2. Discuss all treatment options—regardless of insurance coverage
Determining what should be disclosed as a material risk in the consent process can be challenging. It’s imperative to be familiar with the medical literature as well as the important risks and benefits of treatments. However, use statistics judiciously and meaningfully. Overusing statistical data can confuse and even alienate some patients. The goal is to achieve an understanding about whether a risk is relatively common or relatively rare, but serious.
Present all treatment options regardless of whether the patient’s insurance covers all of them.1 Consider a patient’s unique financial situation in the shared decision-making process.
Exhaustive lists of potential risks are impractical and, more important, are ineffective, as the risks have not been put into context for the patient. A list of routine risks is a good starting point and provides structure to the discussion. Then, by taking the patient’s point of view, identify important, patient-specific risks. Customizing the discussion for each individual is the key principle in the duty to inform.10 Common issues include how a side effect or adverse outcome might affect a person’s occupation, fertility, sexual function, appearance, etc. Other issues include the pain incurred, degree of rehabilitation, restrictions on lifestyle, etc.
3. Use the ABCDEF mnemonic
The following mnemonic is useful for guiding and documenting your discussion with the patient:
- Alternative therapies available
- Benefits of the therapy proposed
- Common but not devastating risks
- Devastating but not common risks
- Extra considerations specific to this patient
- Facial expressions, body language, and questions.
4. Decide how much medication information the patient needs
The learned intermediary doctrine is a legal concept whereby a pharmaceutical company is deemed to have discharged its responsibility to patients (in whole or in part) for side effects they have disclosed to physicians, commonly through the product monograph.11 To limit risks, it is prudent to use a limited number of first-line drugs in each class, rather than a lot of samples and new drugs, until you review monographs and the literature. As a final check on your duty to inform, encourage a patient to discuss with his or her pharmacist the drug you have prescribed, to further reduce inadvertent errors and side effects.
Decide how much information the patient needs. A recital of every risk in taking an antibiotic is untenable. However, certain drugs require more detailed discussion. Oral contraceptives, analgesics, and cardiovascular drugs are a few classes of medications that have infrequent, but serious, side effects. Generally, these risks are so devastating (eg, stroke associated with oral contraceptives) that lawsuits are common. Important information that is not directly health related includes occupational or driving limitations while a patient is taking a drug that alters mental status.
Ask patients to tell you about any supplements or alternative therapies they use. Many complementary treatments can have an effect on medical therapy.
If a patient asks about alternative medicine, disclose your level of training in the area and discuss candidly any known related medical issues. For example, a patient with neck pain may ask for an opinion about, or a referral for, chiropractic care. Discuss known risks, such as vertebral artery dissection, and be frank when you cannot endorse the therapy for lack of training or scientific evidence.
Discussing enrollment in a medication research trial increases a physician’s duties of disclosure before a patient decides to participate.12 You must convey that the therapy has unknown risks and may turn out to be harmful. Also, the sponsor of the study, the institutional review board, and government agencies (eg, the US Food and Drug Administration and the Department of Health and Human Services) may require discussion and documentation of specific risks.
5. Discuss how test results will be communicated
Laboratory or radiology investigations and their results introduce a unique set of issues. Particularly for nonroutine lab work, it’s prudent to discuss the advantages, disadvantages, and limitations of the test being ordered or recommended. These discussions can become the subject of suits when a patient receives a diagnosis and wonders in hindsight if his or her doctor missed the true diagnosis or should have been more aggressive in the investigation. Consider inviting your local laboratory or radiology group to make a presentation to keep you up-to-date on available options.
Obtaining informed consent provides a helpful segue to discussing how test results can best be shared with the patient. An all-too-common problem is that test results can become lost or misfiled. Describe your office policy on calling patients with results, and think about when it might be advisable for the patient to follow up with the office, to reduce error and liability—eg, cancer screenings, Pap tests, and biopsy results.