Informed surgical consent during the COVID-19 pandemic: Exploring the risk of unknown.

To the Editor,

Informed surgical consent is an oxymoron—a complex surgeon‐patient communication which may lead to a legal agreement between them for a surgical intervention performed by the surgeon and his/her team, on the patient who is informed of all the risks involved in the procedure (and obviously benefits too!), and who still decides to undergo that procedure. It would not be an exaggeration to call an “informed surgical consent” more a legal term and less of a medical term as it is supported by the local jurisdiction and international laws. The art of taking surgical informed consent evolved way back in the medieval times as early as 14th century, evident by the archives found in Italian, French, and several other languages. The doctors would ask for a ‘‘hold harmless document’’ aimed at releasing them from any future binding to the patient or family in the event of an adverse outcome following therapy. The corona virus disease 2019 (COVID‐19) pandemic has strained the existing trust between surgeons and the patients—every decision of surgery is being weighed against the anticipated peri‐procedural risks with an unprecedented degree of scrutiny. Moreover, the pandemic has further strengthened the notion that there can never be an ideal and fixed template for informed surgical consent; it is a dynamic process which is not only related to refinements in the surgical techniques and better understanding of disease processes, but also with the varying social, legal, and environmental factors.

In a recently published article, Wainstein et al have rightly emphasized the importance of the informed consent/discussion regarding the risks of surgery during the COVID‐19 pandemic. This includes a detailed discussion regarding the risk‐benefit ratio of proceeding with vs delaying an operative procedure during COVID‐19 pandemic, risk of nosocomial contraction of the virus, and the impact of pandemic‐associated healthcare resource shortages on the care of the postoperative patient. Many litigations over the years regarding the issue of medical negligence during surgical procedures have fueled the controversy to include all the known, and more so unknown, risks involved in the surgery in the surgical consent form. A Canadian Medical Protective Association report highlighted that the majority of medico‐legal actions involving an informed consent—65% of them were surgical—were not decided in favor of surgeons. Diligent documentation of the communication during the process of obtaining informed surgical consent is the only way to safeguard the interests of the surgeon in the face of any legal adversity. We wish to add that the general definition of nosocomial infection does not specifically convey the message that the health care workers (HCWs) are not routinely being tested for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection unless they are symptomatic and that asymptomatic HCWs may transmit the SARS‐CoV‐2 infection to the patients—despite taking all the appropriate precautions and following standard guidelines.

When the COVID‐19 pandemic began to grapple the world at the beginning of the year, there was a huge scarcity of testing facilities across the globe. The initial focus was to test symptomatic patients to isolate them to contain the spread of infection. The routine testing of the asymptomatic patients for SARS‐CoV‐2 infection, who were planned for surgery, was unrealistic due to the limited resources. However, it was soon realized that asymptomatic patients infected with SARS‐CoV‐2, if they undergo surgery, are at higher risk of perioperative complications including cardio‐pulmonary complications, renal failures, and even death. Moreover, there was an anticipated risk of transmission of SARS‐CoV‐2 infection from the asymptomatic patients to the health care workers as well. As testing facilities have surged worldwide, it is now recommended that all patients must undergo screening for SARS‐CoV‐2 infection and consideration of testing. American Society of Anesthesiologists and Anesthesia Patient Safety Foundation issued a joint statement on 28 April 2020 recommending that all patients who are to undergo non‐emergent surgical procedures must undergo nucleic acid amplification testing (including polymerase chain reaction tests) if there is local or regional presence of SARS‐CoV‐2 infection.

However, another scenario is the risk of transmission of SARS‐CoV‐2 infection, though unquantifiable at present, from the unsuspected infected members of the surgical team to the patient during the surgical procedure. A recent study estimated prevalence of SARS‐CoV‐2 infection of 7.3% in a cohort of 546 HCWs during the early phase of community transmission in a large University and two other affiliated university hospitals in the USA; the HCWs had a 7.0% greater risk of acquiring infection compared to non‐HCWs. Many publications have emphasized the transmission of the novel coronavirus from the patients to the HCWs. A retrospective, single‐center case series of 138 consecutive patients with confirmed SARS‐CoV‐2‐associated pneumonia, admitted in a hospital in Wuhan, China highlighted that 41% of the cases resulted from hospital‐related transmission. HCWs are at increased risk of developing the condition as well as spreading it. However, the majority of the carriers of the virus remain asymptomatic. Yet, they continue to harbor the virus without any clinical signs and symptoms—and they are a potential source of spread of disease in the hospital‐based setting as well as in the community. If a patient, admitted for a surgical procedure, contracts the SARS‐CoV‐2 infection from a HCW, it can be a potential source of litigation in the coming days: suitable measures need to be taken at the earliest time to avoid the same. Moreover, it is neither recommended nor logistically possible to repeatedly test all asymptomatic HCWs for SARS‐CoV‐2 infection. Wee et al suggested the use of Systems Engineering Initiative for Patient Safety model to illustrate the ecosystem of measures taken to prevent the intra‐hospital transmission of SARS‐CoV‐2 infection along with the domains of work task, technologies, and tools, work environmental factors, and organizational conditions.

Until such time that the biology of the SARS‐CoV‐2 is clearly understood and widespread facilities for testing are available, in our opinion, it would be prudent to explicitly document in the informed surgical consent form that there exists a small risk, presently unquantifiable, of transmission for SARS‐CoV‐2 infection from the surgical team to the patient.

CONFLICT OF INTERESTS

All the authors declare that there are no conflict of interests.