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

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 staff, to broaden our analysis and explore other factors affecting recruitment. Methods The sample comprised women who accepted or declined trial participation (n=21) and site research staff (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 staff. 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. All transcripts were checked for accuracy, anonymised and entered into NVIVO12 for indexing and retrieval. Data was analysed using a reflexive 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 staff 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 suffering severely from the effects of nausea and vomiting. To illustrate these themes, staff 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 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. 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

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review

“… c Eight studies address 2 trial areas [ 40 , 41 , 45 , 46 , 48 , 60 , 85 , 94 ]. d Twenty-nine papers reported more than 1 participant group [ 43 – 45 , 47 , 51 , 53 – 55 , 57 , 61 , 62 , 64 – 67 , 71 , 73 , 74 , 82 , 85 – 87 , 89 – 91 , 94 – 97 ]. …”

“… d Twenty-nine papers reported more than 1 participant group [ 43 – 45 , 47 , 51 , 53 – 55 , 57 , 61 , 62 , 64 – 67 , 71 , 73 , 74 , 82 , 85 – 87 , 89 – 91 , 94 – 97 ]. …”

“…The 60 papers present data from 27 countries and 4 geographic regions: 13 countries in Africa [ 44 – 47 , 65 , 73 , 78 , 84 , 85 ], 8 countries in Europe [ 38 , 39 , 41 , 48 – 50 , 53 – 56 , 58 , 59 , 61 , 62 , 64 , 67 – 69 , 72 , 74 , 80 – 83 , 86 , 89 , 90 , 92 , 94 , 96 ], 3 countries in the Americas [ 42 , 43 , 51 , 52 , 57 , 60 , 63 , 66 , 70 , 71 , 75 , 77 , 79 , 85 , 88 , 91 , 93 , 95 ], and 3 countries in the Western Pacific [ 40 , 76 , 87 , 97 ].…”

“…Fifty-one papers focused on pregnant women only [ 38 – 41 , 44 , 47 – 50 , 52 , 53 , 55 – 70 , 72 – 94 , 97 ], 2 papers focused on lactating women only [ 46 , 96 ], and 7 papers focused on pregnant and lactating women [ 42 , 43 , 45 , 51 , 54 , 71 , 95 ]. Thirty-seven papers addressed a therapeutic drug-related intervention [ 38 , 40 , 41 , 44 – 49 , 53 , 56 , 59 – 62 , 66 , 69 , 70 , 72 , 73 , 77 , 79 – 90 , 92 , 93 , 96 , 97 ], 11 papers focused on a vaccine-related intervention [ 50 , 51 , 55 , 57 , 58 , 63 , 64 , 67 , 68 , 78 , 94 ...…”

“…Twenty-five papers included perspectives of pregnant women [ 38 , 45 , 47 , 48 , 51 , 57 , 58 , 60 , 61 , 64 , 65 , 67 , 71 – 75 , 77 , 85 , 89 – 91 , 94 , 95 , 97 ], 28 papers included perspectives of postpartum women [ 39 – 41 , 44 – 46 , 49 , 51 , 56 , 57 , 59 , 62 , 63 , 69 – 71 , 74 , 79 – 87 , 92 , 95 ], and 14 papers included health workers’ perspectives [ 44 , 47 , 50 , 52 – 54 , 61 , 64 , 65 , 67 , 87 , 88 , 91 , 94 ]. For other stakeholder groups, please refer to Table 1 .…”