Epidemiology and health services research - ongoing initiatives

Task force on requirements for observational treatment registers

Convenor: Johan Askling, Will Dixon

This Task Force encompassed eleven scientists from independent European rheumatology drug registers. The first deliverable was a strategy paper on points to consider when establishing or analysing data from a biologics register.
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The second deliverable - an implementaton workshop - aimed at communicating the recommendations to a wider community and supporting persons all over Europe in planning and implementing biologics registers. It also gave hints on the challenges connected to those data. No formal experience of registers or of epidemiological data analysis was required; both younger research fellows as well as clinicians with an interest in registers were invited.
Following the workshops participants wish a EULAR Study Group on Longitudinal Observational Registers and Drug Studies was established.
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A checklist should serve as an educative tool to assist authors in writing reports of longitudinal observational drug studies in rheumatology, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. The "EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology" article [1]  and the STROBE statement [2]  provide elucidation and context to the checklist items.
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Regular meetings will provide an opportunity for networking and development of international collaborative studies. The aim is to explore issues throughout the lifespan of studies, from first thoughts around establishing a register, practicalities such as funding, bio-banking and informatics, through methods of data collection, opportunities for harmonizing practice, analysis methodology, to the interpretation and dissemination of results.
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EULAR perspectives in patient-reported outcomes

Convenor: Angela Zink

Based on expert opinions gathered at a EULAR workshop in November 2009, a proactive call on research proposals in the field of patient-reported outcomes (PROs) was launched in November 2010. It covered the areas of cross cultural validation of existing instruments as well as the development of new PROs or personal life impact measures. 28 letters of intent for research projects were sent to EULAR. They were reviewed by three members of the Executive Committee and one patient representative. 21 proposals fulfilled the criteria of the call, and the applicants were encouraged to submit a full proposal. Seventeen proposals received external peer review from experts in the field, and six projects were finally approved for funding in September 2011.
The EULAR Outcomes Measures Library (OML) is part of this initiative. The database includes a detailed description of each instrument, including:

  • The instrument itself
  • Description of the population/s or settings where it has been validated
  • Recommendations and rules for use  (data collection and scoring method)
  • Guideline for interpretation of the results in clinical practice or in research.
  • References and validated translated versions in the EU languages, with download if possible or link to an access page.
  • Information on how validation aspects were tested.

OML aims to be a comprehensive database of validated patient-reported instruments (indices, questionnaires, scales, or others) used in rheumatology.
Go to OML

Symptom measurement in persons at risk of rheumatoid arthritis

Convenor: Dirkjan van Schaardenburg

People with rheumatoid arthritis (RA) usually pass through a phase with rather vague symptoms, before they are diagnosed with RA. Since early treatment is of crucial importance to the progress of the disease, very early recognition is vital. Dr van Schaardenburg and other colleagues were recently awarded a grant by EULAR to develop a validated questionnaire to measure symptoms and symptom complexes in persons at risk for RA.  In phase 1 of the study, a preliminary questionnaire will be developed based on the findings of previous qualitative research on symptoms and symptom complexes as well as a recent systematic literature review. This preliminary questionnaire will be critically evaluated by patient research partners and professionals (face validity). 
In phase 2, the preliminary questionnaire will be tested for construct validity, reliability and feasibility in a longitudinal clinical setting by following over 120 persons with rheumatoid factor and/or anti-citrullinated protein antibody positive arthralgia for 6 months in four different countries: Netherlands, UK, Sweden and Austria.

Recommendations for the standardised content and structure of core data to facilitate patient care and research in RA

Convenor: Johan Askling, Will Dixon

Many modern day research questions in rheumatoid arthritis (RA), such as biologic safety or genetic studies, require ever-larger study populations that exceed the size of individual cohorts or registries. These ‘mega-populations’ can only be obtained by pooling data from different data sources. However, data pooling is only possible if data items are collected in a standardised way and to high standards across settings or, as a minimum, can be mapped to a common data model.
In order to maximise future opportunities for collaborative European research in RA, we propose establishing a core dataset for RA research.


EULAR points to consider for worksorce requirement studies in rheumatology

Convenor: Christian Dejaco, Frank Buttgereit

Early manifestations of rheumatic diseases are considered medically urgent because joint and organ damage occur early in the disease course. To prevent damage (or halt progression at last), EULAR has been developing recommendations and strategies for early referral, diagnosis and treatment. Theses strategies, however, can only be implemented in rheumatology if sufficient manpower is available. The aim of this project is to agree upon the methodology, based on EULAR standards, for the conduction of future national and international workforce models.

Related information

News for epidemiologists from the European Medicines Agency (EMEA)

The European Network fo Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has developed the Guide on Methodological Standards in Pharmacoepidemiology. It reviews existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance, and contains useful links.
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Additionally, ENCePP has revised the Clinical Trials Directive 2001/20/EC, especially with regard to non-interventional trials and type-A trial (low risk). The revised directive should ease the implementation of observational studies in Europe.