[Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. / Verbessert der Innovationsfonds die Versorgung? Eine kritische Bestandsaufnahme zum Stand der Implementierung erfolgreicher Innovationsfondsprojekte in die Versorgungspraxis.

INTRODUCTION: Since 2015, the Federal Joint Committee (G-BA)'s Innovation Fund has been supporting projects in health services research and new health service models ("Neue Versorgungsformen", NVF). By the end of 2022, 211 projects in the NVF category had been funded. A key objective is the transfer of successful projects into standard care. This article analyzes previous projects regarding their incorporation into routine care based on transfer recommendations of the Innovation Fund Committee ("Innovationsausschuss" IA). METHOD: Descriptive analysis of all projects completed by August 1, 2023 with transfer recommendations in the "NVF" funding stream. Presentation by topic, project duration, time until IA transfer decision, categorization, and number of institutions and organizations (recipients) addressed per project, their feedback published on the G-BA website, response rates per recipient group, and a content classification and interpretation of exemplary feedback. Recommendations based on the results and their discussion in an expert workshop. RESULTS: Out of 57 NVF projects, 17 had a transfer recommendation. A total of 57 feedback responses were received from a total of 431 recipients addressed by the IA across these projects. Response rates varied significantly. One-third of inquiries to the G-BA and its member organizations received a response (31%), while only every fifth inquiry to federal states (18%) and professional societies (18%) got a response. Less than one in ten inquiries to the Federal Ministry of Health (8%), administrative bodies (6%), and the German Medical Association (0%) received a response. Project-specific feedback within a recipient group was often contradictory or limited to regional scope. DISCUSSION AND CONCLUSION: The transfer process reveals significant structural and procedural obstacles regarding the incorporation of projects evaluated as successful into routine health care. To ensure that funding from the innovation fund is most effectively used, there needs to be a realistic chance of successful transfer of positive project outcomes into routine care. The DNVF recommends stronger involvement of rule-competent institutions, mandatory publication of responses, structured moderation of the transfer process, expanding types of selective contracts, financing of implementation phases and of studies drawing on results across successful NVF projects.

Investigating rate-limited sorption, sorption to air-water interfaces, and colloid-facilitated transport during PFAS leaching.

Various sorption processes affect leaching of per- and polyfluoroalkyl substances (PFAS) such as PFOA and PFOS. The objectives of this study are to (1) compare rate-limited leaching in column and lysimeter experiments, (2) investigate the relevance of sorption to air-water interfaces (AWI), and (3) examine colloid-facilitated transport as a process explaining early experimental breakthrough. A continuum model (CM) with two-domain sorption is used to simulate equilibrium and rate-limited sorption. A random walk particle tracking (PT) model was developed and applied to analyze complex leaching characteristics. Results show that sorption parameters derived from column experiments underestimate long-term PFOA leaching in lysimeter experiments due to early depletion, suggesting that transformation of precursors contributes to the observed long-term leaching in the lysimeters (approximately 0.003 µg/kg/d PFOA). Both models demonstrate that sorption to AWI is the dominant retention mechanism for PFOS in lysimeter experiments, with retardation due to AWI being 3 (CM) to 3.7 (PT) times higher than retardation due to solid phase sorption. Notably, despite a simplified conception of AWI sorption, the PT results are closer to the observations. The PT simulations demonstrate possible colloid-facilitated transport at early time; however, results using substance-specific varying transport parameters align better with the observations, which should be equal if colloid-facilitated transport without additional kinetics is the sole mechanism affecting early breakthrough. Possibly, rate-limited sorption to AWI is relevant during the early stages of the lysimeter experiment. Our findings demonstrate that rate-limited sorption is less relevant for long-term leaching under field conditions compared to transformation of precursors and that sorption to AWI can be the dominant retention mechanism on contaminated sites. Moreover, they highlight the potential of random walk particle tracking as a practical alternative to continuum models for estimating the relative contributions of various retention mechanisms.

