EURURO Vol. 72 No. 5

796 860

intellectual challenges related to their dual roles of
researchers and clinicians. This role conflict may (uninten-
tionally) affect recruitment in a number ways, for example,
by creating difficulty conveying equipoise, discomfort with
the eligibility criteria, and exploring patient preferences.
Therefore, there is a need to develop training and support
programmes to enable recruiters to become more comfort-
able with the design and principles of RCTs. Donovan and
colleagues state that this should include ensuring that
recruiters understand and can communicate key aspects of
the RCT design, and how to gently explore patients’
preferences. It has also been suggested that nurses and
doctors who recruit to RCTs require different training and
support. Doctors may benefit from support in relation to
assessments of eligibility and equipoise whereas nurses
require support for perceived conflicts in their roles as a
recruiter, patient advocate, and clinician, and for helping
them to be comfortable with approaching all patients .
Whilst common themes haven been identified in this
review, each RCT will have a set of unique issues that need
to be resolved. In urology RCTs, this may include lengthy
patient pathways, complex designs, and rapidly changing
treatment options. Only a small number of training
programmes have been developed from issues identified
by qualitative methods . Most of
these have been QRIs , which consist
of in-depth investigation of recruitment obstacles in real
time, followed by implementation of tailored strategies to
address these challenges as the trial proceeds. These
interventions have optimised practices that enable recruit-
ment to be completed in feasibility/pilot or main RCTs, or
have provided detailed evidence to support a decision to
cease recruitment. The multifaceted and flexible nature of
qualitative research can provide important insights into the
complexities of recruiting to trials so that subsequent
interventions can be developed, although quantitative
research would be more suited to rigorously evaluating
such programmes to determine the components that can
lead to improved recruitment and informed consent in
RCTs.
In summary, this article demonstrates that qualitative
research can provide important insights into the complexi-
ties of recruitment to trials, which can inform support and
training initiatives as required. Investigators should con-
sider implementing such methods in urological RCTs that
are expected to be challenging or are recruiting below target
to tackle the most challenging clinical questions facing
patients and clinicians.
Author contributions: Daisy Elliott had full access to all the data in the study
and takes responsibility for the integrity of the data and the accuracy of the
data analysis.
Study concept and design: Elliott, Donovan.
Acquisition of data: Elliott.
Analysis and interpretation of data: Elliott, Husbands, Donovan.
Drafting of the manuscript: Elliott.
Critical revision of the manuscript for important intellectual content: Elliott,
Husbands, Hamdy, Holmberg, Donovan.
Statistical analysis: None.
Obtaining funding: None.
Administrative, technical, or material support : Elliott, Donovan.
Supervision: Donovan.
Other: None.
Financial disclosures: Daisy Elliott certifies that all conflicts of interest,
including specific financial interests and relationships and affiliations
relevant to the subject matter or materials discussed in the manuscript
(eg, employment/affiliation, grants or funding, consultancies, honoraria,
stock ownership or options, expert testimony, royalties, or patents filed,
received, or pending), are the following: None.
Funding/Support and role of the sponsor: None[15_TD$DIFF].
Acknowledgments: This work was supported by the Medical Research
Council (MRC) ConDuCT-II Hub (Collaboration and innovation for
Difficult and Complex randomized controlled Trials In Invasive
procedures – MR/K025643/1) and the Royal College of Surgeons of
England Bristol Surgical Trials Centre. JLD was supported by the NIHR
Collaboration for Leadership in Applied Health Research and Care
(CLAHRC) West at University Hospitals Bristol NHS Foundation Trust. JLD
and FCH are NIHR Senior Investigators This article presents independent
research funded by the MRC and NIHR. The views expressed are those of
the authors and not necessarily those of the MRC, NHS, NIHR or the
Department of Health. DE, SH and JLD are members of the QuinteT
research group.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at
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