Ethical Considerations in Pediatric Surgery.

Pediatric surgeons need to learn to give as much importance to the ethical approach as they have been giving to the systemic methodology in their clinical approach all along. The law of the land and the governmental rules also need to be kept in mind before deciding the final solution. They need to always put medical problems in the background of ethical context, reach a few solutions keeping in mind the available resources, and apply the best solution in the interest of their pediatric patients.

Suicide-preventive compulsory admission is not a proportionate measure - time for clinicians to recognise the associated risks.

Suicide is considered a global public health issue and compulsory admission is a commonly used measure to prevent suicide. However, the practice has been criticised since several studies indicate that the measure lacks empirical support and may even increase suicide risk. This paper investigates whether the practice has enough empirical support to be considered proportionate. To that end, arguments supporting compulsory admission as a suicide-preventive measure for most suicidal patients are scrutinized. The ethical point of departure is that the expected benefits of compulsory admission should outweigh the potential harms of the measure to be proportionate and defensible. It is concluded that, for most suicidal patients, suicide-preventive compulsory admission cannot be presumed to be a proportionate measure. To be so, the expected medical benefits of the measure should be greater than the potential increase in suicide risk and other harms that compulsory admission could entail. Instead of using compulsory admission as a suicide-preventive measure, extra safety measures may be needed during and after compulsory admission to prevent the risk of hospitalisation-induced suicide.

Conflicts of Interest Among Cardiology Clinical Practice Guideline Authors in Japan.

BACKGROUND: Clinical practice guidelines (CPGs) offer disease management recommendations based on scientific evidence. However, financial conflicts of interest between CPG developers and the pharmaceutical industry could bias these recommendations, potentially affecting patient care. Proper management of these conflicts of interest is particularly crucial for maintaining the integrity of CPGs. The study aimed to evaluate the extent of financial relationships between the pharmaceutical industry and authors of CPGs for cardiovascular diseases in Japan. METHODS AND RESULTS: The study analyzed personal payments from the pharmaceutical industry to authors of cardiovascular disease CPGs published by the Japanese Circulation Society from January 2015 to December 2022. Payment data, including speaking, consultancy, and writing fees from 2016 to 2020, were extracted from a publicly available database containing personal payments disclosed by all major pharmaceutical companies. A total of 929 unique authors from 37 eligible Japanese Circulation Society CPGs were identified. Notably, 94.4% of these authors received personal payments from pharmaceutical companies, totaling >US $70.8 million. The mean±SD payment per author was US $76 314±138 663) and the median payment per author was US $20 792 (interquartile range: US $4262-US $76 998) over the 5-year period. Chairs of CPGs received significantly higher payments than other authors. More than 80% of authors in each CPG received personal payments. CONCLUSIONS: The study elucidated that there were considerable financial relationships between pharmaceutical companies and cardiology CPG authors in Japan. This finding deviates from international conflict of interest management policies, suggesting the need for more stringent conflict of interest management strategies by the Japanese Circulation Society to ensure the development of trustworthy and evidence-based CPGs.

The Value of Screening for a History of Incarceration in the Palliative Care Setting.

The United States (US) has one of the highest rates of incarceration in the world. Due to the aging of the US population as a whole and limited opportunities for early release, the proportion of older people in prison continues to rise. Some correctional health systems have adopted geriatric and palliative care principles to better care for this aging population, many of whom die in prison. However, not everyone who grows old in prison will die behind bars. In this article, we explore existing literature that highlights the unique physical, cognitive, and psychosocial challenges that formerly incarcerated patients face. We proceed to argue that palliative care providers should screen for a history of incarceration to identify and address the needs of this patient population. We also offer strategies to create a safe, welcoming environment to discuss past traumas related to these patients' time in prison.

Values-Based Medicine Is an Ethical Concept for Implementing the Ethical Principles in Daily Practice.

