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Patient preferences in randomised controlled trials: Conceptual framework and implications for research

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  • Bower, Peter
  • King, Michael
  • Nazareth, Irwin
  • Lampe, Fiona
  • Sibbald, Bonnie

Abstract

Patient preferences have recently been highlighted as a potential threat to the validity of randomised controlled trials (RCTs). Although there have been significant methodological and statistical developments in relation to these issues, comparatively little attention has been paid to the development of a conceptual model concerning preferences and their effects on decision-making. This article describes the development of such a model, which was undertaken in parallel with a systematic review of the empirical data concerning preference effects. The model describes the concept of preference in terms of theoretical concepts from the psychological and economics literature, and describes a preliminary model of the development and operation of preferences in the context of RCTs. The paper then examines the implications of the model for informed consent and recruitment procedures. Key issues for future research are also outlined.

Suggested Citation

  • Bower, Peter & King, Michael & Nazareth, Irwin & Lampe, Fiona & Sibbald, Bonnie, 2005. "Patient preferences in randomised controlled trials: Conceptual framework and implications for research," Social Science & Medicine, Elsevier, vol. 61(3), pages 685-695, August.
    • Handle: RePEc:eee:socmed:v:61:y:2005:i:3:p:685-695
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    1. Wade, Julia & Donovan, Jenny L. & Athene Lane, J. & Neal, David E. & Hamdy, Freddie C., 2009. "It's not just what you say, it's also how you say it: Opening the 'black box' of informed consent appointments in randomised controlled trials," Social Science & Medicine, Elsevier, vol. 68(11), pages 2018-2028, June.
    2. Hawe, Penelope & Riley, Therese & Gartrell, Alexandra & Turner, Karen & Canales, Claudia & Omstead, Darlene, 2015. "Comparison communities in a cluster randomised trial innovate in response to ‘being controlled’," Social Science & Medicine, Elsevier, vol. 133(C), pages 102-110.
    3. Dimittri Delevry & Quang A. Le, 2019. "Effect of Treatment Preference in Randomized Controlled Trials: Systematic Review of the Literature and Meta-Analysis," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 12(6), pages 593-609, December.
    4. Barbara Sianesi, 2016. "‘Randomisation bias’ in the medical literature: a review," IFS Working Papers W16/23, Institute for Fiscal Studies.

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