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Learning from the QUEST multicentre feasibility randomization trials in breast reconstruction after mastectomy
Z E Winters1, M Emson, C Griffin
1Breast Reconstruction Patient Reported and Clinical Outcomes Research Group, School of Clinical Sciences, University of Bristol and North Bristol Trust, Bristol, UK.
Recruiting patients for breast reconstruction trials proved challenging due to strong patient preferences for specific surgery types and timings. These preferences made it difficult to meet feasibility targets for the QUEST trials.
Area of Science:
- Oncology
- Plastic Surgery
- Clinical Trials
Background:
- Breast reconstruction aims to enhance quality of life post-mastectomy.
- Limited evidence exists for shared decision-making on optimal breast reconstruction type and timing.
- Patient preferences significantly influence choices in reconstructive surgery.
Purpose of the Study:
- To assess the feasibility of randomized trials on latissimus dorsi breast reconstruction.
- To evaluate the impact of reconstruction type and timing on quality of life.
- To understand patient and healthcare professional acceptability of trial participation.
Main Methods:
- Two parallel feasibility phase III randomized multicentre trials (QUEST A and B) were conducted.
- QUEST A: reconstruction when postmastectomy radiotherapy is unlikely.
- QUEST B: reconstruction when postmastectomy radiotherapy is highly probable.
- A companion QUEST Perspectives Study (QPS) assessed trial acceptability.
Main Results:
- Recruitment rates were lower than the 25% feasibility target (QUEST A: 19%, QUEST B: 22%).
- Patient preference was the primary reason for declining trial participation (53-61% of declines).
- Both trials closed due to challenges in achieving satisfactory patient accrual.
Conclusions:
- It was not feasible to meet recruitment targets within the feasibility study timeframe.
- Strong patient preferences for specific breast reconstruction methods and schedules hindered trial enrollment.
- Further strategies are needed to facilitate shared decision-making and trial participation in breast reconstruction research.
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