Thursday, June 8, 2017

Informed Consent, Consent to Treat and Informed Refusal

A Compilation of Resources Discussing Informed Consent, Consent to Treat and Informed Refusal

As providers redefine processes to ensure more patient-centered care, you will want to reassess your informed consent approach to ensure that it abides by all regulations and protects the provider, patient and practice. Informed consent is a routine aspect of healthcare yet it is one of the most misunderstood concepts even among experienced physicians. This misunderstanding stems from a failure to understand all of the elements that comprise informed consent and recognize the ramifications of patient allegations that he or she did not understand the benefits versus drawbacks of a provider’s treatment recommendation.

A history of informed consent

Hippocrates, who gave us the first set of western writings on conduct for medical professionals, suggested patients are best served when physicians conceal most information. It was not until the 18th century writings of physician Benjamin Rush that we began to see recommendations that physicians share information with their patients. The publication of Medical Ethics in 1803 by Thomas Percival advocated the notion that while patients have a right to the truth, a physician might lie or withhold information if it results in better treatment. Informed consent gained more ground as a result of the atrocities committed by the Nazis who routinely experimented on human subjects.

The American Medical Association via Opinion 8.08, Informed Consent, says, “The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice.” Adopted in 1981 and updated in 2006, the opinion reads, “Physicians should sensitively and respectfully disclose all relevant medical information to patients.

The main purpose of the informed consent process is to protect the patient. A capable adult cannot be forced to have any type of medical treatment. In general, anything other than a life-threatening emergency in which the patient is unconscious requires consent before treatment. Even in that situation, consent may be required if the patient is known to have an advance directive.

The Advance Healthcare Directive
An advance health care directive or advance directive is a kind of legal document that tells the doctor your wishes about your health care.
Advance directives can be general, with very few directions about your care. The directive may just name a substitute person (proxy) to make these decisions for you if you are unable to do so. Or it may include instructions for the chosen proxy.
Advance directives can also be very detailed and clearly outline the different types of life-sustaining treatments you would accept or refuse in certain situations. Some types of advance directives are limited to certain situations, like the living will, organ or tissue donation, or your wishes not to be revived (resuscitated) if your heart or breathing stops.
Who besides the patient is allowed to consent?
For children or others who are unable to make the decision for themselves, the parent or legal guardian is legally responsible for getting the information, making the decision, and signing the consent form. But that doesn’t mean that the child or patient who is not considered mentally competent is always left out of the process. Some facilities require the assent of older children before they go into a research study, even after the parents have agreed on the child’s behalf. Assent means that, even though the parents sign the form, the child must also be OK with the plan before the facility will do the treatment.
Along the same lines, people who are unable to manage their daily affairs because of impaired thinking or emotional problems might still be able to understand the medical situation and make their wishes known. They should be given information in a way they can understand, and asked what they want to do.
In the event that you become unable to take in information and make your wishes known, another person may be asked to take part in the process of informed consent. There are several ways that person can be chosen.
  • Durable power of attorney for health care -- The only way you can choose the person to make these decisions for you is to set up a durable power of attorney for health care (also called a health care power of attorney). In this case, if you are unable to speak for yourself, the person you chose becomes legally responsible for making medical decisions on your behalf. This person is sometimes called your proxy, agent, or surrogate.
  • Court-appointed proxy -- Another option is a court-appointed surrogate or proxy. This is someone a judge chooses to make medical decisions for you. If you become unable to make decisions for yourself, someone else – such as the doctor, facility, a friend, or a family member – may ask (petition) the court to appoint someone to do it for you. The process varies from state to state.
  • State family agency acts -- Many states have passed family agency acts that choose which family members (in a listed order of priority) may act on behalf of a person who cannot speak for her- or himself. This option may be used if you don’t have an advance directive or court-appointed proxy. Depending on your family situation and which state you are in, that person may be your legal guardian, spouse, parent, child, sibling, or other relative.
A consent form is not needed for simple diagnostic tests and situations in which your actions imply consent. For example, if you see your doctor and allow a blood sample to be taken for lab tests, your consent is assumed because you went to the doctor seeking care and allowed blood to be drawn. At any point, you could change your mind and decide to refuse testing, leave the doctor’s office, or seek care elsewhere. This is different from a treatment that puts you in a vulnerable position or can possibly cause serious harm. You need more information about more risky treatments so that you can weigh your options and consider your risks before making a decision.

Even when there are no other accepted medical treatment options, it’s still your right as a competent adult to refuse a treatment that you don’t want or refuse to be in a study that you didn’t choose. But once you sign the consent form, it’s taken to be a formal, legal agreement that you are OK with the plan or procedure that’s listed on the form unless you revoke (take back) your consent before treatment is given. The doctor or facility will usually give you a copy of the consent form, but they keep the original as a legal record that you agreed to the treatment.
For example, a physician makes a recommendation to a patient for surgery and leaves the exam room. A nurse enters, puts a form in front of the patient and asks if there are any questions. The patient, still absorbing the news that he needs surgery, has no questions and signs the form. The surgery proceeds but does not go as planned. Soon thereafter, the physician is served with a claim for malpractice and medical battery citing, among other issues, a lack of informed consent.

