The Doctors Company analyzes closed claims to identify specific factors that lead to patient injury and provide strategies that help our members mitigate risk. Our recent analysis of otolaryngology claims provides an overview of leading allegations and contributing factors. It revealed that inadequate informed consent is frequently identified as a contributing factor to claims. Consider the following discussion, which is illustrated by a case example and suggests strategies to enhance the informed consent process.
We reviewed 599 otolaryngology claims that closed between 2009 and 2018. Our claims review began with a high-level look at allegations—the gist of what went wrong. In our review, the leading allegations were improper performance of surgery (42 percent), followed by improper performance of treatment or procedure (16 percent) and those related to diagnosis (failure, delay, or wrong) (13 percent). These findings are consistent with other specialties that include a surgical component.
We also examined each claim for factors that likely contributed to the adverse outcome. (Each claim may have more than one contributing factor.) The top three contributing factors for all otolaryngology claims analyzed during this study were technical performance (43 percent), patient factors (34 percent), and inadequate informed consent (12 percent).
Technical performance contributing factors may result from poor technique, but may also arise when the patient suffers a known complication of the procedure. Known complications should be included in the informed consent discussion so the patient understands that the complication can occur even with perfect technical performance.
Patient factors in this analysis included patients who sought other providers due to lack of rapport and those who did not adhere to the treatment plan. Often the root cause of patient nonadherence is poor communication between the provider and the patient or family.
Communication also plays a role in inadequate informed consent, the third leading contributing factor. It is not uncommon for the plaintiff’s attorney or expert witnesses to allege that the physician failed to provide sufficient information for the patient to make an informed decision about proposed treatment.
A well-designed informed consent process engages the patient and family and improves satisfaction with care. It can also mitigate some of the risk of being drawn into a claim and facilitate defense if a claim is filed.
Informed consent requires active participation by both the physician and the decision maker, who may be the patient or the patient’s legal guardian. The process has two key components: (1) the informing and (2) the decision.
Informing involves explaining the nature of the condition, the proposed procedure or treatment, any alternatives, the benefits of the treatment and alternatives, the likely associated risks, and the expected outcome (likelihood of success). In order to be informed, the patient must be capable of understanding the information presented. Barriers to understanding—such as language, health literacy, and sensory deficits—must be taken into consideration and addressed. The use of teaching adjuncts, such as anatomical models, drawings, videos, and patient education handouts decrease fear and anxiety and increase the patient’s comprehension—particularly in highly specialized practices such as otolaryngology. Include copies of the handouts and educational materials in the patient’s medical record or document a list of what was provided.
One of the best ways to evaluate if the patient understands well enough to consent is by asking the patient to repeat back what was discussed. If the patient is correct, document in the medical record that the patient was able to reiterate the risks and benefits of the intended procedure. If the patient is not correct, provide more information and reassess comprehension. The Agency for Healthcare Research and Quality provides a Teach-Back Method tool to help with the evaluation process.
Once the patient has been adequately informed, demonstrated understanding, and had the opportunity to ask questions and have them answered, the next step is consent. A signed form should be used when required by law, when a surgical procedure is being performed, when there are significant known risks (such as morbidity or death), when there is a risk of disfigurement or prolonged recovery, and with high-risk medications (such as chemotherapy, narcotics, antipsychotics, and biologicals). Whether the consent is memorialized with a form or not, it is essential to obtain consent and document that the patient gave permission for and agreed to the treatment plan.
The consent process must be revised when dealing with children and adolescents. Pediatric consent involves permission from the parent or guardian in concert with assent from the child. Pediatric informed consent is a combination of education, permission, and assent of both the parent and child—a process sometimes called pediatric shared decision making.
Disagreements between parents or the parent and child regarding the treatment plan must be managed carefully and documented in the record. In life-threatening situations, a procedure may move forward against the expressed wishes of the child, however, due diligence is necessary if the child is old enough to understand the ramifications of refusal. One example is when an older child with cancer refuses treatment. In this case, counseling for the family and legal guidance for the providers may be necessary.
Documentation is critical. Although the parent signs the consent form, educating and obtaining age-appropriate assent from the child is necessary and should be documented in the record. (An article in the AMA Journal of Ethics titled “How Should Adolescent Health Decision-Making Authority Be Shared?” provides an in-depth review of this topic.)
Case Example: Refusal to Consent
A nine-year-old female was evaluated for tonsillectomy. Although the mother denied that the child snored when sleeping, there were other indications of obstructed breathing during sleep and the child was obese. The physician recommended a sleep study, but the mother refused. The decision was made to proceed with the tonsillectomy without a sleep study. The surgery went well, and the child was discharged to home. Later that evening, she was found unresponsive in bed, and resuscitative efforts were not successful.
At trial, the failure to perform a preoperative sleep study became an issue. The mother alleged she was not informed about the importance of a sleep study and denied refusing the test. The medical record contained no mention of the sleep study discussion.
When a patient or a parent admits that they do not intend to follow recommendations, view this situation as an opportunity for discussion rather than nonadherent behavior. Patients have the right to refuse treatment. Physicians have a responsibility to ensure that the patient is educated regarding the risks of refusing treatment.
The same principles used in informed consent can be applied to patient refusal. The first step should be to determine what is preventing the patient from agreeing. What are the barriers and are they addressable? Explain why the treatment is recommended, and include the benefits and anticipated outcome. Discuss alternative options.
If the patient persists in refusal, explain the risks of refusing. Document informed refusal discussions in the medical record as you would for informed consent. Use the teach-back method to evaluate comprehension. When the risks to the patient of refusing the recommended treatment are significant, consider using an informed refusal form. The use of informed refusal encourages open communication, fosters trust, and helps preserve the provider-patient relationship. Informed refusal reduces the risk to the physician of the patient’s nonadherent behavior. For further guidance, read our article “Informed Refusal,” and see our sample form “Refusal to Consent to Treatment, Medication, or Testing.”
The scope of treatment—particularly for surgery—must also be considered. It is possible to provide treatment that exceeds the initial consent process. For example, if it becomes clear during surgery that the patient needs a more extensive procedure, with additional risk of limitation or loss of function or significant disfigurement, additional communication with the patient may be necessary before proceeding. When this is the case, there are three options: (1) wake the patient and discuss, (2) safely complete the current procedure and address the need in a follow-up procedure, or (3) hold the procedure to obtain additional consent from a surrogate, such as the spouse. Obtaining surrogate consent should be reserved for situations in which waking the patient or waiting places the patient at higher risk. The clinical decision-making and pertinent discussion related to the option chosen should be thoroughly documented in the patient’s medical record.
Risk Mitigation Strategies
Consider the following strategies for improving the consent and refusal decision-making processes in your practice:
- Never delegate informed consent. It is the physician’s responsibility.
- Consider the potential scope of a procedure to ensure that the consent discussion is adequate.
- Engage the patient as an active participant in the decision-making process.
- Use the teach-back method to evaluate patient comprehension.
- Include comprehensive documentation of the informed consent or refusal process in the medical record. Include who was present, what was discussed, questions that were asked and answered, an evaluation of the patient’s comprehension, and the final decision.
- Use a consent or refusal form when the stakes are high.
For additional information, see our articles “Informed Consent: Substance and Signature” and “Obtaining Informed Consent in Teaching Institutions,” or contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.