Informed Consent/How to Prevent Medicolegal Issues

27 Informed Consent/How to Prevent Medicolegal Issues

Ridzwan Namazie and Randipsingh Bindra

Abstract

Informed consent is a process by which a patient makes a voluntary decision on treatment based on the information provided by the treating physician. This should include details of the diagnosis, treatment options available, alternatives, risks, and benefits. In some situations, financial consent must be included.

Consent is a process that gives the patient time to digest the information, ask questions, make their independent inquiry, and come to a decision. Patient education sessions, written handouts, and links to resources are all vital tools but are not, in isolation, enough to constitute informed consent. A signed form merely indicates that a discussion has taken place but this may be insufficient to medicolegally qualify as fully informed consent. Detailed records of the discussion in the medical records are equally important.

Every country has their own health delivery system and cultural beliefs—consequently there are varying legal requirements and professional obligations with regard to treating a patient. However, while practitioners are universally familiar with their moral obligation to deliver the best care to the patient and to do no harm, it is their legal responsibility to ensure that the patient is made fully aware of the problem, the treatment offered, and be a part of the decision-making process.

Medicolegal issues arise when there is a breakdown of communication. Avoiding medicolegal issues begins with properly informed consent. Detailed documentation, developing a good rapport with the patient, and being transparent are all vital to ensure that the doctor-patient relationship is maintained.

Keywords: informed consent, medicolegal issues, medical malpractice, doctor-patient relationship, treatment options

27.1 Informed Consent

27.1.1 Background

Treating a competent patient without their permission is a violation of a basic tenet in medicine and transgresses their constitutional rights. Even in Hippocratic times, great emphasis was placed on listening to the patient, careful and comprehensive evaluation, discussing treatment options, and the open disclosure of prognosis.1 Subsequently, medieval Europe changed to a more active-passive model where patients were seen as helpless and the elite doctors knew what was best.² The paternalistic model evolved with improved patient access to knowledge and information leading to increasing levels of participation by the patient to a more patient-centric model that is practiced today.

The European Union has treaties and agreements that cover all EU Citizens. Article 5 of The European Convention of Human Rights and Biomedicine (ECHRB) which was signed in 1997 specifies that a doctor can only carry out medical procedures with the consent of the patient and that consent may be withdrawn.³ Further strengthening this is the Charter of Fundamental Rights of the European Union which states that patients have a right to be informed. Article 3 establishes that a doctor can only act with the consent of the patient.⁴

The standards of what constitutes properly informed consent have undergone constant evolution; however, the principles are largely unchanged. Each country has different laws that dictate the extent of what is acceptable consent. In addition, patient factors, cultural beliefs, religious beliefs, personal beliefs, and moral attitudes will also determine whether the consent obtained is adequate.

The phrase “informed consent” was first credited to an American lawyer PG Gebhard in 1957. He introduced the term in an amicus brief filed on behalf of the American College of Surgeons in a 1957 case of Salgo vs Leland Stanford Jr University. The final judgment of that case outlined principles that form the foundation of informed consent.⁵

27.1.2 Elements of Informed Consent

Medical consent does not apply to surgery alone; even the act of taking a history and examining the patient requires consent, although the patient visiting the physician imparts an implied consent. Further medical treatment, medications, or procedures are to be undertaken with the patient’s expressed consent. There are three key elements that need to be met as part of a valid informed consent.⁵

Capacity to Consent

The patient needs to understand the information provided, weigh potential consequences, and make a decision on whether to undergo treatment or otherwise. Other elements that affect capacity include information retention and the ability to communicate. The default position should always be that a person can consent unless proven otherwise.

If a patient is temporarily incapacitated following a head injury or is under the influence of drugs or alcohol, consent and treatment may be delayed to a later time unless in an emergency, in which case local guidelines and laws will dictate how to proceed in the best interest of the patient. In general, the principle of preservation of life and limb should prevail.

Where patients have a permanent impairment, there generally will be an appointed legal guardian with a power of attorney or an agency that has been given authority to consent. In some countries, the decision of acting in the best interests of an incapacitated patient rests with the doctor. Diminished mental capacity or a psychiatric condition does not automatically exclude a patient from the ability to consent. If patient comprehension is in doubt, written advice should be sought from their usual physician or psychiatrist. In any case, it is always in everyone’s best interest to include the patient as much as possible in the decision-making process.

There are some objective tools such as the MacArthur Competence Assessment Tool For Treatment (MacCAT-T) that have been developed to assess mental competence in giving consent. These tools, however, are not easy to administer and can be time consuming, taking up to 30 minutes to perform.

Consent Must Be Voluntary

The patient must decide to proceed with treatment without any coercion either from the physician, relatives, or a third party. It is difficult and, in some cases, impossible for the surgeon to know if the patient is completely free of external influences.

Just being in the hospital environment itself can be daunting and unfamiliar for many patients and can make patients feel pressurized into agreeing to treatment. Pressure from family on a patient to undergo treatment can be quite subtle. In most cases, family members feel that they have the patient’s best interests at heart; however, it is always important for the doctor to first and foremost respect the patient’s wishes especially when treating the elderly.

Surgeons treating a patient need to be aware of how advice is provided. An open dialogue between the surgeon and the patient which allows the patient to participate in the process is essential. Providing information in such a way that creates unnecessary urgency or in an unduly alarming manner could be viewed as coercion. The patient needs to be reassured that their consent is entirely voluntary and can be revoked, should they change their mind later.

The Patient Must Be Informed

The surgeon needs to be as comprehensive as possible in providing all the necessary information to the patient pertaining to their condition and treatment proposed using terminology that the patient understands. The patient should be informed of their diagnosis, differential diagnoses, and proposed investigations to confirm the diagnosis. The benefits of any intervention should be explained together with the adverse effects and risks. Specific mention should be made if the intervention is controversial or experimental. In a teaching institution, the person undertaking or supervising the intervention should be identified. Other possible treatment options and the option of not having any treatment should also be discussed together with the risks and benefits of each.

A surgeon is expected to tell a patient about the most common risks but not expected to list every conceivable complication following a surgery. In general terms, a known risk should be disclosed when an adverse outcome is a common event even though the detriment is slight, for example, skin tears after collagenase injection, or an outcome is severe even though its occurrence is rare, such as complex regional pain syndrome (CRPS) after carpal tunnel release. The discussion must include any outcomes that a reasonable person in the patient’s position would consider significant and the surgeon should be aware what complications may be of particular significance to that patient. A key aspect of the consent conversation is to find out what is important to the patient in their vocation and hobbies and to inquire about anything the patient may be particularly worried about. For example, loss of flexion at the distal interphalangeal joint would have differing significance for a guitar player versus a manual laborer. Patients need to be aware of the potential for complications in any procedure. When quoting complication rates, practitioners need to be clear on whether the data they are presenting relies on their own experience or whether they are referencing the literature,6 for example, when discussing loss of wrist motion after partial arthrodesis procedures.

The postoperative and rehabilitation protocols should be discussed, including details such as medications, restrictions on function, assistance needed at home, days in the hospital, casting requirements, splintage, and attendance at therapy sessions. Most patients would require an estimate of time off work, and if suitable, a staged return to work plan could be suggested. Further planned surgical intervention (e.g., removal of implants), prognosis, and expected outcomes should be discussed as well.

The use of patient information handouts, diagrams, charts, and educational models in explaining the treatment to patients is helpful. Directing the patient to reputable online resources (e.g., www.handcare.org

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