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A WHO remit to improve global standards for medical products of human origin. 世卫组织的一项任务是改进全球人源医疗产品标准。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-10-01 Epub Date: 2024-09-02 DOI: 10.2471/BLT.24.291569
Eoin McGrath, Marisa R Herson, Matthew J Kuehnert, Karen Moniz, Zbigniew M Szczepiorkowski, Timothy L Pruett

In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure. Moreover, the demand for medical products of human origin often exceeds supply, leading to dependence on international supply chains, and emerging technologies like cell and gene therapy present further challenges because of their unproven efficacy and long-term risks. Current regulatory mechanisms, especially in low- and middle-income countries, are insufficient. The World Health Organization (WHO) has both the mandate and experience to lead the development of international quality and safety standards, consistent product nomenclature, and robust traceability and biovigilance systems. An international, multistakeholder approach is critical for addressing the complexities of how medical products of human origin are used globally and for ensuring their safety. This approach will require promoting uniform product descriptions, enhancing digital communication systems and leveraging existing resources to support countries in establishing regulations for these products. As illustrated by World Health Assembly resolution WHA77.4 on transplantation in 2024, WHO's ongoing efforts to ensure the safe, efficient and ethical use of medical products of human origin worldwide provide the opportunity to galvanize international cooperation on establishing norms.

近几十年来,在确保输血和器官移植安全方面取得了长足的进步。然而,随着源于人类的医疗产品越来越多地跨国流动,有必要加强全球规范和管理。这些产品包括血液、器官、组织、细胞、人乳和粪便微生物群,是当今医疗保健的关键,但也因其来源于人类而带来独特的风险,如疾病传播和移植失败。此外,人类来源的医疗产品往往供不应求,导致对国际供应链的依赖,而细胞和基因治疗等新兴技术因其未经证实的疗效和长期风险而带来更多挑战。目前的监管机制,尤其是中低收入国家的监管机制还不够完善。世界卫生组织(WHO)拥有领导制定国际质量和安全标准、统一产品命名以及健全的可追溯性和生物警戒系统的授权和经验。一个国际性的、多方利益相关者参与的方法对于解决全球范围内如何使用源自人类的医疗产品的复杂性以及确保其安全性至关重要。这种方法需要推广统一的产品说明,加强数字通信系统,并利用现有资源支持各国制定这些产品的法规。正如世界卫生大会关于 2024 年移植问题的第 WHA77.4 号决议所示,世卫组织正在努力确保在全球范围内安全、高效和合乎道德地使用源自人类的医疗产品,这为激发国际合作制定规范提供了机会。
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引用次数: 0
Community engagement in WHO guideline development. 社区参与世卫组织指南的制定。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-10-01 Epub Date: 2024-09-10 DOI: 10.2471/BLT.24.291579
Manjulaa Narasimhan, Patricia Mahecha Gutiérrez, Zoë Osborne, Muluba Habanyama, Karrie Worster, Carrie Martin, Angela Kaida
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引用次数: 0
Policy dimensions of global wastewater surveillance. 全球废水监控的政策层面。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 DOI: 10.2471/BLT.24.292245
Megan B Diamond, Toni Whistler, Karina Rando, Chioma Nwachukwu, Mukhlid Yousif
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引用次数: 0
Public health round-up. 公共卫生综述。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 DOI: 10.2471/BLT.24.010924
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引用次数: 0
District-level monitoring of universal health coverage, India. 印度县级全民医保监测。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 Epub Date: 2024-06-25 DOI: 10.2471/BLT.23.290854
Arnab Mukherji, Megha Rao, Sapna Desai, S V Subramanian, Gagandeep Kang, Vikram Patel

Objective: To develop a framework and index for measuring universal health coverage (UHC) at the district level in India and to assess progress towards UHC in the districts.

Methods: We adapted the framework of the World Health Organization and World Bank to develop a district-level UHC index (UHC d ). We used routinely collected health survey and programme data in India to calculate UHC d for 687 districts from geometric means of 24 tracer indicators in five tracer domains: reproductive, maternal, newborn and child health; infectious diseases; noncommunicable diseases; service capacity and access; and financial risk protection. UHC d is on a scale of 0% to 100%, with higher scores indicating better performance. We also assessed the degree of inequality within districts using a subset of 14 tracer indicators. The disadvantaged subgroups were based on four inequality dimensions: wealth quintile, urban-rural location, religion and social group.

Findings: The median UHC d was 43.9% (range: 26.4 to 69.4). Substantial geographical differences existed, with districts in southern states having higher UHC d than elsewhere in India. Service coverage indicator levels were greater than 60%, except for noncommunicable diseases and for service capacity and access. Health insurance coverage was limited, with about 10% of the population facing catastrophic and impoverishing health expenditure. Substantial wealth-based disparities in UHC were seen within districts.

Conclusion: Our study shows that UHC can be measured at the local level and can help national and subnational government develop prioritization frameworks by identifying health-care delivery and geographic hotspots where limited progress towards UHC is being made.

