For patients, there are no guarantees attached to the services we render as physicians. Actually, as a surgeon I would semi-seriously “guarantee” my patients three things, and three things only: a scar where an incision was made; some transient discomfort at the operative site; and the best job I knew how to do. Having thereby opened the discussion surrounding a recommended surgical intervention, I would begin the time consuming, complex and risky process of informed consent.
Informed consent is quite literally the legal contract for care. The physician receives remuneration from the patient in exchange for providing a service. Moreover, because the service carries with it both deliberate injury (for example, any surgery, or administration of chemotherapeutic agents that target living cells) along with the risk of unintended injury, there is both a moral and legal obligation to inform the patient of the benefits, risks and alternatives available and to obtain legal permission prior to intervention. Failures to properly inform, along with negligence, form the only grounds for malpractice lawsuits. Physical intervention in the complete absence of consent can be grounds for criminal assault and battery. A few plaintiffs’ attorneys have tried the latter approach in recent years, though I’m not aware of successful prosecutions. On the other hand, Lawyers Weekly (July, 2000) reported that “med-mal lawyers are bringing more ‘lack of informed consent’ claims” to increasingly sympathetic juries. The traditional approach to informed consent—“Here! Read this! Sign it! Thanks.” —no longer suffices. Through the 1990s, more than $50 million per year was awarded for medical malpractice claims alleging failure to inform. Recently, a Florida jury awarded $3.8 million to a patient who sustained no injury, but was not afforded the “dignity” of a valid informed consent. Research institutions from coast to coast, Seattle to Baltimore and Boston to Tampa, have pending lawsuits for informed consent negligence. Make no mistake: the first allegation in a malpractice lawsuit begins with “If he had only told me! If I had only known!”
What is driving this seemingly renewed concern for properly executed informed consent? Two things stand out: increasingly complex, multifaceted and risky treatments and interventions for conditions that had few such options in the past, and the readily available glut of information on the Internet. Suppose an oncologist suggests a combined chemotherapy approach to treat advanced lung cancer. The duty to both fully inform the patient and to vet the stack of reprints downloaded from the ‘net that the patient brings to the discussion is a very heavy burden. Nor does the insurance company provide reimbursement for a dutiful, time-consuming patient-doctor interaction and thorough informed consent. Clearly, what the physician needs is an assistant that can methodically and carefully educate the patient in the patient’s native language, gauge and document understanding, capture the relevant questions and concerns that should be addressed by the doctor with the patient, archive the entire session, and obtain the patient’s legal signature—and do it uniformly, repetitively and inexpensively. My experiences with legal and risk management specialists at malpractice insurance companies, hands-on medical practice, and information technology process design have led to the development of just such a system. Let’s call it “electronically-assisted informed consent” or “e-IC.”
The demands for such a system are that it be inexpensive, unobtrusive, widely available and legally defensible. Standards for informed consent are published in the Code of Federal Regulations (CFR) and are mandated by the FDA for clinical trials (21 CFR 50). These principles should underpin any IC process. The next step is to deconstruct the informed consent process into its components, then reconstruct the process electronically. These fundamental steps are:
- Educate the patient in terms that cannot be misunderstood.
- Respond to questions and concerns.
- Document the entire informed consent session.
- Obtain legally valid signed permission to proceed.
To reach the broadest audience at lowest cost, the Internet is the ideal distribution medium. It will allow delivery of the process to the patient in the office or at home. To use the Internet, yet protect the security and privacy of the process, user authentication and data encryption are necessary. The educational content must be medically certified as accurate and complete for its intended purpose (such as a hip arthroplasty procedure). There must be interactivity that assesses patient understanding and captures questions, concerns and data relative to the proposed intervention. All aspects of the session must be captured, stored and archived in auditable form for the protection of doctor and patient. The session report must be sent to the doctor immediately, indicating the patient’s level of understanding, questions, concerns, and sign-off status.
With all this done as prescribed by the doctor, the subsequent doctor-patient interaction becomes highly meaningful and efficient. The physician knows the patient is educated appropriately. The doctor knows what is on the patient’s mind, and the areas where clarification may be needed. The patient has learned the information that the doctor prescribed, and was able to learn at his/her own place and pace. Questions can be posed thoughtfully and completely. But does it work?
Yes. At a clinical trial of the e-IC method at a major Midwest medical school, patient knowledge based on e-IC sessions vs. knowledge imparted by the doctor was far superior (p < 0.0003). Most importantly, patients preferred the e-IC method by a 9.5:1 ratio. Doctors found that there was a more meaningful doctor-patient interaction.
In an era of increasing requirement for informed consent—not only for treatment but for product use, for disclosure and use of personal information (privacy), for organ and tissue donation, for clinical research participation, and for right-to-die (medical durable power of attorney)—e-IC holds great promise for lowering risk and providing better, safer care by creating fully knowledgeable patient partners.
Dr. Terry R. Knapp is CareSpan’s Chief Medical Officer. He is a Stanford-trained, U.S. board-certified surgeon with a 40-year history of multinational care delivery. He is an accomplished medical device and medical services entrepreneur and corporate executive, co-founder of Collagen Corporation, and several other private and public companies, and has served in numerous executive roles and Board of Director positions. more