Journal of Medical Ethics最新文献_第6页

How can non-inferiority studies with mortality end points be ethically justified? 具有死亡率终点的非劣效性研究如何在伦理上被证明是合理的？

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-26 DOI: 10.1136/jme-2024-110517

Dick Willems, Hanno Tan, Nikolaos Dagres, Marieke A R Bak

{"title":"How can non-inferiority studies with mortality end points be ethically justified?","authors":"Dick Willems, Hanno Tan, Nikolaos Dagres, Marieke A R Bak","doi":"10.1136/jme-2024-110517","DOIUrl":"https://doi.org/10.1136/jme-2024-110517","url":null,"abstract":"Background: Non-inferiority (NI) studies with mortality end points are increasingly frequently conducted. They aim to show that a new treatment strategy does not entail an unacceptably higher mortality than the comparator. They raise specific ethical issues related to the rationale of the study, the NI margin, certainty and informed consent. There is a need for ethical reflection.Method: Analysis of ethical issues informed by a literature search using terms related to NI, mortality and ethics, in PubMed, CINAHL and Embase. Results are illustrated using the example of the PROFID-EHRA NI trial that the authors are involved in.Results: Justifications for conducting an NI study instead of a superiority study are often insufficient. The NI margin is most often taken from previous studies without additional justification. There is no consensus about how patients should be involved in the design and justification of the studies and about how participants should be informed.Discussion: We conclude that NI studies with mortality end points can be ethically justified if secondary benefits are proven and large enough for participants, and if the NI margin is acceptable to patients and ethics committees. Acceptability of the NI margin should be determined on a case-by-case basis and risks should be framed appropriately. The justification for choosing an NI rather than a superiority design should be made more explicitly. Further studies are needed on patients' views about NI trials with mortality as an end point; also, the degree of certainty and the very distinction between primary and secondary outcomes deserve systematic study.","PeriodicalId":16317,"journal":{"name":"Journal of Medical Ethics","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A large exploratory survey of electroconvulsive therapy recipients, family members and friends: what information do they recall being given? 一项针对电休克疗法接受者、家庭成员和朋友的大型探索性调查：他们记得被告知的信息是什么？

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-25 DOI: 10.1136/jme-2024-110629

John Read, Christopher Harrop, Lisa Morrison, Sarah Price Hancock, Lucy Johnstone, Sue Cunliffe

{"title":"A large exploratory survey of electroconvulsive therapy recipients, family members and friends: what information do they recall being given?","authors":"John Read, Christopher Harrop, Lisa Morrison, Sarah Price Hancock, Lucy Johnstone, Sue Cunliffe","doi":"10.1136/jme-2024-110629","DOIUrl":"10.1136/jme-2024-110629","url":null,"abstract":"The right to informed consent is a core ethical principle. Recent audits of patient information leaflets about electroconvulsive therapy (ECT), in Australia, England, Northern Ireland, Scotland and Wales, suggest that this principle is often not implemented, with efficacy being exaggerated and risks minimised. In the current study a convenience sample of 858 ECT recipients and 286 family members and friends, from 44 countries, responded to an online survey about their experiences of ECT, including the information they recall being given to them before ECT. Most (59%) of the ECT recipients reported that they had not been given 'adequate information' and a further 17% were 'not sure'. For example, 63% of recipients recall being told that 'ECT can cause temporary memory problems', but only 17% that 'ECT can cause long-term or permanent memory problems, 12% that 'ECT can cause heart problems' and 28% that there are 'Risks from repeated general anaesthesia'. There were higher levels of recalling being told about definite benefits, even though some of these benefits are disputed. When asked to consider a list of items of misinformation, many recipients and relatives reported being told 'Depression is caused by a chemical imbalance in the brain' (58% and 53%, respectively) and 'ECT corrects chemical imbalance or other brain abnormality' (42% and 41%). Study limitations include potential sampling issues (eg, self-selection bias, snowball sampling bias, or other barriers to representativeness due to convenience sampling or network-based recruitment), as well as potential recall bias among survey respondents (last ECT treatment was between 1958 and 2024; average=2012.5). Nevertheless, these findings, in conjunction with previous studies, suggest an urgent need for greater efforts to ensure that patients and families are provided with comprehensive, balanced, evidence-based information when deciding whether to have ECT.","PeriodicalId":16317,"journal":{"name":"Journal of Medical Ethics","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144855524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Trans bodies, multiplicity and the limits of digital representation. 跨性别者，多样性和数字表现的限制。

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-24 DOI: 10.1136/jme-2025-111178

Vishnu R Subrahmanyam, Grayson R Jackson

引用次数: 0

Trapped in the promising role of digital twins? 被数字双胞胎的前景所困？

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-24 DOI: 10.1136/jme-2025-111179

Michiel De Proost, Brandon Ferlito, Seppe Segers

引用次数: 0

Priority for registered organ donors: unfair discrimination against non-donors? 注册器官捐赠者优先：对非捐赠者的不公平歧视？

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-22 DOI: 10.1136/jme-2024-110029

Andreas Albertsen

引用次数: 0

Should newborn genetic testing for autism be introduced? 应该引入新生儿自闭症基因检测吗？

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-20 DOI: 10.1136/jme-2024-110166

