The doctrine of informed consent relates back to English common law. Common law refers to a judge using prior case precedents to determine a legal course as opposed to statutes which are legislated direction. Beginning in the late 18th century, doctors were charged with the tort of battery if they had not gained the consent of their patients prior to performing a surgery. A tort if s a civil wrong intentional or not, not in the context of a contract or statute. Tort law terms, including “standard of care” and “negligence” are front and center in today’s medical malpractice environment.
Within the US, a seminal case involving the concept of consent for surgical procedures is Scholendorff vs. Society of New York Hospital (1914). Mary Schloendorf consented to ether anesthesia to determine the source of an abdominal mass. The surgeon removed a tumor without her consent while she was under anesthesia. Unfortunately, infection, gangrene, and amputation of several fingers occurred following surgery. The courts found that “Every adult of sound mind has a right to determine what shall be done with his own body” and that a surgeon who performs an operation without his patient’s consent performs “assault.” Schloendorff goes against the concept and practice of Paternalism, common at that time.
The concept of informed consent had its birth with Salgo vs. Leland Stanford University Board of Trustees (1957). Martin Salgo had symptoms of cramping in the legs. He became paralyzed after a diagnostic procedure, aortography. He sued indicating that he was not told that paralysis was a risk associated with aortography. The court found that though Mr. Salgo gave his consent for the procedure, the failure to disclose risks and alternatives was a cause for legal action on its own.
Natanson vs. Kline (1960) involved Irma Natanson, a 35 year old housewife who suffered burns as a result of cobalt irradiation treatment for breast cancer. Though the patient gave consent and some risks were discussed, the issue of whether something that happens less than 1 percent of the time needs to be told came up. This case set a precedent for the determining standards of what needs to be disclosed in the informed consent process. The court found and set the standard of disclosure to what “a reasonable practitioner” in the community would provide.
Canterbury vs. Spence (1972) set a different standard of disclosure. In this case, a 19 year old patient became partially paralyzed after thoracic spine surgery. A mitigating factor was that the patient fell out of bed while voiding early after surgery. Canterbury sued for both hospital negligence and lack of informed consent. An important element of this case is that the court found that the standard of disclosure of risks depends on what a “reasonable patient” would need to know to agree to proceed and not what a “reasonable practitioner” would think is important. This ruling avoids a perceived “code of silence” where it was difficult to find a practitioner who would testify against another practitioner.
Other precedents from subsequent case law reinforce the concept that patients need to receive sufficient information upon which to make a sound decision to consent. Also, the patient doesn’t need to inquire about risks and alternatives but it is the physician’s duty to relay these risks. In addition, it is the physician’s duty to make sure the patient understands the information being relayed.
In the typical lack of informed consent malpractice scenario, the issue of informed consent arises when a patient suffers an injurious or harmful outcome from a treatment or surgery. The outcome is usually not the result of negligence. The complication is typically a foreseeable risk. However, the patient alleges that he or she was never informed of the possibility of the injury or the harm. The patient would claim that had he known of the particular risk or that an alternative treatment not disclosed was available, that the patient would have not opted for the chosen treatment. The patient would then have avoided the harm. The patient sues for the lack of being informed because if he were, would have avoided the complication.
According to the General Medical Council: Guidance for Doctors (6/08), our duties to the patient include:
- Make an assessment of the patient’s condition, taking into account the patient’s medical history
- Doctor uses specialist knowledge, experience, and clinical judgment to identify which treatments are likely to benefit the patient.
- Doctor explains options to patient, setting out potential benefits, risks, burdens and side effects of each option, including the option of no treatment
- Recommend a particular option but not put pressure on the patient to accept advice
- Patient weighs benefits, risks, and burdens of the various options as well as non-clinical issues relevant to them.
- Patient decides whether to accept any of the options. They have a right to accept or refuse an option for any or no reason.
- Disclose if a treatment might result in a serious adverse outcome, even if the likelihood is very small.
- Disclose less serious side effects if they occur frequently
Today, states are divided on the level of disclosure during the informed consent process legally obligated. Some states use the concept of the “prudent physician” a.k.a. “community” standard akin to the “reasonable practitioner” standard set forth by Natanson vs. Kline. This is a less stringent standard than the “prudent patient” or “materiality” standard as it is often called which is akin to the “reasonable patient” standard that was set forth by Canterbury vs. Spence.
