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Dear colleagues and friends,

Welcome to another edition of the Perspectives debates. The COVID-19 crisis has directly affected our endoscopy practices, and it’s raised difficult questions about how best to balance safety with continued delivery of health care services. Dr. John Inadomi and Dr. Shahnaz Sultan address the benefits and downsides of universal testing of patients before endoscopic procedures.

Dr. Charles J. Kahi

I hope you find this debate helpful and informative for your endoscopy unit’s policies as we navigate these uncertain times. As always, I welcome your comments and suggestions for future topics at [email protected]. Stay safe!

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is an associate editor for GI & Hepatology News.

Reassurance is important to both patients and providers

The COVID-19 pandemic has been a global economic, societal, and health crisis. As health care systems shifted resources to care for the overwhelming numbers of patients infected with COVID-19 and coincident with lockdown orders issued by local and state governments, elective endoscopy came to a screeching halt. The gastrointestinal professional societies issued a joint statement advocating delays of all elective endoscopies and limiting procedures to those deemed urgent or emergent.1

Dr. John M. Inadomi

Within our GI community, there was great concern raised about the degree of aerosolization and risk of virus transmission during endoscopy and colonoscopy, the type of personal protective equipment (PPE) required to minimize infection risk, and the need for negative pressure rooms or prolonged room turnover to provide adequate air exchange. Our understanding of the role of the GI tract in infection and transmission and presentation with GI symptoms, as well as the true prevalence of asymptomatic infection, was rapidly evolving. Even though our colleagues in Asia and Europe faced the COVID-19 pandemic before we did, we still had no roadmap to navigate these issues.

Public health officials emphasized that a critical step to limit the spread of infection hinged on the availability of accurate and reliable tests. However, during the initial phase of the pandemic, priority was given to patients with symptoms or exposure because of limitations of tests, sampling tools, and reagents. As testing became more available and we began to ramp up endoscopy, the American Gastroenterological Association developed a rapid review and guideline evaluating the role of testing prior to endoscopy.2 In this evidence review and guideline, the authors systematically evaluated the diagnostic accuracy of the reverse transcription polymerase chain reaction (RT-PCR) nucleic acid amplification tests (NAAT) available on the U.S. market and described a framework for how a pre-endoscopy testing strategy could help with triage and decisions around PPE use.

Specifically, they made a conditional recommendation supporting a pre-endoscopy testing strategy: “For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.”2 This is a conditional recommendation based on low certainty evidence, underscoring the limitations in the evidence for diagnostic test accuracy of the currently available tests (limited sample sizes, test accuracy only for symptomatic patients, no reference standard) and limited knowledge of the true prevalence of SARS-CoV-2 infection at the population level.

The authors of the recommendations emphasized that preprocedure testing could help decrease the risk of transmission by triage – that is, delaying the procedure of patients with positive tests who could infect other patients and health care workers. In addition, for patients with negative tests, surgical masks can be considered during endoscopy to allow preservation of N95/N99 masks that are a limited resource in many settings.

Varying strategies for reopening endoscopy have been adopted by endoscopy centers and health systems. According to one survey, most of responding U.S. endoscopy centers (87%) had developed a formal COVID-19 mitigation protocol, with only 52% of the responding centers testing all patients prior to endoscopy, which highlights the large variation of policies in clinical practice.3 In making the case for a strategy of pretesting of all patients prior to endoscopy, it’s important to emphasize that the benefits of testing outweigh any downsides and that, for health care professionals and patients alike, providing reassurance about the safety of endoscopy for everyone is an important aspect to resuming endoscopy operations.

Concerns regarding acquiring COVID-19 infection in the workplace and infecting family members was and remains a source of significant stress for endoscopy unit personnel across the U.S. Recognizing these issues, many institutions initiated a program for preprocedure COVID-19 testing for all patients undergoing endoscopy. An online survey completed by 47 endoscopy unit personnel found that, after implementation of pre-endoscopy testing, fewer personnel reported anxiety regarding contracting infection (58.1% before vs. 44.7% after; P < .001), there was less concern about infecting family members (88.4% before vs. 68.4% after; P < .05), and fewer providers reported self-isolation practices (living in a room separate from family) (21.3% before vs. 10.8% after; P < .05).4

