Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen最新文献

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EbM und Gesundheitspolitik heute – und morgen? EBM 和卫生政策的今天--以及明天？

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.08.003

Jürgen Windeler

引用次数: 0

Versorgungsqualität und -sicherheit nach Implantation eines Linksherzunterstützungssystems: eine qualitative Studie zur Patient*innenperspektive auf relevante Versorgungsaspekte [从患者角度看左心室辅助装置治疗的医疗质量和安全：关于护理相关方面的定性研究]。

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.07.001

Michael Levelink , Anna Levke Brütt

Introduction

Implantation of a left ventricular assist device (LVAD) requires extensive aftercare. It is largely unclear how aftercare should be designed from the patients’ perspective. Implications can be developed based on an examination of the healthcare context. Its main components are mapped on five tiers in the Human Factors of Home Health Care Model by Henriksen, Joseph, and Zayas-Caban (2009). Using this model, the present study explores the patient perspective on the context of healthcare after an LVAD implantation.

Methods

We employed a qualitative cross-sectional study, in which LVAD patients participated in semi-structured interviews. The transcribed interviews were analyzed using content analysis. First, relevant meaning units were identified and deductively categorized into the model. Then, categories of care-related aspects were developed inductively within each of the model tiers.

Results

We interviewed 18 patients aged 33 to 78 years who had been living with the LVAD between a few weeks and more than 10 years. Twenty-eight categories related to care aspects were developed within the model tiers: 3 categories on patient characteristics (e. g., self-management skills), 3 on caregiver characteristics (e. g., professionalism), 11 healthcare-related tasks and requirements (e. g., wound management), 8 on factors of the physical environment (e. g., controllability), medical devices and technologies (e. g., carrying systems for external components), and cultural, social and community environment (e. g., interaction with peers), as well as 3 on external environmental factors (e. g., healthcare infrastructure).

Discussion

The present study represents the first investigation focusing on aspects of the healthcare context influencing healthcare quality and safety from the perspective of LVAD patients in Germany. LVAD aftercare covers a broad and complex range of tasks. For this, patients, caregivers and healthcare professionals need specific knowledge, which is lacking in various respects. In the first place, this is compensated by the patients’ own initiative and the personal care provided by the VAD outpatient clinics.

Conclusion

Three key recommendations to optimize aftercare from the patient perspective are derived: Patients would benefit from a more flexible and decentralized aftercare concept, to which telemedicine could contribute. LVAD-specific expertise among general healthcare providers is perceived as insufficient by patients and could be strengthened through training and counseling services. The broad scope of tasks and the high level of responsibilities in LVAD aftercare pose challenges for patients and their families, which could be addressed through continuous information and training programs.

导言：左心室辅助装置（LVAD）的植入需要大量的术后护理。从患者的角度来看，目前还不清楚应该如何设计术后护理。我们可以根据对医疗环境的考察来制定相关方案。在 Henriksen、Joseph 和 Zayas-Caban（2009 年）所著的 "家庭医疗护理人因模型"（Human Factors of Home Health Care Model）中，家庭医疗护理的主要组成部分被划分为五个层次。本研究利用这一模型，从患者的角度探讨了植入 LVAD 后的医疗环境：我们采用了定性横断面研究，LVAD 患者参与了半结构化访谈。我们采用内容分析法对转录的访谈内容进行了分析。首先，确定相关的意义单元，并将其演绎归类到模型中。然后，在每个模型层中归纳出护理相关方面的类别：我们采访了 18 名年龄在 33 岁至 78 岁之间的患者，他们使用 LVAD 的时间从几周到超过 10 年不等。在各模型层级中，共制定了 28 个与护理相关的类别：3个类别涉及患者特征（如自我管理技能），3个类别涉及护理人员特征（如专业性），11个类别涉及医疗相关任务和要求（如伤口管理），8个类别涉及物理环境因素（如可控性）、医疗设备和技术（如外部组件的携带系统）、文化、社会和社区环境（如与同伴的互动），以及3个类别涉及外部环境因素（如医疗基础设施）：本研究是首次从德国 LVAD 患者的角度出发，对影响医疗质量和安全的医疗环境方面进行的调查。LVAD 术后护理涉及广泛而复杂的任务。为此，患者、护理人员和医疗保健专业人员需要专门的知识，而这些知识在各方面都很缺乏。首先，患者自身的主动性和 VAD 门诊提供的个人护理弥补了这一不足：结论：从患者角度出发，提出了优化术后护理的三大建议：患者将从更加灵活和分散的术后护理理念中获益，而远程医疗可以为此做出贡献。患者认为普通医疗服务提供者在 LVAD 方面的专业知识不足，可以通过培训和咨询服务来加强。LVAD 术后护理的任务范围广、责任重大，这给患者及其家属带来了挑战，可以通过持续的信息和培训计划来解决。

