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“We now need clear implementation strategies”

Zum 15. Mal fand der Deutsche Kongress für Versorgungforschung statt, zum zweiten Mal in der Urania, zudem in Eigenregie des Deutschen Netzwerks für Versorgngsforschung (DNVF) und zum ersten Mal unter der Führung einer Frau: PD Dr. med. Dipl.-Theol. Monika Klinkhammer-Schalke. „Monitor Versorchungsforschung“ sprach mit ihr über den erneut gut besuchten Kongress, der unter dem Motto „Wissen schaf(f)t Nutzen“ stand und der einige Neuerungen im Vergleich zu den bisher stattgefundenen aufwies.

29.11.2016
Off-label use in the care of adjuvant breast cancer patients

Medicines can only be placed on the market in Germany if they have gone through an approval procedure in accordance with Section 21 of the Medicines Act. Based on the data submitted by the applicant pharmaceutical company, the field of application (indication), the type of administration and the dosage of the drug are then determined, among other things, as part of the approval process. In principle, a drug can only be prescribed at the expense of statutory health insurance if it is used in accordance with its approval. The off-label use of a medicinal product outside the area of application approved by the national and European regulatory authorities is referred to as off-label use. Off-label use in oncology in Germany is estimated at up to 60% of patients (Ludwig 2006). However, there is currently no empirical data to support these assessments. A distinction must be made between “classic” off-label use and recognized off-label use, which enables the approval-exceeding regulation in accordance with Section 35c (1) SGB V. In 2003, an expert group was set up at the Federal Institute for Drugs and Medical Devices (BfArM), whose task is to convey the "Assessment of the current state of scientific knowledge about the off-label use of certain drugs as a recommendation" to the G-BA (G-BA press release 2014). Resolutions on recognized off-label use only become legally binding if the pharmaceutical company and the Federal Ministry of Health agree. An example of recognized off-label use in oncology is fluorouracil (5FU), approved for the treatment of advanced colorectal cancer, gastric cancer, pancreatic cancer, and advanced and/or metastatic breast cancer (BCa). According to Section 35b Paragraphs 2 and 3 SGB V, 5FU was additionally approved for the adjuvant therapy of BCa. The recognized off-label use of 5FU has also been adopted into the S3 and Onkopedia guidelines, where adjuvant treatment of patients with 5FU-containing regimens is recommended.

29.11.2016
Big data and digitalization: Need for action for health services research

The healthcare systems of industrialized countries are extremely complex. Anyone who wants to understand, control or improve them absolutely needs functional health services research. Anyone who wants to evaluate innovations in the context of everyday situations cannot ignore efficient health services research. There is no dissent about this in Germany. Funding programs of the BMBF for the development of research structures and for the consolidation of data as well as the anchoring of the innovation fund in the social code also testify to the willingness to invest in the development of health services research in Germany. Alone, there is a lack of the necessary legal basis on the basis of which financial investments in health services research can mature into the development of a sustainable and efficient research infrastructure. Without data there is no research, and without a suitable legal basis, German health services research lacks the necessary access to data. The formal reason to tackle this "hot potato" is given: the forthcoming implementation of the European data protection regulation in German law. The time frame for this is limited, namely until the end of 2018. The (old and new) federal government should not wait too long for other reasons. Other parliaments, for example in the United Kingdom, have long recognized the international competitive pressure and have already taken action. In the next few years it will be decided whether Germany will be the leader in 'Big Data' in health services research or whether it will lead an international niche existence in health services research in the long term. This question will also decide whether Germany will continue to be an export country for health technology or become an import country. Anyone who wants to keep Germany as a research location at the top of the world in the field of health services research must now oblige the departments of research, health, economy and internal affairs to set up a joint action program for health services research, which should be approved by the Bundestag as soon as possible.

29.11.2016
Big data between healthcare and desires

The previous trickle of data from many sciences has now become an avalanche, even a whole deluge, which is constantly increasing and getting stronger (Callebaut 2012). Every day, more data is generated about each individual's life than ever before. Experts estimate that 90 % of all data in the world was collected in the last two years (BBC Health 2016). The main reason for this lies in a core technical innovation of modernity, information technology. The pace of change is getting faster and faster. While in 2003 it took almost ten years to decode the first genome of Homo Sapiens with its 3.27 x 109 base pairs, today that time has shrunk to less than a week. In the near future the same thing will be done in a few hours. Many of the world's problems no longer lie in the "what" but in the "why". Causation remains more important than determination. A saying highlights the problem: You often can't see the forest for the trees. Unlike before, the availability of information has already far outpaced the understanding of the connections between knowledge. The volume of information is now growing faster than traditional analytics can handle the mountain of value.