Moreover, implementation of a pre-endoscopy testing strategy could decrease patient anxiety and decrease patient reluctance to complete endoscopy. With recognition of the long-term consequences of delaying endoscopic evaluation, especially for colorectal cancer screening and surveillance, improving attendance may lessen the impact on colorectal cancer–related morbidity and mortality and other GI-related conditions.5

A pre-endoscopy testing strategy can inform PPE decisions so that N95s and power air-purifying respirators (PAPRs) are reserved for high-risk procedures (such as EGDs in COVID-19-positive patients) with use of surgical masks or extended/reused N95s for patients who test negative. In addition, preprocedure testing can improve endoscopic efficiency eliminating the need to wait for the necessary amount of air exchange between procedures in test-negative patients. In the last 6 months, the testing landscape has changed significantly with the availability of numerous platforms that allow for more efficient processing of tests and the capability of testing saliva instead of nasopharyngeal or nasal swabs. In addition to the original RT-PCR NAAT, more rapid PCR tests, and antigen tests are available. Testing is no longer a scarce resource and for this reason, we should continue our practice of testing all patients prior to endoscopy. Further studies of the false-negative/false-positive rate of various test modalities and test-timing will be important.
 

John M. Inadomi, MD, AGAF, is with the department of medicine at the University of Utah, Salt Lake City. He has no conflicts to declare.

References

1. Gastroenterology Professional Society Guidance on Endoscopic Procedures during the COVID-19 Pandemic. American College of Gastroenterology. 2020 Apr 1.

2. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

3. Moraveji S et al. Gastroenterology. 2020 Oct 1;159(4):1568-70.e5.

4. Podboy A et al. Gastroenterology. 2020 Oct 1;1586-8.e4.

5. Dekker E et al. Gastroenterology. 2020 Dec;159(6):1998-2003.

 

 

Barriers to care should be avoided

In the AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy, the authors made a conditional recommendation for implementation of a preprocedure testing strategy, specifically for endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%).1 The authors stated that, in settings where testing is feasible and there is less perceived burden on patients and when the benefits outweigh the downsides (such as when false positives do not significantly outnumber the true positives), an endoscopy center should implement a preprocedure testing strategy. In addition to the prevalence of SARS-CoV-2 infection, which influences both the positive and negative predictive value of testing, the authors took into account the downstream consequences of test results, the pros and cons of a testing strategy, and the availability of PPE and tests.

Dr. Shahnaz Sultan

The authors further clarify that, in areas with either low or high prevalence of asymptomatic cases, a pre-endoscopy testing strategy may not be informative. The group made a conditional recommendation against testing in these settings, highlighting concerns around the false positive rates in low-prevalence areas and potentially limited availability of tests and false negative rates in high-prevalence areas.

Early in the pandemic, because of the limited availability of tests, symptomatic or high-risk patients were given priority for SARS-CoV-2 testing. Since that time, over 180 different commercially available SARS-CoV-2 assays have become available, and many health systems have developed their own laboratory-developed tests.2 However, despite the aggressive efforts to ramp up test capacity, many endoscopy centers still struggle to obtain timely and reliable results. In light of continued challenges with testing, many endoscopy centers chose to not implement a pretesting strategy and instead proceed with N95 respirators or PAPRs for all procedures. Endoscopy centers that implemented a no-testing strategy emphasized the importance of ramping up productivity as quickly as possible and simultaneously reducing any barriers for patients.

They also highlighted reports that demonstrated a low yield of positive tests and that triaging could be performed equally well with the use of a symptom checklist or fever check. In one study from New York, among 623 asymptomatic patients tested before endoscopy during May and June, which was the height of the first surge, only 6 patients tested positive (overall percentage of SARS-CoV-2–positive tests in asymptomatic patients, 0.96%).3 Similarly, low rates of positive tests were reported in a center in Miami: Among a total of 396 PCR swabs in preparation for endoscopy, one patient had a positive PCR result (positive test rate, 0.25%).4

What are the implications for patients, providers, and endoscopy centers if a preprocedure testing strategy is not adopted? For individual patients, there is a potential for heightened concern about risk of infection from health care staff or other patients, but this may be offset by the decreased burden of testing. For health care professionals, it means that all procedures need to be performed with universal precautions and appropriate PPE. From an endoscopy operations perspective, there remain unanswered questions regarding room turnover and the necessity for negative pressure rooms. Symptom screening, which is locally required for all health visits, may help identify symptomatic patients, and thus, procedures for these individuals could be canceled and rescheduled or moved to negative pressure rooms (based on urgency).

