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Medical Training on Climate Change and Health: Evaluation of an Online Learning Format for Outpatient Care. [气候变化与健康的医生培训:门诊在线学习格式的评估]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2025-11-18 DOI: 10.1055/a-2750-5002
Stefanie Stark, Merle Klanke, Claudia Quitmann, Jessica Nieder, Alina Herrmann, Jörg Lindenthal, David Shimada, Veit Wambach, Fabio Alvarez, Irena Kaspar-Ott, Elke Hertig, Susann Hueber
{"title":"Medical Training on Climate Change and Health: Evaluation of an Online Learning Format for Outpatient Care.","authors":"Stefanie Stark, Merle Klanke, Claudia Quitmann, Jessica Nieder, Alina Herrmann, Jörg Lindenthal, David Shimada, Veit Wambach, Fabio Alvarez, Irena Kaspar-Ott, Elke Hertig, Susann Hueber","doi":"10.1055/a-2750-5002","DOIUrl":"10.1055/a-2750-5002","url":null,"abstract":"<p><strong>Background: </strong>Climate change increasingly affects public health and presents new challenges for outpatient care. Physicians require specific training opportunities to address these developments. As part of the project AdaptNet (\"Adapting primary and specialised outpatient care to the health impacts of climate change\"), an online training course on climate change and health was developed to provide essential foundational knowledge on climate-related health risks and adaptation strategies for medical practice. The aim of this study was to evaluate the training in terms of comprehensibility, applicability, and its relevance to medical practice.</p><p><strong>Methods: </strong>The training was provided as an online learning format. The evaluation followed a mixed-methods approach involving 23 general practitioners and specialised physicians from the Northern Bavaria region (Germany). Data collection included a standardised online questionnaire as well as structured group discussions. The analysis was guided by the Consolidated Framework for Implementation Research, with data being evaluated using qualitative content analysis and quantitative descriptive methods.</p><p><strong>Results: </strong>The quantitative analysis showed that the training was perceived as comprehensible, practically relevant, and well-structured. Participants considered the scope and duration of the training to be appropriate. The multimedia design was particularly positively highlighted. The qualitative results indicated increased awareness of climate-related health risks and a high perceived added value for medical practice. The training generated great interest among participants and was considered relevant for outpatient care. The flexible integration of the online format into daily work routines was seen as advantageous. Critical feedback referred to the lack of opportunities for interactive exchange and a desire for additional regional adaptation of the training content.</p><p><strong>Conclusion: </strong>Climate change and adaptation are recognised as relevant topics in medical practice and can be effectively and practically communicated in the outpatient sector through the online training developed specially for this purpose. Regional customisation of the training content appears sensible in order to address climate and health challenges more specifically. Online formats may prove to be suitable tools for effective knowledge transfer.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S220-S228"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145551349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Inpatient Endometriosis Care in Germany: Hospital Caseloads and their Spatial Distribution. 德国的住院子宫内膜异位症护理:医院病例量及其空间分布。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2025-11-03 DOI: 10.1055/a-2683-9705
Lara Brauer, Limei Ji, Max Geraedts
{"title":"Inpatient Endometriosis Care in Germany: Hospital Caseloads and their Spatial Distribution.","authors":"Lara Brauer, Limei Ji, Max Geraedts","doi":"10.1055/a-2683-9705","DOIUrl":"10.1055/a-2683-9705","url":null,"abstract":"<p><strong>Background: </strong>Endometriosis is a chronic gynaecological disease with an estimated prevalence of 10-15%. The German guideline provides evidence-based recommendations for diagnosis and treatment, but care provided is inadequate care due to long diagnostic pathways. Recent German research focused on regional variations in outpatient care, however research on inpatient endometriosis care is still lacking.</p><p><strong>Aim of the study: </strong>The aim of the study was to examine inpatient endometriosis care - hospital locations and their caseloads. Spatial coverage, caseload distribution patterns and possible clusters, including certified endometriosis centres (CEC) and non-certified hospitals nationwide were analysed.