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Studierende des Bachelorstudiengangs Pflegepädagogik an der KSH München haben im Rahmen eines Studienprojektes für echte Prüfungssituationen in der Gesundheits- und Krankenpflegeausbildung, der Altenpflegeausbildung oder des dualen Pflegestudiums OSCE-Prüfungen entwickelt und durchgeführt. In dieser Ausgabe gibt es ein Prüfungsbeispiel, das die Studierenden für die Berufsfachschule für Krankenpflege Maria Regina entwickelt haben
Der vorliegende Beitrag ist Auftakt einer Serie von OSCE-Prüfungen, die Studierende des Bachelorstudiengangs Pflegepädagogik an der KSH München im Rahmen eines Studienprojektes für echte Prüfungssituationen in der Gesundheits- und Krankenpflegeausbildung, der Altenpflegeausbildung oder des dualen Pflegestudiums entwickelt und durchgeführt haben. Zunächst wird das Konzept der OSCE-Prüfung und der Aufbau des Studienprojektes vorgestellt. In den nächsten Ausgaben folgen Auszüge aus den Prüfungen und kurze Erfahrungsberichte. Abgeschlossen wird mit einer Evaluation durch alle beteiligten Lernenden und Lehrenden.
Versorger und Verlierer
(2011)
Telematik in der Arbeitsmedizin: Praktische Erfahrungen aus einer Machbarkeitsstudie der BGHM
(2019)
In this methodological note on applying the ICF in rehabilitation, we introduce suitable tools that allow us to document comprehensively and systematically the lived experience of health to guide clinical practice, the management of services, evidence-informed policy and scientific inquiry.
The objective of this methodological note is to present the currently available tools with respect to four questions: 1) what ICF domains to document; 2) what perspective to take; 3) what data collection tools to apply; and 4) which approach to use for reporting. The application of these tools is illustrated using the Swiss Spinal Cord Injury (SwiSCI) Cohort Study.
Existing ICF Sets provide a practical approach for identifying the domains to document. One can document from the perspective of biological health, lived health, and appraised health. For identifying suitable data collection tools, either existing tools can be linked to the ICF or available ICF-based data collection tools can be used.
For reporting, an interval scale metric is suggested. The four step approach presented provides users with a logical sequence to follow when planning the documentation of functioning using the ICF as a health information reference system in practice and research.
Objective
Encouraging physical activity is an important public health measure to reduce disability prevalence in the aged. The aims of this study were to determine the association between midlife physical activity and late-life disability and to investigate gender-specific differences.
Method
This data originates from the KORA-Age cohort, a follow-up in 2008 of the MONICA (Multinational Monitoring of Trends and Determinants in Cardiovascular Diseases)/KORA (Cooperative Health Research in the Region of Augsburg) S1–S4 surveys (1984–2001) situated in Augsburg, a city in Southern Germany. We applied a multivariable hurdle model to investigate the association of physical activity and disability.
Results
We analysed 3333 persons with a mean follow-up of 18 ± 5.5 years. Using hurdle models, moderate activity and high activity had a protective effect on the occurrence of disability (OR (odds ratio) = 0.80 and 0.73), but not on severity (i.e. number of limitations). We observed a strong gender-specific difference in this association, with men benefitting more from exercise.
Conclusion
Elevated physical activity reduces the risk of becoming disabled and postpones the onset of disability by several years, but we could not show an effect on the severity of disability. In addition, men seem to benefit more from leisure-time physical activity than women
Objective: To explore whether the concepts important to patients with hand osteoarthritis (OA) are covered by the most commonly used instruments measuring functioning.
Method: A qualitative multicentre study using a focus group technique was performed in five European countries: Austria, The Netherlands, Norway, Sweden and the United Kingdom. The qualitative data analysis followed a modified form of “meaning condensation” and used the International Classification of Functioning, Disability and Health (ICF) as a theoretical framework. Finally, the concepts from the focus groups were compared with the content of the most commonly used instruments which had been identified in an earlier theoretical analysis.
Results: Fifty-six people (51 women, mean (SD) age 62.7 (7.9) years) with hand OA participated in this study in two focus groups per centre. 63 concepts were extracted from the focus groups. Twenty-one (33%) of the 63 concepts were covered by at least one instrument. Psychological consequences, different qualities of pain, aesthetic changes and leisure activities are important concepts from the focus groups which were not covered by the instruments. The qualitative analysis revealed detailed descriptions of pain-concerning sensations, levels and a certain relation to activity, none of which were fully represented in the instruments routinely used.
Conclusion: It was possible to combine the concepts of the focus groups from each centre into a common qualitative analysis. The concepts important to people with hand OA are not fully represented in the most commonly used instruments.
Objective: The aim of the present study was to explore how contextual factors affect the everyday activities of women and men with rheumatoid arthritis (RA), as evident in their life stories.
Methods: Fifteen people with RA, who had retired early due to the disease, were interviewed up to three times, according to a narrative biographic interview style. The life stories of the participants, which were reconstructed from the biographical data and from the transcribed ‘told story’ were analysed from the perspective of contextual factors, including personal and environmental factors. The rigour and accuracy of the analysis were enhanced by reflexivity and peer‐review of the results.
Results: The life stories of the participants in this study reflected how contextual factors (such as gender, the healthcare system, the support of families and social and cultural values) shaped their everyday activities. In a society such as in Austria, which is based on traditional patriarchal values, men were presented with difficulties in developing a non‐paid‐work‐related role. For women, if paid work had to be given up, they were more likely to engage in alternative challenging activities which enabled them to develop reflective skills, which in turn contributed to a positive and enriching perspective on their life stories. Health professionals may thus use some of the women's strategies to help men.
Conclusion: Interventions by health professionals in people with RA may benefit from an approach sensitive to personal and environmental factors.
Background
The admission to a nursing home is a critical life-event for affected persons as well as their families. Admission related processes are lacking adequate participation of older people and their families. To improve transitions to nursing homes, context- and country-specific knowledge about the current practice is needed. Hence, our aim was to summarize available evidence on challenges and care strategies associated with the admission to nursing homes in Germany.
Methods
We conducted a scoping review and searched eight major international and German-specific electronic databases for journal articles and grey literature published in German or English language since 1995. Further inclusion criteria were focus on challenges or care strategies in the context of nursing home admissions of older persons and comprehensive and replicable information on methods and results. Posters, only-abstract publications and articles dealing with mixed populations including younger adults were excluded. Challenges and care strategies were identified and analysed by structured content analysis using the TRANSCIT model.
