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Prevalance and risk factors of congenital malaria in Osogbo, Southwestern Nigeria. 尼日利亚西南部奥索博先天性疟疾的患病率和危险因素。
Q1 Medicine Pub Date : 2025-07-15 eCollection Date: 2025-01-01 DOI: 10.3205/000343
Saheed A Odediji, Surakat A Olabanji, Abdullahi O Olawuyi, Kazeem O Amoo, Basirat O Amoo-Adeboye, Monsuru A Adeleke

Background: Congenital malaria, defined as the presence of malaria parasites in the peripheral smear of newborns within the first seven days of life, remains an underexplored aspect of malaria epidemiology in endemic regions like Nigeria. This study investigated the prevalence and associated risk factors of congenital malaria at the State Specialist Hospital (SSH), Osogbo, Southwestern Nigeria.

Method: This cross-sectional study collected peripheral and cord blood samples from 77 newborns within the first 24 hours of delivery. We examined blood samples for malaria parasites using both light microscopy and malaria rapid diagnostic test (mRDT) kits. A structured research proforma was used to assess various risk factors, including sociodemographic details, gravidity, parity, retroviral status, and malaria prevention measures during pregnancy.

Results: The overall prevalence of congenital malaria was 6.5%, with all infants exhibiting congenital malaria also demonstrating cord blood parasitaemia. Maternal malarial parasitaemia emerged as a strong predictive factor (p<0.05), while factors such as maternal retroviral status, intermittent prophylactic therapy, therapeutic antimalarial use, and bednet usage were not significantly associated with congenital malaria (p>0.05).

Conclusion: Our study observed a low prevalence of congenital malaria in Osogbo and emphasizes the significance of maternal malarial parasitaemia in predicting the condition. However, there is need for additional multicenter studies to comprehensively determine the prevalence of congenital malaria in Osun State and Nigeria, providing a basis for targeted interventions and healthcare strategies.

背景:先天性疟疾的定义是出生后7天内新生儿外周涂片中存在疟疾寄生虫,在尼日利亚等疟疾流行区,先天性疟疾仍然是疟疾流行病学研究不足的一个方面。本研究调查了尼日利亚西南部Osogbo国家专科医院先天性疟疾的患病率和相关危险因素。方法:本横断面研究收集77例新生儿出生后24小时内外周血和脐带血样本。我们使用光学显微镜和疟疾快速诊断测试(mRDT)试剂盒检测血样中的疟疾寄生虫。采用结构化的研究形式来评估各种风险因素,包括社会人口统计学细节、妊娠、胎次、逆转录病毒状况和怀孕期间的疟疾预防措施。结果:先天性疟疾总患病率为6.5%,所有先天性疟疾患儿均伴有脐带血寄生虫病。母体疟原虫血症是一个强有力的预测因素(p0.05)。结论:本研究发现奥索博地区先天性疟疾患病率较低,并强调母体疟原虫血症在预测该病中的重要意义。然而,还需要进行更多的多中心研究,以全面确定奥松州和尼日利亚先天性疟疾的流行情况,为有针对性的干预措施和保健战略提供依据。
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引用次数: 0
Recommendations of the Association of the Scientific Medical Societies in Germany's (AWMF) Ad-hoc Commission Medical Devices on the handling of medical devices after explantation. 德国科学医学学会协会(AWMF)医疗器械特设委员会关于医疗器械外植后处理的建议。
Q1 Medicine Pub Date : 2025-07-11 eCollection Date: 2025-01-01 DOI: 10.3205/000342
Andreas Markewitz, Antje Aschendorff, Wolfram Mittelmeier, Boulos Asfour, Ansgar Berlis, Torsten Beyna, Jens-Uwe Blohmer, Mathias Gorenflo, Marcus Katoh, Wolfram Knapp, Thomas Lenarz, Folker Spitzenberger, Ludger Tüshaus, Peter M Vogt, Gerald Werner, Mathias Wilhelmi

The explantation of medical devices is a common procedure. However, the legal regulations and the resulting obligations of treating physicians and institutions regarding the handling of explanted medical devices are not always well known. The present recommendations aim to summarize the essential legal and practical aspects involved in the process following the explantation of medical devices.

