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.

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.

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.

Abstract

In a qualitative synthesis from six randomized controlled trials, Leila Rooshenas and colleagues examine how clinicians convey equipoise during recruitment for clinical trials.

Author Summary

Why Was This Study Done?

• Randomised controlled trials (RCTs) are a cornerstone of evidence-based medicine, but they need to recruit sufficient numbers of patients if they are to provide answers to the clinical questions they intend to address.

• Front-line clinicians are increasingly responsible for recruiting patients into RCTs, but there are questions around how they reconcile their own views about RCT treatments with the requirement to convey “equipoise” to patients (the principle that the patient would be neither advantaged nor disadvantaged if they were to receive any of the trial treatments under investigation).

• Clinicians’ attempts to communicate equipoise have not yet been investigated in the context of real doctor–patient interactions, and there are no evidence-based recommendations for how clinicians should convey equipoise to patients who are eligible for RCT participation.

What Did the Researchers Do and Find?

• We aimed to investigate how clinicians attempted to communicate equipoise to patients across six RCTs, with the objectives of (i) identifying broad practices that support or hinder equipoise communication and (ii) examining how these practices compare with clinicians’ intentions.

• We interviewed clinicians ( n = 23) to understand their intentions for communicating equipoise to patients, and audio-recorded their discussions (“appointments”) with RCT-eligible patients ( n = 105) to investigate their actual practices.

• Despite clinicians’ best intentions, equipoise communication was omitted or undermined in almost half of the appointments ( n = 48) through commonly recurring practices that were apparent across the RCTs, including (i) offering treatment recommendations, (ii) providing imbalanced descriptions of trial treatments, and (iii) disclosing personal predictions about RCT outcomes.

What Do These Findings Mean?

• Communicating equipoise to patients is a delicate process that can be overridden or undermined through commonly recurring practices that emerge irrespective of clinical context.

• There are opportunities to create generic guidance for clinicians based on these common challenges, with a view to facilitating the communication of equipoise to RCT-eligible patients.

• Our findings were limited by our intentional focus on RCTs that were anticipated to experience recruitment difficulties, and thus this issue needs further consideration in RCTs that are deemed less challenging to recruit patients into.