accessibility

可访问性
  • 文章类型: Journal Article
    行动障碍的日益普遍突出表明,迫切需要获得和负担得起的行动辅助工具。为了克服残疾人的行动限制,背景技术对于可以容易地装载的轻质和便携式电动轮椅的开发的需求日益增加。这项研究旨在对模块化(可拆卸)电动轮椅进行早期健康技术评估和形成性可用性评估。它旨在衡量用户对设备的满意度,指出需要改进的地方,并检测任何不可预见的错误,以告知未来的发展。吸引16名参与者,包括电动轮椅使用者,医疗保健专业人员,和照顾者,这项研究评估了轮椅在各种情况下的功能,强调安全,有效性,和方便。对任务绩效和满意度调查的统计分析强调,当电动轮椅使用者成功完成专注于驾驶和动力控制的任务时,医疗保健专业人员和护理人员在组装和拆卸轮椅时遇到了困难。尽管普遍积极,调查表明,对安全的满意度参差不齐,有效性,和便利,与框架耐久性相关的具体问题,座椅舒适度,和控制机制。这些发现表明,完善轮椅的设计和解决用户的担忧可以显着提高满意度和移动服务。未来的工作将包括对先进原型的彻底审查和进一步的满意度评估。
    我们认为,我们的研究通过解决在理解以用户为中心的设计和动力轮椅可用性测试方面的关键差距,为文献做出了重大贡献。通过强调早期评估的重要性,并将用户反馈纳入开发过程,我们的研究为创建更易于访问和用户友好的移动解决方案提供了实用的见解。这一贡献在推进辅助技术和提高残疾人生活质量方面尤其重要。
    The increasing prevalence of mobility impairments underscores the urgent need for accessible and affordable mobility aids. To overcome the mobility limitations of people with disabilities, there is an increasing need for the development of lightweight and portable powered wheelchairs that can be easily loaded. This study aimed to perform an early health technology assessment and a formative usability evaluation on a modular (detachable) powered wheelchair. It aimed to gauge device satisfaction among users, pinpoint areas for improvement, and detect any unforeseen errors to inform future development. Engaging 16 participants, including powered wheelchair users, healthcare professionals, and caregivers, the research evaluated the wheelchair\'s functionality in various scenarios, emphasizing safety, effectiveness, and convenience. Statistical analyses of task performance and satisfaction surveys highlighted that, while powered wheelchair users successfully completed tasks focusing on driving and power control, healthcare professionals and caregivers encountered difficulties with the wheelchair\'s assembly and disassembly. Despite general positivity, the surveys indicated mixed satisfaction levels regarding safety, validity, and convenience, with specific issues related to frame durability, seat comfort, and control mechanisms. These findings suggest that refining the wheelchair\'s design and addressing user concerns could significantly enhance satisfaction and mobility services. Future efforts will include a thorough review of an advanced prototype and further satisfaction assessments.
    We believe that our study makes a significant contribution to the literature by addressing a critical gap in the understanding of user-centric design and usability testing for powered wheelchairs.By emphasizing the importance of early assessments and incorporating user feedback into the development process, our research offers practical insights for creating more accessible and user-friendly mobility solutions.This contribution is particularly relevant in the context of advancing assistive technology and improving the quality of life for individuals with disabilities.