医疗器械的取出是一个常见的程序。然而,在处理外植医疗装置方面的法律条例和由此产生的治疗医生和机构的义务并不总是为人所熟知。本建议旨在总结医疗器械解释后过程中涉及的基本法律和实际方面。
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引用次数: 0
Patient safety through quality assurance in in-vitro diagnostics - webinar 2024 of the Ad-hoc Commission on In-vitro Diagnostics of the Association of the Scientific Medical Societies in Germany (AWMF). 通过体外诊断质量保证患者安全——德国科学医学学会协会(AWMF)体外诊断特设委员会2024年网络研讨会。
Q1 Medicine Pub Date : 2025-07-11 eCollection Date: 2025-01-01 DOI: 10.3205/000341
Michael Vogeser, Monika Brüggemann, Ulrich Sack, Albrecht Stenzinger, Henning Schliephake

The reliability of laboratory tests is ensured in particular by the interaction of regulated market access and certification of diagnostics, scientific evidence through guidelines, the guideline of the German Medical Association on quality assurance of laboratory medical examinations mentioned in § 9 of the German Medizinproduktebetreiberverordnung, as well as standardisation and accreditation. The Webinar 2024 of the Association of Scientific Medical Societies in Germany's (AWMF) Ad-hoc Commission on In-vitro Diagnostics on 9 October 2024 highlighted this thematic network in four presentations from the perspective of the Federal Ministry of Health, the AWMF Institute for Medical Knowledge Management (IMWi), the German Accreditation Body (DAkkS) and the German Medical Association.

实验室检测的可靠性主要通过以下方面的相互作用来保证:受监管的市场准入和诊断认证、通过准则提供的科学证据、德国医学协会关于德国Medizinproduktebetreiberverordnung第9条中提到的实验室医学检查质量保证的准则,以及标准化和认证。2024年10月9日,德国科学医学学会协会(AWMF)体外诊断特设委员会的网络研讨会2024从联邦卫生部、AWMF医学知识管理研究所(IMWi)、德国认证机构(DAkkS)和德国医学协会的角度,在四场演讲中强调了这一主题网络。
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引用次数: 0
Socio-economic inequalities in the association between diabetes and labour force participation in Germany: A repeated cross-sectional study. 德国糖尿病与劳动力参与之间的社会经济不平等:一项重复的横断面研究。
Q1 Medicine Pub Date : 2025-06-30 eCollection Date: 2025-01-01 DOI: 10.3205/000340
Malwina M Mackowiak, Ralph Brinks, Annika Hoyer, Ute Linnenkamp, Katharina Piedboeuf-Potyka, Markus Neuhäuser, Oliver Kuss, Thaddäus Tönnies

Objective: Diabetes is associated with lower labour force participation. The proportion of people having diabetes is higher among people with a low socio-economic position. We aimed to describe socio-economic differences in the association between diabetes and labour force participation in Germany.

Methods: Based on repeated cross-sectional data from the German Socio-Economic Panel Study, the probability for participating in labour force was modelled with a logistic regression model including diabetes status, sex, socio-economic position, survey year and age as independent variables. Analyses accounted for the complex survey design of the study and used post-stratification weights. For easier interpretation, we estimated relative risks instead of odds ratios from logistic regression using post-estimation techniques. Relative labour force participation shortfall [%] was calculated as (1 - relative risk) x 100.

Results: Labour force participation among people without diabetes was 82.2% compared to 55.9% among people with diabetes. Labour force participation shortfall was higher for low socio-economic position values and decreased with increasing socio-economic position. Labour force participation shortfall was generally larger among women while the association between labour force participation shortfall and socio-economic position was stronger among men.

Conclusions: Diabetes-associated labour force participation shortfall mainly affects people with low socio-economic position, which indicates that this population subgroup not only carries a higher risk of diabetes, but also might be more strongly affected by its negative impact on productivity. Future studies aiming to quantify diabetes-associated productivity losses should take associations specific to socio-economic position into account.

