When health services research becomes important

“Dear health care researchers, we have finally achieved what we have been working for.” With these enthusiastic words, Prof. Dr. Wolfgang Hoffmann, Chairman of the Health Services Research Network (DNVF), the 22nd DKVF, which took place in Berlin's Urania at the beginning of October. The reason for his joy was the fact that - continued Hoffmann - the Innovation Committee recommended that 17 projects from the first and second funding waves of the new forms of care be transferred to standard care, but above all that the results of health care research - including those of the innovation fund project “WiZen “, which demonstrated the superiority of initial therapy in the primary treatment of cancer patients in certified centers - forms an evidence base for the recommendations of the government commission for hospital reform. But that is exactly what the DNVF chairman warned the research community gathered at the German Congress for Health Services Research. Since health services research is now systemically relevant, this not only entails increasing responsibility, but also has serious consequences: “Health services research now has critics.” Because, says Hoffmann: “Our results, recommendations and priorities are now more likely to have consequences , they affect providers, shift weights, change power relations and financial flows.”

>> Also Minister of Health Prof. Dr. In his greeting message recorded via video, Karl Lauterbach addressed the role of the
care research and also on the “WiZen”
project. In order to further develop health care, according to the Health Minister, politics is dependent on scientific orientation, for which “health services research in particular achieves an immense achievement”. This specialty is particularly in demand “where we cannot yet work on an evidence-based basis in medicine because we are breaking new ground”.
The project “Effectiveness of Care in Oncology Centers” with the funding code 01VSF17020, which was funded by the Innovation Fund with 1.6 million euros, also broke new ground and was full of good will to contribute to better care with more evidence. Lauterbach commented on his core statement that initial treatment in a certified – compared to a non-certified – hospital is associated with a longer overall survival of patients with incident cancer: “Anyone who has cancer and is treated in a certified oncology center has an increased chance of survival . This is a great incentive and is politically very relevant information for us." His demand, which he would have to fulfill himself because only politics can do that: "We have to bring the quality requirements for special primary treatment for cancer to the same level across the board lift that is comparable to certified centers.”
This is exactly where mined terrain opens up, into which health services research has unexpectedly found itself - and thus not only between many fronts, but also complex contexts and agendas of the banks that operate in self-administration and play a key role in determining the G-BA.
In its decision (1), the Innovation Committee at the G-BA was convinced that, given the high relevance of the findings on treatment success in certified oncological treatment facilities and the need for further research, “a targeted dissemination of the project results” would make sense. The project, according to the resolution dated October 17, 2022, successfully examined the effectiveness of health care for cancer patients and provided “scientifically based findings on the effectiveness of health care in certified treatment facilities compared to care in non-certified facilities.” Consequently, the project results were forwarded with the “request to examine possible use within the scope of their respective responsibilities” to:
• the G-BA quality assurance subcommittee as well
• the Institute for Quality Assurance and Transparency in Healthcare (IQTIG).

In addition, the Quality Assurance Subcommittee is asked to include the results for the “possibilities of setting minimum requirements for structural, process and result quality and for the development of data-supported quality assurance procedures” as well as their “consideration in the G-BA's comparative reporting for support of patients’ selection decisions in accordance with Section 136a Paragraph 6 SGB V.” So far so good.
Transfer? Still missing
But so far there has been no visible progress in implementation and transfer, as Prof. Dr. Jochen Schmitt from the Center for Evidence-Based Health Care at the Medical Faculty at TU Dresden, head of the project consortium and together with Prof. Dr. Monika Klinkhammer-Schalke from the Association of German Tumor Centers. V. and head of the Center for Quality Assurance and Health Care Research at the University of Regensburg, main authors of the original work that belongs to it and has already been published in the “Deutsches Ärzteblatt”, which was reported on the occasion of a symposium at the DKVF, which the cancer society was responsible for.
