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Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

The concept of 'equipoise', or the 'uncertainty principle', has been represented as a central ethical principle, and holds that a subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology, to explore the reasons for any deviations from equipoise, to examine the concept of 'design bias', and to consider alternative ethical formulations that might improve subject safety a

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… Bioethics. 1999;13:314–326. doi: 10.1111/1467-8519.00160. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141–145. doi: 10.1056/NEJM198707163170304. Loftus EF, Fries JF. Informed consent may be hazardous to health. … Bioethics. 1995;9:127–148. doi: 10.1111/j.1467-8519.1995.tb00306.x. Djulbegovic B. Acknowledgement of uncertainty: a fundamental means to ensure scientific and ethical validity in clinical research. Curr Oncol Rep. 2001;3:389–395. doi: 10.1007/s11912-001-0024-5. Avins AL. …

Artificial Intelligence-Augmented Propensity Score, Cost Effectiveness and Computational Ethical Analysis of Cardiac Arrest and Active Cancer with Novel Mortality Predictive Score.

Background and objectives: Little is known about outcome improvements and disparities in cardiac arrest and active cancer. We performed the first known AI and propensity score (PS)-augmented clinical, cost-effectiveness, and computational ethical analysis of cardio-oncology cardiac arrests including left heart catheterization (LHC)-related mortality reduction and related disparities. Materials and methods: A nationally representative cohort analysis was performed for mortality and cost by active cancer using the largest United States all-payer inpatient dataset, the National Inpatient Sample,

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… This empirical step was followed by the final ethical-policy step in which the above AI-augmented empirical results informed a pluralistic-based global bioethical analysis to optimize equitable care for the above patient populations. … Bioethics during COVID-19. Cambridge Scholars Press; Cambridge, UK: 2022. pp. 5–24. 54. Monlezun D.J., Sotomayor C., Peters N., Steigner L., Gallagher C., Garcia A. …

A Rare Case of Systemic Amyloidosis Involving the Thyroid in a Young Patient.

Thyroid amyloidosis is a rare condition associated with thyroid pathologies such as medullary carcinoma, papillary carcinoma, amyloid goitre, and benign lesions, with a clinically palpable goitre being exceptionally uncommon. As a result, many cases of benign thyroid enlargement caused by amyloid deposits remain undiagnosed. A 28-year-old male patient noticed progressive neck circumference enlargement, voice alteration, decreased appetite, weight loss, dysphagia, fever, and night sweats. Fine-needle aspiration biopsy of the thyroid gland did not reveal the cause of the goitre. A total thyroide

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… Institutional Review Board Statement In connection with the application to the Bioethics Committee of the Pomeranian Medical University in Szczecin regarding the description of the research entitled: ‘Rare systemic amyloidosis in a young patient’, I would like to kindly inform you that the study in … question does not require the opinion of the Bioethics Committee. …

Целая Боди Криотерапия воздействует на уровень D витамина крови у людей с множественным склерозом.

Цель этого исследования заключалась в изучении и оценке воздействия серии из 20 методов криотерапии на уровень витамина D в крови женщин с множественным склерозом и здоровыми женщинами. Методы: Это исследование проводилось с участием трех групп участников. Экспериментальная группа состояла из 15 женщин в возрасте от 34 до 55 лет, у которых был диагностирован множественный склероз (МС), которые прошли криотерапию всего тела. Первая контрольная группа состояла из 20 женщин с РС, которые не проходили криотерапию. Вторая контрольная группа состояла из 15 женщин в возрасте от 30 до 49 лет, которые

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… Participant Characteristics This (controlled and prospective) study was conducted in accordance with the Helsinki Declaration of the World Medical Society, with consent from the Bioethics Committee at the Regional Medical Chamber in Krakow (87/KBL/OIL/2018; 8 May 2018) and registered in the Australian … Institutional Review Board Statement This study was approved by the Bioethical Commission of the Regional Medical Chamber in Krakow (87/KBL/OIL/2018, 8 May 2018) and was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12620001142921, 2 November 2020). …

Severe viral oesophagitis, pharyngitis, and stomatitis as antecedents of ileocecal Crohn's disease.