Questions remain about the need to perform all procedures in negative pressure rooms or with prolonged room turnover to allow for a requisite number of air exchanges. There is general agreement among gastroenterologists that upper endoscopy is an aerosol-generating procedure. The passage of the scope near the pharynx (where the virus has a propensity for colonization and infection) may lead to aerosolization of infective particles and confer an increased risk of infection. However, it is unclear whether colonoscopy actually confers an increased risk. This would require that an asymptomatic patient would be infected with the SARS-CoV-2 virus and have viable viral particles in the colon that are released during the passage of flatus in high enough quantity to allow for aerosolization and transmission of infection. Conceptually, while there are potential risks associated with both endoscopy and colonoscopy, it is reassuring that we are not seeing published reports (or anecdotal evidence) suggesting high rates of COVID-19 infection among endoscopy staff or at endoscopy centers. Requiring prolonged room turnover between every procedure would negatively impact endoscopy efficiency and recovery of endoscopy centers.

Indeed, the aftermath of the COVID-19 pandemic will be far reaching. While telemedicine has helped mitigate some of the collateral damage, the disruption of cancer screening and surveillance programs may lead to high cancer-related morbidity and mortality. In one study evaluating the impact of COVID-19 on the U.S. cancer population, authors analyzed 6,227,474 Medicare Fee for Service claims (representing 5%-7% of the Medicare population) and found a substantial decrease in cancer screening and cancer care (therapy and surgeries).5 Screening for colon cancer was reduced by 75% in April.

Eliminating any potential barriers to care should be the highest priority. A requirement for patients to undergo preprocedure testing may contribute to increased anxiety and added costs and may further delay care. From a patient perspective, finding a testing facility, obtaining the test within 48-72 hours, self-isolating until the day of endoscopy, and dealing with the uncertainty of the test result may serve as additional barriers for completion of endoscopy. Moreover, the differential availability of testing may further exacerbate health inequities.

In the absence of pre-endoscopy testing for all patients, routine screening for symptoms, following COVID-19 infection precautions for all cases with strict adherence to physical distancing, and use of N95 (or PAPRs) during endoscopy may minimize viral transmission among patients and staff while maximizing patient adherence to endoscopy, ensuring resumption of endoscopic services, and ultimately mitigating some of the devastating impact of COVID-19 on population health.
 

Shahnaz Sultan, MD, MHSc, AGAF, FACG, is with the division of gastroenterology at the University of Minnesota in Minneapolis and the Center for Care Delivery and Outcomes Research at Minneapolis Veterans Affairs Healthcare System. She has no conflicts to declare.

References

1. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

2. Food and Drug Administration. Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information. 3. Dollinger MT et al. Gastroenterology. 2020;159:1962-4.

4. Forde JJ et al. Gastroenterology. 2020;159:1538-40.

5. Patt D et al. JCO Clin Cancer Inform. 2020 Nov;4:1059-71.

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Dear colleagues and friends,

Welcome to another edition of the Perspectives debates. The COVID-19 crisis has directly affected our endoscopy practices, and it’s raised difficult questions about how best to balance safety with continued delivery of health care services. Dr. John Inadomi and Dr. Shahnaz Sultan address the benefits and downsides of universal testing of patients before endoscopic procedures.

Dr. Charles J. Kahi

I hope you find this debate helpful and informative for your endoscopy unit’s policies as we navigate these uncertain times. As always, I welcome your comments and suggestions for future topics at [email protected]. Stay safe!

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is an associate editor for GI & Hepatology News.

Reassurance is important to both patients and providers

The COVID-19 pandemic has been a global economic, societal, and health crisis. As health care systems shifted resources to care for the overwhelming numbers of patients infected with COVID-19 and coincident with lockdown orders issued by local and state governments, elective endoscopy came to a screeching halt. The gastrointestinal professional societies issued a joint statement advocating delays of all elective endoscopies and limiting procedures to those deemed urgent or emergent.1

Dr. John M. Inadomi

Within our GI community, there was great concern raised about the degree of aerosolization and risk of virus transmission during endoscopy and colonoscopy, the type of personal protective equipment (PPE) required to minimize infection risk, and the need for negative pressure rooms or prolonged room turnover to provide adequate air exchange. Our understanding of the role of the GI tract in infection and transmission and presentation with GI symptoms, as well as the true prevalence of asymptomatic infection, was rapidly evolving. Even though our colleagues in Asia and Europe faced the COVID-19 pandemic before we did, we still had no roadmap to navigate these issues.

