Abstract
OBJECTIVE: To ascertain attitudes to different methods of obtaining informed consent for randomised clinical trials (RCTs). DESIGN: Structured interviews with members of the public, medical secretaries and medical students. SETTING: The public were approached in a variety of public places. Medical secretaries and students were approached in their place of work. SUBJECTS: Fifty members of the public, 25 secretaries and 25 students. MAIN OUTCOME MEASURES: Views on RCTs were elicited, with particular emphasis on how subjects thought the concept of randomisation should be explained. Each participant was presented with descriptions of proposed clinical trials and asked to select his or her preference from a range of options. RESULTS: Written information was preferred over verbal information in 91% of replies. Most respondents (86%) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour of explanations that were less explicit about the play of chance (ANOVA; p = 0.0004). Eighty-three per cent of participants thought that randomised trials were morally acceptable when there was no prior medical preference between treatments. However, over half (55%) thought they would find it upsetting to be offered entry in such a trial and a quarter thought the outcome of treatment might be adversely affected. CONCLUSIONS: Our results offer some support for the idea that "economy with truth" is less unsettling than a frank description of the stark reality of what randomisation means. It is a matter of debate as to whether, if we are correct, autonomy should have precedence over beneficence. The offer of entry in a clinical trial is likely to affect the experience of care for many people, especially if the process of randomisation is described explicitly. Potential participants should be given a detailed written explanation of the rationale for the trial and be asked to sign a consent form if they agree to take part.
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- Albert T., Chadwick S. How readable are practice leaflets? BMJ. 1992 Nov 21;305(6864):1266–1268. doi: 10.1136/bmj.305.6864.1266. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Cassileth B. R., Zupkis R. V., Sutton-Smith K., March V. Informed consent -- why are its goals imperfectly realized? N Engl J Med. 1980 Apr 17;302(16):896–900. doi: 10.1056/NEJM198004173021605. [DOI] [PubMed] [Google Scholar]
- Dal-Ré R. Informed consent in clinical research with drugs in Spain: perspective of clinical trials committee members. Eur J Clin Pharmacol. 1990;38(4):319–324. doi: 10.1007/BF00315568. [DOI] [PubMed] [Google Scholar]
- Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987 Jul 16;317(3):141–145. doi: 10.1056/NEJM198707163170304. [DOI] [PubMed] [Google Scholar]
- Herxheimer A. The rights of the patient in clinical research. Lancet. 1988 Nov 12;2(8620):1128–1130. doi: 10.1016/s0140-6736(88)90536-3. [DOI] [PubMed] [Google Scholar]
- Llewellyn-Thomas H. A., McGreal M. J., Thiel E. C., Fine S., Erlichman C. Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation. Soc Sci Med. 1991;32(1):35–42. doi: 10.1016/0277-9536(91)90124-u. [DOI] [PubMed] [Google Scholar]
- Marsh B. T. Informed consent--help or hindrance. J R Soc Med. 1990 Oct;83(10):603–606. doi: 10.1177/014107689008301002. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Sacks H., Chalmers T. C., Smith H., Jr Randomized versus historical controls for clinical trials. Am J Med. 1982 Feb;72(2):233–240. doi: 10.1016/0002-9343(82)90815-4. [DOI] [PubMed] [Google Scholar]
- Simes R. J., Tattersall M. H., Coates A. S., Raghavan D., Solomon H. J., 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. doi: 10.1136/bmj.293.6554.1065. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Taylor K. M., Margolese R. G., Soskolne C. L. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med. 1984 May 24;310(21):1363–1367. doi: 10.1056/NEJM198405243102106. [DOI] [PubMed] [Google Scholar]
- White D. R., Muss H. B., Michielutte R., Cooper M. R., Jackson D. V., Richards F., 2nd, Stuart J. J., Spurr C. L. Informed consent: patient information forms in chemotherapy trials. Am J Clin Oncol. 1984 Apr;7(2):183–190. [PubMed] [Google Scholar]