BACKGROUND: The ameloblastoma management is still challenging to the high recurrence rates and significant morbidity associated with radical treatment. The purpose of this 10-year retrospective study was to analyze the influence of ameloblastoma type and treatment strategy on the long-term outcomes and recurrence rates. MATERIAL AND METHODS: The retrospective analyses of 64 histologically-confirmed ameloblastoma cases was performed. The possible risk factors for recurrence and the development of complications were estimated statistically. RESULTS: The treatment strategy applied for this grou

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… The research approved by Bioethics Committee of Bogomolets National Medical University, Kyiv, Ukraine (Protocol No. 107). The database with all cases of ameloblastoma was created and analyzed statistically using IBM SPSS Statistics Version 22 (IBM, Armonk, and North Castle, NY, USA). … Ethics The research approved by Bioethics Committee of Bogomolets National Medical University, Kyiv, Ukraine (Protocol No. 107). Conflicts of interest The authors declare that they have no conflict of interest. Funding There is no funding. References 1. …

Which health technologies should be funded? A prioritization framework based explicitly on value for money.

UnlabelledBackgroundDeciding which health technologies to fund involves confronting some of the most difficult choices in medicine. As for other countries, the Israeli health system is faced each year with having to make these difficult decisions. The Public National Advisory Committee, known as 'the Basket Committee', selects new technologies for the basic list of health care that all Israelis are entitled to access, known as the 'health basket'. We introduce a framework for health technology prioritization based explicitly on value for money that enables the main variables considered by deci

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… Am J Bioethics. 2010;10:56–58. doi: 10.1080/15265161003633045. Kenny N, Joffres C. An ethical analysis of international health priority-setting. Health Care Anal. 2008;16:145–160. doi: 10.1007/s10728-007-0065-5. Holm S. … In: Israeli Bioethics and Health Law. Siegal G, editor. forthcoming. Health resources allocation – addition of new healthcare technologies to the Health Basket. Culyer AJ, Bombard Y. An equity framework for health technology assessments. …

Клинические характеристики раннего и поздних множественных склерозов у пациентов из Литвы.

Предыстория и цели: Ранний набор MS (EOMS) и поздний набор MS (LOMS) различаются в том, что касается представления симптомов, развития заболеваний и результатов инвалидности. Целью этого исследования является оценка клинических характеристик пациентов, имеющих ЭОМС и ЛОМС в Литве. Материалы и методы: Ретроспективный анализ медицинских записей пациентов был проведен в Литовском университете медицинских наук, кафедра неврологии клиник Каунаса. Это исследование включало в себя 97 пациентов с множественным склерозом, из которых 34 :: диагностировали ЭОМС и 63 с LOMS. Результаты: Соотношение числа

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… Ethical approval for the study was obtained from the LUHS Department of Bioethics on 19 January 2023. In all, 97 patients diagnosed with EOMS ( n = 34) and LOMS ( n = 63) were randomly selected for the study and were classified into corresponding groups. … Institutional Review Board Statement The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of the LUHS Department of Bioethics (BEC-MF-174 and date of approval 19 January 2023). …

Экологические и семейные факторы риска, связанные с множественным склерозом.

Предыстория и цели: Множественный склероз (MS) является хроническим аутоиммунным заболеванием, которое оказывает воздействие на центральную нервную систему и вызывает рост заболеваемости во всем мире, особенно в Саудовской Аравии. Материалы и методы: В рамках данного исследования изучаются экологические, жизненные и семейные факторы риска, связанные с MS в регионе Алжуф, на основе перекрестного анализа 155 пациентов, диагностированных по клиническим диагнозам MS. Данные собирались с помощью структурированных вопросников и медицинских обследований для оценки социально-демографических характерис

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… Ethical Considerations This research was executed in compliance with the Declaration of Helsinki and received approval from the Local Committee of Bioethics (LCBE) at Jouf University (Approval No: 07/01/41). … Institutional Review Board Statement The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Local Committee of Bioethics (LCBE) at Jouf University 07/01/41, date 9 October 2019. …

Новое развитие аутоиммунного расстройства после лечения иммунной реконституции при множественном склерозе.

