Informed Consent

What can patients read and understand?

Informed consent forms assume that the patients can read and understand at levels of literacy that will allow them to make sense of the words describing the risks and benefits of the procedure.¹ Data from the National Assessment of Adult Literacy in 2003 show that prose literacy skills vary considerably based on ethnicity and age.² Over 19,000 adults participated in the tests. The average prose literacy scores are not different from 1992 and 2003. There are an estimated 11 million adults who are nonliterate in English. Of these, they belong to two groups: seven million who could not answer simple test questions and four million who could not take the test because of language barriers. Literacy skills are defined as²

1. below basic-simple/concrete literacy skills

2. basic-simple and everyday literacy skills

3. intermediate moderately challenging literacy activities

4. proficient-complex and challenging literacy activities.

Below basic or basic prose literacy skills

43% of all adults

32% whites

67% blacks

74% Hispanics

46% Asian/pacific islanders

61% adults aged 65 or older

Because consent forms are usually long, complicated, and hard to understand, the forms require “proficient” prose literacy skills—which most US adults do not possess.^1,2

A health literacy study has enrolled 3,260 new Medicare enrollees in Cleveland, Houston, and Tampa.³ Inadequate health literacy can be found in Medicare enrollees, aged 85 years or older compared with individuals aged 65 to 69 years. Overall, 33.9% of English-speaking and 53.9% of Spanish-speaking participants had marginal health literacy. Reading ability declined with age despite adjustment for years of school completed and cognitive impairment.³

Almost half of American adults read at or below the eighth grade level.⁴ Illiteracy in the United States is the result of insufficient education.⁴ A New England Journal of Medicine study in 2003 found that 54% of the Institutional Review Board (IRB) Web sites of 114 American medical schools had grade level readability standards.⁵ The standards ranged from 5th grade to 10th grade reading levels. The mean grade level for the Web sites was 10.6 grade. The study authors concluded that the text of informed consent should be directed at the fourth grade level.⁵ While most consent forms are not used in isolation, the fourth grade reading level text would lead to more effective understanding of the text.

Another study originating in Canada cites two cases where the absence of “plain language” in the informed consent led to lawsuits.⁶ In one case, the physician did not tell the patient clearly about the risks and benefits of sterilization. The other was about oral surgery for a wisdom tooth extraction. In the latter case, the patient felt that the printed information in technical language fell short of meeting the requirements of informed consent. Canada, like the United States, has many patients with poor reading skills. In 1995, the International Adult Literacy Survey showed that 42% of the Canadians have inadequate reading skills and cannot read job applications and tables.⁶ Thus, there is a critical relationship among the use of simple, layman’s language, informed consent, and professional liability.

The need to communicate at the level of the patient is important. Once the need for surgery arises, how does one communicate this to the patient? In this conversation, the patient and the physician are in the room; sometimes there are family members present. The primary goal of the conversation is to establish the patient’s understanding of the need for the procedure to regain sight, to speed recovery of vision, and to prevent adverse consequences. The benefits are usually discussed first and then the adverse outcome risks are discussed.

The next part of the conversation hinges on the relationship that the patient has with the physician: is it a long-standing relationship or a new interaction because the physician is a specialist, consultant retina-vitreous surgeon? No matter what, the physician and the patient need to feel comfortable with this relationship. Certain warning signs are not heeded: (i) the patient is very anxious and overanalytical and wants another opinion, (ii) denial or disbelief at the diagnosis or lack of trust in the treatment plan (see “Cross-cultural Considerations About Informed Consent” section in this chapter), and (iii) the need for more time to think about this diagnosis despite the severity and emergent nature of the disease such as a rhegmatogenous retinal detachment in a diabetic patient.

Once the clinician senses any lack of trust, in the diagnosis or the treatment plan, send the patient for another opinion. The patient will thank you for this action, in the end. Even if the treatment plan is simple or straightforward, do not perform the surgery if there is lack of trust. As we know, nothing is perfect, and there are no 100% guarantees.

In different cultures, the patient may have extreme fear and anxiety, but his entire family may believe in the diagnosis and treatment plan. Then, the surgeon can proceed in this situation knowing that the patient’s immediate family and “community” are in support of the treatment plan.

Medical-Legal Background

Medical-legal issues are becoming more important as medical litigation is increasing.⁷ In ophthalmology, cataract surgery is the most frequently performed surgery, and it has become the most common cause of ophthalmologic malpractice litigation. Cataract malpractice cases total one third of all cases against eye surgeons.^7–9

In a 2004 study, a questionnaire was given to cataract patients about to undergo cataract surgery to determine the level of informed consent.⁸ The questionnaires were given to the patients 24 hours in advance of the surgery.⁸ Seventy patients in a hospital in Austria were the participants. Of this group, 40% felt that they had had no information about the surgery. Twenty-three percent believed that there were surgical procedures without risks. Seventy-six percent felt that there were no risks for their cataract surgery. Forty-four percent of the patients wanted the physician to make the decision about the surgery. Twenty-six percent wanted to make the decision of their surgery with their ophthalmologist. Thus, there is an overwhelming majority of these European patients who do not understand that there are risks to their surgery. While this was a study originated in Europe, there are lessons to be learned: provide informed consent so that the patient understands the risks of surgery.

