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The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study
- Source :
- Trials
- Publication Year :
- 2014
- Publisher :
- BioMed Central, 2014.
-
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. Trial registration ISRCTN95696668
- Subjects :
- Blood Glucose
medicine.medical_specialty
Health Knowledge, Attitudes, Practice
Time Factors
Attitude of Health Personnel
media_common.quotation_subject
Alternative medicine
Fidelity
Medicine (miscellaneous)
law.invention
Interviews as Topic
Professional Role
Randomized controlled trial
Nursing
Patient Education as Topic
law
Glycosuria
Intervention (counseling)
medicine
Humans
Pharmacology (medical)
Equipoise
Qualitative Research
media_common
Therapeutic Equipoise
Behavioural intervention
Evidence-Based Medicine
business.industry
Conflict of Interest
Research
Blood Glucose Self-Monitoring
Type 2 diabetes
Evidence-based medicine
Focus Groups
Focus group
Structured education
Treatment Outcome
Self-monitoring of blood glucose
Diabetes Mellitus, Type 2
England
Educator
Physical therapy
business
Biomarkers
Qualitative research
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....f053b1ff7a96e1415a563dee0d0e3c28