The face of equipoise--delivering a structured education programme within a randomized controlled trial: qualitative study

Background: In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT). Methods: Educators’ views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method. Results: Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG. Conclusions: The findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers’ awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT

'Educator talk' and patient change: some insights from the DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) randomized controlled trial

Aims: To determine whether differences in the amount of time educators talk during a self-management education programme relate to the degree of change in participants’ reported beliefs about diabetes. Method: Educators trained to be facilitative and non–didactic in their approach were observed delivering the DESMOND self management programme for individuals newly diagnosed with Type 2 diabetes. Observers used 10 second event coding to estimate the amount of time educators were speaking during different sessions in the programme. Facilitative as opposed to didactic delivery was indicated by targets for levels of educator talk set for each session. Targets were based on earlier pilot work. Participants completed measures of perceived: duration of diabetes (timeline IPQ-R), understanding of diabetes (coherence IPQ-R), personal responsibility for influencing diabetes (personal responsibility IPQ-R), seriousness of diabetes (seriousness DIRQ), and impact on daily life (impact DIRQ), before and after the education programme. Results: Where data from the event coding indicated educators were talking less and meeting targets for being less didactic, a greater change in reported illness beliefs of participants was seen. However, educators struggled to meet targets for most sessions of the programme. Conclusion: The amount of time educators talk in a self-management programme may provide a practical marker for the effectiveness of the education process, with less educator talk denoting a more facilitative/ less didactic approach. This finding has informed subsequent improvements to a comprehensive quality development framework acknowledging that educators need ongoing support to facilitate change to their normal educational style