EURURO Vol. 72 No. 5

790 860

1. Introduction
Clinical policy and practice recommend the use of current
best evidence to guide decisions about patient care, which is
essential for providing high-quality healthcare . Random-
ised controlled trials (RCTs) are recognised as the most
effective methodology for the evaluation of the effective-
ness and safety of healthcare interventions , especially
when brought together in systematic reviews However,
the lack of high-quality evidence to support clinical decision
making means that many fundamental questions in
medicine—including in the management of urological
patients—remain unanswered. Guidelines are often based
on expert opinion or weak evidence and new trials are
therefore required to tackle many major questions in
urology. Studies such as the Prostate Cancer Intervention
Versus Observation Trial and the Prostate Testing for
Cancer and Treatment trial (ProtecT) study demon-
strate that urological RCTs can be undertaken successfully.
However, less than a third of trials achieve their original
recruitment target .
Reviews have reported that successful RCT recruitment
is associated with a number of factors, including addressing
clinically important questions at a timely point, employing
dedicated research staff, ensuring that staff are trained
about trial processes and interventions, and having
straightforward data collection In addition,
effective strategies to improve recruitment include tele-
phone reminders, financial incentives, open-trial designs
where participants know which treatment they are receiv-
ing in the trial, and use of opt-out rather than opt-in
procedures However, Bower and colleagues
highlighted that there was also a need to develop effective
interventions aimed at those recruiting to trials. Although
patient information leaflets are strictly regulated by ethics
committees, the communication style of the recruiter
(usually a clinician or nurse) plays an important role in
patients’ understanding of the information and their
willingness to join the study . Research has shown
that information conveyed during recruitment appoint-
ments varies considerably in content and quality , and
patients often have a poor understanding of RCT concepts
A systematic review of interventions to improve
the recruitment activity of clinicians reported that the most
promising interventions were studies that used qualitative
research to identify key issues and develop interventions to
improve recruitment . This focused review provides
an introduction to qualitative research techniques and
summarises how this approach can be used to understand—
and subsequently improve—recruitment to RCTs.
1.1. Qualitative research
Qualitative research is an umbrella term used for a range of
methodologies used to generate rich accounts of how
people make sense of the world and how they experience
events . Whereas quantitative research focuses on ‘‘how
many’’ and ‘‘how much’’, qualitative research seeks to
answer[1_TD$DIFF] ‘‘how’’ and ‘‘why’’ questions . Data are primarily
gathered from interviews, focus groups, and observations
intensively in small numbers to facilitate understanding.
Data collection and analysis are iterative processes that
continue until saturation is reached (ie, the point at which
no new themes emerge)
2. Evidence acquisition
This [8_TD$DIFF]article does not intend to provide a systematic review
of the current literature, but instead highlights ways in
which qualitative methods can be used to understand
recruitment to RCTs. A search of Medline, Embase, and
CINAHL was undertaken in October 2016 using a combina-
tion of the following keywords qualitative, recruit*, consent,
RCT, trial*, and random*. Titles and abstracts were reviewed
to assess relevance. Studies with a qualitative methodology
that focused on recruitment or informed consent in any RCT
were included. As this article focuses on the recruitment
activity of healthcare professionals, studies focusing solely
on patient experiences of RCTs were not included (studies
that included perspectives of both patients and recruiters
were included, with only the latter reported in the
synthesis). All types of healthcare professionals (ie,
clinicians and nurses) were included. Only articles in
English were reviewed. Studies in paediatric trials were
excluded. No studies were excluded by quality. Reference
lists of the retrieved articles were also examined for
additional relevant articles, and newly published studies
that were identified as relevant whilst the reviewwas being
prepared were included.
The first and senior author discussed which papers
should be included in the review until agreement was
achieved and, in total, 35 articles were selected. Quality
was assessed using the Critical Appraisal Skills Programme
checklist by two reviewers (D.E. and S.H.). Individual
assessments were compared and any areas of discrepancy
were resolved by discussion. presents each step of
the literature search and selection process of articles, and
the full search strategy is available (see Supplementary
material).
3. Evidence synthesis
3.1. Summary of included papers
Thirty-five qualitative studies were included in
the review. Many studies (23/35) explored recruitment
issues within the context of a single RCT
whilst eight provided a
synthesis of results from multiple RCTs
Four studies sampled healthcare professionals who
recruited to RCTs generally, rather than a specific trial
Overall, the quality of these studies was good
(see Supplementary [9_TD$DIFF]material), although common method-
ological issues revolved around whether data analysis was
sufficiently rigorous (it was sometimes not clear if
saturation was achieved or if multiple researchers had
analysed data to enhance reliability of the findings[3_TD$DIFF]).
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