[Research partners in health services research: need, acceptance and feasibility of preparatory trainings]. / Forschungspartner*innen in der Versorgungsforschung: Bedarf, Akzeptanz und Umsetzbarkeit von vorbereitenden Schulungen.

AIM: The aim of this online survey was to assess the need, acceptance and practical feasibility of a training program for research partners in health services research by patients and the public. METHOD: In January 2023, we sent the survey to patient associations and groups nationwide via Patient Advisory Board members of the German Network for Health Services Research (DNVF). The survey included both closed and open questions. The research team analysed the information provided by the participants (n=125) descriptively and used content analysis according to Kuckartz and Rädiker (2022). RESULTS: The majority (90.4%) of respondents considered patient and the public involvement in the planning and implementation of scientific studies to be very or extremely important. 41.5% (17.9%) of respondents indicated that more than 10% (more than 25%) of patients would be willing to participate in free training and be available as research partners. More than three-quarters (76.8%) of respondents agreed that training was very or extremely important. Participants preferred written information (57.3%), short online training (56.5%) and short digital information sessions (53.2%). Frequently cited barriers to delivering training include travel costs (60%), time (53.3%) and the need for extensive prior information (48.3%). Participants' suggestions for successful training implementation included comprehensibility of the training program and its organisation (location, duration and format). CONCLUSION: In addition to the high training needs of research partners, the results also reveal some obstacles. A compact, comprehensible and digital information event with written information material increases acceptance. Researchers should take these results into account when designing and implementing training programs.

[Register-based research and clinical studies : Possibilities, limitations and perspectives]. / Registerbasierte Forschung und klinische Studien : Möglichkeiten, Limitationen, Perspektiven.

Register-based research offers a good opportunity to generate knowledge on questions from the clinical practice. Methodologically high-quality register studies can complement clinical studies, especially for questions that cannot be answered with randomized controlled trials (RCT). The ad hoc committee on healthcare data of the German Network for Health Services Research (DNVF) has set methodological guidelines for register-based studies with a manual for methods and the use of healthcare data. The methodological advantages of both approaches can be integrated through RCTs embedded in registers. In Germany there is a diverse register landscape as shown by the register report commissioned by the Federal Ministry of Health, which, however, show a varying degree of internationally recognized quality criteria. The relevance of register-based studies for the clinical practice (e. g. guideline development) is shown in the examples of applications cited in the article. Although a lot has already been done here in Germany with existing register data, sustainable coordination and promotion of the research infrastructure and research culture, especially in international comparison are necessary.

Immobilization of per- and polyfluoroalkyl substances (PFAS): Comparison of leaching behavior by three different leaching tests.

The evaluation of PFAS immobilization performance in laboratory experiments, especially the long-term stability, is a challenge. To contribute to the development of adequate experimental procedures, the impact of experimental conditions on the leaching behavior was studied. Three experiments on different scales were compared: batch, saturated column, and variably saturated laboratory lysimeter experiments. The Infinite Sink (IS) test - a batch test with repeated sampling - was applied for PFAS for the first time. Soil from an agricultural field amended with paper-fiber biosolids polluted with various perfluoroalkyl acids (PFAAs; 655 µg/kg ∑18PFAAs) and polyfluorinated precursors (1.4 mg/kg ∑18precursors) was used as the primary material (N-1). Two types of PFAS immobilization agents were tested: treatment with activated carbon-based additives (soil mixtures: R-1 and R-2), and solidification with cement and bentonite (R-3). In all experiments, a chain-length dependent immobilization efficacy is observed. In R-3, the leaching of short-chain PFAAs was enhanced relative to N-1. In column and lysimeter experiments with R-1 and R-2, delayed breakthrough of short-chain PFAAs (C4) occurred (> 90 days; in column experiments at liquid-to-solid ratio (LS) > 30 L/kg) with similar temporal leaching rates suggesting that leaching in these cases was a kinetically controlled process. Observed differences between column and lysimeter experiments may be attributed to varying saturation conditions. In IS experiments, PFAS desorption from N-1, R-1, and R-2 is higher than in the column experiments (N-1: +44 %; R-1: +280 %; R-2: +162 %), desorption of short-chain PFAS occurred predominantly in the initial phase (< 14 days). Our findings demonstrate that sufficient operating times are essential in percolation experiments, e.g., in column experiments >100 days and LS > 30 L/kg. IS experiments may provide a faster estimate for nonpermanent immobilization. The comparison of experimental data from various experiments is beneficial to evaluate PFAS immobilization and to interpret leaching characteristics.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

