Please introduce yourself and your role within the EHRA-PATHS project.

My name is Isabelle van Gelder, I am Professor of Cardiology at the University Medical Center Groningen. I am Work Package leader of WP 5 together with my colleague here in Groningen Michiel Rienstra.

When did you join EHRA-PATHS and what drove your involvement in WP5?

I did join EHRA PATHs from the beginning when Professor Hein Heidbuchel asked me to join because of my expertise in running randomised trials and research in atrial fibrillation and comorbidities underlying atrial fibrillation. I was interested to join this consortium because of the topic – the role of comorbidities in elderly patients with atrial fibrillation. Since 20 years I am very interested in how we can improve outcome in patients with AF by identifying and treating underlying risk factors and comorbidities. Throughout the years I always emphasize the relevance of the associated risk factors and comorbidities, and not just focusing on the ECG. However, in clinical practice this is difficult and time-consuming and therefore often insufficiently addressed. Therefore, this project is of pivotal importance for patients with atrial fibrillation and for us to assess whether a systematic approach to identify comorbidities using an easy to use software tool may contribute to reduce health care associated costs.

Please provide an overview of the goals and activities of Work Package 5 (WP5) – Clinical and Health Economic Evaluation, particularly in the context of the newly developed care program for elderly atrial fibrillation patients with multimorbidity. 

Rationale of WP 5: In elderly AF patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways.

The aim of WP 5 is to evaluate the current management of risk factors and comorbidities in the base-mapping part of the study.

Subsequently, in the randomised trial the primary objective is to assess whether systematic implementation of an easy-to-use software tool, improves the identification of AF associated risk factors and comorbidities and increases treatment initiation in elderly patients newly diagnosed with AF.

Secondary outcomes include improvement of symptoms and quality of life, reduction in referrals to other disciplines and an improvement in cost-utility.

We expect that more risk factors and comorbidities will be evaluated, and more patients will receive adequate treatment for their risk factors and comorbidities.

Could you explain the significance of the study protocols and data management plans in the evaluation study, and how they are developed in collaboration with relevant partners?

Study protocols are essential as it must be clear:

• why a trial needs to be performed (rationale, background, what is already known)
• what the objectives are (carefully and precisely defined)
• power calculation: essential to know how many patients need to be included
• randomisation procedure
• outline and flowchart of the conduct of the trial

Data management plans are essential to conduct a trial according to Good Clinical Practice in a uniform way, across all centers in all countries (note that in EHRA-PATHS randomised trial 14 countries will take part !).

Protocols and all other documents are developed in a steering committee. A steering committee is a group of peers with different but for the trial essential expertise. For this trial we selected cardiologists with AF expertise, expertise in conducting randomised trials, health economic expertise, epidemiological and statistical expertise. And above all patients are nowadays also often consulted or included in a steering committee for their expertise regarding the significance and feasibility of the trial.