When patients give informed consent for surgery, they are likely to be anxious and ask many questions. Some also are in considerable pain.

The authors of a recent study examined how compassionate 65 anesthesia residents were during a simulated preoperative evaluation of a patient in acute pain scheduled for urgent surgery.1 “We found substantial variability in the compassionate care behaviors of anesthesiology residents during the informed consent procedure,” says Richard Blum, MD, MSE, FAAP, the study’s senior author and senior associate in perioperative anesthesia at Boston Children’s Hospital. Residents also were inconsistent in the way they elicited questions from patients.

“At stake is the patient’s ability to give fully informed consent, which lies at the heart of respecting patient autonomy,” Blum explains.

It is not that residents lack compassion. “Most residents are truly compassionate. But the system they work and train in can lead to the appearance of a lack of compassionate behaviors,” Blum observes.

The authors of a different larger study investigated anesthesia resident competency overall.2 Certain participants reported the sedating effects of pain medications would render patients unable to participate.

“Some residents were not treating patient pain for fear of invalidation of the informed consent,” Blum reports. In their follow-up, researchers studied the presurgery informed consent process.3 Most residents ordered pain medication as soon as the simulated patient experienced pain. However, many waited until after the informed consent was signed. Notably, 14% did not order pain medication at all. “This supported our clinical observations,” Blum says.

Residents possibly feel pressure to secure a signed consent form, or they lack knowledge on pain management or ethical principles for informed consent. “These and other factors may be driving the process at the expense of attending more compassionately to patients,” Blum offers. All these findings suggest medical training inadequately addresses how providing or withholding pain medication can affect the informed consent process.

“Not treating pain may be considered a harm to patients,” Blum notes. The ethical concern is patients in severe pain cannot fully participate in the informed consent process. Some probably are willing to sign anything to relieve pain. “One could make the argument that withholding pain medication is a form of coercion,” Blum suggests.

Informed consent is more than just a document with a signature. “The process is dynamic, and involves ongoing communication. Yet many healthcare professionals and scientists do not view it as a process,” says Julie M. Aultman, PhD, director of the medical ethics and humanities program at Northeast Ohio Medical University in Rootstown.

Informed consent is individualized. Certain patients may need special resources such as Braille documents or translated materials because of disability or language barriers. “This could potentially be overlooked by busy residents or residents who are uninformed on, or insensitive to, the importance of an ethical informed consent process,” Aultman says.

For some residents, training on informed consent is minimal. It amounts to little more than a list of core elements that need to be in the consent form. “Resident training should take a deeper dive at the informed consent processes for both clinical interventions and research,” Aultman argues.

Ideally, this covers the ethical principles of autonomy, beneficence, and justice in the context of informed consent. “There is also a need for residency education that addresses the importance of moral courage and patient advocacy as steps toward preventing abuses of informed consent,” Aultman adds.

Branavan Ragunanthan, MD, a resident at Summa Akron City Hospital, has seen firsthand that a strong ethics foundation is necessary for informed consent. “The biggest misconception residents tend to have is believing that the informed consent process ends after obtaining a signature on a document,” Ragunanthan says.

In Ragunanthan’s experience, residents do not always understand certain ethical considerations. Informed consent can involve multiple parties and multiple encounters with the patient. Patients have the right to continue asking questions about an intervention even after the consent form is signed. Notably, patients can terminate their voluntary consent at any time.

In his own training, Ragunanthan found simulated patient scenarios dealing with informed consent particularly helpful. In the hospital setting, he says it was helpful when physician faculty emphasized the need for patients to be consented “in a matter that respects their human dignity.”

To ensure residents are prepared to obtain informed consent, Aultman says that ethicists should design educational and training sessions, and emphasize the need to recognize diverse patient and human subject populations. Further, ethicists should identify resources to ensure everyone can participate in voluntary decision-making. Also, ethicists should ensure patients and subjects can consent based on their capacities, interests, and care goals. The process of informed consent takes “time and patience,” Aultman notes. “Ethicists can play a significant role in addressing the need for slower medicine and research.”

REFERENCES

  1. Waisel DB, Ruben MA, Blanch-Hartigan D, et al. Compassionate and clinical behavior of residents in a simulated informed consent encounter. Anesthesiology 2020;132:159-169.
  2. Blum RH, Muret-Wagstaff SL, Boulet JR, et al. Harvard assessment of anesthesia resident performance research group: Simulation-based assessment to reliably identify key resident performance attributes. Anesthesiology 2018;128:821-831.
  3. Blum RH, Boulet JR, Cooper JB, et al. Simulation-based assessment to identify critical gaps in safe anesthesia resident performance. Anesthesiology 2014;120:129-141.