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  • 文章类型: Journal Article
    社会参与与更好的健康有关,生活质量,身体活动,和参与社区生活,因此是一个新兴的健康优先事项。交通运输在促进社会参与方面发挥着重要作用。我们的团队最近在《残疾与健康杂志》上报道说,与那些不使用辅助医疗服务的人相比,使用辅助医疗服务作为主要交通方式的长期身体残疾的密苏里州居住成年人更有可能参与家庭以外的社会角色和活动。2023年3月,为圣路易斯服务的协办公司MetroCall-A-Ride宣布大幅缩减其覆盖范围,部分原因是人员短缺。这项决定已经得到了向美国司法部提出的正式投诉,以及圣路易斯残疾人社区和倡导者的抗议。成千上万的人依靠Call-A-Ride进行日常的社区郊游工作,杂货店,或者医疗预约,例如,受到削减的影响。在这篇评论中,我们将总结这一决定收到的媒体报道,包括残疾人权利倡导者和直接受到影响的个人的观点。然后,我们将在这些最近事件的背景下概述我们的原始研究结果,并简要综述美国辅助运输服务的现有文献。研究,和编程解决方案为圣路易斯的地铁呼叫A乘坐和公共交通。
    Social participation is associated with better health, quality of life, physical activity, and engagement in community living and is thus an emerging health priority. Transportation plays an important role in facilitating social participation. Our team recently reported in the Journal of Disability and Health that Missouri-dwelling adults aging with long-term physical disabilities who use paratransit services as their primary transportation mode are more likely to participate in social roles and activities outside the home compared to those who do not use paratransit. In March of 2023, the paratransit company Metro Call-A-Ride that serves St. Louis announced major scale backs to their coverage zones due in part to staffing shortages. This decision has been met with a formal complaint filed to the U.S. Department of Justice as well as protest from the St. Louis disability community and advocates. Thousands of individuals who relied on Call-A-Ride for their routine community outings-to work, grocery stores, or medical appointments, for example-have been affected by the cuts. In this commentary, we will summarize the media coverage this decision has received, including the perspectives of disability rights advocates and individuals who have been directly affected. We will then present an overview of our original research findings in the context of these recent events and a brief synthesis of existing literature on paratransit services in the U.S. The commentary will end with proposed policy, research, and programming solutions for St. Louis\'s Metro Call-A-Ride and public transportation at large.
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  • 文章类型: Journal Article
    背景:COVID-19大流行给个人和家庭带来了额外的心理健康负担,导致广泛的服务访问问题。数字心理健康干预措施有望改善可访问性。最近的评论显示了个人使用的新证据和多用户的早期证据。然而,数字心理健康干预措施的流失率仍然很高,和额外的复杂性存在时,多个家庭成员在一起。
    目标:因此,本范围审查旨在详细介绍为家庭使用设计的数字心理健康干预措施的报告证据,重点是促进可访问性和参与度并使家庭共同完成的构建和设计特征。
    方法:MEDLINE系统文献检索,Embase,PsycINFO,WebofScience,对2002年1月至2024年3月以英语发表的文章进行了和CINAHL数据库。合格的记录包括对数字平台的实证研究,其中包含一些旨在由相关人员共同完成的元素,以及一些旨在在没有治疗师参与的情况下完成的组件。已记录临床证据的病例包括平台。
    结果:在所审查的9527篇论文中,85(0.89%)符合资格标准。总共确定了24个供相关方共同使用的独特平台。参与者之间的关系包括夫妻,父子二元组合,家庭照顾者护理接受者,和家庭。常见的平台功能包括通过结构化干预来交付内容,而无需提供最少的剪裁或个性化。一些干预措施提供了与治疗师的现场接触。用户参与度指标和调查结果各不相同,包括用户体验,满意,完成率,和可行性。我们的发现对于文献中没有的比现在的更显著。与预期相反,很少有研究报告任何设计和建造特征,使联排。没有研究报告关于实现共同完成的平台功能或确保个人隐私和安全的考虑因素。没有人检查平台构建或设计特征作为干预效果的调节者,没有人对平台本身进行形成性评估。
    结论:在数字心理健康平台设计的早期时代,这项新颖的评论表明,与多个相关用户在治疗过程的任何方面的成功参与相关的设计元素的信息明显缺失。在详细介绍和评估平台设计的文献中仍然存在很大差距,突出未来跨学科研究的重要机会。这篇综述详细介绍了开展此类研究的动机;提出了构建供家庭使用的数字心理健康平台时的设计考虑因素;并为未来的发展提供了建议,包括平台协同设计和形成性评价。
    BACKGROUND: The COVID-19 pandemic placed an additional mental health burden on individuals and families, resulting in widespread service access problems. Digital mental health interventions suggest promise for improved accessibility. Recent reviews have shown emerging evidence for individual use and early evidence for multiusers. However, attrition rates remain high for digital mental health interventions, and additional complexities exist when engaging multiple family members together.