Three of the four speakers in this track with the appropriate title including the all-important question mark “Does the innovation fund contribute to improving care?” reported on their experiences after the end of the project. Ursula Marschall from BARMER shed light on the “TRANSLATE-NAMSE” project and the only limited possibility of “transfer to care through selective contracts”. Prof. Dr. Martin Lambert from the Hamburg UKE focused on the “RECOVER” project in his presentation, which could have produced good results, but still failed to receive a positive recommendation. Schmitt spoke about the transfer into standard care of the “WiZen” project, which he played a key role in initiating, which has not yet been transferred into standard care despite positive recommendations.
Klinkhammer-Schalke, Schmitt and the research team behind “WiZen” are taking the important step, “WiZen”, on their own initiative and based on the self-imposed obligation and mission of health care research to really improve care through their work. -To follow up results with further actions. So far in vain.
The G-BA quality assurance subcommittee, which was formed by the innovation committee
“Targeted dissemination” – i.e. sowing – was requested and has not yet responded. Apparently because, according to insiders, he is of the opinion why he should bother setting the minimum requirements for structural processes and quality of results when the Federal Ministry of Health is doing that anyway as part of the upcoming hospital reform.
But the BMG is not doing that at the moment. Here comes the next complex in which healthcare research is currently moving: the federal hospital reform, into which the results of the “WiZen” study would naturally have to be incorporated - deliberately formulated in the subjunctive.
This is in turn because the federal and state governments consulted with the states and coalition factions from January to July 2023 as part of a “federal-state group for hospital reform” and developed a comprehensive key points paper. The federal and state governments have now agreed to use 60 somatic service groups according to the North Rhine-Westphalia State Hospital Plan 2022 as the starting point for defining the service groups, as well as five additional service groups, which from a medical-scientific perspective are determined by the Working Group of Scientific Medical Societies (AWMF ) were proposed. However, there is currently no oncology service group and certainly no interdisciplinary one that is needed to sustainably improve oncological care.
“What consequences, if any, will the Federal Government and – to the knowledge of the Federal Government – the Federal Joint Committee (G-BA) draw from the findings gained in the “WiZen – Effectiveness of Care in Oncology Centers” project, and how should these be implemented specifically? CDU/CSU member of the Bundestag Sepp Müller addressed this question to the German Bundestag in July of this year (2). From the written answer from the Parliamentary State Secretary Dr. Edgar Franke shows that the “future differentiation and further development of the performance groups should take place with the participation of the AWMF in particular”. In addition, “minimum structural requirements for” should be included in the performance groups based on medical evidence
“Quality-oriented service provision” must be defined. To this end, Franke continued in his answer, the AWMF has set up an ad hoc commission on “supply structures”, which, among other things, includes: The German Cancer Society is involved as the sponsor of the “OnkoZert” certification system for oncology facilities. “Suggestions for comprehensible and guideline-compliant criteria could also be introduced” for requirements for oncological service groups, which also take the results of the “WiZen” project into account.
At least that is hopeful, even if it will take a lot more time than healthcare research would like in terms of patient well-being. Schmitt, still disappointed by the transfer successes of the G-BA and politicians so far: “Although everyone is praising the project, we have not yet managed to implement it, but patting on the back doesn’t do much good – least of all for the patients.” The G -BA – again a subjunctive – using the example of “WiZen” to impressively demonstrate its ability to act.
Reason for transfer to standard care: years of life lost
Above all, the transfer to standard care, which has not yet taken place, does not help those in non-certified centers.
patients who acted and died far too early. Among other things, in order to make the statistical survival figures of the hazard ratios, which are not always obvious to everyone, easier to understand, the government commission
A potential analysis was created for modern and needs-based hospital care, in which Schmitt is involved. With the 5th statement entitled “Ver-
Improving the quality and safety of healthcare – potential analysis
hand of exemplary diseases” (3).
the Government Commission (RK) contribute to objectifying the discussion. The reason: The hospital company (DKG) had already argued in the context of the 3rd statement of the RK, which recommended concentrating care on clinics with high structural quality, that this could contribute to hospitals being closed and also to the fact that quality is the same Accessibility is what, according to Schmitt, is certainly not a tenable statement.