In a 2003 study about vitreoretinal surgery, Kraushar^10,11 used a questionnaire to query the medical malpractice experiences of vitreoretinal specialists. The results showed that rhegmatogenous retinal detachment is the most common presenting diagnosis in these lawsuits. The most common type of surgical management for the rhegmatogenous retinal detachment was pars plana vitrectomy (40%). Negligent treatment (surgical or medical) (63%) was more common than negligent diagnosis (10%). Decreased vision after treatment (40%), failed surgery (13%), and no improvement in vision (10%) were the most frequently cited reasons for the malpractice litigation. Kraushar’s conclusion was that vitreoretinal specialists are at risk for malpractice litigation because many of their patients have a poor prognosis of visual recovery and because most vitreoretinal surgery is more complex in nature than cataract surgery.

Rhegmatogenous retinal detachment has been the most common presenting diagnosis in most studies on ophthalmic malpractice litigation, and most of the patients with this diagnosis are treated by vitreoretinal specialists.¹¹ Many vitreoretinal patients present to the retinologist after penetrating eye trauma or failed treatment by another ophthalmologist. Thus, the patients who have had a poor outcome may be more prone to litigation. As emergency consultants, vitreoretinal specialists may not have enough time to create rapport, central to a good patient-physician relationship. In addition, as consultants, retinal surgeons are at risk for being included in lawsuits directed toward other physicians. These risks suggest the necessity of a thorough discussion of informed consent and the development of a good physician-patient relationship.¹²

The number of malpractice claims in ophthalmology is still constantly increasing.^7,9 Malpractice claims are initiated if there is evidence of negligence, injury, and proximate cause.¹² However, malpractice in this sense is often hard to prove, and therefore, inadequate or lack of informed consent is used as a secondary cause in more than 90% of all ophthalmologic malpractice cases.^11,12

In the million-dollar verdict category, jury trials are 3% of malpractice payments. In Florida, the payments involving one million dollars or more, 7.5% followed a jury trial.¹³

Informed Consent

Informed consent is an important part of every surgeon’s practice. Office procedures and outpatient surgical procedures necessitate that there is communication of the factual details of the procedure, the risks and benefits of surgery. The printed materials are proof and documentation that the ophthalmologist has provided the appropriate information to the patient. The patient, in signing the consent, is agreeing to the procedure. While the patient can still say that he is too confused, anxious, or unable to comprehend English, the signed informed consent with a witness is a useful document in the practice setting.

There are attorneys who advertise on the Internet for eye surgery complications. One example is Hill and Associates in Philadelphia, Pennsylvania, whose web site is www.eyesurgeryinjury.com.¹⁴ This web site is the first of Google search engines because of paid advertising or software coding for the Google search engine. Hill and Associates state on the opening page

“If you have already had eye surgery and developed any of the following complications, you may or may not have grounds for a lawsuit for damages: (A) Did you fully understand the risks? (B) Were you misled about the outcome? (C) Was your injury or side effect the result of normal risk or medical negligence? Contact Hill & Associates, P.C. to determine if you have grounds for a medical malpractice lawsuit”¹⁴ (Table 14-1).

“Did You Fully Understand the Risks?”

The attorneys will focus on the patient’s understanding of all of the risks of the procedure. As a clinician and surgeon, it is important to discuss death as a side effect of anesthesia, especially in Type 1 diabetic patients. Type 2 diabetic patients with a history of hypertension and cardiovascular disease are at risk for ischemic heart disease complications and death perioperatively.¹⁵ Tell the patient the risks, all of them. Do not skip the risk of death.⁷

“Were You Misled About the Outcome?”

Many surgeons have the nursing staff go over the informed consent and then the surgeon goes over the important caveats. Or, the risks of endophthalmitis are not explained in more than one sentence. This has to be told to the patient in terms of risk and benefit analysis: Is the benefit of improving vision worth the risk of the procedure?

Intravitreal injection of bevacizumab has a low risk of endophthalmitis, approximately 0.066% or 6/10,000 according to one 2009 study.¹⁶ The risk of endophthalmitis with 0.87% of intravitreal triamcinolone injections is approximately 1 person in a 100 people or 8 people in a 1,000 people.¹¹ The incidence of endophthalmitis in pars plana vitrectomy is 0.046% or 5 people in 10,000.¹²

“Was Your Injury or Side Effect the Result of Normal Risk or Medical Negligence?”

