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Quantifying pharmaceutical and medical device industry-physician financial ties: An analysis of honorarium payments to Japanese medical association leadership between 2019 and 2021 量化制药和医疗器械行业-医生的财务关系:2019年至2021年日本医学协会领导层的酬金支付分析
IF 3.7 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-28 DOI: 10.1016/j.hlpt.2025.101081
Akemi Hara , Tetsuya Tanimoto , Piotr Ozieranski , James Larkin , Michioki Endo , Hiroaki Saito , Akihiko Ozaki

Objective

To assess the extent and distribution of pharmaceutical and medical device industry honorarium payments to medical association leadership, enhancing our understanding of industry-physician financial ties in Japan.

Methods

We conducted a retrospective analysis of publicly disclosed payment data from pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association and medical device companies affiliated with the Medical Devices Network. Data covered honorarium payments for speaking, writing, and consulting to board members of 18 major professional medical associations from 2019 to 2021.

Results

Of the 399 executive board members, 373 (93.5 %) received payments totaling $15.99 million. The median payment per member over the three years was $22,529, (interquartile range [IQR], $7230.8–$57,223.9). Payments were concentrated, with four professional medical associations—representing Internal Medicine ($2.97 million), Ophthalmology ($1.78 million), Dermatology ($1.78 million), and Urology ($1.87 million)—accounting for 52.5 % of the total. Surgical specialties received a higher proportion of payments from medical device companies, while non-surgical specialties – pharmaceutical companies. Payments declined in 2020, coinciding with the COVID-19 pandemic, recovering by 2021. None of the 18 associations' leadership publicly disclosed their board members' financial ties.

Conclusions

We found extensive and concentrated ties between industry and medical association leadership in Japan, with the pharmaceutical and medical device sectors each displaying distinctive payment patterns. The substantial scale of payments and limited transparency displayed by the association highlight the urgent need for legally mandated disclosure, including specialty-specific solutions.
目的评估制药和医疗器械行业向医疗协会领导支付酬金的程度和分布,增强我们对日本行业-医生财务关系的了解。方法回顾性分析日本医药工业协会所属制药公司和医疗器械网络所属医疗器械公司公开披露的支付数据。数据涵盖了2019年至2021年期间向18个主要专业医学协会董事会成员支付的演讲、写作和咨询酬金。结果在399名执行董事会成员中,373名(93.5%)获得了总计1599万美元的薪酬。每位会员在三年内支付的中位数为22,529美元(四分位数区间[IQR]为7230.8美元至57,223.9美元)。付款集中在四个专业医学协会,分别代表内科(297万美元)、眼科(178万美元)、皮肤科(178万美元)和泌尿科(187万美元),占总数的52.5%。外科专业从医疗器械公司获得的付款比例较高,而非外科专业-制药公司。在2019冠状病毒病大流行期间,支付额在2020年下降,到2021年恢复。18家协会的领导层都没有公开披露其董事会成员的财务关系。我们发现日本的行业和医疗协会领导层之间存在广泛而集中的联系,制药和医疗器械行业各自表现出独特的支付模式。该协会所显示的巨额支付和有限的透明度凸显了法律强制披露的迫切需要,包括专门的解决方案。
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引用次数: 0
Guiding stakeholder involvement in health technology assessment for medical devices: A novel approach for clarifying stakeholders’ roles and contributions 指导利益相关者参与医疗器械卫生技术评估:澄清利益相关者角色和贡献的新方法
IF 3.7 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-23 DOI: 10.1016/j.hlpt.2025.101075
Liliana Freitas , Mónica D. Oliveira , Ana C.L. Vieira

Objectives

Stakeholder involvement is recognized as essential in Health Technology Assessment (HTA), yet engagement remains insufficient, particularly in medical device (MD) evaluations. Literature on how to systematically identify and integrate stakeholders remains scarce. This study proposes a reflective framework to support HTA practitioners think about stakeholder inclusion and applies it to explore perspectives within the medical device context in Portugal.

Methods

We adapted Ulrich’s Critical Systems Heuristics (CSH) as a conceptual lens to structure reflection on stakeholder roles and contributions in MD HTA. The framework is organized around four sources of influence (motivation, control, knowledge, and legitimacy) and was operationalized through 26 semi-structured interviews with experts from Portugal’s HTA agency, hospitals, patient associations, and industry. Interview data were analysed using directed content analysis and the Framework Method, allowing to contrast current ('is') and ideal ('ought') views within each source of influence. The common themes were then used to construct interpretative narratives that captured rationales for stakeholder inclusion.

