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Die Pflegewissenschaft in Deutschland steht vor der Herausforderung, wissenschaftliche Strukturen und Karrierewege auszubilden. Erschwert wird dies durch einen Mangel an wissenschaftlichem Nachwuchs, der das Potential hat, pflegewissenschaftliche Professuren mit wissenschaftlicher Exzellenz und praktischer Erfahrung zu füllen.
Ziel dieses Beitrags ist es, darzustellen, was auslösende Momente für wissenschaftliche Karrieren sind, die in Professuren pflegebezogener Studiengänge münden, und welche Kontextbedingungen diese Karrieren beeinflussen. Es soll auch aufgezeigt werden, wie wissenschaftliche Nachwuchskräfte vorgehen, um ihre Ziele zu erreichen und welche Konsequenzen sich daraus für sie und für die Pflegewissenschaft ergeben. Auf dieser Grundlage sollen Empfehlungen für die Nachwuchsförderung entwickelt werden, um mehr geeignete Personen für Professuren in pflegebezogenen Studiengängen zu gewinnen.
Vorhandene Daten teilnarrativer Interviews mit ProfessorInnen (n=11) und Masterstudierenden (n=11) sowie Promovierenden (n=10) pflegebezogener Studiengänge wurden im Rahmen einer retrospektiven Datenanalyse mit dem dreistufigen Codierverfahren der Grounded Theory Methodologie ausgewertet.
Die Ergebnisse zeigen, dass in der Pflegepraxis gewonnene Erfahrungen auslösende Momente wissenschaftlicher Karrieren sind. Diese lösen den Drang aus, die dort herrschende Situation zu verändern, wobei sich vier Karrieretypen unterscheiden lassen: Typ A forscht, weil er erlebt hat, dass es für pflegerische Phänomene keine geeigneten Pflegeinterventionen gab. Typ B lehrt, um dazu beizutragen, dass Pflegende zukünftig besser ausgebildet werden. Typ C ist als Pflegeperson von ÄrztInnen nicht ausreichend anerkannt worden und absolviert eine wissenschaftliche Qualifikation, um mit ihnen auf Augenhöhe zu gelangen. Typ D wollte in der Praxis bleiben, ist aber bei Weiterentwicklungsprozessen blockiert worden und nimmt als Kompromiss eine Professur an.
Identifizierte Kontextfaktoren sind u.a. mangelnde Wertschätzung für wissenschaftliches Handeln in der Pflege und das Fehlen von Stellen für hochschulisch qualifizierte Pflegepersonen in der Praxis. Angesichts der bestehenden Bedingungen können hochschulisch qualifizierte Pflegende in der Praxis nicht Fuß fassen. Als Konsequenz für die Pflegewissenschaft als Disziplin zeigt sich, dass in der Pflegepraxis Vorbilder fehlen, die zukünftige Generationen Pflegender dazu anregen könnten, selbst eine wissenschaftliche Karriere in der Pflege einzuschlagen. Dadurch besteht die Gefahr einer Verkümmerung der Pflegewissenschaft.
Auf Grundlage der Ergebnisse wird die durchgängige Implementierung geeigneter Stellen für hochschulisch qualifizierte Pflegepersonen in der Pflegepraxis als Ausgangsbasis wissenschaftlicher Nachwuchsförderung betrachtet. Als Konzept werden Hochschul-Praxis-Partnerschaften skizziert, die beginnend auf Bachelorniveau bis zur Post-doc-Phase Strukturen zu einem systematischen praxisbezogenen wissenschaftlichen Kompetenzauf- und -ausbau für akademisch qualifizierte Pflegende etablieren.
Arzneimittel gehören zu den unentbehrlichen Säulen der Medizin. Die Entwicklung neuer Arzneimittel ist ein komplexer, langwieriger, risikoreicher und teurer Prozess. Arzneimittel unterliegen der Zulassungspflicht und der Sicherheitsüberwachung durch Zulassungsbehörden, die die Qualität, Wirksamkeit und Unbedenklichkeit der Arzneimittel sicherstellen. Die Abgabe von Arzneimitteln an Verbraucher erfolgt mit leistungsstarker und komplexer Logistik in Deutschland über Vor-Ort- und Versandapotheken. Der Apothekenmarkt ist geprägt durch inhabergeführte Apotheken mit beschränkten Möglichkeiten, Apothekenfilialen zu eröffnen. Versicherte haben in Deutschland einen sehr breiten Zugang zu Arzneimitteln, d. h. die Kostenübernahme durch die GKV nach dem Sachleistungsprinzip kennt weniger Einschränkungen als in anderen Staaten. Um die Arzneimittelausgabenentwicklung zu kontrollieren, existiert ein umfassendes Instrumentarium an Mechanismen zur Mengen- und Preissteuerung, darunter Erstattungs- und Festbeträge, gesetzlich festgelegte Rabatte sowie vertragliche Rabatte im Rahmen von Ausschreibungen.