    OBJECTIVE: As such, this scoping review aims to detail the reported evidence for digital mental health interventions designed for family use with a focus on the build and design characteristics that promote accessibility and engagement and enable cocompletion by families.
    METHODS: A systematic literature search of MEDLINE, Embase, PsycINFO, Web of Science, and CINAHL databases was conducted for articles published in the English language from January 2002 to March 2024. Eligible records included empirical studies of digital platforms containing some elements designed for cocompletion by related people as well as some components intended to be completed without therapist engagement. Platforms were included in cases in which clinical evidence had been documented.
    RESULTS: Of the 9527 papers reviewed, 85 (0.89%) met the eligibility criteria. A total of 24 unique platforms designed for co-use by related parties were identified. Relationships between participants included couples, parent-child dyads, family caregiver-care recipient dyads, and families. Common platform features included the delivery of content via structured interventions with no to minimal tailoring or personalization offered. Some interventions provided live contact with therapists. User engagement indicators and findings varied and included user experience, satisfaction, completion rates, and feasibility. Our findings are more remarkable for what was absent in the literature than what was present. Contrary to expectations, few studies reported any design and build characteristics that enabled coparticipation. No studies reported on platform features for enabling cocompletion or considerations for ensuring individual privacy and safety. None examined platform build or design characteristics as moderators of intervention effect, and none offered a formative evaluation of the platform itself.
    CONCLUSIONS: In this early era of digital mental health platform design, this novel review demonstrates a striking absence of information about design elements associated with the successful engagement of multiple related users in any aspect of a therapeutic process. There remains a large gap in the literature detailing and evaluating platform design, highlighting a significant opportunity for future cross-disciplinary research. This review details the incentive for undertaking such research; suggests design considerations when building digital mental health platforms for use by families; and offers recommendations for future development, including platform co-design and formative evaluation.
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  • 文章类型: Journal Article
    在过去的十年中,虚拟病房的采用激增。虚拟病房旨在防止不必要的入院,加快家庭出院,提高患者满意度,这对面临住院相关风险的老年人口特别有利。因此,虚拟康复病房(VRW)正在进行大量投资,尽管有证据表明它们的实施取得了不同程度的成功。然而,虚拟病房工作人员为快速实施这些创新护理模式所经历的促进者和障碍仍然知之甚少。
    本文介绍了在澳大利亚VRW上工作的医院工作人员的见解,以应对对旨在防止住院的计划日益增长的需求。我们探讨了员工对VRW的促进者和障碍的看法,在服务设置和交付上发光。
    使用非收养对21名VRW员工进行了定性访谈,放弃,放大,传播,可持续发展(NASSS)框架。使用框架分析和NASSS框架的7个领域进行数据分析。
    结果被映射到NASSS框架的7个领域。(1)条件:管理一定的条件,特别是那些涉及合并症和社会文化因素的,可以是具有挑战性的。(2)技术:VRW证明适合无认知障碍的技术患者,通过远程监控和视频通话在临床决策中提供优势。然而,互操作性问题和设备故障导致员工沮丧,强调迅速应对技术挑战的重要性。(3)价值主张:VRW授权患者选择他们的护理地点,扩大农村社区获得护理的机会,并为老年人提供家庭治疗。(4)采用者和(5)组织:尽管有这些好处,从面对面治疗到远程治疗的文化转变引入了工作流程的不确定性,专业责任,资源分配,和摄入过程。(6)更广泛的系统和(7)嵌入:随着服务的不断发展,以解决医院能力的差距,必须优先考虑正在进行的适应。这包括完善患者顺利转移回医院的过程,解决技术方面的问题,确保护理的无缝连续性,并深思熟虑地考虑护理负担如何转移到患者及其家人身上。
    在这项定性研究中,探索医护人员对创新VRW的体验,我们确定了实施和可接受性的几个驱动因素和挑战。这些发现对考虑在服务设置和交付方面为老年人实施VRW的未来服务具有影响。未来的工作将集中在评估VRW的患者和护理人员体验。
    UNASSIGNED: Over the past decade, the adoption of virtual wards has surged. Virtual wards aim to prevent unnecessary hospital admissions, expedite home discharge, and enhance patient satisfaction, which are particularly beneficial for the older adult population who faces risks associated with hospitalization. Consequently, substantial investments are being made in virtual rehabilitation wards (VRWs), despite evidence of varying levels of success in their implementation. However, the facilitators and barriers experienced by virtual ward staff for the rapid implementation of these innovative care models remain poorly understood.
