Consideraciones bioéticas en el manejo de la esclerosis lateral amiotrófica: Una aproximación al quehacer fonoaudiológico

Introducción: La esclerosis lateral amiotrófica (ELA) es la forma más común de enfermedad degenerativa de motoneurona en la edad adulta y es considerada una enfermedad terminal. Por lo mismo, el accionar del fonoaudiólogo debe considerar el respeto a los principios bioéticos básicos para garantizar una asistencia adecuada. Objetivo: Conocer aquellas consideraciones bioéticas relacionadas al manejo y estudio de personas con ELA para luego brindar una aproximación hacia el quehacer fonoaudiológico. Método: Se efectuó una búsqueda bibliográfica en las bases de datos PubMed, Scopus y SciELO. Se filtraron artículos publicados desde 2000 hasta junio de 2023 y fueron seleccionados aquellos que abordaban algún componente bioético en población con ELA. Resultados: Aspectos relacionados al uso del consentimiento informado y a la toma de decisiones compartidas destacaron como elementos esenciales para apoyar la autonomía de las personas. Conclusión: Una correcta comunicación y una toma de decisiones compartida son claves para respetar la autonomía de las personas. A su vez, la estandarización de procedimientos mediante la investigación clínica permitirá aportar al cumplimiento de los principios bioéticos de beneficencia y no maleficencia, indispensables para la práctica profesional.

Introduction: Amyotrophic lateral sclerosis (ALS) is the most common form of degenerative motor neuron disease in adulthood and is considered a terminal disease. For this reason, the actions of the speech therapist must consider respect for basic bioethical principles to guarantee adequate assistance. Objective: To know those bioethical considerations related to the management and study of people with ALS to then provide an approach to speech therapy. Methodology: A bibliographic search was carried out in the PubMed, Scopus, and SciELO databases. Articles published from 2000 to June 2023 were filtered and those that addressed a bioethical component in the population with ALS were selected. Results: Aspects related to the use of informed consent and shared decision-making stood out as essential elements to support people's autonomy. Conclusion: Proper communication and shared decision-making are key to respecting people's autonomy. In turn, the standardization of procedures through clinical research will contribute to compliance with the bioethical principles of beneficence and non-maleficence, essential for professional practice.

A case study to engage students in the research design and ethics of high-throughput metagenomics.

Case studies present students with an opportunity to learn and apply course content through problem solving and critical thinking. Supported by the High-throughput Discovery Science & Inquiry-based Case Studies for Today's Students (HITS) Research Coordination Network, our interdisciplinary team designed, implemented, and assessed two case study modules entitled "You Are What You Eat." Collectively, the case study modules present students with an opportunity to engage in experimental research design and the ethical considerations regarding microbiome research and society. In this manuscript, we provide instructors with tools for adopting or adapting the research design and/or the ethics modules. To date, the case has been implemented using two modalities (remote and in-person) in three courses (Microbiology, Physiology, and Neuroscience), engaging over 200 undergraduate students. Our assessment data demonstrate gains in content knowledge and students' perception of learning following case study implementation. Furthermore, when reflecting on our experiences and student feedback, we identified ways in which the case study could be modified for different settings. In this way, we hope that the "You Are What You Eat" case study modules can be implemented widely by instructors to promote problem solving and critical thinking in the traditional classroom or laboratory setting when discussing next-generation sequencing and/or metagenomics research.

Challenges and Lessons from Conducting a Community-Engaged Evaluation of a Community Advisory Board-A Case Study from Flint.

Community-engaged research often poses challenges due to exactly those qualities that make it desirable: it provides a new model of research that differs in many ways from top-down, university-led, prospectively designed approaches. While many have discussed the challenges to conducting community-engaged research, few have provided precise and generalizable lessons for how to surmount these challenges. Here we discuss the challenges experienced in a project that was community-engaged at three levels: 1) a research team consisting of an academic and a community partner as well as a community and academic research assistant, 2) the research team engaged with a Community Advisory Board called the CBOP-CERB (Community Based Organization Partners-Community Ethics Research Board) throughout the project, and 3) the research involved recruiting community participants from an area with a historical distrust of researchers and research: Flint Michigan. We also discuss administrative challenges that this multilevel community-engagement posed. Most important, we provide practical lessons in order for future community-engaged research to avoid or mitigate many of these challenges.

Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nationwide implementation study.

