Medical Informed Choice: Understanding the Element of Time to Meet the Standard of Care for Valid Informed Consent

In today’s medical marketplace, physicians are working at a feverish pace to meet the demands of the business model decreed by their employer. That business model has physicians seeing more patients in less time. The operative word is “time,” because quality work requires time and meeting the medical professional standard of care also requires time.

Time is the dependent variable in the informed choice function of meeting the standard of care.

The medical standard of care is the ethical and legal duty of a professional to exercise the level of care, diligence, and skill prescribed in the “code of practice” of her profession, or as other professionals in the same discipline would in the same or similar circumstances. This is the standard physicians face as they practice in a fast-paced medical marketplace where reimbursements are shrinking and increased patient volume is the prevailing mechanism to increase revenues. That creates a dilemma for physicians, because that faster pace means less time per patient, and less time means less deliberation and diligence in taking a medical history, performing a physical examination, developing a differential diagnosis, and educating patients about the elements of medical choice so they can then make an informed, knowledgeable, and voluntary decision about the healthcare they want or don’t want. That shared, informed decision-making process is time dependent.

Time is the dependent variable in the informed choice function of meeting the standard of care. The new healthcare business equations are creating a shrinking time variable. This disconnect between patient care and business models of medicine puts physicians at risk for failing to meet the threshold for the informed consent standard of care. This failure may place physicians at risk for allegations of negligence. The time disconnect weighs heavily on physicians’ minds, because they constantly face the potential of alleged liability. Shrinking time with patients can never lead to increased quality or a trusting physician–patient relationship.

True informed choice results in a meeting of the elements of the standard of care and limits any potential for alleged negligence

Physicians have a moral, legal, and ethical responsibility to understand medical informed choice. This responsibility emanates from the fiduciary duty physicians owe patients. Furthermore, true informed choice results in a meeting of the elements of the standard of care and limits any potential for alleged negligence.(1)

This article addresses the patient and physician criteria for medical choice to be valid, the exceptions to obtaining medical informed choice, the ethical and legal foundations to medical informed choice, the different standards that are adequate to meet the standard of care, and the fact that no single paradigm fits all patient situations.

Medical Informed Choice: Patient Criteria for Valid Informed Choice

What considerations define whether patients are capable of participating in the informed choice/shared decision-making process? That determination is based on deciding whether the patient is mentally capable and has decision-making capability. Capacity is a person’s ability to make an informed decision. Succinctly stated, the patient must be able to comprehend the information presented and the associated potential benefits, risks, and alternative choices in their medical care.

Every part of a patient’s decision must be intentional. Family members, other interested parties, or healthcare professionals should not affect the patient’s decisions. It is imperative that medications or life stressors not compromise patients involved in informed choice/shared decision-making. A patient with intact cognitive capacity and intact decision-making capacity may reverse a medical/surgical decision at any time. The competent patient may reject any proposed treatment, despite the consequences of that decision.

Physician Criteria for Informed Choice to be Valid

What subjects must a physician share with a patient to meet the threshold for valid informed choice/shared decision-making? Physicians must divulge to patients the diagnosis; the nature and purpose of the proposed treatment or procedure; reasonable available alternative approaches; relevant risks, benefits, and uncertainties of each alternative; and the risks and benefits of choosing not to have a treatment or procedure.(1) Additionally, physicians should take the time to ensure that the patient understands the diagnosis, treatment choices, and the risks and benefits of treatment versus no treatment.

The Exceptions to Obtaining Informed Choice

Exceptions to medical informed choice occur when physicians are confronted with medical emergencies that would result in permanent injury or death without immediate intervention. In these unique circumstances, even though the patient’s preferences and desires are unknown, informed consent is presumed.(2)

Additional exceptions to informed choice include a patient foregoing a right of informed choice and therapeutic privilege. By signing a waiver, a patient freely and willfully relinquishes a legal right. Patients may elect to sign a medical waiver when considering medical informed choice/shared decision-making. The patient may choose a surrogate decision-maker or adopt the physician as the decision-maker. Caution should be abundant when using a waiver for informed choice. Legally, waivers can be a slippery slope, and it is in the best interest of physicians to involve the risk management or legal team to develop an exhaustive legal covenant in such a situation.(3)

