RESEARCH ETHICS

"Hello, hello—it’s English I speak!": a qualitative exploration of patients’ understanding of the science of clinical trials

M Stead¹, D Eadie¹, D Gordon² and K Angus¹

¹ Institute for Social Marketing, University of Stirling and the Open University, Stirling, UK
² Department of Public Health, NHS Lanarkshire, Hamilton, UK

Correspondence to:
Correspondence to:
Martine Stead
Deputy Director, Institute for Social Marketing, University of Stirling and the Open University, Stirling FK9 4LA, UK; martine.stead{at}stir.ac.uk

Informed consent may be seriously compromised if patients fail to understand the experimental nature of the trial in which they are participating. Using focus groups, the authors explored how prospective trial participants interpret and understand the science of clinical trials by using patient information sheets relative to their medical condition. An opportunity was provided to hear in the patients’ own words how they interpret the information and why there is variable understanding. Respondents struggled to comprehend the meaning and purpose of concepts such as randomisation and double blinding, and found them threatening to their ideas of medical care. Suggestions are made about how to improve the national guidelines on written information for trial participants and pretesting of the information sheets is advocated.

Abbreviations: RCT, randomised controlled trial; REC, research ethics committee

Keywords: comprehension; controlled clinical trials; focus groups; informed consent; qualitative research

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

• Bower, P., Wallace, P., Ward, E., Graffy, J., Miller, J., Delaney, B., Kinmonth, A. L. (2009). Improving recruitment to health research in primary care. Fam Pract 0: cmp037v1-cmp037 [Abstract] [Full Text]  
• Mangset, M, Forde, R, Nessa, J, Berge, E, Wyller, T B. (2008). "I don't like that, it's tricking people too much...": acute informed consent to participation in a trial of thrombolysis for stroke. J. Med. Ethics 34: 751-756 [Abstract] [Full Text]  
• Chingono, A., Lane, T., Chitumba, A., Kulich, M., Morin, S. (2008). Balancing science and community concerns in resource-limited settings: Project Accept in rural Zimbabwe. Clin Trials 5: 273-276 [Abstract]  
• Jellen, P. A., Brogan, F. L., Kuzma, A. M., Meldrum, C., Meli, Y. M., Grabianowski, C. L. (2008). NETT Coordinators: Researchers, Caregivers, or Both?. Proc Am Thorac Soc 5: 412-415 [Abstract] [Full Text]  
• Carnes, D., Anwer, Y., Underwood, M., Harding, G., Parsons, S., on behalf of the TOIB study team, (2008). Influences on older people's decision making regarding choice of topical or oral NSAIDs for knee pain: qualitative study. BMJ 336: 142-145 [Abstract] [Full Text]