Results
Twelve studies of 1,384 records were finally included. Among those, seven were qualitative studies, three quantitative observational studies and two mixed methods studies. As major challenges neglected participation of older people, psychosocial burden among family caregivers, inadequate professional cooperation and a lack of shared decision-making and evidence-based practice were identified. Identified care strategies included strengthening shared decision-making and evidence-based practice, improvement in professional cooperation, introduction of specialized transitional care staff and enabling participation for older people.
Conclusion
Although the process of nursing home admission is considered challenging and tends to neglect the needs of older people, little research is available for the German health care system. The perspective of the older people seems to be underrepresented, as most of the studies focused on caregivers and health professionals. Reported care strategies addressed important challenges, however, these were not developed and evaluated in a comprehensive and systematic way. Future research is needed to examine perspectives of all the involved groups to gain a comprehensive picture of the needs and challenges. Interventions based on existing care strategies should be systematically developed and evaluated to provide the basis of adequate support for older persons and their informal caregivers.
Hintergrund: Die COVID-19-Pandemie ist eine Ausnahmesituation ohne Präzedenz und erforderte zahlreiche Ad-hoc-Anpassungen in den Strukturen und Prozessen der akutstationären Versorgung.
Ziel: Ziel war es zu untersuchen, wie aus Sicht von Führungspersonen und Hygienefachkräften in der Pflege die stationäre Akutversorgung durch die Pandemiesituation beeinflusst wurde und welche Implikationen sich daraus für die Zukunft ergeben.
Methoden: Qualitative Studie bestehend aus semistrukturierten Interviews mit fünf Verantwortlichen des leitenden Pflegemanagements und drei Hygienefachkräften in vier Krankenhäusern in Deutschland. Die Interviews wurden mittels qualitativer Inhaltsanalyse ausgewertet.
Ergebnisse: Die Befragten beschrieben den auf die prioritäre Versorgung von COVID-19-Fällen hin umstrukturierten Klinikalltag. Herausforderungen waren Unsicherheit und Angst bei den Mitarbeiter_innen, relative Ressourcenknappheit von Material und Personal und die schnelle Umsetzung neuer Anforderungen an die Versorgungleistung. Dem wurde durch gezielte Kommunikation und Information, massive Anstrengungen zur Sicherung der Ressourcen und koordinierte Steuerung aller Prozesse durch bereichsübergreifende, interprofessionelle Task Forces begegnet.
Schlussfolgerungen: Die in der COVID-19-Pandemie vorgenommenen Anpassungen zeigen Entwicklungspotenziale für die zukünftige Routineversorgung auf, z. B. könnten neue Arbeits- und Skill Mix-Modelle aufgegriffen werden. Für die Konkretisierung praktischer Implikationen sind vertiefende Analysen der Daten mit zeitlichem Abstand erforderlich.
Objectives: A historical review of the editorial board and the founding editor of WORK: A Journal of Prevention, Assessment and Rehabilitation was conducted to examine the understanding of the editorship and contributions of this team to the knowledge in WORK.
Participants: The team of four authors worked together to identify an approach to evaluate the contributions and impact of WORK's editorial board (EB) on the journal's scholarship. The editor-in-chief (EIC) and editorial board members were participants in this evaluation.
Methods: Informative and formative evaluations were used to investigate how knowledge was shaped through the development of an epistemic community of scholars in the field of work. Metrics of the EB composition and participation in the journal as well as surveys and interviews with the board and the editor-in-chief were analyzed.
Results: The EB represents an international community of scholars with a common interest in work and who contribute academically both within WORK and beyond. The epistemic community that has evolved through the editorial board represents a pluralistic perspective on work that is needed to inform practice, and knowledge.
Conclusion: Future directions to continue to advance knowledge through WORK's editorial board and EIC are elaborated.
Objectives: The purpose of this article is to share the details, outcomes and deliverables from an international workshop on work transitions in London, Ontario, Canada. Participants: Researchers, graduate students, and community group members met to identity ways to advance the knowledge base of strategies to enhance work participation for those in the most disadvantaged groups within society.
Methods: A participatory approach was used in this workshop with presentations by researchers and graduate students. This approach included dialogue and discussion with community members. In addition, small group dialogue and debate, world cafe discussions, written summaries of group discussion and reflection boards were used to bring new ideas to the discussion and to build upon what we know.
Findings: Two research imperatives and six research recommendations were identified to advance global dialogue on work transitions and to advance the knowledge base. Occupational justice can be used to support future research directions in the study of work transitions.
Conclusions: Moving forward requires a commitment of community of researchers, clinicians and stakeholders to address work disparities and implement solutions to promote participation in work.
Introduction: The aim of this review was to gain an understanding of the first 20 years of contributions to WORK within the assessment domain and to reflect on the perspectives underscoring this knowledge base.
Method: A narrative review of assessment articles using the WORK ARTicle database was conducted. Assessment articles were searched using issues from 1990 to 2009. Descriptive data was analyzed to examine historical trends of the specific types and dimensions of articles, the regional location of the contributions, and the methodological accordance. A reflective process was used by an editorial board member of WORK to inductively interpret perspectives and contextual issues that underpinned the evolution of the assessment domain in WORK.
Results: Over half of N= 108 of the articles on assessment in WORK focused on establishing or reporting reliability and validity of assessments used in clinical practice or evaluation research. The majority of the assessment articles were predominantly focused on the person. Contributions of articles were from 5 regions: North America, Europe, Australia, Asia and Africa.
Conclusions: Assessment articles in WORK have contributed to the development of evidence to support assessment of the worker. These articles represent a knowledge base that emphasizes evidence-based assessments to evaluate what a person can and cannot do to participate in work. Efforts are needed to expand knowledge generation in assessment to include more evaluations on the workplace and occupation dimensions, and that also considers the worker in context.
Implementation of robotic devices in nursing care. Barriers and facilitators: an integrative review
(2020)
Background: Robots in healthcare are gaining increasing attention; however, their implementation is challenging due to the complexity of both interventions themselves and the contexts in which they are implemented. The objective of this integrative review is to identify barriers to and facilitators of the implementation of robotic systems in nursing.
Methods: Articles published from 2002 to 2019 reporting on projects to implement robotic devices in nursing care were searched on Medline (via PubMed), CINAHL and databases on funded research projects (Community Research and Development Information Services and Technische Informationsbibliothek) and in journals for robotic research in November 2017 and July 2019 for an update. No restrictions regarding study designs were imposed. All included articles underwent quality assessments with design-specific critical appraisal tools. Barriers to and facilitators of implementation were classified using the Context and Implementation of Complex Interventions framework.