German cancer registries offer a systematic approach for the collection, storage, and management of data on patients with cancer and related diseases. Much hope in research and healthcare in general is depending on such register-based analyses in order to comprehensively consider the features of a highly diverse population. Next to the data collection the cancer registries are responsible for data protection. To fulfill legal regulations, access to data has to be controlled in a strict way leading to sometimes bureaucratic and slow processes. The situation is especially complicated in Germany, since cancer data is distributed over numerous federal cancer registries. If a nationwide data evaluation is conducted a research team has to negotiate a separate contract with each cancer registry.In a joint work in progress effort of cancer registries, technical, medical, and economical experts we propose a different solution for cooperative data processing. Our approach aims for combining data in a virtual pool based on the selection criteria of individual requests from researchers. To achieve our goal, we adapt the Fraunhofer Medical Data Space as enabling technology. The architecture we propose will allow us to pool data of multiple partners regulated by data access policies. In doing so, each of the data sources can introduce its own rules and specifications on how data is used. Additionally, we add a digital consent management that will allow individual patients to decide how their data is used. Finally, we show the high potential of the cooperative analysis of distributed cancer data supported by the proposed solution in our approach.
In the era of personalized medicine, the identification of driver mutations has paved the way towards targeted therapy. With the identification of anaplastic lymphoma kinase (ALK) as an oncogenic driver mutation, ALK rearrangements became druggable by tyrosine kinase inhibitors and, thus, have improved the prognosis for patients. Nevertheless, these approaches are limited by resistances occurring within the first or second year of administering ALK inhibitors. Among the different ALK resistant mutations, G1202R is the most common mutation, located in the kinase domain of the ALK protein resulting in resistance to treatment with the first- and second-generation kinase inhibitors (e.g., crizotinib, ceritinib, brigatenib and alectinib). Conflicting reports exist regarding the efficacy of lorlatinib, a next generation ALK inhibitor. The aim of this study is to access the potential impact of lorlatinib as a second-line treatment for a metastatic progressive NSCLC disease harboring genomic alteration of ALK G1202R, an AKLi-resistant mutation. The case of a patient with advanced lung cancer and the mentioned mutation is described.
After several years of negative phase III trials in gastric and esophageal cancer, a significant breakthrough in the treatment of metastatic adenocarcinomas of the gastroesophageal junction (GEJ) and stomach (GC) is now becoming evident with the emerging of precision oncology and implementation of molecular targets in tumor treatment. In addition, new generation studies such as umbrella and basket trials are focused on these molecular targets, which makes an early molecular diagnosis based on IHC/ISH and NGS necessary. The required companion diagnostics of Her2neu overamplification or PD-L1 expression is based on immunohistochemistry (IHC) or additionally in situ hybridization (ISH) in case of an IHC Her2neu score of 2+. However, there are investigator-dependent differences in the assessment of Her2neu amplification and different PD-L1 scoring systems obtained by IHC/ISH. The use of high-throughput technologies such as next-generation sequencing (NGS) holds the potential to standardize the analysis and thus make them more comparable. In the presented study, real-world multigene sequencing data of 72 Caucasian patients diagnosed with metastatic adenocarcinomas of GEJ and stomach were analyzed. In the clinical companion diagnostics, we found ESCAT level I molecular targets in one-third of our patients, which directly determined the therapy. In addition, we found potential targets in 14/72 patients (19.4%) who potentially qualify for precision therapies in corresponding molecular studies. The study highlights the importance of comprehensive molecular profiling for precision treatment of GEJ/GC and indicates that a biomarker evaluation should be performed for all patients with metastatic adenocarcinomas before the initiation of first-line treatment and during second-line or subsequent treatment.
Background
Implementation frameworks may support local implementation strategies with a sound theoretical foundation. The Consolidated Framework for Implementation Research (CFIR) facilitates identification of contextual barriers and facilitators, and the Expert Recommendations for Implementing Change (ERIC) allows identifying adequate implementation strategies. Both instruments are already used in German-speaking countries; however, no standardised and validated translation is available thus far. The aim of this study was to translate the CFIR and ERIC framework into German, in order to increase the use of these frameworks and the adherence to evidence-based implementation efforts in German-speaking countries.
Methods
The translation of the original versions of the CFIR and ERIC framework was guided by the World Health Organisation’s recommendations for the process of translating and adapting both conceptual frameworks. Accordingly, a four-step process was employed: first, forward translation from English into German was conducted by a research team of German native speakers with fluent knowledge of the English language. Second, a bilingual expert panel comprising one researcher with German as his mother tongue and expert command of the English language and one English language expert and university teacher reviewed the translation and discussed inconsistencies with the initial translators. Third, back-translation into English was conducted by an English native speaking researcher. The final version was pre-tested with 12 German researchers and clinicians who were involved in implementation projects using cognitive interviews.
