“In the phase in which we are thinking about making the innovation fund permanent, critical reflection is needed on all sides.” This is what Prof. Josef Hecken, the impartial chairman of the G-BA and at the same time chairman of the G-BA's innovation committee, said on the occasion of the first part of the MVF specialist congress "Prioritization Catalog for Health Care Research", which took place online on December 13, 2022. Part 2 took place on January 24, 2023 and will be edited in the upcoming issue of “Monitor Healthcare Research” (MVF 02/23).

> Hecken, for example, demands that the innovation fund “has to have a learning curve”. He gave a few reasons for this. Among other things, in the past (and to date) some things have been funded “even though the knowledge that was the subject of these projects was already available in the care system”. Some projects would also have been funded, “although a more critical examination would have revealed from the outset that certain applications were doomed from the outset by the methodology, the recruitment plans, and the overall structure of the projects” to not be satisfactory within the funding deadlines results to come. In doing so, he first self-critically takes the G-BA and Innovation Committee to task. He stated that he felt it was “absolutely necessary” to “work more closely together before the funding announcements were announced”. There must be greater coordination between the innovation committee, the working committee and the healthcare researchers in advance of each funding round. Here he spoke directly to all those who are organized in the German Health Services Research Network. Its new chairman, Prof. Dr. Wolfgang Hoffmann from the University of Greifswald, who also gave a presentation on the “Prioritization Catalog of Health Services Research” at the MVF specialist congress, was happy to accept the assignment, saying he was “totally pleased” with the discussion “that we are having here today”.

Key topics with “need for health care research” and “genuine medical need”