Results

The application of the framework revealed context-specific insights into stakeholder engagement in MD evaluation. Findings show stakeholder roles in MD evaluations extend beyond traditional classifications. For each CSH source of influence, rationales and conditions for stakeholder engagement were identified. Under motivation, stakeholders identified diverse purposes and measures of success, ranging from improved patient access to innovation to system-wide resource optimization. Under control, providers, purchasers, and payers were seen as central decision-makers, yet ideal processes included multidisciplinary governance and clearer procedural support. Under knowledge, multiple actors (including patients) were valued as contributors of contextual expertise, but gaps were highlighted in methodological tools. Under legitimacy, patients and the public were underrepresented and called for stronger mechanisms for direct involvement and broader societal alignment. Across all sources of influence, significant gaps were found between current practices and stakeholder expectations to highlight areas for development.

Conclusions

Rather than prescribing fixed engagement procedures, the proposed reflective framework offers a structured lens to support HTA practitioners in reasoning through stakeholder roles, values, and contributions in MD evaluations. The framework is transferable to other decision-making contexts and fosters more transparent and inclusive deliberation.
利益相关者的参与在卫生技术评估(HTA)中被认为是必不可少的,但参与仍然不足,特别是在医疗器械(MD)评估中。关于如何系统地识别和整合利益相关者的文献仍然很少。本研究提出了一个反思性框架,以支持HTA从业者思考利益相关者的包容,并将其应用于探索葡萄牙医疗器械背景下的观点。方法我们采用了Ulrich的关键系统启发式(CSH)作为概念透镜来构建对MD HTA中利益相关者角色和贡献的反思。该框架围绕四个影响来源(动机、控制、知识和合法性)进行组织,并通过对来自葡萄牙HTA机构、医院、患者协会和行业的专家进行26次半结构化访谈来实施。使用定向内容分析和框架方法分析访谈数据,允许在每个影响来源内对比当前(“是”)和理想(“应该”)观点。然后使用共同主题来构建解释性叙述,以捕获利益相关者包容的基本原理。结果该框架的应用揭示了在MD评估中利益相关者参与的具体情况。研究结果表明,利益相关者在MD评估中的作用超出了传统的分类。对于每一个CSH的影响来源,确定了利益相关者参与的理由和条件。在激励下,利益相关者确定了不同的目标和成功措施,从改善患者获得创新的机会到全系统资源优化。在控制下,提供者、购买者和支付者被视为中心决策者,然而理想的过程包括多学科治理和更清晰的程序支持。在知识方面,多个行为者(包括患者)被视为情境专业知识的贡献者,但方法工具方面的差距突出。在合法性下,患者和公众的代表不足,并呼吁建立更强有力的直接参与机制和更广泛的社会协调。在所有影响来源中,发现当前做法与利益攸关方强调发展领域的期望之间存在重大差距。建议的反思框架没有规定固定的参与程序,而是提供了一个结构化的视角,以支持HTA从业者通过利益相关者在MD评估中的角色、价值观和贡献进行推理。该框架可转移到其他决策环境,并促进更加透明和包容的审议。
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引用次数: 0
Artificial intelligence in healthcare: Tailoring education to meet EU AI-Act standards 医疗保健中的人工智能:定制教育以满足欧盟人工智能法案标准
IF 3.7 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-25 DOI: 10.1016/j.hlpt.2025.101078
Elena Bignami , Luigino Jalale Darhour , Wolfgang Buhre , Maurizio Cecconi , Valentina Bellini
The integration of Artificial Intelligence (AI) in Intensive Care Units (ICUs) has the potential to transform critical care by enhancing diagnosis, management, and clinical decision-making. Generative and Predictive AI technologies offer new opportunities for personalized care and risk stratification, but their implementation must prioritize ethical standards, patient safety, and the sustainability of care delivery. With the EU AI-Act entering into force in February 2025, a structured and responsible adoption of AI is now imperative. This article outlines a strategic framework for ICU AI integration, emphasizing the importance of a formal declaration of intent by each unit, detailing current AI-use, implementation plans, and governance strategies. Central to this approach is the development of tailored AI education programs adapted to four distinct professional profiles, ranging from experienced clinicians with limited AI knowledge to new intensivists with strong AI backgrounds but limited clinical experience. Training must foster critical thinking, contextual interpretation, and a balanced relationship between AI tools and human judgment. A multidisciplinary support team should oversee ethical AI-use and continuous performance monitoring. Ultimately, aligning regulatory compliance with targeted education and practical implementation could enable a safe, effective, and ethically grounded use of AI in intensive care. This balanced approach would support a culture of transparency and accountability, while preserving the central role of human clinical reasoning and improving the overall quality of ICU care.