Results: After removing all duplicates, the search revealed 11 204 studies, of which 17 met the inclusion criteria and were included in the synthesis. The majority of the studies dealt with the implementation of robots designed to support individuals, either living at home or in nursing homes (n=11). The studies were conducted in Europe, the USA and New Zealand and were carried out in nursing homes, individual living environments, hospital units and laboratories. The quality of reporting and quality of evidence were low in most studies. The most frequently reported barriers were in socioeconomic and ethical domains and were within the implementation outcomes domain. The most frequently reported facilitators were related to the sociocultural context, implementation process and implementation strategies.
Discussion: This review identified barriers to and facilitators of the implementation of robotic devices in nursing within different dimensions. The results serve as a basis for the development of suitable implementation strategies to reduce potential barriers and promote the integration of elements to facilitate implementation.
PROSPERO registration number: CRD42018073486.
Background: The International Classification of Functioning, Disability, and Health (ICF) Generic-30 (Rehabilitation) Set is a tool used to assess the functioning of a clinical population in rehabilitation. The ICF Generic-30 consists of nine ICF categories from the component "body functions" and 21 from the component "activities and participation". This study aimed to develop a rating reference guide for the nine body function categories of the ICF Generic-30 Set using a predefined, structured process and to examine the interrater reliability of the ratings using the rating reference guide.
Methods: The development of the first version of the rating reference guide involved the following steps: (1) a trial of rating patients by several raters; (2) cognitive interviews with each rater to analyze the thought process involved in each rating; (3) the drafting of the rating reference guide by a multidisciplinary panel; and (4) a review by ICF specialists to confirm consistency with the ICF. Subsequently, we conducted a first field test to gain insight into the use of the guide in practice. The reference guide was modified based on the raters' feedback in the field test, and an inter-rater reliability test was conducted thereafter. Interrater agreement was evaluated using weighted kappa statistics with linear weights.
Results: The first version of the rating reference guide was successfully developed and tested. The weighted kappa coefficient in the field testing ranged from 0.25 to 0.92. The interrater reliability testing of the rating reference guide modified based on the field test results yielded an improved weighted kappa coefficient ranging from 0.53 to 0.78. Relative improvements in the weighted kappa coefficients were observed in seven out of the nine categories. Consequently, seven out of nine categories were found to have a weighted kappa coefficient of 0.61 or higher.
Conclusions: In this study, we developed and modified a rating reference guide for the body function categories of the ICF Generic-30 Set. The interrater reliability test using the final version of the rating reference guide showed moderate to substantial interrater agreement, which encouraged the use of the ICF in rehabilitation practice.
As part of international efforts to develop and implement national models including the specification of ICF-based clinical data collection tools, the Italian rehabilitation community initiated a project to develop simple, intuitive descriptions of the ICF Rehabilitation Set, highlighting the core concept of each category in user-friendly language.
This paper outlines the Italian experience in developing simple, intuitive descriptions of the ICF Rehabilitation Set as an ICF-based clinical data collection tool for Italy.Consensus process.Expert conference.
Multidisciplinary group of rehabilitation professionals.The first of a two-stage consensus process involved developing an initial proposal for simple, intuitive descriptions of each ICF Rehabilitation Set category based on descriptions generated in a similar process in China.
Stage two involved a consensus conference. Divided into three working groups, participants discussed and voted (vote A) whether the initially proposed descriptions of each ICF Rehabilitation Set category was simple and intuitive enough for use in daily practice.
Afterwards the categories with descriptions considered ambiguous i.e. not simple and intuitive enough, were divided among the working groups, who were asked to propose a new description for the allocated categories. These proposals were then voted (vote B) on in a plenary session.
The last step of the consensus conference required each working group to develop a new proposal for each and the same categories with descriptions still considered ambiguous.
Participants then voted (final vote) for which of the three proposed descriptions they preferred.Nineteen clinicians from diverse rehabilitation disciplines from various regions of Italy participated in the consensus process. Three ICF categories already achieved consensus in vote A, while 20 ICF categories were accepted in vote B.
The remaining 7 categories were decided in the final vote.The findings were discussed in light of current efforts toward developing strategies for ICF implementation, specifically for the application of an ICF-based clinical data collection tool, not only for Italy but also for the rest of Europe.
Promising as minimal standards for monitoring the impact of interventions and for standardized reporting of functioning as a relevant outcome in rehabilitation.
Background:
Care pathways (CPWs) are complex interventions that have the potential to reduce treatment errors and optimize patient outcomes by translating evidence into local practice. To design an optimal implementation strategy, potential barriers to and facilitators of implementation must be considered.
The objective of this systematic review is to identify barriers to and facilitators of the implementation of CPWs in primary care (PC).
Methods:
A systematic search via Cochrane Library, CINAHL, and MEDLINE via PubMed supplemented by hand searches and citation tracing was carried out. We considered articles reporting on CPWs targeting patients at least 65 years of age in outpatient settings that were written in the English or German language and were published between 2007 and 2019. We considered (non-)randomized controlled trials, controlled before-after studies, interrupted time series studies (main project reports) as well as associated process evaluation reports of either methodology. Two independent researchers performed the study selection; the data extraction and critical appraisal were duplicated until the point of perfect agreement between the two reviewers. Due to the heterogeneity of the included studies, a narrative synthesis was performed.
Results:
Fourteen studies (seven main project reports and seven process evaluation reports) of the identified 8154 records in the search update were included in the synthesis. The structure and content of the interventions as well as the quality of evidence of the studies varied.
The identified barriers and facilitators were classified using the Context and Implementation of Complex Interventions framework. The identified barriers were inadequate staffing, insufficient education, lack of financial compensation, low motivation and lack of time. Adequate skills and knowledge through training activities for health professionals, good multi-disciplinary communication and individual tailored interventions were identified as facilitators.
Conclusions:
In the implementation of CPWs in PC, a multitude of barriers and facilitators must be considered, and most of them can be modified through the careful design of intervention and implementation strategies. Furthermore, process evaluations must become a standard component of implementing CPWs to enable other projects to build upon previous experience.
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).
Mit der Implementierung von Versorgungspfaden kann evidenzbasiertes Wissen unter Berücksichtigung spezifischer kontextualer Anforderungen in lokale Versorgungsstrukturen umgesetzt werden. Das übergeordnete Forschungsprojekt bedient sich diesem Ansatz, um mobilitäts- und teilhabeförderliche physiotherapeutische Interventionen für ältere Menschen mit Schwindel und Gleichgewichtsstörungen in die Primärversorgung zu integrieren. Ziel vorliegenden Promotionsprojektes ist es, die Voraussetzungen für die erfolgreiche Implementierung eines Versorgungspfads für diese Personengruppe im genannten Setting zu untersuchen.