This is mainly due to the fact that Hecken has come to a conclusion: In his opinion, in the health care research funding part, topic clusters should be jointly identified from the outset in the future that go beyond the normal topic announcements of the past, as these were “very abstract and very general”. . By topic clusters, Hecken means focus topics in which health care research sees a “need for health care research” on the one hand, but in which there is also a “real medical need” on the other. In Hecken's opinion, a cluster can also form various related funding applications that shed light on different aspects of the same supply problem and run side by side in order to ultimately generate further insights from two or three or even all projects.
Hecken expects this new approach to funding from the Innovation Fund to provide a significant boost. “At the end of the day, we can move beyond answering rudimentary, small, individual questions that are certainly important but do not significantly change the system,” said the G-BA and Innovation Committee chairman, expressing his hope.
This was not his only suggestion with great potential for improvement, which he believes can be used to improve the Innovation Fund in the future. The second point that, in his words, causes him “very, very great concern,” because it is “reflected to some extent in the failure of many projects,” is the question of selecting the projects to be funded. Here it is urgently necessary to “professionalize the pre-selection of projects in the pool of experts to some extent” - a statement that he himself qualified by putting it in quotation marks. To explain this, he went far back into the history of the Innovation Fund and recalled the expert advisory board headed by Prof. Holger Pfaff, which was installed by the then Federal Minister of Health Hermann Gröhe in July 2015 and dissolved at the end of 2019. This ensured that all incoming applications were assessed by the ten members of the expert advisory board and “especially within the framework of a joint discussion in the expert advisory board according to relatively uniform criteria”. However, with the newly worded Section 92b Paragraph 6 SGB V, the expert advisory board was replaced by a broader pool of experts. Although this “broadens the knowledge in the assessment”, due to the effects of the corona pandemic there is only rudimentary cooperation between the individual experts, now over 100. Hecken: “I occasionally notice that depending on which experts certain applications are assigned to, the assessments are carried out according to completely different criteria.” This could, which he described as very critical, lead to some applications being assessed “possibly worse or worse.” perform better than others.” This is also due to the fact that the reviewers' focus may not necessarily be in the area that is the subject of the application being reviewed. However, in Hecken's opinion, this type of random assessment does not meet the demands that “we have to place on ourselves”. He therefore advocates a mixed model of a pool of experts and an expert advisory board, whereby a “joint, uniform discussion” of the applications to be funded must always take place in order to ensure a “sensible procedural assessment”.
After the more fundamental definition of topics in the area of health services research, a more professional selection and evaluation of project applications, Hecken still has another major construction site: that is that of translation, the transfer into standard care. In his presentation, Hecken calculated that 77 health services research projects (as of December 8, 2022) had now been completed and evaluated after consultation in the Innovation Committee. There was no recommendation for transfer in 52% of the projects in the field of health services research. This is for the simple reason that, according to the Innovation Committee's assessment based on the available evaluation reports, these projects have not produced any findings that can be used in any way for healthcare purposes. Hecken certainly recognizes that scientific proof that something is not effective would also be a result, but that is not the original goal of the innovation fund. According to Hecken's calculations, there was only a clearly positive rating in four percent of the cases. This corresponds to an “accolade for a health care research project” if what was tested in an innovation fund health care research project is to be converted into a new form of care. In addition, in 26% of the cases a recommendation for examination or transfer was made, in 18% only the recommendation to take note. “I wouldn’t equate taking note of it with recommendations,” says Hecken. If someone takes note of something, that's nice, but ultimately it's not a guarantee of transmission with any kind of practical consequences.
The recipients of the recommendations for information (50) were the AWMF and/or medical specialist societies for 26%, the G-BA sponsoring organizations for 14%, and the BMG and/or subordinate authorities for 10%
8% the cases of the G-BA itself, 6% ministries of the federal states and/or GMK, 4% nursing organizations and 2% other federal ministries and/or subordinate authorities as well as the Federal Medical Association. In addition to 26% there are other stakeholders. The addressees for the examination and transfer (38) were the G-BA for 29%, the BÄK for 13%, the sponsoring organizations of the G-BA for 10%, the BMG and/or subordinate authorities as well as other federal ministries and/or subordinate authorities for 8%, 5% each the AWMF and/or medical specialist societies and nursing organizations, 3% ministries of the federal states and/or GMK as well as contractual partners at state level. In addition, there are 16% many other, very different stakeholders.
According to Hecken, almost all recipients of recommendations have one thing in common: apart from the G-BA, none of the recipients of these recommendations have any legal obligation to do anything within certain deadlines! Hecken: "If I'm lucky, I'll get a letter with a thank you, we've taken note of that." Some replies from federal states that were given recommendations based on the results of some emergency projects responded: "We think that's really great, “But we have other systems to which we have become accustomed and therefore do not want to draw any conclusions from the beneficial findings that have been drawn from projects here.”
But so far he hasn't noticed in a single case that someone who has received something for information has said: "That's great, I'll implement it now." Hecken describes this as a "relatively unsatisfactory result" because only G -BA is forced by existing legal regulations to take certain steps and report to the BMG if no conclusions are drawn when a review of the results from innovation fund projects is suggested. Even if health services research delivers good results, it is still unsatisfactory if no legal consequences are derived from such transfers and examinations if the G-BA itself is not affected. That is why he has long been calling for all recipients of recommendations to be required to justify themselves. They should be obliged to report to the G-BA how they want to deal with these recommendations. In Hecken's opinion, these individual reports must then be forwarded to the Federal Ministry of Health as the legal supervisory authority of all these entities, which in turn is obliged to provide justification to the legislature in the case of the Innovation Fund. This “creates a certain amount of pressure”, even if they also have to prove “in a kind of reflection essay” if they did nothing despite a recommendation. This is also owed to the insured persons and citizens who ultimately finance the innovation fund. Hecken: “You rarely see me screaming for the BMG.” It is completely out of character for him when he says: “Please, please, please – supervise me.”

