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Anwendungsbeobachtung
(2018)
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).
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.
BACKGROUND: In clinical practice and research a variety of clinical data collection tools are used to collect information on people’s functioning for clinical practice and research and national health information systems. Reporting on ICF-based common metrics enables standardized documentation of functioning information in national health information systems. The objective of this methodological note on applying the ICF in rehabilitation is to demonstrate how to report functioning information collected with a data collection tool on ICF-based common metrics. We first specify the requirements for the standardized reporting of functioning information. Secondly, we introduce the methods needed for transforming functioning data to ICF-based common metrics. Finally, we provide an example.
METHODS: The requirements for standardized reporting are as follows: 1) having a common conceptual framework to enable content comparability between any health information; and 2) a measurement framework so that scores between two or more clinical data collection tools can be directly compared. The methods needed to achieve these requirements are the ICF Linking Rules and the Rasch measurement model. Using data collected incorporating the 36-item Short Form Health Survey (SF-36), the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and the Stroke Impact Scale 3.0 (SIS 3.0), the application of the standardized reporting based on common metrics is demonstrated.
RESULTS: A subset of items from the three tools linked to common chapters of the ICF (d4 Mobility, d5 Self-care and d6 Domestic life), were entered as “super items” into the Rasch model. Good fit was achieved with no residual local dependency and a unidimensional metric. A transformation table allows for comparison between scales, and between a scale and the reporting common metric.
CONCLUSIONS: Being able to report functioning information collected with commonly used clinical data collection tools with ICF-based common metrics enables clinicians and researchers to continue using their tools while still being able to compare and aggregate the information within and across tools.
Background: Patient reported outcome measures (PROMs) have been integrated in national quality registries or specific national monitoring initiatives to inform the improvement of quality of care on a national scale. However there are many unanswered questions, such as: how these systems are set up, whether they lead to improved quality of care, which stakeholders use the information once it is available. The aim of this study was to examine supporting and hindering factors relevant to integrating patient-reported outcome measures (PROMs) in selected health information systems (HIS) tailored toward improving quality of care across the entire health system.
Methods: First, a systematic search and review was conducted to outline previously identified factors relevant to the integration of PROMs in the selected HIS. A social network analysis was performed to identify networks of experts in these systems. Second, expert interviews were conducted to discuss and elaborate on the identified factors. Directive content analysis was applied using a HIS Evaluation Framework as the frame of reference. This framework is structured into four components: Organization, Human, Technology, and Net benefits.
Results: The literature review revealed 37 papers for the NHS PROMs Programme and 26 papers for the SHPR and SKAR: Five networks of researchers were identified for the NHS PROMs Programme and 1 for the SHPR and SKAR. Seven experts related to the NHS PROMs Programme and 3 experts related to the SKAR and SHPR participated in the study. The main themes which revealed in relation to Organization were Governance and Capacity building; to Human: Reporting and Stakeholder Engagement; to Technology: the Selection and Collection of PROMs and Data linkage. In relation to Net benefits, system-specific considerations are presented.
Conclusion: Both examples succeeded in integrating PROMs into HIS on a national scale. The lack of an established standard on what change PROMs should be achieved by an intervention limits their usefulness for monitoring quality of care. Whether the PROMs data collected within these systems can be used in routine clinical practice is considered a challenge in both countries.
Objective Specifying the content in electronic health records (EHRs) through standardized headings based on international reference classifications will facilitate their semantic interoperability. The objective of this study was to specify potential chapter headings for EHRs aligned with the World Health Organization's (WHO) International Classification of Functioning, Disability, and Health (ICF) based on the perspectives of people living with chronic health conditions, carers, and professionals.
Methods A multistage process was established including (1) a patient workshop, (2) an online survey of both patients and carers, and (3) an online consultation with patient and professional bodies. The ICF served as a starting point. Based on the first stage, a first draft of the headings was developed and further refined based on the feedback at each stage. We examined in a fourth step whether items from existing assessment tools support the operationalization of the identified headings. Therefore, we used the WHO Disability Assessment Schedule 2.0 (WHODAS2.0), a patient-reported instrument, and interRAI, a clinician-administered instrument.
Results The first workshop was attended by eight people, the survey was completed by 250 persons, and the online consultation received detailed feedback by 18 professional bodies. This study resulted in 16 potential chapter headings for EHRs which capture aspects related to the body, such as emotions, motivation, sleep, and memory or thoughts, to being involved in social life, such as mobility, social activities, and finances, as well as to the care process, such as understanding of health issues and treatment or care priorities and goals. When using the WHODAS2.0 and interRAI together, they capture all except one of the proposed headings.
Conclusion The identified headings provide a high level structure for the standardized recording, use, and sharing of information. Once implemented, these headings have the potential to facilitate the delivery of personalized care planning for patients with long-term health problems.
Zielsetzung
In den letzten Jahren konnte eine Steigerung der Anzahl privater Krankenhäuser und Betten festgestellt werden. Die Probleme der Investitionsfinanzierung deutscher Krankenhäuser in Kombination mit verstärkenden Faktoren wie der Einführung der DRGs, aber auch die Erwartung einer höheren Effizienz nach der Privatisierung einer Klinik können als Hauptgründe bei Privatisierungsentscheidungen genannt werden. Es soll untersucht werden, wie ehemalige öffentliche Krankenhausträger den Erfolg der Privatisierung einschätzen.
Methodik
Alle 99 identifizierten ehemaligen öffentlichen Träger, die ihr Krankenhaus in den Jahren 2003–2013 an einen privaten Eigentümer verkauft hatten, wurden hinsichtlich ihrer Einschätzung von Zielen sowie Befürchtungen vor und nach der Privatisierung anonym und schriftlich befragt.
Ergebnisse und Schlussfolgerung
Zusammenfassend lässt sich feststellen, dass bei einer ausreichenden Finanzierung der Krankenhäuser aus Krankenkassenbeiträgen (Betriebsmittel) und Ländermittel (Investitionskosten) der Privatisierungsdruck rapide sinken würde. Wenn jedoch privatisiert wurde, hatte dies aus Sicht der ehemaligen Träger weder einen negativen Einfluss auf die medizinische Versorgung in der Region, noch auf die Qualität der medizinischen Behandlung und auf den Umgang mit den Mitarbeitern.
Die Einschätzungen der ehemaligen Träger weisen eine statistisch überprüfte Übereinstimmung auf. Die mit einer Privatisierung verbundenen Erwartungen und Ziele werden prinzipiell als erfüllt wahrgenommen