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The face of equipoise--delivering a structured education programme within a randomized controlled trial: qualitative
Helen C Eborall1, Helen M Dallosso, Heather Daly
1Social Science Applied to Healthcare Improvement Research (SAPPHIRE) Group, Department of Health Sciences, University of Leicester, Leicester, UK. hce3@le.ac.uk.
Intervention deliverers in diabetes trials can have personal preferences, impacting trial fidelity. Awareness of these preferences and a patient-centered approach help ensure unbiased delivery of behavioral interventions.
Area of Science:
- Behavioral Science
- Clinical Trials
- Diabetes Management
Background:
- Intervention deliverers are crucial for behavioral intervention trial success.
- Little is known about the experiences of these trial personnel.
- This study explores educators' experiences delivering a diabetes self-monitoring intervention.
Purpose of the Study:
- To investigate the views and experiences of educators delivering a structured diabetes education intervention.
- To understand how educators manage personal preferences during a randomized controlled trial (RCT).
Main Methods:
- Focus groups conducted before/after training and at 1 year.
- Semi-structured telephone interviews conducted at 2 years.
- Constant comparative method used for analysis.
Main Results:
- Educators had preferences for intervention variants, impacting equipoise.
- Training increased awareness of preferences and their delivery impact.
- Professionalism, patient-centered care, and protocol flexibility aided unbiased delivery.
Conclusions:
- Intervention deliverers' awareness of personal preferences, not just equipoise, facilitates unbiased delivery.
- Community equipoise, need for evidence, and individual relevance enhance commitment to RCTs.
- Findings offer insights for designing and running similar behavioral intervention trials.
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