The question asks if the physician exposed the patient to normal risk or was there medical negligence. Medical negligence can include errors of omission, that is, lack of informed consent. This question also considers the ultimate side effect, death. Wrongful death is in this category. In the category of “normal risk” and how to define risk, the clinician can provide articles or Internet links which state the statistics of the side effects. Always emphasize that while statistics only tell one side of the story, if the side effect happens to the patient, for that patient, the side effect will become 100%. Thus, some clinicians never reveal the numbers of 1 person in 10,000 but rather emphasize that “while the side effects are rare, but if it happens to you, the side effect is 100%.”

Wrongful Death¹⁹

The Internet provides a trove of data for the patients and their families. It is useful to understand the patient’s point of view. What does he think of the surgery and risks and benefits? Is the patient’s expectation unrealistic, and can we as surgeons manage their unrealistic expectations?

The definition of wrongful death is a lawsuit which alleges that the victim dies as a result of the negligent conduct or misdeeds of another.¹⁹ A wrongful death lawsuit would be brought against a person who negligently, recklessly, or purposefully caused, in whole or in part, the death of another person. A defendant can be held liable by evidence for the wrongful death of another even if there was no direct intention to kill the victim. Usually, to be successful in such an action, the plaintiff must prove the defendant was negligent or strictly liable for the victim’s death. Common wrongful death cases arise as a result of auto accidents, industrial accidents, personal injury, and medical malpractice.¹⁴

While there is no protection against medical malpractice claims, the key to the physician’s legal well-being lies in the informed consent and the ability to establish rapport with the family and patient. If the patient is satisfied with the care and understands why there is a need for surgery, usually, there is no lawsuit, even in adverse medical outcomes. Thus, inform the patient of the risks and possible problems after surgery.

Anesthesia Risks

The surgeon is responsible for the well-being of the patient during the course of surgery. The eye surgery may be successful, but if the patient suffers severe life-threatening complications, the surgeon may be held liable for wrongful death. Diabetic patients are at increased risk for death in undergoing vitrectomy surgery. With general anesthesia, the risk for death is greater than with local, monitored intravenous anesthesia. The basis for the increased risk is the autonomic dysfunction that affects the hemodynamics of the diabetic patient about to have surgery^7,20 (Table 14-2).

Diabetic patients needing vitrectomy surgery are at the advanced stages of eye disease with increased ischemia affecting its microvasculature in the retina and other organs. Presumably, by the time the proliferative diabetic patient needs vitrectomy, he has abnormalities of the cardiovascular system and renal system.

These proliferative diabetic retinopathy patients manifest diabetic automatic neuropathy and autonomic dysfunction. Thus, these patients when anesthetized can experience hypotensive reactions where the systolic blood pressure can be below 90 mm Hg. Marked variability in heart rate and cardiac rhythm disorders during anesthesia are seen in patients with diabetes without known autonomic neuropathy.²⁰

The ophthalmologist and the retina surgeon are concerned with patient survival during the surgery and the perioperative period. It is important that the diabetic patient has preoperative clearance with his internal medicine physician and anesthesiologist.

Even with local anesthesia, the draping of the mildly sedated patient can lead to fright, confusion, and obtunded behavior. Consequently, the partially sedated patient may thrash or flail his arms while the surgeon is operating with microsurgical instruments inside the globe. In these cases, mild confusion may mean hypoxia and eventual cardiovascular compromise leading to the worst possible side effect—death in the operating room.

Thus, for the informed consent, it is important to stress all the complications equally without minimizing any of the complications. To prevent any of the complications to the best of your ability, as the operating eye surgeon, obtain preoperative clearance and have some understanding of how much time the patient will be covered under the drapes, if local anesthesia is to be used. Perform the surgery as quickly and efficiently as possible. In these cases, the use of preoperative bevacizumab reduces inflammation and the severity of neovascularization, which may in turn lead to a quicker vitrectomy in the operating room.^16–18

While the risks are more pronounced in patients with longer duration of diabetes and insulin-dependent diabetes, similar high risks for cardiovascular compromise occur in the advanced elderly patients who have Type 2 diabetes and concomitant heart disease and/or hypertension. Thus, it is important to be vigilant in the surgery of these patients.