BACKGROUND AND PURPOSE: Recent research has highlighted non-operative management (NOM) as a viable alternative for frail older adults with hip fractures in the final phase of life. This study aims to guide Dutch physicians and hospitals nationwide in a standardised implementation of shared decision-making regarding surgery or NOM in selected frail older adults with a hip fracture. METHODS AND ANALYSIS: The patient population for implementation includes frail older adults aged ≥70 years with an acute proximal femoral fracture, nursing home care or a similar level of care elsewhere and at least one additional criterion (ie, malnutrition, severe mobility impairment or ASA≥4). The 2-year implementation study will be conducted in four phases. In phases 1 and 2, barriers and facilitators for implementation will be identified and an implementation protocol, educational materials and patient information will be developed. Phase 3 will involve an implementation pilot in 14 hospitals across the Netherlands. The protocol and educational material will be improved based on healthcare provider and patient experiences gathered through interviews. Phase 4 will focus on upscaling to nationwide implementation and the effect of the implementation on NOM rate will be measured using data from the Dutch Hip Fracture Audit. ETHICS AND DISSEMINATION: The study was exempted by the local Medical Research Ethics Committee (MEC-2023-0270, 10 May 2023) and Medical Ethics Committee United (W23.083, 26 April 2023). The study's results will be submitted to an open access international peer-reviewed journal. Its protocols, tools and results will be presented at several national and international academic conferences of relevant orthogeriatric (scientific) associations. TRIAL REGISTRATION NUMBER: NCT06079905 .

Graduate medical education success coaching for residents and fellows: a single-institution real-world experience.

While coaching has been employed as a success strategy in many areas such as athletics and business for decades, its use is relatively new in the medical field despite evidence of its benefits. Implementation and engagement regarding coaching in graduate medical education (GME) for residents and fellows is particularly scarce. We report our three-year experience of a GME success coaching program that aims to help trainees reach their full potential by addressing various areas of medical knowledge, clinical skills, efficiency, interpersonal skills and communication, professionalism, and mental health and well-being. The majority of participants (87%) were identified by themselves, their program director, and/or the GME coaches to have more than one area of need. The majority (79%) of referrals were identified by the coaches to have additional needs to the reasons for referral. We provide a framework for implementation of a GME coaching program and propose that coaching in GME may provide an additional safe environment for learners to reveal areas of concerns or difficulty that otherwise would not be disclosed and/or addressed.

Pursuance of a Yoruba name for cervical cancer in Southwest Nigeria: a case study.

OBJECTIVES: Participants' comprehension of research process affects the quality of research output, which is the reason why translation of research instruments into local languages is standard practice. Literature has consistently reported that in Africa, knowledge about cervical cancer is low but paradoxically, expressed, and actual uptake of human papillomavirus vaccine for its prevention is high. This study explored the Yoruba names of cervical cancer among Yoruba people in Ibadan, Nigeria to guide the translation of cervical cancer research instruments to Yoruba language. DESIGN: Exploratory case study design was used and data were obtained with 10 in-depth interviews and four focused group discussions. Data were analysed using content analysis. SETTINGS: The study took place in Ibadan North local government area, Southwest Nigeria. PARTICIPANTS: These were 4 traditional healers, 3 Yoruba linguists, 3 public health educators and 38 parents of adolescents. MEASURES: These were Yoruba names for cervical cancer and their meanings. RESULTS: Participants were aware of cervical cancer but only the traditional healers and public health educators had names for it. These names were highly varied. The public health educators gave names that were linked with different parts of the female reproductive system and external genital which were actually different medical conditions. Each traditional healer also had different names for cervical cancer, which either described the female body parts, or symptoms of female genital infections. These various names can lead to unnecessary misconceptions and misinformation about cervical cancer, its prevention, management, and research. CONCLUSIONS: There was no consensus Yoruba name for cervical cancer among the study participants. Efforts to educate the Yoruba speaking populace about cervical cancer, its prevention, management and participation in its research can be frustrated if a generally accepted Yoruba name is not provided for this cancer. Stakeholders' collaboration is required to get an appropriate Yoruba name for cervical cancer.

Evaluating the Impact and Effectiveness of Flint's Community Ethics Review Board (CBOP-CERB): A Pilot Study.

In recognition of the importance of evaluation for funding, research, and quality improvement, a longstanding Community Advisory Board in Flint Michigan embarked on a process to evaluate their impact. The Community-Based Organization Partners (CBOP)-Community Ethics Review Board (CERB) engaged a research team composed of an academic researcher (Solomon Cargill) and a community partner (Spencer) to obtain funding, design and implement an evaluation of the CBOP-CERB. This evaluation study yielded two evaluations of the CBOP-CERB, one with researchers who had engaged with the CBOP-CERB and the other with Flint area community residents. The results of these two evaluations can serve to show other Community Advisory Boards how to establish and expand their impact, establish their worth for future funding, and how to articulate, evaluate, and achieve their goals.