Values-based medicine (VsBM) is an ethical concept, and bioethical framework has been developed to ensure that medical ethics and values are implemented, pervasive, and powerful parameters influencing decisions about health, clinical practice, teaching, medical industry, career development, malpractice, and research. Neurosurgeons tend to adopt ethics according to their own values and to what they see and learn from teachers. Neurosurgeons, in general, are aware about ethical codes and the patient's rights. However, the philosophy, concept, and principles of medical ethics are rarely included in the training programs or in training courses. The impact of implementing, observing the medical ethics and the patients' value and culture on the course, and outcome of patients' management should not underestimate. The main principles of medical ethics are autonomy, beneficence, nonmaleficence, justice, dignity, and honesty, which should be strictly observed in every step of medical practice, research, teaching, and publication. Evidence-based medicine has been popularized in the last 40-50 years in order to raise up the standard of medical practice. Medical ethics and values have been associated with the medical practice for thousands of years since patients felt a need for treatment. There is no conflict between evidence-based medicine and values-based medicine, as a medical practice should always be performed within a frame of ethics and respect for patients' values. Observing the principles of values-based medicine became very relevant as multicultural societies are dominant in some countries and hospitals in different corners of the world.

Should obstetric mortality be an inalienable right?

BACKGROUND: Obstetricians often times find themselves in a conflict of right and duty with their patients, when these patients refuse recommended treatment. On the one hand, the obstetrician, aiming to fulfil the duty of care, recommends a treatment in the best interest of the woman. The woman, on the other hand, exercising her right of self-determination and autonomy, declines the recommended treatment. MATERIALS AND METHODS: A search was conducted for literature, articles and case reports on the subject on PubMed/MEDLINE and Google Scholar using the keywords: medical ethics, medical law, obstetric mortality, maternal medicine, foetal medicine, patient autonomy, informed consent, right to life and right to liberty. RESULTS: Opinions have historically differed on whether maternal or foetal rights should be deferred to in situations where pregnant women refuse obstetric interventions. So also have legal decisions on the issue. The general consensus is, however, to respect a woman's refusal of recommended medical treatment, in deference to her right of self-determination and autonomy. The obstetric outcomes in such instances are however, often times, unfavourable. CONCLUSION: The ethics of patient care in the face of conflicting rights deserves renewed examination and discourse.

Effects of the COVID-19 pandemic on people experiencing incarceration: a systematic review.

OBJECTIVE: To assess the effect of the COVID-19 pandemic on people experiencing incarceration (PEI), focusing particularly on clinical outcomes compared with the general population. DESIGN: Systematic review with narrative synthesis in accordance with the Centre for Reviews and Dissemination's good practice guidelines. DATA SOURCES: Medline, Social Policy and Practice, Criminology Connection, ASSIA, EMBASE, SCOPUS, Web Of Science, CINAHL, Cochrane Library, Cochrane COVID-19 reviews, COVID-19 Evidence Reviews and L*OVE COVID-19 Evidence databases were searched up to 21 October 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included studies presenting data specific to adults ≥18 years experiencing incarceration, with exposure to SARS-CoV-2 infection. All studies with a comparison group, regardless of study design and country were included. Studies with no comparison group data or not measuring clinical outcomes/health inequalities were excluded. Studies focussing on detained migrants, forensic hospitals, prison staff and those not in English were also excluded. DATA EXTRACTION AND SYNTHESIS: Two reviewers extracted data and assessed risk of bias. Data underwent narrative synthesis using a framework analysis based on the objectives, for infection rates, testing, hospitalisation, mortality, vaccine uptake rates and mental health outcomes. There was no scope for meta-analysis, due to the heterogeneity of evidence available. RESULTS: 4516 references were exported from the databases and grey literature searched, of which 55 met the inclusion criteria. Most were from the USA and were retrospective analyses. Compared with the general population, PEI were usually found to have higher rates of SARS-CoV-2 infection and poorer clinical outcomes. Conflicting data were found regarding vaccine uptake and testing rates compared with the general population. The mental health of PEI declined during the pandemic. Certain subgroups were more adversely affected by the COVID-19 pandemic, such as ethnic minorities and older PEI. CONCLUSION: PEI have poorer COVID-19 clinical outcomes than the general public, as shown by largely low-quality heterogenous evidence. Further high-quality research of continuing clinical outcomes and appropriate mitigating interventions is required to assess downstream effects of the pandemic on PEI. However, performing such research in the context of incarceration facilities is highly complex and potentially challenging. Prioritisation of resources for this vulnerable group should be a focus of national policy in the event of future pandemics. PROSPERO REGISTRATION NUMBER: CRD42022296968.

