Most Frequently Asked Questions About Informed Consent

By James F. Holzer, JD

[Digest, Summer, 1992]

Q  Do I need to get informed consent for every single procedure I do?
A  This is actually a misleading question. The correct answer is that physicians must always get informed consent for every treatment, procedure or test, regardless of how simple. How extensive the documentation should be, however, will vary with the type of procedure being performed.

Most ophthalmologists who ask this question are really asking whether a form has to be used for every single procedure, and clearly the answer is no. Most surgical procedures requiring general anesthesia and selected major procedures under locals, including cataract extractions, should have the consent process comprehensively documented on a form. Consent for other minor treatments, including many brief office procedures, can generally be recorded as a thorough note in the patient’s chart.

It is important to remember that “patient consent” first occurs verbally during the process. The signature on a form, or entry on the chart, merely memorializes in writing the patient’s decision and the fact that the consent process took place.

Q  How much information do I ultimately have to convey about the risks of a procedure?
A  Unfortunately, the answer is “it depends.” Many states provide little guidance to physicians about the amount and type of information necessary to satisfy a legal challenge. Most jurisdictions now indicate that “material” information be disclosed to the patient. The term “material” generally means information that a particular patient might consider significant in deciding whether or not to undergo the procedure or treatment. The doctor is not required to be a mind reader or to provide a “minicourse in medical science.” Some courts have even formally opined about not making a consent obligation an “undue burden on physicians.” Clearly, many juries and courts may look at the manner and extent of the consent documentation more as an indicator of a doctor’s overall credibility with respect to the time and attention he or she spent with the patient.

Q  Have many malpractice cases been lost solely on the issue of informed consent?
A  No, because a legal allegation of improper consent is usually accompanied by numerous other complaints. Juries, as a general rule, do not have to specify which pieces of evidence or allegations they regarded as most significant in determining that a doctor was negligent. More often than not, problems surrounding the consent process are aggravating or complicating factors which interfere in the successful defense of a malpractice claim. That’s why documentation which shows good consent process can play a significant role in supporting the physician’s overall believability and credibility if a claim does go into litigation.

Q When should informed consent and accompanying documentation be obtained from the patient?
A For elective procedures, the process should be started at the earliest possible opportunity. Documentation should be ongoing in the patient’s chart. Signatures on a consent form should also be obtained at the earliest opportunity. However, completed forms that are more than three or four weeks old might be re-initialed by the patient prior to the procedure to ensure the patient has no further questions.

Q  Do I need a witness to sign the consent form?
A In most every situation and jurisdiction, there is no legal requirement or necessity to have a witness involved in the signing of a consent form. Witnesses are used primarily to testify that the signature on the form was indeed the patient’s. Frankly, in this day of expert handwriting analysis, very few patients ever allege that the signature is not theirs.

Witnesses can be valuable, however, if the legal competency of the patient is called into question such as with very sick, elderly or mentally disabled patients who may not fully understand the nature and scope of what they are signing. In most situations, it is a good idea to have a member of the patient’s family present during the consent process (with the patient’s permission of course).

Q  What do I do if a patient doesn’t want to know about the risks, benefits and alternatives, but wants the procedure done anyway?
A  Make a complete notation to this effect in the medical record and send a letter to the patient confirming your mutual understanding. Do not force the patient to sign the form merely to comply with hospital policy. Work out an alternative procedure with your hospital’s risk manager if the institution requires a consent form before permitting the O.R. to be used.

Q  How should I handle patients who refuse procedures or diagnostic tests that I believe are critically important to the patient’s life or well-being?
A  There is an emerging medicolegal doctrine called “informed refusal” which would require a physician to disclose to the patient the possible risks of refusing needed care. This doctrine generally is not applicable for most elective procedures and could well be interpreted as harassment if used every time a patient disagreed with a physician’s recommendation. But when certain clinical situations would otherwise indicate that the patient may be exposing himself or herself to significant harm, the patient’s refusal to have the test or procedure should be thoroughly noted in the chart. Some providers use a form requiring the patient’s signature, but physicians should be alert as to whether the use of such a form would be more antagonistic than helpful.

When Complications Arise, Honesty Is the Best Policy

By Jerome W. Bettman Sr., MD

Argus, May, 1992

When, despite your best efforts, a complication of surgery occurs, it is in your best interest-as well as the patient’s-to tell the patient what has happened as soon as possible. Be honest. Never try to obscure the fact that a complication has occurred. Tell the patient that you will do everything in your power to help. Reassure the patient that you will ensure that he or she receives the best possible care and will not be abandoned.