目标:制定衡量印度县级全民健康保险(UHC)的框架和指数,并评估各县在实现全民健康保险方面取得的进展:制定衡量印度县级全民健康覆盖率(UHC)的框架和指数,并评估各县在实现全民健康覆盖率方面取得的进展:我们对世界卫生组织和世界银行的框架进行了调整,以制定地区级全民健康覆盖指数(UHC d)。我们利用在印度例行收集的健康调查和计划数据,从生殖、孕产妇、新生儿和儿童健康、传染病、非传染性疾病、服务能力和获取途径以及金融风险保护这五个示踪领域的 24 个示踪指标的几何平均数中,计算出 687 个县的全民健康覆盖指数 d。全民健康覆盖率 d 采用 0% 到 100% 的评分标准,分数越高,表示表现越好。我们还使用 14 个跟踪指标子集评估了地区内的不平等程度。弱势分组基于四个不平等维度:财富五分位数、城乡位置、宗教和社会群体:全民保健覆盖率的中位数为 43.9%(范围:26.4 至 69.4)。存在很大的地域差异,南部各邦地区的全民健康覆盖率 d 值高于印度其他地区。除非传染性疾病以及服务能力和获取途径外,服务覆盖率指标水平均超过 60%。医疗保险覆盖面有限,约 10%的人口面临灾难性和贫困化的医疗支出。各地区在全民健康保险方面存在巨大的贫富差距:我们的研究表明,全民健康计划可以在地方层面进行衡量,并通过确定医疗服务提供情况以及全民健康计划进展有限的地理热点地区,帮助国家和国家以下各级政府制定优先事项框架。
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引用次数: 0
Health worker protests and the COVID-19 pandemic: an interrupted time-series analysis. 卫生工作者抗议与 COVID-19 大流行:间断时间序列分析。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 Epub Date: 2024-07-04 DOI: 10.2471/BLT.23.290330
Kartik Sharma, Sorcha Brophy, Michael Law, Veena Sriram

Objective: To assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on protests by health workers.

Methods: We conducted an interrupted time series analysis of data from 159 countries for 2 years before and after the World Health Organization classified COVID-19 as a pandemic in March 2020, thus between 2018 and 2022. We produced models examining two main outcomes: (i) the total weekly number of health worker protests globally; and (ii) the number of countries with one or more health worker protests in a given week.

Findings: In total, there were 18 322 health worker protests in 133 countries between 2018 and 2022. The number of weekly health worker protests globally increased by 47% (30.1/63.5), an increase of 30.1 protests per week (95% confidence interval, CI: 11.7-48.6) at the onset of the COVID-19 pandemic. Furthermore, the number of countries experiencing such protests in a given week increased by 24% (5.7/24.1) following the declaration of the pandemic (an increase of 5.7 countries; 95% CI: 3.5-7.8).

Conclusion: The pandemic increased the overall level of health worker protests globally as well as the number of countries experiencing such protests. These protests highlight discontent in the health workforce. Given the ongoing global health workforce crisis, understanding and addressing the drivers of health worker discontent is important for global health policy and security.

目的:评估 2019 年冠状病毒病(COVID-19)大流行对卫生工作者抗议活动的影响:评估 2019 年冠状病毒病(COVID-19)大流行对卫生工作者抗议活动的影响:我们对世界卫生组织于 2020 年 3 月将 COVID-19 列为大流行病前后两年(即 2018 年至 2022 年)159 个国家的数据进行了间断时间序列分析。我们建立了两个主要结果模型:(i) 全球每周卫生工作者抗议活动的总数;(ii) 在某一周内发生一次或多次卫生工作者抗议活动的国家数量:2018 年至 2022 年期间,133 个国家共发生了 18 322 次卫生工作者抗议活动。在 COVID-19 大流行开始时,全球每周卫生工作者抗议活动的数量增加了 47%(30.1/63.5),每周抗议活动增加了 30.1 次(95% 置信区间,CI:11.7-48.6)。此外,疫情宣布后,一周内发生此类抗议活动的国家数量增加了 24%(5.7/24.1)(增加了 5.7 个国家;95% 置信区间:3.5-7.8):结论:大流行病增加了全球医务工作者抗议的总体水平,也增加了发生此类抗议的国家数量。这些抗议凸显了医务工作者的不满情绪。鉴于全球卫生工作者队伍的危机仍在持续,了解和解决卫生工作者不满情绪的驱动因素对全球卫生政策和安全非常重要。
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引用次数: 0
Medical device management reform, United Republic of Tanzania. 医疗器械管理改革,坦桑尼亚联合共和国。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 Epub Date: 2024-07-04 DOI: 10.2471/BLT.23.290636
Ally Kebby Abdallah, Suniva Haule, Reinhold Werlein, Valentino Mvanga, Patrick Delcroix, Jasmina Saric, Manfred Stoermer