Relevance, decent methodology, translation and passion

A different, not necessarily contradictory, point of view was brought by Prof. Dr. med. Wolfgang Hoffmann MPH from the Institute for Community Medicine at the University Medical Center Greifswald and now from Hecken directly
spoken German Network for Healthcare Research (DNVF), with. In his lecture “Health care research: What we already know but have not yet paid attention to (?)” he pointed out the adverbial definition of time, which he “kindly formulated,” because he actually firmly believes that some positive things are happening become. He also said that the discussion that started with the MVF congress “Prioritization Catalog of Health Services Research” had “at least two, probably even three points of view”. This is demonstrated by the fact that “we are not really making any progress, even though so many good things” have happened.
In doing so, he was primarily addressing the great, as yet unsolved task of translation. “Health services research has a clearly defined task that we have defined well in recent years,” explained Hoffmann, who has been a member of the board of the German Network for Health Services Research since 2012, deputy since 2018 and chairman of the DNVF since 2022. Health care research “starts at a place where there is only research and ends up where hopefully most of the care is.” Hoffmann: “We identify supply problems and derive needs from them. We then think about what can be improved, which in turn needs to be researched not just in the laboratory, but in real-world settings. If everything went well in the end, the result should normally be introduced into care.” The rule is that if you want to have an evidence-based healthcare system, you have to be “a learning healthcare system along the way”.
But unfortunately, said Hoffmann, it is not the case that what we health care researchers have “discovered that is good is actually perceived in the way that we believe would make sense in order to actually improve the care system.”
Here the perspectives of science on the one hand and politics and self-administration on the other are “not always congruent”. The DNVF chairman was also self-critical about his own guild. The majority of “very qualified applications” were certainly written for the Innovation Fund and other funding agencies. But his scientific field also knows that “not everyone is equally qualified”. He resisted Hecken's accusation of far too many “small-small” projects, which Hoffmann illustrated with excerpts from the MVF interview in issue 06/22 (see Fig. 2). Of course, all healthcare researchers would be looking for a big hit. But he placed a big question mark on the question of whether this could be achieved in connection with the organization of our self-government.
Nevertheless, the health services research community has managed to get involved since 2015, initially without being asked, but then in good cooperation with the G-BA, to identify key topics for the
to determine the first calls for proposals from the Innovation Fund. Topics such as multimorbidity, chronicity, access, coordination and integration of the different sectors and service providers, quality and safety of care were raised. These were all relevant topics that certainly could not be described as “small-small”.
Many of these suggestions have also been taken up. But what was actually published in terms of funding announcements was something different. Here he primarily addressed the group of open topics already mentioned by Hecken, with an above-average proportion without recommendations. This was by far the largest group of projects supported by the Innovation Fund, which, in Hoffmann's opinion, were not a priority. Hoffmann: “You can of course ask yourself why all these projects were funded, but we healthcare researchers didn’t decide that.”
Relevance and decent methodology. For Hoffmann, these were the most important basis for the initial assessments by the Innovation Committee, which quickly reached its limits. In his opinion, this was due, on the one hand, to the fact that too few proven experts in health services research were allowed to make a significant contribution to the decision. And on the other hand, the expert advisory board was not always able to prevail with its recommendations. So it is not surprising that, in particular, those projects that the expert advisory board rejected and that the G-BA then supported anyway were strongly represented in those projects that did not work afterwards. It is true that a cultural development has taken place over time. From his point of view, the funding decisions have also become significantly better, but there is still “room for improvement”.
Hoffmann used the example of the AGnES project to illustrate how long it can take to get from the initial idea to implementation in standard care. From 2005 to 2009, the Greifswald University Medical Center provided doctor-relieving, community-based, e-health-supported, systemic intervention, a type of family doctor support through qualified practitioners.
xis employees have been examined. At that time there was a great outcry among the medical profession that this would be the downfall of the West and that patients would all die as a result. But that didn't turn out that way. In the end, even the general practitioners said it was great, relieved us of the burden and was also positive for compliance. With the change in the law in Section 87 Paragraph 2b SGB V, the AGnES concept of delegating family doctor activities to qualified practice employees within the framework of home visits was transferred to standard care in 2008. Since then, AGnES specialists have been allowed to work in patients' homes - even without the attending doctor being present.
But that wasn't the end of it, because the concept idea as such can be found in various pilot projects, such as something with RubiN (regionally continuously supported on the internet) with consortium leadership by BARMER and evaluation by Greifswald University Medicine, the UKSH and inav. On the other hand, in various projects such as DelpHi-MV, AHEAD or InDePendent as well as in the National Dementia Strategy or the Standard Care Delegation (NäPA).
The problem always and everywhere: Death Valley after the end of project funding, when all employees have to be laid off and expensively built structures have to be dismantled. This particularly applies to health care research projects, which often create the basis for a subsequent project in the area of new forms of care. Therefore, in his opinion, health care research projects that have been positively evaluated and ennobled with a recommendation should under no circumstances be shut down, because this is exactly where “most innovation occurs.” Hoffmann: “In general, the measures to transfer it to standard care are not effective.” What would be the point, for example, of a recommendation to the National Association of Statutory Health Insurance Funds, the Federal Medical Association, districts or the Conference of Health Ministers, which are not responsible at all for introducing care procedures into standard care. His petition is therefore that we not only have to improve the relevant information offerings, but also that we have to take a straight path to standard care. In Hoffmann's opinion, innovative care models require a translational approach, as has long been the case with medications and medical devices.
But that alone is not enough. Because all projects and the resulting recommendations always remained within the framework of the current health system and its self-management. Hoffmann: “There is nothing that would actually call one of the benches into question.” But that is exactly the problem, because no one really wants to change anything if a project to be funded would be able to improve care, but by doing so could put the position of one of the benches at a disadvantage. That's why it's time to evaluate the practices of the transfer. However, no one has taken on this task yet. Hoffmann: “The DNVF is happy to develop this together with the G-BA.” The Ad Hoc Commission for Innovation Funds was also founded for this purpose within the network by colleagues who, like Professor Hecken, had “passion” for it. to first parameterize the healthcare system, then to fundamentally restructure it and thus make it more future-proof. Hoffmann: “We are very pleased to provide the evidence for this.”