The therapeutic privilege is a doctrine allowing the physician to withhold information if disclosure of the knowledge would actually harm the patient. The therapeutic privilege should be used on rare occasion, because it is dicey, both ethically and legally. State precedent governs the interpretation of the therapeutic privilege, and the court’s analysis is variable from state to state. In these circumstances, it is imperative for the physician to document in detail the rationale for invoking the therapeutic privilege, and the ethics and risk management teams should be involved.(3)

Ethics and Informed Choice: Beneficence and Non-Maleficence

Beneficence (doing good) and non-maleficence (do not harm) underlie the physician’s moral imperative. This moral imperative infers there are times or circumstances when partial disclosure or no disclosures are concordant with meeting the standard of care and fiduciary duties. This flows from the fact that some patients are emotionally incapable of handling discussions that entail life-and-death issues or consequences when they are in a regressed state of mind. This permits physicians the opportunity to modify the medical information they deliver to patients in an empathic manner that meets the moral imperative of beneficence and non-maleficence. The ultimate goal of informed choice should be respect for a patient’s autonomy combined with tactful application of beneficence and non- maleficence.(4) This requires ongoing conversations over time and a trusting partnership.

The Legal Foundation for Informed Choice

The legal basis for mandating informed choice dates back to the 1700s. In Slater v Baker and Stapleton in 1767, the court established that physicians should obtain consent from patients before surgery and could be held legally liable if they proceeded without informed consent.

In Schloendorff v Society of New York Hospital in 1914, a physician removed a tumor from a patient who had consented only to an examination and had refused an operation. Justice Cardozo wrote: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.” Schloendorff established the necessity of voluntary agreement for each specific proposed procedure (Schloendorff v. Society of N.Y. Hosp., 211 N.Y. 125, 129-30).

The phrase “informed consent” was born in the California Court of Appeals case Salgo v Leland Stanford Jr. University Board of Trusteees. The court held that a physician could be held liable for failing to provide facts about a proposed treatment that are necessary for a patient to make an informed decision. Additionally, the decision stated that physicians must exercise discretion when deciding what risks to disclose in order to protect a patient’s well-being (Salgo v Leland Stanford Jr. University Board of Trusteees. Pacific Reporter, 2d Series 1957; 317: 170-182). This decision failed to delineate any clear limits on what must be disclosed. The California Supreme Court articulated this uncertainty: “One cannot know with certainty which medical consent is valid until a lawsuit is filed and resolved” (Moore v Regents of the University of California, 51 Cal 3d D20 165 793. P 2d 479 291 Cal Rptr. note 41 (1990)).

There does not appear to be a standard of disclosure to which physicians can adhere to avoid liability with certainty.(1)

What Does the Court Review When Presented with an Informed Consent Case?

When a case advances to court, appropriate documentation of the informed choice process can be used as a defense that the physician properly informed a patient about a treatment or procedure. That documentation should be stored in the medical record. Physicians should document the details of the discussion and the time devoted to educating the patient and answering the patient’s questions.

Informed consent forms may be helpful to satisfy legal requirements and make documentation more efficient, but they are not an acceptable replacement for time spent with the patient. Consent forms used to replace physician time negatively impact the physician–patient relationship. The use of informed consent forms has evolved into a legalistic process attempting to limit liability rather than facilitating comprehension and understanding of the treatment or proposed procedure. There is a feeling that the focus of physicians is on risk communication and not on informed medical decision-making.

Sensibly, if more time were spent educating and building a trusting partnership with the patient, there would be less need to have consent forms and a lower likelihood of ending up in court facing an allegation of negligent informed consent. Ultimately, upon review of the medical record the court evaluates the time dedicated to information sharing and shared decision-making between the physician and the patient to determine whether a physician met the standard of care for informed consent.

Defining the Standards of Disclosure

Two dominant approaches, the “professional” standard and the “materiality” standard, define the standard of disclosure of information by which a physician’s duty to the patient is measured(1) (Madare v Oschner Foundation Hospital, 505 So 2d 146 (La Ct App 1987)).

The professional standard requires the physician to disclose information that other physicians possessing the same skills and practicing in the same or a similar community disclose in a similar situation(1) (Canterbury v Spence, 446 F2d 772 (CADC 1972)).

