Health Care Analysis最新文献

{"title":"The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies' Soft Impacts into Account.","authors":"Tessa I van Rijssel, Ghislaine J M W van Thiel, Johannes J M van Delden","doi":"10.1007/s10728-024-00483-1","DOIUrl":"10.1007/s10728-024-00483-1","url":null,"abstract":"<p><p>Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"139-150"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141065747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Broader Benefits of Obesity Prevention Community-based Interventions From the Perspective of Multiple Stakeholders.","authors":"J Jacobs, M Nichols, N Ward, M Sultana, S Allender, V Brown","doi":"10.1007/s10728-024-00495-x","DOIUrl":"10.1007/s10728-024-00495-x","url":null,"abstract":"<p><p>Community-based interventions (CBIs) show promise as effective and cost-effective obesity prevention initiatives. CBIs are typically complex interventions, including multiple settings, strategies and stakeholders. Cost-effectiveness evidence, however, generally only considers a narrow range of costs and benefits associated with anthropometric outcomes. While it is recognised that the complexity of CBIs may result in broader non-health societal and community benefits, the identification, measurement, and quantification of these outcomes is limited. This study aimed to understand the perspectives of stakeholders on the broader benefits of CBIs and their measurement, as well as perceptions of CBI cost-effectiveness. Purposive sampling was used to recruit participants from three stakeholder groups (lead researchers, funders, and community stakeholders of CBIs). Online semi-structured interviews were conducted, taking a constructivist approach. Coding, theme development and analysis were based on published guidance for thematic analysis. Twenty-six stakeholders participated in the interviews (12 lead researchers; 7 funders; 6 community stakeholders). Six key themes emerged; (1) Impacts of CBIs (health impacts and broader impacts); (2) Broader benefits were important to stakeholders; (3) Measurement of benefits are challenging; (4) CBIs were considered cost-effective; (5) Framing CBIs for community engagement (6) Making equitable impacts and sustaining changes-successes and challenges. Across all stakeholders, broader benefits, particularly the establishment of networks and partnerships within communities, were seen as important outcomes of CBIs. Participants viewed the CBI approach to obesity prevention as cost-effective, however, there were challenges in measuring, quantifying and valuing broader benefits. Development of tools to measure and quantify broader benefits would allow for more comprehensive evaluation of the cost-effectiveness of CBIs for obesity prevention.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"151-172"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052814/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142373225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying the Human Mortality Costs of Patent-based Intellectual Property: How Many Premature Deaths are due to Patents?","authors":"Joshua M Pearce","doi":"10.1007/s10728-025-00516-3","DOIUrl":"10.1007/s10728-025-00516-3","url":null,"abstract":"<p><p>Patent-based intellectual property (IP) has come under progressively substantiative attack in the peer-reviewed literature as many studies have shown it retards innovation. In addition, the monopoly period no longer fits the innovation cycle. Although the vast majority of patents are not useful, patent proponents argue monopoly-based economic incentives are specifically necessary to fund medical technologies. Rather than use simple economics, quantifying human deaths has also been proposed as a means to guide public policies. Such an approach can be applied to patents by investigating the lives saved by patents as well as those lost in the current IP systems. This study is the first to provide such a theoretical approach to quantifying human mortality costs of patent-based IP systems. To illustrate the mechanism by which patents are responsible for premature deaths, a case study of the 100-year-old innovation of insulin is provided. The U.S. and Canada were selected to compare because the approach to drug costs in the two countries allows for a fraction of the additional costs of IP to be quantified. By comparing the different death rates of diabetics in U.S. and Canada, it was found that insulin-related patents result in over 94,000 American premature deaths annually (in 2021). The results also make it clear that many human deaths are related to price increases and lack of accessibility to needed medications due to the current monopolistic IP system. These findings require patent proponents to defend the continued existence of patents in the medical innovation space.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"109-120"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143765382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Should we Relax Abortion Reporting Requirements in Great Britain?","authors":"Jordan A Parsons","doi":"10.1007/s10728-025-00512-7","DOIUrl":"10.1007/s10728-025-00512-7","url":null,"abstract":"<p><p>In Great Britain, abortion has long proven to be contentious in the context of policy making, with it remaining a criminal offence. Despite progress over the last decade to permit home use of abortion medications and remote consultation, we have seen prosecutions in recent years. Regulatory frameworks such as this have been framed as 'abortion exceptionalism', such that termination of pregnancy is far more tightly regulated than comparable healthcare. One example of this exceptionalism is the strict abortion reporting requirements found in Great Britain. Per these requirements, any doctor providing abortion care must notify the relevant Chief Medical Officer or Public Health Scotland of each and every termination, including a startling amount of information about the patient. The extent of these requirements raises serious questions in relation to patient confidentiality and is, I suggest, an outlier in these terms. Further, it is questionable whether such reporting can be in any way said to be in the public interest. I begin by outlining the Abortion Regulations 1991, which apply in England and Wales, before considering the updated Scottish approach brought about by the Abortion (Scotland) Amendment Regulations 2021. I then move to examine the abortion reporting requirements against our general conception of patient confidentiality, highlighting the discordance. I ultimately argue that the requirements are not adequately justified and represent yet another, often forgotten, example of abortion exceptionalism in Great Britain. Thus, I suggest that all three nations that comprise Great Britain ought to further revise their approach to abortion data.