目的:糖尿病与较低的劳动力参与率有关。在社会经济地位较低的人群中,糖尿病患者的比例较高。我们的目的是描述德国糖尿病和劳动力参与之间的社会经济差异。方法:基于德国社会经济面板研究的重复横断面数据,以糖尿病状况、性别、社会经济地位、调查年份和年龄为自变量,采用logistic回归模型对参与劳动力的概率进行建模。分析考虑了研究的复杂调查设计,并使用了分层后的权重。为了更容易解释,我们使用后估计技术估计了逻辑回归的相对风险,而不是比值比。相对劳动力参与率缺口[%]计算为(1 -相对风险)× 100。结果:非糖尿病患者的劳动参与率为82.2%,而糖尿病患者为55.9%。社会经济地位值越低,劳动力参与率越低,社会经济地位越高,劳动力参与率越低。劳动力参与不足的情况在妇女中普遍较大,而劳动力参与不足与社会经济地位之间的联系在男子中更为密切。结论:糖尿病相关的劳动力参与不足主要影响社会经济地位较低的人群,这表明该人群不仅具有较高的糖尿病风险,而且其对生产力的负面影响可能更强烈。未来旨在量化糖尿病相关生产力损失的研究应考虑到特定社会经济地位的关联。
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引用次数: 0
Evidence-based guideline diagnosis, treatment, prevention and aftercare of oropharyngeal and hypopharyngeal carcinoma. 口咽癌和下咽癌的循证诊断、治疗、预防和术后护理指南。
Q1 Medicine Pub Date : 2025-06-24 eCollection Date: 2025-01-01 DOI: 10.3205/000339
Andreas Dietz, Kathy Taylor, Oliver Bayer, Susanne Singer, Markus Follmann, Monika Nothacker, Thomas Langer, Peter Klussmann, Stephan Lang, Thomas Hoffmann, Georg Maschmeyer, Susanne Wiegand, Michael Fuchs, Wilko Weichert, Jochen Heß, Orlando Guntinas-Lichius, Tim Waterboer, Michael Lell, Jens Büntzel, Panagiotis Balermpas, Kerstin Schmidt, Maria Steingräber, Gunther Klautke, Herbert Hellmund, Gunthard Kissinger, Peter Brossart, Imad Maatouk, Bernd Lethaus, Jan Raguse, Klaus Zöphel, Kristina Lippach, Fritz Sterr, Hans Christiansen, Christian Duncker, Annerose Keilmann, Havva Cici, Jutta Yzer, Alessandro Relic, Kerstin Paradies, Wilfried Budach

The guideline is being drawn up as a joint guideline for oropharyngeal and hypopharyngeal carcinoma. Oropharyngeal carcinoma in particular has experienced the greatest increase in incidence among all head and neck carcinomas in the last 20 years and is now the sixth most common cancer in men in Germany. Together with hypopharyngeal carcinoma, these tumors are currently the most common cancer entity in the head and neck region. Due to the association with human papillomavirus type 16 (HPV16), we now distinguish two groups of oropharyngeal carcinomas in Germany: HPV16-positive (approx. 35%) and HPV-negative (approx. 65%). A HPV16 association with hypopharyngeal carcinoma has not been described. The therapy covers the entire spectrum of head and neck surgery, including diversified reconstructive procedures, transoral and external approaches, the options for primary and adjuvant radiotherapy (possibly in combination with chemotherapy) and the current recommendations for drug-based tumor therapy, which range from classic chemotherapy to immuno-oncology. In addition, measures for early detection and prevention are carried out, with particular consideration of the HPV16-associated genesis of oropharyngeal carcinoma, as well as adequate rehabilitation after the primary treatment of oropharyngeal and hypopharyngeal carcinomas. Finally, the treatment options for recurrences or distant metastases that cannot be cured in the further course of the disease are shown and classified.

