GMS German Medical Science最新文献

{"title":"S2k guideline diagnosis and treatment of carbon monoxide poisoning.","authors":"Björn Jüttner, Hans-Jörg Busch, Andreas Callies, Harald Dormann, Thorsten Janisch, Guido Kaiser, Hella Körner-Göbel, Karsten Kluba, Stefan Kluge, Bernd A Leidel, Oliver Müller, Johannes Naser, Carsten Pohl, Karl Reiter, Dietmar Schneider, Enrico Staps, Wilhelm Welslau, Holger Wißuwa, Gabriele Wöbker, Cathleen Muche-Borowski","doi":"10.3205/000300","DOIUrl":"10.3205/000300","url":null,"abstract":"<p><p>Carbon monoxide (CO) can occur in numerous situations and ambient conditions, such as fire smoke, indoor fireplaces, silos containing large quantities of wood pellets, engine exhaust fumes, and when using hookahs. Symptoms of CO poisoning are nonspecific and can range from dizziness, headache, and angina pectoris to unconsciousness and death. This guideline presents the current state of knowledge and national recommendations on the diagnosis and treatment of patients with CO poisoning. The diagnosis of CO poisoning is based on clinical symptoms and proven or probable exposure to CO. Negative carboxyhemoglobin (COHb) levels should not rule out CO poisoning if the history and symptoms are consistent with this phenomenon. Reduced oxygen-carrying capacity, impairment of the cellular respiratory chain, and immunomodulatory processes may result in myocardial and central nervous tissue damage even after a reduction in COHb. If CO poisoning is suspected, 100% oxygen breathing should be immediately initiated in the prehospital setting. Clinical symptoms do not correlate with COHb elimination from the blood; therefore, COHb monitoring alone is unsuitable for treatment management. Especially in the absence of improvement despite treatment, a reevaluation for other possible differential diagnoses ought to be performed. Evidence regarding the benefit of hyperbaric oxygen therapy (HBOT) is scant and the subject of controversy due to the heterogeneity of studies. If required, HBOT should be initiated within 6 h. All patients with CO poisoning should be informed about the risk of delayed neurological sequelae (DNS).</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc13"},"PeriodicalIF":0.0,"publicationDate":"2021-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8607608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39693393","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}

{"title":"Relationship between cerebrospinal fluid protein level and electrophysiologic abnormalities in the acute inflammatory demyelinating polyradiculoneuropathy variant of Guillain-Barré syndrome.","authors":"Wajid Jawaid,&nbsp;Rabia Sana,&nbsp;Sumera Rafat Umer,&nbsp;Qamar Nisa,&nbsp;Mehwish Butt,&nbsp;Naila Shahbaz","doi":"10.3205/000299","DOIUrl":"https://doi.org/10.3205/000299","url":null,"abstract":"<p><p><b>Objective:</b> Guillain-Barré syndrome (GBS) is an autoimmune disease characterized by weakness in limbs or cranial nerve innervated muscles. Acute inflammatory demyelinating polyradiculoneuropathy (AIDP) is the most common variant. Electrophysiologic abnormalities and elevated cerebrospinal fluid (CSF) protein are frequently present in AIDP, but the relationship between these two parameters is not well known. We aimed to fill this gap by studying this relationship. <b>Methods:</b> This was a prospective cross-sectional study conducted for two years in the Department of Neurology, Dr. Ruth K. M. Pfau Civil Hospital, Karachi, Pakistan. All 90 adult patients with the AIDP variant of GBS were selected. Nerve conduction studies were performed to determine the degree of demyelination through the four electrophysiologic demyelination criteria. The CSF sample was sent to lab immediately after lumbar puncture. SPSS version 20.0 was used. The CSF protein level was measured with mean ±SD. Demyelination criteria were measured in frequency and percentages. Chi-square test was applied to a number of demyelination criteria and T-test/ANOVA was applied on mean CSF protein level. <b>Results:</b> We found a mean CSF protein of 37.41 mg/dl (±3.69) with one demyelination criterion, 81.87 mg/dl (±17.39) with two demyelination criteria, 119.75 mg/dl (±31.42) with three demyelination criteria, and 134.00 mg/dl (±42.87) with four demyelination criteria (P-value <0.001). <b>Conclusion:</b> This study demonstrates a significant relationship between CSF protein levels and degree of demyelination in the AIDP variant of GBS. This is an under-researched area in GBS and this study adds favorably to limited data in this regard.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc12"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8422794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39429875","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}