Who wins? The answer is that no one wins.

Whether there is an adverse event that permanently affects the patient’s health or a patient believes he or she was not given all the necessary information, the patient walks away feeling shortchanged and the trust established with the physician is lost. Worst-case scenario, the patient’s health is adversely affected by a decision that would not have been made with better information, and the physician faces years of litigation that will affect the practice and his or her personal well-being.

Informed consent has been referred to in terms of medical ethics and treatment variation, but the task of obtaining informed consent is a practical issue that can be included in process review and regular staff meetings to ensure that providers are protected from malpractice allegations.

Informed consent

Far too often, physicians provide a treatment recommendation and the implications for not following it stop there. And while informed consent is a routine expectation, especially for high-risk procedures and drugs, it generally is not a legal requirement though informed consent requirements vary by state.

These requirements might be enacted by law or could be included in the policy documents of a state governing medical board. They might also be found in case law for malpractice claims. Because of failure to fully appreciate what constitutes effective informed consent and the inconsistency of requirements across the country, it is often not given its due diligence and can become a pretense for doing the right thing in name only with no meaning. Even when a physician believes they have imparted enough information for a patient to make an informed decision, a patient and a jury might disagree.

Informed consent can take two forms: implied or express.

Implied consent is generally associated with lower risk treatments and procedures, such as immunizations. While disclosure must be made regarding benefits and risks of an injection, generally via a Vaccine Information Sheet (VIS), we generally do not obtain signatures before an immunization unless it carries significant side effects or unknown risks. Instead, we rely on the patient rolling up their sleeve and presenting an arm as evidence of consent. In comparison, express consent is more formal. It is evidenced by a patient or guardian/power of attorney’s signature on a form.

While often referred to in varying terms, the elements that make up an informed consent discussion can be broken down into four categories, which should be included on your informed consent form:

Risks: What is the danger from a recommended treatment? Not every potential adverse outcome has to be mentioned but physicians know which outcomes are most likely to affect patients and those should be addressed. For example, a hand surgeon would probably have a more in-depth conversation with a world-renowned concert pianist than the average patient because an adverse outcome would alter the pianist’s career and life in different ways. Groups might want to consider what procedures or routine activities require express versus implied consent and establish a policy to avoid staff and provider confusion. When in doubt, go for the express consent to protect yourself. In theory, if a patient is properly educated, the execution of a signature on paperwork reflecting this should add very little time on the front end but could save years of wasted time in litigation on the back end.

Benefits: What can be gained from the treatment? Or what can a patient realistically expect to achieve from adhering to the prescribed treatment? For example, will a patient’s pain be minimized or disappear? Will life expectancy increase? Are there limitations? A discussion about the likelihood of potential benefits is prudent, and you should also talk about factors that would prevent this patient from falling within the general expectations.

Alternatives: Are there other treatment choices that should be considered? For example, should a patient consider a nonsurgical approach, such as glasses or contacts in lieu of Lasik surgery? Keep in mind that alternatives include pursuing no treatment, which should be included as an option no matter how wrong you might think it is. The issue of cost for various options might be worth mentioning if there is a significant difference, especially for patients with no insurance. There will be varying opinions among physicians about how to handle alternatives, which they might not advise but it is important for physicians in groups to operate uniformly. Conflicts should be resolved within the governance structure of the organization. Physicians should be encouraged to consider their ethical obligations and reach consensus. Physicians can certainly offer options without endorsing them and be as candid as possible with patients.

Consequences: What are the potential implications of a patient’s decision, whether it is to follow a recommended treatment, pursue an alternative or do nothing? This is when most physicians typically are asked, “What would you do?” There is no harm in answering this question, but remind a patient that he or she has to make the decision based on his or her unique situation.

Informed refusal

While some states require signed consent for certain procedures, such as sterilization, the vast majority have few or no rules. Even when not required, an informed consent form is invaluable in defending a malpractice claim. However, an informed refusal form is equally valuable.

An informed refusal form is really just a twist on an informed consent form and while it is not commonly used, it is worth its weight in gold from a defense perspective with a noncompliant patient. The real difference is that instead of acknowledging and accepting the risks of treatment with an informed consent form, a patient acknowledges the risks of not following a physician’s recommendations. The form acknowledges that a patient is choosing an alternative treatment or no treatment at all and any accompanying consequences. These are particularly important with noncompliant patients to demonstrate that they have made educated decisions to not follow provider advice and knowingly accept the consequences.

