>> When analyzing the health care research projects by resolution type, it becomes clear how heterogeneous the decisions of the Innovation Committee at the Federal Joint Committee in accordance with Section 92b Paragraph 3 SGB V on completed health care research projects are. There are only three types of resolution:
1. no recommendation (received 38% of all health care research projects)
2: no recommendation, but forwarding of the results (25%)
3: Recommendation with forwarding of the results (37%)
Depending on how you do the math, the glass is now half full or half empty: Positivists think: After all, 62% seem to be positive if you take into account the projects that were given a negative “no recommendation” rating, but for which at least the results were were forwarded.

Let’s take – chosen purely at random – the WiZen project (1). The Center for Evidence-Based Health Care at the Medical Faculty at the TU Dresden funded a total of around 1.6 million euros to research the effectiveness of care in oncology centers. “Overall, the study design was appropriate to answer the research questions,” the Innovation Committee ruled on October 12, 2022. The data linking method used also proved to be valid, even if there were limitations due to the availability of data in the data sources. According to the decision-makers working on the Innovation Committee, the project provides “scientifically sound insights into the effectiveness of healthcare in certified treatment facilities compared to care in non-certified facilities.” In addition, the project results on successful data linking are groundbreaking for further research projects, although patient-reported outcomes will also be taken into account in the future should be. Overall, the project results would support the research hypothesis that patients receiving treatment at a certified center would have a greater survival advantage compared to non-certified facilities. The statistical analyzes also showed higher survival rates for cancer patients who were cared for in a certified treatment facility.
With this justification, the Innovation Committee recommends that the positive results by resolution be forwarded to the Quality Assurance Subcommittee of the G-BA, the Institute for Quality Assurance and Transparency in Health Care (IQTIG) and to the Federal Ministries of Health and Education/Research.
Whether the findings from these projects that are forwarded are taken into account by one of the receiving institutions or whether there are plans to implement them is not further documented. Researchers who have completed their work with a results report that is more or less innocuous depending on the project - in the case of WiZen it was 351 pages - may hear by chance on the sidelines of conferences what happens to their findings. However, they are no longer actively involved in the translation process. This means that what has been scientifically researched is also transferred from the field of research to the responsibility of self-administration and politics. What the two of them make of it remains to be seen. In the case of WiZen, one can assume that the BMG noticed the results of the health care research project; For example, Federal Minister of Health Prof. Dr. Karl Lauterbach intensively addressed the WiZen study in his greeting to the German Cancer Congress.
Now the question is how the results will be implemented: in the wording of the scientifically researched results or with a part of them that self-government and politics consider to be assertive, which would no longer be in the original sense of science.

Most recently, the “Specialized Outpatient Palliative Care Guideline: Review based on Innovation Committee projects for evaluation” (2) came into force on November 24, 2022, which is based on a G-BA resolution of September 15, 2022. Although only marginal changes appear to be made in the revised directive, a new sentence is also inserted under Section 7 Paragraph 1 that newly regulates discharge management. The “Basic Reasons” explain exactly which three innovation fund projects came into play here: the projects APVEL (evaluation of the effectiveness of SAPV in North Rhine), SAVOIR (evaluation of the SAPV guideline: outcomes, interactions, regional differences) and ELSAH (evaluation the specialized outpatient palliative care in Hesse).
For all three projects, the Innovation Committee made a positive “recommendation” and arranged for the findings to be passed on to the responsible Subcommittee on Arranged Services (UA VL) in the G-BA. He should check the findings from the projects promptly and, if necessary, include them when revising the SAPV-RL, which he then did in just over a year.

Let’s take – again chosen purely at random – the two projects HIOPP-6 and HIOPP-3-iTBX. “The Innovation Committee does not make a recommendation for the HIOPP-6 project.” (3) What applies to HIOPP-6 does not apply in the same way, but applies in a similar way to the HIOPP project, which sounds similar but deals with a completely different issue -3-iTBX (4): This project also has the main statement “no recommendation”, which the innovation committee at the G-BA justifies by saying that this project did not find any reduction in PIM/neuroleptic prescriptions due to the interventions carried out and also none positive effects on the health situation of the residents could be shown. Therefore, no recommendation can be made for the broader implementation of the interventions used here to optimize medication for nursing home residents. However, the knowledge gained here should be taken into account in the (further) development of similar care approaches and further training measures by professional groups involved, because the knowledge that no improvements could be achieved with this approach is, according to the text of the resolution, “an important result for further research approaches “.
This is exactly the difference to the HIOPP-6 project, in which the innovation committee “does not yet see the possibility of adopting the (researched) tool into standard care and therefore the necessary integration of the tool into the practice software”. After all, there is a “yet” there and, on top of that, it is stated that “a significant effect for patients might have been detectable with a larger number of participants” - but there is “a need for further knowledge”.
These examples make it clear that there cannot be a simple black and white view of projects with negative or partially negative results. Some of the health services research projects that received “no recommendation” are also considered to have gained knowledge. This is particularly clear in the EvaSCa project (5), for which the Innovation Committee also makes “no recommendation”, but based on the recommendations developed here for the further development of skin cancer screening, the results are forwarded to the Method Assessment Subcommittee of the G-BA for information.
Anyone who reads the text of the decision quickly recognizes the reason: Although the methods were “fundamentally appropriate for answering the questions,” limitations arose from the restriction to a 12-month follow-up and from the limitations of the underlying routine data. Due to the-
Due to these limitations, the question about the effects of screening could not have been answered conclusively.

