EURURO Vol. 72 No. 5

800 860

overcoming these. Thirty-five qualitative studies were
included in the review of which nine relate to urological
cancer trials. Importantly not all outcomes were negative
with health care professionals describing some benefits
such as patients having access to novel treatments and to
close monitoring. The need for good collaboration with the
clinical team, detailed understanding of the RCT and the
benefit of study updates were stressed. Although logistical
challenges such as lack of eligible patients and limited time
were discussed, a number of more complex issues emerged
from the synthesis. These include lack of training and
understanding of the trial design and the concept of
equipoise (genuine uncertainty about which trial arm will
be most beneficial), problems in describing randomisation,
difficulty in judging how much the patient has understood,
and discomfort arising from dual roles (clinical/research)
which could lead to gatekeeping. There was a recognition
that RCTs vary considerably and for each trial there may be
unique issues which should be examined and addressed.
The authors recommend the use of training developed from
qualitative research and describe a complex intervention
they have developed as part of the ProtecT study . The
intervention, QuineT Recruitment Intervention (QRI), has
been refined after an implementation in a number of
studies, and comprises two phases The first phase is an
in-depth qualitative analysis aiming to understand the
recruitment process for the specified trial including inter-
views with key staff and patients approached, and
observations and review of study processes. Phase
2 involves the QRI team working with the chief investigator
and trial management group to use the information
gathered in phase one to develop strategies and employ
these to maximise recruitment. QRI has been used
effectively in a number of trials.
This qualitative review and resultant recommendations
contribute to the growing body of evidence concerning
challenges of and solutions to clinical trial recruitment and
the need to implement interventions to improve recruit-
ment. Undoubtedly there will be costs associated with
additional training or intervention over and above the
standard good clinical practice training required for staff
working on RCTs. Dependent upon the complexity of any
trial different levels of intervention may be indicated. RCTs
are expensive to set up and run. If they have to close early
due to poor recruitment this may be seen as an abuse of
public money. When trials are being planned and, if
recruitment is identified as potentially problematic, the
costs of including a recruitment intervention should be
considered and included in grant applications. All stake-
holders (eg, patients, clinicians, funders, policy makers)
need to reflect on and discuss the cost-benefits of including
interventions for effective recruitment strategies to RCTs.
Conflicts of interest: The author has nothing to disclose.
References
[1] UK Health Research Analysis 2014 (UK Clinical Research Collabo-
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E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 7 9 9 – 8 0 0 800