</p><p><strong>Method: </strong>German hospital quality report data from 2021 was used as data source. The location, certification status and caseload, meaning coded ICD-10 N80 Endometriosis cases, were collected for all hospitals. Then, 20-, 40- and 60-minutes' drive radius of CEC and non-certified hospitals were determined. Global and Local Moran's I was calculated to assess spatial clusters in caseload.</p><p><strong>Results: </strong>A CEC 60-minutes' drive radius covers 78.15% of the area in Germany. Including all hospital locations that coded endometriosis, a maximum driving time of 40-minutes provides almost nationwide coverage. High caseload clusters appeared in urban areas and low caseload clusters especially in eastern Germany.</p><p><strong>Conclusion: </strong>The results indicate spatial clusters in providers caseload and difficulties in access to CEC for patients depending on location. Further research with patient-level data is needed to investigate the spatial distribution of patients and precise travel time for inpatient care.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S199-S207"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145439714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Correction: Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. [更正:创新基金改善了医疗保健服务吗?在医疗保健实践中成功实施创新基金项目现状的关键评估]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2026-09-10 DOI: 10.1055/a-2945-0799
Christina Lindemann, Michaela Schunk, Laura Keßler, Thomas Bierbaum, Gerhard Bukow, Michael Eichinger, Erik Farin-Glattacker, Max Geraedts, Martin Härter, Heike Heytens, Andreas Meusch, Olaf Schoffer, Neeltje van den Berg, Horst Christian Vollmar, Milena von Kutzleben, Wolfgang Hoffmann, Jochen Schmitt
{"title":"[Correction: Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice].","authors":"Christina Lindemann, Michaela Schunk, Laura Keßler, Thomas Bierbaum, Gerhard Bukow, Michael Eichinger, Erik Farin-Glattacker, Max Geraedts, Martin Härter, Heike Heytens, Andreas Meusch, Olaf Schoffer, Neeltje van den Berg, Horst Christian Vollmar, Milena von Kutzleben, Wolfgang Hoffmann, Jochen Schmitt","doi":"10.1055/a-2945-0799","DOIUrl":"10.1055/a-2945-0799","url":null,"abstract":"","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":"88 8-09","pages":"e5"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13561638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148931325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Closure of child care centers and SARS-CoV-2 spread: A regional analysis of lockdown measures]. [托儿中心关闭与SARS-CoV-2传播:封锁措施的区域分析]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2026-02-27 DOI: 10.1055/a-2822-5812
Jorma Klebe, Fabian Standl, Heribert Stich
{"title":"[Closure of child care centers and SARS-CoV-2 spread: A regional analysis of lockdown measures].","authors":"Jorma Klebe, Fabian Standl, Heribert Stich","doi":"10.1055/a-2822-5812","DOIUrl":"10.1055/a-2822-5812","url":null,"abstract":"<p><strong>Background: </strong>On 11 March 2020, the World Health Organization (WHO) declared SARS-CoV-2 a pandemic. In the absence of specific vaccines or effective antiviral therapies at the beginning of the pandemic, non-pharmaceutical interventions (NPIs) were widely implemented, including temporary closures of day-care centers (Kitas).</p><p><strong>Methods: </strong>Using routinely reported case data from the Landshut Health Authority, we analyzed the period from November 2020 to February 2021. SARS-CoV-2 incidence before and after Kita closures was assessed for children aged 0-5 years and for the general population using an interrupted time series analysis (ITSA) with a negative binomial regression model.</p><p><strong>Results: </strong>Following Kita closures, reported SARS-CoV-2 infections decreased in both children aged 0-5 years (IRR: 0.96; 95% CI: 0.92-0.99) and the general population (IRR: 0.97; 95% CI: 0.95-0.98).</p><p><strong>Conclusion: </strong>These findings suggest that temporary Kita closures were associated with a reduction in reported SARS-CoV-2 infections and may have influenced pandemic transmission dynamics. However, potential socio-psychological impacts of Kita closures on children should be considered when evaluating NPIs and incorporated - without presupposing direction of effect - into preparedness planning for future pandemic events.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"552-558"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147318512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Position paper of the German Network for Health Care Research: What is health care research? 德国卫生保健研究网络的立场文件:什么是卫生保健研究?