What was that about? The short answer: Because health services research has to rely primarily on routine data, which inherently lacks important data components. This is what the evaluators write – Prof. Dr. medical Andreas Stang, Dr. medical Katrin Schuldt, Dr. re. doctor Michael Nonnemacher and Dr. medical vet. Pietro Trocchin – very clear in their results report. It says: “A mortality evaluation of the HKS with health insurance data only appears possible if these data are individually combined with information from the screening doctor (reason for the skin examination) and with data from the population-based cancer register (exact histology, tumor stage and cause of death), similar to this the mortality evaluation of the mammography screening program is planned.” However, conducting a case-control study based on primary data collection would have weaknesses. The group of authors continues: “Since the health insurance companies only record that an insured person has died, we had to use an adapted algorithm to indirectly determine the death due to melanoma. It can be assumed that this derivation was accompanied by errors, even though we chose strict inclusion criteria to reduce the misclassification of deaths, which reduced the expected number of suitable melanoma deaths by 650 cases. Furthermore, they were unable to diagnose To characterize cutaneous malignant melanomas in more detail in terms of the exact histology, location and tumor stage, as this information is not available in health insurance data. There can be no better indication that there must be a research-compatible combination of as much data as possible - including from registers - in Germany. However, and on the other hand: Every healthcare researcher, as well as every expert in the so-called expert pool of the Innovation Committee, and ultimately every decision-maker on the benches, must be aware of these limitations. If that were the case, the project, which was financed with 374,000 euros and based on routine data evaluation, probably should not have been applied for and certainly not funded.
Would have, would have, bicycle chain, to speak to Peer Steinbrück. If the applicants had not been funded, the project would not have been able to show any possibilities for further developing the G-BA's early cancer detection guidelines with regard to early detection tests for skin cancer, which - according to the text of the resolution - could have a "positive impact on the results of future evaluations". . Here too: Black and white thinking doesn't help, as every additional gain in knowledge has to be viewed positively.

Another, far more serious question is whether the many small healthcare research projects funded by the Innovation Fund - sometimes 374,000 euros here, sometimes 287,830 euros here (6) - make sense.
But what is meaning? Of course, any additional knowledge gain is to be seen as positive and can be attributed to the researcher-driven approach that prevails in Germany. Every scientist can now research whatever they want within the framework of their own agenda and obtain third-party funding for it. The Innovation Committee at the G-BA opened the door to this when it launched the so-called “open-topic approach”
rich” introduced; Even if that was only 20% or 7 million euros in the area of health services research in the years 2020 to 2024 (7).
But here, too, the declared goal is to “promote projects in the field of health services research that are based on knowledge”
“Tnis gain is aimed at the further development of existing care in statutory health insurance and shows a high potential for utilization in care practice”. This is what is written in the health care research funding announcement of September 20, 2023 (8). Conversely, this means that projects that do not show “high potential for utilization in healthcare practice” will not be funded.
There is no other explanation for the fact that in the last tranches of funding the funds available for health care research were never fully allocated. This was given by none other than Prof. Josef Hecken, impartial chairman of the Federal Joint Committee and leader
Chairman of the Innovation Committee at the G-BA went on record in the summer interview with “Monitor Healthcare Research” (9). Hecken's first accusation: there are many qualified funding applications, but with too many "small-small" research approaches that "really don't move our health system forward." Hecken's second accusation: not a big "throw" that would "really catapult us forward."
“If the innovation committee in the area of health services research only receives 10 applications instead of 186, that will make my life a lot easier,” explained Hecken honestly in the MVF interview. Now you have to know hedges a little more closely to know that behind the so easily stated hope of less work there is an important request. He also said, directly addressing the community of health services researchers: “This would certainly make the impact of health services research much greater than that of many 'small-small' projects.”
His wish, repeated here again: “I would like health services research to think more in the direction of cross-sector care, beyond the detailed questions that arise everywhere, which may in and of themselves be quite correct. Or at least to try to pilot and evaluate new cross-sector and cross-professional solutions in certain smaller care settings.”
Think bigger, think further, really change care for the better - according to the health services research
Impact. “Monitor Healthcare Research” is now taking up this demand with its two online congresses, which will take place on December 13th, 2022 and January 24th, 2023.
Representatives of our health system are asked what they believe are the 5 to 10 most pressing and important questions that health services research has to answer in order to really advance our health system and make it more sustainable. <<

by: MVF editor-in-chief Peter Stegmaier