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引用次数: 0

Inhaltsverzeichnis / Table of Contents 目录

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/S1865-9217(24)00164-8

引用次数: 0

Kontinuierliche Überwachung von SARS-CoV-2 Infektionen in Kindertagesstätten: eine qualitative Interviewstudie über die Erfahrungen von Betreuer*innen und Eltern mit verschiedenen Testverfahren im häuslichen Umfeld [日托中心的 SARS-CoV-2 持续监测：关于保育员和家长在家庭环境中使用不同自我采样方法的经验的定性访谈研究]。

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.07.002

Maike Krauthausen , David Gierszewski , Andrea Streng , Johannes Forster , Geraldine Engels , Franziska Pietsch , Julia Wallstabe , Thomas Jans , Viktoria Rücker , Marcel Romanos , Peter Heuschmann , Lars Dölken , Christoph Härtel , Oliver Kurzai , Johannes Liese , Ildikó Gágyor , Wü-KiTa-CoV-Studiengruppe

Background

Since the beginning of the corona pandemic in Germany in January 2020, day care centres (DCC) have faced the challenge of reliably detecting cases of SARS-CoV-2 infection as early and reliably as possible in order to avoid major outbreaks and closures. Conducting regular virological screening tests for asymptomatic DCC children and childcare workers requires a high level of acceptance among participants and should be as easy as possible to implement. The present study aimed to evaluate childcare workers’ and parents’ attitudes and experiences regarding the acceptance and feasibility of various screening methods. This assessment was conducted using additional qualitative interviews designed for home-based screening in the context of a screening study in DCCs.

Method

From May to July 2021, childcare workers and parents of children in nine DCCs in Wuerzburg independently carried out screening tests for SARS-CoV-2 at home twice a week as part of the “Würzburg Child Care Study in the COVID-19 Pandemic 2.0”. The participants were offered two self-sampling methods (mouth-rinsing fluid for pooled PCR tests and/or nasal rapid antigen self-tests). Before and after the 12-week test phase, telephone interviews were conducted with a selected sample of childcare workers and parents in order to ascertain initial attitudes and further experiences with the two self-sampling methods and their implementation. The interviews were fully transcribed for analysis and subjected to a qualitative content analysis according to Kuckartz.

Results

Of the 1,026 eligible participants, 591 individuals, including 139 childcare workers and the parents of 452 children, agreed to take part in the screening tests. A total of 49 interviews were conducted with a specifically selected sample (20 before the start of the test, 29 after the end of the test). In the qualitative content analysis, three overarching topics emerged: ‘aspects of the test performance’, ‘aspects of the perception of safety’ and ‘aspects of the testing in children’. Regardless of the fact that the various test methods and test features were perceived very differently, conducting the tests at home was found to be feasible.

Discussion

The differentiated insights into the participants’ perspectives provide valuable information about factors that influence the acceptance of self-testing. These should be taken into account before such a measure is introduced in DCCs if necessary.

Conclusion

The assessment of test procedures is strongly influenced by individual preferences. Test concepts should be implemented with as little time and organisational effort as possible in order to promote willingness to participate. Clear study information and quick feedback on test results can enhance the sense of security among parents and childcare workers.