Moral distress measurement in animal care workers: a systematic review.

OBJECTIVES: The mental health of veterinary and other animal health professionals is significantly impacted by the psychological stressors they encounter, such as euthanasia, witnessing animal suffering and moral distress. Moral distress, initially identified in nursing, arises when individuals are aware of the right action but are hindered by institutional constraints. We aimed to review existing research on moral distress scales among animal care workers by focusing on the identification and psychometric validity of its measurement. DESIGN: Two-step systematic review. First, we identified all moral distress scales used in animal care research in the eligible original studies. Second, we evaluated their psychometric validity, emphasising content validity, which is a critical aspect of patient-reported outcome measures (PROMs). This evaluation adhered to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). The results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. DATA SOURCES: PubMed, EMBASE and PsycINFO to search for eligible studies published between January 1984 and April 2023. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included original (primary) studies that (1) were conducted in animal care workers; (2) describing either the development of a moral distress scale, or validation of a moral distress scale in its original or modified version, to assess at least one of the psychometric properties mentioned in COSMIN guidelines. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers used standardised methods to search, screen and code included studies. We considered the following information relevant for extraction: study reference, name and reference of the moral distress scale used, psychometric properties assessed and methods and results of their assessments. The collected information was then summarised in a narrative synthesis. RESULTS: The review identified only one PROM specifically adapted for veterinary contexts: the Measure of Moral Distress for Animal Professionals (MMD-AP), derived from the Measure of Moral Distress for Healthcare Professionals (MMD-HP). Both MMD-HP and MMD-AP were evaluated for the quality of development and content validity. The development quality of both measures was deemed doubtful. According to COSMIN, MMD-HP's content validity was rated as sufficient, whereas MMD-AP's was inconsistent. However, the evidence quality for both PROMs was rated low. CONCLUSION: This is the first systematic review focused on moral distress measurement in animal care workers. It shows that moral distress is rarely measured using standardised and evidence-based methods and that such methods should be developed and validated in the context of animal care. PROSPERO REGISTRATION NUMBER: CRD42023422259.

Medical ethics and artificial intelligence in neurosurgery - How should we prepare?

The development of artificial intelligence (AI) raises ethical concerns about its side effects on the attitudes and behaviors of clinicians and medical practitioners. The authors aim to understand the medical ethics of AI-based chatbots and to suggest coping strategies for an emerging landscape of increased access and potential ambiguity using AI. This study examines the medical ethics of AI-based chatbots (ChatGPT, Bing Chat, and Google's Bard) using multiple-choice questions. ChatGPT and Bard correctly answered all questions (5/5), while Bing Chat correctly answered only three of five questions. ChatGPT explained answers simply. Bing Chat explained answers with references, and Bard provided additional explanations with details. AI has the potential to revolutionize medical fields by improving diagnosis accuracy, surgical planning, and treatment outcomes. By analyzing large amounts of data, AI can identify patterns and make predictions, aiding neurosurgeons in making informed decisions for increased patient wellbeing. As AI usage increases, the number of cases involving AI-entrusted judgments will rise, leading to the gradual emergence of ethical issues across interdisciplinary fields. The medical field will be no exception. This study suggests the need for safety measures to regulate medical ethics in the context of advancing AI. A system should be developed to verify and predict pertinent issues.

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

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

Beliefs and practices of physicians in Lebanon regarding promotional gifts and interactions with pharmaceutical companies.