该指南是作为口咽癌和下咽癌的联合指南起草的。在过去20年中,口咽癌的发病率在所有头颈癌中增幅最大,目前是德国男性中第六大常见癌症。与下咽癌一起,这些肿瘤是目前头颈部最常见的癌症实体。由于与人乳头瘤病毒16型(HPV16)的关联,我们现在在德国区分两组口咽癌:HPV16阳性(约;35%)和hpv阴性(约35%)。65%)。HPV16与下咽癌的关系尚未被描述。治疗涵盖了头颈部手术的整个范围,包括多样化的重建手术,经口和外入路,主要和辅助放疗的选择(可能与化疗联合)以及目前推荐的基于药物的肿瘤治疗,范围从经典化疗到免疫肿瘤学。此外,还采取了早期发现和预防措施,特别是考虑到hpv16相关的口咽癌发生,以及口咽癌和下咽癌初级治疗后的充分康复。最后,对复发或远处转移在疾病的进一步过程中无法治愈的治疗方案进行了显示和分类。
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引用次数: 0
Rehabilitation of the lower extremities, standing and walking function in people with spinal cord injury or disease: Guideline of the German-Speaking Medical Society for Spinal Cord Injury. 脊髓损伤或疾病患者下肢、站立和行走功能的康复:德语脊髓损伤医学会指南
Q1 Medicine Pub Date : 2025-06-02 eCollection Date: 2025-01-01 DOI: 10.3205/000338
Sophie Irrgang, Sandra Himmelhaus, Kirstin Allek, Claudio Bartholet, Ines Bersch-Porada, Armin Curt, Burkhart Huber, Daniel Kuhn, Karen Kynast, Norbert Weidner, Anke Scheel-Sailer

Introduction: According of the level and severity of the spinal cord injury or disease (SCI/D), and the impairment of motor, sensory, and autonomic functions, individuals with SCI/D recover some standing and walking capabilities. To increase quality of rehabilitation and use newest evidence, the clinical practice guideline (CPG) "S2e-Guideline Rehabilitation of lower extremities, standing and walking function in people with SCI/D" of the German speaking Medical Association for Paraplegiology (DMGP) was updated.

Methods: Following a multi-tiered approach systematic searches were conducted to identify appropriate literature. For this purpose, the Databases PubMed, EMBASE, Cochrane Library and PEDro were searched. Recommendations on assessments were grouped to the categories "activity and participation" or "body functions/body structures". Recommendations on interventions were labeled with outcomes standing, walking, strength, range of motion, pain and muscle tonus.

Results: In total, 9,871 studies were identified during the search. Of these, four systematic reviews and eleven primary studies were utilized in composing the recommendations. A total of 25 recommendations were made, with 20 derived from the literature and 5 based on expert consensus. In total 14 functional assessments and 11 rehabilitation interventions became compiled. The assembled recommendations regarding assessments could be well built on published literature, while overall there is a paucity of literature proofing the evidence of specific interventions used in clinical practice. Therefore, the expertise of the international expert group and input from patient representatives were pivotal.

Conclusion: The method of an evidence-based guideline was sufficient for the recommendation of functional assessments but showed the need scientific clarification in the field of clinically established interventions.