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"121-138"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143411030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens' Jury for an 'Informed Opt-Out' Approach.","authors":"Arbaz Kapadi, Hannah Turner-Uaandja, Rebecca Holley, Kate Wicks, Leila Hamrang, Brian Turner, Tjeerd van Staa, Catherine Bowden, Annie Keane, Gareth Price, Corinne Faivre-Finn, David French, Caroline Sanders, Søren Holm, Sarah Devaney","doi":"10.1007/s10728-025-00510-9","DOIUrl":"10.1007/s10728-025-00510-9","url":null,"abstract":"<p><p>An emerging approach to complement randomised controlled trial (RCT) data in the development of radiotherapy treatments is to use routinely collected 'real-world' data (RWD). RWD is the data collected as standard-of-care about all patients during their usual cancer care pathway. Given the nature of this data, important questions remain about the permissibility and acceptability of using RWD in routine practice. We involved and engaged with patients, carers and the public in a two-day citizens' jury to understand their views and obtain decisions regarding two key issues: (1) preferred approaches to consent for the use of RWD within the context of patients receiving radiotherapy for lung cancer in RAPID-RT and (2) how RWD use should be best communicated to patients. Individual views were polled using questionnaires at various stages of the jury, whilst group discussion activities prompted further dialogue about the rationale behind choices of consent. Key decisions obtained from the jury include: (1) an opt-out approach to consent for the use of RWD; (2) the opt-out approach to consent should be informed. Furthermore, it was advised that information and communication regarding the consent process and use of RWD should be accessible, clear and available in a variety of formats. It is important that the consent process for patient data use is underpinned by principles of autonomy and transparency with clear channels of communication between those asking for and giving consent. Moreover, the process of seeking consent from patients should be proportionate to the risks presented from their participation.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"192-213"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is Public Health Environmentally Sustainable?","authors":"Martin Marchman Andersen, Michael Z Hauschild, Sigurd Lauridsen","doi":"10.1007/s10728-025-00511-8","DOIUrl":"10.1007/s10728-025-00511-8","url":null,"abstract":"<p><p>In this paper we discuss whether effective public health interventions and policies are environmentally sustainable. First, we suggest that the environmental impact from public health interventions and policies should be considered in the perspective of a human lifecycle. Second, we spell out in greater detail what we take it to mean for a public health intervention or policy to be environmentally sustainable. Third, environmental sustainability regards not only environmental impact, but also shares of our environmental \"budgets\", also referred to as environmentally safe operating spaces. Such budgets represent the limits of the sustainability of a group of individuals, e.g. a population. Each individual is assigned a share of the budget for each category of environmental impact, which represents how much the individual may impact the environmental category in question without doing so unsustainably. We discuss whether individuals ought to have a larger share of these budgets as a function of their ongoing life as this would make a better case for thinking that public health interventions and policies are environmentally sustainable. But we argue that this is incompatible with maximizing health within our environmental budgets and therefore mistaken. Instead, individuals ought to be ascribed a share of these budgets for life, a share that does not increase as individuals get older. We conclude that while some public health interventions and policies might be environmentally sustainable, we cannot merely assume that public health and sustainability are win-win; indeed, we have positive reason to think that some interventions and policies are not environmentally sustainable. Finally, we elaborate on how we ought to think about and react to this conclusion.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"97-108"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"History of the Autism Diagnosis- How the Perspectives Have Changed.","authors":"Heldi Marleen Lang","doi":"10.1007/s10728-025-00527-0","DOIUrl":"https://doi.org/10.1007/s10728-025-00527-0","url":null,"abstract":"<p><p>The diagnosis and perception of autism have undergone significant transformations throughout history. Initially conceptualised as a symptom of schizophrenia, autism later emerged as a distinct diagnosis, evolving into the broader classification of autism spectrum disorder (ASD). This essay explores the main shifts in the understanding of autism throughout its history and different approaches to its treatment. While the traditional psychiatric perspective aligns with a naturalist view of disease, the Neurodiversity Movement advocates for a normative approach, emphasising societal adaptation over medical intervention. The study examines historical milestones, including the contributions of Eugen Bleuler, Grunya Sukhareva, Leo Kanner, and Hans Asperger, alongside the conceptual transition from low- and high-functioning autism to the spectrum model. It also discusses the implications of language in shaping autism discourse, highlighting the shift from person-first to identity-first terminology. The essay ultimately argues that the expansion of the autism diagnosis supports the neurodiversity paradigm, which fosters greater inclusion and empowerment of neurodivergent individuals. However, considerations of severity and linguistic framing remain crucial in advancing this perspective.