人工智能(AI)在重症监护病房(icu)的整合有可能通过加强诊断、管理和临床决策来改变重症监护。生成式和预测性人工智能技术为个性化护理和风险分层提供了新的机会,但它们的实施必须优先考虑道德标准、患者安全和护理服务的可持续性。随着《欧盟人工智能法案》于2025年2月生效,人工智能的结构化和负责任采用现在势在必行。本文概述了ICU人工智能集成的战略框架,强调了每个单元正式声明意图的重要性,详细说明了当前人工智能的使用、实施计划和治理策略。这种方法的核心是开发量身定制的人工智能教育计划,以适应四种不同的专业概况,从经验丰富的临床医生,有限的人工智能知识,到具有强大的人工智能背景,但临床经验有限的新重症医师。培训必须培养批判性思维、上下文解释以及人工智能工具和人类判断之间的平衡关系。一个多学科支持团队应该监督合乎道德的人工智能使用和持续的绩效监测。最终,将监管合规与有针对性的教育和实际实施相结合,可以使人工智能在重症监护中得到安全、有效和合乎道德的使用。这种平衡的方法将支持透明和问责的文化,同时保留人类临床推理的核心作用,并提高ICU护理的整体质量。
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引用次数: 0
Non-clinical direct-to-consumer genetic testing: a scoping review of regulatory frameworks and issues 非临床直接面向消费者的基因检测:监管框架和问题的范围审查
IF 3.7 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-08-18 DOI: 10.1016/j.hlpt.2025.101106
Natasha A. Bujang , Chandrani Ghosh , Kavitha Palaniappan , Silke Vogel , John C.W. Lim , Wei Wei Tiong , Adrian Sim , Beatrice Lee
<div><h3>Introduction</h3><div>Direct-to-Consumer Genetic Testing (DTC-GT) provides consumers access to genetic tests without the mediation of healthcare professionals. This raises regulatory and ethical concerns including potential misinformation from company claims, especially in Singapore where DTC-GT is limited to non-clinical applications and is presently not regulated under health products regulations.</div></div><div><h3>Objective</h3><div>This scoping review aims to map non-clinical DTC-GT regulatory guidelines and compare data protection laws for genetic data to understand the regulatory landscape.</div></div><div><h3>Methods</h3><div>Online databases (PubMed, EBSCO, Springer, ScienceDirect, Embase, Web of Science, and SCOPUS) were used to identify papers published from 2000 onwards along with grey literature like websites and reports from Google searches.</div></div><div><h3>Results</h3><div>Based on the scoping review, 35 publications were identified, comprising 19 regulations and guidelines, and 16 relevant articles. Our findings indicate that the regulatory landscape of DTC-GT lacks uniformity, with most jurisdictions without specific regulations for non-clinical DTC-GT. 7 jurisdictions were identified to have data protection laws concerning genetic data privacy.</div></div><div><h3>Conclusions</h3><div>The review concluded that non-clinical DTC-GT is generally perceived as low-risk, resulting in minimal regulatory scrutiny across the surveyed regions. Despite the fundamental roles of informed consent and anonymisation of genetic data within existing frameworks for genetic data privacy, the regulation of non-clinical DTC-GT remains either limited or entirely absent due to its low-risk classification. Consequently, there is a significant need to enhance consumer health literacy, ensuring individuals are well-informed about GT services and are aware of the limitations and implications of data privacy risks. This approach is essential for safeguarding consumer interests in the evolving genetic testing landscape, as accuracy and reliability of these tests can be questionable, often leading to misinformation.</div></div><div><h3>Public Interest Summary</h3><div>This scoping review highlights that non-clinical DTC-GT often have minimal regulations because they are seen as low risk. However, the lack of specific regulations for how genetic data is collected, used, and shared poses privacy concerns. As genetic research technology advances, regulations should be adaptable and based on fundamental principles to keep up with these changes. It is also crucial to protect individuals from discrimination based on their genetic information. While there is no urgent need to regulate non-clinical DTC-GT that do not impact medical diagnoses, there is a growing concern about companies suggesting these tests have clinical importance without clear evidence. The best way forward is to implement strong consumer education programmes to help people understand
直接面向消费者的基因检测(DTC-GT)为消费者提供了无需医疗保健专业人员调解的基因检测途径。这引起了监管和道德方面的担忧,包括公司声明中可能存在的错误信息,特别是在新加坡,DTC-GT仅限于非临床应用,目前不受健康产品法规的监管。目的:本综述旨在绘制非临床DTC-GT监管指南,并比较遗传数据的数据保护法律,以了解监管格局。方法利用在线数据库(PubMed、EBSCO、谷歌、ScienceDirect、Embase、Web of Science和SCOPUS)识别2000年以来发表的论文以及谷歌搜索的网站和报告等灰色文献。结果根据范围审查,确定了35篇出版物,包括19篇法规和指南以及16篇相关文章。我们的研究结果表明,DTC-GT的监管格局缺乏统一性,大多数司法管辖区没有针对非临床DTC-GT的具体法规。确定有7个司法管辖区制定了有关遗传数据隐私的数据保护法。该综述的结论是,非临床DTC-GT通常被认为是低风险的,因此在调查地区的监管审查很少。尽管知情同意和遗传数据匿名化在现有遗传数据隐私框架中发挥着重要作用,但由于其低风险分类,对非临床DTC-GT的监管仍然有限或完全缺失。因此,非常需要提高消费者的健康知识,确保个人充分了解GT服务,并意识到数据隐私风险的局限性和影响。这种方法对于在不断发展的基因检测领域维护消费者利益至关重要,因为这些检测的准确性和可靠性可能受到质疑,经常导致错误信息。该范围审查强调,非临床DTC-GT通常具有最小的法规,因为它们被视为低风险。然而,缺乏关于如何收集、使用和共享基因数据的具体规定,引发了隐私问题。随着基因研究技术的进步,法规应该具有适应性,并以基本原则为基础,以跟上这些变化。保护个人免受基于其遗传信息的歧视也至关重要。虽然没有迫切需要对不影响医学诊断的非临床DTC-GT进行监管,但越来越多的公司在没有明确证据的情况下暗示这些测试具有临床重要性。最好的方法是实施强有力的消费者教育计划,帮助人们了解非临床DTC-GT的风险和益处,确保他们能够做出明智的选择。