Research gap, impact on burden, feasibility and implementation

“What do we learn from the completed health services research projects in the innovation fund?” And: “How should future funding be designed?” Prof. Dr. Bertram Häussler, Chairman of the Board of the Berlin IGES Institute, in his lecture: “Matrix: What can be researched vs. what is feasible.” With the third question he looked far ahead: by saying: “What should be the topics of the future ?" In order to create an initial evidence base for these questions, the IGES boss took a list published in MVF 06/22 in which the health care research projects that have now been completed were presented according to the type of decision: recommendation, forwarding to individual institutions, no recommendation. Without an evaluation order, an own project was started in which every eighth project shown in this list was selected and examined in more detail: These were nine projects, two with recommendation, three without, but with forwarding and four without recommendation.
When looking at the resolution texts in detail, it was noticeable that up to six objections were formulated for projects without a recommendation for forwarding. Häussler: “The objections were often such that one could say that in some cases one could have known in advance that no one or too few participants would be found for certain questions - often simply for reasons of time.” That is why the decisions of the Innovation Committee are absolutely correct worth reading because they would point out central problems that could probably have been partially addressed before the respective project was funded. However, this would have required a more expert review.
The resolutions also indicate the funding amount, the duration of the project and the institutions involved. According to Häussler, important insights can also be drawn from this. What is striking here is that there is a huge range in funding amounts from 0.2 million to 1.9 million per project, i.e. a ratio of 1:8. Häussler finds the average duration of 3.2 years “not insignificantly long”. And when it comes to the institutions involved, ranging from two to 15, he also pointed out that the number of institutions involved should not be viewed uncritically. The motto applies here: “A lot doesn’t always help a lot!” The reason for the statement becomes apparent when you correlate the amount of the respective funding amount with the number of institutions involved. Häussler: “Then we see a very interesting effect.” The more institutions involved in a project, the higher the funding amount. Here the Innovation Committee certainly followed the applicants' argument that larger consortia simply needed more money. “I would like to question whether this principle should be retained,” said the IGES boss.
In order to approach the question not only quantitatively but qualitatively, IGES called together six proven experts from its own ranks. They had the task of evaluating the selected nine projects according to four questions on a scale of 1 to 3: relevance to care, knowledge gap, degree of innovation and practical significance (see Fig. 4). Häussler: “On average we awarded 1.2 points. Expressed in school grades, that means: satisfactory.”
If you look at the four questions more closely, you can also see that the relevance to care and therefore the topic was rated best at 1.7. From the perspective of the IGES experts, the other categories would all be “around 1”. Häussler: “One can conclude from this that we had the impression that the questions were well chosen, but that relatively few gaps in knowledge were closed.” In addition, the level of innovation was classified as moderate and the practical importance was given the lowest point value.
According to Häussler, it is precisely at this point that what Hecken and Hoffmann had previously talked about in their lectures becomes clear. Namely when it comes to the question of how what was researched in a project can be implemented later.
Another finding from this mini-evaluation, which is not representative and requires a broader database:

