Informed consent for prostate cancer screening—a call for equity in medical interventions☆

To many physicians, “informed consent” refers to the act of providing the patient with the advantages and disadvantages of a medical management option and thereafter, having the patient sign a form. To many, it conjures up the vision of a patient signing a consent form. To a student of ethics, informed consent is actually a process in which information is transferred to a patient regarding options for health management (eg, treatment or prevention of disease) and assisting the patient with integrating individual priorities with the risks and benefits of an intervention, ultimately reaching a personalized treatment plan.

During the past 20 years, while observing the debate on prostate cancer screening, I have been struck by the degree of attention that this specific medical intervention and the attendant patient decision-making process have received while other interventions of similar ilk have had significantly less interest. Given that a student of outcomes for almost any medical intervention could reach different conclusions regarding treatment choices, why prostate cancer has received this degree of attention is unclear.

If we examine almost any medical condition, a variety of management options are available. Yet, for many such situations, a physician will recommend an intervention without a lengthy informed consent process. Sometimes, the treatment is simply prescribed with a superficial or no discussion of pros and cons. Many examples come to mind. Although anticoagulation is almost the rule for atrial fibrillation, a serious study of outcomes could lead an informed patient (young, low-risk factors) to not choose this treatment.1 Similarly, population-based recommendations for antihypertensive therapy clearly do not benefit every person treated.2 For some individual patients, serious side effects will occur from an intervention for a disease process that is not destined to alter their quality or length of life. The most recent conclusion of the lack of evidence of efficacy of antibiotic treatment for otitis media in a randomized, controlled study is an example of a time-honored intervention with unclear benefit.3 Finally, for almost any intervention there is an inescapable disadvantage: cost. Either society or the individual must bear the cost and redistribute resources from other opportunities that bring pleasure (eg, a movie ticket), a contribution to a retirement fund, or a good to society (eg, a contribution to a charity).

How do we approach the traditional “informed consent” today? It is an interesting observation that generally, “formal” informed consent—a patient signature—is only requested for an “invasive” procedure. Thus, a surgical procedure, insertion of a central line, or an angioplasty requires a piece of paper with the patient’s signature. Conversely, a young woman with a very low lifetime risk of breast cancer who opts for a screening mammogram at a young age is not required to provide informed consent, despite evidence of potential harm.4 I am bewildered why some interventions with very low risk may require signed informed consent and others that could have extraordinary risk do not. Certainly, the right approach is to provide each patient with sufficient information for each and every intervention so that they understand the rationale for it, as well as their other options. Although a piece of paper with a signature may satisfy some, again, it is the process of information provision, rather than the piece of paper, that should be sought.

Finally, although I would concur that some process of informed consent is necessary for prostate cancer screening, I would encourage (or demand) that advocates of a complex and comprehensive process examine their own medical practices and hold all their activities to the same level of rigid inspection. For indeed, if we demand that no intervention be accepted until Class I evidence of efficacy (eg, benefit from a randomized prospective clinical trial) is available, it would be my conclusion that we would need very few physicians for any preventive interventions. Similarly, other prevention interventions must be held up to the same degree of scrutiny and presented to patients with a similar degree of assiduity.