{"title":"Non-clinical direct-to-consumer genetic testing: a scoping review of regulatory frameworks and issues","authors":"Natasha A. Bujang ,&nbsp;Chandrani Ghosh ,&nbsp;Kavitha Palaniappan ,&nbsp;Silke Vogel ,&nbsp;John C.W. Lim ,&nbsp;Wei Wei Tiong ,&nbsp;Adrian Sim ,&nbsp;Beatrice Lee","doi":"10.1016/j.hlpt.2025.101106","DOIUrl":"10.1016/j.hlpt.2025.101106","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Direct-to-Consumer Genetic Testing (DTC-GT) provides consumers access to genetic tests without the mediation of healthcare professionals. This raises regulatory and ethical concerns including potential misinformation from company claims, especially in Singapore where DTC-GT is limited to non-clinical applications and is presently not regulated under health products regulations.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;This scoping review aims to map non-clinical DTC-GT regulatory guidelines and compare data protection laws for genetic data to understand the regulatory landscape.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Online databases (PubMed, EBSCO, Springer, ScienceDirect, Embase, Web of Science, and SCOPUS) were used to identify papers published from 2000 onwards along with grey literature like websites and reports from Google searches.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Based on the scoping review, 35 publications were identified, comprising 19 regulations and guidelines, and 16 relevant articles. Our findings indicate that the regulatory landscape of DTC-GT lacks uniformity, with most jurisdictions without specific regulations for non-clinical DTC-GT. 7 jurisdictions were identified to have data protection laws concerning genetic data privacy.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;The review concluded that non-clinical DTC-GT is generally perceived as low-risk, resulting in minimal regulatory scrutiny across the surveyed regions. Despite the fundamental roles of informed consent and anonymisation of genetic data within existing frameworks for genetic data privacy, the regulation of non-clinical DTC-GT remains either limited or entirely absent due to its low-risk classification. Consequently, there is a significant need to enhance consumer health literacy, ensuring individuals are well-informed about GT services and are aware of the limitations and implications of data privacy risks. This approach is essential for safeguarding consumer interests in the evolving genetic testing landscape, as accuracy and reliability of these tests can be questionable, often leading to misinformation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Public Interest Summary&lt;/h3&gt;&lt;div&gt;This scoping review highlights that non-clinical DTC-GT often have minimal regulations because they are seen as low risk. However, the lack of specific regulations for how genetic data is collected, used, and shared poses privacy concerns. As genetic research technology advances, regulations should be adaptable and based on fundamental principles to keep up with these changes. It is also crucial to protect individuals from discrimination based on their genetic information. While there is no urgent need to regulate non-clinical DTC-GT that do not impact medical diagnoses, there is a growing concern about companies suggesting these tests have clinical importance without clear evidence. The best way forward is to implement strong consumer education programmes to help people understand","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"14 6","pages":"Article 101106"},"PeriodicalIF":3.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145018605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From accuracy to comprehensibility: Evaluating large language models for myopia patient queries 从准确性到可理解性:评估近视患者查询的大型语言模型
IF 3.4 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.hlpt.2025.101073
Ezgi Karataş , Ceren Durmaz Engin

