Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials

Leila Rooshenas, Daisy Elliott, Julia Wade, Marcus Jepson, Sangeetha Paramasivan, Sean Strong, Caroline Wilson, David Beard, Jane M Blazeby, Alison Birtle, Alison Halliday, Chris A Rogers, Rob Stein, Jenny L Donovan, Study Group Acst-2, By-Band-Sleeve study Group, Chemorad study Group, Study Group Csaw, Optima prelim study Group and Study Group Pout

PLOS Medicine, 2016, vol. 13, issue 10, 1-24

Abstract: Background: Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians’ difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians’ reported intentions compared with their actual practices. Methods and Findings: Six pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded. Conclusions: Communicating equipoise is a challenging process that is easily disrupted. Clinicians’ personal views about trial treatments encroached on their ability to convey equipoise to patients. Clinicians should be encouraged to reflect on personal biases and be mindful of the common ways in which these can arise in their discussions with patients. Common pitfalls that recurred irrespective of RCT context indicate opportunities for specific training in communication skills that would be broadly applicable to a wide clinical audience. In a qualitative synthesis from six randomized controlled trials, Leila Rooshenas and colleagues examine how clinicians convey equipoise during recruitment for clinical trials.Why Was This Study Done?: What Did the Researchers Do and Find?: What Do These Findings Mean?:

Date: 2016
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pmed00:1002147

DOI: 10.1371/journal.pmed.1002147

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