States currently using the community standard include Arkansas, California, Delaware, Florida, Georgia, Idaho, Illinois, Iowa, Kentucky, Maine, Michigan, Missouri, Nebraska, New Hampshire, New York, North Carolina, Tennessee, Those adhering to the materiality standard include Alaska, Hawaii, Indiana, Louisiana, Massachusetts, Ohio, Oregon, Pennsylvania, Texas, Utah, Vermont, Washington, West Virginia
The American Academy of Ophthalmology “Advisory Opinion of the Code of Ethics (6/2008)” advocates an ethical standard similar the materiality standard, regardless of state requirements. It recommends disclosing complications that are common or significant such they might reasonably influence the patient’s judgment to accept the proposed treatment. It states also that exclusions include very minor, rare, or inconsequential risks.
OMIC (Ophthalmic Mutual Insurance company) risk management data shows that the majority of malpractice claims reported to them are related to cataract surgery. This may be related to the fact that cataract surgery is the most frequently performed ophthalmic procedure in the US. More recently, allegations related to physician advertising overstating benefits can destroy the validity of consent forms. Patients are also using state consumer protection laws to claim physician fraud.
OMIC emphasizes the proper management of patient expectations, highlighting the importance of various factors and tailoring it to the individual patient.
- Determine role of cataract in vision loss
- Evaluate ocular and medical comorbidities that can affect the outcome of cataract surgery including:
- Previous trauma Very Large or small eyes Weak zonules (pseudoexfoliation syndrome) Anticoagulants, antiplatelets, Flomax
- Surgical and non-surgical options for near vision and astigmatism reduction need to be discussed
- Standard of care requires informing patients these options as part of informed consent, including referring out if those procedures not offered at the particular practice.
Data for success rates for cataract surgery include:
ASCRS National cataract database: (3 months data) 5788 patients
- 86% had 20/40 or better vision (BCVA, or vision with their best glasses after surgery)
- 57% had 20/25 or better BCVA
- 75% were within 1 diopter of anticipated refractive target.
AAO National Eyecare Outcomes Network (NEON) 7626 patients 96-97 (2 year data)
- 92% had an improvement in visual acuity
- 90% had an improvement in VF-14, a subjective vision questionnaire
- 89% had 20/40 or better BCVA
- 96% had 20/40 or better BCVA (when no ocular comorbid conditions
- 95% were satisfied with their results
Complications of cataract surgery include:
Synthesis of literature prior to 1992, American Academy of Ophthalmology (AAO) preferred practice patterns:
- Infectious endophthalmitis 0.13%
- Cystoid macular edema 1.4%
- Retinal detachment 0.7%
- Corneal Edema (BK) 0.3%
- IOL dislocation 1.1%
European Cataract Outcome Study, 1999 with 8646 patients (95-99)
- Intraoperative complications 3.1% Posterior capsule rupture 1.8%
- Vitreous loss 1.3%
- Wound leak 1.2%
- Retained lens material 1.1%
- Posterior capsule rupture 4.4%
- Iris damage 0.77%
European Cataract Outcome Study, 1999 with 8646 patients (95-99)
- Intraoperative complications 3.1%
- Posterior capsule rupture 1.8%
- Vitreous loss 1.3%
There is an increased risk for developing retinal detachments following cataract surgery. Generalized long-term risk of RD after cataract surgery
Seminars in Ophthalmology 17(3)206-21L;
Non post-surgical Retinal detachment:
- Prevalence 5 per 100,000 per year lifetime risk 1 in 300 67% of RD’s occur in nearsighted individuals with myopic lifetime risk (above 5-6 diopters) 1 in 20
- Associated with cataract surgery: 5 to 16 per 1000 cataract surgeries
Ophthalmology 106: 154-159
- 0.36% retinal detachment at 2 years after surgery
- 0.77% at 5 years
- 1.29% at 10 years
Because of this induced increased risk, counseling with regard to the symptoms of retinal detachment is indicated to cataract post-surgical patients, in particular those with myopia. These include the sudden onset of photopsias (multiple, split second, lightning-like flashes of light), a new shower of floaters, or a curtain-like veil covering part or all of a person’s vision. Prompt treatment often lessens morbidity.
At OMNI Eye Specialists, we are committed to the principles of informed consent prior to cataract surgery. The presence alone of cataractous lens changes is not sufficient to require cataract surgery. The decision to go forward with cataract surgery depends on whether a patient experiences a functional loss of visual clarity related to cataract formation sufficient to impact his or her daily visual tasks. An appropriate level of disclosure including rates of success and complications provides the patient the basis from which he or she can make an informed decision.