What Every Physician Should Know About Informed Consent
By V. F. Colon, MD
Informed consent is required by law to provide patients with the opportunity to make a fully informed decision regarding the nature of a medical or surgical intervention, which is recommended by a physician.
Every physician has the duty to inform a patient when an invasive or therapeutic intervention is indicated, but the surgical specialties have a special duty to fully explain the “material risks,” benefits and treatment alternatives to a patient so that he or she can consent to or decline the procedure.
Material risks are based on legal theory known as the Reasonable Person Standard. That standard was founded on the principal that certain operative or postoperative risks presented to a “reasonable person” may cause a patient to decline a proposed therapy or surgery.
Material risks are risks that are substantial in terms of seriousness, frequency and disability. Serious complications include such things as: wound dehiscence, infection, vascular or nerve damage and postoperative disability. Material risks generally pertain to loss of life, limb and quality of life. These risks must be presented to and understood by the patient in order to acquire a legally valid informed consent. When instructing patients of material risks, it is important to disclose certain severe but infrequent complications; just because they are infrequent they should not be disregarded.
It is required that patients be advised of the reasonable options to the proposed procedure; failure to provide them can complicate a legal defense should a problem related to the procedure arise, whether or not there was physician negligence.
Institutional General Consent forms are inadequate for the protection of surgeons or physicians because they do not meet the standard of care of fully informing patients as to risks, benefits and alternative therapeutic options for proposed procedures.
General Consent forms authorize institutional treatment and establish the basis for institutional billing purposes, but fail to provide evidence of an adequate informed consent process.
It is clearly the physician’s legal responsibility to acquire the informed consent. Many physicians delegate that task to others, e.g., a nurse or other assistant. Though frequently done, it is not a good idea. Should the issue of inadequate IC arise in a patient’s care, the surgeon is absolutely liable for the failure; that is what is known as vicarious liability.
It is obvious that many physicians do not acquire legally valid informed consents from patients prior to surgery. This places the physicians in unnecessary legal jeopardy, when in today’s technically sophisticated milieu relatively simple preparations can make this legally required activity nearly foolproof.
Physicians and surgeons have easy access to materials that can be used to produce very effective IC documents. Here’s what one can do:
- Acquire surgical videos germane to your practice from the web or create surgical videos of your own explaining to patients how you plan to deal with their problem(s). A two- to five-minute video can provide the patient with an adequate explanation of the injury and the nature of the recommended repair.
- After the video, it is essential to provide a personal Q&A opportunity for the patient and answer all questions.
- Create a form which reflects the patient’s choice to view or decline to view the procedural video. The form should include a printed list of material risks, along with their frequencies and that the patient understands the risks and benefits of the proposed surgery, and reasonable treatment alternatives. It must also reflect that the patient was given the opportunity to ask questions of the operating physician which were fully answered. When the form is signed by the patient it is placed in the record as evidence of a thorough and valid IC. When a physician establishes this process as “habit and practice,” it is an excellent and verifiable medico-legal tool.
Again, I emphasize that it is important to understand the specific duty of the operating surgeon to obtain IC. Using the methodology recommended above in conjunction with the patient having the opportunity to ask questions allows you to fulfill the tenets of the standard of care related to this issue.
I am providing you with this information as a friend and colleague and not as a legal advisor. If you wish to verify what I have written, I encourage you to discuss this with legal counsel. If you do these for your most commonly performed procedures, you will probably need to do them once. Review of content every year or so is a good idea.
Shorten consent forms to enhance patient understanding
By Karen M. Cheung
Long, jargon-filled consent forms, not surprisingly, may result in patients not fully understanding their care, according to a Johns Hopkins University study published in the Journal of General Internal Medicine.
Researchers looked at 124 informed consent documents of HIV/AIDs research patients and found that the median length of the form was 22 pages. In addition, the forms required at least a ninth-grade reading level, and confidentiality sections required a 12-grade reading level. The authors recommended that consent forms have simpler language.
The recent stent scandal raised questions about patients’ informed consent. When Dr. Mark Midei of St. Joseph Medical Center in Maryland was convicted of performing unnecessary heart stents, many wonder whether his patients fully understood the medical procedures, its necessity, and effects, according to an editorial in The Baltimore Sun. In addition, the case highlighted the responsibility of informed content on the physician, the patient, and the organization. St. Joseph’s CEO Jeffrey K. Norman also recently announced he is resigning at the end of this month.
“Consent forms are extremely long, exceeding recommendations for how much information readily can be processed. Networks should consider providing shorter consent templates, consistent with federal recommendations,” states the study.
http://www.ama-assn.org/amednews/2011/08/01/prsd0803.htm
http://www.springerlink.com/content/n2671q0593647610/
Comment by Editors — August 3, 2011 @ 7:11 pm |
Informed Consent
The principle of informed consent requires a physician to provide information about a patient’s medical condition and the available medical care options so that the patient may make an informed decision as to whether or not to consent to a proposed plan of treatment. The doctor must adequately inform the patient of the diagnosis, the nature and purpose of the treatment, any available alternatives, the benefits and risks of the procedure itself and the risks of not undergoing the procedure. In essence, under the concept of informed consent, the doctor must not only get the patient’s consent to treatment, but the treatment must be obtained from a fully informed patient.
While consenting to treatment may impose certain limits on your rights, signing a statement assuming the risks involved with a procedure does not mean that you have no recourse if the health care provider fails to perform according to acceptable levels of care and is negligent. Though you may be consenting to certain risks inherent in the medical procedure, you generally do not consent to the negligence of the practitioner performing the procedure.
Forms of consent
Consent to a treatment can be given either orally or in writing, as is common where doctors provide consent forms for patients to sign. There are some situations where consent of a patient is implied, as where the patient exhibits conduct indicating a willingness to undergo the treatment, or in the case of an unconscious patient who is unable to consent, and there is no family member available to give consent on his or her behalf (and no living will which directs otherwise).
If the patient is a child it is usually necessary for a parent or guardian to consent to any treatment, unless treatment is required in an emergency situation and the parent or guardian is unavailable to give consent. Exceptions may apply to situations where a minor seeks treatment for a sexually transmitted disease, or for alcohol or drug problems.
Damages
The damages a patient may recover in this kind of medical liability action are different from the damages that might be obtained in a medical malpractice negligence action. Because the liability relates to the lack of consent to a procedure, a patient may be able to recover damages even if the medical procedure was successful, whereas in a negligence case, the plaintiff is required to prove damages.
Source: http://www.johnsonvorhees.com/content/embed/MO/pi/malp/malp_informconsent/
Comment by Editors — August 23, 2011 @ 7:59 pm |
ONC aims to ease patient ‘informed’ consent problem
WASHINGTON – Patient consent is one of the thornier issues in healthcare today. The benefits of patients allowing providers to share their data and those providers, in turn, playing nicely with competitors, stand to improve care both for individuals and global populations in myriad ways.
http://www.govhealthit.com/news/onc-aims-ease-patient-consent-problem
Dr. David Edward Marcinko MBA CMP™
http://www.BusinessofMedicalPractice.com
Comment by Dr. David Edward Marcinko MBA — September 21, 2011 @ 12:41 am |