GMS German Medical Science最新文献

{"title":"Gender-based differences in the antidepressant treatment of patients with depression in German psychiatric practices","authors":"L. Jacob, K. Kostev","doi":"10.3205/000229","DOIUrl":"https://doi.org/10.3205/000229","url":null,"abstract":"Background: Depression is recognized as the leading cause of disability in the world. Our goal was to compare treatment initiation in men and women treated in German neuropsychiatric practices after diagnosis of depression. Methods: Patients aged between 18 and 80 first diagnosed with depression between 2010 and 2013 were identified by 223 psychiatrists in the IMS Disease Analyzer database. Patients who had received antidepressant prescriptions prior to the index date were excluded. The main outcome measure was the initiation of antidepressant drug therapy in men and women within three years after index date in three subgroups of different severity (mild, moderate and severe depression). Results: A total of 35,495 men and 54,467 women were included in this study. After 3 years of follow-up, 77.3% of men and 78.5% of women diagnosed with mild depression (p-value=0.887), 89.2% of men and 90.7% of women with moderate depression (p-value=0.084), and 88.6% of men and 89.5% of women with severe depression (p-value=0.769) had been treated. No association was found between the chances of treatment initiation after diagnosis of depression and gender. Finally, patients with moderate and severe depression were more likely to receive therapy than those with mild depression. Selective serotonin reuptake inhibitors and tricyclic antidepressants were the two most commonly prescribed families of drugs in this study (SSRIs: 34.5% to 44.6%, and TCAs: 19.1% to 26.9%). Conclusions: Gender did not impact therapy initiation in depressed patients. Further studies are needed to identify other potential factors involved.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2016-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/000229","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recurrent urinary tract infections and complications after symptomatic versus antibiotic treatment: follow-up of a randomised controlled trial","authors":"J. Bleidorn, E. Hummers-Pradier, G. Schmiemann, B. Wiese, I. Gágyor","doi":"10.3205/000228","DOIUrl":"https://doi.org/10.3205/000228","url":null,"abstract":"Background: Uncomplicated urinary tract infections (UTI) are common in general practice, and are usually treated with antibiotics. Recurrent UTI often pose a serious problem for affected women. Little is known about recurrent UTI and complications when uncomplicated UTI are treated without antibiotics. With ICUTI (Immediate vs. conditional antibiotic use in uncomplicated UTI, funded by BMBF No. 01KG1105) we assessed whether initial symptomatic treatment with ibuprofen could be a treatment alternative for uncomplicated UTI. The presented analysis aims to assess the influence of initial (non-)antibiotic treatment on recurrent UTI rates and pyelonephritis after day 28 up to 6 months after trial participation. Methods: This study is a retrospective long-term follow-up analysis of ICUTI patients, surveyed telephonically six months after inclusion in the trial. Recurrent UTI, pyelonephritis or hospitalizations were documented. Statistical evaluation was performed by descriptive and multivariate analyses with SPSS 21. Results: For the six months follow-up survey, 386 trial participants could be contacted (494 had been included in ICUTI initially, 446 had completed the trial). From day 28 until 6 months after inclusion in ICUTI, 84 recurrent UTI were reported by 80 patients. Univariate and multivariate analyses showed no effect of initial treatment group or antibiotic treatment on number of patients with recurrent UTI. Yet, both analyses showed that patients with a history of previous UTI had significantly more often recurrent UTI. Pyelonephritis occurred in two patients of the antibiotic group and in one patient in the non-antibiotic group. Conclusion: This follow-up analysis of a trial comparing antibiotic vs. symptomatic treatment for uncomplicated UTI showed that non-antibiotic treatment has no negative impact on recurrent UTI rates or pyelonephritis after day 28 and up to six months after initial treatment. Thus, a four week follow-up in UTI trials seems adequate.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2016-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/000228","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality expectations and tolerance limits of trial master files (TMF) – Developing a risk-based approach for quality assessments of TMFs","authors":"Arthur Hecht, Barbara Busch-Heidger, Heiner Gertzen, H. Pfister, Birgit Ruhfus, Per-Holger Sanden, Gabriele B. Schmidt","doi":"10.3205/000227","DOIUrl":"https://doi.org/10.3205/000227","url":null,"abstract":"This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/000227","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Autoimmune thyroiditis associated with neuromyelitis optica (NMO)","authors":"Sreenivasa Rao Sudulagunta, Mahesh Babu Sodalagunta, Hadi Khorram, Mona