Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network

Abstract

BackgroundRecruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined.MethodsA cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data.ResultsQuestionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and communication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not conducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to successful recruitment.ConclusionsIn the mental health context, researcher access to potential trial participants is multiply influenced. Gatekeeping clinicians are faced with competing priorities and resources constrain research activity. It seems that environmental adjustment predicated on equitable resource allocation is needed if clinicians in NHS mental health services are to fully support the conduct of randomised controlled trials. Whilst cultural transformation, requiring changes in assumptions and values, is complex, our findings suggest that attention to practical matters can support this and highlight issues requiring careful consideration.

Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective

“…For example, time‐consuming project‐related activities that take place immediately after recruitment, such us arranging pathology rather than taking blood samples by a clinical nurse and contacting pharmacy staff to arrange either placebo or the medicine at some sites rather than having them on site, may also influence clinicians’ decision to avoid recruitment as a matter of saving time for their clinical work. Concurrent recruitment to other studies at the same site should also be considered …”

Improving recruitment to healthcare research studies: clinician judgements explored for opting mental health service users out of the time to change viewpoint survey

“…In some instances, clinicians do not know the client sufficiently well to make an informed judgement about non-maleficence and beneficence, key principles in medical bio-ethics (Beauchamp & Childress, 2001). Research shows that gatekeepers having protected time to undertake research activity enhances access to potential participants (Borschmann et al, 2014).…”

“…Research has identified a wide range of factors influencing recruitment in mental health randomised controlled trials (RCT) (Borschmann et al, 2014). Low recruitment This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http:// creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.…”

“…Lack of equipoise included views expressed by recruiters, in this case care coordinators and research staff, that the intervention arm was better, as the control arm was not an equivalent form of support, and that the topic should not be the subject of an RCT impacting on their attitudes and approach to recruitment. Paternalism in research recruitment, when clinicians prioritise their own views on whether their client should take part without giving people the opportunity to choose for themselves, has been found in several studies exploring clinicians and researchers' views (Borschmann et al, 2014;Mairs et al, 2012). In one, a qualitative study exploring barriers to general practitioners (GPs) recruiting people with depression into trials, it was found GPs wanted to protect vulnerable service users, an example of paternalism, and they also felt they lacked the skills to introduce research requests within consultations, and gave priority to clinical and administrative duties (Mason et al, 2007).…”

“…Such studies acknowledge that efforts to improve the quality of mental health trials have to address filtering by clinicians, including cultural values and staff attitudes towards research (Borschmann et al, 2014;Patterson et al, 2010). Most research assessing participant recruitment to date has only considered RCT study designs (Fletcher et al, 2012).…”