Public health officials emphasized that a critical step to limit the spread of infection hinged on the availability of accurate and reliable tests. However, during the initial phase of the pandemic, priority was given to patients with symptoms or exposure because of limitations of tests, sampling tools, and reagents. As testing became more available and we began to ramp up endoscopy, the American Gastroenterological Association developed a rapid review and guideline evaluating the role of testing prior to endoscopy.2 In this evidence review and guideline, the authors systematically evaluated the diagnostic accuracy of the reverse transcription polymerase chain reaction (RT-PCR) nucleic acid amplification tests (NAAT) available on the U.S. market and described a framework for how a pre-endoscopy testing strategy could help with triage and decisions around PPE use.

Specifically, they made a conditional recommendation supporting a pre-endoscopy testing strategy: “For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.”2 This is a conditional recommendation based on low certainty evidence, underscoring the limitations in the evidence for diagnostic test accuracy of the currently available tests (limited sample sizes, test accuracy only for symptomatic patients, no reference standard) and limited knowledge of the true prevalence of SARS-CoV-2 infection at the population level.

The authors of the recommendations emphasized that preprocedure testing could help decrease the risk of transmission by triage – that is, delaying the procedure of patients with positive tests who could infect other patients and health care workers. In addition, for patients with negative tests, surgical masks can be considered during endoscopy to allow preservation of N95/N99 masks that are a limited resource in many settings.

Varying strategies for reopening endoscopy have been adopted by endoscopy centers and health systems. According to one survey, most of responding U.S. endoscopy centers (87%) had developed a formal COVID-19 mitigation protocol, with only 52% of the responding centers testing all patients prior to endoscopy, which highlights the large variation of policies in clinical practice.3 In making the case for a strategy of pretesting of all patients prior to endoscopy, it’s important to emphasize that the benefits of testing outweigh any downsides and that, for health care professionals and patients alike, providing reassurance about the safety of endoscopy for everyone is an important aspect to resuming endoscopy operations.

Concerns regarding acquiring COVID-19 infection in the workplace and infecting family members was and remains a source of significant stress for endoscopy unit personnel across the U.S. Recognizing these issues, many institutions initiated a program for preprocedure COVID-19 testing for all patients undergoing endoscopy. An online survey completed by 47 endoscopy unit personnel found that, after implementation of pre-endoscopy testing, fewer personnel reported anxiety regarding contracting infection (58.1% before vs. 44.7% after; P < .001), there was less concern about infecting family members (88.4% before vs. 68.4% after; P < .05), and fewer providers reported self-isolation practices (living in a room separate from family) (21.3% before vs. 10.8% after; P < .05).4

Moreover, implementation of a pre-endoscopy testing strategy could decrease patient anxiety and decrease patient reluctance to complete endoscopy. With recognition of the long-term consequences of delaying endoscopic evaluation, especially for colorectal cancer screening and surveillance, improving attendance may lessen the impact on colorectal cancer–related morbidity and mortality and other GI-related conditions.5

A pre-endoscopy testing strategy can inform PPE decisions so that N95s and power air-purifying respirators (PAPRs) are reserved for high-risk procedures (such as EGDs in COVID-19-positive patients) with use of surgical masks or extended/reused N95s for patients who test negative. In addition, preprocedure testing can improve endoscopic efficiency eliminating the need to wait for the necessary amount of air exchange between procedures in test-negative patients. In the last 6 months, the testing landscape has changed significantly with the availability of numerous platforms that allow for more efficient processing of tests and the capability of testing saliva instead of nasopharyngeal or nasal swabs. In addition to the original RT-PCR NAAT, more rapid PCR tests, and antigen tests are available. Testing is no longer a scarce resource and for this reason, we should continue our practice of testing all patients prior to endoscopy. Further studies of the false-negative/false-positive rate of various test modalities and test-timing will be important.
 

John M. Inadomi, MD, AGAF, is with the department of medicine at the University of Utah, Salt Lake City. He has no conflicts to declare.

References

1. Gastroenterology Professional Society Guidance on Endoscopic Procedures during the COVID-19 Pandemic. American College of Gastroenterology. 2020 Apr 1.

2. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

3. Moraveji S et al. Gastroenterology. 2020 Oct 1;159(4):1568-70.e5.

4. Podboy A et al. Gastroenterology. 2020 Oct 1;1586-8.e4.

5. Dekker E et al. Gastroenterology. 2020 Dec;159(6):1998-2003.

 

 

Barriers to care should be avoided

In the AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy, the authors made a conditional recommendation for implementation of a preprocedure testing strategy, specifically for endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%).1 The authors stated that, in settings where testing is feasible and there is less perceived burden on patients and when the benefits outweigh the downsides (such as when false positives do not significantly outnumber the true positives), an endoscopy center should implement a preprocedure testing strategy. In addition to the prevalence of SARS-CoV-2 infection, which influences both the positive and negative predictive value of testing, the authors took into account the downstream consequences of test results, the pros and cons of a testing strategy, and the availability of PPE and tests.

Dr. Shahnaz Sultan

The authors further clarify that, in areas with either low or high prevalence of asymptomatic cases, a pre-endoscopy testing strategy may not be informative. The group made a conditional recommendation against testing in these settings, highlighting concerns around the false positive rates in low-prevalence areas and potentially limited availability of tests and false negative rates in high-prevalence areas.

Early in the pandemic, because of the limited availability of tests, symptomatic or high-risk patients were given priority for SARS-CoV-2 testing. Since that time, over 180 different commercially available SARS-CoV-2 assays have become available, and many health systems have developed their own laboratory-developed tests.2 However, despite the aggressive efforts to ramp up test capacity, many endoscopy centers still struggle to obtain timely and reliable results. In light of continued challenges with testing, many endoscopy centers chose to not implement a pretesting strategy and instead proceed with N95 respirators or PAPRs for all procedures. Endoscopy centers that implemented a no-testing strategy emphasized the importance of ramping up productivity as quickly as possible and simultaneously reducing any barriers for patients.

They also highlighted reports that demonstrated a low yield of positive tests and that triaging could be performed equally well with the use of a symptom checklist or fever check. In one study from New York, among 623 asymptomatic patients tested before endoscopy during May and June, which was the height of the first surge, only 6 patients tested positive (overall percentage of SARS-CoV-2–positive tests in asymptomatic patients, 0.96%).3 Similarly, low rates of positive tests were reported in a center in Miami: Among a total of 396 PCR swabs in preparation for endoscopy, one patient had a positive PCR result (positive test rate, 0.25%).4

What are the implications for patients, providers, and endoscopy centers if a preprocedure testing strategy is not adopted? For individual patients, there is a potential for heightened concern about risk of infection from health care staff or other patients, but this may be offset by the decreased burden of testing. For health care professionals, it means that all procedures need to be performed with universal precautions and appropriate PPE. From an endoscopy operations perspective, there remain unanswered questions regarding room turnover and the necessity for negative pressure rooms. Symptom screening, which is locally required for all health visits, may help identify symptomatic patients, and thus, procedures for these individuals could be canceled and rescheduled or moved to negative pressure rooms (based on urgency).

Questions remain about the need to perform all procedures in negative pressure rooms or with prolonged room turnover to allow for a requisite number of air exchanges. There is general agreement among gastroenterologists that upper endoscopy is an aerosol-generating procedure. The passage of the scope near the pharynx (where the virus has a propensity for colonization and infection) may lead to aerosolization of infective particles and confer an increased risk of infection. However, it is unclear whether colonoscopy actually confers an increased risk. This would require that an asymptomatic patient would be infected with the SARS-CoV-2 virus and have viable viral particles in the colon that are released during the passage of flatus in high enough quantity to allow for aerosolization and transmission of infection. Conceptually, while there are potential risks associated with both endoscopy and colonoscopy, it is reassuring that we are not seeing published reports (or anecdotal evidence) suggesting high rates of COVID-19 infection among endoscopy staff or at endoscopy centers. Requiring prolonged room turnover between every procedure would negatively impact endoscopy efficiency and recovery of endoscopy centers.

Indeed, the aftermath of the COVID-19 pandemic will be far reaching. While telemedicine has helped mitigate some of the collateral damage, the disruption of cancer screening and surveillance programs may lead to high cancer-related morbidity and mortality. In one study evaluating the impact of COVID-19 on the U.S. cancer population, authors analyzed 6,227,474 Medicare Fee for Service claims (representing 5%-7% of the Medicare population) and found a substantial decrease in cancer screening and cancer care (therapy and surgeries).5 Screening for colon cancer was reduced by 75% in April.