Konform mit der new MRC guidance for developing and evaluating complex interventions liegt ein essentieller Schritt in der Aufarbeitung vorhandener wissenschaftlicher Evidenz. Trotz der Relevanz von Versorgungspfaden in der Primärversorgung stellt das durchgeführte systematische Review (Publikation I) gemäß unserem Kenntnisstand die erste publizierte Forschungsarbeit zu dieser Thematik dar. Methodisch wurde hierfür eine Literaturrecherche über CINAHL, Cochrane Library und MEDLINE über PubMed durchgeführt; neben der Publikation der Hauptstudien (RCT, NRCT, CBA, ITS) wurden die dazugehörigen Prozessevaluationen mittels narrativer Synthese analysiert. Es konnten in allen Domänen des CICI frameworks beeinflussende Faktoren identifiziert werden. So sind Personal- und Zeitmangel, unzureichende Qualifikation und Motivation der Gesundheitsprofessionen, zeitintensive und komplexe Interventionskomponenten sowie fehlende finanzielle Anreize Barrieren. Schulungsmaßnahmen sowie Kenntnisse und Fähigkeiten der Interventionsanwender*innen und eine gute multidisziplinäre Kommunikation sind für eine erfolgreiche Implementierung förderlich. Die Literaturanalyse zeigte eine verbesserungswürdige Praxis der Berichterstattung, was erhebliche Wissenslücken bedingt. Die Übertragbarkeit der Ergebnisse auf Regionen mit anderen Gesundheitssystemen ist beschränkt, da die eingeschlossenen Projekte lediglich in drei unterschiedlichen Ländern durchgeführt wurden.
Die entwickelte Intervention und die geplanten Studienabläufe wurden in einer Machbarkeitsstudie auf Akzeptanz und Durchführbarkeit untersucht (Publikation II). Teilnehmende waren fünf Hausärzt*innenpraxen, 10 Physiotherapiepraxen und 22 Patient*innen. Als Endpunkte dieser prospektiven Kohortenstudie wurden Daten mittels Fragebögen (DHI, EQ-5D-5L, IPAQ), Performancetest (mini-BEST), Aktivitätssensoren (Move4, StepWatch4) und einem Bewegungstagebuch erhoben; für die Prozessevaluation kontinuierliche Feldnotizen, standardisierte Fragebögen und semistrukturierte Interviews. Eine positive Einstellung gegenüber der Intervention, Anwendungsroutine und die Unterstützung durch Angehörige wirkten förderlich, Zeitmangel hingegen hinderlich. Trotz der guten Bewertung der Schulungen hatten Hausärzt*innen Schwierigkeiten bei der Einhaltung des Studien- und Interventionsprotokolls. Hinsichtlich der physiotherapeutischen Maßnahmen erwies sich die Behandlungstreue der Patient*innen als gut. Trotz der sorgfältig entwickelten Intervention und Implementierungsstrategie, konnte ein Optimierungsbedarf identifiziert werden. Dennoch sahen alle Teilnehmenden einen Mehrwert in der Intervention.
Zusammenfassend lässt sich konstatieren, dass für eine erfolgreiche Implementierung von Versorgungspfaden in der Primärversorgung frühestmöglich unterschiedlichste Voraussetzungen zu berücksichtigen sind. Um von den vielversprechenden Vorteilen in der Praxis zu profitieren, ist ein sorgfältiger Interventionsaufbau und ein gezieltes Implementierungsvorgehen essentiell. Die Forschung ist in diesem Bereich weiter voranzutreiben, vorwiegend in bisher unzureichend erforschten Settings und Regionen. Zudem bedarf es einer Verbesserung der Forschungsqualität und Berichterstattung.
Die zunehmende Zahl an Asyl und Schutz suchenden Menschen in Europa und die damit einhergehenden dramatischen Fluchtverläufe mit vielen Todesopfern haben Flucht zu einem Thema gemacht, das eine außerordentliche öffentliche Aufmerksamkeit erlangt hat und gleichzeitig enorm polarisiert und polarisierend verhandelt wird. Besonders auffällig ist die personale Verbindung von Flucht und Flüchtlingen, deren Kategorisierung und Zuschreibung ein wesentliches Merkmal der aktuellen Debatten ist: Geschlecht, Alter, Fluchtgründe und Herkunftsländer sind Merkmale, anhand derer diese Kategorisierung vorgenommen wird und die sowohl faktische Folgen auf das Aufenthaltsrecht haben (vgl. Wild 2010), als auch symbolisch mit Bewertungen und Verwertungslogiken verknüpft sind. Der folgende Artikel geht solchen Kategorisierungen anhand des Merkmals Geschlecht diskursanalytisch nach. Die Analyse bezieht sich auf den aktuellen öffentlich-medialen Diskurs zum Thema Flüchtlinge, in dem - so unsere These - bestimmte geschlechtsspezifische Stereotypisierungen hervor gebracht und essentialisiert werden.
Das Elterngeld wurde als familienpolitische Innovation eingeführt, die Müttern wie Vätern höchstmögliche Spielräume bei der Entscheidung für ein Kind bieten sollte. Der Beitrag geht der Frage nach, ob diese Spielräume auch empirisch von Relevanz sind. Die Daten belegen, dass das Elterngeld zwar für Väter die Möglichkeit der Existenzsicherung bietet. Dies gilt jedoch nur, wenn sie erwerbstätig sind. Der überwiegende Anteil der Mütter bleibt mit dem Elterngeld unterhalb der Armutsgrenze. Es lässt sich zudem kein massiver Geburtenanstieg durch das Elterngeld feststellen, womit die zentralen familienpolitischen Anliegen nicht erfüllt werden. Jüngste Reformen des Elterngeldes führen zu Verschlechterungen für arme und erwerbslose junge Eltern. Der Ausblick zeigt, dass Auswege aus dem Dilemma möglich sind, wenn entscheidende Schritte zur Reform des Elterngeldes eingeleitet werden.
In diesem Beitrag wird untersucht, wie sich das bedarfsgewichtete Pro-Kopf-Einkommen in Haushalten Alleinerziehender mit Kindern im Vergleich zu entsprechenden Haushalten mit verheirateten Eltern im Zuge der arbeits-, familien- und sozialpolitischen Reformen seit 1997 vor und nach staatlicher Umverteilung verändert hat. Zweitens wird mit Effekt-Dekompositionen analysiert, inwieweit Veränderungen der Einkommenssituation von alleinerziehenden und verheirateten Müttern auf Veränderungen ihrer Merkmale und deren Auswirkungen zurückgeführt werden können. Die Analysen basieren auf 19 Wellen des Sozio-ökonomischen Panels (SOEP) von 1997 bis 2015. Während das bedarfsgewichtete Netto-Pro-Kopf-Einkommen von alleinerziehenden Müttern auch dank staatlicher Transfer weitgehend unverändert geblieben ist, hat sich die Einkommenssituation von verheirateten Müttern vor allem aufgrund ihres steigenden Bildungsniveaus und ihrer gestiegener Erwerbstätigkeit verbessert. Die zunehmende Einkommensungleichheit zwischen beiden Familienformen kann demnach auf die zunehmend besseren Bildungsressourcen und die gesteigerte Arbeitsmarktaktivität verheirateter Mütter zurückgeführt werden, wohingegen Alleinerziehende vermehrt auf Sozialleistungen angewiesen waren.
