BackgroundRecruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment.MethodsInterviews were undertaken with 72 individuals (32 doctors or RCT Chief investigators (CIs); 40 nurses/other health professionals) who were actively recruiting participants in six RCTs to explore their experiences of recruitment. The RCTs varied in scale, duration, and clinical contexts. Interviews were fully transcribed and analysed using qualitative content and thematic analytic methods derived from grounded theory. For this analysis, data were systematically extracted from each RCT and synthesised across all six RCTs to produce a detailed and nuanced understanding of the recruitment process from the perspectives of the recruiters.ResultsRecruiters readily identified organisational difficulties, fewer than expected eligible patients, and patients’ treatment preferences as the key barriers to recruitment. As they described their experiences of recruitment, several previously hidden issues related to their roles as researchers and clinicians emerged, imbued with discomfort and emotion. The synthesis across the RCTs showed that doctors were uncomfortable about aspects of patient eligibility and the effectiveness of interventions, whereas nurses were anxious about approaching potential RCT participants and conflicts between the research and their clinical responsibilities. Recruiters seemed unaware that their views contributed to recruitment difficulties. Their views were not known to RCT CIs. Training and support needs were identified for both groups of staff.ConclusionsThe synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters’ roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.

ObjectiveThe aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs).Study Design and SettingIn-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs.ResultsAll six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having “hunches” about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment.ConclusionRecruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.

Background: Poor recruitment and retention of participants in randomised controlled trials (RCTs) is problematic but common. Clear and detailed reporting of participant flow is essential to assess the generalisability and comparability of RCTs. Despite improved reporting since the implementation of the CONSORT statement, important problems remain. This paper aims: (i) to update and extend previous reviews evaluating reporting of participant recruitment and retention in RCTs; (ii) to quantify the level of participation throughout RCTs.

From the earliest studies of doctor-patient interaction (Byrne & Long, 1976), it has been recognized that treatment recommendations may be expressed in more or less authoritative ways, based on their design and delivery. There are clear differences between I'm going to start you on X and We can give you X to try and Would you like me to give you X? Yet little is known about this variation, its contexts, or its consequences. In this paper, we develop a basic taxonomy of treatment recommendations in primary care as a first step toward a more comprehensive investigation. We take as our point of departure the observation that treatment recommendations such as those above represent not only different formulations but also different social actions. We distinguish five main treatment recommendation actions: pronouncements, suggestions, proposals, offers, and assertions. We ask: what are the main dimensions on which these recommendations vary and to what end? And what sorts of factors shape a clinician's use of one action type over another with respect to recommending a medication in the primary care context?

This article compares two practices for initiating treatment decision-making, evident in audio-recorded consultations between a neurologist and 13 patients in two hospital clinics in the UK. We call these 'recommending' and 'option-listing'. The former entails making a proposal to do something; the latter entails the construction of a list of options. Using conversation analysis (CA), we illustrate each, showing that the distinction between these two practices matters to participants. Our analysis centres on two distinctions between the practices: epistemic differences and differences in the slots each creates for the patient's response. Considering the implications of our findings for understanding medical authority, we argue that option-listing -relative to recommending -is a practice whereby clinicians work to relinquish a little of their authority. This article contributes, then, to a growing body of CA work that offers a more nuanced, tempered account of medical authority than is typically portrayed in the sociological literature. We argue that future CA studies should map out the range of ways -in addition to recommending -in which treatment decision-making is initiated by clinicians. This will allow for further evidence-based contributions to debates on the related concepts of patient participation, choice, shared decisionmaking and medical authority.

No abstract

Straightforward replication of the ProtecT complex intervention was more complicated than expected. However, the study has increased understanding of RCT recruitment and identified ways to overcome barriers to collaboration. Such research is more easily undertaken in the feasibility stage of an RCT, and greater success will be achieved if the research is integrated into the everyday conduct of RCTs.

No abstract