What are registries?
Registries provide data that describe health care under everyday conditions using scientific, multidisciplinary methods. This data can explain relationships and examine the effectiveness of individual interventions in practice. Through longitudinal collection, registries create the basis for more detailed analyses – from epidemiological research to investigating the situation of care for a specific condition.
There are a large number of different registries worldwide. They are divided into product registries (often industry-funded, e.g.: for a new implant in orthopaedic interventions), disease registries (e.g. for diabetics), care registries (e.g. for comparing minimally invasive interventions and open surgery), and drug registries.
Historically, collections of individual data regarding certain diseases have been made for a long time. However, the first permanent record that was following up on the cases recorded appeared in Norway in 1856: The National Leprosy Registry. 1
Other registries followed and provided information on prevalence and incidence of different diseases at the population level and other basic epidemiological data. Registries have therefore long been established as a basis for health policy and care-related decisions.
A dynamic development
Since their introduction, registries have evolved dynamically. In addition to epidemiological data, clinical data has increasingly been included in large registries in recent decades. This includes data from everyday care that is collected and forwarded directly by the treatment team.
This made it possible to conduct the first comprehensive registry studies. Especially for questions that a classic randomized controlled trial (RCT) cannot answer well, registry studies showed that they can offer great added value.
A registry study can evaluate the effectiveness of individual treatments and interventions and draw conclusions for specific groups of people affected. 2 As a consequence, many procedures could be adapted or improved until today resulting in better survival and less secondary effects. Many patients could directly benefit from these improvements. 3
Real World Data and PROMs
Further new possibilities are opened up by the increasing importance of real world data, also known as care-related data in German.
Real World Data (RWD), in contrast to clinical data, comes from the “real world.” They include all information collected in a non-interventional, observational manner in a natural setting and come from a variety of sources, such as electronic health records, routine health insurance data, or mobile applications and health apps.
Patient-Reported Outcomes (PROs) are also included: With the help of structured questionnaires, the Patient-Reported Outcome Measures (PROMs), the patient’s perspective can be presented; a point of paramount importance for medical research. For this purpose, PROMs collect a self-assessment of the symptoms, impairments and basically the quality of life of patients. PROMs can be collected electronically in a fast and structured way, while the effort for health professionals and patients is low.
PROMs in particular, but also real world data in general, are increasingly being included in registries: The promise of mapping the reality of care is hereby getting a lot closer. Registries that are supplemented by PROMs and RWD have a completely new significance.
Registries generate evidence
For a long time, randomized controlled trials were considered the only source for generating evidence. However, with the help of special study designs, so-called real world evidence (RWE) can now also be derived from register-based real world data: Real world evidence complements evidence from controlled trials in these cases. Current studies can demonstrate equivalence of evidence derived from good registries to the gold standard of randomized controlled trials.
In important areas such as the approval and reimbursement of new drugs or digital health applications, registry-based real world data play an increasing role. Similarly, registries are increasingly taking on tasks in quality assurance and health services research. 4 Here, too, PROMs and the collection of data on health-related quality of life are particularly important from the patient’s point of view. It is no longer just a question of treatment improving individual clinical parameters; patients should achieve a noticeably and demonstrably higher quality of life when they are treated.
Digitalization also makes working with registries much easier. This is because planning and managing registers is still very time-consuming. A registry can only achieve the necessary high data quality with the correct methodological approach. A lack of time and personnel in hospitals and medical practices is already a problem in the care of patients and also limits access to registries.
In addition, the standard data already available are often too general, unstructured or inconsistent. Thus, although there are many registries, there are seldom suitable, prospectively designed, high-quality registries. This heterogeneity is another problem.
Digital solutions make it possible to significantly reduce the time required to maintain a registry. Moreover, a modern IT system for data management allows data to be recorded uniformly and made available in high quality for various evaluations. Automated consent management meets data protection requirements. In this way, versatile studies can be carried out with comparatively little effort.
Insights for the future
Registries have been providing valuable insights for medical care for over a hundred years. In the 21st century, they include not only epidemiological and clinical data, but also real-world data – primarily PROMs. In this way, they provide a better picture than ever before of the reality of patients’ treatment, the course of their illnesses, and the effects of the pharmaceutical and medical technology products used.
Digital technology facilitates the work with registries enormously and makes it possible to integrate real world data from different sources on a large scale. By taking patient-reported outcomes into account, the focus shifts to the patient’s perspective: a healthcare system becomes possible in which diseases can be treated effectively and cost-effectively – and at the same time the quality of life of patients increases.