{"title":"Impaired psychological well-being of healthcare workers in a German department of anesthesiology is independent of immediate SARS-CoV-2 exposure - a longitudinal observational study.","authors":"Benedikt Schmid,&nbsp;Stefan M Schulz,&nbsp;Michael Schuler,&nbsp;Dennis Göpfert,&nbsp;Grit Hein,&nbsp;Peter Heuschmann,&nbsp;Thomas Wurmb,&nbsp;Paul Pauli,&nbsp;Patrick Meybohm,&nbsp;Heike L Rittner","doi":"10.3205/000298","DOIUrl":"https://doi.org/10.3205/000298","url":null,"abstract":"<p><p><b>Background:</b> The study aimed to assess the mental well-being of healthcare professionals at a German department of anesthesiology and critical care with a specialized ICU for treatment of COVID-19 patients during the first two peaks of the 2020 pandemic, and identifying risk and protective factors. <b>Methods:</b> A single-center longitudinal, online-based survey was conducted in healthcare workers from a department of anesthesiology and critical care in Bavaria, the most affected federal state in Germany at the time of assessment. Validated scores for depression, anxiety, somatic disorders, burnout, resilience, and self-management were used and complemented by questions about perceived COVID-19-related stressors. In parallel, patient characteristics in the ICU were collected. <b>Results:</b> 24 and 23 critically ill COVID-19 patients were treated during both observation periods in April/May and November/December 2020, respectively. 87.5% and 78.2% of patients had moderate to severe acute respiratory distress syndrome. From March 6, 2020 onwards, the hospital had switched to a command and control-based hospital incident command system (HICS) and increased work forces. Point prevalence of depression-like symptoms (13.6% and 12.8%) and burnout (21.6% and 17.4%) in the department's healthcare professionals was high. Exposure to SARS-CoV-2 did not increase psychological burden. Consequences of the lockdown were rated as highly distressing by a majority of all ICU personnel. High self-reported trait resilience was protective against signs of depression, generalized anxiety, and burnout. <b>Conclusions:</b> During the pandemic, healthcare professionals have been suffering from increased psychological distress compared to reference data for both the general population and ICU personnel. General effects of the lockdown appear more relevant than actual COVID-19 patient contact. High trait resilience has a protective effect, yet vulnerable individuals may require specific support. Prevention against potential after effects of the lockdown, and in particular measures allowing to avoid another lockdown, appear warranted.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc11"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8422798/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39429874","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}

{"title":"Management of a swallowed denture: our experience with 34 patients.","authors":"Vaishnevy Ganesh,&nbsp;Sara Drever,&nbsp;Joshua Agilinko,&nbsp;Vamsidhar Vallamkondu,&nbsp;Samit Majumdar,&nbsp;Muhammad Shakeel","doi":"10.3205/000297","DOIUrl":"https://doi.org/10.3205/000297","url":null,"abstract":"<p><p><b>Background:</b> Swallowed dentures can present with upper aerodigestive tract obstruction needing urgent intervention. Removing such an ingested denture can prove challenging and needs careful planning. <b>Aim:</b> To share our experience of managing patients with a swallowed denture focusing on the practical aspects of denture removal along with relevant literature review. We aim to raise a public health message on the safety aspect of usage of dentures. <b>Subjects and methods:</b> A retrospective analysis of the patients managed by our team in the ENT department at two hospitals in Scotland, over 10 years (2009-2019), who were found to have swallowed a denture. Data on demographics, clinical history, examination findings and management of patients were collected and analysed using Microsoft Excel. <b>Results:</b> A total of 34 patients were admitted with a swallowed denture, of which 24 (71%) were male and 10 (29%) were female. The mean age was 60 years (range 17-83). Of the 34 patients, 2 had a feeling of something stuck in the throat but were able to eat and drink; the rest of the patients complained about dysphagia and pain in the throat, with 2 patients also showing signs of respiratory distress. Twenty-four (71%) patients required denture removal under general anaesthetic in the theatre; 20 (59%) by rigid oesophagoscopy, 1 with tracheostomy (3%), 1 with (3%) laparoscopy and gastrostomy, and 2 (6%) with external neck exploration. Seven (20%) patients were taken to the theatre and the denture was removed with Magill forceps under light sedation using intubating laryngoscope or video laryngoscope. In 1 patient (3%), the denture material was successfully removed under flexible pharyngolaryngoscopy guidance in the clinic without sedation. The final 2 (6%) patients were reassured as no foreign body was seen on flexible laryngoscopy. <b>Conclusion:</b> In the absence of a clear evidence of denture ingestion, a detailed history and examination are needed to identify this serious pathology. Once confirmed, the ingested denture should be removed as soon as possible to minimize the risk of serious complications.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc10"},"PeriodicalIF":0.0,"publicationDate":"2021-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8422795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39431954","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}

