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Title: Recruitment to clinical trials in adult and child settings : qualitative case study in cystic fibrosis
Author: Sowden, Emma R.
ISNI:       0000 0004 7428 4747
Awarding Body: University of Liverpool
Current Institution: University of Liverpool
Date of Award: 2017
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Empirical evidence indicates that clinical trials are the most challenging type of research where the recruitment of willing volunteers is required. Insights into the process of recruitment are being gained from research examining the perspectives of those individuals directly involved, but there is limited comparative work in this area. Cystic fibrosis (CF), a serious life-long health condition was chosen as a case study for this thesis. It enabled recruitment to be compared across both adult and child settings and from both sides of the exchange. Qualitative interviews were conducted with 82 informants, comprising 20 adult patients, 22 mothers, eight fathers, 12 young people and 20 practitioners, across ten specialist CF centres (five paediatric and five adult). Analysis of transcribed recordings was pluralistic, drawing on elements of grounded theory and discourse analysis. Findings from this case study indicated that informants were able to make sense of invitations to participate in clinical trials based on personal perceptions of fairness, which could be discerned according to three distinct yet interdependent discourses namely: a rational; a social and a psycho-moral discourse. Rather than a universal ethical principle of fairness, informants made their own judgements of fairness, which took different forms depending on their personal sense of responsibility. Parents acting on behalf of infants and young children focused on doing the right thing and acting in the child's best interest, balancing both parental responsibilities and personal values. Parents of older children focused on negotiating the young person's level of involvement in decisions according to pre-existing family dynamics. Adult patients balanced their own health status, past research experience and personal values to make sense of and respond to the invitation to enter a trial. Practitioners illustrated the delicate balance required for the 'unbiased marketing' of trials, in which they considered their duty of care to patients, inherent trial uncertainty, 'a pressure of numbers' and their own personal values. In the context of this lifelong condition, recruitment was a social exchange as well as an informational one, in which hope, trust and a sense of moral responsibility were central for informants. Vulnerabilities could arise in relation to these processes, where high hopes could lead to disappointment, a sense of responsibility could lead to obligation, or trust could turn to acquiescence. The findings have implications for enhancing recruitment and raise questions about the appropriateness of generic checklist guidelines for enhancing and supporting the recruitment process. Individuals and families approached about trials want to be part of something of value and to be valued; engaging in what they believe is a worthwhile and fair collaborative endeavour.
Supervisor: Young, Bridget ; Jacoby, Ann Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral