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

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  • Snowdon, Claire
  • Garcia, Jo
  • Elbourne, Diana

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.

Suggested Citation

  • Snowdon, Claire & Garcia, Jo & Elbourne, Diana, 1997. "Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial," Social Science & Medicine, Elsevier, vol. 45(9), pages 1337-1355, November.
  • Handle: RePEc:eee:socmed:v:45:y:1997:i:9:p:1337-1355
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    Citations

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    Cited by:

    1. Dixon-Woods, Mary & Ashcroft, Richard E. & Jackson, Clare J. & Tobin, Martin D. & Kivits, Joelle & Burton, Paul R. & Samani, Nilesh J., 2007. "Beyond "misunderstanding": Written information and decisions about taking part in a genetic epidemiology study," Social Science & Medicine, Elsevier, vol. 65(11), pages 2212-2222, December.
    2. Dawson, Liza & Kass, Nancy E., 2005. "Views of US researchers about informed consent in international collaborative research," Social Science & Medicine, Elsevier, vol. 61(6), pages 1211-1222, September.
    3. Morris, Norma & BĂ lmer, Brian, 2006. "Volunteer human subjects' understandings of their participation in a biomedical research experiment," Social Science & Medicine, Elsevier, vol. 62(4), pages 998-1008, February.
    4. Hallowell, Nina & Cooke, Sarah & Crawford, Gill & Lucassen, Anneke & Parker, Michael, 2009. "Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies," Social Science & Medicine, Elsevier, vol. 68(11), pages 2010-2017, June.
    5. Lawrence, David S. & Ssali, Agnes & Moshashane, Neo & Nabaggala, Georgina & Maphane, Lebogang & Harrison, Thomas S. & Meya, David B. & Jarvis, Joseph N. & Seeley, Janet, 2022. "Decision making in a clinical trial for a life-threatening illness: Therapeutic expectation, not misconception," Social Science & Medicine, Elsevier, vol. 305(C).
    6. Snowdon, Claire & Elbourne, Diana & Garcia, Jo, 2006. ""It was a snap decision": Parental and professional perspectives on the speed of decisions about participation in perinatal randomised controlled trials," Social Science & Medicine, Elsevier, vol. 62(9), pages 2279-2290, May.
    7. Lawton, Julia & Jenkins, Nicholas & Darbyshire, Julie & Farmer, Andrew & Holman, Rury & Hallowell, Nina, 2012. "Understanding the outcomes of multi-centre clinical trials: A qualitative study of health professional experiences and views," Social Science & Medicine, Elsevier, vol. 74(4), pages 574-581.

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