PB1532 - How can we improve recruitment to trials for prevention of venous thromboembolism during pregnancy and the puerperium? A qualitative evaluation of the patients’ perspective

Tuesday, June 27, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Beverley J. Hunt, MD, FRCP, FRCPath

Professor of Thrombosis & Haemostasis, Consultant Haematologist
Guy's & St Thomas' NHS Foundation Trust
London, England, United Kingdom

Co-Author(s)

FS

Fiona Sampson

Professor
University of Sheffield
Sheffield, Wyoming, United States
SG

Steve Goodacre

Professor of Emergency Medicine
School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom
Sheffield, England, United Kingdom
AP

Abdullah Pandor

Senior Lecturer
University of Sheffield
Sheffield, Wyoming, United States
CN

Catherine Nelson-Piercy

Professor
Kings Healthcare Partners
London, Wyoming, United States
JD

Jahnavi Daru

Lecturer
Barts & The London School of Medicine
London, Wyoming, United States
RC

Rosemary Carser

Finance director
Northern Ireland Civil Service
Belfast, Wyoming, United States
AM

Andrew BS Metry

Research Associate (Health Economics and Decision Modelling)
School of Health & Related Research, Sheffield University
Sheffield, Wyoming, United States
SD

Sarah Davis

Senior Lecturer
University of Sheffield
Sheffield, Wyoming, United States

Background: Thromboprophlyaxis during pregnancy and the puerperium is widespread, but there is a lack of evidence on the risks and benefits within this population. For pregnancy is a common trial exclusion criteria, and there is also low recruitment and retention in trials targeting pregnancy.

Aims: As part of a wider study to identify where further trials would have highest future benefit, we undertook qualitative evaluation of patient perspectives to understand willingness to participate in future trials for this population.

Methods: Four focus groups of 22 women who had pregnancy/puerperium thromboprophylaxis due to prior VTE (n=10) or thrombophilia (n=12) were held online November 2021 - January 2022. We recruited via national special interest groups representing diverse cultural and socio-economic backgrounds; as well as social media, sampling purposively for condition, age, ethnicity, and socio-economic status. Participants received a £50 voucher. We analysed transcribed data using thematic analysis, focusing on understanding the factors that influence future trial participation.

Results: Lack of communication around the risks and benefits of thromboprophylaxis influenced how women perceived future trial participation. Lack of understanding of thromboprophylaxis risks, led participants to perceive entering a trial was withholding treatment due to the risk of not receiving thromboprophylaxis. Some were unaware of why they had been given thromboprophylaxis but still perceived receiving a placebo as an inferior option. Concerns were often minimised and ignored by healthcare professionals.
These experiences motivated women to participate in future trials to receive a higher standard of care, as well as improving future care for others. Adherence to treatment may be affected by negative experiences of injecting and limited understanding of why they had been offered thromboprophylaxis.

Conclusion(s): To improve recruitment and retention in pregnancy and puerperium clinical trials, women need to be given clear explanations of the risks and benefits of treatment, and understand where there is genuine clinical equipoise.