If, during the informed consent process the patient was told that the results could not be guaranteed, it will be easier to explain that this case most likely fell into that group of complications that were discussed preoperatively. It does little good to blame yourself or the patient for the complication. Even if the patient might have been at fault, this generally will not be accepted as a justification.

The most difficult medicolegal cases to defend are those in which the surgeon was not forthright with the patient or did not seem sympathetic or concerned. It is amazing what difficult situations patients will accept gracefully if they have been treated with kindness and sympathy, and if they have been properly informed at every stage of the procedure, from the first visit through the postoperative period. Otherwise, the surprised, angry patient will be more likely to seek an attorney.

A case in point involves a 23-year-old auto mechanic who sustained a foreign body injury to one eye while hammering out a fender. The surgeon warned the patient that the foreign body had caused significant and irreparable damage upon entering the eye and that there would be further trauma to the eye during removal of the fragment. Unfortunately, the metal did not respond to a magnet and had to be removed with forceps, which caused a vitreal hemorrhage. Glaucoma ensued, and the patient eventually lost the eye.

The ophthalmologist averted a potential lawsuit by reminding the patient that they had previously discussed the possibility of serious complications. In explaining that everything possible had been done to save the eye, the ophthalmologist expressed sympathy and concern regarding the poor outcome. He assured the patient that he would continue to carefully supervise care of the remaining eye.

In some cases, you may want to suggest bringing in a consultant ophthalmologist. Do so early in the case. Tell the patient that because you are familiar with the skills, training and experience of the various ophthalmologists, you know who can be the most helpful. A complicated situation can be further complicated by a poor consultant.

Always adhere to these risk management principles:

1. Be certain to convey the proper information to the patient in a clear and understandable manner so he or she can give meaningful consent to surgery. This is essential.
2. Discuss the complication and its effects honestly. Never obfuscate.
3. Be sympathetic and kind.
4. Reassure the patient that you will continue to provide the best care possible.
5. Suggest a consultant ophthalmologist if the patient wishes to see one.

The Irreducible Minimum: When Is Enough, Enough?

By Michael R. Redmond, MD

Argus, January, 1993

No matter what type of medical and/or surgical intervention is recommended, accepted and undertaken, there is always the risk of a maloccurrence and possibly a secondary complication resulting in permanent damage.

One area of potential risk often overlooked in discussions with patients concerns the technical portion of surgery. Mechanical or electrical equipment failures, or the breaking off and loss of needle portions for example, are rare but potentially serious occurrences. Others, such as perforation of the globe during strabismus surgery, happen more frequently (perforation of the globe has been reported to occur in 20-30% of strabismus surgeries), but rarely lead to complications.

What should we tell our patients? How far down the statistical risk table should we go? There is no absolute answer. The ophthalmologist must in each individual case, provide the patient or the family with enough information to make an informed decision. To simply tell the patient that he or she could lose an eye from the surgery or die from the anesthetic is not enough. An uncomfortable unsightly eye may be more unacceptable to the patient than total loss of vision and surgical removal of the globe. The threat of a vegetative state from anesthesia might be feared more than death itself.

As always, preoperative discussion with an appropriate warning of potential risks that a reasonable, informed patient would care about is most important. Even with the incident of strabismus surgery perforation, the ophthalmologist can explain that this rarely causes a problem, in spite of its relatively frequent occurrence. Also, the physician can discuss the thickness (or thinness) of the sclera, the special-shaped needle used, and so on in order to show the consideration and care given to the issue.

If any complication or maloccurrence happens that might jeopardize the patient, the ophthalmologist should immediately disclose the appropriate information to the patient and note this in the chart. Disclosure should not be delayed in order to see what happens over time.

We all know there is an irreducible minimum for maloccurrence and complications. Only by making and keeping the patient a true “partner” in the choice of his or her care and throughout the continuum of that care can we as ophthalmologists bring our risk down to the irreducible minimum.

Mentally Incompetent Patients Pose Informed Consent Challenge

By Claire Harkrider Topp, JD

[ARGUS, July 1993]

Mr. Smith comes to see Dr. Jones, a general ophthalmologist, with complaints of hazy and blurred vision both while reading and driving. In the waiting room, Mr. Smith appears confused and is unable to understand simple directions from the nurse to hang up his coat. Informed of this behavior, Dr. Jones reviews the patient’s chart before calling him in. The medical history indicates Mr. Smith was recently diagnosed with Alzheimer’s disease, although it is in the early stages. The social history indicates Mr. Smith is single, lives with his elderly mother and supports himself as a registered nurse.