Sepehrar, Jayadevappa Gonivada, Zahra Noroozpour, N. Prasad","doi":"10.3205/000226","DOIUrl":"https://doi.org/10.3205/000226","url":null,"abstract":"Neuromyelitis optica (NMO or Devic’s syndrome) is a rare relapsing demyelinating disease of the central nervous system (CNS) that mainly affects the spinal cord and optic nerves and shares many clinical and radiological features with multiple sclerosis. The association of NMO with other autoimmune diseases was reported, but very few reports described association with autoimmune thyroid disease. Early differentiation between NMO and multiple sclerosis is very important as the natural course and treatment regimens differ significantly. We report a case of a 50-year-old woman who was admitted initially with vomiting, hiccups and paraesthesias but was not diagnosed with NMO and presented with a severe progression of the disease. The patient was also diagnosed to have autoimmune thyroiditis with lymphocytic infiltration of the thyroid which progressed from hyperthyroidism to hypothyroidism. NMO diagnosis was established with seropositivity for NMO-IgG and MRI showing longitudinally extensive spinal cord lesions (3 or more spinal segments). In spite of treatment, the response was poor due to lack of early diagnosis and aggressive immunosuppressant therapy.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/000226","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union","authors":"I. Ramírez","doi":"10.3205/000225","DOIUrl":"https://doi.org/10.3205/000225","url":null,"abstract":"Objective: The purpose of this article is to give an overview of the complexities and unexpected regulatory requirements for obtaining approval of multinational and multicentre non-interventional studies (NIS) in the European Union (EU). Methods: The websites of national competent authorities (CAs), ethics committees (ECs) and data protection (DP) authorities were consulted to find regulations and guidance information related to the authorisation of NIS in various member states of the EU. Results: Many additional hurdles, neither disclosed nor clear in the various regulations/guidances for NIS, were identified. Although approval from the CA is not needed for NIS, in many countries request of CA opinion is nevertheless recommended, prior to submission to the EC, to obtain confirmation that the planned NIS does not fall in the interventional trial category. Clinical trial insurance was required in some countries. In countries like Belgium and Italy, the multicentre NIS required the approval from a central EC and local ECs as a single central EC opinion was not considered sufficient. The EC document requirements for submission and the fees were extremely variable among all member states. Additional approvals from data protection authorities and insurance companies were required in some countries. Conclusions: The process of obtaining approval for multicentre and multinational NIS is time consuming due to lack of transparency and the different regulatory requirements among member states. The EU pharmacovigilance legislation and clinical trial regulation No 536/2014 is a step forward in providing a regulatory framework for PASS (post-authorisation safety studies) and low intervention clinical trials, but since regulation No 536/2014 excludes NIS, it will be difficult to enforce harmonization of requirements for approval of NIS among member states.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/000225","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The scholar role in the National Competence Based Catalogues of Learning Objectives for Undergraduate Medical Education (NKLM) compared to other international frameworks.","authors":"Stefanie C Hautz, Wolf E Hautz, Niklas Keller, Markus A Feufel, Claudia Spies","doi":"10.3205/000224","DOIUrl":"10.3205/000224","url":null,"abstract":"<p><strong>Background: </strong>In Germany, a national competence based catalogue of learning objectives in medicine (NKLM) was developed by the Society for Medical Education and the Council of Medical Faculties. As many of its international counterparts the NKLM describes the qualifications of medical school graduates. The definition of such outcome frameworks indents to make medical education transparent to students, teachers and society. The NKLM aims to amend existing lists of medical topics for assessment with learnable competencies. All outcome frameworks are structured into chapters, domains or physician roles. The definition of the scholar-role poses a number of questions such as: What distinguishes necessary qualifications of a scientifically qualified physician from those of a medical scientist?</p><p><strong>Methods: </strong>13 outcome frameworks were identified through a systematic three-step literature review and their content compared to the scholar role in the NKLM by means of a qualitative text analysis. The three steps consist of (1) search for outcome frameworks, (2) in- and exclusion, and (3) data extraction, categorization, and validation. The results were afterwards matched with the scholar role of the NKLM.