Zuwanderung, demografische Veränderungen und familialer Wandel betreffen alle gesellschaftlichen Bereiche und Akteure. Kindertageseinrichtungen als erste und wichtigste Bildungs- und Sozialisationsinstanzen nach den Eltern sind davon nicht ausgenommen. Im Gegenteil: Kinderarmut, Zeitknappheit von Familien, Migration und soziale Ungleichheiten kommen hier zuallererst an und stellen die Einrichtungen vor neue Herausforderungen. Hinzu kommen gesellschaftliche Bewegungen, wie der neu erstarkte Rechtspopulismus, gruppenbezogene Menschenfeindlichkeit und Abwertung bis zu Rechtsextremismus. Ein Phänomen, das in ostdeutschen Bundesländern präsenter ist. Die vorliegende Untersuchung hat deshalb 94
Leitungen von Kindertageseinrichtungen in Sachsen und Thüringen nach ihren Umgangsweisen mit gesellschaftlicher Vielfalt gefragt. Hierzu wurde spezifisch der Umgang mit benachteiligten Gruppen und mit Diversität untersucht. 10 qualitative ExpertInneninterviews mit Einrichtungsleitungen wurden ergänzend dazu durchgeführt, um spezifischen und sensiblen Fragestellungen auf den Grund zu gehen.
Die wichtigsten Mittel gegen menschenfeindliche Tendenzen sind Demokratieförderung, Demokratiebildung und Partizipation. Die Untersuchung hat deshalb einen Schwerpunkt auf die Untersuchung der Umsetzung und Hindernisse sowie der Bedarfe mit Blick auf Partizipation gelegt.
Das deutsche Kinder- und Jugendhilferecht normiert in seinem § 1 Deutsches Sozialgesetz, Achtes Buch (SGB VIII) ein Recht auf Erziehung, das mit spezifischen Erziehungszielen verbunden ist. Der vorliegende Artikel zeichnet die historische Entwicklung und Veränderung dieser Erziehungsziele nach und zeigt anhand einer Diskursanalyse neuerer Verhandlungen um das Kinder- und Jugendhilferecht, wie Erziehung und ihre Ziele mit Blick auf das generationale Ordnen verhandelt werden.
Der vorliegende Beitrag befasst sich anhand eines Bundesverfassungsgerichtsurteils zu »heimlichen Vaterschaftstests« mit Fragen nach der Materialität von Kindheit. Die rechtliche Verwertbarkeit eines Vaterschaftstests für die Vaterschaftsanfechtung, beziehungsweise die das mögliche Anrecht auf Kenntnis der Abstammung des eigenen Kindes verbindet naturalisierende Vorstellungen von Eltern-Kind-Beziehungen mit rechtlichen Regelungen. So entsteht eine Wechselwirkung: das legitime Kind materialisiert sich einerseits in der Idee der Fortsetzung des Selbst als das »genetisch eigene Kind« und andererseits in der Idee des rechtmäßigen Kindes, das durch die genetische Abstammung begründet wird. Genetische Informationen tragen damit nicht nur zur Naturalisierung der Vorstellung von »eigenen« Kindern bei, sie dienen auch als naturalisierende Begründung der rechtmäßigen Vater-Kind-Beziehung. Wie nimmt die genetische Wahrheit diesen Status in der Legitimation einer Beziehung ein und welchen Beitrag kann diese Verfasstheit für die Beantwortung der Frage nach der Materialität von Kindheit leisten? Welche Form erlangt Kindheit in der Konzeption eines Generationenverhältnisses, das auf biologische Abstammung fundiert wird und in welcher Beziehung steht diese Konzeption zu ihrer rechtlichen Normierung?
Der Beitrag stellt das laufende Forschungsprojekt „Sexuelle Gewalt gegen Mädchen und Jungen in Institutionen“ des Deutschen Jugendinstituts vor. Inhalt ist eine quantitative retrospektive Befragung zum Vorkommen, Ausmaß und zum Umgang mit sexueller Gewalt in Schulen, Internaten sowie stationären Einrichtungen der Hilfen zur Erziehung. Anhand von Fokusgruppen soll die Perspektive der Fachkräfte und Beratungsstellen einbezogen werden.
Wie wird Vaterschaft ermittelt? Das Bundesverfassungsgerichtsurteil zu so genannten heimlichen Vaterschaftstests hat einen Anspruch auf die genetische Abstammungsklärung verankert. Ziel dieser Klärung ist es für Väter, festzustellen, ob ihr rechtliches Kind auch ihr biologisches Kind ist. Dem Urteil folgte ein Gesetz zur Klärung der Abstammung. Das neue Gesetz schafft den „stets sicheren“ Vater. Wie ist es vor diesem Hintergrund um die Sicherheit des Kindes bestellt? In welchem Verhältnis stehen Vaterrechte und Kinderrechte? Diesen Fragen geht Sabina Schutter anhand eines diskursanalytischen Verfahrens nach.
Alleinerziehende
(2013)
Diskursanalyse
(2012)
„Hier wie da wird geliebt“: Liebe als universales Phänomen in Verhandlungen zum Familienrecht
(2016)
Obwohl Liebe eines der zentralen Begründungsmotive dauerhafter Paarbeziehungen darstellt, wird der Begriff im deutschen Familienrecht mit Bezug auf die Ehe oder die eingetragene Lebenspartnerschaft nicht genannt. Davon ausgehend, dass in politischen Verhandlungen über Gesetzesänderungen eine Übersetzung gesellschaftlicher Realität in juristische Normen stattfindet, geht der Beitrag der folgenden Frage nach: Wie und wann sprechen Bundestagsabgeordnete von Liebe, wenn im Rahmen familienrechtlicher Reformen über Beziehungen zwischen hetero- und homosexuellen Paaren verhandelt wird? Das Material zeigt eine Spaltung zwischen einer Zuschreibung der Berechtigung von Liebe, die entweder mit sakralen Motiven in Verbindung gebracht wird, oder, wenn sie als unberechtigt gilt, als sexualisiertes Begehren abgewertet wird. Es ist außerdem darstellbar, dass eine universale Zuschreibung von Liebe bei hetero- und homosexuellen Paaren stattfindet, was allerdings wesentlich mit der Bereitschaft zur lebenslangen Unterhaltsverpflichtung zusammenhängt.