Иммунная реконституционная терапия (IRT) является относительно новым и высокоэффективным средством лечения множественного склероза (MS). Неопределенность в отношении развития аутоиммунных расстройств (АД) после сохранения некоторых методов лечения. Цель этого исследования состояла в том, чтобы провести оценку новых разработок в области АД после IRT у пациентов с РС и описать характер этих АД и время их начала. В исследование было включено в общей сложности 179 пациентов с множественным склерозом (37 после аналоговой трансплантации гематопоэтических стволовых клеток (АХСТ), 19 пациентов после а

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… The Lithuanian Bioethics Committee approved the study in 2011 (2011–01–27 Nr: L-12–01/2), the permission to continue the study was granted by the Lithuanian Bioethics Committee in 2018 (2018–02–22 Nr: 6B-18–41). …

Impact of Aspiration Pneumonia on the Clinical Course of Progressive Supranuclear Palsy: A Retrospective Cohort Study.

IntroductionAlthough aspiration pneumonia is the most common complication of progressive supranuclear palsy (PSP), the clinical impact of aspiration pneumonia on disease course and survival has not been fully estimated. Thus, we retrospectively analyzed the prognostic factors and clinical consequences of pneumonia in PSP.MethodsThe clinical course of patients with aspiration pneumonia was surveyed. The association between baseline clinical features (2 years from disease onset) and latency to the initial development of pneumonia was investigated using survival time and Cox regression analyses.R

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… Ethics This study was approved by the Bioethics Committee of Utano National Hospital (registry number: 25–21) and the protocol was consistent with the principles of the Declaration of Helsinki. … The Bioethics committee waved the need for informed consent due to the retrospective nature of the study and anonymity of the collected data, according to the Ethical Guideline for Medical and Health Research Involving Human Subjects from Ministry of Health, Labour and Welfare, Japan. …

Кинесиофобия у больных строкой, множественный склероз и болезнь Паркинсонаса

Фон: Строке (S), множественный склероз (MS), болезнь Паркинсона (PD) являются хроническими неврологическими заболеваниями, которые являются коллангом для общественного здравоохранения и представляют собой реальную социальную проблему. Физическая активность (ПА) улучшает функциональные характеристики, снижает различные симптомы в ПД и MS, уменьшает неврологические расстройства инсульта у пациентов и дает им шанс на независимость. One Среди основных препятствий на пути успешной реабилитации - пассивность пациентов. Причина может заключаться в психологических аспектах, в частности в боязни передв

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… Ethics Approval The study was approved by the Bioethics Committee of the Medical University of Silesia in Katowice (Decision no. KNW/0022/KB/119/18; 19 June 2018 and PCN/0022/KB1/120/19; 12 November 2019). It is conformed to the Helsinki Declaration. … Institutional Review Board Statement The study was approved by the Bioethics Committee of the Medical University of Silesia in Katowice (Decision no. KNW/0022/KB/119/18; 19 June 2018 and PCN/0022/KB1/120/19; 12 November 2019). It is conformed to the Helsinki Declaration. …

Life-Sustaining Treatment States in Korean Cancer Patients after Enforcement of Act on Decisions on Life-Sustaining Treatment for Patients at the End of Life.

PurposeIn Korea, the "Act on Hospice and Palliative Care and Decisions on Life-sustaining Treatment for Patients at the End of Life" was enacted on February 4, 2018. This study was conducted to analyze the current state of life-sustaining treatment decisions based on National Health Insurance Service (NHIS) data after the law came into force.Materials and methodsThe data of 173,028 cancer deaths were extracted from NHIS qualification data between November 2015 and January 2019.ResultsThe number of cancer deaths complied with the law process was 14,438 of 54,635 cases (26.4%). The rate of patie

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… In addition, according to the 2019 annual report on the life-sustaining treatment decision system by Korea National Institute for Bioethics Policy, the rate of withholding or withdrawing of life-sustaining treatment was 99.4% for cardiopulmonary resuscitation, 86.5% for mechanical ventilation, 83.4% … Seoul: Korea National Institute for Bioethics Policy; 2019. …

Understanding Harm Generated by Analytic Technique Bias from the Afro-communitarian Perspective.

