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conducting in-depth interviews with healthcare profes-

sionals involved in recruitment and patients approached

about the study, audio recording recruitment discussions,

analysing screening log data to understand patient pathways,

observing study meetings, and reviewing study documenta-

tion, with rapid analysis of findings and reporting to the CI

and trial management group (TMG). In phase 2, the QRI team

works collaboratively with the CI and TMG to implement

strategies to improve recruitment (see

Fig. 2

)

[26] .

To date,

these methods have been implemented in 25 RCTs. The QRI

has optimised methods that enable recruitment to be

completed in feasibility/pilot or main RCTs

[25,26, 31,52] .

In other instances, the QRI has provided detailed

evidence to support a decision to cease recruitment

[32] .

3.3.2.

Challenges of integrating qualitative research in RCTs

Whilst these methods produce important insights about

recruitment practices, the challenges of integrating quali-

tative research with RCTs has been well documented. For

instance, recruiters are often reluctant to provide audio

recordings of consultations

[24,26,38,44,50,52] .

If the

qualitative research is integrated into an RCT where

recruitment is already ongoing, the process of obtaining

additional ethical approval can be lengthy

[26]

. It has

therefore been suggested that qualitative work should be

integrated structurally and culturally into the RCT, ideally

before recruitment begins and at the feasibility stage, in

order to produce the greatest results

[50]

.

3.3.3.

Future directions for research

It is important to note that current interventions are limited

by the availability of only observational evidence of their

effectiveness, therefore limiting the ability to determine

causality between interventions and recruitment rates

[26]

. A recent review has identified the need to develop

more robust designs to develop an evidence base on how

best to support recruiters

[59]

. More robust studies are

needed to assess the effectiveness of training programmes,

although these will need to give careful consideration to

how ‘‘successful’’ interventions should be defined (ie,

completion of study or evidence to support closure) and

what the outcomes should be (ie, screening and eligibility

counts, recruitment rates, or changes in informed consent).

Furthermore, given that research has demonstrated that

patients can find RCT concepts confusing

[14–17] ,

it is

important not to neglect the patient’s perspective of the

recruitment process, and to further develop methods to

facilitate joint decision making and ensure fully informed

consent.

4.

Conclusions

Many fundamental questions in the management of

patients in most specialities remain unanswered, and RCTs

are required to provide high-quality evidence to support

clinical decision making. Recruitment difficulties were

often attributed to logistical issues (such as a lack of time

for research activities) or patient-related factors (including

strong treatment preferences or disliking randomisation).

In 2012, Fletcher and colleagues

[18]

highlighted the

potential of using qualitative research to understand

recruitment, and since this, qualitative studies have shed

further light on the challenges of recruiting patients

[24,26– 29,31–34,36–38,40,43,45,48,49,52–54]

. Taken together,

these highlight how recruitment is a complex and fragile

process in which recruiters can experience emotional and

[(Fig._2)TD$FIG]

Fig. 2 – Overview of the QuinteT Recruitment Intervention.

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