Appropriate informed consent requires disclosure of the proposed treatment, the risks and benefits of that treatment, the risks and benefits of not proceeding, and alternatives to the treatment. This practice has become widely accepted, primarily because it supports patients’ autonomy.
However, perfect autonomy is impossible because there are always factors influencing non-rational decision making.
Further, autonomy can sometimes conflict with nonmaleficence (do no harm). Patients can be harmed by the disclosure of risks and/or side effects because the mere mention of side effects causes patients to experience those side effects. This is a corollary to the placebo effect, called the nocebo effect.
For example, patient A is told that erectile dysfunction (ED) is a side effect of an antidepressant and develops ED even though he previously never suffered from that problem. The medication is discontinued, but the ED remains unresolved.
Nocebo effects are common and, when medications are involved, may occur more frequently than side effects caused by the specific pharmacological action of drugs.
Nocebo effects can cause unpleasant side effects, eliminate the efficacy of a beneficial treatment and increase perceived pain. Patients may discontinue needed treatments and may seek additional medical consultations. Medication changes and hospitalizations may rise, patient distress may increase and quality of life may decline. In the extreme, these negative expectations may increase the risk of suicide.
Nocebo effects can be caused by patients’ fear, anxiety, increased attention to symptoms and even direct neurobiological changes. Patients who somatize or who are anxious or depressed may be at greater risk of nocebo effects.
Minorities and other vulnerable populations may also be at greater risk.
The suggestibility of mental health patients to placebo/nocebo effects may be especially strong. For example, antidepressant clinical trials consistently show placebo response rates of 30 percent to 50 percent. Similarly, clinical trials have found a drug vs. placebo effect difference of only 0.5 standard deviations.
The nocebo effect has implications for mental health professionals, not only for our own informed consent process, but when assisting other healthcare professionals. For example, health psychologists might consider designing the informed consent process for medical practices.
Accordingly, given that the nocebo effect can be potentially harmful to patients, increased consideration should be afforded to this potential for harm during the informed consent process.
The following suggestions are offered as ways to reduce the frequency and severity of nocebo effects during informed consent:
* Recognize that informing patients about side effects is not a mere presentation of “facts,” but is an important component of treatment and requires one’s clinical judgment.
* Personalize the disclosure provided, according to patients’ needs (i.e., don’t use the same boilerplate “contract” with every patient).
* Frame information in a positive manner (i.e., to reduce loss aversion)
* Have a discussion with patients regarding how the anticipation or fear of an adverse reaction can become a self-fulfilling prophecy.
* Discuss the nocebo effect explicitly.
* Discuss those risks that are more common and potentially more detrimental to patients.
* Provide opportunities for those patients who desire more information – i.e., creating separate documents with more details, etc.
* Discuss with patients how side effects occur and how to guard against them.
* Avoid unintentional negative suggestions, such as trivialization (e.g., “You don’t need to worry.”), or focusing attention on symptoms (e.g., “Are you in pain today? Are you depressed today?”).
* Practice validation (involving both understanding and acceptance) and take care that the reassurance is not seen as being patronizing.
* Elicit discussion of patients’ negative expectations by encouraging question-asking and correct any mistaken assumptions.
* Discuss any prior bad experiences with mental health professionals, in treatment, evaluations, or via personal contact.
An ongoing controversy in the ethics community is whether patients should be provided with all information — in the name of autonomy — or whether withholding information is sometimes permissible. Some have even argued that patients should be nudged to make “better” decisions (a la Thaler, 2009), while others are horrified by this suggestion.
The concept of the nocebo effect makes clear that not all information is helpful for all patients; as psychologists, we should be mindful of the effect that our words and actions have on patient decision making.
Bruce Borkosky, Psy.D., has been practicing forensic psychology for 26 years. Currently working as a prison psychologist and in private practice, he regularly publishes on the law and ethics of the clinician-patient relationship. His articles may be found online at fl-forensic.com and he can be contacted at firstname.lastname@example.org. A number of relevant articles on the nocebo effect are available at https://paperpile.com/shared/DA7kHr