Ethical principles in dental healthcare: Relevance in the current technological era of artificial intelligence.

In the current technological era, dental practitioners are faced with various ethical challenges, highlighting the importance of bioethics in this healthcare discipline. The rise of artificial intelligence has recently sparked a debate regarding the privacy of patient data. While the advancements may offer innovative treatment options, their long-term effects may not be fully understood, raising questions about the responsible implementation of such methods. Thus, conscientious and ethical AI use in dentistry encompasses that patients be notified about how their data is used and also about the involvement of AI-based decision-making. This paper explores the key bioethical considerations in dental healthcare, with a focus on evidence-based AI development and use. The framework of ethical principles and guidelines provided would foster trust between the clinician and patients, while promoting the highest standards of care.

Legal and Ethical Issues Associated With Challenges in the Implementation of the Electronic Medical Record System and Its Current Laws in India.

Electronic health records (EHR) have revolutionized healthcare by providing efficient access to patient information, but their implementation poses various challenges. This paper examines the ethical and legal issues surrounding EHR adoption, particularly focusing on the healthcare landscape in India. Ethical considerations, including patient autonomy, confidentiality, beneficence, and justice, must guide EHR implementation to protect patient rights and privacy. Legal issues such as medical errors, malpractice, data breaches, and billing inaccuracies underscore the importance of robust policies and security measures. Threats to EHRs, such as phishing attacks, malware, encryption vulnerabilities, and insider threats, emphasize the need for comprehensive cybersecurity strategies. Overcoming challenges in EHR implementation requires meticulous planning, financial investment, staff training, and stakeholder support. Despite the complexities involved, the benefits of EHR adoption in improving patient care and operational efficiency justify the efforts required to address legal, ethical, and technical concerns. Embracing EHRs while mitigating associated risks is essential for delivering high-quality healthcare in the digital age.

The Adoption of Genetically Modified Crops in Africa: the Public's Current Perception, the Regulatory Obstacles, and Ethical Challenges.

Genetically modified (GM) crops are the most important agricultural commodities that can improve the yield of African smallholder farmers. The intricate circumstances surrounding the introduction of GM agriculture in Africa, however, underscore the importance of comprehending the moral conundrums, regulatory environments, and public sentiment that exist today. This review examines the current situation surrounding the use of GM crops in Africa, focusing on moral conundrums, regulatory frameworks, and public opinion. Only eleven of the fifty-four African countries currently cultivate GM crops due to the wide range of opinions resulting from the disparities in cultural, socioeconomic, and environmental factors. This review proposed that addressing public concerns, harmonizing regulations, and upholding ethical standards will improve the adoption of GM crops in Africa. This study offers ways to enhance the acceptability of GM crops for boosting nutrition and food security globally.

A Web-Based Intervention Based on Acceptance and Commitment Therapy for Family Caregivers of People With Dementia: Mixed Methods Feasibility Study.

BACKGROUND: Acceptance and commitment therapy (ACT), as an empirically based third-wave cognitive behavioral therapy, has shown promise in enhancing well-being and functioning across diverse populations. However, in the context of caregiving, the effect size of available ACT interventions remains at best moderate, sometimes accompanied by high dropout rates, highlighting the need for more effective and feasible intervention designs. OBJECTIVE: The objective of our study was to evaluate the feasibility and acceptability of a fully online ACT program designed for family caregivers of people with dementia. This study aimed to boost psychological flexibility and support caregivers, enabling them to realize and prioritize their own life values alongside their caregiving responsibilities. METHODS: A mixed methods feasibility study using an uncontrolled pretest-posttest design was conducted. This intervention included a 9-week web-based self-help program based on ACT incorporating collaborative goal setting and weekly web-based motivational coaching for family caregivers of people with dementia. This study involved 30 informal caregivers recruited through memory clinics and social media platforms in the Netherlands and received approval from the Medical Ethics Committee of the Maastricht University Medical Center+ (NL77389.068.21/metc21-029). RESULTS: A total of 24 caregivers completed the postintervention assessment, indicating a high adherence rate (24/29, 83%). Caregivers reported positive feedback regarding collaborative goal setting, but some found challenges in implementing new skills due to their own habitual responses or the unpredictable context of dementia caregiving. Personalizing the intervention based on individual value preferences was highlighted as beneficial. CONCLUSIONS: Compared to other web-based self-help ACT interventions for family caregivers, this intervention showed a high adherence and sufficient level of feasibility, which underscores the use of personalization in delivering web-based interventions. Moreover, the potential of this ACT-based intervention for family caregivers of people with dementia was demonstrated, suggesting that further research and a larger-scale controlled trial are warranted to validate its effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2022-070499.