Eliminating any potential barriers to care should be the highest priority. A requirement for patients to undergo preprocedure testing may contribute to increased anxiety and added costs and may further delay care. From a patient perspective, finding a testing facility, obtaining the test within 48-72 hours, self-isolating until the day of endoscopy, and dealing with the uncertainty of the test result may serve as additional barriers for completion of endoscopy. Moreover, the differential availability of testing may further exacerbate health inequities.

In the absence of pre-endoscopy testing for all patients, routine screening for symptoms, following COVID-19 infection precautions for all cases with strict adherence to physical distancing, and use of N95 (or PAPRs) during endoscopy may minimize viral transmission among patients and staff while maximizing patient adherence to endoscopy, ensuring resumption of endoscopic services, and ultimately mitigating some of the devastating impact of COVID-19 on population health.
 

Shahnaz Sultan, MD, MHSc, AGAF, FACG, is with the division of gastroenterology at the University of Minnesota in Minneapolis and the Center for Care Delivery and Outcomes Research at Minneapolis Veterans Affairs Healthcare System. She has no conflicts to declare.

References

1. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

2. Food and Drug Administration. Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information. 3. Dollinger MT et al. Gastroenterology. 2020;159:1962-4.

4. Forde JJ et al. Gastroenterology. 2020;159:1538-40.

5. Patt D et al. JCO Clin Cancer Inform. 2020 Nov;4:1059-71.

 

Dear colleagues and friends,

Welcome to another edition of the Perspectives debates. The COVID-19 crisis has directly affected our endoscopy practices, and it’s raised difficult questions about how best to balance safety with continued delivery of health care services. Dr. John Inadomi and Dr. Shahnaz Sultan address the benefits and downsides of universal testing of patients before endoscopic procedures.

Dr. Charles J. Kahi

I hope you find this debate helpful and informative for your endoscopy unit’s policies as we navigate these uncertain times. As always, I welcome your comments and suggestions for future topics at [email protected]. Stay safe!

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is an associate editor for GI & Hepatology News.

Reassurance is important to both patients and providers

The COVID-19 pandemic has been a global economic, societal, and health crisis. As health care systems shifted resources to care for the overwhelming numbers of patients infected with COVID-19 and coincident with lockdown orders issued by local and state governments, elective endoscopy came to a screeching halt. The gastrointestinal professional societies issued a joint statement advocating delays of all elective endoscopies and limiting procedures to those deemed urgent or emergent.1

Dr. John M. Inadomi

Within our GI community, there was great concern raised about the degree of aerosolization and risk of virus transmission during endoscopy and colonoscopy, the type of personal protective equipment (PPE) required to minimize infection risk, and the need for negative pressure rooms or prolonged room turnover to provide adequate air exchange. Our understanding of the role of the GI tract in infection and transmission and presentation with GI symptoms, as well as the true prevalence of asymptomatic infection, was rapidly evolving. Even though our colleagues in Asia and Europe faced the COVID-19 pandemic before we did, we still had no roadmap to navigate these issues.

Public health officials emphasized that a critical step to limit the spread of infection hinged on the availability of accurate and reliable tests. However, during the initial phase of the pandemic, priority was given to patients with symptoms or exposure because of limitations of tests, sampling tools, and reagents. As testing became more available and we began to ramp up endoscopy, the American Gastroenterological Association developed a rapid review and guideline evaluating the role of testing prior to endoscopy.2 In this evidence review and guideline, the authors systematically evaluated the diagnostic accuracy of the reverse transcription polymerase chain reaction (RT-PCR) nucleic acid amplification tests (NAAT) available on the U.S. market and described a framework for how a pre-endoscopy testing strategy could help with triage and decisions around PPE use.

Specifically, they made a conditional recommendation supporting a pre-endoscopy testing strategy: “For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.”2 This is a conditional recommendation based on low certainty evidence, underscoring the limitations in the evidence for diagnostic test accuracy of the currently available tests (limited sample sizes, test accuracy only for symptomatic patients, no reference standard) and limited knowledge of the true prevalence of SARS-CoV-2 infection at the population level.

The authors of the recommendations emphasized that preprocedure testing could help decrease the risk of transmission by triage – that is, delaying the procedure of patients with positive tests who could infect other patients and health care workers. In addition, for patients with negative tests, surgical masks can be considered during endoscopy to allow preservation of N95/N99 masks that are a limited resource in many settings.