{"title":"A neonate with late-onset hypocalcemia due to unrecognized maternal hyperparathyroidism and a systematic overview of similar cases.","authors":"Georgios Mitsiakos,&nbsp;Georgios N Katsaras,&nbsp;Ilias Chatziioannidis,&nbsp;Anastasia Gkampeta,&nbsp;Christina Mitsiakou,&nbsp;Nikolaos Nikolaidis","doi":"10.3205/000296","DOIUrl":"https://doi.org/10.3205/000296","url":null,"abstract":"<p><p><b>Objective:</b> Neonatal seizures are alarming manifestations of an underlying significant disorder demanding immediate attention and intervention. Hypocalcemia, although rare, must be considered in the differential diagnosis of neonatal seizures. <b>Method:</b> We present an unusual case of a 10-day-old infant with unexplained symptomatic hypocalcemia, experiencing multiple episodes of focal tonic-clonic seizures, born by an entirely asymptomatic mother. Moreover, we conducted a systematic search in PubMed and Scopus databases to present a clinical overview of all similar cases. <b>Result:</b> Maternal laboratory investigation revealed markedly increased calcium levels with concomitant high parathyroid hormone levels due to a parathyroid adenoma, undiagnosed during antenatal checkup. <b>Conclusion:</b> This is one of the few cases in the literature where neonatal symptomatology led to the diagnosis of undiagnosed maternal hyperparathyroidism. Early detection and appropriate management of neonatal hypocalcemia could eliminate serious maternal and fetal morbidity.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc09"},"PeriodicalIF":0.0,"publicationDate":"2021-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8422796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39431953","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}

{"title":"Studying effects of neuromuscular electrostimulation therapy in patients with dysphagia: which pitfalls may occur? A translational phase I study.","authors":"Simone Miller,&nbsp;Daniela Diers,&nbsp;Michael Jungheim,&nbsp;Cornelia Schnittger,&nbsp;Hans Jörg Stürenburg,&nbsp;Martin Ptok","doi":"10.3205/000294","DOIUrl":"https://doi.org/10.3205/000294","url":null,"abstract":"<p><p><b>Background:</b> Previous results of clinical studies suggest that neuromuscular electrostimulation (NMES) therapy, especially in combination with traditional dysphagia therapy, may be helpful in patients with neurogenic swallowing disorders. In these studies, repetitive application of a rectangular current impulse was used to increase muscle strength of the anterior neck. However, according to sports physiological findings, an increase of muscle strength can be better achieved by using different NMES stimulation protocols, e.g. KOTS. The aim of the translational investigator-initiated, non-commercial pilot study presented here was to provide data and insights for the planning of subsequent phase II and III studies on the effectiveness of such stimulation protocols in dysphagia therapy. <b>Methods:</b> 30 post-stroke patients with oropharyngeal dysphagia were included in this prospective pilot study and randomly allocated to either neuromuscular electrostimulation (NMES) or sham stimulation in combination with traditional dysphagia therapy (TDT), a pre- and post-therapeutic fiberoptic-endoscopic evaluation of swallowing (FEES) with the Dysphagia Outcome and Severity Scale (DOSS) (primary outcome measure), Secretion Scale by Murray, Penetration and Aspiration Scale (PAS) and throat clearance (TC) abilities. Recruitment rate, interrater comparison and number of relevant adverse events were recorded as metadata. <b>Results:</b> Despite a recruiting time of over 24 months, only twelve patients could be included. Moreover, clinical data indicated a significant variance of clinical pictures. Significant differences in verum versus sham therapy were not observed. DOSS values in both study groups showed general improvements at the end of the trial. Interrater reliability was low. No adverse events were reported. <b>Discussion:</b> When planning further dysphagia therapy studies, it must be taken into account that it can be problematic to recruit sufficiently large study collectives within an appropriate study period. This is especially important since a possible additional benefit of NMES to TDT is probably rather small or may only occur in certain deficit constellations. The low interrater reliability observed here must be improved by appropriate training measures. Fortunately, no relevant undesirable side effects occurred. This could have a positive effect on the acceptance of volunteers to participate in the study.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc07"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204381/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39147540","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}

