5/4/2023 0 Comments Cultural boundary![]() Because of poor recruitment rates, interviews were extended to include site research staff, to broaden our understanding and explore other factors affecting recruitment.Methods Date: Īs part of the internal pilot of the EMPOWER trial investigating second line antiemetic therapies in severe emesis in pregnancy (), 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. Trial registration number ISRCTN16924692. Qualitative work in pilot and feasibility studies of a clinical trial is recommended, to evaluate whether recruitment strategies remain viable in unanticipated contexts. The qualitative results also demonstrate the impact of the trial on women and staff 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. 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. To illustrate these themes, staff perspectives are given more prominence. Ethical issues discussed included the use of double dummy and time to treat, particularly those suffering severely from the effects of nausea and vomiting. ![]() 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 staff morale and (c) the ethics of caring for a patient with emesis. In total, 72 codes were generated from the thematic analysis, and 36 from each sample group. Data was analysed using a reflexive thematic analytic approach. All transcripts were checked for accuracy, anonymised and entered into NVIVO12 for indexing and retrieval. Of the women interviewed, seven had declined trial participation, and of the staff interviewed, 16 were research midwives/research nurses and six were principal investigators. 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 staff. The sample comprised women who accepted or declined trial participation ( n =21) and site research staff ( n =22). Interviews were also conducted with site research staff, to broaden our analysis and explore other factors affecting recruitment. As part of the internal pilot of the EMPOWER trial investigating the second-line antiemetic therapies in severe emesis in pregnancy ( ), 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.
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