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Emesis in pregnancy – a qualitative study on trial recruitment failure from the EMPOWER internal pilot

Lookup NU author(s): Dr Mabel LieORCiD, Dr Catherine McParlin, Emerita Professor Elaine McCollORCiD, Dr Ruth Graham, Professor Steve RobsonORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

Background: As part of the internal pilot of the EMPOWER trial investigating the second-line antiemetic therapies in severe emesis in pregnancy (https://www.isrctn.com/ISRCTN16924692), a qualitative study of women’s views was carried out, to improve our understanding of why women did, or did not, consent to participation in the trial. Interviews were also conducted with site research staf, to broaden our analysis and explore other factors afecting recruitment. Methods: The sample comprised women who accepted or declined trial participation (n=21) and site research staf (n=22). A structured topic guide was used, in four email interviews and 17 telephone interviews with women, and semi-structured telephone interviews were carried out with staf. Of the women interviewed, seven had declined trial participation, and of the staf interviewed, 16 were research midwives/research nurses and six were principal investigators. All transcripts were checked for accuracy, anonymised and entered into NVIVO12 for indexing and retrieval. Data was analysed using a refexive thematic analytic approach. In total, 72 codes were generated from the thematic analysis, and 36 from each sample group. Results: Three key themes based on all the interviews were (a) the diversity of recruitment pathways and boundaries of care, (b) the impact of trial complexity on recruitment and staf morale and (c) the ethics of caring for a patient with emesis. Ethical issues discussed included the use of double dummy and time to treat, particularly those sufering severely from the efects of nausea and vomiting. To illustrate these themes, staf perspectives are given more prominence. Conclusions: The main reason the trial was stopped related to the high proportion of women ineligible for recruitment due to prior treatment with study drug(s) because of unanticipated changes in clinical practice. The qualitative results also demonstrate the impact of the trial on women and staf and highlight how the diversity of referral pathways, boundaries of care and the complexity of the trial and protocol resulted in additional barriers to successful trial recruitment. Qualitative work in pilot and feasibility studies of a clinical trial is recommended, to evaluate whether recruitment strategies remain viable in unanticipated contexts. Trial registration: Trial registration number ISRCTN16924692. Date: 08/01/2018


Publication metadata

Author(s): Lie MLS, McParlin C, McColl E, Graham RH, Robson SC

Publication type: Article

Publication status: Published

Journal: Pilot and Feasibility Studies

Year: 2022

Volume: 8

Online publication date: 14/07/2022

Acceptance date: 15/06/2022

Date deposited: 15/07/2022

ISSN (electronic): 2055-5784

Publisher: BioMed Central Ltd.

URL: https://doi.org/10.1186/s40814-022-01093-1

DOI: 10.1186/s40814-022-01093-1


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Funding

Funder referenceFunder name
16/15/03National Institute for Health Research (NIHR)

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