Dr. Jones examines the patient, who is cooperative and asks appropriate questions, but appears confused once or twice during the examination. The examination reveals Mr. Smith has bilateral cataracts with a visually impairing cataract in the right eye that should be removed as soon as possible. Mr. Smith appears cooperative and lucid, but due to his Alzheimer’s diagnosis may not be able to give informed consent.

As a general rule, because a patient has the right to participate in decisions affecting his or her physical and mental welfare, ophthalmologists and other health care providers cannot perform a medical procedure on a patient without that person’s informed consent. Failure to obtain this consent can subject an ophthalmologist, and potentially his or her clinic, to tort liability to the patient, even though the ophthalmologist believed the medical procedure was necessary.

The rights of a court-declared mentally incompetent patient are well established. In such cases, the ophthalmologist must obtain authorization for treatment from the patient’s court-appointed legal guardian. Patients who voluntarily commit themselves to a psychiatric facility retain the right to decide on treatment unless subsequently found to be incompetent.

More difficult are cases involving patients like Mr. Smith who have not been declared mentally incompetent by a court, but may be incompetent because they are exhibiting signs of mental illness, are under the influence of drugs or intoxicants, are unconscious, or have other permanent or temporary impairment of reasoning power. In these situations, the ophthalmologist first must conclude that the patient is mentally incompetent, then must obtain proper authorization for treating the patient. Neither task is an easy one.

To determine if a patient like Mr. Smith is incompetent, the ophthalmologist should consider whether the person has sufficient mental ability to reasonably understand the condition, nature and effect of the proposed treatment as well as the attendant risks in pursuing or not pursuing the treatment, and whether the patient is able to make a rational decision as to treatment. Mr. Smith apparently understands his condition and the proposed treatment and risks, especially in light of the fact he is a registered nurse. However, it could be argued that his Alzheimer’s diagnosis and confused behavior indicates he may not grasp the true significance of his medical situation. When Dr. Jones tried to discuss Alzheimer’s disease with Mr. Smith, he denied that Alzheimer’s was impairing him in any way.

Dr. Jones wants to treat Mr. Smith, but understands that an ophthalmologist who considers a patient incompetent must obtain appropriate legal consent. Some state statutes identify a “surrogate” who can consent to medical, dental or surgical treatment for a mentally incompetent person and set forth the procedure for obtaining and documenting this consent. State or local medical societies may be able to provide information about state laws regarding surrogates.

Typically, the surrogate must be competent and may be a parent, spouse, close relative, duly appointed guardian, or the medical director, administrator or superintendent of a health care facility entrusted with the patient’s care. Because consent given by anyone must be informed consent, the ophthalmologist should fully disclose to the surrogate all information regarding treatment that would have been conveyed to the patient.

Ophthalmologists who treat mentally incompetent patients are advised to carefully note the consent process in the patient’s medical record, ensuring that valid authorization for treatment is obtained. The signature of the patient or other individual empowered to give consent should be witnessed, and the ophthalmologist who informs the patient and obtains the consent should be identified in the medical record.

Mr. Smith’s case is complicated because he is single and his patient information form indicates only his elderly mother as a possible surrogate. She might not be competent enough to give informed consent for her son’s surgery.

In emergency cases, where it may be impossible to obtain proper informed consent, ophthalmologists should not hesitate to provide necessary care when immediate treatment is required to preserve life or prevent a serious impairment to health. Even if a state does not have specific legislation relating to emergency treatment of mentally disabled people, the common-law rule that consent to treatment may be presumed in an emergency is recognized explicitly in some statutes and implicitly in others. The ophthalmologist should seek concurrence from another member of the medical staff that an emergency exists and that the proposed treatment is necessary. Thoroughly documenting this concurring opinion along with the facts surrounding the emergency, i.e., the nature of the threat, its immediacy and its magnitude, is imperative in the event the decision to treat is subsequently challenged.

Although Mr. Smith’s case is not an emergency, it is highly preferable that he be treated promptly and while he is cooperative and lucid. Before proceeding with surgery, Dr. Jones should secure a second opinion from another ophthalmologist as if this were an emergency situation, and document in the patient record the concurrence of the other ophthalmologist and the facts and reasoning in going forward with treatment. Finally, Dr. Jones should document that although Mr. Smith was somewhat impaired due to Alzheimer’s, he appeared to understand the risks and benefits of the procedure and was competent to give informed consent. If a claim then arises from an unfortunate result of the cataract treatment, the record will show that Dr. Jones was prudent and careful in taking the necessary steps to obtain informed consent and document the process.

