How much information should be disclosed

The amount of information given to patients as part of the randomization and consent process varies greatly. The level of verbal information is often decided by doctors on an individual and sometimes ad hoc basis. Whilst some clinicians believe that only total disclosure of all information is ethical, others suggest that information overload can distress the patient unduly. An Australian randomized study, which compared two methods of seeking consent (an individual approach at the discretion of the doctor versus total disclosure) for entry to trials of different standard cancer treatments, found that patients who experienced total disclosure were less willing to enter the trial and were significantly more anxious [22]. A more recent randomized study comparing standard consent methods with the same plus a follow up telephone call from an oncology nurse found that the latter resulted in the patients being better informed about the trial and their treatment. It did not significantly affect anxiety or participation rates [23]. Studies of patients' attitudes have indicated that most (but not all) would like comprehensive information about trials and treatments [6,24] and would prefer to have a combination of written and verbal explanation [24].

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