AG Registries

The DNVF working group (WG) registries develops standpoints and recommendations on the methodology of registers. In this way, existing registries are strengthened in their further development and the buildup of new registries is supported. results of this WG include: the presentation of a consented definition of a registries‘ concept, a description of relevant quality criteria for registries as well as recommendations for the creation, functioning and use of registries. In addition, the WG registries offers the opportunity for exchange and networking to stakeholders and interested persons.

The WG is composed of representatives of the DNVF member companies and personal members of the DNVF and has been founded in February 2009. Its members represent registries on a legal basis, registries of pharmaceutical companies and science-driven registries. Also, generally interested persons are also welcome.

On one hand, the WG results are addressed to experts and institutions involved in the conception and operation of registries. Additionally, scientists who intend to use data from registries and want to perform a qualitative evaluation are also addressed. The WG wants to convey the concept of registries and their potential to improve health care to potential sponsors, self-governance and health policy.

According to § 35a paragraph 3b SGB V which defines application-related data collection, a position paper has been developed an published in 2021 [1].

In order to convey the memorandum "Registries for health services research", the working group participates in the DNVF Spring School, offering courses on registers.

At its meeting during fall 2021, the WG expanded spokespersons' team to four persons, which is the WG's response to its growing membership and the increasing attention to registries.

In 2014, preliminary work on a register of registries and cohorts, known as the Registerportal, was completed and published[5]. The results include a recommendation on the characteristics used to describe registers and cohorts in the registry portal - the metadata. On the other hand, a list of procedural rules for the operation of the register portal is proposed. The aim in setting up the Registerportal is to create transparency about existing projects, to promote cooperation and to improve the quality of registries.

The first „Memorandum Registry for Health Services Research“ [6] has been published in 2010. An Update was developed and published early 2020 by an interdisciplinary group of WG members.

In the accompanying project to the BMBF funding measure "Establishment of model registers in health care research", templates for the research protocol of a register ("register protocol") and for the catalogue of characteristics of a register were developed. The development was funded by the Federal Ministry of Education and Research under the codes 01GY1720A and 01GY1720B. The templates were coordinated with 16 projects that were funded by the BMBF in the concept development phase under the funding measure. The templates are available in German and English.
>>Templates for the research protocol and for the feature catalogue of a register

Software profiles for registries and cohorts:

Profile Adjumed.net
Profile BAP-Register-Technologie
Profile BQS-Register-Software
Profile CentraXX
Profile Climedo
Profile Clinspire
Profile DESTINY
Profile DIS
Profile E-PIX
Profile ForgaDB
Profile GesundheitsforenRegistersoftware
Profile gICS
Profile gPAS
Profile iOstudy office edc
Profile LibreClinica
Profile Magana Trial Manager
Profile Marvin-EvidentIQ Platform
Profile OpenClinica
Profile OpenEDC
Profile OSSE
Profile ProWebDB
Profile REDCap
Profile secuTrial
Profile StudyArchive
Profile STUDYSTAR
Profile tripletrax
Profile UNITY Outcome
Profile Webspirit Systems EDC
Profile YARG

Description of registries

A proposal for a structured and uniform description of registries has been developed in the DNVF (Stausberg J., Semler S., Neugebauer E.A.M. A registry for registries and cohorts: recommendations on metadata and procedural rules. Das Gesundheitswesen 2014; 76: 865-873.). This proposal has been used by the projects of the BMBF funding measure " Aufbau modellhafter Register in der Versorgungsforschung - Establishment of exemplary registries in health services research" to describe the six funded registries. Selected aspects of the exemplarity were added.
The descriptions can be downloaded in German language here as a PDF document.

Here Registry profile: HerediCaRe

Here Registry profile: RECUR

Here Registry profile: TOFU

Here Registry profile: ParaReg

Here Registry profile: FieberApp-Registry

Here Registry profile: SOLKID-GNR

Registries' metadata

In the project which accompanied the BMBF funding measure "Aufbau modellhafter Register in der Versorgungsforschung", the metadata of six funded registries were compiled. This is working material from the accompanying project of the BMBF funding measure. The compilation has been developed by the accompanying project of the funding measure in order to support these registries‘ metadata-design in many ways: a harmonization of metadata, a standardization of metadata, the completion of metadata, the consistencies improvement of metadata as well as a reflection of the metadata format.

>> Metadata

In a multi-stage process, new work priorities and activities were developed in 2022 which will determine the future work in the WG. For this purpose, work packages (WP) were defined on which the members of the WG can contribute. The coordination within each WP will be assumed by at least one member of the speakers-team.

1. rRCT - Registry-based RCT

This WP deals with issues related to the development, conduct and evaluation of registry-based trials. This includes, among others, a categorization of the rRCT considering the objective, the comparison of an intervention (research question) and the context (e.g. regulatory) as well as the selection of appropriate case studies.

After the preparation of an exposé for review and approval by the DNVF Board, a position paper or memorandum shall follow.

In the medium-term, events on rRCT with international guest speakers and an intensification of national and international networking are planned.

In the long term, an overview of registries that can be used for rRCTs (with different objectives) will be created. Furthermore, assistance will be developed to facilitate existing and newly established registries in order to integrate rRCTs in a better way.

2. Preparation of a statement on the draft of the register law

The register law which has been announced through the coalition agreement 2021 shall be accompanied in elaborately and technicaly. Work will begin as soon as the publication of a draft is foreseeable.

A more precise determination when this WP is likely to start, will likely be possible from mid-2023.

3. exemplary application of the evaluation criteria

In the expert opinion on the further development of medical registries (Gutachten zur Weiterentwicklung medizinischer Register) published in 2021, an evaluation catalog was developed by the expert team and mapped in a maturity model. It is meant to be applied and reviewed in practice with various registries on a voluntary basis. Approaches for further development will be derived from the subsequent evaluation. In a further step, the technical preparation of a procedure for auditing registers shall be carried out.

4. Virtual Register Round Table

In order to intensify the exchange of information and to improve the registries' networking, a virtual registry regulars' table will be established. Approximately 4-6 times a year, important topics are discussed in a casual atmosphere and the networking of registries is strengthened. The regulars' table always follows the same agenda. First, a registry introduces itself in a presentation of about half an hour, focusing on a previously determined content. This focus is then discussed with the participants. The first regulars' table with the focus on networking and financing will take place on the 28. Sept. 2022. The other dates and thematic focuses for the regulars' table have not yet been determined.

5. Concretization of the registry memorandum

In this work package, the "Memorandum Register" [2] will be concretized and a harmonized process model for the register setup will be developed. The generic register protocol will be extended with a focus on the integration of IT.

6. Creation of handouts

In order to support the establishment of new registries and the further development of existing ones, a compilation and provision of existing handouts as well as the development of different types of new handouts will be carried out in this WP. Topics include support in selecting the "right" IT solution, recommendations for standard parameters / data sets and the development of a strategy for provision / distribution.