背景：自 2020 年 1 月日冕大流行在德国开始以来，日托中心（DCC）就面临着一个挑战，即如何尽可能早地可靠检测出 SARS-CoV-2 感染病例，以避免重大疫情的爆发和关闭。对无症状的 DCC 儿童和保育员进行定期病毒学筛查需要参与者的高度认可，并应尽可能简单易行。本研究旨在评估保育员和家长对各种筛查方法的接受程度和可行性的态度和经验。这项评估是在幼儿保育中心筛查研究的背景下，利用为家庭筛查设计的额外定性访谈进行的：2021 年 5 月至 7 月，维尔茨堡 9 家幼儿保育中心的保育员和儿童家长每周两次在家独立进行 SARS-CoV-2 筛查测试，这是 "COVID-19 大流行 2.0 维尔茨堡幼儿保育研究 "的一部分。研究人员为参与者提供了两种自我采样方法（漱口液用于 PCR 检测和/或鼻腔快速抗原自我检测）。在为期 12 周的测试阶段之前和之后，我们对选定的儿童保育员和家长样本进行了电话访谈，以了解他们对两种自我采样方法及其实施的初步态度和进一步体验。访谈内容已全部转录，并按照库卡茨的方法进行了定性内容分析：在 1026 名符合条件的参与者中，有 591 人同意参加筛选测试，其中包括 139 名保育员和 452 名儿童的家长。我们对专门挑选的样本进行了 49 次访谈（20 次在测试开始前，29 次在测试结束后）。在定性内容分析中，出现了三个主要议题："测试表现方面"、"安全感方面 "和 "儿童测试方面"。尽管对各种测试方法和测试特点的看法大相径庭，但在家中进行测试被认为是可行的：讨论：对参与者观点的不同看法为了解影响自我检测接受度的因素提供了宝贵的信息。讨论：对参与者观点的不同见解提供了有关影响自我检测接受度的因素的宝贵信息，如有必要，在残疾儿童中心引入这一措施前应考虑到这些因素：对测试程序的评估深受个人偏好的影响。测试概念的实施应尽可能减少时间和组织工作，以提高参与意愿。明确的研究信息和对测试结果的快速反馈可以增强家长和保育员的安全感。

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引用次数: 0

Complex primary care for multimorbid patients in the Netherlands: Interprofessional perspectives within and beyond general practice 荷兰多病患者的复杂初级保健：全科医生内外的跨专业视角。

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.08.002

Marloes A. van Bokhoven , Robin Brünn , Marjan van den Akker

Many consultations in general practice concern patients with multimorbidity, pressuring our healthcare systems with complex care needs. The number of people affected from multimorbidity is still increasing, as is the average number of co-occurring diseases per patient. The resulting complexity of care needs cannot be managed by health professionals from a single discipline, but requires interprofessional collaborative practice.

This paper describes best practices from the Netherlands to facilitate interprofessional caretaking of patients with multimorbidity in primary care. The focus here is on collaborations within general practice and at community level.

全科医学中的许多咨询都涉及到多病症患者，复杂的护理需求给我们的医疗系统带来了压力。多重疾病患者的人数仍在不断增加，每位患者并发疾病的平均数量也在不断增加。由此产生的复杂护理需求无法由单一学科的医疗专业人员来管理，而需要跨专业的合作实践。本文介绍了荷兰在初级医疗中促进跨专业护理多发病患者的最佳实践。本文的重点是全科医生内部和社区层面的合作。

引用次数: 0

Liste der Affiliierten Institute und Fachgesellschaften / List of Affiliations Affiliierten Institute und Fachgesellschaften / 关联机构列表

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/S1865-9217(24)00166-1

引用次数: 0

Arzneimittelzulassung im Bereich seltener Erkrankungen: die europäische regulatorische Perspektive am Beispiel der Gen- und Zelltherapeutika [罕见疾病的上市许可：以基因和细胞疗法为例的欧洲监管视角]。

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.08.007

Martina Schüßler-Lenz , Benjamin Hofner

Technological and scientific innovations in the area of gene and cell therapies, so-called advanced therapy medicinal products (ATMPs), have contributed to the steep increase in treatment options for patients with rare diseases. They offer opportunities to address the underlying genetic defect by gene addition, i.e., the delivery of the gene of interest to the target cells, or by genome editing approaches through direct repair of disease-causing mutations. This paper outlines clinical evidence requirements in the context of marketing authorisations for rare diseases. Two out of fifteen gene therapies that have been approved in the European Union since 2018 are used as case studies: Libmeldy (atidarsagen autotemcel) for the treatment of patients with metachromatic leukodystrophy, and Roctavian (valoctocogen roxaparvovec) for the treatment of patients with haemophilia A. Special aspects of the evaluation of single-arm trials with small sample size and requirements with regard to the isolation and causal attribution of the treatment effect are discussed. The role of clinical data obtained under everyday conditions (real world data) to support the generation of evidence in the pre- and post authorisation phase is critically examined. Furthermore, the paper outlines aspects related to conditional versus standard marketing authorisations as well as aspects related to registry-based non-interventional studies in the context of market and patient access to urgently needed drugs.