As frustrating as it can be, competent adults get to make their own healthcare decisions. That word “competent” is key here. Informed consent discussions should occur while a patient is coherent and able to have the discussion. Ideally, the conversation should occur when the patient is best able to understand the information, which might require a follow-up appointment if the patient has just received difficult news or needs a family member present.

Do not initiate this type of discussion after drugs have been administered or when a patient is distraught over a serious diagnosis. That could result in a signed form being declared void for lack of competency at that moment. (It has happened.) Obtaining a signed form at this point opens a physician up to a “he said/she said” argument that can easily be avoided. And while most physicians understand this, it is important to ensure that the team members who assist a physician also understand these guidelines so they do not pressure a patient for a signature after medications have been administered.

If a situation goes to court, a patient might allege that he or she did not understand the conversation or did not have the opportunity to ask questions. While a patient can still make this assertion, a signed form goes a long way with a jury to show that processes were followed. And a jury ultimately decides the issue in a trial situation. If you choose to not use a form and obtain a signature, it is still wise to document the conversation in the medical record. A note made at the time of the discussion bolsters a physician’s account of what transpired. Lawsuits can take years to reach the deposition or trial phase, and if a physician acts as a witness in his or her own defense, citing a written note is more reliable than relying on his or her memory.

Any number of resources can be used in the informed consent process, such as printed patient education materials, websites and videos. Physicians might also use experienced staff to talk with patients and address questions. That team would include a nonphysician provider, nurse, medical assistant or anyone else who a physician believes has the skill and knowledge to discuss treatment options. However, the physician is ultimately responsible for ensuring that the process was properly conducted and that he or she was available to answer any questions. Failure to do so can result in dissatisfied patients, which carries its own ramifications, and it can prompt needless litigation.

See: Weinmeyer R. “Lack of standardized informed consentpractices and medical malpractice.” AMA Journal of Ethics. February 2014;16(2):120-123.

Requirements for Informed Consent

Informed consent is an ethical concept—that all patients should understand and agree to the potential consequences of their care—that has become codified in the law and in daily practice at every medical institution. One of the earliest legal precedents in this area was established in 1914 when a physician removed a tumor from the abdomen of a patient who had consented to only a diagnostic procedure (Schloendorff vs. Society of New YorkHospital). The judge in this case ruled that the physician was liable for battery because he violated an “individual’s fundamental right to decide what is being done with his or her body.” The first case actually defining the elements of informed consent occurred in the late 1950's and involved a question of potential negligence and whether a patient was given sufficient information to make a decision.

The case law and rules pertaining to informed consent have changed over the years and all 50 states now have legislation that requires some level of informed consent. Although the details of these laws vary from state to state, the bottom line is that failure to obtain informed consent renders any U.S. physician liable for negligence or battery and constitutes medical malpractice.

Exceptions are made for emergencies or legally adjudicated mental incompetency or physical incapacity. Several of the common elements required for full disclosure have been summarized by the American Medical Association (Table 1 - below) and other groups representing specialists or quality assurance organizations. For example, federal regulations spell out the minimum requirements for a properly executed informed consent form (Table 2 - below) and state that this form must be in the patient’s chart before surgery. [CFR Title 42] These regulations also stipulate that the information must be given in a language or means of communication that the patient understands. The U.S. government requires interpretation and translation services for individuals with limited English proficiency at institutions that receive federal funding; these regulations also state that informed consent forms must be translated into languages spoken by 5% or 1,000 of a provider’s patients—whichever is less. [Executive Order13166]

The Basic Features of Everyday Informed Consent - [Table 1]
               
The physician (not a delegated representative) should disclose and discuss:
  • The diagnosis, if known
  • The nature and purpose of a proposed treatment or procedure
  • The risks and benefits of proposed treatment or procedures
  • Alternatives (regardless of costs or extent covered by insurance)
  • The risks and benefits of alternatives
  • The risks and benefits of not receiving treatments or undergoing procedures
Source: AMA 1998

What’s Needed on the Informed Consent Form - [Table 2]
  • Name and signature of the patient, or if appropriate, legal representative
  • Name of the hospital
  • Name of procedure(s)
  • Name of all practitioners performing the procedure and individual significant tasks if more than one practitioner
  • Risks
  • Benefits
  • Alternative procedures and treatments and their risks
  • Date and time consent is obtained
  • Statement that procedure was explained to patient or guardian
  • Signature of person witnessing the consent
  • Name and signature of person who explained the procedure to the patient or guardian
Source: Federal Code (Title 42 C.F.R. § 482.51 (b) (2)) Interpretive Guideline A-0392

Which procedures require informed consent? Unfortunately there is no continually updated national list describing exactly when informed consent is required. Again, it varies from state to state and is also influenced by clinician or hospital interpretation of recommendations from professional and specialty groups.

