Association for Academic Surgery (AAS)

by and

Informed Consent During the COVID-19 Pandemic: Addressing Known Unknowns

Informed consent is the crux of the doctor-patient relationship, balancing patient autonomy and self-determination to choose what aligns with their goals and values with the beneficence and non-maleficence of treatment options presented by the physician. This shared decision-making process begins with information and ends with consent, evolving from a mutual understanding of the clinical concern to the decided treatment based on either the reasonable physician or the reasonable patient standard. However, what would the ‘reasonable’ physician disclose when risks are not well known?

At the beginning of the COVID-19 pandemic, informed consent focused on the risk of contracting COVID-19 during hospitalization, as testing was not yet robust enough to pre-emptively isolate patients. Similarly, the risk of worsened surgical outcomes with unknown positivity status at the time of operation was a concern with little data to support, referencing small retrospective studies and case reports. Shortages of resources required healthcare rationing and rapid adaptation. Elective surgeries were temporarily banned. Surgical societies made statements to delay elective surgeries and consider overall patient health, COVID-19 risk, and expected hospital resource utilization when scheduling patients for surgery.

Treatment protocols were changed. Patients with breast cancer were ranked from lowest (atypical/benign lesions) to highest (receiving neoadjuvant chemotherapy) priority for surgery. Patients with malignant polyps and hereditary conditions requiring prophylactic colectomy had surgeries postponed. Risk scores were created to triage surgical cases in a form of healthcare rationing to minimize utilization of hospital resources and decrease the risk of COVID-19 transmission. At the time of consent, data did not exist for surgeons to discuss the possible consequences of delays in care, only the intent of the postponement to do what was in the patients’ best interest. Shared decision-making typically between the surgeon and patient now included a third party, the hospital itself, as high resource settings across the country experienced profound limitations. Now that hundreds of thousands of patients have since undergone postponed surgery, protocols for care are adapting to changes in care timing that can be safely implemented without affecting patient outcomes.

By June 2021, half of the American population has received at least one dose of the COVID-19 vaccine, with a 7-day average positivity rate of about 2% (The New York Times, 2021). The CDC now permits those who are fully vaccinated to navigate indoors and outdoors without masking, a stark contrast to the initial lockdown in March 2020 as COVID-19 soared across the country with a positivity rate of over 20%. Now that over thirty million people have contracted COVID-19, what are the ramifications of their prior infection? patients recover from their COVID-19 infections, now we must ask ourselves and disclose to our patients – what is the best time to undergo surgery? Multiple studies have found that patients are at increased risk of post-operative complications after COVID-19 infection (Cano-Valderrama O, 2020) (Khonsari RH, 2021), recommending delays in surgical care as much as possible from the time of infection and convalescence. At our institution alone, over 2,000 patients have recovered from a COVID-19 infection and undergone a procedure afterward. As clinics open back up, how do we address new considerations regarding the extent and timing of surgery for our patients who have previously been infected with a virus whose long-term consequences are unknown?

Informed consent in a legal sense requires physicians to explain a treatment course to patients, highlighting risks and benefits for patients to make an informed choice. While patients may still defer to and prefer physician paternalism, informing patients about possible outcomes is a legal and ethical obligation of the physician. When the risks are not yet known, it is important to arm ourselves with the best available information by studying the outcomes of surgery performed in COVID-convalesced patients. As data become available, we can inform patients of our understanding of risk as we currently know it to be, while also maintaining humility in the context of persistent uncertainty. Data currently suggests delaying surgery as long as possible for patients who have had prior COVID-19 infection to reduce the risk of post-operative complications, which must be weighed against the risk of delaying surgery, especially for those with developing pathology, such as those with peripheral vascular disease or those requiring oncologic resections. We must also consider limiting the extent of surgery for patients who are still recovering, for example by performing a local tumor excision but omitting a corresponding lymph node biopsy to avoid placing a still-recovering patient under general anesthesia. Though the pandemic has changed our practice of medicine in many ways, the fundamental principles of informed consent and shared decision making, with an honest discussion regarding areas of clinical uncertainty, remain unchanged.

 

 

Connie Shao, MD

Connie Shao, MD

Connie Shao, MD is a general surgery resident at the University of Alabama at Birmingham (UAB) where she is also obtaining an MSPH. Originally from Michigan, she completed her undergraduate degree at Washington University in St. Louis where she majored in Biomedical Engineering before attending the University of Chicago Pritzker School of Medicine. Her research is in health services, focusing on improving equitable health engagement among patients via clinical outcomes research.
Kristy Broman, MD, MPH

Kristy Broman, MD, MPH

Kristy Broman, MD, MPH is an Assistant Professor in the UAB Division of Surgical Oncology with a clinical practice in skin and soft tissue surgical oncology. She is a graduate of Vanderbilt University School of Medicine in Nashville, Tennessee, where she earned her Medical Degree and Master of Public Health Degree. She then completed residency in General Surgery at Vanderbilt University Medical Center, which included a three-year research fellowship in the Veterans Affairs National Quality Scholar Program, a national training program in conduct of health services research, quality improvement and implementation science. She completed her two-year clinical fellowship training in Surgical Oncology at Moffitt Cancer Center in Tampa, Florida. She is faculty member of the UAB Institute for Cancer Outcomes and Survivorship where she conducts health services and outcomes research, emphasizing implementation strategies for delivery of high-quality care across the cancer care continuum.