    UNASSIGNED: This paper presents insights from hospital staff working on an Australian VRW in response to the growing demand for programs aimed at preventing hospital admissions. We explore staff\'s perspectives on the facilitators and barriers of the VRW, shedding light on service setup and delivery.
    UNASSIGNED: Qualitative interviews were conducted with 21 VRW staff using the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. The analysis of data was performed using framework analysis and the 7 domains of the NASSS framework.
    UNASSIGNED: The results were mapped onto the 7 domains of the NASSS framework. (1) Condition: Managing certain conditions, especially those involving comorbidities and sociocultural factors, can be challenging. (2) Technology: The VRW demonstrated suitability for technologically engaged patients without cognitive impairment, offering advantages in clinical decision-making through remote monitoring and video calls. However, interoperability issues and equipment malfunctions caused staff frustration, highlighting the importance of promptly addressing technical challenges. (3) Value proposition: The VRW empowered patients to choose their care location, extending access to care for rural communities and enabling home-based treatment for older adults. (4) Adopters and (5) organizations: Despite these benefits, the cultural shift from in-person to remote treatment introduced uncertainties in workflows, professional responsibilities, resource allocation, and intake processes. (6) Wider system and (7) embedding: As the service continues to develop to address gaps in hospital capacity, it is imperative to prioritize ongoing adaptation. This includes refining the process of smoothly transferring patients back to the hospital, addressing technical aspects, ensuring seamless continuity of care, and thoughtfully considering how the burden of care may shift to patients and their families.
    UNASSIGNED: In this qualitative study exploring health care staff\'s experience of an innovative VRW, we identified several drivers and challenges to implementation and acceptability. The findings have implications for future services considering implementing VRWs for older adults in terms of service setup and delivery. Future work will focus on assessing patient and carer experiences of the VRW.
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  • 文章类型: Journal Article
    结核分枝杆菌是一种传染性病原体,需要生物安全3级实验室进行处理。对实验室工作人员来说传播的风险很高,为了安全地管理有机体,有必要以高昂的费用建造高安全系数的实验室设施。这限制了结核病诊断应用于没有足够资本投资于实验室基础设施的领域。在这种方法中,我们描述了通过加热或硫氰酸胍(GTC)灭活痰液样品的过程,使其安全,而不影响活细菌的定量。这种方法消除了对结核病分子细菌负荷测定(TB-MBLA)的3级防护实验室的需要,适用于低收入和中等收入国家。
    Mycobacterium tuberculosis is an infectious pathogen that requires biosafety level-3 laboratory for handling. The risk of transmission is high to laboratory staff, and to manage the organism safely, it is necessary to construct high containment laboratory facilities at great expense. This limits the application of tuberculosis diagnostics to areas where there is insufficient capital to invest in laboratory infrastructure. In this method, we describe a process of inactivating sputum samples by either heat or guanidine thiocyanate (GTC) that renders them safe without affecting the quantification of viable bacteria. This method eliminates the need for level 3 containment laboratory for the tuberculosis molecular bacterial load assay (TB-MBLA) and is applicable in low- and middle-income countries.
