Informed consent is an essential aspect of ethical patient care. But what does the term really mean in practical terms? And what are physical therapists’ and physical therapist assistants’ obligations for obtaining informed consent from patients? This column provides some answers.
Key Principles
Two core principles underlie informed consent: patient autonomy and shared communication and decision-making between the patient and provider. The American Medical Association’s Code of Medical Ethics states:
Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making. The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention.
For patients to make what AMA calls a “well-considered” choice about their treatment, they must know what the proposed treatment promises, any associated risks, and the benefits and risks of the alternatives.
What Constitutes Informed Consent in Physical Therapy?
The APTA Guide for Professional Conduct, which provides interpretation for the APTA Code of Ethics for the Physical Therapist, does not use the phrase “informed consent.” It does say that a PT must “respect the individual’s right to make decisions regarding the recommended plan of care, including consent, modification, or refusal.” The APTA Code of Ethics states that PTs must “provide the information necessary to allow patients or their surrogates to make informed decisions about physical therapy care” and “collaborate with patients and clients to empower them in decisions about their health care.”
But the APTA Guide for Professional Conduct is tentative in its interpretation of the Code of Ethics regarding exactly what a PT must tell a patient. The document says only that a PT should “use sound professional judgment in informing the patient or client of any substantial risks of the recommended examination and intervention” without further defining what said judgment entails. The APTA Standards of Ethical Conduct for the Physical Therapist Assistant is similarly vague, stating that PTAs “shall provide patients and clients with information regarding the interventions they provide.”
So what information does the patient need in order to give informed consent? A policy statement from World Physiotherapy (formerly the World Confederation for Physical Therapy) states:
Competent individuals should be provided with adequate, intelligible information about the proposed physical therapy. This information should include a clear explanation of:
- The planned examination/assessment.
- The evaluation, diagnosis, and prognosis/plan.
- The intervention/treatment to be provided.
- The risks which may be associated with the intervention.
- The expected benefits of the intervention.
- The anticipated time frames.
- The anticipated costs.
- Any reasonable alternatives to the recommended intervention.
Legal Liability
Whether a PT could be considered legally liable for failing to give a patient information needed to make an “informed” decision depends on state law. Some state laws provide specific answers about which providers are obligated to obtain informed consent, what information they must provide to patients, and what kind of evidence will be sufficient to prove informed consent in the event of a lawsuit. Consult your state law, an attorney, and HPSO for specific questions on legal liability.
Some states have informed consent statutes that apply to PTs. Arkansas state law applies to claims against PTs and contains specific provisions regarding what a plaintiff must prove to show lack of informed consent. Utah’s code gives specifics as to what a patient needs to show to be able to claim damages against a health care provider (including a PT) for failing to obtain informed consent, and what the proper defenses are for providers who fail to obtain informed consent. Other states have informed consent statutes that apply to PTs providing dry needling (Colorado), or services using telehealth (Kentucky).
In addition to the possibility of liability in a personal injury lawsuit, PTs might be subject to disciplinary action by their licensing board for failing to provide a patient with the information necessary to make an informed decision. For example, the rules of the Minnesota State Board of Physical Therapy provide that, in general, a PT “shall not provide patient care without disclosing benefits and substantial risks, if any, of the recommended examination, intervention, and the alternatives to the patient or patients’ legal representative.” Similarly, the rules of the Arizona Board of Physical Therapy provide that a PT:
Shall respect a patient’s right to make decisions regarding examination and the recommended plan of care including the patient’s decision regarding consent, modification of the plan of care, or refusal of examination or treatment. To assist the patient in making these decisions, the physical therapist shall: 1. Communicate to the patient: a. Examination findings, b. Evaluation of the findings, and c. Diagnosis and prognosis, 2. Collaborate with the patient to establish the goals of treatment and the plan of care, and 3. Inform the patient that the patient is free to select another physical therapy provider.
What To Disclose
State laws vary, and there is no universally applicable rule about what, if anything, PTs must disclose to patients, or how they should document what they disclose. As a starting point, PTs should comply with their state physical therapy practice acts and state regulations and consult with an attorney for specific questions. But, generally, it is better to err on the side of caution. The more information a PT provides about benefits, risks, and alternatives, the less likely it is that they will be held liable to a patient who claims the PT failed to provide adequate information.
The World Physiotherapy statement on informed consent offers a useful overview of the basic categories of information that PTs most likely would need to disclose. It cites the expected benefits of the therapy, associated risks, and reasonable alternatives to the proposed therapy, among others. It also states that PTs should record in their documentation, in a format required by their jurisdiction, that they have obtained informed consent.
Given the enormous scope of physical therapist practice, it is impossible to catalog all the expected benefits or risks of physical therapy. However, PTs should present the risks associated with manual therapy with careful consideration. One case worth examining is Wilson v. Merritt, in which a patient with preexisting paralysis who greatly depended on his arms was injured by manipulation performed by a chiropractor while the patient was under anesthesia. The court in that case held that there was sufficient evidence that a reasonable and prudent person would not have undergone the procedure had he or she been informed of the risk of injury to the shoulder.
Another risk that PTs should consider is that of falls associated with therapy intended to improve ambulation. Falls are among the most common instances in which patients are injured during physical therapy. Common sense, therefore, suggests that PTs specializing in geriatric care should not only guard against falls but also warn patients about the risk of falling.
Disclosure and informed consent are needed in other areas as well, such as pelvic health and internal exams. Check with your relevant sections and academies to see if they have additional attorney-reviewed consent information.
Documentation
Documentation of informed consent should show two things: that the PT gave information, and that the patient understood that information and consented to the proposed treatment. Some states’ regulations expressly require providers to document informed consent. Missouri requires that PTs and PTAs document informed consent but does not provide details as to what is required.
Proving that a patient understood what the PT communicated is more difficult than proving what information the PT provided. Therefore, obtaining the patient’s signature at the bottom of an appropriate recitation of the information provided would be helpful, but not definitive. A statement saying only that the patient was given the opportunity to ask questions may not be very helpful in court to a PT needing to prove that they actually gave information about a particular risk or alternative treatment.
Some patients might be unable to understand the information provided by the PT, while others might be incapable legally of giving consent. For example, an adult patient with dementia might be unable to grasp even simple information presented by the PT, whereas an astute 12-year-old might be too young to give legal consent to a procedure that they understand perfectly. Further, for patients with limited English proficiency, failing to provide qualified interpreters could interfere with a patient’s legal right to informed consent, in addition to preventing a patient’s participation in shared decision-making. This failure could qualify as national origin discrimination under federal law. For specific issues relating to informed consent regarding incapacity and limited English proficiency, check your state laws and consult an attorney.
Summing Up
Because state laws, statutes, and regulations differ, there are few one-size-fits-all answers. By staying current and taking a measured, thoughtful approach, with input from legal counsel as appropriate, PTs can successfully handle the issue of informed consent in their own practice settings.
Note: The information provided is offered for general informational purposes only. It is not offered or intended, nor should it be relied upon, as legal advice. Legal doctrines, statutes, and case law vary from state to state. You should consult with your own attorney for specific legal advice on legal issues.