The potential analysis has been recalculated as the 5th statement by the RK with current treatment numbers from 2021. In addition, the methodology for estimating a nationwide, absolute effect of patient benefit through centralization from the relative effect measures (hazard ratios) determined in the “WiZen” study is an original work in the DNVF Journal, which was first published for the DKVF and integrated into the “Healthcare” journal “Health Care Research & Implementation” (4) has been published.
The results of the government commission’s potential analysis are also impressive.
Here, the Germany-wide potential for preventing life years lost (YLL) or preventable deaths in stroke and endoprosthetics was calculated for cancer, stroke and endoprosthetics.
In the case of cancer, it was again possible to refer to the “WiZen” project and show how high the annual potential of concentrating initial cancer treatment in DKG-certified hospitals really is (in years of life saved). The Germany-wide potential for concentrating initial treatment in DKG-certified hospitals results from the product of the quality potential per patient and the number of patients initially treated in non-certified hospitals in the status quo.
Relevant quality potential is revealed for each of the 11 cancer entities examined - from endometrial to breast to cervical cancer. Between 665 (cervical cancer) and 4,873 (colon cancer) years of life could be saved per year for each type of cancer by concentrating initial treatment exclusively on certified clinics. With regard to breast cancer, there is particularly high potential because, according to the 5th statement, the number of cases and the advantage of treatment in a certified center are particularly high. Overall, the quality potential for all entities for the initial treatment of cancer diagnoses is 20,404 life years per year.
According to the more recent projections based on the figures from 2021, according to Schmitt, the potential for all eleven types of cancer still adds up to over 20,000 avoidable years of life lost - every year, mind you! The decline could be due, on the one hand, to the fact that more clinics have now been certified than in 2017 or, on the other hand, to the fact that patients are having surgery in certified hospitals on their own initiative. Whatever the case, Klinkhammer-Schalke and Schmitt say in unison: “Even the 20,000 years of life lost are still too many.”
The estimate of years of life lost, as well as the estimated potential to prevent deaths five years after diagnosis (4,729 cases per year), should prevent misinterpretation of the hazard ratios commonly used in survival analysis. The presentation, as the original paper states, could help to “achieve a presentation of results for important players in the healthcare system without a special background in statistics.”
In order to refute the always popular narrative that care close to home is then at risk, the commission also analyzed the effects, for example, of colon, breast and prostate cancer and brain tumors. According to this, over half of the population can reach a certified colon or breast cancer center from their own home in well under 20 minutes. For prostate and brain tumors, the median accessibility for the German population is just over 20 and 30 minutes, respectively. Travel times to a certified cancer center of over 40 minutes exist for around 11% of the population for colon and breast cancer, for 20% for prostate cancer and around 40% for brain tumors.
The interpretation of the government commission regarding the concentration of cancer care in certified clinics: “The potential analysis shows a high potential for improving the quality of care by concentrating the initial treatment of patients with cancer in certified centers while maintaining comprehensive care and good accessibility for the population. “The initial treatment for cancer does not constitute an emergency in which the travel time would have medical relevance. And further: “The structural requirements for service groups that are approved for the initial treatment of people with cancer should be based as closely as possible on the DKG certification criteria. These include requirements that ensure the necessary interdisciplinary and professional cooperation as well as the expertise of the treatment partners.”
It is also important that the present impact analysis, like the “WiZen” study, addressed the initial treatment in the center and thus generally the surgical treatment of the types of cancer examined. Further treatment can then be carried out close to home by cooperating hospitals and/or outpatient service providers in coordination with the initial treating clinic - a network of regional service providers should be promoted here.
Then why the delay of over a year? It is proven with the highest possible evidence that - according to the government -
Commission in its 5th opinion
– “Specialization and concentration of health care through evidence-based minimum requirements for structural quality for the population offer considerable potential for improving results and quality without leading to significant restrictions in accessibility.”
That's why it's all the more disappointing that no concrete steps have been taken to save years of life lost, but also to reduce unnecessary pain and suffering for those affected and their families. There is no other way to understand the perceived standstill in the urgent transfer of the “WiZen” results into standard care after the end of the project a good year ago.