An Ethical analysis of Conditional and Partially Directed Live Kidney Donation among Strangers - the Israeli Experience.

Living donor kidney transplantation (LDKT) is one of the most effective treatment options for people suffering from end stage renal disease. Traditionally, LDKT can be either: "directed" or "non-directed," based on whether the recipient is specified by the donor. Recently there has been an increase in conditional and semidirected live kidney donation among strangers; where the donor specifies characteristics of the recipient whom they wish to donate to. This practice has both gained popularity and sparked controversy in the State of Israel through the non-profit organization Matnat Chaim. We analyze the ethical implications of this practice by applying traditional principles of medical ethics to conditional LDKT. While semidirected and conditional LKDT presents some ethical challenges, overall, its practice effectively aligns with core ethical principles. The donors' right to make stipulations respects the donor's autonomy, the practice avoids harm and benefits both donor and recipient, justice and utility are upheld as the practice specifically benefits marginalized patients and optimizes resource utilization. Finally, we present data from our institution demonstrating how conditional LDKT increased transplantation for all ethnic groups; Jewish Recipients of LDKT increased by 151.32% (P = 0.034) Arab Recipients of LDKT increased by 111.11% (P = 0.036).

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.

Exercise oncology clinical trials during treatments: a commentary to address the safety concerns of human subjects regulatory reviewers and committees.

Exercise oncology clinical trials contribute to the advancement of our scientific knowledge and to the safety and care of patients diagnosed with cancer. Nevertheless, regulatory reviewers and committees may not be familiar with the well-documented long-term health benefits and safety of the regular practice of physical activity. Moreover, they may not see how the benefits outweigh the risks in the context where patients diagnosed with cancer are typically seen as vulnerable. Therefore, we would like to provide a purpose-built overview of exercise oncology clinical trials for members involved in institutional review committees, including the Scientific Review Committee (SRC), the Institutional Review Board (IRB), and the Data Safety Monitoring Committee (DSMC) to facilitate a greater understanding of the safety and benefits of physical activity during cancer treatments. Communication is key to improve the success of exercise oncology clinical trials, which are vital for patients diagnosed with cancer.

[Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines].

Due to the lack of specialized guidance, the post-marketing research on clinical effectiveness of Chinese patent medicines demonstrates varied quality and lacks high-quality evidence, failing to meet the demands of policy-making, clinical decision-making, and industrial decision-making. To address this issue, this project gathered experts in clinical medicine, clinical pharmacy, evidence-based medicine, drug epidemiology, medical ethics, and policy and regulation in China. They referred to the model of international post-marketing research on medicines and developed Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines under the framework of relevant laws and regulations and technical guidance documents in China. The guidelines were developed with consideration to the characteristics of Chinese patent medicines, China's national conditions, and all the stakeholders including marketing authorization holders, clinical researchers, drug administration, and users. The development of the guidelines followed the requirements for developing group standards set by the China Association of Chinese Medicine. The guidelines fully implement the concept of full life-cycle research, emphasizing the combination of traditional Chinese medicine(TCM) theory, human use experience, and clinical trials and pay attention to the compliance, scientificity, and ethics of research. The guidelines clarify the topic selection and decision-making path of the post-marketing research on effectiveness of Chinese patent medicines through six steps: determining research purpose, analyzing drug characteristics, evaluating research basis, proposing clinical orientation, clarifying research purpose, and implementing classified research. The general principles of research design and implementation were clarified from eight aspects: research type, research objects, sample size, efficacy indicators, bias, missing data, evidence level, and practicality. It focuses on the research on the TCM syndrome-based efficacy evaluation, clinical value-oriented mechanism of action, and the effectiveness of Chinese patent medicines with different routes of administration. The guidelines provide a universal methodological basis for the post-marketing research on clinical effectiveness of Chinese patent medicines.

Language in Bioethics: Beyond the Representational View.

Though assumptions about language underlie all bioethical work, the field has rarely partaken of theories of language. This article encourages a more linguistically engaged bioethics. We describe the tacit conception of language that is frequently upheld in bioethics-what we call the representational view, which sees language essentially as a means of description. We examine how this view has routed the field's theories and interventions down certain paths. We present an alternative model of language-the pragmatic view-and explore how it expands and clarifies traditional bioethical concerns. To lend concreteness, we apply the pragmatic view to a pervasive concept in bioethics and adjacent fields: decision making. We suggest that problems of the decision-making approach to bioethical issues are grounded in adherence to the representational view. Drawing on empirical work in surgery and critical care, we show how the pragmatic view productively reframes bioethical questions about how medical treatments are pursued.

