@article{684f7346f31a47c49b5ee430b9a22d27,
title = "Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): statistical and qualitative analysis plan for a randomised controlled feasibility trial",
abstract = "Background: There are significant knowledge gaps regarding the effectiveness of serial prophylactic exchange blood transfusion (SPEBT) for pregnant women with sickle cell disease (SCD). The protocol for the randomised feasibility trial assessing SPEBT versus usual care in women with SCD (TAPS2 trial) has previously been published. This publication outlines the statistical and qualitative analysis plan for the study. Methods and design: TAPS2 is a randomised two-arm phase 2 feasibility trial with a nested qualitative study and health economic evaluation. Up to 50 pregnant women with SCD and a singleton pregnancy will be recruited and individually randomised to either SPEBT approximately every 6–10 weeks until delivery (intervention arm) or to usual care (control arm). Information will be collected on a range of feasibility and clinical outcomes. Results: Due to the impact of COVID-19 on study recruitment, the initial study period of 24 months was extended to 48 months. Other protocol updates designed to mitigate the impact of COVID-19-related disruption included allowing for remote consent and conducting all qualitative interviews by telephone. The primary outcome for the trial is the overall recruitment rate. The number of women screened, eligible, consented, randomised and withdrawn will be summarised as a CONSORT flow diagram. Differences in clinical outcomes will additionally be presented as an initial assessment of efficacy and to inform sample size calculations for a future definitive trial. Qualitative interviews with trial participants and clinicians will be analysed using reflexive thematic analysis; data from interviews with participants who declined to participate in the trial will be extracted and incorporated into summary tables to report key findings. The health economic analysis plan is not covered by this update. Conclusion: The publication of this analysis plan is designed to aid transparency and to reduce the potential for reporting bias. Trial registration: NIH registry (www.clinicaltrials.gov), registration number NCT03975894 (registered 05/06/19); ISRCTN (www.isrctn.com), registration number ISRCTN52684446 (retrospectively registered 02/08/19).",
author = "Seed, {Paul T.} and Brien, {Sarah B.} and Oakley, {Laura L.} and Vicky Robinson and Joseph Sharif and Hilary Thompson and Jeannine Joseph and Eugene Oteng-Ntim",
note = "Funding Information: This study is funded by the National Institute for Health Research (NIHR) Research for Patient Benefit Programme (PB-PG-0317–20024). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funder had no role in the design of the study, in the writing of this manuscript, or the decision to submit for publication. Paul T Seed is partly funded by Tommy{\textquoteright}s (Registered charity no. 1060508) and by ARC South London (NIHR). Funding Information: We acknowledge the additional contribution to the study design by the following individuals: John James (Chief Executive, Sickle Cell Society), Jemma Johns (Lead Consultant for Obstetric Haematology and Sickle Cell Disease, King{\textquoteright}s College Hospital), Maria Chorozoglou (Senior Health Economist, University of Southampton) and Jo Howard (formerly Consultant Haematologist, Guy{\textquoteright}s and St Thomas{\textquoteright} NHS Foundation Trust). Many thanks also to all the current and former principal investigators, local network clinical researchers and coordinators at our participating hospitals: Guy{\textquoteright}s and St Thomas{\textquoteright} NHS Foundation Trust, Imperial College Healthcare NHS Trust, King{\textquoteright}s College Hospital NHS Foundation Trust, Manchester University NHS Foundation Trust, St George{\textquoteright}s University Hospitals NHS Foundation Trust, University Hospitals of Leicester NHS Trust, and Whittington Health NHS Trust. A further acknowledgement is due to the current and past members of the TAPS2 Trial Steering Committee: Professor Isabel Reading (chair) (Professorial Fellow in Medical Statistics & Director, Research Design Service South Central, University of Southampton), Dr Amma Kyei-Mensah (Consultant Obstetrician, Whittington Health NHS Trust), Dr Oseme Etomi (Consultant Obstetrician, Guy{\textquoteright}s and St Thomas{\textquoteright} NHS Foundation Trust), and Lorna Williamson (formerly Medical and Research Director, NHS Blood and Transplant). Finally, we wish to acknowledge our patient PPI group who reviewed the research proposal and study documents and offered advice from the patients{\textquoteright} perspective. Publisher Copyright: {\textcopyright} 2023, The Author(s).",
year = "2023",
month = mar,
day = "24",
doi = "10.1186/s13063-023-07235-x",
language = "English",
volume = "24",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",
}