One of the clinical challenges presented by the COVID-19 pandemic has been uncertainty about how to safely resume elective procedures such as endoscopy.
Researchers at the University of Miami Miller School of Medicine are helping to address those knowledge gaps by reporting on their experience with a preprocedural protocol aimed at keeping staff and patients safe from the coronavirus.
Doctors and nurses in the Division of Digestive Health and Liver Diseases at the Miller School of Medicine tested the protocol on nearly 400 endoscopy patients. Their results are published in the journal Gastroenterology.
“This work is novel because it provides objective data about what to expect as endoscopy units open across the country,” said study author Sunil Amin, M.D., M.P.H., assistant professor of clinical medicine, gastroenterology and director of endoscopy in The Lennar Foundation Medical Center at the Miller School. “For endoscopy centers around the country and the world that don't have the resources to test every single patient, the good news is that with simple screening questions alone they can probably reopen safely without worrying about widespread transmission to other patients and staff members.”
The Gastroenterology study appears to be one of the first to outline a real-world experience using a pre-procedure COVID-19 polymerase chain reaction (PCR) testing protocol, according to first author Justin J. Forde, M.D., a gastroenterology fellow at the Miller School.
Current guidelines available to gastroenterologists and other providers are inconsistent, vague and might be challenging in settings where resources are limited. And those guidelines are based on expert opinion rather that real-life data or experience, according to Dr. Forde.
“We feel that this experience may assist others in individualizing recommendations for their practice, and it may help in formulating more inclusive and clear guidelines as we move toward a new normal,” Dr. Forde said.
The Protocol and Study
Miller School researchers used their protocol to test patients having emergent, urgent and elective endoscopy procedures between April 13 and May 15.
For outpatient procedures:
- Nurses called patients 7 to 9 days before their procedures to ask COVID-19 screening questions.
- They postponed procedures on patients with flagged responses on the verbal questionnaire for 14 days.
- Patients who passed the verbal screenings proceeded with PCR testing. PCR testing was mandatory 72 hours before the procedure to ensure results would be available 24 hours prior to the procedure.
- Staff proceeded with procedures when patients had negative PCR tests. They cancelled or postponed and retested for procedures if patients had positive tests.
- Nurses preformed verbal screenings and did temperature checks when patients arrived for their procedures.
On the inpatient side:
- Staff ordered rapid in-house COVID-19 testing on urgent patients, so results would be available in two hours. Doctors performed emergent procedures regardless of results, wearing full-barrier personal protective equipment (PPE).
Staff would wear full-barrier PPE, with head-to-toe coverage, even with negative PCR test results. They also complied with hygiene and social distancing practices before and after procedures.
Of the 396 patients tested for COVID-19 prior to endoscopy, only one was positive for the virus. That was a positive test rate of 0.25%, compared with a positive test rate of 12.7% in Miami-Dade County’s general population.
“That was much lower than we expected, given that there is so much concern about asymptomatic carriers. We think that was because our pre-procedure screening questions were quite effective at identifying those at higher risk, and who were automatically re-scheduled for a later date without being tested,” Dr. Amin said.
Researchers also reported no instances of COVID-19 or associated symptoms among endoscopy staff.
“Our findings call into question the feasibility, efficacy and yield of guidelines, particularly routine preprocedural COVID-19 testing. We show that the pre-procedure questionnaires appear to have effectively screened out patients with COVID-19 infections and that routine COVID-19 PCR testing of these asymptomatic patients was low yield,” Dr. Forde said.
Results from the Miller School experience suggest screening questionnaires are effective for identifying high-risk patients whose procedures should be delayed. The authors recommend that all practices adhere to social distancing, hygiene and use of full barrier PPE during every procedure, regardless of PCR test results