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Improvement of Reimbursement Policies for Medical Products Through Health Technology Assessment 通过卫生技术评价完善医疗产品报销政策
Q4 Social Sciences Pub Date : 2021-07-07 DOI: 10.14748/SM.V28I1.7849
Iliyana Belichenova, Evgeniya Delcheva
Reimbursement policies for medical devices in EU and health technology assessment (HTA) are at the heart of this article. Their development is the result of coordination of many institutions - the European Commission, the European Parliament, the government, agencies and their importance is key. The financial instruments in the reimbursement policies for medical devices in the EU are becoming more and more avant-garde, with the key importance of those from donations or crowdfunding, fundraising for patient organizations and others. The authors emphasize the role of public administration in the formation of effective reimbursement policies for medical devices in line with trends and good practices in the field of medical devices and active participation in the processes, together with European institutions and programs. The authors of the article discuss alternative and innovative approaches, budget impact assessment and reimbursement policies for medical devices in Europe and the EU based on HTA. The authors focus their research on the European experience, the synchronization with European regulations, the harmo-nization of management methods and the role of HTA in the field of management of public funds by institutions and public organizations in Bulgaria. The authors of the publication examine the experience of international institutes in the field of HTA-experience of Great Britain, Germany, France, given the benchmark they have and the need to educate health professionals, administrators, companies in Bulgaria.
欧盟医疗器械的报销政策和卫生技术评估(HTA)是本文的核心。它们的发展是许多机构协调的结果——欧盟委员会、欧洲议会、政府、机构和它们的重要性是关键。欧盟医疗器械报销政策中的金融工具正变得越来越前卫,其中最重要的是捐赠或众筹,为患者组织筹款等。作者强调了公共管理在医疗器械领域形成有效的报销政策方面的作用,这些政策符合医疗器械领域的趋势和良好做法,并与欧洲机构和方案一起积极参与这一进程。本文的作者讨论了欧洲和欧盟基于HTA的医疗器械替代和创新方法、预算影响评估和报销政策。作者的研究重点是欧洲经验、与欧洲法规的同步、管理方法的协调以及保加利亚机构和公共组织在公共资金管理领域中的HTA的作用。该出版物的作者审查了国际机构在卫生保健领域的经验——英国、德国和法国的经验,因为它们有基准,而且需要对保加利亚的卫生专业人员、行政人员和公司进行教育。
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引用次数: 0
Transmission mechanism in COVID-19 and the management of the epidemic process COVID-19的传播机制和流行过程管理
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7568
R. Konstantinov
The health significance, determined by the severity of the clinical course, the mass systemic nature of the epidemic process and the high intensity of coverage of the population worldwide, posed to epidemiological science the problem of studying and clarifying the peculiarities of the epidemic process in COVID-19 and its management. In this epidemiological study, we set out to examine the mechanisms and routes of transmission of SARS-CoV-2 in human society and the possibilities for managing the epidemic process. Theoretical and epidemiological methods, analysis and prognosis were used. A theoretical-epidemiological and applied analysis of the peculiarities of the process of the transmission mechanism in COVID-19 has been performed and the specific practical directions for the effective and rational anti-epidemic behavior are indicated.
临床病程的严峻性、流行过程的群众性和全球范围内人口的高覆盖强度所决定的健康意义,向流行病学提出了研究和阐明新冠肺炎流行过程特点及其管理的问题。在这项流行病学研究中,我们着手研究SARS-CoV-2在人类社会中的传播机制和途径,以及管理流行过程的可能性。采用理论和流行病学方法,分析和预后。对新冠肺炎传播机制过程的特殊性进行了理论流行病学和应用分析,指出了有效合理的抗疫行为的具体实践方向。
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引用次数: 0
Nursing’s motives for work in pediatric care 儿科护理工作的护理动机
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7572
A. Georgieva
The purpose of this study is to investigate the motives of the nurses for career choices in pediatric care. An analysis of literary sources, a documentary method and a questionnaire are attached. The opinion of 70 nurses working in children’s departments of Multiprofile Active Care Hospitals, Creches and Individual Practices for Primary Care in Varna in the period November 2017 - August 2018 was studied. The results prove that the selection of careers in the field of pediatric nursing for a significant part of the respondents is considerable and purposeful. The majority of the nurses confirm that if they had the opportunity to repeat their choice, they would once again turn to work in the field of pediatric care, driven by love for children and the belief that this is vocation. Leading factors that motivate them to continue to care for the children are the nature of the work and the favorable working environment.
