Elsevier

Social Science & Medicine

Volume 45, Issue 9, November 1997, Pages 1337-1355
Social Science & Medicine

Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial

https://doi.org/10.1016/S0277-9536(97)00063-4Get rights and content

Abstract

Randomized controlled trials (RCTs) are widely accepted by the scientific community as the most rigorous way of evaluating interventions in health care. Although their central feature, random allocation of treatment, is generally seen as methodologically appropriate, its application has caused much debate amongst health professionals and ethicists. This paper describes the views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial. In-depth interviews were used to determine their responses to the trial and randomization. The nature of the trial was often poorly understood. The random basis of the allocation of treatment and the rationale behind this approach were also problematic issues. Some parents did not perceive a random element in the process at all. These findings advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs. Greater understanding of participants' views provides the potential to improve the management of future trials and so the experience of those agreeing to take part.

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