Objectives

This study evaluated the accuracy and comprehensibility of responses from three large language models (LLMs)—ChatGPT-4, Gemini, and Copilot—when addressing patient queries about myopia. Accurate, understandable information is crucial for effective patient education and management of this common refractive error.

Methods

Sixty questions across six categories (definition, etiology, symptoms and diagnosis, myopia control, correction, and new treatments) were presented to ChatGPT-4, Gemini, and Copilot. Responses were assessed for accuracy by two experienced ophthalmologists using a 3-point Likert scale. Quality and reliability were evaluated using the DISCERN and EQIP scales, while readability was measured with the Flesch Reading Ease Score, Flesch-Kincaid Grade Level, and Coleman-Liau Index. Statistical analyses were conducted using SPSS version 25.

Results

ChatGPT-4 provided the most accurate responses in the defsinition, symptoms, and diagnosis categories, with a 75 % overall success rate. Copilot had a similar success rate of 73.3 % but the highest inaccuracy rate (6.7 %). Gemini had a 71.7 % success rate. Copilot scored highest in reliability (DISCERN 76) and readability (Flesch Reading Ease 46.74), followed by ChatGPT-4 and Gemini. No significant differences in accuracy were found among the LLMs across categories.

Conclusions

All three LLMs performed well in providing myopia-related information. Copilot excelled in readability and reliability despite a higher inaccuracy rate. ChatGPT-4 and Copilot outperformed Gemini, likely due to their advanced architectures and training methodologies. These findings highlight the potential of LLMs in patient education and the need for ongoing improvements to ensure accurate, comprehensible AI-generated health information.
目的:本研究评估了chatgpt -4、Gemini和copilot这三种大型语言模型(LLMs)在回答患者关于近视的询问时的回答的准确性和可理解性。准确,可理解的信息是有效的患者教育和管理这种常见的屈光不正至关重要。方法向ChatGPT-4、Gemini和Copilot提出6个类别(定义、病因、症状和诊断、近视控制、矫正和新治疗)的60个问题。由两名经验丰富的眼科医生使用李克特3分量表评估回答的准确性。使用DISCERN和EQIP量表评估质量和可靠性,使用Flesch Reading Ease Score、Flesch- kincaid Grade Level和Coleman-Liau Index测量可读性。采用SPSS 25进行统计分析。结果schatgpt -4在定义、症状和诊断分类上提供了最准确的反应,总成功率为75%。副驾驶有相似的73.3%的成功率,但最高的不准确率(6.7%)。双子座的成功率为71.7%。Copilot在可靠性(DISCERN 76分)和可读性(Flesch Reading Ease 46.74分)方面得分最高,其次是ChatGPT-4和Gemini。在不同类别的法学硕士中,准确率没有显着差异。结论3种llm均能较好地提供近视相关信息。副驾驶在可读性和可靠性方面表现出色,尽管误差率较高。ChatGPT-4和Copilot的表现优于Gemini,可能是由于它们先进的架构和训练方法。这些发现强调了法学硕士在患者教育方面的潜力,以及不断改进以确保人工智能生成的准确、可理解的健康信息的必要性。
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引用次数: 0
Towards equity-oriented topic selection in health technology assessment for orphan drugs in Iran: A commentary 伊朗孤儿药卫生技术评价的公平选题研究述评
IF 3.7 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-18 DOI: 10.1016/j.hlpt.2025.101074
Fatemeh Sadat Hosseini , Mohammadreza Mobinizadeh
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引用次数: 0
Contributing factors of sentinel events involving medical devices: A cross-sectional retrospective human factors analysis 涉及医疗器械的哨点事件的影响因素:横断面回顾性人为因素分析
IF 3.4 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.hlpt.2025.101068
Mees Casper Baartmans , Steffie Marijke Van Schoten , Cordula Wagner

Background and objective

Although most medical device applications in hospitals are safe and effective, in a small number of cases devices are involved in patient safety events causing serious unintended patient harm. These so-called sentinel events are thoroughly investigated by hospitals, with detailed event descriptions filed in reports. Studying these reports may help fill the knowledge gap on the latent contributing factors of sentinel events involving medical devices. This study aims to identify the contributing factors of sentinel events involving medical devices and how these factors lead to unintended patient harm.

Design

A cross-sectional retrospective analysis of 20 sentinel event reports involving medical devices from Dutch general hospitals, using a human factors approach and specific classification system for medical device related events.

Results

A total of 105 contributing factors were identified. For most events, factors relating to the operator (e.g., flaws in setting up and checking devices before use), device (e.g., design issues), infrastructure (e.g., poor environmental ergonomics) and patient (e.g., complicating anatomy) mutually contributed and interacted. Jointly these factors triggered events causing unintended patient harm.

Conclusions

In-depth analysis of reports of sentinel events using a human factors approach, showed the underlying patterns of interacting contributing factors leading to unintended patient harm. Sentinel events involving medical devices are triggered by an interplay of factors related to the operator, device, infrastructure, and patient. To prevent future patient harm, an integral approach addressing all these elements is needed.