根据脊髓损伤或疾病(SCI/D)的程度和严重程度,以及运动、感觉和自主神经功能的损害,SCI/D患者可以恢复一定的站立和行走能力。为了提高康复质量和使用最新证据,临床实践指南(CPG)德语截瘫医学协会(DMGP)的“s2e -指南SCI/D患者下肢、站立和行走功能康复”更新。方法:采用多层方法进行系统检索,以确定合适的文献。为此,检索了PubMed、EMBASE、Cochrane Library和PEDro数据库。关于评估的建议分为“活动和参与”或“机构职能/机构结构”两类。干预措施的建议被标记为结果站立,行走,力量,活动范围,疼痛和肌肉张力。结果:在搜索过程中,总共确定了9871项研究。在这些建议中,利用了四项系统综述和十一项初步研究。总共提出了25项建议,其中20项来自文献,5项基于专家共识。共编制了14项功能评估和11项康复干预措施。关于评估的综合建议可以很好地建立在已发表的文献基础上,而总体而言,缺乏文献证明临床实践中使用的特定干预措施的证据。因此,国际专家组的专业知识和患者代表的投入至关重要。结论:循证指南的方法足以推荐功能评估,但在临床建立的干预措施领域需要科学澄清。
{"title":"Rehabilitation of the lower extremities, standing and walking function in people with spinal cord injury or disease: Guideline of the German-Speaking Medical Society for Spinal Cord Injury.","authors":"Sophie Irrgang, Sandra Himmelhaus, Kirstin Allek, Claudio Bartholet, Ines Bersch-Porada, Armin Curt, Burkhart Huber, Daniel Kuhn, Karen Kynast, Norbert Weidner, Anke Scheel-Sailer","doi":"10.3205/000338","DOIUrl":"10.3205/000338","url":null,"abstract":"<p><strong>Introduction: </strong>According of the level and severity of the spinal cord injury or disease (SCI/D), and the impairment of motor, sensory, and autonomic functions, individuals with SCI/D recover some standing and walking capabilities. To increase quality of rehabilitation and use newest evidence, the clinical practice guideline (CPG) \"S2e-Guideline Rehabilitation of lower extremities, standing and walking function in people with SCI/D\" of the German speaking Medical Association for Paraplegiology (DMGP) was updated.</p><p><strong>Methods: </strong>Following a multi-tiered approach systematic searches were conducted to identify appropriate literature. For this purpose, the Databases PubMed, EMBASE, Cochrane Library and PEDro were searched. Recommendations on assessments were grouped to the categories \"activity and participation\" or \"body functions/body structures\". Recommendations on interventions were labeled with outcomes standing, walking, strength, range of motion, pain and muscle tonus.</p><p><strong>Results: </strong>In total, 9,871 studies were identified during the search. Of these, four systematic reviews and eleven primary studies were utilized in composing the recommendations. A total of 25 recommendations were made, with 20 derived from the literature and 5 based on expert consensus. In total 14 functional assessments and 11 rehabilitation interventions became compiled. The assembled recommendations regarding assessments could be well built on published literature, while overall there is a paucity of literature proofing the evidence of specific interventions used in clinical practice. Therefore, the expertise of the international expert group and input from patient representatives were pivotal.</p><p><strong>Conclusion: </strong>The method of an evidence-based guideline was sufficient for the recommendation of functional assessments but showed the need scientific clarification in the field of clinically established interventions.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc02"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12247552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144627366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medical laboratory diagnostics in Germany - a status report 2024. 德国医学实验室诊断——2024年状况报告。
Q1 Medicine Pub Date : 2025-04-09 eCollection Date: 2025-01-01 DOI: 10.3205/000337
Michael Vogeser, Timo Schumacher, Frank Bühling