[Necessity and Ways to Develop Care Goals for the Health System in Germany - a Position Paper of the DNVF]. / Notwendigkeit und Wege zur Entwicklung von Versorgungszielen für das Gesundheitssystem in Deutschland ­ ein Positionspapier des DNVF.

Goals for health and health care are an indispensable basic requirement for a functioning health care system. The dilemma of the German health care system is that it has not been designed in a planned way, but that it has grown historically. In recent years, it has developed through the free play of forces into what it is today. The OECD characterizes the current state as follows: The costs of the German health system do not correspond to the often only average health outcomes for the population. To meet the legal requirements (especially SGB V §§ 12, 27 and 70), health care/the health system in Germany needs concrete goals. An orientation towards health care goals entails measures on all levels of health care: on the macro level (overall system/total population), on the meso level (subdivided according to regions, specific population groups, etc.) as well as on the micro level (patients and health care providers). Based on national and international experiences, this position paper of the DNVF e.V. (German Network for health services research) shows the potential of how operationalised health care targets can ensure effective, affordable and high-quality health care. The coalition agreement of the current government propagates a reorientation with patient-related health care goals. Now it is important to derive concrete and realisable goals from this declaration of intent and to involve all important groups in the process. In addition, values and ethical standards for implementation shall be agreed upon in this process. The Health Ministry (BMG) should facilitate and promote the process of societal will-building for the definition of national health care goals. This requires a clear political will. As a result, the National Health Care Goals are available at the end of the process, which are published and maintained together with evidence-based facts as well as valid and resilient data in a Manual "National Health Care Goals". The operational responsibility for implementation could lie with the newly to be founded Federal Institute of Public Health, as already announced in the agreement of the governing coalition. The DNVF is willing to actively participate in the development of health care targets.

[Routine Practice Data for Evaluating Intervention Effects: Part 2 of the Manual]. / Versorgungsnahe Daten zur Evaluation von Interventionseffekten: Teil 2 des Manuals.

The evaluation of intervention effects is an important domain of health services research. The ad hoc commission for the use of routine practice data of the German Network for Health Services Research (DNVF) therefore provides this second part of its manual focusing on the use of routine practice data for the evaluation of intervention effects. First, we discuss definition issues and the importance of contextual factors. Subsequently, general requirements for planning, data collection and analysis as well as concrete examples for the evaluation of intervention effects for the 3 fields of application regarding pharmacotherapy, nonpharmaceutical interventions as well as complex interventions are elaborated. We consider scenarios in which no information from randomized controlled trials (RCTs) comparing the two groups directly is yet available or in which RCTs are already available but an extension of the research question is required. In all examples either with or without randomization, the first and foremost question is always whether the data source is suitable for the specific research question. Most of the examples chosen are from oncology trials, because the necessary data are already available for Germany, at least in some form. Finally, the manual discusses possible challenges for future use of these data.

[Characteristics of Innovation Fund-supported Intervention Studies: Review and Document Analysis of Study Protocols, Publications and Final Reports]. / Charakteristika von durch den Innovationsfonds geförderten Interventionsstudien: Review und Dokumentenanalyse von Studienprotokollen, Publikationen und Abschlussberichten.

This prospectively registered review characterizes 50 intervention studies from the 1st wave of the Innovation Fund based on study protocols or original articles, among other sources. The mainly (randomized) controlled intervention studies included predominantly adults/seniors in ambulatory care without a regional focus and analyzed treatment processes, clinical and patient outcomes as outcomes. The substantial lack of study protocols and methodological details (e. g., sample size planning) reveals (avoidable) methodological problems regarding the scientific quality of the funded studies.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).