title: The face of equipoise--delivering a structured education programme within a randomized controlled trial: qualitative study.
abstract: 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.
  
  
  BACKGROUND
  ISRCTN95696668.
authors.affiliation: Social Science Applied to Healthcare Improvement Research (SAPPHIRE) Group, Department of Health Sciences, University of Leicester, Leicester, UK. hce3@le.ac.uk.
authors.forename: Helen C
authors.initials: HC
authors.lastname: Eborall
authors.forename: Helen M
authors.initials: HM
authors.lastname: Dallosso
authors.forename: Heather
authors.initials: H
authors.lastname: Daly
authors.forename: Lorraine
authors.initials: L
authors.lastname: Martin-Stacey
authors.forename: Simon R
authors.initials: SR
authors.lastname: Heller
mesh_terms: D001291:Attitude of Health Personnel; D015415:Biomarkers / Q000097:blood / Q000652:urine; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring; D016265:Conflict of Interest; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000523:psychology / Q000628:therapy* / Q000652:urine; D004739:England; D019317:Evidence-Based Medicine; D017144:Focus Groups; D006029:Glycosuria / Q000175:diagnosis / Q000652:urine; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007407:Interviews as Topic; D010353:Patient Education as Topic; D024382:Professional Role; D036301:Qualitative Research; D057212:Therapeutic Equipoise; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose