A recruitment intervention (the QRI) has been developed to address recruitment challenges, and has been applied successfully in 13 RCTs to date. ‘Success’ is achieved either by optimising practices that enable recruitment to be completed in feasibility/pilot or main RCTs, or providing detailed evidence to support a decision to cease recruitment. A major aim of a QRI is to understand the recruitment process as it happens and to address clear obstacles and hidden challenges  to the provision of clear and accurate information to facilitate informed decision-making by patients about RCT participation. The QRI uses standard and innovative research methods (primarily qualitative and some simple quantification) to provide a clear understanding of the application of the RCT protocol in clinical settings. The first phase of the QRI investigates eligibility assessment and recruitment from the perspective of RCT designers and recruiters in interviews as well as the recruitment process as it actually happens through data collected in logs, and also how the RCT is presented to potential participants in study documents and audio-recordings of appointments. In phase II, anonymised feedback of the phase I QRI findings to the CI/CTU/TMG enables the development of a specifically tailored ‘plan of action’ to improve recruitment and informed consent. A key part of the plan is anonymised feedback, based on the findings, to groups of recruiters, to particular clinical centres, or confidentially to individual recruiters. This feedback encourages reflection about the emotional and intellectual challenges that recruiters (doctors or nurses) often experience, particularly in relation to equipoise, patient eligibility, and perceived role-conflict . Another important aspect of the plan of action is to ensure that information about the RCT is presented as clearly and understandably as possible to increase patient understanding of the rationale of the RCT and the practicalities of research participation. The main aim is to encourage greater patient and recruiter engagement in decision making—with evidence from audio-recordings of participation in appointments—as well as written informed consent . A description of the Phases that constitute the QRI and two examples of its application in two different RCT contexts provide guides to its use more widely.
Recruitment is frequently identified as a major problem for RCTs [2, 4]. Interventions that lead to more effective and efficient recruitment are urgently required, particularly as so many systematic reviews have identified so few [6, 33]. The small number of effective interventions that have been identified have tended to focus on simple administrative aspects aimed at RCT participants, such as ways to increase questionnaire responses . Few have supported recruiters, although there is evidence of demand for these [5, 14]. Most interventions have been developed to address issues identified within particular RCTs, as CIs and RCT staff attempt to do everything they can to rectify poor recruitment. This limits the generalisability of interventions and deals only with issues that are clearly evident to CIs and RCT staff (not the ‘hidden’ challenges ).
The QRI was developed to address the limitations with existing interventions in three ways. First, it was developed to understand the recruitment process as it occurred in clinical centres and from the perspectives of recruiters and patients—through the use primarily of qualitative research methods. Second, during its development period, it was applied in as many different sorts of RCTs as possible. Third, it sought to address the difficulties that arose for recruiters and potential participants by actively optimising recruitment quality and informed consent.
In terms of its development using qualitative methods, the QRI built on pioneering research that was conducted alongside pragmatic RCTs (or integrated within them) and produced important incremental insights about understanding experiences of RCT participation. Several groups illuminated, for example, the difficulties for patients arising from poor explanations of randomisation [9, 10] and the importance of clear presentation of equipoise [34, 35]. A small number of studies explored the experiences of clinician recruiters [14, 36, 37]. More recently, a synthesis of interviews conducted with recruiters during the application of the developmental version of the QRI in six RCTs led to a detailed and nuanced understanding of recruitment as a complex and fragile process, fraught with logistical/organisational obstacles, and the identification of several previously hidden emotional and intellectual challenges for recruiters [12, 13].
The application of the QRI in a wide range of different RCTs in terms of their designs, clinical contexts, and recruitment processes provided opportunities to identify generic as well as RCT-specific outcomes. While there were specific recruitment issues in most of the RCTs that were of interest to specialists, [21–23], there were also findings of more generic concern that fed into the further development of the QRI . The final version of the QRI emerged from the symbiotic relationship between the insights gained from the qualitative research about recruitment from the perspectives of patient participants and clinician/nurse recruiters and the implementation of the plan by recruiters to improve recruitment based on those understandings. The theoretical background justifying this approach originates from the view that RCTs are Complex Adaptive Systems (CAS)—collections of individual agents (recruiters) with the freedom to act in ways that are not always predictable . There is a need with CAS to understand the contextual factors influencing behaviour (QRI-determined clear obstacles and hidden challenges), with built-in feedback loops to enable changes to agents’ actions (the QRI plan of action).
The necessity of integrating the QRI in the RCT reflects its holistic approach to optimising recruitment and the need to engage patients and recruiters in the process. Its aim is to ensure that the presentation of the RCT is accurate and fair, so that recruiters and patients can fully discuss the purpose of the research, and patients can make informed decisions about whether to take part. The neglected aspect in many previous interventions has been the lack of understanding about recruiters’ views and instincts about the RCT. Clinicians need to be ‘in equipoise’ to believe that there is no advantage or disadvantage for a patient to receive one of the RCTs arms  and to be uncertain about the best option because of the lack of evidence . There have been many debates about the philosophical issues underlying equipoise, but now it has also been shown empirically that it raises immense difficulties for some recruiters, and that they may need support and training to deal with it [13, 14, 36]. Further, if these ‘hidden’ issues are not openly discussed, the presentation of the RCT to patients is likely to be affected and the participation and decision making of the patients may be compromised . The feedback process in the QRI encourages recruiters to reflect on factors such as their own understanding of the evidence, their own equipoise, the balance between community equipoise with colleagues and in relation to actual patients, and the potential conflicts that can emerge from combined clinical and research roles .
For patients (potential RCT participants), the provision of clear information is crucial for fully informed consent. Ethics and governance procedures should ensure this, but they focus primarily on the written PIS. Audio-recording recruitment appointments in the QRI has shown that these interactions are crucial for enabling patient engagement with difficult aspects of RCT participation such as preferences . Ultimately, full engagement of patients as potential participants will be beneficial for recruitment to RCTs. When clinicians and other recruiters, as well as patients, perceive that participating in the RCT is an appropriate decision in the face of uncertainty regarding the optimal treatment, a more engaged and participatory form of informed consent can be achieved. This is the primary aim of the QRI, and if there is no confidence in the RCT, recruitment should not continue (see, for example, ).
The costs of a QRI primarily relate to the need to employ an experienced qualitative researcher at 0.5 FTE for the first year of recruitment (with associated on-costs and overheads, this amounts to c.£60–80,000). A formal cost-effectiveness analysis has not yet been undertaken, but if the QRI is effective in increasing recruitment, the costs of the main RCT are likely to be reduced.
Strengths and limitations of the QRI
The strength of the QRI is its grounding in a nuanced understanding of the recruitment process based on its own and others’ qualitative research, its focus on the needs of recruiters and potential participants, and its application in RCTs that anticipate recruitment challenges, or are underway and experiencing difficulties. It is limited, however, by the availability of only observational evidence of its effectiveness and not yet proven cost-effectiveness. Undertaking a randomised study to robustly evaluate it is a goal, but this is not without severe difficulties. An RCT of QRIs applied to feasibility or pilot RCTs would be particularly difficult, as the iterative nature of the data collection and spread of the influence of feedback and training across centres produces an accumulation of evidence rather than enabling analysis of a static primary outcome. QRIs applied to ongoing RCTs with recruitment shortfalls might be possible as there is then a more rapid data collection period and a clearer implementation phase. But there are then questions about whether to randomise clinical centres or whole RCTs, which would present practical and methodological challenges unless a sizable funding body agreed to randomise its portfolio of RCTs with recruitment problems. There would remain, however, the thorny issue of what the outcome measure would be. Simple quantitative measures of eligibility and recruitment rates could be used, but they are only part of the story. Of greater importance is the quality of the recruitment as represented by evidence of truly engaged and informed consent by participants. Such a measure is currently under development in QuinteT as existing measures focus primarily on recruiter information provision [41, 42].
Other aspects that remain to be evaluated include levels of compliance with the randomised allocation and whether the QRI leads to greater or lesser longer-term retention. Another potential limitation is that QRIs have only been implemented by one team—QuinteT (http://www.bristol.ac.uk/social-community-medicine/research/groups/social-sciences-health/quintet/qri-rcts/)—although several CIs, CTUs and TMGs have been involved. This paper is aimed at enabling others to understand the basis and methods, so the intervention can be spread in collaboration with the QuinteT team and/or implemented more widely. It is important to note that many of the qualitative methods underlying the QRI are standard: in-depth interviews, content, and thematic approaches to analysis using the techniques of constant comparison, for example. The QuinteT team has also developed several innovative methods to address particular issues, such as Q-QAT to assess the balance of information provision . Other aspects, however, will be unfamiliar to traditional qualitative researchers, including the use of targeted methods of data collection and analysis that are essential to produce findings quickly while retaining robustness. Another unfamiliarity is the intention of the QRI at the outset to influence the conduct of the recruitment process of the RCT and put into place opportunities for discussion and feedback that may lead to changes to RCT recruitment, overall conduct, or even design. The QuinteT team has developed working methods and team approaches to support the research; it will be interesting to see how much of this is transferable.