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  • 文章类型: Journal Article
    背景:在非洲,视力障碍和失明的患病率很高。难以获得眼保健服务,在其他障碍中,已发现对可避免的视力丧失和失明的负担有相当大的影响,特别是在低收入和中等收入国家。
    目的:确定加纳库马西大都市眼科健康服务的可及性和利用障碍。
    方法:在加纳阿散蒂地区的库马西大都会进行了描述性横断面调查,以确定影响眼保健服务利用的障碍。
    方法:首次采用便利抽样方法招募了在五个选定的地区市政医院眼科诊所就诊的参与者。通过问卷调查收集数据,并使用社会科学统计软件包(SPSS)进行分析。
    结果:参与者在获得眼保健服务时面临的障碍包括到诊所的距离,服务成本,远离工作和/或学校的时间,自我治疗和漫长的等待期。
    结论:研究发现,库马西大都会的眼部护理服务,加纳基本上是可以接近的,但未得到充分利用。通过与社区团体的接触来改善公共卫生教育举措也将提高卫生保健设施的使用率。贡献:研究中已确定大都市的卫生服务利用不足,必须由各个部门的卫生管理人员解决。可达性相对较好,但可以进一步提高,特别是对于老年人,以便能够轻松利用医疗保健服务。
    BACKGROUND:  There is a high prevalence of vision impairment and blindness in Africa. The poor access to eye health services, among other barriers, has been found to have a considerable effect on the burden of avoidable vision loss and blindness, particularly in low- and middle-income countries.
    OBJECTIVE:  To determine the accessibility of and barriers to the utilisation of eye health services in the Kumasi Metropolis of Ghana.
    METHODS:  A descriptive cross-sectional survey was conducted in the Kumasi Metropolis of the Ashanti Region in Ghana to identify barriers affecting the utilisation of eye health services.
    METHODS:  Convenience sampling was used to recruit participants visiting the eye clinics at five selected District Municipal Hospitals for the first time. Data were collected by means of questionnaires and analysed using Statistical Package for Social Sciences (SPSS).
    RESULTS:  Barriers faced by participants when accessing eye health services included distance to the clinic, cost of services, time spent away from work and/or school, self-medication and long waiting periods.
    CONCLUSIONS:  The study found that eye care services in the Kumasi Metropolis, Ghana are largely accessible, but underutilised. Improvement of public health education initiatives through engagement with community groups will also enhance uptake at health care facilities.Contribution: Underutilisation of health services in the Metropolis has been identified in the study and must be addressed by health managers in various sectors. Accessibility is relatively good but can further be improved especially for the elderly to be able to utilise health care services with ease.
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  • 文章类型: Journal Article
    该综合探讨了同位素分析中常见的特定伦理问题。四十多年来,同位素分析已用于考古研究,以探索过去的人类和动物的饮食习惯,流动模式,以及人类或动物一生中居住的环境。这些分析需要考虑道德问题。虽然讨论了理论概念,我们专注于实践方面:与后代社区和其他权利持有人合作,选择方法,创建和共享数据,并在学术界认真工作。这些层次的尊重和关怀应该围绕着我们的科学。本文与同位素分析专家以及将这些方法纳入大型项目的专家有关。通过涵盖整个研究过程,从设计到输出管理,我们广泛呼吁考古学,并提供可操作的解决方案,建立在一般领域的讨论。
    This synthesis explores specific ethical questions that commonly arise in isotopic analysis. For more than four decades, isotope analysis has been employed in archeological studies to explore past human and animal dietary habits, mobility patterns, and the environment in which a human or animal inhabited during life. These analyses require consideration of ethical issues. While theoretical concepts are discussed, we focus on practical aspects: working with descendant communities and other rights holders, choosing methods, creating and sharing data, and working mindfully within academia. These layers of respect and care should surround our science. This paper is relevant for specialists in isotope analysis as well as those incorporating these methods into larger projects. By covering the whole of the research process, from design to output management, we appeal broadly to archaeology and provide actionable solutions that build on the discussions in the general field.