Background: Pharmaceutical companies invest greatly in promotional gifts to influence prescription of medications by physicians, yet there is limited published information evaluating its impact on healthcare. Aim: This study aimed to assess the beliefs and practices of physicians in Lebanon regarding promotional gifts and their interactions with representatives of pharmaceutical companies. Methods: This cross-sectional study was conducted between December 2019 and January 2020 through an email-based questionnaire sent to 5936 physicians of different specialties registered in the Lebanese Order of Physicians. Assessment was done using a validated tool and data analysis was conducted using SPSS version 26.0. Results: Of the 268 respondents, 188 (70.4%) reported that physicians in Lebanon accepted gifts from representatives of pharmaceutical companies. Most of the physicians (31.7%) interacted with company representatives more than once a week. Medication samples (251 respondents) and stationary items (222 respondents) were the most common gifts accepted by physicians who admitted accepting gifts. Overall, 225 (84.9%) respondents believed that prescriptions by physicians in Lebanon were influenced by the gifts. Only 74 (40.0%) of those who accepted gifts from pharmaceutical companies believed that it was unethical, and around half did not know if the Lebanese Code of Medical Ethics allowed them to accept gifts from pharmaceutical companies. Conclusion: Although physicians in Lebanon were aware of the effect that gifts from pharmaceutical companies could have on their prescription behaviours, many of them still accepted the gifts. This study provides evidence to policymakers for decision-making regarding ethical guidance on interactions between physicians and pharmaceutical companies in Lebanon.

Residency Requirements for Medical Aid in Dying.

In 1997, when Oregon became the first U.S. jurisdiction authorizing medical aid in dying (MAID), its law included a requirement that patients be legal residents of the state. Other U.S. jurisdictions legalizing MAID followed Oregon in adopting residency requirements. Recent litigation challenges the legality, as well as the justification, for such requirements. Facing such challenges, Oregon and Vermont eliminated their MAID residency requirements. More states could follow this move, for, in certain circumstances, the U.S. Constitution's privileges and immunities clause protects citizens' right to travel to secure medical care. Policy considerations could also motivate states to reexamine whether such requirements are justified in light of existing evidence of how MAID laws have been applied.

The gender-affirming model of care is incompatible with competent, ethical medical practice.

OBJECTIVE: To examine the compatibility of gender-affirming care with the principles and practices of psychiatry. CONCLUSIONS: The assumption that there is no pathology involved in the development of gender diversity is a necessary precondition for the unquestioning affirmation of self-reported gender identity. Cases where psychosis is the undeniable cause of gender diversity demonstrate this assumption is categorically false. To protect this false assumption, gender-affirming guidelines forbid the application of the core psychiatric competencies of phenomenology and psychopathology to the assessment of gender diversity. They substitute the political goal of expanding personal liberty for the evidence-based medicine processes of clinical reasoning, rendering them incompatible with competent, ethical medical practice.

Latent class analysis of Chinese healthcare providers' attitudes towards oocyte cryopreservation: a cross-sectional study.

OBJECTIVES: The present study was designed to examine the attitudes towards oocyte cryopreservation among healthcare providers working in hospitals across specialties and potential influencing factors. DESIGN: A cross-sectional study. SETTING: The questionnaire was distributed among Chinese healthcare providers via the Credamo platform. PARTICIPANTS: There were 877 respondents recruited from 8 April to 8 May 2022, among whom 160 were identified as unqualified because of inconsistency between the IP and work addresses. OUTCOME MEASURES: Individual attitudes towards oocyte cryopreservation under four different settings, familiarity with oocyte cryopreservation and perceived risks about oocyte cryopreservation of healthcare providers were measured using a self-designed questionnaire. RESULTS: There were 877 respondents recruited, and 717 were identified as qualified respondents. Two latent classes of healthcare providers characterised by different attitudes towards oocyte cryopreservation under four different settings were identified, the supportive and reluctant. Familiarity with oocyte cryopreservation had a significant direct effect on perceived risks, with better familiarity predicting lower perceived risks (ß=-0.102, p<0.05). Perceived risks showed a significant direct effect on participants' attitudes towards oocyte cryopreservation, with higher perceived risks predicting a more reluctant attitude (ß=0.165, p<0.001). CONCLUSIONS: The majority of healthcare providers held a reluctant attitude towards oocyte cryopreservation of unmarried women for non-medical reasons, which might relate to their worries about the risks to offspring's health and lack of knowledge about a reproductive technique.

