Emesis in Pregnancy – a qualitative study on trial recruitment failure

Abstract BackgroundAs part of the internal pilot of the EMPOWER trial investigating 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. Because of poor recruitment rates, interviews were extended to include site research staff, to broaden our understanding and explore other factors affecting recruitment.MethodsThe sample comprised women who accepted or declined trial participation (n = 21) and site research staff (n = 22). To reduce the burden on women, a structured topic guide was used, in four email interviews and 17 telephone interviews. Following slow trial recruitment, semi-structured telephone interviews were carried out with staff. All transcripts were checked for accuracy, anonymised, and entered into NVIVO12 for indexing and retrieval. Data was analysed using a generative thematic approach.ResultsOf the women interviewed, seven were decliners, and of the site research staff interviewed, 16 were research midwives/research nurses and six were principal investigators. In total, 72 codes were generated from the thematic analysis, 36 from each sample group. The themes focused on in this paper 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. To address these themes, staff perspectives are given more prominence.ConclusionsThe main reasons the trial did not progress were the patient population and their ineligibility due to prior treatment with study drug(s). We describe how staff had to manage the diversity of referral pathways, boundaries of care and the complexity of the trial and protocol. Ethical issues discussed included the use of double dummy and the time to treat women, particularly those suffering severely from the effects of nausea and vomiting. Qualitative work in feasibility and pilot stages of a clinical trial is recommended.Trial registrationTrial registration number ISRCTN16924692. Date of registration: 08/01/2018