How to Improve Patient Compliance

By Paul Weber, JD

Argus, June, 1994

Caring for a patient means more than merely treating a patient’s disease. To reduce malpractice risk and assure the best possible result, the ophthalmologist must be certain that the patient understands and actively participates in the prescribed treatment plan. The patient’s cooperation is essential not only to achieve the benefits of the treatment but also because noncompliance could lead to an undeserved liability claim against the ophthalmologist.

Scope of the Problem

A number of medication studies highlight the scope of the problem of patient noncompliance. A study at the Veteran Affairs Medical Center in West Haven, CT, showed that 82% of patients complied with instructions five days after their visit to a physician. However, compliance dropped to 65% one month after the visit. This study illustrates the temporal nature of a patient’s ability to follow a treatment plan: As time passes, some patients forget, begin to feel better, suspect the medication is not helping, or become less motivated to adhere to the treatment plan.

Another medication study, conducted at Carnoustle Health Centre, Tayside, England, showed that a surprising number of patients are noncompliant from the beginning, never even starting their course of treatment. In this study, 15% of patients failed to pick up prescriptions they had ordered at a pharmacy.

Sometimes when medical malpractice claims arise, the role of noncompliance in causing the injury or poor result may not be fully appreciated by those who evaluate the claim. Thus, identifying noncompliant patients becomes extremely important for purposes of risk management.

Identifying the Noncompliant Patient

Physicians should try to determine if patients are complying with a prescribed treatment. One of the best methods is to ask a series of questions about the treatment regimen. For example, with a postop ophthalmic patient who was prescribed antibiotic ointment, ask, “What ointments are you using?” “How often do you use the ointment?” “How much ointment do you use?” “Can you demonstrate how you were taught to use the ointment?” These questions will compel the patient to reveal if he or she is using the medication properly.

Such open-ended questions are invariably better than the direct question, “Have you been applying the ointment?” This allows a noncompliant patient to cover up and assumes that the person has filled the prescription. This patient may be one who never even picked up the medication after it was ordered.

If a claim should arise where the patient failed to follow a treatment regimen, the plaintiff’s (patient’s) attorney will thoroughly investigate what the ophthalmologist did or did not do to instruct the patient in the treatment plan and will want to know what steps, if any, the ophthalmologist took to determine if the patient was compliant.

Intervening with Noncompliance

When an ophthalmologist discovers that a patient is noncompliant, the physician should identify the reasons so the problems impeding the patient can be remedied. If a postop ophthalmic patient is not using the prescribed ointment, this may be because the patient is having difficulty administering the medication or finds it irritates the eye. If the ophthalmologist questions the patient further, the physician might discover that the patient did not understand the purpose for using the antibiotic ointment, i.e., to prevent infection. A patient may discontinue using a medication if an immediate benefit is not realized.

Even if prior to surgery a patient is given oral or written instructions describing the benefits of a medication, compliance studies indicate that the ophthalmologist cannot rely on a patient remembering these instructions or having the diligence necessary to follow them.

Noncompliance may be financially related. Patients may be too embarrassed to admit they cannot afford a prescribed therapy. In these situations, the ophthalmologist could give the person a sample or try a less expensive, though equally effective, medication or therapy. Financial hardship presents a potential liability problem if the patient later states that he or she would have bought the medication or undergone the therapy if the physician had made clear the importance of the treatment. Carefully document any refusal of or delay in treatment that is caused by the patient. In some cases, the physician may want to have the patient sign a refusal of recommended medical or surgical treatment form.

Another reason for noncompliance is that the treatment may be inappropriate for the patient, who may feel the inconvenience or side effects of a medication outweigh its benefits. With glaucoma therapy, pilocarpine can cause such an accommodative spasm that the patient cannot function after using the drop. The patient may be able to help the ophthalmologist determine what therapy is best in a particular situation. Without allowing the patient’s health to be jeopardized, the ophthalmologist may want to discuss how to accommodate the patient’s preferences. Again, carefully document the reasons for any change in a selected course of treatment.

The time taken to talk to a patient to secure compliance with treatment is time well spent. Patients who understand and appreciate the importance of following their treatment plan are less likely to bring a claim against the physician for complications arising from their own noncompliance.