Results
The translation and review process revealed some inconsistencies between the original version and the German translations. All issues could be solved by discussion. Central aspects of the items were confirmed in 60 to 70% of the items, and modifications were proposed in 30% of the items. Finally, we revised one CFIR-item heading after pre-testing. The final version was given consent by all involved parties.
Conclusions
Now, two validated and tested implementation frameworks to guide implementation efforts are available in the German language and can be used to increase the application of agreed-on implementation strategies into practice.
Background
Community-dwelling older people are frequently affected by vertigo, dizziness and balance disorders (VDB). We previously developed a care pathway (CPW) to improve their mobility and participation by offering standardized approaches for general practitioners (GPs) and physical therapists (PTs). We aimed to assess the feasibility of the intervention, its implementation strategy and the study procedures in preparation for the subsequent main trial.
Methods
This 12-week prospective cohort feasibility study was accompanied by a process evaluation designed according to the UK Medical Research Council’s Guidance for developing and evaluating complex interventions. Patients with VDB (≥65 years), GPs and PTs in primary care were included. The intervention consisted of a diagnostic screening checklist for GPs and a guide for PTs. The implementation strategy included specific educational trainings and a telephone helpline. Data for mixed-method process evaluation were collected via standardized questionnaires, field notes and qualitative interviews. Quantitative data were analysed using descriptive statistics, qualitative data using content analysis.
Results
A total of five GP practices (seven single GPs), 10 PT practices and 22 patients were included in the study. The recruitment of GPs and patients was challenging (response rates: GP practices: 28%, PT practices: 39%). Ninety-one percent of the patients and all health professionals completed the study. The health professionals responded well to the educational trainings; the utilization of the telephone helpline was low (one call each from GPs and PTs). Familiarisation with the routine of application of the intervention and positive attitudes were emphasized as facilitators of the implementation of the intervention, whereas a lack of time was mentioned as a barrier. Despite difficulties in the GPs’ adherence to the intervention protocol, the GPs, PTs and patients saw benefit in the intervention. The patients’ treatment adherence to physical therapy was good. There were minor issues in data collection, but no unintended consequences.
Conclusion
Although the process evaluation provided good support for the feasibility of study procedures, the intervention and its implementation strategy, we identified a need for improvement in recruitment of participants, the GP intervention part and the data collection procedures. The findings will inform the main trial to test the interventions effectiveness in a cluster RCT.
Trial registration
Projektdatenbank Versorgungsforschung Deutschland (German registry Health Services Research) VfD_MobilE-PHY_17_003910, date of registration: 30.11.2017; Deutsches Register Klinischer Studien (German Clinical Trials Register) DRKS00022918, date of registration: 03.09.2020 (retrospectively registered).
Background
Vertigo, dizziness and balance disorders (VDB) are common in older people and cause restrictions in mobility and social participation. Due to a multifactorial aetiology, health care is often overutilised, but many patients are also treated insufficiently in primary care. The purpose of this study was to develop a care pathway as a complex intervention to improve mobility and participation in older people with VDB in primary care.
Methods
The development process followed the UK Medical Research Council guidance using a mixed-methods design with individual and group interviews carried out with patients, physical therapists (PTs), general practitioners (GPs), nurses working in community care and a multi-professional expert panel to create a first draft of a care pathway (CPW) and implementation strategy using the Consolidated Framework of Implementation Research and the Expert recommendations for Implementing Change. Subsequently, small expert group modelling of specific components of the CPW was carried out, with GPs, medical specialists and PTs. The Behaviour Change Wheel was applied to design the intervention´s approach to behaviour change. To derive theoretical assumptions, we adopted Kellogg´s Logic Model to consolidate the hypothesized chain of causes leading to patient-relevant outcomes.
Results
Individual interviews with patients showed that VDB symptoms need to be taken more seriously by GPs. Patients demanded age-specific treatment offers, group sessions or a continuous mentoring by a PT. GPs required a specific guideline for diagnostics and treatment options including psychosocial interventions. Specific assignment to and a standardized approach during physical therapy were desired by PTs. Nurses favoured a multi-professional documentation system. The structured three-day expert workshop resulted in a first draft of CPW and potential implementation strategies. Subsequent modelling resulted in a CPW with components and appropriate training materials for involved health professionals. A specific implementation strategy is now available.
Conclusion
A mixed-methods design was suggested to be a suitable approach to develop a complex intervention and its implementation strategy. We will subsequently test the intervention for its acceptability and feasibility in a feasibility study accompanied by a comprehensive process evaluation to inform a subsequent effectiveness trial.
