Part 1: Defining Informed Consent
Have you ever considered what the term “informed consent” means to you? Informed consent is a foundational component of patient care with the assertion that the patient has the right to make his/her own health decisions without external influence. Ridley (2001) describes informed consent as “the fundamental ethical and legal doctrine that protects the patient’s rights of personal autonomy and bodily self-determination.” The premise of this principle is that the patient decides freely and independently of his or her medical choices without judgment or coercion.
The process of informed consent is a joint responsibility between the physician and patient. The underlying principles include that the patient must have awareness of their state of health and diagnosis, choices of treatment, risks and benefits of the options, alternative possibilities, and potential outcomes (Lewis & Pignone, 2009). Additionally, the respect of patient goals, preferences, and values should be taken into consideration by the healthcare team when determining the plan of care.
Unfortunately, the ability for patients to receive true informed consent is not without barriers. Historically, the estimate of proper informed consent is only 20% (Lewis & Pignone, 2009) of the time. The physician may not communicate adequately to the patient and neglect to explain the full scope of the patient options, risks, and benefits. Other challenges reported by doctors include lack of time; lack of experience and training to discuss elements of informed consent; and individual patient circumstances, such as reluctance (Vikas et al., 2021).
In a study by Vikas and colleagues (2021), 200 patients were interviewed to assess the level of information provided to them before surgery. While 100% of the surgeons discussed the patient’s current problem, improvements were needed in other areas. The authors discovered that the physicians performed well with sharing the indications, purpose, and benefits of the surgery, as well as the follow-up care required. The surgeons sought to ask the patient if there were any questions and confirmed the willingness to give consent. However, only 34% of patients were informed of the risks involved with the surgery. Twenty-six percent received knowledge of alternative options available to them and 24% were notified of the risks and benefits of those other treatments. Knowledge and awareness of the components required for informed consent is important for patients to apply when faced with a health decision.
Elements of Informed Consent:
The healthcare provider should:
Inform you that you can and should participate in decisions
Give information about the issue
Notify you of the alternatives
Share both risks and benefits
Review any uncertainties surrounding the decision
Ask you to convey understanding and repeat the information back to verify the information you heard
Ask you to discuss your thoughts and opinions
(Braddock & Edwards, 1999)
In a qualitative survey of 734 women (Dixon-Woods et al., 2006), researchers investigated the consent of women facing elective and emergency gynecological and obstetrical surgery. Their findings showed that 33% of women assigned to elective surgery and 40% to emergency surgery reported hesitancy when signing the consent. Within these percentages, 24% of elective and 40% of emergency patients conveyed feeling forced to sign the consent form. The reasons reported were not reading or comprehending the consent form and not having the opportunity to have their questions answered by the medical staff.
The patient may struggle to comprehend the information shared during the consent process. Not understanding health information, or low health literacy, may impede the ability for the patient to provide consent. Hickey and colleagues (2018) define health literacy as “able to engage in complex disease management and self-care.” When patients exhibit low health literacy, they are thought to have “increased hospitalization rates, develop more diseases, and experience higher mortality (Hickey et al., 2018, p. 49).” Additionally, these patients may utilize emergency departments more, tend to be elderly, face lower income, suffer more chronic conditions, and encounter language barriers. If information is difficult to understand, patient strategies could be: ask the healthcare provider to use clear language in non-medical terms (Cornett, 2009); inquire if printed instructions could be provided; and repeat back to the provider the knowledge grasped, such as “what I am understanding you to say is…”
In general, the patient may not know that their own role in decision-making is so essential. Advocating for oneself could be a new responsibility for some people. Often healthcare professionals are perceived to have an authoritative role, with patients submitting to the advice of their physician with a lot of trust. Influences from society may create an assumption that the patient should not take an active role in their plan of care. However, in a study by Levinson and colleagues (2005), of the 2,765 English-speaking adults were surveyed, 96% reported that they wanted choices offered and their preferences heard.
The benefits of informed care are profound. As stated by the World Council for Health (2022), “informed consent exists to protect people from coercion, medical experimentation, and procedures that may cause them more harm than benefit.” Invasive treatment may be avoided, less drastic measures pursued, outcomes better, and patient preferences valued. Above all, making choices for oneself empowers people to be in control of their own life.
How can you better participate in decisions? Educate yourself on informed consent. Learn about your health condition, and seek different solutions. Try not to become consumed by feeling overwhelmed, being rushed, or sensing fear. Slow down and take time to decide. Your life is yours!
References:
Braddock, C. H., Edwards, K. A., Hansenberg, N. M., Laidley, T. L., Levinson, W. (1999). Informed decision making in outpatient practice: Time to get back to basics. JAMA, 282(24), 2313 – 2320.
Cornett, S. (2009). Assessing and addressing health literacy. The Online Journal of Issues in Nursing, 14(3). https://ojin.nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OJIN/TableofContents/Vol142009/No3Sept09/Assessing-Health-Literacy-.html
Dixon-Woods, M., Williams, S. J., Jackson, C. J., Akkad, A., Kenyon, S., & Habiba, M. (2006). Why do women consent to surgery, even when they do not want to? An interactionist and Bourdieusian analysis. Social Science & Medicine, 62(11), 2742-2753.
Hickey, K. T., Masterson Creber, R. M., Reading, M., Sciacca, R. R., Riga, T. C., Frulla, A. P., & Casida, J. M. (2018). Low health literacy: Implications for managing cardiac patients in practice. The Nurse Practitioner, 43(8), 49–55. https://doi.org/10.1097/01.NPR.0000541468.54290.49
Levinson, W., Kao, A., Kuby, A., & Thisted, R. A. (2005). Not all patients want to participate in decision making. A national study of public preferences. Journal of General Internal Medicine, 20(6), 531–535. https://doi.org/10.1111/j.1525-1497.2005.04101.x
Lewis, C. L., & Pignone, M. P. (2009). Promoting informed decision-making in a primary care practice by implementing decision aids. North Carolina Medical Journal, 70(2), 136–139. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3213756/
Ridley, D. T. (2001). Informed consent, informed refusal, informed choice – What is it that makes a patient’s medical treatment decisions informed? Medicine and Law, 20(2), 205 – 214.
Strini, V., Schiavolin, R., & Prendin, A. (2021). The role of the nurse in informed consent to treatments: An observational-descriptive study in the Padua Hospital. Clinics and Practice, 11(3), 472-483. https://doi.10.3390/clinpract11030063
Vikas, H., Kini, A., Sharma, N., Gowda, N. R., & Gupta, A. (2021). How informed is the informed consent?. Journal of Family Medicine and Primary Care, 10(6), 2299–2303. https://doi.org/10.4103/jfmpc.jfmpc_2393_20
Why is informed consent so important? (2022). World Council for Health. https://worldcouncilforhealth.org/resources/why-is-informed-consent-important