Trial reportTrials2014
The face of equipoise--delivering a structured education programme within a randomized controlled trial: qualitative study.
Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 25 citations in OpenAlex.
- Trial
- Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study.Trials · 2017Trial
- Explaining engagement in self-monitoring among participants of the DESMOND Self-monitoring Trial: a qualitative interview study.Family practice · 2015Trial
- Trial
- "The hardest part of what we're doing": research staff perspectives on engaging marginalized populations in substance use trials.Substance abuse treatment, prevention, and policy · 2025Article
- Using Normalisation Process Theory (NPT) to develop an intervention to improve referral and uptake rates for self-management education for patients with type 2 diabetes in UK primary care.BMC health services research · 2022Article
- Article
- The Impact of Delivering School-Based Wellness Programs for Emerging Adult Facilitators-A Quasi-Controlled Clinical Trial.International journal of environmental research and public health · 2022Article
- Skill Acquisition Methods Fostering Physical Literacy in Early-Physical Education (SAMPLE-PE): Rationale and Study Protocol for a Cluster Randomized Controlled Trial in 5-6-Year-Old Children From Deprived Areas of North West England.Frontiers in psychology · 2020Article
- 'It's trying to manage the work': a qualitative evaluation of recruitment processes within a UK multicentre trial.BMJ open · 2017Article
- Searching for Real-World Effectiveness of Health Care Innovations: Scoping Study of Social Prescribing for Diabetes.Journal of medical Internet research · 2017Article
- Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians' Practices across Six Randomised Controlled Trials.PLoS medicine · 2016Article
- Article
- Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.Trials · 2015Article
- Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers.Pilot and feasibility studies · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 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).
methodsEducators' 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.
resultsEducators 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.
conclusionsThe 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 registrationISRCTN95696668.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.