The EULAR´S repository of research databases
Introduction
Objective
The main objective is to create a repository of databases of European Studies of arthritis of recent onset and biological treatments. Repository does not contain patient data, but describes the database, the criteria for entry, the fields in the nature, any monitoring and reporting of individual or aggregated data.
Methodology
The study contains observations prospective longitudinal studies of recent start of Arthritis, including the recent start of RA or patients with rheumatic diseases treated with biological (more data sets that include tools for comparing standard therapies. Randomized controlled trials may be part of this initiative).
To ensure a minimum quality, the databases will be included only if they have been reviewed by a rheumatologist, fellows under the supervision of a recognized researcher or results published in journal Rheumatology.
Data sets of cross-sectional studies and retrospective cohort will not be included. Instead databases of prospective studies that have completed data collection in the past it was accepted.
Background
International journal editors have been instrumental in setting up a registry of all proposed randomised clinical trials, as a condition to be accepted for publication. During the meeting of the EULAR Standing Committee on Epidemiology and Health Care Services, held at Berlin in June 2004, it was clear that there are several countries with patient databases with overlapping objectives which the other investigators were unaware of. Increasing awareness will enhance collaboration between European rheumatologists and the SC proposed the development of an inventory of major rheumatological patient databases with sufficient detail of the variables they contain to inform the design of joint projects and data analyses
There are several early arthritis cohorts established within member countries of EULAR, many of which are too small to address detailed issues regarding the relationship between infrequently occurring predictors and outcomes. A more recent focus has been the establishment of registers of patients treated with biologic agents in several countries. At a meeting, under the patronage of EULAR in Stockholm early 2005, there were several countries’ registers presented, with a shared goal of identifying rare but serious adverse events. It is unlikely that any single register would be sufficiently large to address that question on its own, but by pooling data, or by meta-analysis of the different datasets, a robust answer can be achieved
The initial aim of this proposal is modest. The first task is to derive an inventory on databases that exist both for early arthritis and for the use of biologics treatments. The inventory would not contain the actual data but would describe the database, the entry criteria, the fields collected, the nature of any follow up and any information concerning access either to the individual or to the aggregated data.
Principal Investigator
Dr. Loreto Carmona Ortells. Director Research Unit. Spanish Society of Rheumatology
Duration
3 years
Financing
EULAR
Current status of the project
Retreving data