</p><p><strong>Results: </strong>Extracted contents of all frameworks may be summarized into the components Common Basics, Clinical Application, Research, Teaching and Education, and Lifelong Learning. Compared to the included frameworks the NKLM emphasises competencies necessary for research and teaching while clinical application is less prominently mentioned.</p><p><strong>Conclusion: </strong>The scholar role of the NKLM differs from other international outcome frameworks. Discussing these results shall increase propagation and understanding of the NKLM and thus contribute to the qualification of future medical graduates in Germany.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 1","pages":"Doc20"},"PeriodicalIF":0.0,"publicationDate":"2015-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4645747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520596","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":"Evidence and consensus based guideline for the management of delirium, analgesia, and sedation in intensive care medicine. Revision 2015 (DAS-Guideline 2015) – short version","authors":"R. Baron, A. Binder, R. Biniek, S. Braune, H. Buerkle, P. Dall, Sueha Demirakça, R. Eckardt, Verena Eggers, Ingolf Eichler, I. Fietze, S. Freys, A. Fründ, L. Garten, B. Gohrbandt, I. Harth, W. Hartl, H. Heppner, J. Horter, R. Huth, U. Janssens, C. Jungk, K. Kaeuper, P. Kessler, S. Kleinschmidt, M. Kochanek, M. Kumpf, A. Meiser, Anika Mueller, M. Orth, C. Putensen, B. Roth, M. Schaefer, R. Schaefers, P. Schellongowski, M. Schindler, Reinhard Schmitt, J. Scholz, S. Schroeder, G. Schwarzmann, C. Spies, R. Stingele, P. Tonner, U. Trieschmann, M. Tryba, F. Wappler, C. Waydhas, B. Weiss, G. Weißhaar","doi":"10.3205/000223","DOIUrl":"https://doi.org/10.3205/000223","url":null,"abstract":"In 2010, under the guidance of the DGAI (German Society of Anaesthesiology and Intensive Care Medicine) and DIVI (German Interdisciplinary Association for Intensive Care and Emergency Medicine), twelve German medical societies published the “Evidence- and Consensus-based Guidelines on the Management of Analgesia, Sedation and Delirium in Intensive Care”. Since then, several new studies and publications have considerably increased the body of evidence, including the new recommendations from the American College of Critical Care Medicine (ACCM) in conjunction with Society of Critical Care Medicine (SCCM) and American Society of Health-System Pharmacists (ASHP) from 2013. For this update, a major restructuring and extension of the guidelines were needed in order to cover new aspects of treatment, such as sleep and anxiety management. The literature was systematically searched and evaluated using the criteria of the Oxford Center of Evidence Based Medicine. The body of evidence used to formulate these recommendations was reviewed and approved by representatives of 17 national societies. Three grades of recommendation were used as follows: Grade “A” (strong recommendation), Grade “B” (recommendation) and Grade “0” (open recommendation). The result is a comprehensive, interdisciplinary, evidence and consensus-based set of level 3 guidelines. This publication was designed for all ICU professionals, and takes into account all critically ill patient populations. It represents a guide to symptom-oriented prevention, diagnosis, and treatment of delirium, anxiety, stress, and protocol-based analgesia, sedation, and sleep-management in intensive care medicine.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/000223","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A novel nonparametric measure of explained variation for survival data with an easy graphical interpretation","authors":"V. Weiss, Matthias Schmidt, M. Hellmich","doi":"10.3205/000222","DOIUrl":"https://doi.org/10.3205/000222","url":null,"abstract":"Introduction: For survival data the coefficient of determination cannot be used to describe how good a model fits to the data. Therefore, several measures of explained variation for survival data have been proposed in recent years. Methods: We analyse an existing measure of explained variation with regard to minimisation aspects and demonstrate that these are not fulfilled for the measure. Results: In analogy to the least squares method from linear regression analysis we develop a novel measure for categorical covariates which is based only on the Kaplan-Meier estimator. Hence, the novel measure is a completely nonparametric measure with an easy graphical interpretation. For the novel measure different weighting possibilities are available and a statistical test of significance can be performed. Eventually, we apply the novel measure and further measures of explained variation to a dataset comprising persons with a histopathological papillary thyroid carcinoma. Conclusion: We propose a novel measure of explained variation with a comprehensible derivation as well as a graphical interpretation, which may be used in further analyses with survival data.","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69520550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Why do - or don't - patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine.","authors":"Jutta