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    由于使用卫生厕所的机会有限,土著人民(IP)仍然容易受到土壤传播的蠕虫病(STH)的侵害。干净的水,优质健康教育,和服务。世界卫生组织建议定期对驱虫药进行大规模药物管理(MDA),健康教育,和水的改善,卫生,和卫生(WASH)作为控制策略,以减少学龄儿童(SAC)等目标人群中由STH引起的发病率。本文补充了在选定的Aeta和Ata-Manobo社区中进行的寄生虫学调查(STH的患病率和强度)的已发表结果。
    本研究旨在描述STH控制策略的可访问性,以响应Pampanga和DavaodelNorte的IP社区中SAC的需求,菲律宾。它同样旨在描述这些IP社区对STH控制策略的访问。
    使用关键线人访谈(KII)和焦点小组讨论(FGD)收集了有关STH控制策略的可访问性和访问性的数据。卫生和教育部门的11名官员和工作人员,地方政府单位,两名知识产权领导人就SAC现有的STH负担接受了采访,实施STH控制策略,特别是MDA,健康教育运动,以及WASH的改进,包括计划实施中的良好做法和挑战。三个FGD和父母,知识产权学校的小学教师,和农村卫生助产士分开进行。指南问题侧重于知识产权社区SAC的可访问性和可访问性传播和控制策略。参与者在参与前获得了进行和记录KII和FGD的知情同意书。多学科小组的分析是基于Davy等人获得土著初级卫生保健服务的IP的可及性框架。(2016)。
    STH控制策略和目标人群的特征是影响可及性的相互关联的因素。MDA计划可用性方面的挑战,特别是,人员配备不足,药物短缺,交付延迟会影响免费STH控制策略的可访问性和访问性。感知到的伤害,不良事件,污名,信仰,和实践同样影响访问。缺乏有关通过社区和基于学校的MDA计划进行治疗的相似性的信息也影响了SAC的参与。IP社区是地理隔离的特殊环境,需要考虑和平与秩序状况以及供水,以帮助确保获得某种控制战略,高MDA覆盖率,和改进WASH导致预期的结果。
    考虑到知识产权社区的背景,解决可访问性和获取性STH控制策略方面的挑战,对于确保在STH预防和控制策略中成功实施综合方法是必要的。可获得性控制战略的挑战是人员配备不足,库存差,以及药物交付的延误,以及恶劣的环境卫生和个人卫生。SAC的访问同样受到对驱虫药的安全性和有效性的误解的影响,包括污名和文化习俗。需要传播基于学校或社区的MDA程序的相似性。
    UNASSIGNED: Indigenous peoples (IPs) remain vulnerable to soil-transmitted helminthiasis (STH) due to limited access to sanitary toilets, clean water, quality health education, and services. The World Health Organization recommends periodic mass drug administration (MDA) of anthelminthics, health education, and improvements in water, sanitation, and hygiene (WASH) as control strategies to reduce morbidities caused by STH in target populations such as school-age children (SAC).This paper complements the published results of the parasitological survey (prevalence and intensity of STH) conducted in selected Aeta and Ata-Manobo communities.
    UNASSIGNED: This study aimed to describe the accessibility of STH control strategies to respond to the needs of SAC in IP communities in Pampanga and Davao del Norte, the Philippines. It likewise intended to describe access of these IP communities to STH control strategies.
    UNASSIGNED: Data on accessibility of and access to STH control strategies were collected using key informant interviews (KIIs) and focus group discussions (FGDs). Eleven officials and workers from the departments of health and education, local government units, and two IP leaders were interviewed on the existing STH burden in SAC, implementation of STH control strategies, particularly of MDA, health education campaigns, and improvements in WASH including good practices and challenges in program implementation.Three FGDs with parents, elementary school teachers of IP schools, and rural health midwives were conducted separately. Guide questions focused on accessibility of and access to STH prevention and control strategies for SAC in IP communities. Informed consent to conduct and record KIIs and FGDs were obtained from participants prior to participation.Analysis of a multi-disciplinary team was based on the accessibility framework for IPs accessing indigenous primary health care services by Davy et al. (2016).
