There has been a new focus on the empowerment of patients through enhanced engagement and robust shared decision-making (SDM). Health literacy is a strong social determinant of health. Inherent in both SDM and health literacy is strong communication between provider and patient, centered on informed consent (IC). With this effort in mind, it is critical patients understand the importance of informed consent and its elements. Concurrently, there is an obligation for physicians to have a strong understanding of IC to effectively communicate crucial information. Patient centered care requires efforts to place IC and communication high on the list of objectives of care.
For patients understanding the correct questions to ask will dramatically alter and likely enhance the care they receive. It is equally important for physicians to understand what information is needed by patients and present it in an unbiased and understandable way.
Patients increasingly are encouraged to become vocal advocates of their own health and savvy consumers. Many patients research and Google their symptoms /diseases, bringing this new found knowledge to their care givers. The informed consumer will enhance a synergistic physician patient relationship rather than a dependent one. While no one suggests an equivalency of years of training and clinical experience of providers to a focused education by patients, the more patients know, the better choices they can make to fulfill their personal preferences for care. SDM should be the goal of patients and caregivers.
Many physicians and administrators have viewed informed consent for years as being an inconvenience, requiring a signature on the bottom of a form. Informed consent is much more than that. By soliciting the participation of the patient in their own care there is greater understanding and compliance in treatment regimens. The new scrutiny of patient satisfaction, Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores and patient reported outcome measures (PROM) further incentivizes caregivers to become knowledgeable about informed consent. Much research supports enhanced perceived quality of life and emotional well-being with SDM. Additional research also confirms greater compliance in patients with SDM.
Informed consent legally requires caregivers to communicate the risks, benefits and alternatives, including the risk of doing nothing, to patients. The frequent question arises, “Must all risks benefits and alternatives be communicated?” The answer is “Clinicians must communicate all risk alternatives and benefits that a reasonable patient would want to know who is in that patients situation”. The “reasonable person “ standard creates an objective basis for disclosure to minimize the self-serving hindsight assessment that all people have when a risk unfortunately occurs but the balance is the requirement to give information that a patient similarly situated would wish to know, which adds a subjective component. A good example would be disclosures of the risks of shoulder surgery, which may be more expansive to a major league pitcher than to an opera singer. The requirement for disclosure balances objective and subjective components of decision-making.
Many incorrectly suggest that remote or rare risks need not be disclosed. Even remote risks which are catastrophic should be disclosed since they are so impactful and a reasonable person likely would wish to be notified. Also remote risks should be disclosed when alternatives are available that have dramatically lower risk or no risk. The best example of this is in the field of radiology. When ordering an imaging study to evaluate for liver function test abnormalities, all patients should be informed of the risk of radiation and contrast injection since US and MRI are available and do not use ionizing radiation and both tests can be performed without contrast. The importance of revealing remote risks is especially important for diagnostic tests since the patient is not having a direct therapeutic benefit for undergoing the risk, but a potential diagnostic benefit.
The examples in radiology are very telling and serve as a springboard on how to approach IC and SDM. Some practices get informed consent for the administration of iodinated contrast. The risk of death has been approximated at between 1in 100,000 to 1 in 400,000. While this is remote, knowing that there is an alternative for many examinations such as MRI or US (with relatively equivalent accuracy) without contrast would likely lead most reasonable people to consider other options. 80 million contrast injections are given yearly, these means somewhere between 150 to 800 people die each year due to contrast reactions. In my department a 12 year old girl died due to a contrast reaction during a urologic workup. Based on this experience I vowed to ask myself every time I use contrast whether there was an equivalent means to do the workup avoiding the use of contrast. The answer is almost always “yes there is”.
How often is the risk of radiation discussed with patients and IC obtained? The answer is not frequently. Would a reasonable patient want to know the risks? Let’s look at the data. The FDA published their conclusion based on the assumption of 10 millisieverts of exposure for a CT. They concluded a 1 in 2000 chance of developing cancer which is very small incremental risk as compared to the underlying risk of cancer for the population. Fortunately again, if there is a real alternative such as US or MRI, a reasonable person would likely benefit from this information and view it as material in making a choice. I rarely perform a CT with contrast for appendicitis prior to attempting a good US exam, especially in children.
Of much greater concern regarding radiation risk is a recent study which determined based on the 85 million CTs performed in 2012 that an additional 47,000 additional cancers would result annually. The methodology relied on the most recent BIER VII risk estimates. As a matter of public health, radiologists need to stand up and listen. Again would a reasonable person wish to know this information? Most patients would want to know in my opinion. I follow the golden rule in medicine which is I recommend to my patients the treatment that I would want for myself, a relative or close friend. Following this rule has served me well.
I agree that risk of missing significant disease by not performing CT far outweighs the above described risks but that is not the question when assessing IC and SDM. The real question is would a reasonable person consider US or MRI as an alternative to radiation and contrast if presented with the information? Again the answer to that is quite obvious as well. The cautionary tale is that patients and both ordering physicians and radiologists should be practicing in a patient centric model that encourages SDM with meaningful IC. Many more MR exams and US should be considered by all.
The examples in radiology are the tip of the iceberg for all patients and clinicians moving to a more engaged patient model. Much of the literature and understanding of medical decision making and communicating information shows over estimation of benefits and minimizing of risks by caregivers and patients alike. This may be more a reflection of cognitive bias than informational ignorance. It is also vital that patients and doctors become much more facile with the use of the intention to treat principle which has become the cornerstone of the evaluation of randomized controlled trials with the goal of selecting the best medical therapies. Intention to treat principles are concisely explained in a 2014 JAMA article
The effectiveness of a therapy is not simply determined by its pure biological effect but is also influenced by the physician’s ability to administer, or the patient’s ability to adhere to, the intended treatment. The true effect of selecting a treatment is a combination of biological effects, variations in compliance or adherence, and other patient characteristics that influence efficacy. Only by retaining all patients intended to receive a given treatment in their original treatment group can researchers and clinicians obtain an unbiased estimate of the effect of selecting one treatment over another. (The Intention-to-Treat Principle How to Assess the True Effect of Choosing a Medical Treatment, Michelle A. Detry, PhD; Roger J. Lewis, MD, PhD)
In order to maximize our autonomy and health we must become informed consumers and as caregivers communicate meaningful material information to our patients. SDM has already been shown to enhance compliance and satisfaction and with patient centered and reported outcomes being scrutinized, we should embrace this new model. By understanding the elements of IC and SDM we can help our patients and be better clinicians.
Nicolas Argy, MD, JD
Copyright © 2016 Nicolas Argy