摘要本研究旨在探讨儿科护理护士的职业选择动机。附文献来源分析、文献法和问卷调查。研究了2017年11月至2018年8月在瓦尔纳市多类型积极护理医院、托儿所和个人初级保健诊所儿童科工作的70名护士的意见。结果证明,在儿科护理领域的职业选择的显著部分的受访者是相当可观的和有目的的。大多数护士确认,如果他们有机会重新选择,他们会再次转向儿科护理领域的工作,出于对孩子的爱,并相信这是一种职业。促使她们继续照顾孩子的主要因素是工作的性质和良好的工作环境。
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引用次数: 0
Nursing cares at fast - track (laparoscopic and robotic ) surgery 快速通道(腹腔镜和机器人)手术的护理
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7574
M. Nankova, S. Borisova
Introduction: The concept of accelerated surgical recovery after laparoscopic surgery, also called ERAS aims at faster discharge from the hospital and faster recovery of the body after various volumes of surgical interventions without increasing complications or mortality. The application of nursing care with the fast recovery method postoperatively can reduce postoperative complications and pain, shorten the hospital stay, so that the quality of rehabilitation is significantly improved. Aim: To study the application of rapid recovery syrgery (RRS) by surgical nurses (SN) and to reveal the possibilities for its optimization.. Material and methods: In nine large hospitals in Bulgaria the opinion of doctors and senior nurses (122) on the application of RRS by SN was studied; self-assessment of SN (147) who are working according to the rules of RRS. Applied methods - documentary analysis, structured interview and direct anonymous poll. Results: A high degree of knowledge of the rules and experience in practicing RRS from SN is established, as well as the need for additional nursing documentation related to postoperative care - algorithms for work and introduction of a checklist. Suggestions for improvement of the SN work protocol have been made.
引言:腹腔镜手术后加速手术恢复的概念,也称为ERAS,旨在在不增加并发症或死亡率的情况下,在各种手术干预后更快地出院和更快地恢复身体。术后应用护理配合快速恢复法,可减少术后并发症和疼痛,缩短住院时间,使康复质量明显提高。目的:探讨外科护士对快速恢复手术(RRS)的应用,并探讨其优化的可能性。材料与方法:调查保加利亚9家大型医院122名医生和高级护士对临床护理人员应用RRS的意见;对按RRS规则工作的SN(147)进行自我评价。应用方法-文献分析,结构化访谈和直接匿名调查。结果:建立了高度的规则知识和实践经验,以及需要额外的与术后护理相关的护理文件-工作算法和清单的引入。对SN工作协议提出了改进建议。
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引用次数: 0
Pharmacoeconomic analysis of medical abortion in Bulgaria 保加利亚药物流产的药物经济学分析
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7570
D. Marinov, E. Grigorov, V. Belcheva, S. Djambazov
The drug treatment for interrupting early pregnancy begins with the identification of prostaglandins. In the 1970s, many developed countries legalized abortion, which led to the development and active application of this healthcare technology worldwide. The cost-effectiveness method was used in the pharmacoeconomic analysis by comparing the costs of abortion of two of the most popular protocols and dosage regimens with the medicines available at the time of the study on the Bulgarian market and the costs of classic abortion. The eventual complications were also noted. With equivalent efficiency of the two procedures, the application of cost-minimum analysis (CMA) is an appropriate and logical choice. The analysis shows that the drug termination of pregnancy under the EMA protocol is (600 mg Mifepristone + 400 mcg Misoprostol) a slightly higher cost per patient compared to the surgical abortion if the procedure is performed during the first trimester of pregnancy (∆Costs = +10,61 BGN) and leads to cost savings for the patient during the second trimester of pregnancy (∆Costs = -90,96 BGN). Medication termination of pregnancy under WHO protocol results in a cost-saving per patient compared to surgical abortion, regardless of the period of pregnancy during which the procedure is performed (∆Cost = -50,43 BGN in the first trimester and ∆Cost = -156,60 BGN in the second trimester). Drug termination is non-invasive, highly effective, and safe, resembling the natural mechanism of spontaneous abortion. In most cases, medical abortion is cost-saving and can be considered as a reasonable alternative to surgical abortion.