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2025-08-28 DOI: 10.1055/a-2592-5998
Wolfgang Hoffmann, Martin Härter, Thomas Bierbaum, Lena Ansmann, Anna Levke Brütt, Karsten Dreinhöfer, Max Geraedts, Juliane Köberlein-Neu, Nadine Janis Pohontsch, Steffi Riedel-Heller, Horst Christian Vollmar, Milena von Kutzleben, Hauke Felix Wiegand, Fabian Baum, Larissa Burggraf, Lars Gabrys, Eva Grill, Uta Gühne, Antje Hammer, Lorenz Harst, Angélique Herrler, Anne Herrmann, Christian Heuser, Christoph Kowalski, Silke Kuske, Stefanie March, Anne Neumann, Stefan Nöst, Ivonne Panchyrz, Stefan Peters, Heinrich Recken, Elisabeth C Sturm-Inwald, Christian Thiel, Katharina van Baal, Holger Pfaff, Jochen Schmitt
{"title":"Position paper of the German Network for Health Care Research: What is health care research?","authors":"Wolfgang Hoffmann, Martin Härter, Thomas Bierbaum, Lena Ansmann, Anna Levke Brütt, Karsten Dreinhöfer, Max Geraedts, Juliane Köberlein-Neu, Nadine Janis Pohontsch, Steffi Riedel-Heller, Horst Christian Vollmar, Milena von Kutzleben, Hauke Felix Wiegand, Fabian Baum, Larissa Burggraf, Lars Gabrys, Eva Grill, Uta Gühne, Antje Hammer, Lorenz Harst, Angélique Herrler, Anne Herrmann, Christian Heuser, Christoph Kowalski, Silke Kuske, Stefanie March, Anne Neumann, Stefan Nöst, Ivonne Panchyrz, Stefan Peters, Heinrich Recken, Elisabeth C Sturm-Inwald, Christian Thiel, Katharina van Baal, Holger Pfaff, Jochen Schmitt","doi":"10.1055/a-2592-5998","DOIUrl":"10.1055/a-2592-5998","url":null,"abstract":"<p><strong>Abstract: </strong>The scope and definition of health care research is a matter of discussion in our scientific community. The Board of the German Network for Health Care Research has drafted a position paper that was extensively reviewed and commented upon by all working groups and specialist groups of the network. The present version represents consented common grounds to a large degree but is neither complete nor final. We consider this position paper a living document that will evolve and further converge in an ongoing discussion in the network.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S208-S213"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144974136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Methods for health economic evaluation of complex interventions in healthcare: current practice, challenges and guidance for future research. [卫生保健复杂干预措施的卫生经济评价方法:当前实践、挑战和对未来研究的指导]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2025-03-31 DOI: 10.1055/a-2569-9765
Nadja Chernyak, Damon Mohebbi, Adrienne Alayli, Johann Behrens, Helene Eckhardt, Cornelia Henschke, Rolf Holle, Nadja Kairies-Schwarz, Sebastian Liersch, Ralph Möhler, Dirk Müller, Anja Neumann, Markus Vomhof, Ingrid Zechmeister-Koss, Juliane Köberlein-Neu, Andrea Icks
{"title":"Methods for health economic evaluation of complex interventions in healthcare: current practice, challenges and guidance for future research.","authors":"Nadja Chernyak, Damon Mohebbi, Adrienne Alayli, Johann Behrens, Helene Eckhardt, Cornelia Henschke, Rolf Holle, Nadja Kairies-Schwarz, Sebastian Liersch, Ralph Möhler, Dirk Müller, Anja Neumann, Markus Vomhof, Ingrid Zechmeister-Koss, Juliane Köberlein-Neu, Andrea Icks","doi":"10.1055/a-2569-9765","DOIUrl":"10.1055/a-2569-9765","url":null,"abstract":"<p><strong>Abstract: </strong>Health economic methods can support the development and evaluation of new healthcare interventions by generating data on the resources used and relating these to a defined benefit. However, the standard methodology of health economic evaluation that is usually used does not do justice to the high degree of complexity of interventions in healthcare. As a result, there is a lack of decision-relevant information, for example, on the preferences of the target group, on spillover effects on the part of carers, or on implementation costs and the role of different contexts in the implementation of interventions into routine care. The UK Medical Research Council's (MRC) standard-setting framework for complex interventions therefore emphasises the need to incorporate health economic aspects more strongly into all phases of the development and evaluation of complex interventions. To make this possible, the MRC's recommendations for expanding and adapting the standard methodology of health economic evaluation must be concretised and supplemented. Building on already established methodological procedures, recommendations should be developed and proposals for necessary further research formulated.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S186-S190"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transferring Knowledge on Patient-Centered Care through the Establishment of an International Network. [N / A]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2025-07-31 DOI: 10.1055/a-2673-6046
