Most of us are not doctors. We are not nurses or paramedics. When we are sick or hurt we rely almost entirely on the recommendation of our health care provider and, typically, we do not question the decision because these providers must know best. However, the mere fact that we have faith in how our physicians determine our care does not mean that we fully understand those decisions. Healthcare providers may do their best to inform patients of their diagnoses and courses of treatment, but ultimately patients without any medical education often cannot comprehend the full scope of their medical situations. When patients cannot understand their situations, how can physicians possibly inform them of their options? More importantly, how can patients ever make truly informed decisions that reflect their wishes rather than those of their physicians?
In a 1991 study of patients admitted to a hospital for joint replacement, patients were studied for their understanding of various aspects of informed consent. Patients were only permitted to sign a consent form after successfully completing a quiz covering several items about which they were informed, including risk of infection, risk of nerve damage, relief of pain, and increased mobility. In a survey 6 months after giving consent, only 25% of patients could successfully recall the risk of infection and only 22% of patients could remember all potential benefits. Patients evidently remembered the different facets of the care they received in the short term; however, a failure of patient to recall essential information after only a few months indicates a failure of informed consent as a whole. If patients cannot remember the information for which they gave consent then as far as the patient is concerned, they might as well have received no information at all.
Informed consent becomes even more essential when considering clinical trials. In order to regulate the administration and execution of clinical trials, the 1964 Declaration of Helsinki outlined principles of research and medical care in the clinical trial setting. This provision for the protection of patients considered items such as patients with impaired abilities to give consent and excessive patient attachment to their physician that could alter their willingness to consent. However, in spite of these recommendations, issues with informed consent remain in clinical trials.
In a clinical trial in pediatric oncology, physicians discussed risks and benefits of various courses of treatment with parents and children. However, death was only discussed as a risk of participation in 9% of cases. The study suggests that this is a result of investigators concluding that the relatively low risk of death warranted not discussing the risk at all. It is entirely possible that even a low risk of death could dissuade patients from consenting to potentially life-saving treatments and physicians may reason that this psychology could negatively impact patients’ outcomes. Still, informing patients to the greatest extent that it is possible must remain the highest priority for healthcare providers.
Without actual medical knowledge, patients must more or less concede to the knowledge of their physicians. Several factors can prevent patients from fully giving informed consent, including the failure of physicians to inform, the failure of patients to understand, and physician recommendations that could ultimately conflict with patients’ wishes. In situations of simpler medical issues, with less variable possibilities and outcomes, patients can more effectively give informed consent. However, most medical situations are not simple: they are nuanced, with a multitude of possible treatments, side effects, and positive and negative outcomes. Among these many and complicated outcomes, patients must weigh what they believe to be positive outcomes against those outcomes that they believe to be negative. There is no guarantee that physicians’ paraphrasing of medical processes or relaying of patients’ options will not precipitate a decision that a patient would otherwise not have made. If, in fact, the patient makes the appropriate decision for him or herself, there is also no guarantee that the patient will have a complete, or even a sufficient, understanding of that decision.
Effectively providing patients with informative medical understanding will never be a universal occurrence. Whether it is because medicine is complicated or because human beings, both patient and physician, are inherently flawed, there will always be patients who do not fully understand their situations. However, physicians can provide informational pamphlets as well as online resources about medical conditions to improve patient understanding. Additionally doctors should provide full disclosure and encourage patients to ask questions about their care. If feasible, patients should also seek advice from multiple doctors about possible treatments to make an informed decision. A reasonable solution to poor informed consent is for physicians to inform as fully and with as little bias as possible, and for patients to strive to understand their diagnoses.
- Hutson, M. M., & Blaha, J.D. (1991). Patients’ recall of preoperative instruction for informed consent for an operation. Journal of Bone & Joint Surgery, 73(2): 160-162
- World Medical Association 52nd General Assembly. (2001). Declaration of Helsinki. Bulletin of the World Health Organization, 79(4): 373-374.
- Hazen, R.A., Zyzanski, S., Baker, J.N., Drotar, D., & Kodish, E. (2015). Communication about the risks and benefits of phase I pediatric oncology trials. Contemporary Clinical Trials, 41(1): 139-145.