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Title: 'Held together with human glue' : understanding participation in non-therapeutic paediatric randomised controlled trials
Author: Fisher, Helen
Awarding Body: King's College London
Current Institution: King's College London (University of London)
Date of Award: 2013
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Background: Successful recruitment, adherence and retention are essential for randomised controlled trials (RCTs) to produce robust and meaningful findings. Studies exploring trial participation predominantly focus on the characteristics and views of participants and staff and often reveal contradictory findings. To date little is known about adherence and retention to RCTs. Aim: To further understanding of recruitment, adherence and retention to non-therapeutic paediatric RCTs, with particular emphasis on the role of social context. Methods: An ethnographic approach was taken using two RCTs as case studies. Participant observation (130 hours) was conducted on a clinical trials unit. Twenty-six trial staff and 56 parents who considered or had participated in the RCTs were interviewed and relevant documents collected. Data were analysed using the principles of thematic analysis. Results: Drawing on Bourdieu’s (1977; 1990) ’Theory of Practice’ and Titmuss’ (1970) ’The Gift Relationship’ it was evident that recruitment, adherence and retention were influenced by the values and beliefs of parents and staff and by the wider context in which the RCTs were conducted. Recruitment and adherence were influenced by the degree of concordance between the philosophies of the trials’ fields and those of the wider fields of parenting, infant feeding, medical research and allergy healthcare. Perceptions of personal and societal benefit were relevant to participation but, reflecting the philosophy of the parenting field, families often prioritised personal benefit.
Conclusion: Open and regular personal communication between parents and staff was particularly important for retention. Trials that maximise personal contact may have more success retaining participants. Comparing recruitment, adherence and retention between the two RCTs illuminated the relevance of the wider context for participation, particularly recruitment and adherence. Conducting a thorough assessment of the context in which an RCT will take place will allow potential barriers to participation to be identified before trial commencement.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available