Nadine Lages, Isabelle Scholl, Constanza Quezada, Pola Hahlweg, Stefan Zeh, Angelina Dois, Paulina Bravo, Martin Härter
{"title":"Transferring Knowledge on Patient-Centered Care through the Establishment of an International Network.","authors":"Nadine Lages, Isabelle Scholl, Constanza Quezada, Pola Hahlweg, Stefan Zeh, Angelina Dois, Paulina Bravo, Martin Härter","doi":"10.1055/a-2673-6046","DOIUrl":"10.1055/a-2673-6046","url":null,"abstract":"<p><strong>Background: </strong>Patient-centered care (PCC) is a key principle of high-quality health care and is becoming increasingly relevant in many countries. In 2006, Chile declared PCC as a fundamental pillar of its health care system. However, PCC implementation in the Chilean healthcare system is still lagging. Some factors contributing to this are 1) the complexity of the concept, 2) the interdependence between healthcare activities and policy regulations, and 3) the need for a cultural change in health politics and care. This paper shares experiences of how we have tried to address some of these challenges by establishing an international network for PCC.</p><p><strong>Methods: </strong>As part of a collaborative project between researchers and clinicians based in Chile and Germany, have established the International Network for Patient-Centered Care (PCC NET) that enables knowledge exchange and trainings through different means.</p><p><strong>Results: </strong>A website was developed and launchedas a platform to share knowledge. Furthermore, a series of online seminars on PCC was organized, each conducted by an international expert in the field. In January 2023, several face-to-face were held in Chile attended by 51 participants, comprising health care professionals responsible for implementing PCC in the country, those working for the Ministry of Health or those in primary care in Chile. Workshops were evaluated by assessing the participants&apos; reactions via surveys, and the participants rated the workshops positively. In January 2024, the first Latin American Conference on Patient-Centered Care was implemented in Santiago de Chile. There were four keynotes, two roundtables, five workshops, 31 oral and 19 poster presentations from both research and clinical practice during the two conference days with 196 participants on location.</p><p><strong>Conclusion: </strong>Establishing the PCC NET has facilitated international collaboration, knowledge exchange, and capacity-building for PCC implementation in Chile. Through different communication strategies, such as workshops, seminars and a conference, it was possible to enhance awareness and practical knowledge among healthcare professionals and policymakers. These initiatives represent significant steps toward advancing PCC in Chile, although continued efforts are needed to address remaining challenges and sustain momentum in policy and practice.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S191-S198"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144761785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cross-sectoral physical activity-related health services: a qualitative study on the tasks and competencies in network coordination using the example of the Network ActiveOncoKids (NAOK). [跨部门运动供应-以ActiveOncoKids网络(NAOK)为例,对网络协调中的任务和能力进行定性研究]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2026-01-14 DOI: 10.1055/a-2786-4697
Stefan Peters, Hannah Bleier, Lea A L Dejonghe, Andrea Schaller