The materiality, or “prudent patient,” approach allows the jury to decide whether other information would have been considered important by a reasonable patient in making a decision and therefore requiring disclosure(1) (Cowman v Hornaday, 329, NW 2d 422 (Iowa 1983)).

The courts recognize situations when a physician’s nondisclosure will be excused, including cases of the patient’s mental incompetence, medical emergencies, and the therapeutic privilege exception.(1,5) If a patient is incompetent to make a reasoned decision, then disclosure to the patient might not be required(1) (Banks v Wittenberg, 266 NW 2d 788 82 Mich App 274 (Mich App 1978)).

The physician also can withhold information under the therapeutic privilege if disclosure would interfere with treatment or would adversely affect the condition or recovery of the patient.(1,6) The emergency exception to disclosure applies in situations where attempting to secure consent would delay necessary and proper treatment(1) (Shafford v Louisiana State University, 448 So 2d 852 (La Ct App 1984)).

Last, physicians need not disclose risks of which the patient is already aware, or risks that are commonly known(1) Kissinger v Lofgren, 836 F 2d 678 (CA 1 [Mass] 1987)).

Individual state law and court decisions determine which approaches and exceptions apply in an individual physician’s practice.

In order to facilitate true informed consent, some states have initiated shared decision-making legislation. Shared decision-making requires intense education of the patient. Pamphlets, videos, and a vast array of telecommunication infomercials often are provided to patients, allowing them to more fully understand the proposed treatment or procedure and then incorporate their own values and preferences into the decision-making process. Providing additional written material; audiovisual, multimedia and test and feedback techniques; in addition to adequate time for education and shared decision-making all improve patient comprehension, especially regarding risks and general knowledge about the procedure.

Conclusion

There is no single prototype that meets the elements of the standard of care for informed consent and applies to all patients. Medical informed consent is essential to a true patient–physician relationship. Patients need to participate in the informed consent process to understand the risk–benefit relationship for the proposed treatment strategy. This understanding is essential because patients often are psychologically regressed secondary to the realization that they are confronting a life-preserving procedure that carries significant risk.

Physicians need to participate in the informed consent process to provide patients with the best treatment available by sharing decision-making and limiting any potential for liability. Medical ethics, common law, and, in many states, codified statutory law mandate the informed consent process. Physicians would be prudent to be knowledgeable in these areas of medical ethics, common law, and statutory law.

Physicians would be judicious also to understand that the consent process is vital to the physician–patient relationship and that no single archetype can define the ethical, medical, and legal approach a physician should undertake to achieve informed consent. The process should be individualized within the boundaries of the patient’s desires for self-determination, thus reflecting true patient autonomy.

The overarching principle is meeting the elements of true informed choice/consent, and informed consent requires time. Despite the evolving business model of medicine, physicians must demand abundant time to educate, counsel, and share decisions with patients. The constellation of abundant time, true partnership, and sharing in decisions is the panacea to preventing allegations of negligence.

Time cannot and must not be shorted. Adjuncts such as pamphlets and videos are helpful, but cannot replace a physician taking time with a patient. All true relationships are time dependent. Meaningful shared decisions require time, and taking that time will result in better clinical decisions and outcomes and less potential for liability.

References

1. Paterick TJ, Carson GV, Allen MC, Paterick T. Medical informed consent: general considerations for physicians. Mayo Clin Proc. 2008;83:313-319.

2. Arard A, Herlitz J, Hermeren G. Obtaining informed consent from patients in the early phase of acute myocardial infarction: physician experiences and attitudes (letter). Heart. 2004;90:208-210.

3. Klove C, DiBoise SJ, Pang B, Yarbrough C. Informed consent: ethical and legal aspects. Thorac Surg Clin. 2005;15:213-219.

4. Steinberg A. Disclosure of information and informed consent: ethical and practical considerations. J Child Neurol. 2009;24:1568-1571.

5. Meisel A. The “exceptions” to the informed consent doctrine: striking a balance between competing values in medical decision-making. Wis L Rev. 1979;1979(2):413-488.

6. Carnerie F. Crisis and informed consent: analysis of a law-medicine malocclusion. Am J Law Med. 1987;12(1):55-97.