Dem Wandel gerecht werden? Ungleichzeitigkeiten in Geschlechterverhältnissen und Familienrecht
(2020)
Nichteheliche Lebensgemeinschaften zwischen "romantischer Himmelsmacht" und rechtsfreiem Raum?
(2014)
Kinderschutz
(2014)
Diese Arbeit geht im Rahmen der qualitativen Forschung der Frage nach, was deutschsprachige Physiotherapeuten unter dem Begriff Clinical Reasoning verstehen. Clinical Reasoning und das angewandte Forschungsdesign werden erläutert. Die Ergebnisse zeigen ein uneinheitliches Verständnis von Clinical Reasoning und ein hohes Maß an Selbstreflexion als Ausdruck der Unsicherheit beim physiotherapeutischen Handeln. Es besteht Unzufriedenheit mit der Qualität der Grundausbildung, die nur unzureichende Kompetenz für die Berufsausübung vermittelt. Dafür notwendig und förderungsbedürftig sind bewusstes, strukturiertes und dokumentiertes Handeln. Clinical Reasoning muss ein wesentlicher Bestandteil der physiotherapeutischen Ausbildung werden.
Hintergrund und Ziel:
Humane Papillomviren (HPV) sind ursächlich für die Entstehung des Zervixkarzinoms verantwortlich. Impfstoffe, die Schutz vor den HPV-Genotypen 16 und 18 bieten, sind bereits bzw. werden in Kürze verfügbar sein (Stand: Mai 2007). Ihre Anwendung mit dem Ziel der Reduktion der Krankheitslast durch das Zervixkarzinom ist von der Ständigen Impfkommission (STIKO) für alle Mädchen im Alter von 12–17 Jahren empfohlen. Ziel der Studie ist es, den möglichen langfristigen Effekt einer HPV-Impfung auf die Inzidenz des Zervixkarzinoms und die assoziierte Mortalität in Deutschland abzuschätzen.
Methodik:
Mittels eines entscheidungsanalytischen Modells (diskrete Ereignissimulation) wurde der Impfeffekt auf die lebenslange Inzidenz von Zervixkarzinom und auf die Lebenserwartung einer Kohorte von 399 400 10-jährigen Mädchen untersucht. HPV-16 und HPV-18 sind mit 73,5% der Zervixkarzinome kausal assoziiert. Bei einer Impfstoffeffektivität von 95,1% wird eine Teilnahmerate von 100% an einer Impfung im Alter zwischen 10 und 25 Jahren angenommen.
Ergebnisse:
Ohne Impfung kommt es zu 4 563 Krebsfällen (kumulierte Lebensinzidenz: 1,14%) und 1 376 Todesfällen (Letalität: 30,2%). Die Impfung 10-Jähriger reduziert diese Zahl um jeweils 70%, was zu einem Gewinn von 17 819 Lebensjahren in der Gesamtkohorte führt. 416 Mädchen müssen geimpft werden, um einen Todesfall zu verhindern. Wird erst im 25. Lebensjahr geimpft, können noch 50% der Todesfälle durch Zervixkarzinom verhindert werden.
Schlussfolgerung:
Die HPV-Impfung Jugendlicher kann die trotz gynäkologischer Krebsvorsorge noch bestehende Krankheitslast an Zervixkarzinom Krankendrastisch vermindern. Auch die Impfung junger Erwachsener stellt noch einen großen Nutzen dar. Die HPV-Impfung empfiehlt sich daher auch über die Empfehlung der STIKO hinaus als Ergänzung zur bestehenden Krebsfrüherkennung.
Fragestellung: Ziel ist die Analyse der langfristigen Auswirkungen einer Impfung gegen onkogene humane Papillomaviren (HPV-16, HPV-18) in Deutschland.
Material/Methode: Die Analyse wird mittels eines publizierten entscheidungsanalytischen Markov-Modells durchgeführt, das an den epidemiologischen und Versorgungskontext des deutschen Gesundheitssystems angepasst wurde. Es wird die Fortführung der Krebsfrüherkennung in der heutigen Form mit einer ergänzenden Impfung in einer Kohorte von 399 400 heute 10-jährigen Mädchen verglichen.
Die Teilnahmerate der Impfung ist 100 %. Für die Impfung mit dem GSK-Kandidatimpfstoff wird eine Effektivität von 95 % gegen HPV-16 und HPV-18 sowie von 90 % gegen HPV-45 und 50 % gegen HPV-31 (Kreuzprotektion gegen phylogenetisch verwandte HPV-Typen) unterstellt.
Ergebnisse: Die Fortführung der Krebsfrüherkennung resultiert in der Kohorte in 300 400 auffälligen Pap-Abstrichen, 42 434 behandelten CIN-Läsionen (29 948 [70,6 %] durch onkogene HPV-Typen verursacht), 4425 ICC-Erkrankungen (invasives Zervixkarzinom) und 1139 ICC-Todesfällen. Die Impfung reduziert die Zahl der auffälligen Pap-Abstriche um 45 905 (- 15,3 %), der behandelten CIN-Läsionen um 17 661 (- 41,6 %), der ICC-Erkrankungen um 3462 (- 78,2 %) und der Todesfälle um 885 (- 77,7 %). Ein Anteil von 5,1 % der Effektivität gegen ICC kann auf Kreuzprotektion zurückgeführt werden.
In Sensitivitätsanalysen erwiesen sich das Impfalter und die Impfrate als einflussreiche Faktoren. Eine Impfung erst im Alter von 30 Jahren reduziert die Zahl der ICC-Erkrankungen beispielsweise um 59 %.
Schlussfolgerungen: Trotz Krebsfrüherkennung verbleibt eine hohe Krankheitslast durch Zervixkarzinom und präkanzeröse Läsionen. Die HPV-Impfung als Ergänzung der Krebsfrüherkennung kann die Krankheitslast entscheidend verringern. Dabei ist eine frühe Impfung von weiblichen Jugendlichen am effektivsten, die Impfung erwachsener Frauen ist aber ebenfalls von hohem Nutzen.