Public Interest Summary

Medical devices can be involved in events leading to unintended patient harm in hospitals. We know little about the underlying factors contributing to such events. Therefore, 20 reports of events involving a medical device that led to serious patient harm were analysed in depth. In most events, the patient harm was triggered by factors relating to the operator of the device, the device itself, the organisation and environment in which the device was applied, and the patient to whom the device was applied. Jointly, these factors prompted the events and led to patient harm. The insights from this study can be used to further improve the safe application of medical devices in hospitals.
背景和目的虽然大多数医疗器械在医院的应用是安全有效的,但在少数情况下,设备涉及患者安全事件,造成严重的意外患者伤害。医院对这些所谓的哨点事件进行了彻底调查,并在报告中详细描述了这些事件。研究这些报告可能有助于填补关于涉及医疗器械的前哨事件的潜在影响因素的知识空白。本研究旨在确定涉及医疗器械的哨点事件的影响因素,以及这些因素如何导致意外的患者伤害。采用人为因素方法和医疗器械相关事件的特定分类系统,对荷兰综合医院涉及医疗器械的20例哨点事件报告进行横断面回顾性分析。结果共鉴定出105个影响因素。对于大多数事件,与操作人员(例如,在使用前设置和检查设备的缺陷),设备(例如,设计问题),基础设施(例如,恶劣的环境人体工程学)和患者(例如,复杂的解剖结构)相关的因素相互影响和相互作用。这些因素共同引发了对患者造成意外伤害的事件。结论使用人为因素方法对哨点事件报告进行深入分析,显示了导致患者意外伤害的因素相互作用的潜在模式。涉及医疗设备的前哨事件是由操作员、设备、基础设施和患者相关因素的相互作用触发的。为了防止未来对患者造成伤害,需要采取一种解决所有这些因素的综合方法。医疗器械可能涉及导致医院患者意外伤害的事件。我们对导致这些事件的潜在因素知之甚少。因此,深入分析了20份涉及医疗装置导致患者严重伤害的事件报告。在大多数情况下,患者伤害是由与设备操作人员、设备本身、设备应用的组织和环境以及设备应用的患者相关的因素引发的。这些因素共同促成了这些事件,并导致了患者的伤害。本研究的见解可用于进一步改善医院医疗器械的安全应用。
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引用次数: 0
A scoping review of modelling in target product profile development for medical innovation 医学创新中目标产品概要开发建模的范围综述
IF 3.7 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.hlpt.2025.101070
Ying Jie Chong , Nitirot Phasitthanaphak , Teerawat Wiwatpanit , Yot Teerawattananon , Yi Wang
<div><h3>Background</h3><div>Target Product Profiles (TPPs) serve as strategic tools for planning medical innovation development, facilitating communication with regulators, and developing market access strategies. Modelling can assist TPPs development and provide guidance on defining attributes. This scoping review aims to outline the general steps in employing models in developing or refining TPPs and to identify the common themes of the attributes informed by modelling.</div></div><div><h3>Methods</h3><div>PRISMA-ScR checklist was used to guide this review. Literature search in PubMed, Scopus, Web of Science, Embase, and the World Health Organization Institutional Repository for Information Sharing (WHO IRIS) was conducted between August and September 2023. Subsequently, two researchers reviewed abstracts independently. Only full text articles used modelling to inform TPPs of health technologies with detailed modelling and methodology reported were included in this review. General information, technology-related information, TPP-related information, and model-related information were extracted from the articles and analysed thematically. EPIFORGE 2020 checklist was used to assess the reporting quality of modelling approach of the included articles.</div></div><div><h3>Results</h3><div>This review included 23 articles published from 2010 onward, reflecting a growing interest in using modelling to inform TPPs development. The studies covered diverse medical innovations, including drugs, vaccines, devices, procedures, and vector control tools. Commonly modelled attributes for devices included health impact, economic value, and efficacy. For non-device innovations, clinical efficacy, economic value, and dosage were the most frequently modelled attributes. The modelling process typically involved three steps: scoping, model development and validation, and analysis with recommendations. Limitations from the modelling process discussed across studies fell into three categories: evidence quality, modelling assumptions and structure, and the generalisability of findings. While some attributes, like clinical efficacy, are straightforward to model, certain attributes such as human factors require considering proxies such as compliance rates or capacity constraints.</div></div><div><h3>Conclusions</h3><div>This review identified common product attributes in TPPs that were informed by modelling, outlined the modelling process, and highlighted key limitations. It provided recommendations to improve the modelling approach in TPPs development and highlighted the need for further research to standardise the modelling process.</div></div><div><h3>Public Interest Summary</h3><div>Target Product Profiles (TPPs) are documents that outline targets for new medical innovations to effectively address specific public health needs. These documents are developed through multiple rounds of consultations with domain experts and stakeholders. We aimed to study how mathemati
