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Zusammenfassung: Es gibt keinen Konsens über die Beschreibung und Schweregradeinteilung allergischer Nebenwirkungen bei Immuntherapien, obwohl zumindest hinsichtlich der Verwendung der Klassifikationssysteme der World Allergy Organisation (WAO) zur Beschreibung lokaler unerwünschter Ereignisse bei sublingualer Immuntherapie (SLIT) und systemischer allergischer Reaktionen (SAR) bei subkutaner Immuntherapie (SCIT) ein Konsens zwischen den wichtigsten nationalen/regionalen Allergiegesellschaften zu bestehen scheint. In diesem Artikel wird eine Modifikation des bestehenden WAO-Klassifikationssystems für SAR vorgeschlagen, die mit der neu vorgeschlagenen Klassifikationsskala des Consortium for Food Allergy Research (CoFAR) für systemische allergische Reaktionen bei Lebensmittelallergien (Version 3.0) übereinstimmt. Wir hoffen, dass damit ein einheitliches Klassifikationssystem zur Verfügung steht, das für Berichte über unerwünschte Reaktionen auf eine Allergen-Immuntherapie unabhängig vom Allergen und Verabreichungsweg sowohl in der klinischen Praxis als auch in der Forschung geeignet ist. [ABSTRACT FROM AUTHOR]

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Copyright of Die Urologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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Die Entwicklung und die Zugänglichkeit von Kinderarzneimitteln unterliegen in der EU einer speziellen Förderung und Regulierung bei der Zulassung. Im Rahmen des Marktzuganges durchlaufen nach dem Inkrafttreten des Arzneimittelmarktneuordnungsgesetzes (AMNOG) im Jahr 2011 neue Arzneimittel die Nutzenbewertung nach § 35a SGB V. Der Zusatznutzen wird durch den Gemeinsamen Bundesausschusses (G-BA) bewertet, anschließend werden die Erstattungsbeträge mit dem GKV-Spitzenverband verhandelt. Der Nutzenbewertung unterliegen auch solche Arzneimittel, die ein neues Anwendungsgebiet erhalten. Dazu gehören u. a. Erweiterungen des Anwendungsgebietes für pädiatrische Patient:innen. Auch Arzneimittel mit einer sog. PUMA-Zulassung (Paediatric Use Marketing Authorisation) sind vom AMNOG betroffen. Im Folgenden werden die bisherigen praktischen Erfahrungen mit der AMNOG-Nutzenbewertung für Arzneimittel mit solchen Zulassungen beschrieben. Im Fokus steht hierbei insbesondere die Berücksichtigung der Besonderheiten bei der Durchführung von pädiatrischen klinischen Studien.

Background: Brain tumors represent a disease that causes both physical and psychological distress for those affected. The pharmacological treatment of depressive symptoms in particular has not been sufficiently researched in these patients. Depression can severely affect the quality of life and has an impact on the course of the disease. Objective: The aim of this work is to describe the diagnosis and treatment of depressive symptoms in brain tumor patients. Material and methods: For this work a comprehensive literature search was conducted to identify relevant studies addressing the topic of depressive symptoms in brain tumors. The included studies were critically appraised to ensure their quality and relevance. Results: The review of the literature revealed that depressive symptoms are a common complication in brain tumor patients. It was found that there are no studies to date on the efficacy of antidepressant medications in brain tumor patients. Discussion: The results of this work highlight the need to pay increased attention to mental health in brain tumor patients. It is important that healthcare professionals identify depression in these patients at an early stage and provide appropriate interventions to improve their quality of life. Future research should focus on further exploring the mechanisms behind the association between brain tumors and depression in order to develop targeted and effective intervention options. [ABSTRACT FROM AUTHOR]

