor without reaching statistical significance, with an HR 0.5 (95%CI 0.1-1.4). Mastectomy presented a double risk of distant recurrence compared to breast-conservative surgery (BCS), supporting BCS as a safe option after NACT. After a mean follow-up of 126 (SD 43) months, luminal tumors presented a substantial difference in survival rates calculated at 5 or 10 years (81.2% compared to 74.7%), whereas that for TNBC was 75.3 and 73.5, respectively. The greatest difference was seen according to the response in patients with pCR, who exhibited a 10 years DDFS of 95.5% vs. 72.4% for those patients without pCR, p < 0001. This difference was especially meaningful in TNBC: the 10 years DDFS according to an RCB of 0 to 3 was 100%, 80.6%, 69% and 49.2%, respectively, p < 0001. Patients with a particularly poor prognosis were those with lobular carcinomas, with a 10 years DDFS of 42.9% vs. 79.7% for ductal carcinomas, p = 0.001, and patients with vascular invasion at the surgical specimen, with a 10 years DDFS of 59.2% vs. 83.6% for those patients without vascular invasion, p < 0.001. Remarkably, BRCA carriers presented a longer survival, with an estimated 10 years DDFS of 89.6% vs. 77.2% for non-carriers, p = 0.054. Conclusions: Long-term outcomes after neoadjuvant chemotherapy can help patients and clinicians make well-informed decisions.

Bioethics and Neurosurgery: An Overview of Existing and Emerging Topics for the Practicing Neurosurgeon.

Neurosurgery is field with complex ethical issues. In this article, we aim to provide an overview of key and emerging ethical issues in neurosurgery with a focus on issues relevant to practicing neurosurgeons. These issues include those of informed consent, capacity, clinical trials, emerging neurotechnology, innovation, equity and justice, and emerging bioethics areas including community engagement and organizational ethics. We argue bioethics can help neurosurgeons think about and address these issues, and in turn, the field of bioethics can benefit from engagement by neurosurgeons. Several ideas for increasing engagement in bioethics are proposed.

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.

Enhancing patient acceptance of ICD implantation through structured shared decision making: conversation is key.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) are lifesaving treatments for patients at risk for sudden cardiac death. Effective physician-patient communication during the shared decision-making process is essential. Electrophysiologist-patient conversations were targeted to obtain objective data on the interaction, understand the conversation framework, and uncover opportunities for improved communication. METHODS: Individuals previously identified as requiring an ICD/CRT-D but declined implantation were recruited for this four-stage interview and survey-based study. Quantitative analysis of surveys and AI analysis of conversation videos was conducted to evaluate patient participant expectations, analyze feedback about the conversations with study physicians, and gauge willingness for device implantation. RESULTS: The study included 27 patients (mean age 51 years, 51.9% female) and 9 study physicians. Patients were significantly more willing to undergo ICD/CRT-D implantation after conversing with study physicians compared to their own physicians and pre-conversation surveys (mean scores: 5.0, 3.1, and 4.4 out of 7, respectively; p < 0.001). Patient participants had higher satisfaction with the study conversation, rating study physicians higher in effectiveness of explanations, responsiveness to questions, and overall quality of the conversation compared to their own physicians (all p < 0.001). CONCLUSIONS: In a cohort of patients who previously declined ICD/CRT-D implantation, patient satisfaction and willingness to undergo implantation of a guideline-directed device therapy increased significantly following a structured conversation with study physicians. Identified key elements could be integrated into user-friendly tools and educational materials to facilitate these conversations, improving patient engagement with the decision-making process and enhancing informed acceptance of indicated device therapies.

Physics-Informed Online Learning for Temperature Prediction in Metal AM.

In metal additive manufacturing (AM), precise temperature field prediction is crucial for process monitoring, automation, control, and optimization. Traditional methods, primarily offline and data-driven, struggle with adapting to real-time changes and new process scenarios, which limits their applicability for effective AM process control. To address these challenges, this paper introduces the first physics-informed (PI) online learning framework specifically designed for temperature prediction in metal AM. Utilizing a physics-informed neural network (PINN), this framework integrates a neural network architecture with physics-informed inputs and loss functions. Pretrained on a known process to establish a baseline, the PINN transitions to an online learning phase, dynamically updating its weights in response to new, unseen data. This adaptation allows the model to continuously refine its predictions in real-time. By integrating physics-informed components, the PINN leverages prior knowledge about the manufacturing processes, enabling rapid adjustments to process parameters, geometries, deposition patterns, and materials. Empirical results confirm the robust performance of this PI online learning framework in accurately predicting temperature fields for unseen processes across various conditions. It notably surpasses traditional data-driven models, especially in critical areas like the Heat Affected Zone (HAZ) and melt pool. The PINN's use of physical laws and prior knowledge not only provides a significant advantage over conventional models but also ensures more accurate predictions under diverse conditions. Furthermore, our analysis of key hyperparameters-the learning rate and batch size of the online learning phase-highlights their roles in optimizing the learning process and enhancing the framework's overall effectiveness. This approach demonstrates significant potential to improve the online control and optimization of metal AM processes.

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.

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.

Causal prior-embedded physics-informed neural networks and a case study on metformin transport in porous media.

This study introduces a novel approach to transport modelling by integrating experimentally derived causal priors into neural networks. We illustrate this paradigm using a case study of metformin, a ubiquitous pharmaceutical emerging pollutant, and its transport behaviour in sandy media. Specifically, data from metformin's sandy column transport experiment was used to estimate unobservable parameters through a physics-based model Hydrus-1D, followed by a data augmentation to produce a more comprehensive dataset. A causal graph incorporating key variables was constructed, aiding in identifying impactful variables and estimating their causal dynamics or "causal prior." The causal priors extracted from the augmented dataset included underexplored system parameters such as the type-1 sorption fraction F, first-order reaction rate coefficient α, and transport system scale. Their moderate impact on the transport process has been quantitatively evaluated (normalized causal effect 0.0423, -0.1447 and -0.0351, respectively) with adequate confounders considered for the first time. The prior was later embedded into multilayer neural networks via two methods: causal weight initialization and causal prior regularization. Based on the results from AutoML hyperparameter tuning experiments, using two embedding methods simultaneously emerged as a more advantageous practice since our proposed causal weight initialization technique can enhance model stability, particularly when used in conjunction with causal prior regularization. amongst those experiments utilizing both techniques, the R-squared values peaked at 0.881. This study demonstrates a balanced approach between expert knowledge and data-driven methods, providing enhanced interpretability in black-box models such as neural networks for environmental modelling.

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.