目标产品简介(TPPs)是规划医疗创新发展、促进与监管机构沟通和制定市场准入战略的战略工具。建模可以帮助ppp开发,并为定义属性提供指导。这一范围审查的目的是概述在开发或改进TPPs中使用模型的一般步骤,并确定建模所告知的属性的共同主题。方法采用sprima - scr检查表进行评价。2023年8月至9月在PubMed、Scopus、Web of Science、Embase和世界卫生组织信息共享机构知识库(WHO IRIS)中进行文献检索。随后,两位研究人员独立审查了摘要。只有全文文章使用模型向TPPs介绍卫生技术,并报告了详细的模型和方法,才被纳入本综述。从文章中提取一般信息、技术相关信息、tpp相关信息和模型相关信息,并进行主题分析。使用EPIFORGE 2020检查表评估纳入文章的建模方法的报告质量。本综述纳入了2010年以来发表的23篇文章,反映了人们对使用模型为TPPs开发提供信息的兴趣日益浓厚。这些研究涵盖了各种医疗创新,包括药物、疫苗、设备、程序和病媒控制工具。设备的常用建模属性包括健康影响、经济价值和功效。对于非器械创新,临床疗效、经济价值和剂量是最常见的建模属性。建模过程通常包括三个步骤:确定范围、模型开发和验证,以及带建议的分析。研究中讨论的建模过程的局限性分为三类:证据质量、建模假设和结构以及研究结果的普遍性。虽然有些属性(如临床疗效)可以直接建模,但某些属性(如人为因素)需要考虑诸如依从率或容量限制等代理。本综述通过建模确定了tpp中常见的产品属性,概述了建模过程,并强调了关键的局限性。它提出了建议,以改进发展合作伙伴计划的建模方法,并强调需要进一步研究以使建模过程标准化。公共利益摘要目标产品概况(TPPs)是概述新的医疗创新目标的文件,以有效地满足特定的公共卫生需求。这些文件是通过与领域专家和利益相关者的多轮磋商制定的。我们的目标是研究如何使用数学建模来支持ppp的发展。通过系统搜索,我们确定并研究了23篇使用建模的论文。我们观察到一个结构化的三步过程:确定合适的模型,测试和调整模型,并使用模型输出来设置目标。建模主要用于建立与医疗创新的功效和经济价值有关的目标。我们的研究结果为建模在TPPs发展中的作用提供了见解,并为潜在的未来方法指导提供了信息。
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引用次数: 0
Exploring policy and regulations of clinical AI systems: Views from patients with chronic diseases 探讨临床人工智能系统的政策法规:来自慢性病患者的观点
IF 3.4 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-09-01 Epub Date: 2025-05-29 DOI: 10.1016/j.hlpt.2025.101035
Bijun Wang , Onur Asan , Turki Alelyani
<div><h3>Background</h3><div>Artificial Intelligence (AI) has become a transformative force in healthcare, offering opportunities to enhance patient care, improve efficiency, and reduce costs. However, patients' perspectives, which greatly influence the acceptance and implementation of AI technologies, remain under-researched.</div></div><div><h3>Objective</h3><div>This study explores patients with chronic conditions’ perspectives on clinical AI systems, focusing on their concerns, government involvement, accountability for potential AI error, and preferences between AI and doctor recommendations. These insights are crucial for tailoring AI technologies to meet patients' needs and expectations and better engage patients in adopting new technologies.</div></div><div><h3>Method</h3><div>This study conducted an online open-ended survey with valid responses from 140 patients with chronic conditions, exploring four aspects of clinical AI perspectives. The data was systematically coded and analyzed using an inductive thematic analysis approach to identify emergent themes.</div></div><div><h3>Result</h3><div>The majority of participants expressed concerns about the implementation of AI in healthcare (92.86 %), with the top worries including lack of human touch (22.86 %), potential AI bias and fairness (16.43 %), and over-dependence on AI (16.43 %). Regarding responsibility for potential treatment damages, 37.14 % of participants believed that physicians should bear the responsibility, 16.43 % considered AI developers accountable, and 1.42 % viewed the government as the responsible party. Furthermore, 44.57 % suggested that responsibility should be shared among stakeholders. In terms of government role, 51.43 % saw regulation and monitoring as key responsibilities, while 8.57 % perceived no government role in AI healthcare. Finally, around 80 % of patients preferred treatment recommendations from care providers over AI.</div></div><div><h3>Conclusion</h3><div>The findings suggest patients are looking for a balanced approach between technology and human involvement, with clear accountability and proper regulation. Though most prefer human doctors, an openness to AI's potential indicates an evolving perception. This underscores the need for a governance-inclusive and patient-centric strategy that addresses these aspects to ensure successful AI integration in healthcare.</div></div><div><h3>Lay Summary</h3><div>This study explores the opinions of chronic patients on using AI in healthcare. It found that while patients appreciate the potential benefits of AI, they have concerns about losing the personal touch of human doctors, potential biases, and over-reliance on technology. They also believe that accountability for AI errors should be shared among doctors, developers, and the government. The findings highlight the need for careful integration of AI in healthcare, with clear regulations and a focus on patient safety to build trust and acceptance.</div></di
人工智能(AI)已成为医疗保健领域的变革力量,为加强患者护理、提高效率和降低成本提供了机会。然而,患者的观点对人工智能技术的接受和实施有很大影响,但仍未得到充分研究。本研究探讨慢性病患者对临床人工智能系统的看法,重点关注他们的担忧、政府参与、对潜在人工智能错误的问责,以及人工智能和医生建议之间的偏好。这些见解对于定制人工智能技术以满足患者的需求和期望以及更好地吸引患者采用新技术至关重要。方法对140例慢性疾病患者进行在线开放式问卷调查,从四个方面探讨临床人工智能的应用前景。使用归纳主题分析方法对数据进行系统编码和分析,以确定紧急主题。结果大多数受访者对人工智能在医疗领域的应用表示担忧(92.86%),其中最担心的是缺乏人情感(22.86%)、潜在的人工智能偏见和公平性(16.43%)和过度依赖人工智能(16.43%)。关于潜在治疗损害的责任,37.14%的参与者认为医生应该承担责任,16.43%的参与者认为人工智能开发者应该负责,1.42%的参与者认为政府应该负责。此外,44.57%的人认为利益相关者应该分担责任。在政府角色方面,51.43%的人认为监管和监督是主要职责,而8.57%的人认为政府在人工智能医疗中没有作用。最后,大约80%的患者更喜欢护理提供者的治疗建议,而不是人工智能。结论研究结果表明,患者正在寻找技术和人类参与之间的平衡方法,具有明确的责任和适当的监管。尽管大多数人更喜欢人类医生,但对人工智能潜力的开放态度表明了一种不断发展的看法。这突出表明,需要制定包容性治理和以患者为中心的战略,解决这些问题,以确保人工智能在医疗保健领域的成功整合。摘要本研究探讨慢性患者在医疗保健中使用人工智能的意见。研究发现,虽然患者欣赏人工智能的潜在好处,但他们担心失去人类医生的个人接触、潜在的偏见和对技术的过度依赖。他们还认为,人工智能错误的责任应该由医生、开发人员和政府共同承担。研究结果强调了将人工智能纳入医疗保健的必要性,需要制定明确的法规,并关注患者安全,以建立信任和接受度。
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引用次数: 0
Developing economic evaluation guidelines for the Kingdom of Saudi Arabia: Engagement of local experts 为沙特阿拉伯王国制定经济评价准则:当地专家的参与
IF 3.4 3区 医学 Q1 HEALTH POLICY & SERVICES Pub Date : 2025-09-01 Epub Date: 2025-06-06 DOI: 10.1016/j.hlpt.2025.101042
Fatma Maraiki , Tusneem Elhassan , Shouki Bazarbashi , Paul Scuffham , Haitham Tuffaha

