The ethical basis for informing patients about every possible side-effect of treatment has been rooted in the principle of respect for patient autonomy. This model suggests that all information a clinician uses to make a specific treatment recommendation should be discussed explicitly with the patient if it helps them to make an informed decision. Thus patients are exposed to unfiltered information about nonspecific side-effects from providers and written material, such as those on consent forms and labels, without consideration of the nocebo effect.
For this model to work on behalf of patients, the risks and benefits of a specific treatment have to be completely unrelated to the act of information disclosure to the patient.⁸ Although this notion might be true for some treatments, it is not uniformly applicable. With surgery, the outcome of treatment is more likely to be related to patient anatomy and surgical technique and less likely to be affected by information exchange during the consent process. For example, a patient who develops insulin deficiency after undergoing surgery for pancreatic cancer can be counselled quite objectively that this risk is likely to manifest on the basis of the size of the tumour and location within the pancreas and is unlikely to be affected by the act of disclosure of this risk to the patient before surgery.
For patients with cancer who undergo non-invasive treatments or are prescribed drugs associated with non-specific side-effects, the act of disclosure itself could affect the possibility of side-effect manifestation. This tenet challenges the applicability of information disclosure as an independent component of informed consent that is separate from a risk–benefit analysis. Rather, in many clinical circumstances in which the potential for non-specific side-effects is high, such as in the non-invasive treatment of cancer, the act of information disclosure could be more accurately viewed as part of the risk–benefit analysis, thus dependent on real-time discussion, and personalised to the patient.
Amit K Garg,
Department of Radiation Oncology, MD Anderson Cancer Center,
Radiation Treatment Center at Presbyterian Kaseman Hospital,
Albuquerque, NM, USA
agarg [at] mdanderson [dot] org

„I declare that I have no conflicts of interest.“

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www.thelancet.com/oncology
Published Online September 23, 2011, DOI:10.1016/S1470-2045(11)70268-6