<p><strong>Background and aim of the work: </strong>Laboratory diagnostics (in-vitro diagnostics, IVD) is one of the main pillars of evidence-based medicine; for many medical fields - such as endocrinology - laboratory tests are conditional, but not indispensable for any discipline. The majority of diagnoses can only be reliably made if laboratory tests are taken into account. The aim of this study is to describe the provision of IVDs to the population in Germany in an overall view and to discuss development perspectives in the sense of basic healthcare research, particularly on the basis of publicly accessible data.</p><p><strong>Methods: </strong>For this purpose, in particular the federal health reporting, reports of the German Federal Statistical Office, the medical register of the German Medical Association and data from the Associations of Statutory Health Insurance Physicians were analysed, as well as a large amount of publicly accessible information from associations and medical institutions.</p><p><strong>Results: </strong>The provision of laboratory services in Germany is strongly interlinked between the sectors as they are offered by practicing laboratory physicians, in inpatient facilities and also directly in the practices and medical care centres of other specialist groups. There are currently around 1,200 specialists in laboratory medicine and 840 specialists in microbiology, which together equates to around 0,7% of all specialized physicians in Germany. Around 2/3 of laboratory physicians work in private practice. After the group of general practitioners, laboratory doctors are the second most frequently consulted group of doctors in Germany as representatives of a non-curative specialty. A total of around 108,000 people work in medical laboratories (1.8% of the entire healthcare workforce). The annual cost of laboratory diagnostics is around 150 euros per capita, totaling around 12.9 billion euros per year, which corresponds to around 2.6% of the total costs of the German healthcare system. Only around 17% of hospitals - predominantly maximum care facilities - have their own laboratory infrastructure, while the majority of hospitals are supplied with laboratory services by practicing laboratory doctors. In the latter, it is now predominantly quite large laboratory medicine units that provide laboratory tests nationwide on the basis of a complex logistics and data infrastructure, which is flanked by patient-related laboratory diagnostics in practices and medical care centres in a wide range of disciplines.</p><p><strong>Conclusion: </strong>A fairly comprehensive picture of the provision of laboratory services in Germany can be obtained from publicly accessible sources. Laboratory diagnostics is an essential and efficient, system-relevant element of the German healthcare system, in which a relatively small number of medical specialists and healthcare professionals bear a great degree of responsibility for maintaining adequate care
工作背景和目的:实验室诊断(in-vitro diagnostics, IVD)是循证医学的主要支柱之一;对于许多医学领域,如内分泌学,实验室检查是有条件的,但不是任何学科都必须的。只有考虑到实验室检查,才能可靠地作出大多数诊断。本研究的目的是从整体上描述向德国人口提供ivd的情况,并在基本医疗保健研究的意义上讨论发展前景,特别是在可公开获取数据的基础上。方法:为此,特别分析了联邦健康报告、德国联邦统计局的报告、德国医学协会的医疗登记册和法定健康保险医师协会的数据,以及协会和医疗机构提供的大量可公开获取的信息。结果:在德国,实验室服务的提供在各部门之间紧密相连,因为这些服务是由执业实验室医生在住院设施中提供的,也直接在其他专科团体的实践和医疗保健中心提供。目前,德国约有1200名检验医学专家和840名微生物学专家,这些专家加起来约占德国所有专业医生的0.7%。大约2/3的实验室医生在私人诊所工作。在全科医生之后,实验室医生是德国第二常被咨询的医生群体,作为非治疗专业的代表。总共约有108,000人在医学实验室工作(占整个医疗保健工作人员的1.8%)。实验室诊断的年人均成本约为150欧元,每年总计约129亿欧元,相当于德国医疗保健系统总成本的2.6%左右。只有约17%的医院(主要是最高护理机构)拥有自己的实验室基础设施,而大多数医院由执业实验室医生提供实验室服务。在后者,现在主要是相当大的实验室医学单位,在复杂的后勤和数据基础设施的基础上,在全国范围内提供实验室检测,这些基础设施的两侧是与患者有关的实验室诊断实践和各种学科的医疗保健中心。结论:一个相当全面的图片提供实验室服务在德国可以从公共资源获得。实验室诊断是德国医疗保健系统中必不可少的、高效的、与系统相关的要素,在德国医疗保健系统中,相对少数的医学专家和医疗保健专业人员承担着维持充分护理的很大程度的责任。
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引用次数: 0
From evidence to care delivery: Opportunities and risks in health and science policy. A position paper of the Association of the Scientific Medical Societies in Germany (AWMF). 从证据到提供护理:卫生与科学政策的机遇与风险。德国科学医学协会(AWMF)的立场文件。
Q1 Medicine Pub Date : 2024-11-06 eCollection Date: 2024-01-01 DOI: 10.3205/000336
Bernhard Wörmann, Ina Kopp, Monika Nothacker, Ernst Klar, Martin Sedlmayr, Michael Vogeser, Henning Schliephake, Rolf-Detlef Treede