In summary, diabetics who are about to undergo surgery, experience considerable risks: preoperative fasting, stress, and inadequate application of insulin. All the preoperative fasting can lead to metabolic derangement.²⁰

One study examined 332 consecutive patients who had had a vitrectomy for diabetic retinopathy. It was thought that the 5-year survival rate was 68%. Fifty percent of patients with heart disease died within 3.5 years of the surgery. Patients without heart disease had a 5-year survival rate of 90%.²¹

Hypertensive and diabetic patients were evaluated as they underwent elective noncardiac surgery. Their preoperative status and intraoperative changes in mean arterial pressure (MAP) were recorded as predictors of postoperative ischemic complications. Of the 254 patients studied, before surgery and monitored during surgery, 30 (12%) had postoperative cardiac death, ischemia, or infarction. Twenty-four percent of the patients with a previous myocardial infarction or cardiomegaly had an ischemic postoperative cardiac complication. Even if the patient had no previous myocardial infarction or cardiomegaly, 7% still had an ischemic complication.²¹

This study concluded that patients with a previous infarction or radiographic cardiomegaly are at high risk for postoperative ischemic complications. Prolonged intraoperative increases or decreases of 20 mm or more in MAP also results in a significant increase in life-threatening surgical complications.^15,19–21

Diabetic patients who have other associated diseases such as pancreatic transplant that requires long-term prednisone dosages are at higher anesthesia risks than their normal counterparts. Diabetic patients who have chronic drug addiction to illegal drugs require higher dosages of the anesthesia premedications. They may also need more intravenous anesthetic agents to create a pain-free state during local anesthesia. Some of these patients are elderly but have been taking sleeping medications or antianxiety drugs for many years. These patients will require large doses of anesthetic agents.

Cancer patients with diabetes about to have retinal surgery are at higher anesthesia risk than similar aged counterparts without cancer or diabetes. These patients may have had extensive radiation to the head and neck region and thus normal vascularization of the postoperative wound may not occur.^22–28 There may be problems with sclerotomy closure after vitrectomy.

Of equal concern is the cancer patient’s complete blood count, which may show anemia of chronic disease. The cancer patient may be hypotensive and pose a cardiac risk.²³ These patients may need a visit to the anesthesiologist 1 week prior to surgery. They also need a visit to their internist to ensure a proper history and physical examination prior to anesthesia.²³

AIDS patients with diabetes requiring vitreoretinal surgery, need preoperative clearance with their Infectious Disease consultants and hematologists.^23,24 They need to have the infectious disease precautions while at the hospital and in the operating room. Diabetic patients also do not have the same wound-healing qualities as their same-aged counterparts without diabetes.^19–21 Thus, informed consent is essential. The patients and their families must understand the risks and benefits of the surgery versus no surgery. The postoperative recovery may take longer than other vitreoretinal surgical patients without diabetes, cancer, or AIDS.^23–26

An elderly diabetic patient with Alzheimer’s Disease has to be treated with special care. If this person needs surgery for proliferative diabetic retinopathy, informed consent should be obtained with his family members in the room. If there is one person in the family with the power of attorney, he needs to be present for the informed consent.

In patients with mental illness, controlled by antidepressants or antischizophrenic medications, the clinician must be careful with the informed consent. Identify the family member with the power of attorney. Or, is there a social worker who can vouch for the informed consent? A witness has to be present in these cases. The surgeon should try to contact the family, establish rapport with them, and ascertain that the family also consents to the surgery. The family must agree on the surgery since the patient may not be able to verbalize his consent.

Monetary Awards

Plaintiffs win less than half the medical malpractice lawsuits that go to trial. There are a low percentage of jury trials, but the million-dollar verdicts can occur with or without a jury trial.^27,28

The median verdict for ophthalmology lawsuits in 1999 is $500,000 compared to the median jury award of $800,000 in the same year.²⁷ Whereas, the median jury award in 1993, 6 years earlier, was only $500,000. Nationally, there are 54 jury awards of at least $1 million in 2000, compared with 27 awards of at least $1 million in 1999. Thus, the number of claims is increasing and so is the dollar amount.^10,27,28

Cross-Cultural Considerations About Informed Consent

Informed Consent and Cultural Competence

Cultural competence in the context of medicine is the sensitivity to the cultural background and language of the patient. Understanding the need for a variety of communication skills is important in the process of informed consent. For example, verbal and nonverbal communication and written communication all play a role in the process of informed consent. Some cultures want a verbal description of the surgery about to be performed. The consent must be communicated to the patient’s extended family since there might be a need to address the group of concerned family members to arrive at a consensus for surgery.

Whereas Western societies may favor verbal openness or directness about the type of surgery for the patient, other societies may prefer silence as a form of respect. Consequently, the patient and family, in being silent, may be showing signs of respect in their own cultural setting, but for the Western-trained physician, the silence may be confusing. As another by-product of the silence, the patient may never ask the questions that he may want to ask. If the surgery does not meet the expectations of the patient in the cross-cultural context, the patient may feel very confused and disappointed. For the Western-trained physician, confusion reigns as well: the patient never asks questions so how could the physician anticipate any concerns?

For the patient from another culture, he may feel that there are spiritual alternatives to health care. While this might not be true for patients ingrained with the practice patterns of Western medicine, spiritual healing is common in Native American, Asian, and South Asian cultures (Tables 14-3 and 14-4).

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