中断早孕的药物治疗始于前列腺素的鉴定。20世纪70年代,许多发达国家将堕胎合法化,这导致了这项医疗技术在世界范围内的发展和积极应用。在药物经济学分析中使用了成本效益方法,将两种最流行的方案和剂量方案的流产费用与研究时保加利亚市场上可获得的药物和传统流产费用进行比较。最后的并发症也被注意到了。在两种方法效率相当的情况下,应用最小成本分析(CMA)是一种合理的选择。分析表明,EMA方案下的药物终止妊娠(600mg米非司酮+ 400 mcg米索前列醇)与在妊娠早期(∆成本= +10,61 BGN)进行手术流产相比,每位患者的成本略高,并且在妊娠中期(∆成本= -90,96 BGN)为患者节省成本。根据世卫组织方案,与手术流产相比,无论在妊娠期间进行药物终止妊娠,每位患者均可节省费用(妊娠前期费用= -50,43 BGN,妊娠中期费用= -156,60 BGN)。药物终止无创、高效、安全,类似自然流产的自然机制。在大多数情况下,药物流产可以节省费用,可以被认为是手术流产的一种合理选择。
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引用次数: 0
Aesthetic restoration of the front teeth (case of practice) 门牙美学修复(实践案例)
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7576
Izabela Oganesyan-Boeva
Ever since ancient times, the social nature of human existence had to look for ways and means of recovery, replacement and alignment of the frontal teeth, mainly for aesthetic reasons. Natural teeth have an anatomy and a certain position in accordance with principles, maintaining an excellent balance with the surrounding tissues. Emphasizing the beauty of the face is one of the basic requirements of patients who are looking for high quality dental services. The perfect smile is made up of natural-shaped teeth and colors, corresponding to face shape and natural skin pigments, eyes and hair. The teeth have different shapes and sizes, but in combination they create a sense of naturalness, harmony, beauty and health. To achieve successful results ,we must also consider all the factors - aesthetics, functionality, structural dynamics, biological and periodontal factors and last but not least our visual perception. The purpose of this article is to present two case studies, in which the treatment is with the help of dental technique laboratory and restoration materials. For this purpose, a team was formed to maximize aesthetic dental restoration.
