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Say Anything | Oct 2020

Say Anything: CRST Europe Readers Comment on Whether Their Informed Consent Has Changed in the COVID-19 Era

How has your informed consent changed in the COVID-19 era? What language do you include when providing important pre- and postoperative safety considerations? Do you ask patients to acknowledge that they assume the risk of contracting the SARs-CoV-2 virus?

Denise M. Visco, MD, MBA<br>President and Medical Director, Eyes of York, Pennsylvania

Denise M. Visco, MD, MBA
President and Medical Director, Eyes of York, Pennsylvania

"When we reopened on May 4 in the midst of the coronavirus pandemic, we considered the necessity of a legal waiver for seeing patients and performing surgeries. Although we knew we were going above and beyond following US Centers for Disease Control and Prevention guidelines, we consulted our attorney, who was adamant about using a waiver. In fact, he drafted a strong one that says in no uncertain terms that we are not liable, as we all know how ubiquitous this virus is becoming (see Sample Patient Waiver for Treatment Care During COVID-19 Pandemic). Patients will sign the waiver one time to consent to treatment at the clinic and/or ambulatory surgery center. On subsequent visits, patients are asked COVID-19 screening questions, and their temperature is taken and recorded with their answers in the medical chart. Documentation of the COVID-19 processes and precautions during patient care is also entered into the chart with every examination. We employ the waiver for all patients. Anyone who is not comfortable accepting and signing the waiver is offered the option to postpone their care until after the pandemic is over or to seek care with another provider."

Rosa Braga-Mele, MD, MEd, FRCSC<br>Professor of Ophthalmology and Director of Professionalism and Biomedical Ethics, Department of Ophthalmology, University of Toronto, Canada

Rosa Braga-Mele, MD, MEd, FRCSC
Professor of Ophthalmology and Director of Professionalism and Biomedical Ethics, Department of Ophthalmology, University of Toronto, Canada

"Since the return to both the office and the OR with COVID-19, we have modified our practices and what we discuss with our patients. Patients are called 1 week before any appointment. They are informed that they need to attend their appointments on their own (unless there is a physical or communication-related reason for someone to accompany them inside) and that they need to wear a mask, and the symptoms of COVID-19 are reviewed with them. They are instructed to call and cancel the appointment if they have any symptoms at all. We also inform them to arrive at their designated appointment time and not before or after to avoid crowding in the office.

It is much the same for the OR; however, we also ask patients to quarantine for 2 weeks before their surgery date to minimize any potential exposure. I have also started to consent for bilateral sequential same-day surgery to minimize the number of patients and the number of visits needed. Most patients have been grateful and gracious through the entire process, as it helps make everyone safer.”

Arthur B. Cummings, MB ChB, FCS(SA), MMed(Ophth), FRCS(Edin<br>Consultant Ophthalmologist, Wellington Eye Clinic and Beacon Hospital, Dublin, Ireland

Arthur B. Cummings, MB ChB, FCS(SA), MMed(Ophth), FRCS(Edin
Consultant Ophthalmologist, Wellington Eye Clinic and Beacon Hospital, Dublin, Ireland

"The COVID-19 pandemic has catapulted the world forward regarding the use of technology to do business and access services, and our practice is no different. We have adapted our informed consent process in the COVID-19 era by reassessing how we educate our patients.

We conduct a previsit virtual appointment with our nurses or technicians for each refractive surgery patient at least 72 hours before the patient's in-clinic visit. During this virtual appointment, the nurse or technician discusses the patient's visual needs, motivations for surgery, assessment of dry eye, the clinic's COVID safety protocols for their visit, the refractive procedures they may be good candidates for, and the differences between these options. This previsit appointment results in a relaxed, reassured, and informed patient arriving to safely meet the team in person.

Before laser vision correction, patients watch a recording of me walking them through exactly what to expect under the laser. This was previously done in person, but everyone prefers the video approach under the pandemic conditions. Postoperative medications and instructions are also provided this way, and patients have access to this information on their phone for later use. Patients watch this video on the day of surgery before discussing any questions with the nurse. This strategy, which is time-saving for the team, provides increased safety considering COVID.

For cataract surgery, we educate patients that the surgery, in most cases, is not urgent and can be deferred if they would prefer, considering the risk of contracting COVID. This is a reassuring reminder for those patients who are vulnerable and/or live with vulnerable family members. Patients are requested to cocoon for 14 days before the cataract procedure, and they undergo a COVID swab test 3 to 5 days before surgery, proceeding only with a negative result.

Including a COVID risk assessment is crucial in the patient journey and informed consent process of our new normal. It remains a focus for us in the COVID-19 era as we continue to deliver excellent care to our patients safely. We hope to further improve our process with a move to electronic consent forms soon.”