Varying strategies for reopening endoscopy have been adopted by endoscopy centers and health systems. According to one survey, most of responding U.S. endoscopy centers (87%) had developed a formal COVID-19 mitigation protocol, with only 52% of the responding centers testing all patients prior to endoscopy, which highlights the large variation of policies in clinical practice.3 In making the case for a strategy of pretesting of all patients prior to endoscopy, it’s important to emphasize that the benefits of testing outweigh any downsides and that, for health care professionals and patients alike, providing reassurance about the safety of endoscopy for everyone is an important aspect to resuming endoscopy operations.

Concerns regarding acquiring COVID-19 infection in the workplace and infecting family members was and remains a source of significant stress for endoscopy unit personnel across the U.S. Recognizing these issues, many institutions initiated a program for preprocedure COVID-19 testing for all patients undergoing endoscopy. An online survey completed by 47 endoscopy unit personnel found that, after implementation of pre-endoscopy testing, fewer personnel reported anxiety regarding contracting infection (58.1% before vs. 44.7% after; P < .001), there was less concern about infecting family members (88.4% before vs. 68.4% after; P < .05), and fewer providers reported self-isolation practices (living in a room separate from family) (21.3% before vs. 10.8% after; P < .05).4

Moreover, implementation of a pre-endoscopy testing strategy could decrease patient anxiety and decrease patient reluctance to complete endoscopy. With recognition of the long-term consequences of delaying endoscopic evaluation, especially for colorectal cancer screening and surveillance, improving attendance may lessen the impact on colorectal cancer–related morbidity and mortality and other GI-related conditions.5

A pre-endoscopy testing strategy can inform PPE decisions so that N95s and power air-purifying respirators (PAPRs) are reserved for high-risk procedures (such as EGDs in COVID-19-positive patients) with use of surgical masks or extended/reused N95s for patients who test negative. In addition, preprocedure testing can improve endoscopic efficiency eliminating the need to wait for the necessary amount of air exchange between procedures in test-negative patients. In the last 6 months, the testing landscape has changed significantly with the availability of numerous platforms that allow for more efficient processing of tests and the capability of testing saliva instead of nasopharyngeal or nasal swabs. In addition to the original RT-PCR NAAT, more rapid PCR tests, and antigen tests are available. Testing is no longer a scarce resource and for this reason, we should continue our practice of testing all patients prior to endoscopy. Further studies of the false-negative/false-positive rate of various test modalities and test-timing will be important.
 

John M. Inadomi, MD, AGAF, is with the department of medicine at the University of Utah, Salt Lake City. He has no conflicts to declare.

References

1. Gastroenterology Professional Society Guidance on Endoscopic Procedures during the COVID-19 Pandemic. American College of Gastroenterology. 2020 Apr 1.

2. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

3. Moraveji S et al. Gastroenterology. 2020 Oct 1;159(4):1568-70.e5.

4. Podboy A et al. Gastroenterology. 2020 Oct 1;1586-8.e4.

5. Dekker E et al. Gastroenterology. 2020 Dec;159(6):1998-2003.

 

 

Barriers to care should be avoided

In the AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy, the authors made a conditional recommendation for implementation of a preprocedure testing strategy, specifically for endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%).1 The authors stated that, in settings where testing is feasible and there is less perceived burden on patients and when the benefits outweigh the downsides (such as when false positives do not significantly outnumber the true positives), an endoscopy center should implement a preprocedure testing strategy. In addition to the prevalence of SARS-CoV-2 infection, which influences both the positive and negative predictive value of testing, the authors took into account the downstream consequences of test results, the pros and cons of a testing strategy, and the availability of PPE and tests.

Dr. Shahnaz Sultan

The authors further clarify that, in areas with either low or high prevalence of asymptomatic cases, a pre-endoscopy testing strategy may not be informative. The group made a conditional recommendation against testing in these settings, highlighting concerns around the false positive rates in low-prevalence areas and potentially limited availability of tests and false negative rates in high-prevalence areas.

