S Risks Risk Minimization and Prophylactic Measures

Every diagnostic and interventional procedure harbors potential risks to the patient. Risks can be very real and immediate, that is, they can directly harm the patient's health, or they can be indirect, resulting in other risky studies to prove or disprove a preliminary suspicious finding. Counterbalancing the risk of a study is, of course, the potential benefit it brings to the patient: an invasive procedure may yield a comprehensive diagnosis allowing for immediate therapy such as in angiography followed by balloon dilation.

The physician's careful explanation of risks and benefits of a planned study or procedure aims to enable the patient to make an informed decision whether or not to proceed with the study.

The starting point is different for every patient. Because of the radiation dose incurred, computed tomography of the abdomen in a young woman three months pregnant will only be performed in a life-threatening emergency, for example, after severe trauma to the abdomen. In an elderly cancer patient scheduled for radiation therapy, on the other hand, the radiation dose administered during an abdominal CT is without clinical relevance. The cancellation of a study naturally also carries risks: a tumor may go undetected or an inadequate or wrong therapy might be chosen. Thus there are many reasons to take the time for a comprehensive and personal conversation with the patient and to remind yourself of the risks and relevance of your own actions.

In most countries, obtaining signed informed consent of the patient or his/her legal representative (e.g., for children) is an obligatory prerequisite prior to performing procedures that carry a higher risk (administration of contrast media, interventional measures). A preparatory conversation between the patient and the physician needs to take place leaving the patient with sufficient time to ponder the options prior to the study.

Consent should be obtained from the patient prior to entering the procedure room if the administration of contrast is intended. If elective angiography or balloon dilation is planned, consent should be obtained at least 24 hours prior to the intervention. Asking patients to consent while they are already on the procedure table is legally nonbinding except in a life-threatening emergency. A countersignature of the physician is usually necessary. One should make it a habit to jot down explanatory drawings and handwritten notes on the consent form because they prove the very per sonal quality of the conversation. If a fully conscious patient rejects the suggested procedure—for whatever reasons— this must be accepted; that is, the patient must have the possibility to decline without further interference. A study or procedure performed in spite of the patient's refusal amounts to inflicting bodily harm, with associated potential legal consequences. If a patient loses his or her legal decision-making capacity in the further course of events—becomes unconscious, develops a psychosis, etc.—the case must be reconsidered in the best interest of the patient.

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