Trial Registration
The research project is registered in “Projektdatenbank Versorgungsforschung Deutschland” (Project-ID: VfD_MobilE-PHY_17_003910; date of registration: 30.11.2017).
Die Pflegewissenschaft in Deutschland steht vor der Herausforderung, wissenschaftliche Strukturen und Karrierewege auszubilden. Erschwert wird dies durch einen Mangel an wissenschaftlichem Nachwuchs, der das Potential hat, pflegewissenschaftliche Professuren mit wissenschaftlicher Exzellenz und praktischer Erfahrung zu füllen.
Ziel dieses Beitrags ist es, darzustellen, was auslösende Momente für wissenschaftliche Karrieren sind, die in Professuren pflegebezogener Studiengänge münden, und welche Kontextbedingungen diese Karrieren beeinflussen. Es soll auch aufgezeigt werden, wie wissenschaftliche Nachwuchskräfte vorgehen, um ihre Ziele zu erreichen und welche Konsequenzen sich daraus für sie und für die Pflegewissenschaft ergeben. Auf dieser Grundlage sollen Empfehlungen für die Nachwuchsförderung entwickelt werden, um mehr geeignete Personen für Professuren in pflegebezogenen Studiengängen zu gewinnen.
Vorhandene Daten teilnarrativer Interviews mit ProfessorInnen (n=11) und Masterstudierenden (n=11) sowie Promovierenden (n=10) pflegebezogener Studiengänge wurden im Rahmen einer retrospektiven Datenanalyse mit dem dreistufigen Codierverfahren der Grounded Theory Methodologie ausgewertet.
Die Ergebnisse zeigen, dass in der Pflegepraxis gewonnene Erfahrungen auslösende Momente wissenschaftlicher Karrieren sind. Diese lösen den Drang aus, die dort herrschende Situation zu verändern, wobei sich vier Karrieretypen unterscheiden lassen: Typ A forscht, weil er erlebt hat, dass es für pflegerische Phänomene keine geeigneten Pflegeinterventionen gab. Typ B lehrt, um dazu beizutragen, dass Pflegende zukünftig besser ausgebildet werden. Typ C ist als Pflegeperson von ÄrztInnen nicht ausreichend anerkannt worden und absolviert eine wissenschaftliche Qualifikation, um mit ihnen auf Augenhöhe zu gelangen. Typ D wollte in der Praxis bleiben, ist aber bei Weiterentwicklungsprozessen blockiert worden und nimmt als Kompromiss eine Professur an.
Identifizierte Kontextfaktoren sind u.a. mangelnde Wertschätzung für wissenschaftliches Handeln in der Pflege und das Fehlen von Stellen für hochschulisch qualifizierte Pflegepersonen in der Praxis. Angesichts der bestehenden Bedingungen können hochschulisch qualifizierte Pflegende in der Praxis nicht Fuß fassen. Als Konsequenz für die Pflegewissenschaft als Disziplin zeigt sich, dass in der Pflegepraxis Vorbilder fehlen, die zukünftige Generationen Pflegender dazu anregen könnten, selbst eine wissenschaftliche Karriere in der Pflege einzuschlagen. Dadurch besteht die Gefahr einer Verkümmerung der Pflegewissenschaft.
Auf Grundlage der Ergebnisse wird die durchgängige Implementierung geeigneter Stellen für hochschulisch qualifizierte Pflegepersonen in der Pflegepraxis als Ausgangsbasis wissenschaftlicher Nachwuchsförderung betrachtet. Als Konzept werden Hochschul-Praxis-Partnerschaften skizziert, die beginnend auf Bachelorniveau bis zur Post-doc-Phase Strukturen zu einem systematischen praxisbezogenen wissenschaftlichen Kompetenzauf- und -ausbau für akademisch qualifizierte Pflegende etablieren.
Objective: The study aimed to explore existing prediction models of functioning in spinal cord injury (SCI).
Study design and setting: The databases PubMed, EBSCOhost CINAHL Complete, and IEEE Xplore were searched for relevant literature. The search strategy included published search filters for prediction model and impact studies, index terms and keywords for SCI, and relevant outcome measures able to assess functioning as reflected in the International Classification of Functioning, Disability and Health (ICF). The search was completed in October 2020.
Results: We identified seven prediction model studies reporting twelve prediction models of functioning. The identified prediction models were mainly envisioned to be used for rehabilitation planning, however, also other possible applications were stated. The method predominantly used was regression analysis and the investigated predictors covered mainly the ICF components of body functions and activities and participation, next to characteristics of the health condition and health interventions.
Conclusion: Findings suggest that the development of prediction models of functioning for use in clinical practice remains to be fully exploited. By providing a comprehensive overview of what has been done, this review informs future research on prediction models of functioning in SCI and contributes to an efficient use of research evidence.