• The fewer objections there are to the Innovation Committee's decisions, the higher the IGES ratings will be.
• Higher funding amounts do not result in better results for either IGES or the Innovation Committee.
• The funding amount increases with the number of institutions, but not the evaluation.
• The better the evaluation of a project, the lower the impact factor of the publications that resulted from the projects.

Häussler sees the latter as an “almost paradoxical result” because an inverse connection emerges here. A project considered by the IGES experts has the lowest practical assessment and the highest number of objections formulated by the Innovation Committee, but the highest impact factor. Häussler asked himself how it could be that a project on the one hand would not answer a question that could have any practical significance, but would still be published at a high level. One could assume that healthcare researchers would select projects based on whether they are important for their own academic careers. His advice for an important basic principle of future funding: “You have to bring project funding into line with the benefits that these projects are intended to create.” It is worth taking a look at Section 92a paragraph 2 in SGB V.
It says here that the innovation fund is intended to support projects that gain knowledge about existing care or improve existing care.
At this point, Häussler addressed a fact that has not been discussed so far: the gap between setting a topic and the point at which knowledge gained from projects arrives in the reality of care. The head of IGES: “If we think about health services research today, we must
“It should be clear that we are thinking about a future that is easily 10 to 15 years away from today.” In addition to the average project duration of 3.2 years, there is a pre- and post-processing time of more than five years. This includes the duration of implementation, including any necessary adjustments to the legal framework. Häussler: “In Hoffmann’s lecture you can clearly see that implementation is a very laborious process, especially in Germany.”
His conclusion: “If we now think about a research program in the sense of a prioritization catalog for health care research-
If we think about it, we have to look to a future that is at least a decade away.” All stakeholders who want or need to have a say in setting funding topics must be aware that these are topics whose unmet needs are not today, but in ten will play a role in the years ahead.
For Häussler, this definitely does not include the question of digitalization: “We can confidently assume that in ten years we will have much more digitalization than we have today.” That is why we should no longer research in detail today whether it would help if we helped an app sends some information from A to B. Rather, future funding topics should be clustered according to whether they close a research gap, prevent an impact on burden and, above all, whether feasibility and chance of implementation even exist.
The associated complexity (see Fig. 5) leads Häussler to say that the funding procedure must generally change. So far, funding announcements have basically been calls for proposals, not calls for tenders. If you want to be more efficient in the future, you have to move away from this appeal and be much more precise about which projects should be supported and with what benefits.
A kind of “supply observatory” could also be set up. For example, it could be experimentally investigated how the willingness to change of service providers in the health system can be motivated. In this experimental environment, existing compensation systems could also be subjected to a closer look and evaluation. <<

by: MVF editor-in-chief Peter Stegmaier