29.11.2016
Model of prevalence-adjusted demand planning

Psychotherapeutic care in Germany is good compared to many neighboring countries. In Austria and Great Britain, for example, psychotherapeutic services are largely concentrated in major cities and, in many European countries, must be paid for out of pocket (Bühring). However, waiting times for a therapy appointment are also a problem in Germany (BPtK); and half of all psychotherapists practice in large cities, where only a quarter of the population lives. To address this situation, the German legislature, in the Healthcare Strengthening Act (VSG) of 2015, tasked the Federal Joint Committee (G-BA) with revising needs assessment. More needs-based care is to be provided by January 1, 2017 – particularly with regard to psychotherapeutic care. To this end, the legislature has given the G-BA specific guidelines: It is to review the ratios, taking into account the possibility of more localized planning and considering demographic trends as well as morbidity and social structures.

29.11.2016
Five steps for better care

The view of the 5-star marina at the Hohe Düne Yacht Harbour Residence in Rostock-Warnemünde is truly something special – the seemingly endless vista across the Baltic Sea, with a few large and many small ships cutting through the waves. However, it wasn't the exquisite panorama that drew 40 distinguished representatives from healthcare practice to Rostock, but rather the topic: "Matters of the Heart? – The Next Five Steps for Better Care for Heart Patients from the Perspective of Practitioners," to which the German Society for Integrated Care in Healthcare (Deutsche Gesellschaft für Integrierte Versorgung im Gesundheitswesen e.V.), with the support of Vivantes – Network for Health GmbH and AOK Nordost – The Health Insurance Fund (AOK Nordost – Die Gesundheitskasse), had invited them. The stated goal, which was achieved, was to develop and, moreover, reach consensus on a roadmap for realigning healthcare in the field of heart health, not only in Mecklenburg-Western Pomerania, but also throughout Germany.

29.11.2016
Independent, comprehensive scientific evaluation

Neither the top 20 speakers nor the ever-eloquent Prof. Dr. Jürgen Wasem (Alfried Krupp von Bohlen und Halbach Foundation Chair of Medical Management at the University of Duisburg-Essen) could have been the reason for the surprisingly low attendance at the 21st Handelsblatt Annual Conference – Health 2016, essentially the nucleus of all health congresses in Germany. Perhaps the three-day program was somewhat unfortunate in its duration, or perhaps the overly broad range of topics and the array of speakers, including politicians like Annette Widmann-Mauz, Parliamentary State Secretary at the Federal Ministry of Health, who opened the conference, or State Secretary Karl-Josef Laumann, who spoke about the current state of nursing care legislation but seemed strangely out of place amidst the topics of AMNOG and Morbi-RSA (which was discussed here).

29.11.2016
Steegers: "Quality indicators are important"„

The 3rd National Pain Forum, organized by the German Pain Society (Deutsche Schmerzgesellschaft e. V.), once again brought together politicians, scientists, physicians, health insurance representatives, and patient advocates. Their statements and active participation in discussions demonstrated the importance they place on the topic of pain, and especially its multiprofessional and multimodal therapy. The highlight of this third Pain Forum was the presentation by Dr. Monique Steegers (MD, PhD, FIPP, jPL), Chancellor of the World Institute of Pain (WIP), who described the real problems associated with quality indicators – a highly topical issue given the upcoming publication of the IQTIG's set of quality indicators.

29.11.2016
Baas: “Not a luxury, but a necessity”

On the occasion of the tenth anniversary celebration, Dr. Jens Baas, the chairman of the board of the Techniker Krankenkasse (TK), describes the “TK Scientific Institute for Benefits and Efficiency in Health Care” (WINEG), founded ten years ago by his predecessor Dr Norbert Klusen, as a “transmission belt”. Although such an institute is not anchored in the original range of services and tasks of a health insurance company, WINEG would be an important institution in order to reduce the “gap between what happens in science and health services research and what reaches our insured people”. It was precisely this approach that ran through the entire program of the scientific birthday congress, in which every topic addressed was examined and questioned from two perspectives: from the perspective of health services research and the reality of care.

29.11.2016
Hydroaktive Wundbehandlung – heute Standard?

Ein bis zwei Millionen Menschen leiden nach Expertenschätzungen in Deutschland aufgrund von Durchblutungsstörungen an chronischen Wunden: Ulcus cruris (offenes Bein), Dekubitus (Wundliegegeschwür) und das diabetische Fußsyndrom sind mögliche Folgen. Mehr als 60.000 Mal wurden im Jahr 2014 in deutschen Krankenhäusern Anwendungen zur Amputation und Exartikulation am Fuß durchgeführt, was die Relevanz einer guten Versorgung chronischer Wunden verdeutlicht (Quelle: INSIGHT Health-Klinikspiegel).

29.11.2016

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