Research Article
Factors Affecting Recruitment and Attrition in
Randomised Controlled Trials of Complementary and
Alternative Medicine for Pregnancy-Related Issues
Ciara Close,
1
Marlene Sinclair,
2
Julie E. M. McCullough,
2
Sarah Dianne Liddle,
2
and Ciara M. Hughes
2
1
Centre of Public Health, Queen’s University, Belfast, Northern Ireland BT12 6BJ, Ireland
2
Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim,
Northern Ireland BT37 0QB, Ireland
Correspondence should be addressed to Ciara Close; oprey-c5@email.ulster.ac.uk and Marlene Sinclair; m.sinclair1@ulster.ac.uk
Received 13 March 2016; Revised 3 July 2016; Accepted 10 July 2016
Academic Editor: Jenny M. Wilkinson
Copyright © 2016 Ciara Close et al. Tis is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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 afecting recruitment included recruitment
timing, competition for participants, limited support from staf, 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.
1. Introduction
During pregnancy, women ofen sufer a range of complaints
such as nausea, vomiting, heartburn, and low back and/or
pelvic pain (LBPP), and many women turn to Comple-
mentary and Alternative Medicine (CAM) to alleviate these
symptoms [1–4]. Te percentage of women using CAM
during pregnancy has been reported to be as high as 87%
[5]. However, despite the high percentage of pregnant women
using CAM, there are surprisingly few well-designed ran-
domised controlled trials (RCTs) which have assessed the
efectiveness of CAM interventions during pregnancy and
many of the existing RCTs have encountered difculties with
recruitment and attrition [6–11].
CAM trials with pregnant women ofen have small sam-
ple sizes and this is likely related to issues with recruitment.
Mollart [6] recruited just 96 pregnant women during a two-
year period to an RCT investigating the efectiveness of
refexology for ankle oedema. In addition to this, in a pilot
RCT investigating the efectiveness of chiropractic treatment
and neuroemotional technique compared to exercise for
pregnancy low back pain, researchers recruited just 57 preg-
nant women in 20 months. Kimber et al. [10] took 14 months
to recruit 90 pregnant women to an RCT investigating
massage for labour pain. Small sample sizes such as these
afect the inferential capacity to make frm conclusions on
the efectiveness of these CAM interventions for pregnancy-
related issues. Recruitment of pregnant women into trials
may not be an issue isolated to CAM trials, as other types of
trials with pregnant women have struggled with recruitment.
For example, recruitment rates to dietary and exercise trials
Hindawi Publishing Corporation
Evidence-Based Complementary and Alternative Medicine
Volume 2016, Article ID 6495410, 9 pages
http://dx.doi.org/10.1155/2016/6495410