Objective: After over 25 years of developing clinical practice guidelines, the Association of the Scientific Medical Societies in Germany (AWMF) held a symposium to discuss the following topics in order to improve the way evidence is implemented in the delivery of care: expansion of the data pool for guideline development, the regulatory policy framework for this expansion, the transfer of clinical practice guideline statements to medical practice, the associated opportunities and risks resulting from the European legislation.

Methods: The AWMF held its Berlin Forum on 27 April 2022 where experts from scientific medical societies and national institutions in the healthcare sector reported their experiences and perceptions on the topics mentioned. Three writing groups compiled the key statements from these contributions to and discussions made at the Berlin Forum into a position paper.

Results: The AWMF recommends the following:- The creation of a digital infrastructure that serves the quality assurance of clinical practice guidelines and makes their content available at the bedside and during consultations- An increase in the number of industry-independent clinical trials on prevention, diagnostics and therapy with medicinal products, medical devices or other procedures - The funding of registry structures to generate point-of-care healthcare data- The reduction of excessive bureaucratic hurdles at both the national and EU level.

Conclusions: By making concrete recommendations in this position paper, the AWMF maps out the steps required to improve the translation of evidence to the delivery of clinical care.

目的:经过25年的临床实践指南的制定,德国科学医学学会协会(AWMF)召开了一次研讨会,讨论以下主题,以改进证据在提供护理中的实施方式:指南开发的数据池的扩展,这一扩展的监管政策框架,临床实践指南声明向医疗实践的转移,欧洲立法带来的相关机会和风险。方法:AWMF于2022年4月27日举行了柏林论坛,来自科学医学学会和医疗保健部门国家机构的专家报告了他们对所提到主题的经验和看法。三个写作小组将这些对柏林论坛的贡献和讨论的主要发言汇编成一份立场文件。结果:AWMF建议:-创建数字基础设施,以保证临床实践指南的质量,并使其内容在床边和会诊期间可用-增加行业独立的药物预防、诊断和治疗临床试验的数量;医疗设备或其他程序-为生成即时医疗保健数据的注册结构提供资金-在国家和欧盟层面减少过多的官僚主义障碍。结论:通过在本立场文件中提出具体建议,AWMF制定了改善证据转化为临床护理提供所需的步骤。
{"title":"From evidence to care delivery: Opportunities and risks in health and science policy. A position paper of the Association of the Scientific Medical Societies in Germany (AWMF).","authors":"Bernhard Wörmann, Ina Kopp, Monika Nothacker, Ernst Klar, Martin Sedlmayr, Michael Vogeser, Henning Schliephake, Rolf-Detlef Treede","doi":"10.3205/000336","DOIUrl":"10.3205/000336","url":null,"abstract":"<p><strong>Objective: </strong>After over 25 years of developing clinical practice guidelines, the Association of the Scientific Medical Societies in Germany (AWMF) held a symposium to discuss the following topics in order to improve the way evidence is implemented in the delivery of care: expansion of the data pool for guideline development, the regulatory policy framework for this expansion, the transfer of clinical practice guideline statements to medical practice, the associated opportunities and risks resulting from the European legislation.</p><p><strong>Methods: </strong>The AWMF held its Berlin Forum on 27 April 2022 where experts from scientific medical societies and national institutions in the healthcare sector reported their experiences and perceptions on the topics mentioned. Three writing groups compiled the key statements from these contributions to and discussions made at the Berlin Forum into a position paper.</p><p><strong>Results: </strong>The AWMF recommends the following:- The creation of a digital infrastructure that serves the quality assurance of clinical practice guidelines and makes their content available at the bedside and during consultations- An increase in the number of industry-independent clinical trials on prevention, diagnostics and therapy with medicinal products, medical devices or other procedures - The funding of registry structures to generate point-of-care healthcare data- The reduction of excessive bureaucratic hurdles at both the national and EU level.</p><p><strong>Conclusions: </strong>By making concrete recommendations in this position paper, the AWMF maps out the steps required to improve the translation of evidence to the delivery of clinical care.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"22 ","pages":"Doc10"},"PeriodicalIF":0.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11636552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142819645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices. 欧洲和德国医疗器械法律框架下的病理学:体外诊断医疗器械的操作、使用和内部制造。
Q1 Medicine Pub Date : 2024-10-11 eCollection Date: 2024-01-01 DOI: 10.3205/000335
Andy Kahles, Hannah Goldschmid, Anna-Lena Volckmar, Daniel Kazdal, Ulrich M Gassner, Michael Vogeser, Monika Brüggemann, Karl-Friedrich Bürrig, Vanessa Kääb-Sanyal, Christa Flechtenmacher, Peter Schirmacher, Albrecht Stenzinger

Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation on medical devices (Regulation (EU) 2017/745, MDR) and the EU regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746, IVDR) resulted in a need for regulatory adjustments to German medical device law. This has created a new legal framework in which institutes for pathology operate, depending on their function as users, operators or in-house manufacturers of in vitro diagnostic medical devices. This overview of the current legal situation represents a snapshot and provides an up-to-date overview of the landscape of European and German medical device law.

病理机构是体外诊断医疗器械的操作者、使用者和内部制造商,并根据其职能受国家和欧洲法规的约束。欧盟医疗器械法规(Regulation (EU) 2017/745,MDR)和欧盟体外诊断医疗器械法规(Regulation (EU) 2017/746,IVDR)的生效导致德国医疗器械法需要进行法规调整。这创建了一个新的法律框架,病理机构可根据其作为体外诊断医疗器械的用户、运营商或内部制造商的职能,在此框架内开展业务。对当前法律状况的概述是对欧洲和德国医疗器械法的一个缩影和最新概述。
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引用次数: 0
Significance of EEG-electrode combinations while calculating filters with common spatial patterns. 在计算具有共同空间模式的滤波器时,脑电图电极组合的重要性。
Q1 Medicine Pub Date : 2024-09-25 eCollection Date: 2024-01-01 DOI: 10.3205/000334
Dominik Wetzel, Paul-Philipp Jacobs, Dirk Winkler, Ronny Grunert

Objective: Common spatial pattern (CSP) is a common filter technique used for pre-processing of electroencephalography (EEG) signals for imaginary movement classification tasks. It is crucial to reduce the amount of features especially in cases where few data is available. Therefore, different approaches to reduce the amount of electrodes used for CSP calculation are tried in this research.

Methods: Freely available EEG datasets are used for the evaluation. To evaluate the approaches a simple classification pipeline consisting mainly of the CSP calculation and linear discriminant analysis for classification is used. A baseline over all electrodes is calculated and compared against the results of the approaches.

Results: The most promising approach is to use the ability of CSP to provide information about the origin of the created filter. An algorithm that extracts the important electrodes from the CSP utilizing these information is proposed.The results show that using subject specific electrode positions has a positive impact on accuracy for the classification task. Further, it is shown that good performing electrode combinations in one session are not necessarily good performing electrodes in another session of the same subject. In addition to the combinations calculated using the developed algorithm, 26 additional electrode combinations are proposed. These can be taken into account when selecting well-performing electrode combinations. In this research we could achieve an accuracy improvement of over 10%.

Conclusions: Carefully selecting the correct electrode combination can improve accuracy for classifying an imaginary movement task.

目的:共空间模式(CSP)是一种常用的滤波技术,用于预处理脑电图(EEG)信号,以完成假想运动分类任务。减少特征数量至关重要,尤其是在可用数据较少的情况下。因此,本研究尝试了不同的方法来减少用于计算 CSP 的电极数量:方法:使用免费提供的脑电图数据集进行评估。为了评估这些方法,使用了一个简单的分类管道,主要包括 CSP 计算和用于分类的线性判别分析。计算出所有电极的基线,并与各种方法的结果进行比较:最有前途的方法是利用 CSP 的能力,提供有关所创建滤波器来源的信息。结果表明,使用特定对象的电极位置对分类任务的准确性有积极影响。此外,研究还表明,在某一疗程中表现良好的电极组合不一定在同一受试者的另一疗程中表现良好。除了使用开发的算法计算出的组合外,还提出了 26 种额外的电极组合。在选择性能良好的电极组合时,可以将这些因素考虑在内。在这项研究中,我们的准确率提高了 10%:仔细选择正确的电极组合可以提高假想运动任务分类的准确性。
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GMS German Medical Science
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