This primarily normative article draws on three ideas - exclusivism, (transformative) inclusivism and incompleteness/conviviality - grounded in Afro-communitarian thinking - to argue that isolation/alienation, minimization, and essentialism are three distinct forms of harm that analytic technique bias (that results from training data and human actions) may generate. Since the healthcare context will be a leading consumer of these new techniques, this study recommends that future studies focus on outlining how various traditions or moral frameworks can increase our understanding of the ways ana

Conscience: A Brief History.

The lived experience of human moral agency suggests that some actions favour human flourishing while others lead to division and conflict: the universal human desire for happiness is bound up with the effort to discern and do 'good' and to avoid 'evil'. Words exist to convey an experience, and the word 'conscience' has emerged as an attempt to describe the experience of moral discernment. We offer an account of the development of the word 'conscience'. Our treatment is divided into three sections: the first beginning around 600 BCE until the arrival of Christianity; the second will cover the C

Women's reproductive choice and (elective) egg freezing: is an extension of the storage limit missing a bigger issue?

Egg freezing can allow women to preserve their eggs to avoid age-related infertility. The UK's recent extension of elective egg freezing storage has been welcomed as a way of enhancing the reproductive choices of young women who wish to delay having children. In this paper, I explore the issue of enhancing women's reproductive choices, questioning whether there is a more significant aspect overlooked in egg freezing. While increasing storage limits expands reproductive choices for some women, focus on this extension alone, I argue, misses a fundamental issue with egg preservation that often re

Prospects for limiting access to prenatal genetic information about Down syndrome in light of the expansion of prenatal genomics.

Down syndrome (Trisomy 21) is a mild to moderate intellectual disability. Historically, this condition has been a primary target for prenatal testing. However, Down syndrome has not been targeted for prenatal testing because it is an especially severe illness. The condition was just one that could be easily identified prenatally using the techniques first available decades ago. We are moving into an era in which we can prenatally test for a vast range of human traits. I argue that when we can test for anything, there is no longer any reason to continue targeting Down syndrome. I present an arg

Why inconsistency arguments fail: a response to Shaw.

Opponents of abortion are commonly said to be inconsistent in their beliefs or actions, and to fail in their obligations to prevent the deaths of embryos and fetuses from causes other than induced abortion. We have argued that these 'inconsistency arguments' conform to a pattern which is susceptible to a number of objections, and that consequently they fail en masse. In response, Joshua Shaw argues that we misrepresent inconsistency arguments, and that we underestimate the extent to which our opponents have anticipated and addressed counterarguments. In this essay we draw on aspects of Shaw's

Abortion, Rights, and Cabin Cases.

Many people believe the morality of abortion stands or falls on the moral status of the fetus, with abortion opponents arguing fetuses are persons with a right to life. Judith Jarvis Thomson bypasses this debate, arguing that even if we assume fetuses have a right to life, this is not a right to use other people's bodies. Recently Perry Hendricks attempts to bypass discussion of rights, assuming that if he can show that some people have a right to use other's bodies, then we ought to restrict abortion (and perhaps compel organ donation, charity, etc.). Hendricks attempts to illustrate this by

Diagnosing death 50 years after the Harvard brain death report.

More than 50 years after the publication of the Harvard Committee Report that sought to define death according to whole-brain function criteria, this document continues to generate a diversity of opinions regarding how death should be defined. The various perspectives show that doubts linger regarding when brain death should be diagnosed, the criteria to pinpoint the occurrence of death, and the alignment of medical practices seeking to establish human death with these criteria. This study reviews and assesses three perspectives that have made significant contributions to the debate. Attention

Miscarriage Can Kill … But it Usually Does Not: Evaluating Inconsistency Arguments.

Recent publications debate the value of inconsistency arguments. Here, I argue that 'Cause of Death Arguments' - inconsistency arguments that claim miscarriage causes death far more often than induced abortion - are unsound or invalid. 'Miscarriage' ambiguously refers both to intrauterine death, an outcome that does not itself cause death, and preterm delivery, which only sometimes causes death. The referential ambiguity also obscures actions people do take to prevent 'miscarriage.' When using the most plausible versions of each premise, these arguments equivocate. Thus, they cannot prove anyt