• Let patients know that informed consent is an interactive process leading to mutual agreement, rather than a formality and forced choice. C
• Present all treatment options even if a patient’s insurance does not cover them all. C
• Discuss the advantages, disadvantages, and limitations of the tests you are ordering or recommending—particularly nonroutine lab work. C
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Once viewed as simply a legal preamble to treatment, informed consent today encompasses much more. An essential part of the ethical practice of medicine,1 it is also an opportunity to strengthen the doctor-patient relationship. Effective informed consent embodies the shift in primary care medicine to guide rather than dictate an individual’s health care decisions, often termed shared decision making.2 Furthermore, informed consent is increasingly relevant in today’s evolving legislative expectations3 and health care initiatives.4 For risk management, the physician has more direct control over the process of informed consent than most other areas pertaining to medical negligence. Thus, incorporating improvements to the process of informed consent is time well invested.
In this article I will discuss the components of informed consent and recommend practical steps to its effective delivery for mentally competent adult patients.
What informed consent requires
In the office setting, obtain informed consent before you start treatments or procedures, prescribe medications, or order most diagnostic tests. Informed consent requires that the patient understands the following:
- the material risks and benefits of a proposed treatment
- the reasonable alternative treatments
- the consequences of no treatment.
Physicians are not expected to disclose every risk to a patient. However, both common risks and uncommon but serious risks are considered material.5 In the extreme, a mentally competent patient may refuse lifesaving therapy if she or he understands the risk of doing so.6
The legal criteria that determine whether a physician satisfied the standard of care for informed consent vary from state to state. Some states test the physician’s conduct against what a “reasonable physician” should have disclosed. Other states apply what a “reasonable patient” would want to know, and some apply a combination of both. As such, legal cases provide little direction to physicians on how to decide what is material.7
Patients generally take 1 of 2 approaches when pursuing action against a physician that is related to informed consent.8
The first, and most common, cause of action is negligence. This occurs when a patient claims that the physician’s disclosures in the consent process were inadequate. The patient is then required to prove the elements of negligence: breach of standard of care, causation, and damages.
The second potential cause of action is battery, which is an unlawful touching. Proving battery is simpler because there are fewer elements to the claim. If a procedure or examination took place without the patient’s consent or was beyond the scope of the consent given, a battery action is possible, whether or not the outcome of a treatment was beneficial to the patient.
Now, on to the steps that can help improve the informed consent process.
1. Work on your rapport
The importance of good rapport between the patient and physician cannot be overemphasized. The level of rapport is a better predictor of the risk of litigation than the actual content of any particular discussion.9
A few tips to improve rapport. If you approach informed consent merely as a legal technicality, the tone you take in the discussion may reflect that attitude. Instead, enter into a consent discussion in such a manner that the patient understands it is an interactive process leading to mutual agreement rather than a formality. Should an adverse outcome occur, a patient who recalls feeling pressured may claim that not all the key information was presented. Don’t be dogmatic in making recommendations; scientific evidence and medical opinion can change with time. Hormone replacement therapy and cyclooxygenase-2 inhibitors are current examples that demonstrate the importance of allowing the patient to make a decision about therapy.
Effective communication reduces the likelihood of litigation.7 One model of more effective communication is the “teach back” approach,4 in which you identify the principal messages of the discussion and ask the patient to paraphrase them. This approach emphasizes the use of simple, clear language in layman’s terms, relying on your ability to explain rather than the patient’s ability to comprehend. Questions such as “Do you have any questions?” or “Do you understand?” are less effective than saying “I want to be sure we have the same understanding” or asking “Can you tell me in your own words?”4 (See “Putting informed consent principles into practice” by going to jfponline.com and scrolling to the end of this article.)