title: Factors Affecting Recruitment and Attrition in Randomised Controlled Trials of Complementary and Alternative Medicine for Pregnancy-Related Issues.
abstract: Background. Randomised controlled trials (RCTs) investigating Complementary and Alternative Medicine (CAM) for pregnancy-related issues have encountered issues with recruitment and attrition. Little is known about the cause of these issues.Methods. Data was gathered from an antenatal CAM randomised controlled trial. During foetal anomaly appointments, women meeting inclusion criteria were invited to participate in the trial. Numbers of women invited and eligible were recorded. Reasons for noninterest were noted and analysed. Focus groups exploring trial experience of participants were also conducted.Findings. Of the 428 women invited to participate, 376 were eligible and just under a quarter participated. Reasons for nonparticipation included concerns about CAM and lack of interest in participation in research. Other factors negatively affecting recruitment included recruitment timing, competition for participants, limited support from staff, and inadequate trial promotion. Factors encouraging recruitment included being interested in research and seeking pain relief. Reasons for dropping out were time constraints, travel issues, work commitments, and pregnancy issues. Several women in the sham and usual care group dropped out due to dissatisfaction with treatment allocation.Conclusion. CAM researchers must explore problems encountered with recruitment and attrition so that evidence-based implementation strategies to address the issues can be developed.
authors.affiliation: Centre of Public Health, Queen's University, Belfast, Northern Ireland BT12 6BJ, Ireland.
authors.forename: Ciara
authors.identifier: 0000-0002-3203-303X
authors.initials: C
authors.lastname: Close
authors.affiliation: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim, Northern Ireland BT37 0QB, Ireland.
authors.forename: Marlene
authors.identifier: 0000-0003-4444-1505
authors.initials: M
authors.lastname: Sinclair
authors.affiliation: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim, Northern Ireland BT37 0QB, Ireland.
authors.forename: Julie E M
authors.identifier: 0000-0002-0442-6629
authors.initials: JE
authors.lastname: McCullough
authors.affiliation: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim, Northern Ireland BT37 0QB, Ireland.
authors.forename: Sarah Dianne
authors.identifier: 0000-0001-8151-641X
authors.initials: SD
authors.lastname: Liddle
authors.affiliation: Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim, Northern Ireland BT37 0QB, Ireland.
authors.forename: Ciara M
authors.identifier: 0000-0002-1064-6775
authors.initials: CM
authors.lastname: Hughes