Randomised Comparison of Procedures for Obtaining Informed Consent in Clinical Trials of Treatment for Cancer
BMJ (British Medical Journal). 1986 Oct 25; 293(6554): 1065-1068.
Methods of obtaining informed consent have evolved differently in Western countries without substantive information on the impact of these different practices on the patients. A randomised study was performed to compare two commonly adopted methods of seeking consent to randomised treatment: an individual approach at the discretion of each doctor and a uniform policy of total disclosure of all relevant information...Fifty-seven patients were assigned at random to two groups...The main effects of total disclosure of all information compared with an individual approach to seeking consent were: a better understanding of treatment and side effects and of research aspects of the treatments; less willingness to agree to randomised treatment; and increased anxiety. No significant differences were found in patients' perceptions of the doctor-patient relationship....
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Randomised Comparison of Procedures for Obtaining Informed Consent in Clinical Trials of Treatment for Cancer Simes, R.J.; Tattersall, M.H.N.; Coates, A.S.; Raghavan, D.; Solomon, H.J.; Smartt, H. (1986-10-25)