Pub Date : 2025-07-15eCollection Date: 2025-01-01DOI: 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.
{"title":"Prevalance and risk factors of congenital malaria in Osogbo, Southwestern Nigeria.","authors":"Saheed A Odediji, Surakat A Olabanji, Abdullahi O Olawuyi, Kazeem O Amoo, Basirat O Amoo-Adeboye, Monsuru A Adeleke","doi":"10.3205/000343","DOIUrl":"https://doi.org/10.3205/000343","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc07"},"PeriodicalIF":0.0,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12372249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144972998","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}
Pub Date : 2025-07-11eCollection Date: 2025-01-01DOI: 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.
{"title":"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.","authors":"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","doi":"10.3205/000342","DOIUrl":"https://doi.org/10.3205/000342","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc06"},"PeriodicalIF":0.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12372263/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973023","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}
Pub Date : 2025-07-11eCollection Date: 2025-01-01DOI: 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.
{"title":"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).","authors":"Michael Vogeser, Monika Brüggemann, Ulrich Sack, Albrecht Stenzinger, Henning Schliephake","doi":"10.3205/000341","DOIUrl":"https://doi.org/10.3205/000341","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc05"},"PeriodicalIF":0.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12372243/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144972972","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}
Pub Date : 2025-06-30eCollection Date: 2025-01-01DOI: 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.
{"title":"Socio-economic inequalities in the association between diabetes and labour force participation in Germany: A repeated cross-sectional study.","authors":"Malwina M Mackowiak, Ralph Brinks, Annika Hoyer, Ute Linnenkamp, Katharina Piedboeuf-Potyka, Markus Neuhäuser, Oliver Kuss, Thaddäus Tönnies","doi":"10.3205/000340","DOIUrl":"10.3205/000340","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc04"},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12247544/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144627367","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}
Pub Date : 2025-06-24eCollection Date: 2025-01-01DOI: 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.
{"title":"Evidence-based guideline diagnosis, treatment, prevention and aftercare of oropharyngeal and hypopharyngeal carcinoma.","authors":"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","doi":"10.3205/000339","DOIUrl":"10.3205/000339","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc03"},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12247573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144627365","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}
Pub Date : 2025-06-02eCollection Date: 2025-01-01DOI: 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.
{"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}
Pub Date : 2025-04-09eCollection Date: 2025-01-01DOI: 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
{"title":"Medical laboratory diagnostics in Germany - a status report 2024.","authors":"Michael Vogeser, Timo Schumacher, Frank Bühling","doi":"10.3205/000337","DOIUrl":"10.3205/000337","url":null,"abstract":"<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","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"23 ","pages":"Doc01"},"PeriodicalIF":0.0,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12101470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143884","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}
Pub Date : 2024-11-06eCollection Date: 2024-01-01DOI: 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.
{"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}
Pub Date : 2024-10-11eCollection Date: 2024-01-01DOI: 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.
{"title":"Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.","authors":"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","doi":"10.3205/000335","DOIUrl":"10.3205/000335","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"22 ","pages":"Doc09"},"PeriodicalIF":0.0,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142669505","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}
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.
{"title":"Significance of EEG-electrode combinations while calculating filters with common spatial patterns.","authors":"Dominik Wetzel, Paul-Philipp Jacobs, Dirk Winkler, Ronny Grunert","doi":"10.3205/000334","DOIUrl":"10.3205/000334","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%.</p><p><strong>Conclusions: </strong>Carefully selecting the correct electrode combination can improve accuracy for classifying an imaginary movement task.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"22 ","pages":"Doc08"},"PeriodicalIF":0.0,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142394073","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}