基因和细胞疗法（即所谓的先进治疗药物产品（ATMP））领域的技术和科学创新为罕见病患者治疗选择的急剧增加做出了贡献。它们提供了通过基因添加（即向靶细胞传递相关基因）或通过直接修复致病突变的基因组编辑方法来解决潜在基因缺陷的机会。本文概述了罕见病上市许可对临床证据的要求。本文以 2018 年以来欧盟批准的 15 种基因疗法中的两种作为案例研究：讨论了样本量较小的单臂试验评估的特殊方面，以及治疗效果的分离和因果关系归因方面的要求。本文对在日常条件下获得的临床数据（真实世界数据）在授权前和授权后阶段支持证据生成的作用进行了严格审查。此外，本文还概述了有条件上市授权与标准上市授权的相关问题，以及在急需药品的市场和患者准入方面与基于登记册的非干预性研究相关的问题。

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Herausgeberkollegium / Editorial Board 编辑委员会

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/S1865-9217(24)00163-6

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Testimonial: Leben mit einer Seltenen Erkrankung: suchen, kämpfen, hoffen 感言：与罕见病共存：寻找、抗争、希望

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.07.005

Michael Scholz, Christine Mundlos, Mirjam Mann

引用次数: 0

Psychische Belastungen und Auffälligkeiten von Kindern und Eltern im Verlauf der COVID-19-Pandemie (2020–2022) [COVID-19大流行期间（2020-2022年）儿童及其父母的心理困扰和心理健康问题]。

IF 1.4 Q4 HEALTH POLICY & SERVICES

Zeitschrift fur Evidenz Fortbildung und Qualitaet im Gesundheitswesen

Pub Date : 2024-09-01 DOI: 10.1016/j.zefq.2024.06.006

Ann-Kathrin Napp , Martha Gilbert , Anne Kaman , Sophie Möller , Janine Devine , Michael Erhart , Ulrike Ravens-Sieberer

Introduction

The COVID-19 pandemic and accompanying containment measures created major changes to everyone’s daily life that had an impact on mental health and psychological burden.

Methods

In five surveys of the COPSY study more than 1,500 parents of 7- to 17-year-olds and their children between the ages of 11 and 17 were interviewed using established mental health assessment tools and a self-developed item on the experience of mental burden. Pre-pandemic comparative data were drawn from the representative BELLA study (BEfragung zum seeLischen Wohbefinden und VerhAlten).

Results

The majority of children and adolescents as well as their parents in Germany felt stressed by the pandemic between 2020 and 2022. There was an increase in both mental health problems and symptoms of anxiety and depression at the beginning of the COVID-19 pandemic and during the second nationwide lockdown. A slight decrease in the subjective experience of psychological burden and mental health problems among children and their parents was observed in the fall of 2022. However, the prevalence of mental health problems and anxiety remained above pre-pandemic levels.

Discussion

The results illustrate the difficult situation of many children, adolescents and parents, even after 3 years of pandemic. Low-threshold counseling and support services as well as more therapy places and professional support services should be made available.

引言COVID-19 大流行和随之而来的遏制措施给每个人的日常生活带来了重大变化，对心理健康和心理负担产生了影响：在 COPSY 研究的五次调查中，1500 多名 7 至 17 岁儿童的父母及其 11 至 17 岁的子女接受了访谈，访谈中使用了成熟的心理健康评估工具和自行开发的心理负担体验项目。大流行前的对比数据来自具有代表性的 BELLA 研究（BEFragung zum seeLischen Wohbefinden und VerhAlten）：结果：2020 年至 2022 年期间，德国大多数儿童和青少年及其父母都感到大流行带来的压力。在 COVID-19 大流行初期和第二次全国封锁期间，心理健康问题以及焦虑和抑郁症状都有所增加。2022 年秋季，儿童及其家长的主观心理负担和心理健康问题略有减少。然而，心理健康问题和焦虑的发生率仍高于大流行前的水平：讨论：研究结果表明，即使在大流行 3 年后，许多儿童、青少年和家长的处境依然艰难。应提供低门槛的咨询和支持服务，以及更多的治疗场所和专业支持服务。

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