自古以来,人类生存的社会性就不得不寻找门牙恢复、替换和排列的方法和手段,主要是出于审美的原因。天然牙齿有一定的解剖结构和位置,与周围组织保持良好的平衡。强调面部美是寻求高质量牙科服务的患者的基本要求之一。完美的微笑是由自然形状的牙齿和颜色组成的,与脸型和自然的皮肤色素、眼睛和头发相对应。牙齿有不同的形状和大小,但它们结合在一起,给人一种自然、和谐、美丽和健康的感觉。为了达到成功的效果,我们还必须考虑所有的因素-美学,功能,结构动力学,生物和牙周因素,最后但并非最不重要的是我们的视觉感知。本文的目的是提出两个案例研究,其中治疗是借助牙科技术实验室和修复材料。为此,我们成立了一个团队,以最大限度地提高牙科修复的美观性。
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引用次数: 0
Feldsher education and practice in Bulgaria 在保加利亚的教育和实践
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7577
P. Tsonov
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引用次数: 0
Study of the terms for performing procedures under the HTA of a medicinal product in Bulgaria for the period 04.2016-12.2018 对2016年4月至2018年12月期间保加利亚药品HTA下执行程序的条款进行研究
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7573
Anelia Nikolova, E. Grigorov
Introduction: The Health technology assessment (HTA) is a multidisciplinary activity that systematically assesses the effects of technology on health, on the availability and allocation of resources and their effectiveness for the health system. It is a dynamic, rapidly evolving process that helps make informed decisions about the benefits, risks and costs of introducing new technologies. The administrative terms for the HTA vary in different European countries and depend on the type of evaluation that is performed - single, multiple, rapid assessments and more. For Bulgaria, the statutory deadline for carrying out the procedure under the HTA according to Ordinance № 9 of 01.12.2015 is 90 days from the date of submission of the application by the Marketing Authorization Holder (MAH). Objective: To monitor and analyze the average duration of HTA procedures and the factors that affect it in order to assess whether the normatively determined term of 90 days is sufficient. Methodology: Monitoring, analysis and synthesis are applied for data extraction and interpretation of information about the submitted applications for HTA in National Center of Public Health and Analyses (NCPHA), as well as the overall organization of the process. Criteria for completeness and duration of the procedure are analyzed. Results: In the general case of conducting HTA, the practice shows that the normatively determined term is extremely insufficient. The leading reason for going beyond the time frame is the interval for convening and holding regular meetings of the Heath Technology Assessment Committee (HTAC). Other factors are the incomplete information in the submitted documents or the need to revise the reports. The analysis of the deadlines shows that the share of procedures completed on time is very small and decreases over the years. The longest terms are for procedures in the field of oncology, urology and hematology, and the shortest - in the field of dermatology, rheumatology and endocrinology. Conclusion: The normatively set term is insufficient and regardless of the efforts made, it was not observed in 90% of the implemented procedures. The average duration of a HTA procedure in Bulgaria in the analyzed period is about 156 days. The established practice shows that in the country the duration of HTA is close to the group of EU countries with an established term of 90-220 days.
卫生技术评估(HTA)是一项多学科活动,系统地评估技术对卫生、资源的可得性和分配及其对卫生系统的有效性的影响。这是一个动态的、快速发展的过程,有助于对引进新技术的收益、风险和成本做出明智的决定。HTA的管理术语在不同的欧洲国家有所不同,并取决于所进行的评估类型——单次、多次、快速评估等等。对于保加利亚,根据2015年12月1日第9号条例,在HTA下执行程序的法定截止日期是上市许可持有人(MAH)提交申请之日起90天。目的:监测和分析HTA手术的平均持续时间及其影响因素,以评价规范确定的90天是否足够。方法:监测、分析和综合应用于国家公共卫生和分析中心(NCPHA)关于HTA提交申请的数据提取和信息解释,以及整个过程的组织。分析了程序完备性和持续时间的标准。结果:在进行HTA的一般情况下,实践表明,规范确定的条件是极其不足的。超出时间框架的主要原因是召开和举行卫生技术评估委员会(HTAC)定期会议的间隔时间。其他因素包括提交的文件信息不完整或需要修改报告。对截止日期的分析表明,按时完成的程序所占比例很小,而且逐年减少。最长的是肿瘤学、泌尿学和血液学领域的手术,最短的是皮肤科、风湿病学和内分泌学领域的手术。结论:规范设定的期限不够充分,无论如何努力,90%的实施程序都不符合规定。在分析期间,保加利亚HTA程序的平均持续时间约为156天。根据既定的实践,该国的HTA期限接近欧盟国家集团,其既定期限为90-220天。
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引用次数: 0
The Nurse and prophylactic care for children in their early age 幼儿期的护士和预防性护理
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7571
G. Petrova, S. Dimitrova
Introduction: The prophylactic care for children in their early age, traditionally provided by Children consultations, today is delivered by the General practitioners and the role of the nurse was minimized if not missing. Aim: To analyze the relevant legislation concerning health and preventive care for children and the role of nurse and to point out the problems to be solved in order to improve quality of service. Methods: Document analysis, Inquiries of nurses (188) working at children healthcare facilities. Results: Document analysis show that there is no regulation that mandates nurse’s participation in the team that provides basic health care service including prophylactic care for children. There is no good definition or distinction for the functions of GPs and nurses in the terms of prophylactic care for children. There is contradiction in the established professional competencies for a nurse and the restrictions in the existing legislation towards healthcare for children. Inquired nurses find their role in improving the quality of the health care service in children consultations by helping doctors in the routine activities like immunizations and anthropometry and also in educating parents in terms of health culture and prevention. Home visits or patronage is suggested as appropriate action in this regard. Conclusion: Changes in the legislation and reorganization focused on the recipients may lead to better inclusion of the nurse with an increased capacity for improving the prophylactic care for children in their early age.