The influence of the COVID-19 pandemic on the adoption and impact of AI ChatGPT: Challenges, applications, and ethical considerations.

DESIGN/METHODOLOGY/APPROACH: This article employs qualitative thematic modeling to gather insights from 30 informants. The study explores various aspects related to the impact of the COVID-19 pandemic on AI ChatGPT technologies. PURPOSE: The purpose of this research is to examine how the COVID-19 pandemic has influenced the increased usage and adoption of AI ChatGPT. It aims to explore the pandemic's impact on AI ChatGPT and its applications in specific domains, as well as the challenges and opportunities it presents. FINDINGS: The findings highlight that the pandemic has led to a surge in online activities, resulting in a heightened demand for AI ChatGPT. It has been widely used in areas such as healthcare, mental health support, remote collaboration, and personalized customer experiences. The article showcases examples of AI ChatGPT's application during the pandemic. STRENGTH OF STUDY: This qualitative framework enables the study to delve deeply into the multifaceted dimensions of AI ChatGPT's role during the pandemic, capturing the diverse experiences and insights of users, practitioners, and experts. By embracing the qualitative nature of inquiry and this research offers a comprehensive understanding of the challenges, opportunities, and ethical considerations associated with the adoption and utilization of AI ChatGPT in crisis contexts. PRACTICAL IMPLICATIONS: The insights from this research have practical implications for policymakers, developers, and researchers. This reserach emphasize the need for responsible and ethical implementation of AI ChatGPT to fully harness its potential in addressing societal needs during and beyond the pandemic. SOCIAL IMPLICATIONS: The increased reliance on AI ChatGPT during the pandemic has led to changes in user behavior, expectations, and interactions. However, it has also unveiled ethical considerations and potential risks. Addressing societal and ethical concerns, such as user impact and autonomy, privacy and security, bias and fairness, and transparency and accountability, is crucial for the responsible deployment of AI ChatGPT. ORIGINALITY/VALUE: This research contributes to the understanding of the novel role of AI ChatGPT in times of crisis, particularly in the era of COVID-19 pandemic. It highlights the necessity of responsible and ethical implementation of AI ChatGPT and provides valuable insights for the development and application of AI technology in the future.

What Is "Key Information"? Consideration of the Reasons People Do or Do Not Take Part in Research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Neoadjuvant Chemotherapy in Locally Advanced Sinonasal Teratocarcinosarcoma a Rare Malignancy: An Audit From an Academic Tertiary Care Centre in India.

AIMS: Sinonasal teratocarcinosarcomas (SNTCS) are rare sinonasal malignancies, the incidence of which is less than 1% of all tumors. There is limited data available on SNTCS's, often as case reports and small case series. The management of SNTCS is complicated because of its location, locally aggressive biology, difficulty in achieving complete resection, and limited data on chemotherapy in these malignancies. This audit was performed to understand the role of neoadjuvant chemotherapy (NACT) in SNTCS's, its ability to downstage the disease, achieve complete resection, and impact on long-term survival outcomes. METHODS: This was a retrospective analysis of a prospectively maintained database approved by the Institutional Ethics Committee (IEC). The baseline characteristics, the extent of tumor, Kadish stage, NACT regimen, and adverse events were extracted from the Electronic Medical Records and the patient's case file. Patients with baseline extensive/inoperable disease were referred for NACT from the multidisciplinary joint clinic followed by response assessment (RECIST v1.1). Patients underwent skull-base surgery if respectable post-completion of NACT, however, if deemed unresectable were treated with non-surgical modalities or palliative therapies. RESULTS: The data of 27 patients were evaluated from the year 2015-2022. The median age was 42 years (IQR:30-56) and 85.2% (n = 23) were males. The ECOG-PS was 0-1 in 88.8% (n = 24) patients. All 27 patients received NACT in view of extensive disease at presentation. 74.1% (n = 20) patients received Cisplatin-Etoposide and 25.9% (n = 7) received other chemotherapy regimens. The median number of chemotherapy cycles was 2(IQR:2-3). 96.3% patients (n = 26) completed the planned NACT cycles. 70.4% (n = 19) patients achieved a partial response in post-NACT imaging. 77.8% (n = 18) underwent surgery, 18.5% (n = 5) received CTRT, and 7.4% (n = 2) received definitive-RT alone. The median PFS and OS of the cohort was 19months (95%CI:12.0-25.6) and 23months (95%CI:5.94-40.06) respectively. CONCLUSION: NACT is safe, feasible, and effective with significant response rates, leading to effective downstaging, resectability and improved survival in patients with locally advanced SNTCS's.