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

Date Published: October 18, 2016

Publisher: Public Library of Science

Author(s): 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, Sanjay Basu

Abstract: BackgroundRandomised 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 FindingsSix 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.ConclusionsCommunicating 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.

Partial Text: Optimising recruitment to randomised controlled trials (RCTs) is a priority for clinicians, funding bodies, and healthcare decision-makers. Increasingly constrained resources reinforce the need for efficient generation of high-quality evidence to optimise patient care and inform service provision. Despite stringent review processes, at least half of funded RCTs fail to meet recruitment targets [1], and recruitment difficulties remain the most frequent reason for premature trial closure [2]. Not only are these difficulties associated with considerable financial waste [3], but poor recruitment can delay progress or leave unanswered clinical questions in underpowered or incomplete studies.

Ethical approval for this study was granted by six UK research ethics committees, with full details (e.g., dates, reference numbers) presented in S1 Text.

Given the complex and novel approach to data collection and analysis of this study, the findings have been presented in an order that most clearly conveys the key messages to emerge from the study. A summary of clinicians’ individual perspectives on equipoise is presented first, to provide a framework for drawing comparisons between reported intentions and actual practices. The findings from the audio-recorded appointments—the focus of this study—are presented next. References are made to clinicians’ interview accounts where relevant to demonstrate how reported intentions compared with actual practices.

This study investigated how clinicians communicated equipoise in RCT recruitment appointments. Presenting and sustaining equipoise was found to be a challenging process that was highly entwined with clinicians’ own perceptions of equipoise. Clinicians varied in terms of their individual sense of equipoise, but were committed to the RCTs and reported that they intended to present treatments to patients in a neutral and balanced way. These expressed intentions did not always translate into practice—especially when clinicians harboured individual preferences or polarised views about treatments. Although equipoise was articulated in most appointments, observations across the RCTs revealed common practices that compromised equipoise communication. Clinicians with treatment preferences or less balanced views overrode or undermined equipoise through offering treatment recommendations, presenting imbalanced descriptions of trial treatments, or making clear their predictions about trial outcomes. These difficulties arose despite clinicians’ intentions to conceal or suspend their personal inclinations or beliefs.

Source:

http://doi.org/10.1371/journal.pmed.1002147

 

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