title: Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians' Practices across Six Randomised Controlled Trials.
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.
  
  
  RESULTS
  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. Interviews revealed that clinicians' sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician's expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving their communication skills. However, the frequency of occurrence of equipoise issues across the RCTs suggests that the findings are likely to be reflective of clinical recruiters' practices more widely.
  
  
  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.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Leila
authors.identifier: http://orcid.org/0000-0002-6166-6055
authors.initials: L
authors.lastname: Rooshenas
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Daisy
authors.initials: D
authors.lastname: Elliott
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Julia
authors.initials: J
authors.lastname: Wade
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Marcus
authors.initials: M
authors.lastname: Jepson
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Sangeetha
authors.identifier: http://orcid.org/0000-0001-7329-9574
authors.initials: S
authors.lastname: Paramasivan
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Sean
authors.initials: S
authors.lastname: Strong
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Caroline
authors.initials: C
authors.lastname: Wilson
authors.affiliation: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Beard
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom.
authors.forename: Alison
authors.initials: A
authors.lastname: Birtle
authors.affiliation: St George's, University of London, London, United Kingdom.
authors.forename: Alison
authors.initials: A
authors.lastname: Halliday
authors.affiliation: Clinical Trials and Evaluation Unit, Bristol Royal Infirmary, School of Clinical Sciences, University of Bristol, Bristol, United Kingdom.
authors.forename: Chris A
authors.identifier: http://orcid.org/0000-0002-9624-2615
authors.initials: CA
authors.lastname: Rogers
authors.affiliation: University College London Hospitals, London, United Kingdom.
authors.forename: Rob
authors.identifier: http://orcid.org/0000-0003-2969-0415
authors.initials: R
authors.lastname: Stein
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.|National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West), University Hospitals Bristol NHS Trust, Bristol, United Kingdom.
authors.forename: Jenny L
authors.identifier: http://orcid.org/0000-0002-6488-5472
authors.initials: JL
authors.lastname: Donovan
mesh_terms: D001291:Attitude of Health Personnel; D002983:Clinical Competence; D003142:Communication; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D018579:Patient Selection; D010817:Physician-Patient Relations; D010818:Practice Patterns, Physicians'; D016032:Randomized Controlled Trials as Topic