Health-care technology is central to boosting the productivity and quality of health-care systems. In many sub-Saharan African countries, however, medical device management systems are weak or absent. The aim of this article is to illustrate, using a case study, how policy reforms can help ensure policy on health-care technology is translated into everyday practice and how an integrated systems approach can enhance the operation of medical device management. Between 2011 and 2023, a plan to improve medical device management systems in the United Republic of Tanzania was developed and implemented through Swiss-Tanzanian cooperation within the Health Promotion and System Strengthening Project. The availability of biomedical engineers was increased through new training courses and the creation of permanent positions in government. Moreover, additional district and regional maintenance and repair workshops were built, and a National Centre for Calibration and Training was established to ensure the correct functioning of medical devices. The introduction of an electronic medical device management system provided health facilities and the health ministry with data on the operational status of medical devices and the need for repairs and spare parts. Every level of government was encouraged to allocate more human and financial resources to medical device management. Following this decade-long effort, the percentage of functioning equipment increased substantially, and costs were reduced by repairing rather than replacing equipment. The project also demonstrated the value of an integrated, system-strengthening approach that considered personnel, maintenance and repair facilities, documentation and management, and government policy and budgeting.

医疗保健技术对于提高医疗保健系统的生产力和质量至关重要。然而,在许多撒哈拉以南非洲国家,医疗设备管理系统薄弱或不存在。本文旨在通过一个案例研究,说明政策改革如何有助于确保医疗保健技术政策转化为日常实践,以及综合系统方法如何能够加强医疗设备管理的运作。2011 年至 2023 年期间,通过瑞士与坦桑尼亚在 "健康促进和系统强化项目 "中的合作,制定并实施了一项旨在改善坦桑尼亚联合共和国医疗设备管理系统的计划。通过新的培训课程和在政府中设立长期职位,增加了生物医学工程师的数量。此外,还建立了更多的地区和区域维护和维修车间,并成立了国家校准和培训中心,以确保医疗设备的正常运行。电子医疗设备管理系统的引入为医疗机构和卫生部提供了有关医疗设备运行状况以及维修和备件需求的数据。鼓励各级政府为医疗设备管理分配更多的人力和财力资源。经过长达十年的努力,正常运行设备的比例大幅提高,通过维修而不是更换设备降低了成本。该项目还证明了综合的系统强化方法的价值,这种方法考虑到了人员、维护和维修设施、文件和管理以及政府政策和预算编制。
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引用次数: 0
Wastewater surveillance to track influenza viruses. 跟踪流感病毒的废水监测。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 DOI: 10.2471/BLT.24.292285
Leshan Xiu, Kun Yin
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引用次数: 0
Helping people to die. 帮助人们死亡。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 DOI: 10.2471/BLT.24.020924

As an increasing number of jurisdictions legalize assisted dying, attention is focusing on palliative care clinicians' role in service delivery. Gary Humphreys reports.

随着越来越多的司法管辖区将协助死亡合法化,人们开始关注姑息关怀临床医生在提供服务中的作用。加里-汉弗莱斯(Gary Humphreys)报道。
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引用次数: 0
Drug-resistant tuberculosis treatments, the case for a phase III platform trial. 耐药性结核病治疗,III 期平台试验的案例。
IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-09-01 DOI: 10.2471/BLT.23.290948
Tom A Yates, Samara Barnes, Martin Dedicoat, Onn Min Kon, Heinke Kunst, Marc Lipman, Kerry A Millington, Andrew J Nunn, Patrick Pj Phillips, Jessica L Potter, S Bertel Squire

Most phase III trials in drug-resistant tuberculosis have either been underpowered to quantify differences in microbiological endpoints or have taken up to a decade to complete. Composite primary endpoints, dominated by differences in treatment discontinuation and regimen changes, may mask important differences in treatment failure and relapse. Although new regimens for drug-resistant tuberculosis appear very effective, resistance to new drugs is emerging rapidly. There is a need for shorter, safer and more tolerable regimens, including those active against bedaquiline-resistant tuberculosis. Transitioning from multiple regimen A versus regimen B trials to a single large phase III platform trial would accelerate the acquisition of robust estimates of relative efficacy and safety. Further efficiencies could be achieved by adopting modern adaptive platform designs. Collaboration among trialists, affected community representatives, funders and regulators is essential for developing such a phase III platform trial for drug-resistant tuberculosis treatment regimens.

大多数耐药性结核病的 III 期试验要么没有足够的能力量化微生物终点的差异,要么需要长达十年的时间才能完成。以治疗中断和治疗方案改变差异为主的综合主要终点可能会掩盖治疗失败和复发方面的重要差异。尽管治疗耐药性结核病的新方案似乎非常有效,但对新药的耐药性正在迅速出现。我们需要更短、更安全、更耐受的治疗方案,包括那些对贝达喹啉耐药结核病有效的治疗方案。从多个治疗方案 A 与治疗方案 B 的对比试验过渡到单一的大型 III 期平台试验,将加快获得对相对疗效和安全性的可靠估计。采用现代适应性平台设计可进一步提高效率。试验人员、受影响社区代表、资助者和监管者之间的合作对于开发这种针对耐药结核病治疗方案的 III 期平台试验至关重要。
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引用次数: 0
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