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.

Reflexology: A randomised controlled trial investigating the effects on beta-endorphin, cortisol and pregnancy related stress

“…This complex intervention investigated quantitative physiological and biochemical outcomes. Close et al [33,[37][38] and McCullough et al [39] have reported elsewhere on findings relating to the feasibility of the study, recruitment and retention, and additional data including patient reported pain and disability and labour outcomes. However, the small sample size was insufficient to demonstrate statistically significant differences between groups or the true effect of reflexology versus a sham treatment and, therefore, a larger study is warranted.…”

“…Furthermore, the participant-therapist interaction, which is an integral part of CAM therapies, will also have affected physiological and biochemical results. The high rates of attrition and the reasons for this may also have influenced results and this has been discussed elsewhere [37].…”

“…Using computer generated block randomisation and sealed opaque envelopes, all eligible participants (Table 1) were randomised into one of three arms of the study; reflexology (intervention), footbath (sham treatment), to control for the patienttherapist interaction, and usual ante-natal care (control group). This study has been reported elsewhere including additional study outcome data, including feasibility, recruitment and retention, and details of the reflexology and footbath procedures [37][38][39].…”

A qualitative study of the factors influencing recruitment to a pilot trial on the prevention of striae gravidarum

“…Participants in our study were not over burdened by requests to participate in other research studies since becoming pregnant. We are not aware of any evidence on research demands on women during pregnancy but Close et al, [18] report how participation in another study was an exclusion criteria in their study due to the extra time and travel expense burden. Not being asked to join other studies was most likely related to the early stage of their pregnancy for participants in our study.…”

“…Challenges with recruitment are not unique to this study. Challenges with recruitment to trials in maternity care are reported by others [17][18][19][20]. In light of this, and following a review of the literature on maternal trials and discussion with maternity staff, we decided that an exploration of the factors influencing recruitment to the trial was necessary to elucidate factors influencing recruitment and to guide future research on this topic.…”