{"title":"Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR).","authors":"Petra Hoffmüller,&nbsp;Monika Brüggemann,&nbsp;Thomas Eggermann,&nbsp;Kamran Ghoreschi,&nbsp;Detlef Haase,&nbsp;Jörg Hofmann,&nbsp;Klaus-Peter Hunfeld,&nbsp;Katharina Koch,&nbsp;Christian Meisel,&nbsp;Patrick Michl,&nbsp;Jens Müller,&nbsp;Carsten Müller,&nbsp;Holger F Rabenau,&nbsp;Dirk Reinhardt,&nbsp;Markus J Riemenschneider,&nbsp;Ulrich J Sachs,&nbsp;Ulrich Sack,&nbsp;Albrecht Stenzinger,&nbsp;Thomas Streichert,&nbsp;Nils von Neuhoff,&nbsp;Wilko Weichert,&nbsp;Christof Weinstock,&nbsp;Stefan Zimmermann,&nbsp;Folker Spitzenberger","doi":"10.3205/000295","DOIUrl":"https://doi.org/10.3205/000295","url":null,"abstract":"<p><p>In view of the approaching application date of Regulation (EU) 2017/746 (\"IVDR\") and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scientific Medical Societies (AWMF) takes a national position on the details of the requirements and conditions related to the use of these IVD products. The Ad hoc Commission IVD emphasizes the relevance of examination procedures developed in medical laboratories, especially in the field of orphan diseases and new diagnostic markers. The IVDR sets an adequate regulatory framework for IVD manufactured and used within health institutions as long as these requirements are fulfilled with reliability and in accordance with the current state of the art in medical laboratory sciences. At the same time, the IVDR requirements have to be regarded under a pragmatic view and in accordance with the quality management systems approved within the different EU Member States. On the one hand, the mandatory requirements of the RiLiBÄK play an essential role in Germany. On the other hand, elements of voluntarily applicable international standards may support the fulfilment of product requirements for safety and performance according to Annex I of the IVDR. Both the complexity and possible solutions for the implementation of the IVDR requirements are discussed on the basis of examples such as the required documentation, performance evaluation and software validation. The Ad hoc Commission IVD recommends that, while aiming at a preferably EU-wide harmonized interpretation of the IVDR requirements, the flexibility in medical laboratory diagnostics necessary for patient care, including the use of IVD from in-house production, should be emphasized.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc08"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39147541","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}

{"title":"Laboratory tests for the detection of SARS-CoV-2 infection: basic principles and examples.","authors":"Khaled R Alkharsah","doi":"10.3205/000293","DOIUrl":"https://doi.org/10.3205/000293","url":null,"abstract":"<p><p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has circulated throughout the world causing the worst pandemic since 1918. All efforts have been marshalled towards testing different treatment approaches, obtaining clinical and epidemiological information, developing suitable diagnostic tests, and developing new vaccines. New ribonucleic acid (RNA)-based and viral vector-based vaccines have been developed and licensed under emergency use in many countries; however, there is a huge demand for vaccines, and it will take some time before a sufficient number of people are vaccinated to stop the circulation of the virus. Therefore, the proper diagnosis and identification of infected individuals are crucial for the isolation and treatment of these patients and tracing of their contacts. Many diagnostic tests and diag-nostic kits have been developed in a relatively short time. This review summarizes the principles of the available laboratory assays that are in use for the detection of SARS-CoV-2 RNA, antigens, or antibodies.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc06"},"PeriodicalIF":0.0,"publicationDate":"2021-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39079849","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}