Artificial intelligence tools for optimising recruitment and retention in clinical trials: a scoping review protocol.

INTRODUCTION: In recent years, the influence of artificial intelligence technology on clinical trials has been steadily increasing. It has brought about significant improvements in the efficiency and cost reduction of clinical trials. The objective of this scoping review is to systematically map, describe and summarise the current utilisation of artificial intelligence in recruitment and retention process of clinical trials that has been reported in research. Additionally, the review aims to identify benefits and drawbacks, as well as barriers and facilitators associated with the application of artificial intelligence in optimising recruitment and retention in clinical trials. The findings of this review will provide insights and recommendations for future development of artificial intelligence in the context of clinical trials. METHODS AND ANALYSIS: The review of relevant literature will follow the methodological framework for scoping studies provided by the Joanna Briggs Institute. A comprehensive electronic search will be conducted using the search strategy developed by the authors. Leading medical and computer science databases such as PubMed, Embase, Scopus, IEEE Xplore and Web of Science Core Collection will be searched. The search will encompass analytical observational studies, descriptive observational studies, experimental and quasi-experimental studies published in all languages, without any time limitations, which use artificial intelligence tools in the recruitment and retention process of clinical trials. The review team will screen the identified studies and import them into a dedicated electronic library specifically created for this review. Data extraction will be performed using a data charting table. ETHICS AND DISSEMINATION: Secondary data will be attained in this scoping review; therefore, no ethical approval is required. The results of the final review will be published in a peer-reviewed journal. It is expected that results will inform future artificial intelligence and clinical trials research.

Return of participant-level clinical trial results to participants: pilot of a simplified centralised approach.

OBJECTIVES: Public access databases such as clinicaltrials.gov achieve dissemination of clinical trial design and aggregated study results. However, return of participant-level data is rarely done. A key barrier includes the proprietary ownership of data by the sponsor. Additionally, investigators may not have access to centralised data, and per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, must maintain the confidentiality of participants. This study piloted an approach to return both individual and aggregate clinical trial data to parents of children participating in a series of open-label clinical trials. SETTING AND DESIGN: A small biotech company obtained central ethics approval (centralised institutional review board [IRB], non-exempt). The study was advertised via parent advocacy groups. Parents of trial participants were offered the option to contact an employee (coordinator) within the company, requesting return of their child's study results. Ethics approval covered participation in six countries. The study focused on the sequential clinical trials of vamorolone VBP15-002 (NCT02760264) and VBP15-003 (NCT02760277) (post-results). INTERVENTIONS: Contact initiated by the parent enabled the coordinator to obtain informed consent (and separate General Data Protection Regulations consent), with phone translation when needed. Using date of birth and study site location provided by the parent, the data manager reported the participant number to the coordinator. The coordinator retrieved and compiled data, along with an aggregate summary, which was mailed via a password protected and encrypted memory device to the parent. Prereturn and postreturn surveys were sent to consented parents (n=19; 40% of 48 total trial participants) and investigators. RESULTS: Prereturn surveys indicated a request for as much data as offered, in all formats offered. Postreturn survey showed high satisfaction with the process and data returned. Survey of the physician site investigators (n=10; 100% participation of investigators) voiced general satisfaction with the process, with some reservations. CONCLUSIONS: This pilot study demonstrates an innovative, cost-effective, centralised and labour conservative approach to return of participant-level and aggregate data to participants in studies.