HAEM-PROSPECT-1
Research type
Research Study
Full title
HAEM-PROSPECT-1: A qualitative study to explore patient and clinician attitudes towards risk and benefits with regard to Advanced Therapy Medicinal Products (ATMPs) in haemophilia to inform a future Discrete Choice Experiment (DCE) (HAEM-PROSPECT-2)
IRAS ID
318248
Contact name
John Spoors
Contact email
Sponsor organisation
Research Governance & Integrity Office
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Research Summary
The purpose of this research project is to undertake the necessary preparatory work to design a future study which will use a discrete choice experiment (DCE) with the integration of a clinician information video (HAEM-PROSPECT-2) to collate the preferences of patients about the use of Advanced Therapy Medicinal Products (ATMPs) for haemophilia. A separate ethics application will be submitted for HAEM-PROSPECT-2.
The research for HAEM-PROSPECT-1 is split into two phases and will employ qualitative focus groups and semi-structured interviews.
The research will explore patient and clinician attitudes towards risk and benefits when considering ATMPs in relation to current prophylaxis therapy in haemophilia. The clinician information video is being designed to simulate a more realistic approach within DCEs and to test how clinicians directly influence patient choices.The research for HAEM-PROSPECT-1 is split into two phases and will employ qualitative focus groups and semi-structured interviews.
The research will explore patient and clinician attitudes towards risk and benefits when considering ATMPs in relation to current prophylaxis therapy in haemophilia. The clinician information video is being designed to simulate a more realistic approach within DCEs and test the concept of reference dependence identified under prospect theory.
Summary of Results
Five summary themes were extracted and analysed in the research with three themes relating to clinician-patient communication: (i) active vs passive patients (ii) health literacy (iii) external factors, one theme relating to gene therapy perspectives on benefit-risk and one theme on the scar of the blood infection scandal.
There remains scepticism about gene therapy across all research participant groups which suggests that uptake is likely to be relatively slow with divergence anticipated between haemophilia A and B. Treatment decision-making and risk-benefit discussions are complex and multi-faceted issues which in haemophilia are heavily influenced by the infected blood scandal. Clinicians frame treatment decision-making which necessitates the requirement for risk-benefit training and high-quality tailored patient gene therapy information materials.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0271
Date of REC Opinion
7 Sep 2022
REC opinion
Favourable Opinion