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Educated consent is key to patient safety: even if patients give consent for procedures, there are still plenty of risks, as some don't know expected outcomes, which could lead to medical malpractice claims.


* Getting informed patient consent can make the difference between performing the right procedure or doing someone grave harm.

* Flawed assumptions can lead to incomplete consent communication and pose substantial risk exposure.

* Detailed procedure-specific consent forms can be a vital tool in avoiding these "never events."

* Best practices in patient communication can reduce liability.



In the high-tech world of healthcare, a simple and well-crafted communication process may be one of the most effective risk management tools available. It can help mitigate the danger that exists when intended messages are lost due to assumptions and variations in context.

Consider, for example, an 86-year-old woman with hearing and vision problems going to the doctor for a knee injury. As providers examine the knee and discuss surgery options, the patient appears "disinterested," only nodding at questions and briefly looking at the information sheets offered. Providers are disturbed when she later declares she was never properly informed about the benefits and risks of her treatment options. If, as a result of this miscommunication, the patient or her family were to file a malpractice claim, the average cost to defend it would be $40,649, according to a American Medical Association study.

The underlying problem? Providers assumed the patient could hear them and see well enough to read the tiny font on the instructional pamphlets. They mistakenly attributed her lack of involvement to her age. Without understanding her hearing and visual impairments, they also did not realize these factors might cast doubt on the validity of the patient's surgical consent.

Flawed assumptions can lead to incomplete consent communication and pose substantial risk exposure. Vulnerabilities in the informed consent process fall into three distinct and potentially problematic "exposure areas" that providers must be prepared to address: Patients who do not fully understand the risks and benefits of treatment; consent processes that lack patient-specific detail; and consent processes that fail to disclose reasonable alternative treatments.

The following eases explore these risk areas, and show why truly informed patient consent is best achieved with a three-step procedure that ensures full patient comprehension and participation in the decision-making process.


A recent study in the Annals of Internal Medicine reveals that patient understanding of the treatments to which they consent is often fraught with misconceptions. It found that 88 percent of patients contemplating pereutaneous coronary intervention had an erroneous expectation that the procedure would reduce their risk of myocardial infarction. "Our findings ... highlight the difficulty of obtaining informed consent when patients overestimate the benefits of treatment," according to the study.

The key is to explain anticipated treatment results in a way that brings patient and provider expectations into alignment. However, successfully reducing the risk inherent in unrealistic patient expectations is not as simple as merely providing more information.

Ensuring comprehensive patient understanding requires offering meaningful information to patients far enough in advance of a procedure that they can adequately weigh their options, according to a recent article in the Journal of the American Medical Association. The article suggests that technology applications such as the software currently used by the Department of Veterans Affairs hospitals may help improve patient understanding while freeing physicians to more effectively address individual concerns. The software provides a consent document, information to educate patients and even quizzes them to ensure they know what procedure they're signing up for. Patient information cannot be abstract or stated in complex medical language. Instead, it must be simplified, balanced and patient-specific.


Patient specificity is also a critical issue, as evidenced by a medical malpractice case involving a Pittsburgh ophthalmologist who performed LASIK surgery on a man with unusually thin corneas. The procedure left the patient with permanently limited vision in one eye due to a known complication called ectasia. The ophthalmologist argued the ectasia did not result from any action or inaction on his part, however, a jury awarded the patient $875,000 in damages, contending the ophthalmologist negligently performed surgery without informed consent.

The problem was not the lack of a consent form; the patient had signed a standard consent document. The jury believed the ophthalmologist failed to adequately address the patient's uniquely individual risk factor--the fact that his thin corneas might elevate his personal surgery risks.

This example underscores a significant concept: The conventional focus on ensuring that patients sign the appropriate consent forms, treatment agreements, and other key documents is inadequate. Without full patient understanding and participation in the consent process, it remains an area of potential liability for providers. Mitigating that liability requires strengthening the process itself.


A Wisconsin Supreme Court ruling reminds institutions about the importance of a core requirement in consent communication: conveying information to patients about diagnostic and treatment alternatives. In this case, a gentleman suffering a suspected transient ischemic attack was discharged from a hospital emergency room without being admitted for further diagnostic tests. Two days later, he suffered a debilitating stroke.

Despite ongoing medical debate over admitting patients following a transient ischemic attack, the court found that the physician failed to adequately inform the patient and his wife "of all alternate, viable medical modes of treatment and about the benefits and risks of tho[s]e treatments," according to court documents. The ruling further concluded a, "reasonable person in [the patient's] position would have wanted to know about the alternative of admission with further diagnostic testing."


While cases of inadequate informed consent often go to court quietly, situations involving wrong-patient, wrong-procedure, wrong-site surgery capture headlines. Consider a recent case where a surgeon operated on the wrong eye of a four-year-old patient. In spite of marking the correct eye, the surgeon reported she "lost her sense of direction" resulting in the error.

In addition to devastating press accounts, these "never events" have other serious repercussions for both providers and hospitals. Hospitals receive no reimbursement for cases involving the wrong patient, procedure, or surgical site, according to the Centers for Medicare & Medicaid Services. That moratorium on reimbursement extends not only to the responsible practitioner but to all individuals and services associated with the error. In addition, these events could invite investigations by state and federal regulators and health plans.

Detailed procedure-specific consent forms can be a vital tool in avoiding these "never events." A 30-month study of all cases of wrong-patient/wrong-procedure/ wrong-site surgery across all hospitals and ambulatory surgery centers in Pennsylvania found that verification of the consent form--where the surgical team confirms each step of the process with the consent form--was one of the most effective practices for avoiding these errors. In the aforementioned case, if the surgical site consented to by the patient's parents had been enumerated on the consent form, and that consent form had been verified during the time-out in the operating room, the wrong-site surgery on the boy's eye might have been avoided.

Patients who are not active, well-informed participants in their medical decisions put healthcare providers and institutions at risk. Those potential risks include: the cost to defend claims; damaged facility reputation; loss of market share; and increased regulatory scrutiny. Physicians, institutions, and insurers can effectively reduce the total cost of risk associated with flawed communications through: Active patient engagement; strategic use of technology; well-designed, patient-specific forms; and leveraging that documentation during the time-out process.

These are four keys to ensuring patient-centered processes that avoid the exposure areas of incomplete informed consent.

Insurer Offers Benefits to Help with Informed Consent Risks

Incomplete informed consent ranks right after missed or delayed diagnoses as the largest risk factor for medical practices, according to Ernest Sussman, a practicing urologist who is also risk manager for Scrubs Mutual Assurance Company Risk Retention Group.

The group provides long-term medical liability insurance coverage to its member physicians. However, it also includes as a member benefit a subscription to an automated informed consent application (iMedConsent, Dialog Medical, Atlanta) to make it easier to document consent discussions within workflow.

By making sure patients have adequate time to: read through their consent forms, discuss them with their providers, and sign them to indicate full comprehension, Sussman hopes to lower his group's exposure to malpractice risk. His goal is for all of Scrubs Urologic Surgeons to reach 100 percent compliance with the automated consent application.

"We are all in this together," he said. "Each physician's actions affect the financial solvency of the whole risk retention group." --By Fay Rozovsky

FAY ROZOVSKY is president of The Rozovsky Group Inc. and author of Consent to Treatment: A Practical Guide.
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Title Annotation:LIABILITY
Author:Rozovsky, Fay
Publication:Risk & Insurance
Article Type:Clinical report
Date:Oct 1, 2011
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