Early in the pandemic, because of the limited availability of tests, symptomatic or high-risk patients were given priority for SARS-CoV-2 testing. Since that time, over 180 different commercially available SARS-CoV-2 assays have become available, and many health systems have developed their own laboratory-developed tests.2 However, despite the aggressive efforts to ramp up test capacity, many endoscopy centers still struggle to obtain timely and reliable results. In light of continued challenges with testing, many endoscopy centers chose to not implement a pretesting strategy and instead proceed with N95 respirators or PAPRs for all procedures. Endoscopy centers that implemented a no-testing strategy emphasized the importance of ramping up productivity as quickly as possible and simultaneously reducing any barriers for patients.

They also highlighted reports that demonstrated a low yield of positive tests and that triaging could be performed equally well with the use of a symptom checklist or fever check. In one study from New York, among 623 asymptomatic patients tested before endoscopy during May and June, which was the height of the first surge, only 6 patients tested positive (overall percentage of SARS-CoV-2–positive tests in asymptomatic patients, 0.96%).3 Similarly, low rates of positive tests were reported in a center in Miami: Among a total of 396 PCR swabs in preparation for endoscopy, one patient had a positive PCR result (positive test rate, 0.25%).4

What are the implications for patients, providers, and endoscopy centers if a preprocedure testing strategy is not adopted? For individual patients, there is a potential for heightened concern about risk of infection from health care staff or other patients, but this may be offset by the decreased burden of testing. For health care professionals, it means that all procedures need to be performed with universal precautions and appropriate PPE. From an endoscopy operations perspective, there remain unanswered questions regarding room turnover and the necessity for negative pressure rooms. Symptom screening, which is locally required for all health visits, may help identify symptomatic patients, and thus, procedures for these individuals could be canceled and rescheduled or moved to negative pressure rooms (based on urgency).

Questions remain about the need to perform all procedures in negative pressure rooms or with prolonged room turnover to allow for a requisite number of air exchanges. There is general agreement among gastroenterologists that upper endoscopy is an aerosol-generating procedure. The passage of the scope near the pharynx (where the virus has a propensity for colonization and infection) may lead to aerosolization of infective particles and confer an increased risk of infection. However, it is unclear whether colonoscopy actually confers an increased risk. This would require that an asymptomatic patient would be infected with the SARS-CoV-2 virus and have viable viral particles in the colon that are released during the passage of flatus in high enough quantity to allow for aerosolization and transmission of infection. Conceptually, while there are potential risks associated with both endoscopy and colonoscopy, it is reassuring that we are not seeing published reports (or anecdotal evidence) suggesting high rates of COVID-19 infection among endoscopy staff or at endoscopy centers. Requiring prolonged room turnover between every procedure would negatively impact endoscopy efficiency and recovery of endoscopy centers.

Indeed, the aftermath of the COVID-19 pandemic will be far reaching. While telemedicine has helped mitigate some of the collateral damage, the disruption of cancer screening and surveillance programs may lead to high cancer-related morbidity and mortality. In one study evaluating the impact of COVID-19 on the U.S. cancer population, authors analyzed 6,227,474 Medicare Fee for Service claims (representing 5%-7% of the Medicare population) and found a substantial decrease in cancer screening and cancer care (therapy and surgeries).5 Screening for colon cancer was reduced by 75% in April.

Eliminating any potential barriers to care should be the highest priority. A requirement for patients to undergo preprocedure testing may contribute to increased anxiety and added costs and may further delay care. From a patient perspective, finding a testing facility, obtaining the test within 48-72 hours, self-isolating until the day of endoscopy, and dealing with the uncertainty of the test result may serve as additional barriers for completion of endoscopy. Moreover, the differential availability of testing may further exacerbate health inequities.

In the absence of pre-endoscopy testing for all patients, routine screening for symptoms, following COVID-19 infection precautions for all cases with strict adherence to physical distancing, and use of N95 (or PAPRs) during endoscopy may minimize viral transmission among patients and staff while maximizing patient adherence to endoscopy, ensuring resumption of endoscopic services, and ultimately mitigating some of the devastating impact of COVID-19 on population health.
 

Shahnaz Sultan, MD, MHSc, AGAF, FACG, is with the division of gastroenterology at the University of Minnesota in Minneapolis and the Center for Care Delivery and Outcomes Research at Minneapolis Veterans Affairs Healthcare System. She has no conflicts to declare.

References

1. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

2. Food and Drug Administration. Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information. 3. Dollinger MT et al. Gastroenterology. 2020;159:1962-4.

4. Forde JJ et al. Gastroenterology. 2020;159:1538-40.

5. Patt D et al. JCO Clin Cancer Inform. 2020 Nov;4:1059-71.

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