    UNASSIGNED: The characteristics of the STH control strategies and the target populations are interrelated factors that influence accessibility. Challenges in the availability of the MDA program, particularly, inadequate staffing, drug shortages, and delays in delivery affect accessibility of and access to the free STH control strategies. Perceived harm, adverse events, stigma, beliefs, and practices likewise affect access. Lack of information on the similarity of treatment through community- and school-based MDA programs also affected engagement of SAC.IP communities are special settings where geographic isolation, peace and order situation as well as water supply need to be considered to help ensure access to STH control strategies, high MDA coverage, and improvements in WASH leading to desired outcomes.
    UNASSIGNED: Considering the context of IP communities and addressing the challenges in the accessibility of and access to STH control strategies are necessary to ensure successful implementation of an integrated approach in STH prevention and control strategies. Challenges in the accessibility of STH control strategies are inadequate staffing, poor inventory, and delays in the delivery of drugs, as well as poor sanitation and hygiene. Access of SAC is likewise affected by misconceptions on safety and efficacy of anthelminthics, including stigma and cultural practices. The similarity of the MDA programs based in school or community need to be disseminated.
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  • 文章类型: Journal Article
    罕见的疾病有各种类型,发病率低,复杂的条件,而且往往难以诊断。由于中国人口众多,有相当数量的罕见疾病患者,但是孤儿药短缺。因此,这些患者经常发现自己处于无法获得或负担不起必要药物的情况。为了解决这一迫切的临床需求,中国实施了一系列孤儿药政策,旨在提高药物的可及性和可负担性。在药物可及性方面,鼓励公司通过实施税收优惠来加快药物开发,罕见病临床研究指导,并提供6年的数据保护期,市场独占期最长为7年。此外,临床试验豁免,接受海外临床试验数据,并建立了优先考虑海外临床紧急新药的清单,以加快药品注册申请,review,检查,和审批流程。在药物负担能力方面,罕见病药物的进口增值税已下调3%,各省市建立了代表性的罕见病保护模式,其中包括专项资金,医疗援助计划,和严重疾病保险。国家医保目录进行了调整,减轻了罕见病患者的经济负担,导致截至2024年3月,目录涵盖的孤儿药数量增加到95。通过比较美国的孤儿药政策,欧洲联盟,Japan,澳大利亚,和其他国家(或地区),为进一步完善我国孤儿药政策提供相关建议,从而为罕见疾病患者带来更多的治疗选择和希望。
    Rare diseases have various types, low incidence rates, complex conditions, and are often difficult to diagnose. Due to China\'s large population, there is a significant number of rare disease patients, but there is a shortage of orphan drugs. Consequently, these patients often find themselves in a situation where necessary medications are either unavailable or unaffordable. To address this urgent clinical need, China has implemented a series of orphan drug policies aimed at improving drug accessibility and affordability. In terms of drug accessibility, companies are encouraged to expedite drug development through the implementation of tax incentives, guidance for clinical research on rare diseases, and the provision of data protection periods of 6 years, along with market exclusivity periods limited to a maximum of 7 years. Moreover, exemptions for clinical trials, acceptance of overseas clinical trial data, and the creation of a list prioritizing clinically urgent new drugs from overseas have been introduced to expedite the drug registration application, review, inspection, and approval processes. In terms of drug affordability, the import value-added tax on rare disease drugs has been reduced by 3%, and various provinces and cities have established a representative rare disease protection model, which includes special funds, medical assistance programs, and serious disease insurance. The national medical insurance catalog has been adjusted to reduce the financial burden on rare disease patients, resulting in an increase in the number of orphan drugs covered by the catalog to 95 as of March 2024. By comparing orphan drug policies in the United States, the European Union, Japan, Australia, and other countries (or regions), we will provide relevant suggestions to further improve orphan drug policies in China, thus bringing more treatment options and hope to patients with rare diseases.
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