Ramkumar Aishworiya, Hui-Lin Chin, Julian Savulescu

{"title":"Should newborn genetic testing for autism be introduced?","authors":"Ramkumar Aishworiya, Hui-Lin Chin, Julian Savulescu","doi":"10.1136/jme-2024-110166","DOIUrl":"10.1136/jme-2024-110166","url":null,"abstract":"This manuscript provides a review of the potential role of newborn genetic testing for autism, and whether the state has an inherent responsibility to facilitate and subsidise this. This is situated within the broader construct of benefits and limitations of genetic testing currently. Potential benefits of such presymptomatic genetic testing include facilitating earlier diagnosis and access to appropriate intervention which can improve the treatment outcome for the child and indirectly benefit caregivers and society by reducing the care needs of the child and adult in future. However, there are several limitations to newborn genetic testing including the variable penetrance of 'autism-risk' genes, marked phenotypic heterogeneity of autism, real-world limitations in access to treatment, potential psychological harm to caregivers and financial considerations. We hence argue for facilitation of diagnostic genetic testing instead, especially for parents who seek to have greater understanding of recurrence likelihoods, related to reproductive decision-making. Facilitation of such testing can be in the form of both financial subsidies and infrastructural elements including availability of testing facilities and trained healthcare personnel for individualised pregenetic and postgenetic test counselling.","PeriodicalId":16317,"journal":{"name":"Journal of Medical Ethics","volume":" ","pages":"603-608"},"PeriodicalIF":3.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7617952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Defending manic competence: a reply to Kane. 为狂躁能力辩护：对凯恩的回应。

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-20 DOI: 10.1136/jme-2025-110744

Samuel Director

引用次数: 0

On interpreters: the ethics of interpreter use in general practice. 关于口译员：全科医生使用口译员的伦理问题。

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-20 DOI: 10.1136/jme-2024-110389

Richard Armitage

{"title":"On interpreters: the ethics of interpreter use in general practice.","authors":"Richard Armitage","doi":"10.1136/jme-2024-110389","DOIUrl":"10.1136/jme-2024-110389","url":null,"abstract":"In the absence of language congruency between patient and general practitioner (GP), the use of an interpreter is essential for a safe and effective clinical consultation. A substantial proportion of individuals living in the UK lack sufficient command of the English language to allow direct communication with their GP. Interpreters in UK general practice can be classified into three major categories: Casual, professional in-person and professional telephone interpreters. The use of casual interpreters threatens the safety and quality of care provided in interpreted consultations, increases the potential for safeguarding concerns to go unrecognised by the GP, poses a potential legal risk to the GP and is burdensome for and potentially harmful to the relatives, friends and carers who act as such interpreters. The use of professional in-person interpreters greatly improves the safety and quality of care above that of casually interpreted consultations, increases the probability that safeguarding concerns will be recognised by the GP, avoids the legal risk inherent to casually interpreted consultations, is neither burdensome nor potentially harmful to accompanying relatives, friends and carers or the interpreter and permits interpreter continuity while generating a small non-clinical opportunity cost borne by administrative staff. The use of professional telephone interpreters shares the same advantages as the use of professional in-person interpreters but prevents interpreter continuity and generates a large clinical opportunity cost borne by other patients. The paper also explores ethical challenges that are common to the use of all major categories of interpreter and offers four policy recommendations in light of the analysis.","PeriodicalId":16317,"journal":{"name":"Journal of Medical Ethics","volume":" ","pages":"614-619"},"PeriodicalIF":3.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Ethics round table: choice and autonomy in obstetrics. 伦理圆桌会议：产科的选择与自主。

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-20 DOI: 10.1136/jme-2024-110503

Dominic Wilkinson, Safoora Teli, Claire Litchfield, Anna Madeley, Brenda Kelly, Lawrence Impey, Rebecca Ch Brown, Elselijn Kingma, Helen Lynne Turnham

引用次数: 0

When the patient can't walk away. 当病人不能走开的时候。

IF 3.4 2区哲学

Journal of Medical Ethics Pub Date : 2025-08-20 DOI: 10.1136/jme-2024-110615

Edwin Jesudason

{"title":"When the patient can't walk away.","authors":"Edwin Jesudason","doi":"10.1136/jme-2024-110615","DOIUrl":"10.1136/jme-2024-110615","url":null,"abstract":"When the clinician and patient are unable to reconcile differences over treatment, does this mean the latter lacks capacity to decide in such matters? Wellesley et al analyse the legal judgements in the case of Ms Sudiksha Thirumalesh where, on the particulars, the Court of Protection answered yes, only for the Court of Appeal to disagree. The authors highlight concerns about using isolated false belief as an indicator of incapacity and advise that such matters may be better resolved by greater discussion of the benefits and burdens of treatment, alongside consideration of their costs. Here, I suggest that a disability perspective is also helpful to such cases, recognising that this was a disagreement from which the patient couldn't walk away. Disability means that particular care is required when considering the burdens and benefits of treatment as these may vary widely in the eye of the beholder. Second, the costs of litigation are particularly high when a disabled person, with life-limiting illness, is left feeling they are using precious time and energy arguing for their existence. Third, any such legal judgments ought to make clear what reasonable adjustments have been offered to include the disabled person in proceedings. Fourth, and relatedly, such disputes should be attentive to the significant risk of epistemic injustice, where disabled patients find themselves less believed, in part because the 'able-bodied' have not shared their experiences. Together, these considerations (i) add to the call made by Wellesley et al for better discussions and (ii) suggest that early involvement of Rehabilitation Medicine, with expertise in disability and related ethics, could offer an important means to reduce the need for such litigation in the future.","PeriodicalId":16317,"journal":{"name":"Journal of Medical Ethics","volume":" ","pages":"649-650"},"PeriodicalIF":3.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0