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Clinical trials are currently the best tool in determining the safety and therapeutic efficacy of interventions. Many trials fail due to different reasons such as a lack of funding, recruitment issues, treatment futility, and many more. Trial registries like ClinicalTrials.gov and the EU clinical trials register provide digital descriptions of trials and outcomes. Failure reasons for trials are at best available as full text information and not easily analyzed but would benefit policy-making as well as drug-repurposing efforts as negative training data among other things. Here we describe a novel web-based annotation platform for failure reasons of clinical trials. As of September 23rd 2022 the database contains 14,232 clinical trials meeting the failed trial criteria of which 7,329 (51.5%) are already annotated. These annotations already allow basic assumptions, however, more annotation and consensus work is needed. [ABSTRACT FROM AUTHOR]

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Copyright of Anaesthesiologie & Intensivmedizin is the property of DGAI e.V. - Deutsche Gesellschaft fur Anasthesiologie und Intensivmedizin e.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background Active patient participation in research is becoming increasingly important and contributes to patient-relevant research. In order to gain first experiences with patient participation, a patient advisory board was established in the double-blind trial REGATTA which deals with treatment of uncomplicated urinary tract infections. The aim of this paper is to present the direct and indirect effects of the advisory board on the research project and beyond. Methods Establishing the advisory board, wishes and expectations of participants were recorded, main topics were agreed upon, and spontaneously arising topics were taken up. Based on audio recordings, minutes were taken and consensus reached. For the present work, the protocols were evaluated descriptively by content analysis. The discussions on the given topics were assigned to categories, spontaneously introduced topics were classified or new categories were mapped. The significance for the project or research in general was reflected and consented in team meetings. Results A total of six advisory board meetings took place. Among the direct results effective in the project were, for example, the optimization of documents and the joint development of strategies for the dissemination of results. In addition, there were important indirect findings: the importance of early involvement of patients already in the planning phase, the diversity of individual therapy preferences and their consideration in the interpretation of results, the benefit for the researchers' own professional development through a more comprehensive understanding of the condition have effects beyond the actual project. Conclusions Participation of patients in research causes direct positive effects not only in the actual project, but also beyond through a broader understanding of the researchers for the condition itself, and perspectives of affected patients. [ABSTRACT FROM AUTHOR]

Copyright of Best Practice Onkologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Kommentar von Dr. PH Dipl.-Stat. Carsten Schwenke (SCO:SSiS Statistical Consulting, Berlin).

Background: Based on international randomized controlled trials (RCT) the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) recommends acute treatment in the domestic environment (AHU) and intensive outreach treatment (IAB) with the highest level of evidence; however, due to large differences in national healthcare systems the transference of results from international studies to the healthcare systems in Germany, Austria and Switzerland could be limited. Objective: Evaluation of studies on outreach psychiatric treatment forms in Germany, Austria and Switzerland and discussion of the results in the light of international evidence. Material and methods: A systematic literature search for clinical trials on outreach community treatment from Germany, Austria and Switzerland was conducted in the PubMed database. Results: A total of 19 publications were identified which could be assigned to 5 publications on 4 studies with 2857 patients on AHU and 14 publications on 10 studies with 3207 patients on IAB. The studies on AHU showed this treatment form to be superior regarding the duration of inpatient stay and healthcare costs. The studies on IAB showed more positive outcomes in comparison to controls regarding symptoms, severity of illness, substance abuse, functioning level, remission, satisfaction with treatment, quality of life, healthcare costs, work and housing situations. Conclusion: The studies from Germany, Austria, and Switzerland suggest that outreach community treatment is superior regarding several outcome parameters. Thus, there are no indications suggesting that international evidence could not be valid for these countries. Additionally, with one RCT for AHU and one for IAB the requirements for an evidence level of 1b for outreach community treatment in the healthcare systems in question are fulfilled. [ABSTRACT FROM AUTHOR]

Medidata, ein Unternehmen von Dassault Systèmes, kündigte kürzlich die Veröffentlichung des Berichts „Europäischer Industrie-Forschungsbericht: Die Zukunft klinischer Studien“ (Originaltitel: „European Industry Research Report: The Future of Clinical Trials“) an. Der Report stützt sich auf neue unabhängige Erhebungen, die Erkenntnisse von 400 Führungskräften aus dem Bereich Klinische Studien aus Deutschland, der Schweiz, Frankreich und Großbritannien enthalten. Ziel der Befragung war es, ein tieferes Verständnis dafür zu gewinnen, wie sich klinische Studien in den vergangenen zwei Jahren verändert haben, in welcher Form neue Technologien eine Rolle spielen und was die Zukunft in diesem Bereich bringen könnte.

