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Appendices:

[Appendix B]
Barriers to Effective Informed Consent

Based on studies such as those cited in Appendix A and also on the rich clinical literature on general patient-physician communications, several barriers to effective informed consent have been identified. While a comprehensive review of general communication pitfalls are beyond the scope of this guide, a list of common barriers published in a recent review by physicians at Temple University is reproduced along with tips for improved communication in the nearby Tables. [Travaline 2005] Ten of the main challenges that have been identified in direct relation to informed consent are summarized here.

1] Lack of clinician time

In most cases, if they had more time, clinicians would likely pay closer attention to the description of the procedure, its benefits, its potential complications, and the alternatives. Given more time, the staff would also likely customize an array of informed consent forms that reflected the group’s attitudes and legal stance. This lack of time is of course a function of the perceived priority of informed consent quality in the institution-and that’s why changing this perception with staff education is one of the first steps in improving an institution’s disclosure practices.

2] Confusion among clinicians about when informed consent is needed

More explicit institutional standards that delineate when informed consent is needed may be required [Manthous 2003]

3] Physician concerns about giving too much information

Liability concerns lead some clinicians or institutions to limit the amount of information given to the patient in order to avoid “leaving something out” as if they try to describe all the risks. In some cases, the clinician’s hesitancy in disclosing too much information is based on the belief that full descriptions of the potential side effects may unnecessarily scare the patient away from a potentially life-saving or life-enhancing surgery or procedure.

4] Perception of patients that the informed consent form is “just a legal release” for the doctor or hospital to proceed

The purpose of consent forms is often unclear and patients frequently perceive them as a form of legal protection for hospitals and treatment centers rather than as a source of information. [Dawes 1994] One study confirmed that informed consent forms seem to be designed to authorize treatment or protect hospitals or caregivers from liability rather than to clarify information about the procedure or aid patients in decision-making [Bottrell 2000] In fact, many patients don’t read the forms before signing them.

5] Patient unawareness that they can refuse the procedure or delay the decision

Patients may be unaware that they have the right to decline procedures, or may not be given an opportunity to do so. They may also not realize that they can ask for more time and request more information before making their decision.

6] Patient language and cultural issues

In their responses to a Robert Wood Johnson 2001 survey, 73% of healthcare providers said that a patient’s understanding of treatment advice was the most compromised aspect of care due language barriers and 71% said language issues complicated their patients’ ability to explain symptoms and concerns. [Wescott 2005, Wirthlin 2001] As the U.S. becomes increasingly diverse, these language issues will only grow. According to the 2005 Census, over 11% of US population (33.5 million) was born in another country; about 23 million speak English “less than very well” and nearly 13 million are linguistically isolated. Beyond language, cultural issues will also affect a patient’s understanding of the consent process and content. In some cases, for example, a patient’s community or self-identified group may have a relative lack of background knowledge about a certain disease or risk factor. In other cases, the patient may share a set of core beliefs that essentially rule out a proposed procedure or test (e.g., drawing of blood) or that otherwise powerfully shape the likely response to the proposal for consent. For such situations, the whole context of the consent situation must be integrated into the process and, if necessary, the consent form. Factors to be considered in evaluating a patient’s cultural influences include: cultural values, socioeconomic status, family structure, health-seeking behaviors, immigration status, country of origin, migration history, and decision-making styles (e.g., familial, individual, delegated, deferential).

7] Special patient circumstances and human factors (e.g. stress, timing)

Other factors that may limit the ability of patients to understand the medical content and their choices include: emergency situations; mental disabilities, or unconscious states.

8] Poor quality of consent form and related educational materials

Most consent forms are too complex for patients. They are often written at a level requiring a high school, college, or graduate degree education. [Krause 2001] Further, the quality of the information is highly variable, often missing key elements and many times being simply too generic to be of any value. Thus, if the form is not improved or supplemented with verbal descriptions or other educational print or audio/visual information, then the patient will not understand the proposed procedure. Also, note that an emphasis on written documentation may undermine the importance of verbal communication between the patient and the practitioner.

9] Patient misunderstanding of information on the informed consent form or related educational information about the proposed surgery or procedure

If patients are unable to understand the information they are reading in a consent form or don’t read the form at all, this clearly undermines and negates the primary purpose of the form (i.e., documenting that the patient has been informed of the risks and benefits of a given medical procedure). Even if the consent form and the accompanying education appear objectively to be superior, and even if they are written and provided in the patient’s native language, there is always the possibility that a patient will simply “not get it.” The patient’s comprehension or lack thereof, in other words, must be separated from the objective quality of the written consent form or the accompanying verbal or written educational descriptions. Comprehension is a separate factor that, as described in the final barrier, requires a separate quality-check step.

10] Clinician inability to detect patient’s lack of comprehension

Sometimes even a clear consent form and a careful explanation of the procedure will not be enough for a patient to fully comprehend the situation. Clinicians who have just spent 10 minutes detailing an operation to a patient who seems alert and nods may have trouble believing that the patient does not understand. There is often a perception, for example, that English-speaking patients who do not ask questions are fully informed. This attitude is, of course, incorrect as it does not account for the high levels of low health literacy in the general population. When combined with a patient’s feeling stressed, overwhelmed, or intimidated in the healthcare setting, this silence, even if accompanied by a signature, should not be interpreted as consent.

Developed with a grant from the Robert Wood Johnson Foundation

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