{"title":"Cross-sectoral physical activity-related health services: a qualitative study on the tasks and competencies in network coordination using the example of the Network ActiveOncoKids (NAOK).","authors":"Stefan Peters, Hannah Bleier, Lea A L Dejonghe, Andrea Schaller","doi":"10.1055/a-2786-4697","DOIUrl":"10.1055/a-2786-4697","url":null,"abstract":"<p><strong>Background: </strong>Pediatric cancer leads to various health issues that call for long-term, cross-sectoral aftercare. Physical activity and exercise are effective regarding many outcomes, but remain underused in pediatric oncology. Initiatives like the German ActiveOncoKids network (NAOK) aim to integrate physical activity into usual care. Effective cross-sectoral networks require coordination and leadership. NAOK has made recent advancements in network coordination. This study aimed to better understand the role of network coordination to strengthen future network development and explored the tasks of network coordination and the required competencies from the viewpoint of NAOK stakeholders.</p><p><strong>Methods: </strong>In an exploratory approach, qualitative, partly structured interviews were led with 23 stakeholders of NAOK: members of the project team and the advisory board, physicians and exercise therapists from acute clinics and aftercare as well as affected families. The interviews were analyzed using structuring content analysis with concurrent deductive and inductive creation of main categories, dimensions and expressions.</p><p><strong>Results: </strong>Based on the interviews, 3 main categories were created: current tasks on an organizational level, current tasks on an individual level and required competencies with 11 dimensions and 33 expressions overall. Regarding organizational-level tasks, network management as well as public relations were mentioned. Additionally, contact with locations such as clinics and both research and implementation efforts were stressed. Tasks at the individual level were identified by interviewees in counseling for both affected families as well as professionals. Mentioned competencies stretched across professional, socio-communicative and personal ones.</p><p><strong>Conclusion: </strong>The findings provide first insights into tasks and competencies in network coordination at NAOK. Both tasks and competencies that are being mentioned are very broad, which reflects the nature of pediatric oncology and cross-sectoral physical activity promotion. The study offers hints for future task allocation of network coordination and indicates the need for a competency framework.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S237-S246"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145985903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Integration of Real-World Data into Clinical Trials: An Interdisciplinary Discussion from Regulatory and Practical Perspectives. 将真实世界的数据整合到临床试验中:从监管和实践的角度进行跨学科讨论。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2026-02-23 DOI: 10.1055/a-2736-6561
Jeanette Köppe, Anja Schiel, Christoph Gerlinger, Heiko Götte, Dominic Edelmann, Stella Erdmann
{"title":"Integration of Real-World Data into Clinical Trials: An Interdisciplinary Discussion from Regulatory and Practical Perspectives.","authors":"Jeanette Köppe, Anja Schiel, Christoph Gerlinger, Heiko Götte, Dominic Edelmann, Stella Erdmann","doi":"10.1055/a-2736-6561","DOIUrl":"10.1055/a-2736-6561","url":null,"abstract":"<p><strong>Background: </strong>Increasing efforts are required to integrate the growing volume of so-called real-world data (also named routine practice data), which are data generated outside of randomized controlled trials, into regulatory studies. Various stakeholders anticipate that such integration could save time and financial resources during the approval process of new therapies, and ethical considerations also partially support such an approach. The aim of this manuscript is to provide an overview of the methodological, ethical, and regulatory considerations when integrating routine practice data into randomized controlled trials. It targets clinical researchers, biostatisticians, regulators, and decision-makers involved in evidence generation and trial design.</p><p><strong>Results: </strong>The inclusion of real-world data in randomized controlled trials can be meaningful from both ethical and economic perspectives. However, implementing this requires addressing various and sometimes significant limitations of the data, which need to be methodologically addressed. Therefore, it is essential to carefully weigh the risks and benefits of incorporating real world data into clinical studies.