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Table 1 Detailed study objectives by sub-study

From: Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial

  Objectives
TrialFeasibility: primary1. Assess the willingness of pregnant women with SCD to take part in a randomised controlled trial comparing SPEBT to standard care.
Feasibility: secondary2. Identify barriers and facilitators to participation in the trial, including assessing reasons for refusal.
3. Assess retention rates of participants throughout pregnancy in both arms of the study.
4. Assess the willingness of clinicians to recruit into this trial.
Clinical: infant5. Assess the proportion from the control arm advised clinically to start prophylactic blood transfusion.
6. Measure clinical outcomes for women and infants including an initial preliminary assessment of efficacy for future definitive trial.
7. Generate data to inform the design of a definitive trial, including identifying the primary outcome.
Clinical: maternal
Safety8. Record safety issues around blood transfusions in both arms of the study
QualitativeFeasibility9. Identify barriers and facilitators to participation from study participants, clinicians and, where possible, those unwilling to participate
10. Identify strategies to optimise recruitment and retention
11. Assess acceptability of the intervention, trial procedures and study conduct, including identifying the core outcomes that are considered important to measure and preference for either HRQOL measure
12. Identify reasons for attrition
13. Assess women’s experience of taking part in the study
EconomicResource Use & Costs14. Explore the cost implications of the proposed intervention and to assess measurement tools and methods
HRQoL & health benefits15. Assess two widely used HRQoL measures against each other and other health benefits