Objectives

Economic evaluation has increased due to the emergence of national health technology assessment (HTA) agencies. This study aims to develop a country-specific guideline for conducting economic evaluation in the Kingdom of Saudi Arabia (KSA) as an HTA component to determine the value for money of new health interventions.

Methods

The study conducted a real-time Delphi survey using 17 items from the method component of the Consolidated Health Economic Evaluation Reporting Standards checklist as foundation for guidelines. Consensus was reached for the relevance of guideline recommendations for the KSA healthcare system. We set a threshold of 80 % for agreement and an interquartile range less than three on a nine-point Likert scale. Interim analysis provided feedback for recommendations of items if no consensus exists. A natural language processing (NLP) approach was employed to examine the relationship between experts’ comments and consensus decisions.

Results

The study recruited 78 % experts with an average response progress rate of 97.2 %. Interim analysis provided a 63 % adjustment rate for recommendations with the majority requiring further clarification (65 %). The guidelines concluded with a consensus on 76 % of recommendations, while four remained undetermined, namely, choice of discount rate, use of same rates for health benefits and costs, outcome selection, and gross costing. The NLP results supported the consensus decision.

Conclusions

Expert consensus contributed to the development of informative guidelines relevant to KSA. The guidelines serve as a reference case, thus providing a foundation for HTA practices, reimbursement decisions, and future research for the KSA and its neighboring countries.
目的随着国家卫生技术评价机构的出现,经济评价有所增加。本研究旨在制定一项针对具体国家的指导方针,以便在沙特阿拉伯王国(KSA)开展经济评估,作为卫生评估的一个组成部分,以确定新的卫生干预措施的物有所值。方法采用《综合卫生经济评价报告标准》方法部分的17个项目进行实时德尔菲调查,作为指导方针的基础。达成共识的相关性指南建议的KSA医疗保健系统。我们设定了80%的一致性阈值,在9分李克特量表上,四分位数范围小于3。如果没有协商一致意见,临时分析提供了对项目建议的反馈。采用自然语言处理(NLP)方法来检验专家意见与共识决策之间的关系。结果共招募专家78%,平均应答率97.2%。中期分析显示,建议的调整率为63%,大多数建议需要进一步澄清(65%)。最后,指南对76%的建议达成了共识,而四项建议仍未确定,即选择贴现率、使用相同的健康福利和成本率、结果选择和总成本计算。NLP结果支持共识决定。结论专家共识有助于制定与KSA相关的信息指南。该指南可作为参考案例,从而为卫生保健协会的实践、报销决策和沙特阿拉伯及其邻国的未来研究提供基础。
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