儿童早期的预防性护理,传统上是由儿童咨询提供的,今天是由全科医生提供的,护士的作用如果不是缺失的话,也被最小化了。目的:分析我国儿童保健和预防保健的相关立法及护士的作用,指出应解决的问题,以提高服务质量。方法:对188名在儿童保健机构工作的护士进行问卷调查。结果:文献分析显示,在为儿童提供包括预防保健在内的基本卫生保健服务的队伍中,没有规定护士必须参与。在儿童预防性护理方面,全科医生和护士的职能没有很好的定义或区分。既定的护士专业能力与现行立法对儿童保健的限制之间存在矛盾。被询问的护士通过帮助医生进行免疫接种和人体测量等日常活动以及在健康文化和预防方面教育父母,发现她们在提高儿童咨询保健服务质量方面的作用。在这方面,建议采取家访或赞助的适当行动。结论:以受助人为中心的立法改革和重组可能会使护士更好地融入其中,提高早期儿童预防保健的能力。
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引用次数: 0
Prefered shannels for health information depending on health status 根据健康状态显示健康信息的首选通道
Q4 Social Sciences Pub Date : 2020-12-31 DOI: 10.14748/SM.V27I3.7567
T. Karanesheva, N. Danova, I. Yaneva
Background: In a rapidly changing communication environment study of the communication preferences of different audience segments allows the selection of channels for health information to be tailored to the needs and characteristics of the audience. The purpose of the study is research the channels preferred for health information depending on the health status. Material and methods: A direct individual anonymous questionnaire was used, with a questionnaire on paper. The preferred channels for health information among 2979 persons over 20 years of age, from the 28 districts of the country, depending on their health status, were studied. The main statistical methods are: descriptive analysis, graphical analysis; variation analysis, Z-test to establish a significant difference. The results show significant differences in the choice of sources of health information between people with disease and people without disease. Physicians are the most commonly preferred health information channel, with a statistically significant difference depending on the health status (p<0,001). The Internet is twice as often preferred for health information by healthy people than by people with a disease (p<0.001). Television is a major channel for health information for people with a specific disease or medical problem, while healthy respondents more frequently prefer the Internet.
背景:在快速变化的传播环境中,研究不同受众群体的传播偏好,可以根据受众的需求和特点选择健康信息的渠道。本研究的目的是研究健康状况对健康信息的偏好渠道。材料与方法:采用直接的个人匿名调查问卷,纸上问卷。对来自全国28个县的2979名20岁以上的人根据其健康状况选择的健康信息渠道进行了研究。主要的统计方法有:描述性分析、图形化分析;方差分析,z检验建立显著差异。结果显示,患病人群和未患病人群在选择健康信息来源方面存在显著差异。医生是最常用的健康信息渠道,根据健康状况不同,差异有统计学意义(p< 0.001)。健康人群对互联网健康信息的偏好是患病人群的两倍(p<0.001)。对于患有特定疾病或医疗问题的人来说,电视是获取健康信息的主要渠道,而健康的受访者往往更喜欢互联网。
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引用次数: 0
期刊
Social Medicine
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