For example:
  • Pennsylvania state law specifically requires that consent be obtained for blood transfusions, chemotherapy, and methadone use as part of a narcotics treatment program. [PA Law Code]
  • Many states have developed specific laws governing breast cancer diagnosis and treatment. [ACS 2007]
  • The American College of Obstetrics and Gynecology has developed detailed guidelines for informed consent issues related to sterilization and carrier testing for cystic fibrosis. [ACOG 2004]
  • Increased levels of institutional quality (e.g., compliance with accreditation standards)
  • Potential time and money savings (or offsets) related to reduced litigation
Thus, based on guidance from staff and counsel, each institution generally develops its own list of surgeries, procedures, or situations where full informed consent is needed. In fact, the Joint Commission (formerly known as the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) has set a standard that hospitals must establish and follow policies that describe which procedures or care, treatment, or services require informed consent. [Joint Commission 2005] One of the first steps recommended is to clarify your institution's policies about when informed consent is required.

Another area subject to local interpretation is exactly how much to disclose. How many potential risks must be described, for example, and how many alternatives must be mentioned? While many states rely on a standard of what a “reasonable physician” would provide or what a “reasonable patient” would need, this still leaves room for interpretation. Most laws describe the need to cover all “material” (i.e., significant) risks. But common sense suggests that not every potential risk can be described in detail and that only the most prevalent and/or serious risks and side effects would be covered. The number and type of complications also may vary widely depending on the severity of the patient’s underlying conditions or comorbidities (e.g., pneumothorax following central vein catheterization may not be life-threatening in a patient admitted for a soft-tissue abscess but could be extremely risky in a patient receiving mechanical ventilation for severe acute respiratory distress syndrome). How can a single form cover both situations? Further complicating the issue, of course, is the fact that there are limitations and variations in the capacity of individual patients to comprehend many of these details—and therefore the information needs to be tailored for each individual.

It is precisely these gray areas in the requirements for informed consent - When is it needed? How much is needed? And how can I make sure the patient understands? - that have opened the door for many of the documented failures of informed consent in everyday practice. (See below: “Informed Consent in Practice”).

One common defensive response to the uncertainties about how much to disclose, for example, is use of “blanket” informed consent forms that contain only boiler-plate generalities that “all potential risks and side effects and alternatives have been explained and understood by the patient.” If such a generic consent form is accompanied by genuine documented education involving appropriate explanation and printed material, this may work. (Attorneys also usually advise clinicians to document the details of this interchange in the patient’s record.)

But on its own, an overly generic consent form without any significant accompanying education, interchange and documentation - that is, a quick request for a signature while the patient is on the gurney - is not adequate. On the other hand, an exhaustive list of all the potential risks may be difficult for patients to understand. (Attorneys reviewing such a list would also likely point out that any omission from such a long and seemingly comprehensive list might be a red flag, and that such a form would therefore need to state that the list is not inclusive. [AMA 1998])

Informed Consent in Practice
  • How often does informed consent work as intended?
  • How do your practices match up to the national norms for informed consent?
  • How does one even begin to measure the “success” of informed consent?
These are complex questions that have been tackled by clinicians and researchers from different settings and perspectives. Many studies have focused on one therapeutic area of interest. Others have analyzed the consent process only in the research setting. And some have evaluated the process in targeted patient groups such as those with low literacy.
Reviewing the results from such studies provides a sense of the problems that must still be overcome in planning for and delivering informed consent in everyday clinical practice. While much of this data comes out of the clinical research setting, many of the broader “lessons learned” in these studies are highly applicable to the setting of everyday informed consent.

Best Practices



Developing an Informed Consent Form

Download this Style Guide template for improving you Informed Consent Form(s).

In summary and based on all of this information, two points stand out:
  1. Patients have a fundamental right and need to receive information, both orally and written, about their care in a manner they can fully comprehend and that will lead to truly shared decision-making, and 
  2. current practices of informed consent are often inadequate and are especially hampered by growing rates of health illiteracy in the U.S. 
A number of studies indicate that improving consent forms and the overall consent process can lead to better patient comprehension and recall. Although the research on improved consent forms has been mixed, some studies have found that when consent forms are improved, patients are more likely to read and understand them before signing. Using a consistent informed consent template as a starting point for the creation of forms for various procedures also appears to improve consistency and quality in the forms. Providing clear and simple information about procedures may also lower patient anxiety levels and increase understanding and recall in a way that produces a more deliberative decision-making process.

However, a clearly written consent form does not guarantee that patients will read and understand them. A properly constructed and clearly formatted consent form is a necessary but not sufficient condition for ensuring that patients read, understand, and remember the information presented. Thus, a variety of other methods are needed to increase patient involvement in the consent process and improve patient comprehension of the information presented. For example, several recent studies show that repeating information to patients in various formats and modes and at different times can strengthen comprehension and recall.





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