The BioDay Registry is a prospective multicenter registry in which patients treated with new systemic treatment options in AD in daily practice are enrolled. The main centers of the BioDay Registry are the National Expertise Center for Atopic Dermatitis from the University Medical Center Utrecht (UMCU) and the department of Dermatology, University Medical Center Groningen.
Dermatology departments in both university hospitals and non-university hospitals with experience in the management of difficult to treat Atopic Dermatitis (AD) patients (according to Dutch Quality Criteria for AD care) are selected in different regions of the country. A feasibility visit will be performed by the registry team. Nurses and doctors in the selected centers will be trained by members of the registry team in clinical scoring and the introduction of patient-reported outcomes in daily practice. Standard texts (“autotexts”) will be provided to the centers for incorporation in the electronic patient files, to secure adequate data collection.
Data will be collected by the health care provider in a daily practice setting in the electronic patient file through a fixed format (“autotext”). The electronic patient file is thus always the source document.
At the sites, the data from the source document will be transferred to an online Good Clinical Practice database called BioDay Registry. This database was developed and tested by a senior data manager and will be continuously managed. Data entry can be performed by the site staff themselves but could also be facilitated by UMC Utrecht’s staff registry team who will travel to these sites. Only authorized healthcare practitioners / researchers are authorized to access this database. The quality and integrity of the data will be monitored by the database coordinator.
The Registry is registered at ClinicalTrials.gov
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.