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Background: In recent years, resistance to antibiotics has become a global threat, and alternatives to antibiotics have become an area of research. The main alternative methods are briefly described in this review. However, the main focus is bacteriophage-related therapy. Bacteriophages are viruses which, due to the production of the enzyme endolysin, are able to kill bacterial host cells. Bacteriophage therapies have a long tradition. Their potential to function as antibiotics lies in their bactericidal activity and specificity in killing bacteria without infecting or affecting eukaryotic cells. Objective: To systematically review the outcomes of bacteriophage therapy in patients with bacterial infections. Methods: The MEDLINE, EMBASE, Web of Science and CENTRAL databases were searched electronically using search terms referring to bacteriophages, endolysins and antimicrobial resistance. After the literature was screened for their titles and abstracts, full-text reviews considering inclusion/exclusion criteria were performed. Data concerning patients with bacterial infections, treatment with either bacteriophages or its enzyme endolysin and their outcomes were extracted and analysed. Results: Thirteen publications were identified that met all inclusion criteria. Data extraction shows that bacteriophages or endolysins have the potential to combat bacterial infections and significantly reduce inflammatory mediators. However, 3 out of 4 randomized controlled trials revealed that there was no significant difference between phage/endolysin treated patients and control group. Significant clinical improvements were seen in cohort and case studies. A few minor side effects were reported. Conclusions: Although there are countries in which bacteriophages are prescribed as an alternative to established antibiotics, this valuable experience has yet to be examined sufficiently in clinical trials conducted to modern standards. Despite improvements in symptoms shown in the reviewed clinical trials, the infection and the bacteria themselves were rarely completely eradicated. Therefore, no definite answer can be given as to effectiveness, and further clinical trials are necessary. [ABSTRACT FROM AUTHOR]

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Background Trained practice personnel play an important role in successfully recruiting patients and carrying out health services research in family medicine. Up to now, little is known about the everyday tasks performed by health care assistants (HCA) when trials are conducted in family practices. Methods In 2017, a cross-sectional survey of HCAs was used to find out how responsibilities are divided up when trials are conducted in family practices. The survey was conducted during a practice visit to prepare practice personnel for their participation in a prospective cohort study. Some of the questions concerned the experiences HCAs had made during previous trials. The collected data were evaluated descriptively. Results The HCAs were responsible for most of the administrative work, many of which involved direct contact with patients, for example, in making appointments (81 %), collecting questionnaires (74 %), gathering signatures (59 %) and sending out invitations (55 %). According to the HCAs, the physicians took sole responsibility for checking inclusion and exclusion criteria and carrying out explanatory discussions in 30 % of cases. In- and exclusion criteria were checked by both physician and HCA in 21 % of cases, while they shared responsibility for explanatory discussions 26 % of the time. The HCAs said they were solely responsible for these tasks in 29 % and 28 % of cases respectively. Conclusions It would appear that HCAs are not only responsible for administrative work but also for providing information and orientation to patients. Physicians and HCAs both require basic training in Good Clinical Practice (GCP), which should also explicitly deal with the distribution of responsibilities. [ABSTRACT FROM AUTHOR]

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Dieser Beitrag stellt sich der Herausforderung, die beiden Begriffe „Chaos“ und „Struktur“ zu einem harmonischen Ganzen zu verbinden. Es wird dargelegt, wie aus dem Gedankenchaos im Kopf eines Forschers ein klares Konzept entsteht, wie Chaos bereits bei der Studienplanung vermieden werden kann und wie es mittels statistischer Methoden gelingt, einem unstrukturierten Datenchaos ein strukturiertes Profil zu verleihen. Das Entdecken dieser Strukturen ermöglicht es, Zusammenhänge zu erkennen und neues Wissen zu erlangen. Diese Vorgehensweise wird anhand ausgewählter Therapiestudien aus zwei Jahrhunderten erläutert.

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