Patients Are Signing Consent Forms They Don’t Understand. We Can Do Better.
Most medical, surgical, and diagnostic procedures carry some sort of risk—from mild side effects like a sore arm after getting the flu shot to serious potential complications such as stroke or death during surgeryunder general anesthesia. An important aspect of communication that occurs prior to these types of medical interventions is the process of informed consent, when healthcare providers inform patients about the possible risks and hazards of a procedure. As part of this process, patients usually sign forms that summarize the risks and document patients have consented to treatment. Unfortunately, plenty of evidence suggests that consent forms do not adequately serve their purpose because they are too difficult for the average patient to understand. This is an ethical and legal problem because by law Americans are entitled to provide informed consent and refuse medical treatment.
My research team and I designed a study to test whether we could improve patients’ understanding of the information contained in a typical consent form. We began by examining a standardized medical disclosure and consent document approved for use in Texas. Then we modified how the information in the consent form was communicated and worked to make it more straightforward. We based our modifications on evidence from our own and other researchers’ previous work on informed consent. For instance, we knew that patients tended to struggle with complex and ambiguous information as well as technical jargon.
First, we reworded complex and confusing sentences. For example, the original version of the consent form said, “I (we) authorize my physician, and such associates, technical assistants, and other health care providers, to perform such other procedures, which are advisable in their professional judgment.” We changed it to this: “I authorize my physician, and any other necessary health care providers, to use their professional judgment to perform the additional procedures that they believe are needed.” We also removed as much medical and legal jargon as we could, and where the technical terms were absolutely necessary, we supplemented them with plain language definitions. We explained that an “acute myocardial infarction,” for instance, is “commonly known as a heart attack.”
Then we visited doctors’ office waiting rooms and interviewed 278 patients to get their opinions about the informed consent documents. Our study was an experiment, so patients were randomly assigned to see only one version of the consent form. Approximately half of the participants reviewed the original and the other half saw the revised version of the consent form.
After participants finished reading the document, we asked them a series of questions about how well they thought they could effectively weigh the pros and cons of the proposed treatment. We also asked them what they thought was confusing about the form, if anything. Then we “quizzed” them on the content of the document to see if they could explain what various technical terms meant in everyday language. Finally, we gathered data about participants’ health literacy, which is their ability to understand and use health information.
The results of our study indicated that patients were much better able to understand the material contained in the revised consent document we had developed. The average patient understood twice as many medical and legal terms after reading the revised form, compared with patients who saw the original one. When we quizzed them on content, only four percent of people correctly explained all of the medical and legal terms on the original form, but 57 percent could do so with the revised form. Patients also had fewer questions about the meaning of the material in the consent form when they reviewed the revised version.
One of our other questions was whether changing the communication within the consent form would matter for people who were already high in health literacy. We found, in general, that a simplified consent form was better understood by people in both the high and low literacy groups. The people who were relatively low in health literacy, though, made especially great strides in improving their level of understanding. This finding is useful because it indicates high-quality consent communication can be created for wide audiences. Resources do not necessarily need to be devoted to preparing separate types of consent information for people based on their health literacy.
Many people are familiar with the notion of a reading level—for example, most informed consent documents in the United States are written at a college reading level. So based on typical calculations, a patient would require a college-level education to understand consent material. What was notable about our study was that we kept the reading levels consistent between the original and revised versions of the consent forms, but we still observed significant differences between groups. This suggested to us that traditional reading level metrics may not be the best gauge of assessing whether medical and risk information is reader friendly.
Moreover, we did not add to the overall length of the documents. In contrast to other informed consent interventions, our approach was not about giving people more information, but giving them better information they could more easily understand. We believe rather than focusing on reading levels and extra materials, we should rely on our knowledge about effective communication to make disclosure and consent information as simple, yet meaningful, as possible.