Bleidorn,&nbsp;Sermin Bucak,&nbsp;Ildikó Gágyor,&nbsp;Eva Hummers-Pradier,&nbsp;Marie-Luise Dierks","doi":"10.3205/000221","DOIUrl":"https://doi.org/10.3205/000221","url":null,"abstract":"<p><strong>Background: </strong>Insufficient patient recruitment can impair the conduct of clinical trials substantially, not least because a significant number of eligible patients decline trial participation. Though barriers and motivational factors have been worked out for patients with cancer or chronic diseases, little is known about primary care patients' perceptions towards trial participation when visiting their family practitioner (FP) with acute uncomplicated conditions. This study aims to assess primary care patients' motivation and barriers to participate in trials, and to identify factors that optimize patient recruitment in future trials.</p><p><strong>Methods: </strong>This study was embedded in a drug trial comparing two treatment strategies for women with uncomplicated urinary tract infection in primary care. Semi-structured telephone interviews both with trial participants and decliners were conducted. The interview guideline focused on patients' personal motivational or hampering factors. Further topics were study theme, FPs' role, randomization, trial procedures, and potential motivational factors or barriers presumed to be relevant for other patients. Transcripts were analyzed by summarizing content analysis.</p><p><strong>Results: </strong>20 interviews with trial participants and 5 interviews with trial decliners were conducted. RESULTS show various reasons for trial participation from three categories: personal aspects, trial related aspects and patient-physician-relationship. A relevant trial topic and perceived personal benefit promotes participation as well as the wish to support research in general. Additionally, a maximum of safety concerning symptom relief reassures patients significantly. Trust in the FP plays also an important role in the decision process. Trial decliners show strong individual treatment preferences, which, together with individual reasons, lead to trial refusals.</p><p><strong>Conclusions: </strong>To optimize recruitment conditions for further clinical trials on acute and common conditions in family medicine, the following key issues should be considered: emphasizing patients' personal benefit, featuring patient relevant trial topics, providing a maximum of safety, keeping effort by trial procedures comfortable.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 ","pages":"Doc17"},"PeriodicalIF":0.0,"publicationDate":"2015-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4606084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34127431","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":"Evaluation in medical education: A topical review of target parameters, data collection tools and confounding factors.","authors":"Sarah Schiekirka,&nbsp;Markus A Feufel,&nbsp;Christoph Herrmann-Lingen,&nbsp;Tobias Raupach","doi":"10.3205/000219","DOIUrl":"https://doi.org/10.3205/000219","url":null,"abstract":"<p><strong>Background and objective: </strong>Evaluation is an integral part of education in German medical schools. According to the quality standards set by the German Society for Evaluation, evaluation tools must provide an accurate and fair appraisal of teaching quality. Thus, data collection tools must be highly reliable and valid. This review summarises the current literature on evaluation of medical education with regard to the possible dimensions of teaching quality, the psychometric properties of survey instruments and potential confounding factors.</p><p><strong>Methods: </strong>We searched Pubmed, PsycINFO and PSYNDEX for literature on evaluation in medical education and included studies published up until June 30, 2011 as well as articles identified in the \"grey literature\". RESULTS are presented as a narrative review.</p><p><strong>Results: </strong>We identified four dimensions of teaching quality: structure, process, teacher characteristics, and outcome. Student ratings are predominantly used to address the first three dimensions, and a number of reliable tools are available for this purpose. However, potential confounders of student ratings pose a threat to the validity of these instruments. Outcome is usually operationalised in terms of student performance on examinations, but methodological problems may limit the usability of these data for evaluation purposes. In addition, not all examinations at German medical schools meet current quality standards.</p><p><strong>Conclusion: </strong>The choice of tools for evaluating medical education should be guided by the dimension that is targeted by the evaluation. Likewise, evaluation results can only be interpreted within the context of the construct addressed by the data collection tool that was used as well as its specific confounding factors.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"13 ","pages":"Doc15"},"PeriodicalIF":0.0,"publicationDate":"2015-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34047800","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}