Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Abstract

Background Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. Participants Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. Results We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registration ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018,

Using a qualitative sub-study to inform the design and delivery of randomised controlled trials on medicinal cannabis for symptom relief in patients with advanced cancer

“…Key barriers underpinning decisions to decline participation in MedCan included gatekeeper influence, perceptions of risks outweighing benefits and aversion to randomised trials of unproven interventions. These reflect and confirm well-established barriers within the literature on RCT participation decision-making [ 8 , 13 , 49 , 58 , 66 ]. Specifically, when symptom burden was being sufficiently managed, several participants expressed a fear that trial participation would ‘upset the apple cart’—adversely interacting with their careful regime of medications.…”

“…These finding suggest that barriers to RCT participation are both common and context-specific [ 49 ]; studies are always embedded within hospital, cultural and urban systems, with distinct policies, legal-political structures, urban density or sprawl and associated public transportation systems. Thus, while some have called for a ‘methodological shift’ toward employing the existing ‘wealth of knowledge’ on RCT recruitment challenges, rather than accumulating further evidence [ 13 ], this study shows the value of nesting qualitative sub-studies into RCTs: identifying and countering intervention- and setting-specific hurdles [ 14 ].…”

“…Although some of these challenges are common to all RCTs, specific trials can also have their own unique challenges [ 13 , 14 ]. Recruiting patients with advanced cancer within palliative care, for instance, poses significant and distinct challenges.…”

“…International guidelines advocate for the use of qualitative sub-studies within RCTs to identify and address recruitment challenges, specific to local contexts and cultures [ 45 – 47 ]. Qualitative research can improve the potential viability and depth of RCT findings [ 13 , 48 ]. Moreover, qualitative sub-studies can provide insight into in situ barriers and enablers to participation specific to the intervention, population and setting [ 13 , 14 ], including those related to study design (e.g.…”

“…Qualitative research can improve the potential viability and depth of RCT findings [ 13 , 48 ]. Moreover, qualitative sub-studies can provide insight into in situ barriers and enablers to participation specific to the intervention, population and setting [ 13 , 14 ], including those related to study design (e.g. eligibility, participation requirements), participants (e.g.…”