It has become part of the South African accreditation of an oncology facility to obtain signed, informed consent to chemo. This has evolved over time as it was previously implied that if the patient simply showed up for treatment, they automatically consented to it. But consenting to chemo has now become a very important part of the quality of care and the communication process.
By providing informed consent the physician must convey the necessary information to the patient to understand the scope and nature of the intended treatment. It is important to assess the potential risks and benefits in order to make a decision. Ultimately it is the patient who assigns weight to the risks and benefits. Nonetheless, the potential benefit of any intervention or treatment must outweigh the risks in order for the action to be ethical.
Informed consent is an on-going communication process. It is not intended to limit or replace the discussion of information between the physician and patient. It is not set in stone, so a patient has the right to re-evaluate and withdraw consent at any stage. Each oncology unit has a form in place to confirm, not replace, the face-to-face conversation.
Due to the toxic nature of chemo, it introduces numerous risks and potential side effects. It is the legal duty of the physician to disclose these. Decisions are made weighing potential harms and intended benefits. The doctor needs to be forthcoming about uncertainties inherent in chemo. Specific disclosures, such as statistical data may not be legally necessary. But, if the patient requests such information, it is the duty of the doctor to supply it. However, when the treatment is innovative, untested or outside the standard of care, this should be disclosed. Consent to medical treatment is very different from consent to research medication or participation in a clinical trial.
Standardised documents are helpful in litigation. It can be considered strong evidence that the doctor did encourage the appropriate discussion with the patient, and it can create the presumption that the patient was adequately informed.
Disclosures that the physician is required to make include location, type, and stage of the disease. They must inform the patient of diagnostic test results that may influence treatment decisions. The doctor needs to discuss the prognosis with the patient. They must inform the patient of benefits to treatment, which might include cure, reduction in tumour size, prolongation of survival, or palliative care.
The risk of adverse events is high due to the toxic nature of the chemo. Specific circumstances that make some risks more material than others need to be considered for example, diabetes, hypertension or any number of other co-morbidities, as well as social considerations. Long term planning must be discussed, for example fertility preservation where applicable. This is important because there can be both long term and short-term side effects to treatment.
Alternatives, costs, length for recuperation, and likely success are also important facets for the conversation. The physician needs to assess the patient’s level of understanding and provide appropriate information in a manner most useful to the patient. There must be a chance for questions and answers. How the treatment will be administered and by whom it will be given, are important questions. The patient takes the treatment of free will. The patient must be of adult years and sound mind to consent, or a legal guardian may provide such consent on the patient’s behalf. If translation is required, this must also be incorporated in an appropriate manner. The patient must be supplied with a copy of the consent form.
Please remember that the patient is at the centre of the decision-making process and has a right to decide on treatments that affect the course of their own health. There is a right to a second opinion, continuity of care and to refuse treatment.
The HPCSA (Health Professions Council of South Africa) states that a health care profession implies promise or commitment to sound professional and ethical practices and an over-riding dedication to the interests of human beings and society. Evidence-based medicine has become the gold standard of clinical practice, whereby science and studies and expert medical opinions give rise to guidelines for treatment. This can, however, not replace clinical judgement or patient-centred care.
Know your rights. Discuss your treatment. Equip yourself with information as a patient, especially when you are due to undergo chemo. Remember: “Knowledge is power!”
Written by Andrea Brummer