</p><p><strong>Conclusion: </strong>Randomized trials remain the gold standard for evaluating the efficacy of new therapies. Nevertheless, real-world data have the potential to improve the complex and costly process of drug development. The assessment of the potential for a specific clinical study should be made in collaboration with all relevant stakeholders. Apart from that, real-world data have a substantial potential to expand the evidence from randomized trials after post-market approval, thereby ensuring the safety of all patients.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"S214-S219"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Formal quality of electronic discharge prescriptions and estimated supply by community pharmacies]. [社区药房电子出院处方的正规质量及估计供应]。
IF 1.1 4区 医学
Gesundheitswesen Pub Date : 2026-08-01 Epub Date: 2025-08-08 DOI: 10.1055/a-2643-5891
Sophia Klasing, Janina A Bittmann, Christine K Faller, Michael Metzner, Hanna M Seidling
{"title":"[Formal quality of electronic discharge prescriptions and estimated supply by community pharmacies].","authors":"Sophia Klasing, Janina A Bittmann, Christine K Faller, Michael Metzner, Hanna M Seidling","doi":"10.1055/a-2643-5891","DOIUrl":"10.1055/a-2643-5891","url":null,"abstract":"<p><strong>Introduction: </strong>To ensure continuous medication supply after hospital discharge, German hospitals are allowed to issue discharge prescriptions since 2017 with the requirement to issue electronically since 2025. It is known that 44% of those prescriptions are not filled in on the same day; however, it remains unknown whether these delays are caused by the patient, drug shortages, or difficulties in processing the prescription in the community pharmacies as e. g. formal errors of prescriptions. As the latter are reported by surveyed community pharmacies for paperbased prescriptions, we analysed the formal quality of electronic discharge prescriptions. Additionally, we simulated the dispensing process in the community pharmacy to estimate how well discharge prescriptions can be delivered.</p><p><strong>Methods: </strong>We drew a prospective sample of signed electronic discharge prescription from the University Hospital Heidelberg and conducted descriptive analysis: The formal quality was assessed with regard to the validity and eligibility for reimbursement. In a natural experiment, six community pharmacies assessed at least 100 discharge prescriptions regarding whether the medicinal product (a) would have been on stock, (b) could have been delivered by the main pharmaceutical wholesaler, or (c) a partner pharmacy or a different wholesaler, or (d) could not have been supplied within a short period of time.</p><p><strong>Results: </strong>In total, 484 electronic prescriptions were included (15.10. - 29.11.2024) belonging to 117 patient cases. 479 electronic prescription were documented via central pharmaceutical number and classified as valid as the name of the medicinal product, strength, form of application, amount to be dispensed and dosage were documented. In terms of reimbursement, all prescriptions contained the speciality of the physician and in 79.3% the smallest package size was prescribed. On average, the six community pharmacies assessed 335 [121-380] discharge prescriptions. In 43.5%-60.3% cases the medicinal product would have been on stock (a) and 37.9%-53.6% of prescriptions could have been delivered by the main pharmaceutical wholesaler (4.3 daily tours). The availability did not differ significantly between the pharmacies.</p><p><strong>Conclusion: </strong>While paperbased discharge prescriptions were described as errorprone, there were no formal errors in the electronic prescriptions analysed that would have disrupted the medication supply. The prescribed medicinal products were avalaible in nearly all cases at least until the next delivery of the main wholesaler.</p>","PeriodicalId":47653,"journal":{"name":"Gesundheitswesen","volume":" ","pages":"534-536"},"PeriodicalIF":1.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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