PB0396 - Understanding Stakeholder Perspectives: A Qualitative Exploration to Shape a Core Outcome Set for Venous Thromboembolism Treatment

Sunday, June 23, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

Lisa Duffett, MD, MSc

The Ottawa Hospital, Canada

Co-Author(s)

NL

Nicole Langlois

Senior Research Associate
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
CW

Carol West

Patient Partner
CanVECTOR
Chelsea, Quebec, Canada
SD

Suzanne Dubois

Patient Partner
CanVECTOR
Burlington, Ontario, Canada
LM

Lbena Michael

Student
Carleton University
Ottawa, Ontario, Canada
LS

Leslie Skeith

Associate Professor
University of Calgary
Calgary, Alberta, Canada
Tobias Tritschler, MD, MSc

MD, MSc
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Bern, Bern, Switzerland
MC

Maeve Crowley

Consultant Haematologist
Cork University Hospital
Cork, Cork, Ireland
Lai Heng Lee, MBBS FRCP

Senior Consultant
Singapore General Hospital
Singapore, Singapore
Helia Robert-Ebadi

Staff physician vascular medicine
Geneva University Hospitals and Faculty of Medicine
Geneva, Geneve, Switzerland
BA

Bader Al-Rawahi

Physician
Sultan Qaboos University
al-Seeb, Masqat, Oman
Zoubida Tazi Mezalek

Head of Hematology Department
Ibn Sina University Hospital, Mohammed V University, Rabat, Morocco
Rabat, Rabat-Sale-Zemmour-Zaer, Morocco
BS

Beverley Shea

Senior Methodologist
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
LC

Lindsay Cowley

Research Assistant
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
RK

Roy Khalife

Assistant Professor
University of Ottawa
Ottawa, Ontario, Canada
Gregoire Le Gal

Hematologist
University of Ottawa
Ottawa, Ontario, Canada

Background: Clinical trials in VTE often prioritize physiological endpoints, neglecting broader outcomes that impact patient care and experiences and healthcare resources. In response, this study addresses this critical knowledge gap by developing a Core Outcome Set (COS), ensuring a standardized and inclusive evaluation of VTE treatments. The COS approach enhances consistency, promotes data accuracy and comparability, and aligns with diverse stakeholders' priorities in shared decision-making.

Aims: We aim to identify distinctive and pertinent outcomes for VTE treatment trials, drawing insights from patients and other stakeholders.

Methods: We conducted 41 semi-structured interviews with 33 patients and 8 other stakeholders with diverse experiences from 8 countries and 4 continents. Data collection and analysis occurred iteratively. Data analysis followed key steps of thematic analysis and coding structure was grounded in the data. Transcripts were analyzed line by line to identify initial concepts, and similar concepts (outcomes) were grouped into themes (outcome domains). Outcome domains were categorized using OMERACT's four core areas conceptual framework. Outcomes domains were identified and refined over a series of team and steering committee meetings.

Results: Stakeholders (professional and patients) identified diverse professional and lived experiences in VTE (Table 1). The analysis of interviews generated 81 unique outcomes, and the outcomes relevant to the VTE COS were consolidated into 20 outcome domains (Table 2). Emerging themes of outcomes with high value to stakeholders included regaining a normal life, easing the overall burden, addressing the psychological impact, particularly fear, ensuring treatment safety, especially bleeding, and enhancing physical well-being to baseline function.

Conclusion(s): This international qualitative study sheds light on the diverse outcomes considered meaningful by stakeholders in the context of VTE treatment and informs the next steps of our project. Using consensus methodologies, we plan to establish a globally accepted minimum set of outcomes to enhance the robustness and relevance of VTE treatment trials.