The 2nd EHDEN & OHDSI Studyathon on Rheumatoid Arthritis

Between January 13 and 17, approximately 40 people of all disciplines, from clinical to academic to Data Partners (all with data mapped to the OMOP common data model) gathered in Barcelona for the second EHDEN study-a-thon. This time, research questions were situated in the domain of Rheumatoid Arthritis as we set out to evaluate the drug utilisation of Disease Modifying Anti Rheumatic Drugs (DMARDs), their safety profiles and outcomes, as well as prediction modelling.

The study-a-thon started by giving the participants a short introduction to the topic, OHDSI, and study-a-thon process, after which the group focused on cohort definitions and evaluation with Data Partners from Spain, Estonia, the Netherlands and IQVIA data sources (UK, Belgium, France, Germany). Supported by Rheumatology clinical and academic colleagues, they established the study cohorts per protocol for the Drug Utilisation, Population Estimation and Population Prediction studies which would be conducted through these five days. The work around the abstract and manuscript content was initiated in parallel.

On Tuesday, the participants continued the journey by evaluating the cohort outputs from the multiple OMOP common data model mapped databases and evaluating the definition for Rheumatoid Arthritis. By using the Cohort Diagnostics tool, confidence in the populations being studied could be evaluated and outcomes cohorts for specific adverse events were defined. Further work on the draft abstracts and manuscript content continued in the afternoon for the drug utilisation, population-level effect estimation and patient-level prediction studies.

On the third day, the group worked on evaluating the outcomes cohorts, on validating the negative controls to be included and on achieving agreement about propensity score matching parameters. A subset of clinicians finalized the consensus on negative controls following the group work. Thereafter, the group split into three subgroups working on the drug utilisation, population-level effect estimation and patient-level prediction, working on the content development of the various abstracts and manuscripts. In the late afternoon the group visited the Barcelona Supercomputing Centre.

On Thursday, the study-a-thon group worked on various aspects of prediction, focusing on setting model development and validation parameters for predicting outcomes following RA treatment for adverse events such as infections, cardiovascular (myocardial infarction or stroke) and blood disorders such as pancytopenia. Results from the work on propensity matching were evaluated for the impact of covariants, and the negative controls. The rest of the day, work contributed on predictive modelling, and the three groups on drug utilisation, population-level effect estimation and patient-level prediction studies continued work on data and abstract content. Alignment on the publication plan, target journals and timelines was agreed.

During the fifth and final day of the study-a-thon, it all came together as the results for the drug utilisation, population-level effect estimation and patient-level prediction studies were unblinded, and the protocol finalised for submission. Abstracts will be submitted to the EULAR meeting (3-6 June 2020, Frankfurt) and the group agreed on the publication plan for the three respective journal articles.

This five-day study-a-thon had been an inspirational, disruptive and thought-provoking experience for all. 'The power of EHDEN and OHDSI' and a new way of thinking about and conducting real world research had been demonstrated during this hands-on, instructional and educational five days, with the largest ever studies conducted in Rheumatoid Arthritis. Ordinarily such studies would have taken at least two years to have planned and executed, and therefore the clinical, research, and patient communities would have to have waited for these new insights into the management of RA, now truncated into five days of study and the time to submit and all being well, be accepted for presentation and publication.

Watch this space for future study-a-thons and an increasing opportunity to conduct research at speed, but with quality, via EHDEN and OHDSI. On to the 3rd EU OHDSI Symposium in Oxford, 27-29 March!