Sponsoringvertrag
(2014)
Die Haftungsverteilung im Innenverhältnis zweier an der fehlerhaften Behandlung beteiligten Krankenhäuser erfolgt nicht gemäß § 426 Abs. 1 S. 1 BGB, sondern richtet sich gemäß § 254 BGB nach dem Maß der Verursachung. Maßgeblich ist dabei, mit welchem Grad von Wahrscheinlichkeit die beiderseitigen Verursachungsbeiträge zur Herbeiführung des Schadens jeweils geeignet waren. Die Haftung des einen Ersatzpflichtigen kann dabei so in den Hintergrund treten, dass der andere im Innenverhältnis allein haftet. (Leitsatz des Bearbeiters)
Verf. gelangt zu dem Fazit, dass auch im Profisport das Transferverhalten der konkurrierenden Vereine als Wettbewerbshandeln auf dem Arbeitsmarkt an Hand des UWG zu überprüfen ist. Unlauter i.S.v. § 1 UWG ist es daher, einen Spieler, ähnlich wie im Fall des Fußballers Anthony Yeboah, mit Schwarzgeld zum Wechsel oder Verbleib zu veranlassen. Ein solches wettbewerbswidriges Verhalten führt zu einem Unterlassungs- bzw. Schadensersatzanspruch und vor allem zu einem Anspruch auf ein Beschäftigungsverbot auf Seiten des geschädigten vereins, welches dem Spieler verbietet, am Spielbetrieb für den abwerbenden Verein teilzunehmen. Zulässig ist jedoch das Anbieten von Handgeldern, um den Sportler zum Wechsel zu bewegen. Verf.-Referat
Datenschutzrechtliche Bedenken bei der Direktansprache von Beschäftigten durch Personalberater
(2003)
Führen Vertragsverhandlungen durch Spielervermittler zur Unwirksamkeit der Vermittlungsverträge?
(2001)
Konsignationsvertrag
(2014)
Sponsoring
(2013)
Anwendungsbeobachtung
(2018)
Purpose
Visual height intolerance (vHI) occurs when a trigger causes the apprehension of losing balance and falling. Depending on the severity of vHI, an avoidance behavior may develop in about 50 % of the thus afflicted, and it can have considerable impact on their daily life and interpersonal interactions. It seems obvious that such experiences may be impairing and distressing, but this has not yet been examined systematically. Objective of this study was to examine the consequences of vHI for quality of life.
Methods
A qualitative, phenomenological exploratory approach was chosen. Individual face-to-face interviews were conducted with individuals who had reported in a previous study that they were susceptible to vHI. The interview transcripts were segregated into distinct meaning units, which were used to create a coding guideline with meta- and subcodes. Meaning units were then systematically extracted and assigned to the appropriate codes. Weights and links were used to assign priorities for interpretation.
Results
Eighteen participants were interviewed (mean age 53, range 30–73; 11 females). Data analysis resulted in 29 meta-codes and 115 subcodes. Responses indicated that vHI can be very disabling and has a relevant impact on quality of life and daily activities of the affected persons, including their family life and behavior towards partner, children and friends.
Conclusion
Relevant topics for further quantitative studies were identified, for example, strategies of compensation and the influence of vHI on family life. Other quantitative studies should determine whether comorbidities and the typologies found in this study have consequences for individual therapeutic approaches.
Background: Acquired joint contractures have a significant impact on functioning and quality of life in nursing home residents. There is very limited evidence on measures for prevention and treatment of disability due to joint contractures. We have developed the PECAN intervention (Participation Enabling CAre in Nursing) to improve social participation in nursing home residents. A cluster-randomised pilot trial was conducted to assess the feasibility of study procedures in preparation for a main trial according to the UK Medical Research Council (MRC) framework.
Methods: Nursing homes in two regions of Germany were randomly allocated either to the intervention or optimised standard care (control group). All residents with joint contractures aged > 65 years were eligible for the study. The residents’ data were collected through structured face-to-face interviews by blinded assessors at baseline, after 3 and 6 months. The primary outcome was social participation, measured by a subscale of the PaArticular Scales. Secondary outcomes included activities and instrumental activities of daily living, health-related quality of life, falls and fall-related consequences. Data on the trial feasibility were collected via documentation forms.
Results: Seven out of 12 nursing homes agreed to participate and remained in the trial. Of 265 residents who fulfilled the inclusion criteria, 129 were randomised either to the intervention (n = 64) or control group (n = 65) and analysed. A total of 109 (85%) completed the trial after 6 months. The mean age was 85.7 years (SD 7.0), 80% were women. The severity of the residents’ disability differed across the clusters. The completion rate was high (> 95%), apart from the Instrumental Activities of Daily Living Scale. Some items of the PaArticular Scales were not easily understood by residents. The frequency of falls did not differ between study groups.
Conclusion: Our data confirmed the feasibility of the overall study design. We also revealed the need to improve the procedures for the recruitment of residents and for data collection before implementation into a main trial. The next step will be an adequately powered main trial to assess the effectiveness and cost-effectiveness of the intervention.
Background
acquired joint contractures have significant effects on quality of life and functioning.
Objective
to determine the effects of interventions to prevent and treat disabilities in older people with acquired joint contractures.
Methods
systematic search (last 8/2016) via Cochrane Library, PubMed, EMBASE, PEDro, CINAHL, trial registries, reference lists of retrieved articles and scientific congress pamphlets. Controlled and randomised controlled trials in English or German comparing an intervention with another intervention or standard care were included. Two independent researchers performed the selection of publications, data extraction and critical appraisal.
Results
seventeen studies with 992 participants met the inclusion criteria: 16 randomised controlled trials and 1 controlled trial (nursing homes = 4, community settings = 13). The methodological quality of the studies varied. Splints were examined in four studies, stretching exercises in nine studies, and ultrasound, passive movement therapy, bed-positioning and group exercise were each examined in one study. Studies on splints revealed inconclusive results regarding joint mobility or spasticity. Five of seven studies that assessed active stretching programmes for healthy older people reported statistically significant effects on joint mobility in favour of the intervention. Pain, quality of life, activity limitations and participation restrictions were rarely assessed.
Conclusion
the evidence for the effectiveness of interventions to prevent and treat disability due to joint contractures is weak, particularly for established nursing interventions such as positioning and passive movement. Better understanding is required regarding the delivery of interventions, such as their intensity and duration. In addition to functional issues, activities and social participation should also be studied as outcomes.
Background
Joint contractures in nursing home residents limit the capacity to perform daily activities and restrict social participation. The purpose of this study was to develop a complex intervention to improve participation in nursing home residents with joint contractures.
Methods
The development followed the UK Medical Research Council framework using a mixed-methods design with re-analysis of existing interview data using a graphic modelling approach, group discussions with nursing home residents, systematic review of intervention studies, structured 2-day workshop with experts in geriatric, nursing, and rehabilitation, and group discussion with professionals in nursing homes.