{"title":"Hepatobiliary complications from ruptured silicone breast implants - a comprehensive literature review.","authors":"Joshua Agilinko,&nbsp;Dharshanan Raj,&nbsp;Ken Vin Wong,&nbsp;Daniele Fanelli,&nbsp;Nicklaus Ng,&nbsp;Bertrand Agilinko,&nbsp;Mohammad Hasan","doi":"10.3205/000292","DOIUrl":"https://doi.org/10.3205/000292","url":null,"abstract":"<p><p>Cronin and Gerow first introduced silicone breast implants in 1962; they now serve as first-line for breast augmentation. Breast augmentation is effective in restoring both physical and psychological well-being in women post-mastectomy. Many studies in the literature on complications of silicone breast implant rupture focus on lymphomas and capsular contractures. Only a few studies discuss the hepatobiliary complications. By reviewing the literature over the past 30 years, the authors aim to analyse the clinical presentation, diagnostic findings, as well as management outcomes amongst women with ruptured silicone implant-related hepatobiliary complications. To the best of our knowledge, this is the first comprehensive review on this topic.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc05"},"PeriodicalIF":0.0,"publicationDate":"2021-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39079848","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}

{"title":"Heterogeneity of national legislation and practice on clinical trials with vulnerable patients based on the EU Clinical Trials Directive by the example of adults permanently incapable of giving informed consent.","authors":"Janna K Schweim,&nbsp;Michael Nonnemacher,&nbsp;Karl-Heinz Jöckel","doi":"10.3205/000290","DOIUrl":"https://doi.org/10.3205/000290","url":null,"abstract":"<p><p>In principle, persons wishing to participate in a clinical trial must give informed consent in advance after comprehensive information has been provided. Under certain conditions, it is possible to deviate from this requirement in the European Union (EU) in order to enable the participation of so-called vulnerable persons who are incapable of giving their informed consent. Kuthning et al. [1] have already dealt with general and specific aspects of vulnerable patients and the principle of informed consent in clinical trials. One group of vulnerable persons, for example, are adults temporarily or permanently incapable of giving consent due to their state of health. For a long period of time, no systematic and uniform legal basis for clinical trials existed in the EU as a whole. The Clinical Trials Directive (CTD) [2], adopted in 2001, aimed to change this by harmonizing all legal regulations on clinical trials applicable in the EU, but nevertheless allowing national deviations in implementation into national laws through opening clauses and aspects that were left unregulated. In view of the Clinical Trials Regulation (CTR) [3] which, according to the current status, will with high probability be applied from 2022 on, and which in future will be the legal basis for clinical trials with medicinal products in humans, applied directly in all EU member states, the necessity to take stock of the effects of the CTD was evident. The national deviations with regard to the participation of patients incapable of giving informed consent were investigated qualitatively and quantitatively by means of a systematic analysis of legislation in 16 EU countries and a retrospective database analysis of a European clinical trial registry over a ten-year observation period. Although the analysis initially showed a predominantly homogeneous picture, the differences between the EU member states became apparent in a detailed examination. The database analysis yielded a clear result, since in some countries the majority of clinical trials are carried out. The clearest difference was found between the legal analysis and the results of the evaluated clinical trials concerning adults who are permanently incapable of giving informed consent. A presumed association between the \"degree of liberality\" of the national law and the frequency of clinical trials conducted in the respective country could not be confirmed. In the past, the selection of countries for conducting a clinical trial was based less on legal requirements and more on experience and financial considerations.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"19 ","pages":"Doc03"},"PeriodicalIF":0.0,"publicationDate":"2021-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25540628","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}