EURURO Vol. 72 No. 5

793 860

and that eligible patients often disliked
the concept of randomisation or had
strong treatment preferences for particular interventions
. Recruiters also described lack of
time as a key barrier to recruiting to RCTs
.
However, some studies suggested that even when
logistical and organisational issues were addressed, recruit-
ment continued to be challenging Indeed,
several recent studies have highlighted that there may be
more deep-rooted reasons as to why recruitment can be
difficult. These relate to complex emotional and intellectual
issues, which may—albeit unintentionally—affect recruit-
ment, and are described below.
3.2.2. Misunderstanding RCT concepts and design
Whilst recruiters acknowledge the importance of evidence-
based practice most have not had
formal training and can show poor understanding
of RCT methods and concepts For
instance, interviews with surgeons who had recently
completed recruitment to a multicentre, pragmatic RCT
comparing a rehabilitation programme with surgery for
treatment of chronic low back pain showed that they had
misunderstandings about the trial design. Many did not
understand the concept of equipoise, were unclear about the
trial’s aims, and were not aware of the rationale for the
pragmatic inclusion criteria
Given this, it is perhaps not surprising that recruiters can
find it challenging to communicate with patients about
trials can find it difficult to
articulate the trial design in simple terms , and
struggle to explain randomisation . Furthermore,
studies have showed that recruitment consultations tend to
be led by the recruiter and predominately cover the topics
that they deem important to discuss This means
that there is often insufficient evidence for the recruiter to
judge the participant’s level of understanding or willingness
to join the trial. It has instead been suggested that
information provision should be tailored to the patient’s
concerns and questions, and that specific communication
techniques—such as using open questions and pauses, and
enabling the patient to interrupt—provide opportunities for
the patient to discuss what is important to them .
3.2.3. Emotional challenges of dual roles
Several studies alluded to the complexities of combining
research with clinical roles
Findings from interviews with recruiting staff from
six RCTs showed that whilst they expressed strong commit-
ment to the RCT and research in general, clinicians and nurses
experienced emotional and intellectual challenges related to
their roles as scientists and clinicians Clinicians
described themselves as scientists or practicing clinicians,
with some combining both. Nurses identified themselves as
having three major roles: caring clinical nurse, patient
advocate, and recruiter/scientist. As both groups [13_TD$DIFF]discussed
their roles and the challenges and conflicts within them, they
expressed emotion and discomfort. Lawton and colleagues
have also highlighted the emotional challenges that
could arise from [14_TD$DIFF] the conflicting priorities of their research
roles and clinical responsibilities. In these studies, most
recruiters had not raised these issues with chief investigators
(CIs) and colleagues, and were unaware how their views
contributed to recruitment difficulties.
3.2.4. Discomfort with RCT eligibility criteria
The synthesis by Donovan and colleagues found that
within their research roles, clinicians were typically respon-
sible for eligibility assessments of patients and nurses had
considerable influence over which eligible patients to
approach. Clinicians often described reluctance to recruit
particular patients or groups of patients who fitted the
eligibility criteria for the RCT but were perceived to be
‘‘unsuitable’’ for other reasons. Most nurses expressed their
right to use clinical judgement to decide whom to approach
about the RCT. In some trials, when they approached patients,
they had a tendency to become awkward and apologise for
‘‘bothering’’ potential patients about the trial. These findings
were also identified in part in several single RCT studies
reporting that recruiters may not approach all eligible
patients . Taken to-
gether, this means that many eligible patients will not have
had the opportunity to consider RCT participation.
3.2.5. Lack of equipoise between RCT treatment options
‘‘Community equipoise’’ refers to the principle that there is
uncertainty or disagreement in the clinical community
about which treatment is best whilst ‘‘individual
equipoise’’ exists when an individual is uncertain about
treatment superiority . Interviews have suggested that
recruiters can find it difficult to be in individual equipoise
and instead favour a particular treatment arm in an RCT
. Donovan and
colleagues found that clinicians, particularly surgeons,
had ‘‘hunches’’ that particular treatments were superior in
general or for specific patients or groups. The conflict
between the wish to gain robust evidence and personal
preferences created considerable discomfort in some cases.
Using data from six RCTs, Rooshenas et al interviewed
23 clinicians to understand their intentions for communicat-
ing equipoise, and audio recorded 105 of their consultations
where they presented the RCT to eligible patients. Interviews
revealed that clinicians expressed different levels of uncer-
tainty, ranging from complete ambivalence to clear beliefs
that one treatment was superior. Irrespective of their
personal views, all clinicians intended to set their personal
biases aside to convey trial treatments neutrally to patients.
However, analysis of the consultations demonstrated that
equipoise was omitted or compromised in 46% of the
recorded appointments, by clinicians offering treatment
recommendations, presenting imbalanced descriptions of
trial treatments, or disclosing their personal opinions or
predictions about trial outcomes
3.2.6. Difficulty exploring patient preferences
Across many studies, recruiters reported that patients
declined RCT participation because they held strong
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