A search for why
However, one can try to shed light on the background and at the same time name the benches operating here with their own respective agendas. An exciting AOK symposium in April of this year, at which the “WiZen” results were presented to a broad public via stream (5), provided a deep insight into the situation lurking in the background. After introductory presentations on the results of the study, the moderators discussed
tion from Klinkhammer-Schalke (Association of German Tumor Centers and representative of the “WiZen” research group) Dr. Carola Reimann, Chairwoman of the AOK Federal Association, Prof. Josef Hecken, Impartial Chairman of the G-BA, Dr. Gerald Gaß, General Manager of DKG e. V., Markus Algermissen, head of the medical and professional law sub-department at the BMG, and as patient representative Hedy Kerek-Bodden, chairwoman of the board of the House of Cancer Self-Help - Federal Association. V. in Bonn.
The patient representative will not have believed her ears because of the arguments presented here as to why meaningful, better cancer care in certified centers is not so easy to implement.
Theoretically, according to Hecken, the G-BA of course has the opportunity to define certain structural requirements in Section 136 SGB V, such as the minimum quantities necessary for the treatment of oncological diseases. The Federal Committee could also define certification, as required by the government commission, as a requirement in a guideline. Hecken: “We can do that very quickly, but with the result that the states would be inhibited in their hospital planning.”
According to Hecken, minimum quantities also have another impact – namely on the number of clinics that are allowed to operate. According to the figures presented by Hecken, of the 564 hospitals that currently operate on women (and rarely men) with breast cancer, 220 carry out fewer than 10 operations. And not even per year, because the minimum quantities were stretched over two years by the G-BA. The minimum quantity would then be gradually increased from 50 to 100 - but only from 2024 or 2025.
With a minimum quantity of 100, only 355 hospitals in this country would be allowed to operate on breast cancer instead of the current 732. This would mean that these surgeries would be allocated to the remaining hospitals, which would then be able to carry them out more successfully - because they are much more common - with better equipment and greater experience on the part of the treatment team and more routine in the processes.
If these 355 clinics were to remain the same as a result of changing the minimum quantity, the distance would also be extended, which is naturally the case in the area of tension between local and specialized care. According to the G-BA chairman, the average travel time for breast cancer care would then increase from the current 15 to 18 minutes. Hecken: “If I had breast cancer, which is quite rare for men, I would happily take the 18-minute drive.” Mind you: on average. He is of course aware that the travel time in rural areas looks a little different, but will not be longer than 35 to 40 minutes.
As DKG managing director Gaß emphasized in the discussion, the hospital company is not opposed to minimum quantities. The DKG made the suggestion to increase the minimum quantity to 50 instead of 100, which would have been a significant increase (from the current 10). However, since minimum quantities are a control instrument, because all those hospitals that remain below the specified surgical level are then no longer allowed to offer these surgeries, this is tantamount to interfering with the commercial operations carried out by hospitals.
Gaß also had figures for this: Increasing the minimum quantity to 50 would mean a significant reduction in the number of hospitals that are now allowed to operate on breast cancer: to just 428, i.e. almost half. This shows the “field of tension between”, as Gaß put it in a deliberately provocative way, “optimal treatment of the individual patient and the question of care close to home”. The sheer size or number of cases of a hospital is correlated, but what is much more important is the quality of treatment it delivers, which is what certification also stands for, as Gaß emphasized. The certification carried out by the German Cancer Society, to which many hospitals have so far undergone voluntarily (note: depending on the cancer entity, this is 25 to 60% - Fig. 2), defines an ideal treatment process so that certified hospitals can achieve good treatment results even with a minimum quantity of less than 100 the meaning of this study”. Gaß' suggestion to health services research: “This fact needs to be further evaluated.”
So far, the “WiZen” study has provided important and additional evidence that the survival effect increases if a hospital is certified for a longer period of time. In the case of breast cancer, the survival advantage changes depending on how long a house has been certified: from 17% if a house has been certified for less than a year, rising to an impressive 23% if the certificate has been held for more than 5 years (Fig. 2) .
Given these numbers, does the question really still arise as to where women suffering from breast cancer or those suffering from cancer in general should seek initial treatment? <<
from:
MVF editor-in-chief Peter Stegmaier