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The \"Newborn Gang\" Scandal in Türkiye: Ethics in a Neoliberal Health System.","authors":"Maide Barış, Gürkan Sert, M İnanç Özekmekçi","doi":"10.1007/s10728-025-00522-5","DOIUrl":"https://doi.org/10.1007/s10728-025-00522-5","url":null,"abstract":"<p><p>In October 2024, Türkiye was shocked by the \"Newborn Gang\" scandal, in which a network of healthcare professionals allegedly exploited newborns for financial gain in private hospitals. The accused are charged with intentionally neglecting, mistreating or even killing of healthy infants in neonatal intensive care units to prolong their stays and maximize government reimbursements. This paper critically examines the structural and ethical failures exposed by the 2024 \"Newborn Gang\" scandal in Türkiye, in which healthcare professionals in private hospitals allegedly allowed or caused the deaths of newborns to profit from the state's healthcare reimbursement system. Drawing on the frameworks of neoliberal critique and medical humanities, the study argues that such extreme violations are not isolated incidents of individual misconduct, but manifestations of deeper systemic vulnerabilities fostered by the neoliberalization of healthcare. It explores how deregulation, market incentives, and the erosion of ethical values-exacerbated by Türkiye's Health Transformation Program-have created an environment where financial gain is prioritized over patient welfare. Comparative case studies are employed to contextualize these findings within broader global patterns of ethical collapse in healthcare systems influenced by market logic. The paper contends that merely strengthening oversight is insufficient; rather, a structural reorientation is needed. As a potential alternative, the study introduces Value-Based Healthcare as a model that aligns clinical outcomes with ethical imperatives. Ultimately, the paper calls for a fundamental moral recalibration of healthcare-one that affirms care, integrity, and justice as core values over profit and efficiency.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Mindfulness, Emotional Intelligence, and Employee Well-being on Mental Healthcare of Workers' Affectiveness: The Mediating Role of Employee Satisfaction and the Moderating Effect of Digital Leadership.","authors":"Junjian Zheng, Hao Hong, Nan Wang, JiuJian Sun, Xiaowei Xu","doi":"10.1007/s10728-025-00523-4","DOIUrl":"https://doi.org/10.1007/s10728-025-00523-4","url":null,"abstract":"<p><p>Recently, the most critical psychological challenges have compelled healthcare professionals to confront their mental health issues. Consequently, many employees experiencing elevated levels of psychological stress have reported disengagement and dissatisfaction across various aspects of their work. Given the strong association between individual well-being and job satisfaction, how healthcare employees regulate their emotions and psychological health to attain job satisfaction remains largely unexplored. To address this issue, the present study investigates the effects of mindfulness, emotional intelligence, and employee well-being on healthcare workers' emotional and mental health while considering the mediating role of employee satisfaction and the moderating role of digital leadership. Data were collected through a structured questionnaire distributed to 633 healthcare employees in China. We employed SPSS and Smart PLS for reliability, discriminant validity, and structural equation modeling analyses. The findings reveal that mindfulness (MFN), emotional intelligence (EI), and employee well-being (EWB) significantly and positively influence both emotional health (EH) and mental health (MH). Furthermore, employee satisfaction (ES) mediated the relationship between mindfulness, emotional intelligence, and employee well-being to emotional and mental health. The moderating role of digital leadership (DL) was also examined, demonstrating its influence on emotional and mental health. These findings hold important implications for healthcare professionals, managers, policymakers, practitioners, and other stakeholders seeking to enhance employee well-being and job satisfaction in healthcare settings.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144162830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Shared Decision-Making with the \"Professionally-Driven Zone of Patient or Surrogate Discretion\" Model and its Application in Acute Care.","authors":"Joshua T Landry","doi":"10.1007/s10728-025-00524-3","DOIUrl":"https://doi.org/10.1007/s10728-025-00524-3","url":null,"abstract":"<p><p>Shared decision-making (\"SDM\") has increased in acceptance and become a gold standard in medical decision-making over the last two decades. Despite this, there continues to be disagreement about several facets of SDM that many existing models or versions do not sufficiently address, including: that there is a lack of agreement about which version or model of SDM to utilize in practice; that there are practical limitations on when SDM ought to be utilized; that SDM may be required to use different \"harm thresholds\" when making decisions for patients who have lost decision-making capacity or competence, or for those who have never had such capacity in the first place; and that many existing models of SDM succumb to what is known as the \"framing problem,\" among other concerns. Elsewhere, this author presented a model of SDM titled, the Professionally-Driven Zone of Patient or Surrogate Discretion (or, Professionally-Driven ZPSD) as a more comprehensive and defensible way forward. This article sets out to expand on the expected benefits of the model, and apply it to several case studies in the acute-care setting in order to demonstrate its functionality as a model of SDM.</p>","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}