Equipoise can be defined as genuine uncertainty within the expert medical community regarding the comparative therapeutic merits of each arm in a trial . A growing literature has demonstrated that trial participants have difficulties making sense of randomized controlled trial (RCT) procedures, random allocation and the principle of equipoise, and tend to hold preferences for certain treatment arms [2–7]. Clinician-researchers’ views also indicate varied levels of understanding of equipoise [8, 9]. However, little is known about the views and experiences of those who deliver interventions in the RCT context (‘deliverers’), despite their influential position on participants’ adherence to the intervention and thus the outcome of the RCT.
In RCTs of pharmaceutical interventions, achieving equivalence in the delivery of the different arms is relatively straightforward; in a double-blind RCT, using a placebo that appears identical to a drug can reduce the potential for bias [10, 11]. With interventions that cannot be blinded (for example, because the intervention cannot be disguised), minimizing variation in delivery presents more of a challenge [12, 13]. This difficulty increases with the complexity of the intervention . Randomized controlled trials of health and lifestyle educational interventions typically require an individual or team of individuals for delivery. These deliverers introduce the potential for variation in delivery, and thus a potential impact on trial outcomes [15, 16].
Variation arising from different levels of skill and experience of deliverers can be reduced, to some extent, through training, and assessed through observation or recording of delivery [15, 16]. Variation in deliverers’ behaviour, attitudes and beliefs, and the potential for these to distort the intervention delivery, are harder to address . Furthermore, in a trial of two or more variants of a behavioural intervention, these must all be delivered in the same unbiased manner . This raises the question of whether deliverers should be in a state of individual equipoise, that is, genuine uncertainty on their part regarding the comparative therapeutic merits of each arm in a RCT , or whether awareness of their own views is sufficient to avoid bringing bias to their delivery.
In this article, we explore the accounts of individuals delivering two variants of a structured education intervention as part of a multi-site cluster-randomized controlled trial. Of relevance is that one of the trial arms, which is education about, and training in, self-monitoring of blood glucose (SMBG) for self-management of type 2 diabetes, is the subject of much (and often emotive) debate; clinicians, nurses and patients have strong opinions on the matter; and thus, little individual equipoise (as demonstrated by a recent point-counterpoint feature in the journal Diabetes Care[18, 19]). Furthermore, questions about the funding and cost-effectiveness of SMBG testing strips fuels the contentiousness of the debate and the strength of opinion . We first situate our data in relation to two relevant areas of literature: role conflict and equipoise.
The usual personnel involved in delivering, and communicating with participants in, clinical trials are doctors, nurses and allied healthcare professionals. In their everyday jobs, that is, when delivering care in a normal non-trial situation, they are expected to abide by a set of standards clearly defined by their respective professional bodies (such as the General Medical Council or the Nursing and Midwifery Council) with regard to their ethical conduct and roles. Some of the professional ethics and roles of a researcher may appear to be at odds with these.
In the case of the doctor-researcher, conflict may arise from different care responsibilities imbued by ‘normal’ doctor and researcher roles, whereby the level of care owed to trial participants differs from that owed to the doctor’s own patients [21, 22]. One way of resolving this comes from the General Medical Council’s guidance for Good Medical Practice, which, while prioritizing the protection of research participants’ interests, emphasizes the need for participation in research for improving care for future patients and the wider population . A second approach to resolving the tension borrows from the legal paradigm of ‘bailment’: a contractual agreement, whereby the custody of a patient’s care is temporarily transferred to the doctor-researcher, while remaining the overall responsibility of the patient’s usual doctor, allowing doctor-researchers to focus on the researcher side of their dual role [21, 22]. While these approaches may help resolve conflict in theory, in practice, doctor-researchers have revealed unease and mixed understandings of the meaning of care in the trial context. For example, doctor-researchers have reported compensating for the altered duty of care by giving trial participants more attention and psychological support than expected in a usual clinical situation .
A similar role conflict can arise from the distinction between the set of values required for research and those required for nursing and midwifery, particularly pertaining to the consequences of research participation on confidentiality and trust in the nurse-patient relationship [24–26]. Unlike doctor-researchers, who may be more involved in the initiation and running of research trials, in the RCT context, research nurses are more likely to be involved in measuring, monitoring and caring for trial participants. Thus, their personal investment in the research question, and the importance they place on it, may also differ.
Randomized controlled trials of behavioural interventions, that is, educational or therapeutic interventions directed at behavioural or cognitive change, present fundamental differences from pharmacological or surgical RCTs, and raise different conflicts for personnel involved. On the one hand, the absence of pharmaceuticals, surgery or other medical treatment, may raise fewer concerns (for personnel) about potential adverse consequences of random allocation to a particular trial arm. On the other hand, conflict may arise from the requirement to deliver an intervention in an unbiased fashion while holding personal views about the research question. Such a conflict could potentially impact on the outcome of the trial through (intentional or unintentional) lack of fidelity in delivery of the intervention, perhaps by undermining the principle of equipoise.
Equipoise and associated conflict
A central factor in the role conflicts discussed is the issue of a researcher’s personal views about, and emotional and intellectual investment in, the specific research question and trial. Not being in individual equipoise about the specific research question can impact on involvement in the trial in the first place, willingness to recruit patients, communication with patient participants, and delivery of the intervention [8, 9, 27, 28]. Previous research has focused largely on the first two of these. For example, a study of clinicians recruiting to neonatal trials revealed that a lack of equipoise had a mixed impact on their comfort with recruitment. Some stated that they felt a moral obligation that they would not be able to take part if not in individual equipoise, whereas other (more experienced) clinicians recognized the need to accept collective or community equipoise, if evidence did not support their own personal view that one drug worked better than another .
A lack of equipoise might indeed raise clinicians’ interest in a trial. In a study of surgeons involved in a trial of invasive urodynamic testing, most were not in individual equipoise, as they believed in the benefits of the testing. Moreover, there was little evidence of community equipoise, that is, there was neither a majority of individuals reportedly undecided on the issue, nor a balance between those who regarded the treatment as beneficial and those who did not, as the majority considered it necessary . However, the lack of evidence from trials at that point constituted formal community equipoise, and most surgeons interviewed recognized this. They were therefore willing to suspend the lack of either individual equipoise or informal community equipoise, and randomize their patients into such trials, with the intention that the results could provide the missing evidence that, they expected, would support their view and change others’ practice .
When involved in recruiting participants, researchers’ personal views can be unambiguous and influence potential participants’ decisions about participating (for example, see ), but little is known about the impact during intervention delivery. Useful insight comes from a study of research nurses involved in a trial comparing different ways of initiating intensive insulin therapy . Nurses described their dilemma when the protocol required them to deliver different care from their usual practice, and prevented them from using their experience to provide individualized care. They queried the quality of the data informing the trial, and the lack of individual equipoise led some (particularly the more experienced nurses) to deviate from the trial protocol .
In this article, we explore the views and experiences of deliverers of a structured education intervention to people with type 2 diabetes incorporating training in either SMBG or self-monitoring of urine glucose (SMUG), as two arms of a RCT. Of particular interest, in this contentious area, was whether these intervention deliverers considered themselves to be in equipoise or not and, if not, how they felt this impacted upon their delivery.