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Logo of jmedethJournal of Medical EthicsCurrent TOCInstructions to authors
J Med Ethics. Nov 2005; 31(11): 664–669.
PMCID: PMC1734055

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

Abstract

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.

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Selected References

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  • Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med. 1997 Nov;45(9):1337–1355. [PubMed]
  • Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics. 1996 Aug;22(4):227–231. [PMC free article] [PubMed]
  • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001 Jan 17;93(2):139–147. [PubMed]
  • Ellis Peter M, Dowsett Sharon M, Butow Phyllis N, Tattersall Martin HN. Attitudes to randomized clinical trials amongst out-patients attending a medical oncology clinic. Health Expect. 1999 Mar;2(1):33–43. [PubMed]
  • Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA. 1982 Aug 27;248(8):968–970. [PubMed]
  • Bjørn E, Rossel P, Holm S. Can the written information to research subjects be improved?--an empirical study. J Med Ethics. 1999 Jun;25(3):263–267. [PMC free article] [PubMed]
  • Sutherland HJ, Lockwood GA, Till JE. Are we getting informed consent from patients with cancer? J R Soc Med. 1990 Jul;83(7):439–443. [PMC free article] [PubMed]
  • Gallo C, Perrone F, De Placido S, Giusti C. Informed versus randomised consent to clinical trials. Lancet. 1995 Oct 21;346(8982):1060–1064. [PubMed]
  • Thornton H. Understanding "informed consent". Lancet. 1995 Oct 21;346(8982):1047–1048. [PubMed]
  • Simes RJ, Tattersall MH, Coates AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. Br Med J (Clin Res Ed) 1986 Oct 25;293(6554):1065–1068. [PMC free article] [PubMed]
  • Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials. 1981 Dec;2(4):287–303. [PubMed]
  • Kerr C, Robinson E, Stevens A, Braunholtz D, Edwards S, Lilford R. Randomisation in trials: do potential trial participants understand it and find it acceptable? J Med Ethics. 2004 Feb;30(1):80–84. [PMC free article] [PubMed]
  • Asai Atsushi, Ohnishi Motoki, Nishigaki Etsuyo, Sekimoto Miho, Fukuhara Shunichi, Fukui Tsuguya. Focus group interviews examining attitudes toward medical research among the Japanese: a qualitative study. Bioethics. 2004 Sep;18(5):448–470. [PubMed]
  • Gascón Juan J, Sánchez-Ortuño Montserrat, Llor Bartolomé, Skidmore David, Saturno Pedro J. Why hypertensive patients do not comply with the treatment: results from a qualitative study. Fam Pract. 2004 Apr;21(2):125–130. [PubMed]
  • Robling MR, Hood K, Houston H, Pill R, Fay J, Evans HM. Public attitudes towards the use of primary care patient record data in medical research without consent: a qualitative study. J Med Ethics. 2004 Feb;30(1):104–109. [PMC free article] [PubMed]
  • Smith SM, O'Leary M, Bury G, Shannon W, Tynan A, Staines A, Thompson C. A qualitative investigation of the views and health beliefs of patients with Type 2 diabetes following the introduction of a diabetes shared care service. Diabet Med. 2003 Oct;20(10):853–857. [PubMed]
  • Hutton JL, Ashcroft RE. Some popular versions of uninformed consent. Health Care Anal. 2000;8(1):41–53. [PubMed]
  • Turney J. Public understanding of science. Lancet. 1996 Apr 20;347(9008):1087–1090. [PubMed]
  • Stockdale A. Public understanding of genetics and Alzheimer disease. Genet Test. 1999;3(1):139–145. [PubMed]
  • Mackillop WJ, Palmer MJ, O'Sullivan B, Ward GK, Steele R, Dotsikas G. Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment. Br J Cancer. 1989 Mar;59(3):388–395. [PMC free article] [PubMed]
  • Thornton HM. Breast cancer trials: a patient's viewpoint. Lancet. 1992 Jan 4;339(8784):44–45. [PubMed]

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