Results
Graphic modelling identified restrictions in the use of transportation, walking within buildings, memory functions, and using the hands and arms as the central target points for the intervention. Seven group discussions with 33 residents revealed various aspects related to functioning and disability according the International Classification of Functioning, Disability and Health domains body functions, body structures, activities and participation, environmental factors, and personal factors. The systematic review included 17 studies with 992 participants: 16 randomised controlled trials and one controlled trial. The findings could not demonstrate any evidence in favour of an intervention. The structured 2-day expert workshop resulted in a variety of potential intervention components and implementation strategies. The group discussion with the professionals in nursing homes verified the feasibility of the components and the overall concept. The resulting intervention, Participation Enabling CAre in Nursing (PECAN), will be implemented during a 1-day workshop for nurses, a mentoring approach, and supportive material. The intervention addresses nurses and other staff, residents, their informal caregivers, therapists, and general practitioners.
Conclusions
In view of the absence of any robust evidence, the decision to use mixed methods and to closely involve both health professionals and residents proved to be an appropriate means to develop a complex intervention to improve participation of and quality of life in nursing home residents. We will now evaluate the PECAN intervention for its impact and feasibility in a pilot study in preparation for an evaluation of its effectiveness in a definitive trial.
Trial registration
German clinical trials register, reference number DRKS00010037 (12 February 2016).
Objectives
To examine the association between electrocardiographic (ECG) findings and disability status in older adults.
Study Design and Setting
KORA-Age, a population-based cross-sectional study of the MONICA/KORA project, a randomized sample from Southern Germany of people aged 65 years or older.
Results
A total of 534 (51.5%) of 1,037 participants were characterized as disabled. Disabled participants were on average 4.5 years older than those who were not disabled. Crude associations of left-axis deviation, ventricular conduction defects, atrial fibrillation, and QT prolongation with disability status were significant (P < 0.05). In models controlled for age and sex, these effects remained constant except for QT prolongation. In the models adjusted for the minimal sufficient adjustment set (consisting of the variables sex, physical activity, age, obesity, diabetes, education, heart diseases, income, lung diseases, and stroke) identified by a directed acyclic graph (DAG), no significant association could be shown.
Conclusion
Associations between specific ECG findings and disability were found in unadjusted analysis and logistic models adjusted for age and sex. However, when adjusting for other possible confounders identified by the DAG, all these associations were no longer significant. It is important to adequately identify confounding in such settings.
Zielsetzung
Seit 2011 werden in Deutschland neuartige Arzneimittel zum Zeitpunkt der Markteinführung einer frühen Nutzenbewertung (FNB) mit anschließender Preisverhandlung unterzogen (AMNOG). Zu diesem Zeitpunkt ist die Evidenz zum Nutzen des Arzneimittels limitiert. Eine erneute Nutzenbewertung (ENB) im gleichen Anwendungsgebiet auf Basis neuerer Evidenz ist allerdings nicht regelhaft, sondern nur in Einzelfällen vorgesehen. Ziel ist, die Ergebnisse von ENB im gleichen Anwendungsgebiet zu untersuchen.
Methodik Analyse sämtlicher Verfahren mit abgeschlossener ENB in den Jahren 2011–2016.
Ergebnisse
Unter den 228 Nutzenbewertungsverfahren sind 52 zu 26 Arzneimitteln mit FNB und ENB im gleichen Anwendungsgebiet. Überproportional viele ENB wurden bei Onkologika und Antidiabetika durchgeführt. Bei 15 Arzneimitteln mit nachgewiesenem Zusatznutzen hatte der G-BA den FNB-Beschluss befristet wegen unzureichender Datenlage zur Markteinführung, teils begründet durch bedingte Zulassungen. Die ENB fand nach 2,6 Jahren statt. Sie führte in 4 Fällen zu einer höheren und in 5 Fällen zu einer niedrigeren Nutzenbewertung. Für 7 Arzneimittel ohne Zusatznutzen beantragten die Hersteller eine ENB auf Basis neuer Evidenz nach ca. 1,7 Jahren. Drei dieser Arzneimittel konnten in der ENB einen Zusatznutzen nachweisen. 4 Orphan Drugs wurden gemäß gesetzlicher Vorgabe erneut bewertet, nachdem sie die Jahresumsatzschwelle von 50 Mio. € überschritten. Bei einem Orphan Drug kam es zu einer besseren, bei 2 zu einer schlechteren Nutzenbewertung. Die durchschnittliche Verbesserung beträgt 1,5 Punkte auf einer Bewertungsskala von −3 (Beleg für geringeren Zusatznutzen) bis 9 (Beleg für erheblichen Zusatznutzen) und ist begründet durch neue Datenschnitte und Studien. Die Verschlechterung beträgt durchschnittlich −1,4 Punkte. Es zeigt sich eine signifikante Korrelation der Veränderung der Nutzenbewertung mit der Veränderung des verhandelten Preises.
Schlussfolgerungen
Die ENB auf Basis einer breiteren Evidenzgrundlage führt nicht zu einer wesentlichen Änderung der Nutzenbewertung und kann die Aussagesicherheit auch nur geringfügig erhöhen. Eine generelle ENB erscheint daher vor dem Hintergrund des administrativen Aufwands nicht gerechtfertigt. Das selektive Verfahren, erneute Nutzenbewertungen durchzuführen, ist hinreichend für Adjustierungen der Nutzenbewertung, wenn die Datenlage zur Markteinführung unzureichend erscheint.
Objective: The aims of this study were to evaluate the feasibility of using the International Classification of Functioning, Disability and Health (ICF) Generic Set in routine clinical practice, and of creating a functioning score based on it, and, subsequently, to examine its sensitivity to change.
Methods: In this prospective cohort study, data from 761 adult inpatients from 21 Chinese hospitals were analysed. Each patient was assessed at admission and discharge. Feasibility was evaluated by analysing mean assessment time. The Rasch model was used to create a metric of functioning. Sensitivity to change was analysed with mixed-effects regression and by calculating standardized effect size based on Cohen's f2.
Results: Mean duration of assessment was 5.3 min, with a significant decrease between admission and discharge. After removal of the item remunerative employment, the remaining ICF Generic Set categories fitted the Rasch model well. With a mean improvement in functioning of 12.1 (95% confidence interval (95% CI): 11.5–12.6), this metric proved sensitive to change, both in terms of statistical significance (p < 0.001) and standardized effect size (Cohen's f2 = 2.35).
Discussion: The ICF Generic Set is feasible for use in routine clinical practice and is promising to serve as the basis for the development of a functioning score that is sensitive to change.
Background
Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes.
Methods
A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted.
Results
A total of 20 randomized and 2 non-randomized controlled trials with 1876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms.
Conclusion
To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.
Trial registration
PROSPERO 2017 CRD42017080291.
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).
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.