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8 Ways to Improve the Informed Consent Process

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8 Ways to Improve the Informed Consent Process Preethy D. Kaibara, MD, Esq 8 ways to improve the Shufeldt Law Firm, Mesa, Ariz [email protected] informed consent process The author reported no potential conflict of interest relevant to this article. These practical suggestions can strengthen your rapport with patients and help ensure your professional counsel is complete and documented. nce viewed as simply a legal preamble to treat- PracticE ment, informed consent today encompasses much rEcommenDation more. An essential part of the ethical practice of O 1 › Let patients know that medicine, it is also an opportunity to strengthen the doctor- informed consent is an patient relationship. Effective informed consent embodies interactive process leading the shift in primary care medicine to guide rather than dictate to mutual agreement, rather an individual’s health care decisions, often termed shared de- than a formality and forced cision making.2 Furthermore, informed consent is increas- C choice. ingly relevant in today’s evolving legislative expectations3 and › Present all treatment health care initiatives.4 For risk management, the physician options even if a patient’s has more direct control over the process of informed con- insurance does not cover sent than most other areas pertaining to medical negligence. them all. C Thus, incorporating improvements to the process of informed › Discuss the advantages, dis- consent is time well invested. advantages, and limitations In this article I will discuss the components of informed of the tests you are ordering or consent and recommend practical steps to its effective deliv- recommending—particularly ery for mentally competent adult patients. nonroutine lab work. C Strength of recommendation (SOR) A Good-quality patient-oriented What informed consent requires evidence In the office setting, obtain informed consent before you start B Inconsistent or limited-quality treatments or procedures, prescribe medications, or order patient-oriented evidence most diagnostic tests. Informed consent requires that the pa- C Consensus, usual practice, opinion, disease-oriented tient understands the following: evidence, case series • 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 pa- tient. However, both common risks and uncommon but seri- ous 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 jfponline.com Vol 59, no 7 | jUlY 2010 | The joUrnal of familY pracTice 373 states apply what a “reasonable patient” likelihood of litigation.7 One model of more would want to know, and some apply a com- effective communication is the “teach back” bination of both. As such, legal cases provide approach,4 in which you identify the princi- little direction to physicians on how to decide pal messages of the discussion and ask the what is material.7 patient to paraphrase them. This approach Patients generally take 1 of 2 approaches emphasizes the use of simple, clear language when pursuing action against a physician in layman’s terms, relying on your ability to that is related to informed consent.8 explain rather than the patient’s ability to z the first, and most common, cause of comprehend. Questions such as “Do you have action is negligence. This occurs when a pa- any questions?” or “Do you understand?” are tient claims that the physician’s disclosures in less effective than saying “I want to be sure we the consent process were inadequate. The pa- have the same understanding” or asking “Can tient is then required to prove the elements of you tell me in your own words?”4 (See “Putting negligence: breach of standard of care, causa- informed consent principles into practice” by tion, and damages. going to jfponline.com and scrolling to the end z the second potential cause of action of this article.) is battery, which is an unlawful touching. Proving battery is simpler because there are fewer elements to the claim. If a procedure 2 Discuss all treatment options— Your level of or examination took place without the pa- regardless of insurance coverage rapport with a tient’s consent or was beyond the scope of Determining what should be disclosed as a ma- patient better the consent given, a battery action is possible, terial risk in the consent process can be chal- predicts risk of whether or not the outcome of a treatment lenging. It’s imperative to be familiar with the litigation than was beneficial to the patient. medical literature as well as the important risks does the content Now, on to the steps that can help im- and benefits of treatments. However, use statis- of any particular prove the informed consent process. tics judiciously and meaningfully. Overusing discussion. statistical data can confuse and even alienate some patients. The goal is to achieve an under- 1 Work on your rapport standing about whether a risk is relatively com- The importance of good rapport between the mon or relatively rare, but serious. patient and physician cannot be overempha- Present all treatment options regardless sized. The level of rapport is a better predictor of whether the patient’s insurance covers all of of the risk of litigation than the actual content them.1 Consider a patient’s unique financial sit- of any particular discussion.9 uation in the shared decision-making process. z a few tips to improve rapport. If you Exhaustive lists of potential risks are im- approach informed consent merely as a legal practical and, more important, are ineffective, technicality, the tone you take in the discus- as the risks have not been put into context for sion may reflect that attitude. Instead, enter the patient. A list of routine risks is a good start- into a consent discussion in such a manner ing point and provides structure to the discus- that the patient understands it is an interactive sion. Then, by taking the patient’s point of view, process leading to mutual agreement rather identify important, patient-specific risks. Cus- than a formality. Should an adverse outcome tomizing the discussion for each individual is occur, a patient who recalls feeling pressured the key principle in the duty to inform.10 Com- may claim that not all the key information was mon issues include how a side effect or adverse presented. Don’t be dogmatic in making rec- outcome might affect a person’s occupation, ommendations; scientific evidence and medi- fertility, sexual function, appearance, etc. Other cal opinion can change with time. Hormone issues include the pain incurred, degree of re- replacement therapy and cyclooxygenase-2 habilitation, restrictions on lifestyle, etc. inhibitors are current examples that demon- strate the importance of allowing the patient 3 Use the aBcDEF mnemonic to make a decision about therapy. The following mnemonic is useful for guid- Effective communication reduces the ing and documenting your discussion with 374 The joUrnal of familY pracTice | jUlY 2010 | Vol 59, no 7 INFORMED CONSENT the patient: py for lack of training or scientific evidence. Alternative therapies available Discussing enrollment in a medication Benefits of the therapy proposed research trial increases a physician’s duties Common but not devastating risks of disclosure before a patient decides to par- Devastating but not common risks ticipate.12 You must convey that the therapy Extra considerations specific to this has unknown risks and may turn out to be patient harmful. Also, the sponsor of the study, the Facial expressions, body language, and institutional review board, and government questions. agencies (eg, the US Food and Drug Admin- istration and the Department of Health and Human Services) may require discussion and 4 Decide how much medication documentation of specific risks. information the patient needs The learned intermediary doctrine is a legal concept whereby a pharmaceutical company 5 Discuss how test results is deemed to have discharged its responsibility will be communicated to patients (in whole or in part) for side effects Laboratory or radiology investigations and they have disclosed to physicians, commonly their results introduce a unique set of issues. through the product monograph.11 To limit Particularly for nonroutine lab work, it’s pru- risks, it is prudent to use a limited number dent to discuss the advantages, disadvantages, Use statistics of first-line drugs in each class, rather than and limitations of the test being ordered or judiciously and a lot of samples and new drugs, until you re- recommended. These discussions can become meaningfully. view monographs and the literature. As a final the subject of suits when a patient receives a the goal is check on your duty to inform, encourage a pa- diagnosis and wonders in hindsight if his or to achieve an tient to discuss with his or her pharmacist the her doctor missed the true diagnosis or should understanding drug you have prescribed, to further reduce have been more aggressive in the investiga- about whether a inadvertent errors and side effects. tion. Consider inviting your local laboratory risk is relatively Decide how much information the pa- or radiology group to make a presentation to common or tient needs. A recital of every risk in taking an keep you up-to-date on available options. relatively rare, antibiotic is untenable. However, certain drugs Obtaining informed consent provides a but serious. require more detailed discussion. Oral contra- helpful segue to discussing how test results ceptives, analgesics, and cardiovascular drugs can best be shared with the patient. An all- are a few classes of medications that have in- too-common problem is that test results can frequent, but serious, side effects.
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