Berlin - Against the background of discussions about big data and the hype about artificial intelligence (AI), registers in medical research sometimes find it difficult to step out of the shadows of these topics. Six register projects have just started this spring, which the Federal Ministry of Education and Research will fund with total of 15.5 million euros over the next five years. During the registration days on May 6th and 7th in Berlin, the successful finalists of the call for applications were presented.
The funding projects Fever-App, HerediCaRe (evaluation and improvement of risk-adapted prevention for hereditary breast and ovarian cancer), ParaReg (lifelong monitoring of paraplegics), register for recurrent stone diseases of the upper urinary tract, living donation register and the "TOFU" register for non-infectious uveitus had prevailed against 16 applications in selection process.
Patient-centered analysis under routine conditions
Patient-related registers are suitable for analyzing the care process under routine conditions and highlighting potential for improvement. From these it can be deduced what influence certain care offers have on the course of the disease and the quality of life of those affected and what the quality of treatment looks like in various facilities and care sectors.
"Collecting quality-assured data sets with high range under defined question is what distinguishes high-quality register", explained Sebastian C. Semler, Managing Director of the technology and method platform for networked medical research (). The TMF, together with the German Health Services Research Network (DNVF), organized the symposium, at which around 150 representatives of registers discussed quality criteria and challenges of patient-related registers.
Connection to the medical informatics initiative
To the Funded registers include, for example, the prospective, longitudinal register for recurrent stone diseases of the upper urinary tract under the direction of Martin Schönthaler, Freiburg University Hospital. connected, ”explained Schönthaler. It feeds in the medical data from the local hospital information systems of the participating centers, which are collected as part of MIRACUM. In addition, there is data that is recorded via the patient app.
By linking registry and care data, the MI-I will, in the opinion of the experts, have major influence on the registry landscape in the future. In the future, register inquiries will be possible via the MI-I data integration centers.After the completion of the five-year project, the German Society for Urology will continue to run the register. The data collection of the decentralized register is to be largely automated as soon as the technical infrastructure is in place.
App-based data collection
Patients are increasingly included as active partners in research projects. Patient involvement is also an important topic for Register, as can be seen from the example of the sponsored "" under the direction of David Martin, University of Witten-Herdecke, and Ekkehart Jenetzky, University Medical Center Mainz.
The app is intended for parents, Train practices and hospitals in the rational handling of fever and develop quality standards for treatment. For this purpose, it relies on the one hand on conveying evidence-based information, in particular via an explanatory video, and on the other hand on data that is documented by the parents of the children concerned using checklist (temperature, symptoms, well-being of the child, etc.).
A first prototype The interactive app will shortly be tested together with parents and doctors. A website is planned at the same time. Jenetzky emphasized that it was the first app-based register that was also symptom-oriented and not disease-oriented. The later certification of the app as medical product is being considered.
In the web-based model register "" for lifelong monitoring of paraplegic patients, the aim is to record the acute and post-acute care of those affected nationwide and the different treatment paths in the special centers through patient-centered documentation with regard to medical, neurological-functional and social parameters, for example.
The aim is to improve care, therapy planning and treatment management in the long term, explained project manager Rüdiger Rupp, University Hospital Heidelberg. The project is technically based on the open source registry system for rare diseases (OSSE). Rupp assumes that around 250 patients can be included in the registry every year. According to him, the first findings could already emerge in the first year.
Registers under pressure
What contribution can registers make to digitization in the healthcare system with their quality-assured long-term history data? Experts addressed this question in panel discussion.
"Registers are not an all-purpose weapon," said Gerd Antes, the long-time former director of Cochrane Germany. In terms of method, these are observational studies - with all their advantages and disadvantages. According to him, like RCTs (randomized clinical trials), they also serve the purpose of providing information and avoiding errors.
While RCTs deal specifically with question, registers are more long-term, see for example the endoprosthesis register. "The concept of quality is the top criterion by which everything has to be measured," emphasized Antes. At the moment, registers are coming under increasing pressure from big data and artificial intelligence, because millions of euros in funding have flowed into these areas - not in very targeted manner.
Improve public awareness
According to Edmund Neugebauer, - Managing directors, RCTs and registers complement each other. “Registers have an important place in the continuous long-term observation of patients, in order to enable benefit assessments, for example.” They answered practical questions and also generate hypotheses for RCTs. As systematic collections of data, they made valuable contribution to research and care. But: “You have to communicate your data and its value better in order to strengthen the registry community,” he demanded.
Even in the information technology advanced university hospitals, data is currently not yet available in structured electronic way , said the medical IT specialist Jürgen Stausberg, University Hospital Essen, to consider. Although the collection of data in registers, as in care, is also dependent on the examination by the treating person, the data collection can be carried out in quality-assured manner - in contrast to what is usually daily practice in the doctor's practice or in hospitals.
This is currently an essential unique selling point of registers. "It gets interesting when we have structured electronic patient file," said Stausberg. Questions such as quality of life or socio-economic status will probably not be able to be obtained from the existing file data in the medium term either.
"Valid statements are only possible when evaluating high-quality data," explained Anna Niemeyer from. In their view, this also requires standardization initiatives for the patient-related registers of health services research, such as the establishment of the clinical cancer registries. In the opinion of the expert, there is also lack of an overview of where and in what quality data are.
A register of the data stocks in empirical health services research is necessary. From their point of view, more needs to be done for the public perception of medical registers: “In comparison to Big Data, registers don't exactly sound sexy‘, and registers are lot of work, ”said Niemeyer. It is important to bring valuable findings from the registry work into language that is “Facebook compatible”.