Who's Afraid of the Randomised Controlled Trial? Parents' Views of an SLT Research Study.

Speech and Language Therapy, Research Unit Frenchay Hospital, Bristol, BS16 1LE.
International Journal of Language & Communication Disorders (Impact Factor: 1.47). 01/2001; 36(s1):499-504.
Source: PubMed


Evidence-based health care is now a reality within the national health service (NHS) and the randomised controlled trial (RCT) is the linchpin of this movement. In modern health care, there has also been a shift towards understanding client perspectives. With regard to clients' participation in research, much consideration has been given to ethical issues and barriers to participation. However, less attention has been paid to the participants' views of clinical trials and understanding how they construe the research. This paper reports a study of the attitudes of parents whose children took part in an RCT. Data were collected from the parents of 20 children, using qualitative in-depth interviews. Parents talked about the meaning of their participation, their motivation for taking part and their understanding of the nature of the trial. The implications of the findings for future research will be considered.

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    ABSTRACT: Randomised controlled trials of healthcare interventions depend on the participation of volunteers who might not derive any personal health benefit from their participation. The idea that altruistic-type motives are important for trial participation is understandably widespread, but recent studies suggest considerations of personal benefit can influence participation decisions in various ways. Non-participant observation of recruitment consultations (n = 25) and in-depth interviews with people invited to participate in the UK REFLUX trial (n = 13). Willingness to help others and to contribute towards furthering medical knowledge featured strongly among the reasons people gave for being interested in participating in the trial. But decisions to attend recruitment appointments and take part were not based solely on consideration of others. Rather, they were presented as conditional on individuals additionally perceiving some benefit (and no significant disadvantage) for themselves. Potential for personal benefit or disadvantage could be seen in both the interventions being evaluated and trial processes. The term 'conditional altruism' concisely describes the willingness to help others that may initially incline people to participate in a trial, but that is unlikely to lead to trial participation in practice unless people also recognise that participation will benefit them personally. Recognition of conditional altruism has implications for planning trial recruitment communications to promote informed and voluntary trial participation. ISRCTN15517081.
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