Opinion

Imagine a time when RSV doesn’t rage through the community each year. That time would result from decades of research that uncovered RSV’s secrets and explained the only partly successful initial vaccines and prophylactic interventions (for example, palivizumab). 

Key discovery: The original RSV antigen target, RSV’s fusion (F) protein, is suboptimal despite having been associated with RSV attachment to and breaching of host cell membranes. 
Some amazing work showed that having antibodies block the F-protein was like putting up a shield to protect against an arrow only after the arrow had already struck its target. Indeed, the F-protein evolves only after the attachment/breach. The preattachment/breach version (prefusion protein) sits on the virus surface and is like a loaded bow with an arrow in place. The prefusion protein changes configuration when RSV contacts host cells to uncoil and release the “arrow,” creating the entry point for RSV nucleic acids.

Nirsevimab was created to glom onto the prefusion protein and prevent it from uncoiling/releasing its “arrow,” the critical event in RSV infecting a cell. So, it is not surprising that it works better than palivizumab, which targets the fusion protein.

The prefusion protein is also the target of newer vaccine candidates, including one that showed 87% efficacy against RSV challenge in adults (think of mother getting this vaccine and endowing newborns with antiprefusion antibodies; N Engl J Med. 2022;386:2377-86).

The time when RSV is not an annual scourge is closer than ever.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

Imagine a time when RSV doesn’t rage through the community each year. That time would result from decades of research that uncovered RSV’s secrets and explained the only partly successful initial vaccines and prophylactic interventions (for example, palivizumab). 

Key discovery: The original RSV antigen target, RSV’s fusion (F) protein, is suboptimal despite having been associated with RSV attachment to and breaching of host cell membranes. 
Some amazing work showed that having antibodies block the F-protein was like putting up a shield to protect against an arrow only after the arrow had already struck its target. Indeed, the F-protein evolves only after the attachment/breach. The preattachment/breach version (prefusion protein) sits on the virus surface and is like a loaded bow with an arrow in place. The prefusion protein changes configuration when RSV contacts host cells to uncoil and release the “arrow,” creating the entry point for RSV nucleic acids.

Nirsevimab was created to glom onto the prefusion protein and prevent it from uncoiling/releasing its “arrow,” the critical event in RSV infecting a cell. So, it is not surprising that it works better than palivizumab, which targets the fusion protein.

The prefusion protein is also the target of newer vaccine candidates, including one that showed 87% efficacy against RSV challenge in adults (think of mother getting this vaccine and endowing newborns with antiprefusion antibodies; N Engl J Med. 2022;386:2377-86).

The time when RSV is not an annual scourge is closer than ever.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

Imagine a time when RSV doesn’t rage through the community each year. That time would result from decades of research that uncovered RSV’s secrets and explained the only partly successful initial vaccines and prophylactic interventions (for example, palivizumab). 

Key discovery: The original RSV antigen target, RSV’s fusion (F) protein, is suboptimal despite having been associated with RSV attachment to and breaching of host cell membranes. 
Some amazing work showed that having antibodies block the F-protein was like putting up a shield to protect against an arrow only after the arrow had already struck its target. Indeed, the F-protein evolves only after the attachment/breach. The preattachment/breach version (prefusion protein) sits on the virus surface and is like a loaded bow with an arrow in place. The prefusion protein changes configuration when RSV contacts host cells to uncoil and release the “arrow,” creating the entry point for RSV nucleic acids.

Nirsevimab was created to glom onto the prefusion protein and prevent it from uncoiling/releasing its “arrow,” the critical event in RSV infecting a cell. So, it is not surprising that it works better than palivizumab, which targets the fusion protein.

The prefusion protein is also the target of newer vaccine candidates, including one that showed 87% efficacy against RSV challenge in adults (think of mother getting this vaccine and endowing newborns with antiprefusion antibodies; N Engl J Med. 2022;386:2377-86).

The time when RSV is not an annual scourge is closer than ever.

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.

The common element among these very different legal issues is that physicians typically have no idea what to do when they find themselves potentially in trouble, but how they choose to deal with the issue can have significant consequences.

In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.

More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.

Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.

Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.

There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.

In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.

If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).

• Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
• If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
• Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
• Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
• Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
• Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
• If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
• Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
• If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
• If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
• Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.

There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.

Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.

The common element among these very different legal issues is that physicians typically have no idea what to do when they find themselves potentially in trouble, but how they choose to deal with the issue can have significant consequences.

In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.

More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.

Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.

Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.

There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.

In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.

If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).

• Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
• If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
• Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
• Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
• Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
• Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
• If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
• Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
• If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
• If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
• Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.

There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.

Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.

The common element among these very different legal issues is that physicians typically have no idea what to do when they find themselves potentially in trouble, but how they choose to deal with the issue can have significant consequences.

In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.

More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.

Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.

Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.

There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.

In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.

If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).

• Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
• If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
• Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
• Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
• Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
• Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
• If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
• Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
• If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
• If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
• Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.

There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.

Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Four years ago, I was fully employed in a “traditional” rheumatology clinic. I met Alan, a 42-year-old gentleman who was a high school math teacher in my town. He was the first patient on my panel that day. Once I entered the examining room, Alan greeted me with: “You are the third rheumatologist who I have consulted for what everybody believes is fibromyalgia. I am paying out of pocket to see you as you are not on my insurance panel. I have researched your background, and I have high expectations of you.” He was cutting to the chase.

Alan had struggled with pain for about 1½ years. He insisted that he was very healthy before his symptoms started abruptly. In the past 2 years, his personal life had been under much stress as he was caring for a disabled child and facing an imminent divorce. While his symptoms were suggestive of an inflammatory arthritis, his workup was not. Unfortunately, the allocated time with Alan was 15 minutes – too short to cover both medical and personal struggles. Meanwhile, my nurses had to room in another two patients. I felt rushed and responsible for not letting the others wait. I asked Alan to keep a diary of his symptoms and come back in 2 weeks. A few minutes after discharging Alan, my nurse followed and asked me: “Where would you like me to add this patient, as you have no openings for 4 months ?”

“Overbook him!” I said.

This was happening almost every day. Scheduled patients, overbooked patients, tens of emails, calls to patients, and fights with insurance companies to approve tests and medications. Nearly every day I was getting home, preparing dinner, feeding my family, and going back to writing notes, as I would be financially penalized if my notes were not submitted in 24-48 hours. I had no time for my family and didn’t even think about any hobbies.

In 2 weeks, Alan came back for his visit. That day, I paid someone to take my kids to school and came to my office earlier. We had 1 hour to talk about his history. At the end of the visit, Alan said: “What kind of doctor are you? You looked into my eyes while I was talking, and you didn’t touch the computer keyboard?!” His remark was not uncommon for me. Most patients complain that physicians spend more time typing than looking at them. Maybe patients do not realize, but this is the only way that physicians get paid: writing the “proper notes” and placing the correct billing code.

Alan was diagnosed and treated successfully for seronegative rheumatoid arthritis. In 1 year, paying out of pocket to see me, he ended up spending many, many thousands of dollars. As you can imagine, I was not in control of those bills.

After 4 years in the traditional system, I decided to change something for my patients and for myself as their physician, and as a mother of three kids, a wife, a daughter, and a sister.

I decided to create a clinic where I am comfortable practicing “uncomplicated” medicine, as a friend of mine said. Today, insurance companies are restricting patients to limited panels of specialists. They dictate patients’ care, giving the false impression that they will save money. Insurance companies interfere with the physician’s medical judgment. They make algorithms to approve tests and have preferred lists of medication. They decide whether a test or a medication is appropriate for you. In addition, they don’t disclose how much they pay for your consultation, tests, and medication, and they ban the contracted parties from disclosing this information. They force patients to use their testing facilities and mailing pharmacies. Although patients and employers are the payers, they do not have access to their insurance companies’ “real” prices.

I decided that it was time to take control of my time spent with patients to make my services available when patients need me, without becoming a financial burden. I created a clinic where patients do not have copayments and will never receive a “surprise bill.” All costs are transparent to patients, including laboratory and imaging tests. Patients can talk to me on the phone, send a text, or email. A clinic where patients can talk to the physician on the phone or send a text or email? This is direct specialty care.

Is direct care a new concept? No, not at all. Is direct care the same as concierge medicine? I think it is a type of concierge service, but without the price tag.

Why?

Physicians practicing the traditional concierge medicine model here in the United States still bill patients’ insurance. In addition, to make their practice profitable, they charge a retainer fee that will allow them to keep a small patient panel. In contrast, direct care specialists do not have a contract with insurance companies.

I believe that both concierge medicine and direct care specialists offer exceptional care and better access to physicians. The difference is in costs: One is more expensive than the other. Traditional concierge medicine practices usually ask for high retainer fees in addition to copayments for visits. They do not offer any access to discounted pricing for laboratory or imaging tests. Patients continue to receive surprise bills from their insurance company.

Why don’t direct specialty care practices contract with insurance companies? Contracting with insurance companies increases a practice’s overhead costs (as more money is spent on coding and billing services and more office staff). When practice overhead is lower, the cost of patient care can be significantly lower. Patients pay a monthly membership to become a direct specialty care practice member. The membership covers the cost of visits and access to the benefits of the practice. In addition, direct care specialists do not charge copayments or send surprise bills. They can contract directly with laboratory and imaging centers and offer discounted prices. Patients with insurance are welcome to use it to cover tests, imaging, and medication. The patient has the power to choose between paying a cash price versus a “covered” service.

Most young patients, like Alan, have a high-deductible plan. A few regular blood tests might cost a patient hundreds of dollars before meeting a deductible. One MRI scan costs $4,000-$6,000. Patients who join a direct specialty care practice pay $30-$40 for regular labs and $400-$500 for an MRI.

I am now 2 years into practicing medicine as a direct care specialist. It is not a dream anymore. Yes, you may call it “concierge medicine without the price tag.” I call it “direct specialty care.” My patients and I are both accountable to one another. Together, we make a plan, and we have the time to implement it.

I am not alone. Other specialists are embracing this model. That is why we created the Direct Specialty Care Alliance, a place where physicians are welcome to network and share with others what they have learned along their journeys.

After I started my company, Alan was one of the first patients to join. He embraced my practice model and became one of the ambassadors of the direct specialty care movement. He is back to a normal life of taking care of his family, getting his wife back, and teaching math to high school kids.

Dr Girnita is the CEO and founder of RheumatologistOnCall, actively seeing patients via telemedicine in 10 U.S. states. She is an advocate for digital health and telemedicine that will empower physicians and patients to take charge of their medical care. She is a cofounder of the Direct Specialty Care Alliance. She disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Four years ago, I was fully employed in a “traditional” rheumatology clinic. I met Alan, a 42-year-old gentleman who was a high school math teacher in my town. He was the first patient on my panel that day. Once I entered the examining room, Alan greeted me with: “You are the third rheumatologist who I have consulted for what everybody believes is fibromyalgia. I am paying out of pocket to see you as you are not on my insurance panel. I have researched your background, and I have high expectations of you.” He was cutting to the chase.

Alan had struggled with pain for about 1½ years. He insisted that he was very healthy before his symptoms started abruptly. In the past 2 years, his personal life had been under much stress as he was caring for a disabled child and facing an imminent divorce. While his symptoms were suggestive of an inflammatory arthritis, his workup was not. Unfortunately, the allocated time with Alan was 15 minutes – too short to cover both medical and personal struggles. Meanwhile, my nurses had to room in another two patients. I felt rushed and responsible for not letting the others wait. I asked Alan to keep a diary of his symptoms and come back in 2 weeks. A few minutes after discharging Alan, my nurse followed and asked me: “Where would you like me to add this patient, as you have no openings for 4 months ?”

“Overbook him!” I said.

This was happening almost every day. Scheduled patients, overbooked patients, tens of emails, calls to patients, and fights with insurance companies to approve tests and medications. Nearly every day I was getting home, preparing dinner, feeding my family, and going back to writing notes, as I would be financially penalized if my notes were not submitted in 24-48 hours. I had no time for my family and didn’t even think about any hobbies.

In 2 weeks, Alan came back for his visit. That day, I paid someone to take my kids to school and came to my office earlier. We had 1 hour to talk about his history. At the end of the visit, Alan said: “What kind of doctor are you? You looked into my eyes while I was talking, and you didn’t touch the computer keyboard?!” His remark was not uncommon for me. Most patients complain that physicians spend more time typing than looking at them. Maybe patients do not realize, but this is the only way that physicians get paid: writing the “proper notes” and placing the correct billing code.

Alan was diagnosed and treated successfully for seronegative rheumatoid arthritis. In 1 year, paying out of pocket to see me, he ended up spending many, many thousands of dollars. As you can imagine, I was not in control of those bills.

After 4 years in the traditional system, I decided to change something for my patients and for myself as their physician, and as a mother of three kids, a wife, a daughter, and a sister.

I decided to create a clinic where I am comfortable practicing “uncomplicated” medicine, as a friend of mine said. Today, insurance companies are restricting patients to limited panels of specialists. They dictate patients’ care, giving the false impression that they will save money. Insurance companies interfere with the physician’s medical judgment. They make algorithms to approve tests and have preferred lists of medication. They decide whether a test or a medication is appropriate for you. In addition, they don’t disclose how much they pay for your consultation, tests, and medication, and they ban the contracted parties from disclosing this information. They force patients to use their testing facilities and mailing pharmacies. Although patients and employers are the payers, they do not have access to their insurance companies’ “real” prices.

I decided that it was time to take control of my time spent with patients to make my services available when patients need me, without becoming a financial burden. I created a clinic where patients do not have copayments and will never receive a “surprise bill.” All costs are transparent to patients, including laboratory and imaging tests. Patients can talk to me on the phone, send a text, or email. A clinic where patients can talk to the physician on the phone or send a text or email? This is direct specialty care.

Is direct care a new concept? No, not at all. Is direct care the same as concierge medicine? I think it is a type of concierge service, but without the price tag.

Why?

Physicians practicing the traditional concierge medicine model here in the United States still bill patients’ insurance. In addition, to make their practice profitable, they charge a retainer fee that will allow them to keep a small patient panel. In contrast, direct care specialists do not have a contract with insurance companies.

I believe that both concierge medicine and direct care specialists offer exceptional care and better access to physicians. The difference is in costs: One is more expensive than the other. Traditional concierge medicine practices usually ask for high retainer fees in addition to copayments for visits. They do not offer any access to discounted pricing for laboratory or imaging tests. Patients continue to receive surprise bills from their insurance company.

Why don’t direct specialty care practices contract with insurance companies? Contracting with insurance companies increases a practice’s overhead costs (as more money is spent on coding and billing services and more office staff). When practice overhead is lower, the cost of patient care can be significantly lower. Patients pay a monthly membership to become a direct specialty care practice member. The membership covers the cost of visits and access to the benefits of the practice. In addition, direct care specialists do not charge copayments or send surprise bills. They can contract directly with laboratory and imaging centers and offer discounted prices. Patients with insurance are welcome to use it to cover tests, imaging, and medication. The patient has the power to choose between paying a cash price versus a “covered” service.

Most young patients, like Alan, have a high-deductible plan. A few regular blood tests might cost a patient hundreds of dollars before meeting a deductible. One MRI scan costs $4,000-$6,000. Patients who join a direct specialty care practice pay $30-$40 for regular labs and $400-$500 for an MRI.

I am now 2 years into practicing medicine as a direct care specialist. It is not a dream anymore. Yes, you may call it “concierge medicine without the price tag.” I call it “direct specialty care.” My patients and I are both accountable to one another. Together, we make a plan, and we have the time to implement it.

I am not alone. Other specialists are embracing this model. That is why we created the Direct Specialty Care Alliance, a place where physicians are welcome to network and share with others what they have learned along their journeys.

After I started my company, Alan was one of the first patients to join. He embraced my practice model and became one of the ambassadors of the direct specialty care movement. He is back to a normal life of taking care of his family, getting his wife back, and teaching math to high school kids.

Dr Girnita is the CEO and founder of RheumatologistOnCall, actively seeing patients via telemedicine in 10 U.S. states. She is an advocate for digital health and telemedicine that will empower physicians and patients to take charge of their medical care. She is a cofounder of the Direct Specialty Care Alliance. She disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Four years ago, I was fully employed in a “traditional” rheumatology clinic. I met Alan, a 42-year-old gentleman who was a high school math teacher in my town. He was the first patient on my panel that day. Once I entered the examining room, Alan greeted me with: “You are the third rheumatologist who I have consulted for what everybody believes is fibromyalgia. I am paying out of pocket to see you as you are not on my insurance panel. I have researched your background, and I have high expectations of you.” He was cutting to the chase.

Alan had struggled with pain for about 1½ years. He insisted that he was very healthy before his symptoms started abruptly. In the past 2 years, his personal life had been under much stress as he was caring for a disabled child and facing an imminent divorce. While his symptoms were suggestive of an inflammatory arthritis, his workup was not. Unfortunately, the allocated time with Alan was 15 minutes – too short to cover both medical and personal struggles. Meanwhile, my nurses had to room in another two patients. I felt rushed and responsible for not letting the others wait. I asked Alan to keep a diary of his symptoms and come back in 2 weeks. A few minutes after discharging Alan, my nurse followed and asked me: “Where would you like me to add this patient, as you have no openings for 4 months ?”

“Overbook him!” I said.

This was happening almost every day. Scheduled patients, overbooked patients, tens of emails, calls to patients, and fights with insurance companies to approve tests and medications. Nearly every day I was getting home, preparing dinner, feeding my family, and going back to writing notes, as I would be financially penalized if my notes were not submitted in 24-48 hours. I had no time for my family and didn’t even think about any hobbies.

In 2 weeks, Alan came back for his visit. That day, I paid someone to take my kids to school and came to my office earlier. We had 1 hour to talk about his history. At the end of the visit, Alan said: “What kind of doctor are you? You looked into my eyes while I was talking, and you didn’t touch the computer keyboard?!” His remark was not uncommon for me. Most patients complain that physicians spend more time typing than looking at them. Maybe patients do not realize, but this is the only way that physicians get paid: writing the “proper notes” and placing the correct billing code.

Alan was diagnosed and treated successfully for seronegative rheumatoid arthritis. In 1 year, paying out of pocket to see me, he ended up spending many, many thousands of dollars. As you can imagine, I was not in control of those bills.

After 4 years in the traditional system, I decided to change something for my patients and for myself as their physician, and as a mother of three kids, a wife, a daughter, and a sister.

I decided to create a clinic where I am comfortable practicing “uncomplicated” medicine, as a friend of mine said. Today, insurance companies are restricting patients to limited panels of specialists. They dictate patients’ care, giving the false impression that they will save money. Insurance companies interfere with the physician’s medical judgment. They make algorithms to approve tests and have preferred lists of medication. They decide whether a test or a medication is appropriate for you. In addition, they don’t disclose how much they pay for your consultation, tests, and medication, and they ban the contracted parties from disclosing this information. They force patients to use their testing facilities and mailing pharmacies. Although patients and employers are the payers, they do not have access to their insurance companies’ “real” prices.

I decided that it was time to take control of my time spent with patients to make my services available when patients need me, without becoming a financial burden. I created a clinic where patients do not have copayments and will never receive a “surprise bill.” All costs are transparent to patients, including laboratory and imaging tests. Patients can talk to me on the phone, send a text, or email. A clinic where patients can talk to the physician on the phone or send a text or email? This is direct specialty care.

Is direct care a new concept? No, not at all. Is direct care the same as concierge medicine? I think it is a type of concierge service, but without the price tag.

Why?

Physicians practicing the traditional concierge medicine model here in the United States still bill patients’ insurance. In addition, to make their practice profitable, they charge a retainer fee that will allow them to keep a small patient panel. In contrast, direct care specialists do not have a contract with insurance companies.

I believe that both concierge medicine and direct care specialists offer exceptional care and better access to physicians. The difference is in costs: One is more expensive than the other. Traditional concierge medicine practices usually ask for high retainer fees in addition to copayments for visits. They do not offer any access to discounted pricing for laboratory or imaging tests. Patients continue to receive surprise bills from their insurance company.

Why don’t direct specialty care practices contract with insurance companies? Contracting with insurance companies increases a practice’s overhead costs (as more money is spent on coding and billing services and more office staff). When practice overhead is lower, the cost of patient care can be significantly lower. Patients pay a monthly membership to become a direct specialty care practice member. The membership covers the cost of visits and access to the benefits of the practice. In addition, direct care specialists do not charge copayments or send surprise bills. They can contract directly with laboratory and imaging centers and offer discounted prices. Patients with insurance are welcome to use it to cover tests, imaging, and medication. The patient has the power to choose between paying a cash price versus a “covered” service.

Most young patients, like Alan, have a high-deductible plan. A few regular blood tests might cost a patient hundreds of dollars before meeting a deductible. One MRI scan costs $4,000-$6,000. Patients who join a direct specialty care practice pay $30-$40 for regular labs and $400-$500 for an MRI.

I am now 2 years into practicing medicine as a direct care specialist. It is not a dream anymore. Yes, you may call it “concierge medicine without the price tag.” I call it “direct specialty care.” My patients and I are both accountable to one another. Together, we make a plan, and we have the time to implement it.

I am not alone. Other specialists are embracing this model. That is why we created the Direct Specialty Care Alliance, a place where physicians are welcome to network and share with others what they have learned along their journeys.

After I started my company, Alan was one of the first patients to join. He embraced my practice model and became one of the ambassadors of the direct specialty care movement. He is back to a normal life of taking care of his family, getting his wife back, and teaching math to high school kids.

Dr Girnita is the CEO and founder of RheumatologistOnCall, actively seeing patients via telemedicine in 10 U.S. states. She is an advocate for digital health and telemedicine that will empower physicians and patients to take charge of their medical care. She is a cofounder of the Direct Specialty Care Alliance. She disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

It would be overused and trite to say that the pandemic has drastically altered all of our lives and will cause lasting impact on how we function in society and medicine for years to come. While it seems that the current trend of the latest Omicron variant is on the downslope, the path to get to this point has been fraught with challenges that have struck at the very core of our society. As a primary care physician on the front lines seeing COVID patients, I have had to deal with not only the disease but the politics around it. As critical and life saving as the vaccines have been, many physicians have not been able to get access to these vaccines and give them to their patients. I am one of those physicians. I practice in Florida, and I still cannot give COVID vaccines in my office. 

I am a firm believer in the ability for physicians to be able to give all the necessary adult vaccines and provide them for their patients. The COVID vaccine exacerbated a majorly flawed system that further increased the health care disparities in the country. The current vaccine system for the majority of adult vaccines involves the physician’s being able to directly purchase supplies from the vaccine manufacturer, administer them to the patients, and be reimbursed.
 

Third parties can purchase vaccines at lower rates than those for physicians

The Affordable Care Act mandates that all vaccines approved by the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention must be covered. This allows for better access to care as physicians will be able to purchase, store, and deliver vaccines to their patients. The fallacy in this system is that third parties get involved and rebates or incentives are given to these groups to purchase vaccines at a rate lower than those for physicians.

In addition, many organizations can get access to vaccines before physicians and at a lower cost. That system was flawed to begin with and created a deterrent for access to care and physician involvement in the vaccination process. This was worsened by different states being given the ability to decide how vaccines would be distributed for COVID.

Many pharmacies were able to give out COVID vaccines while many physician offices still have not received access to any of the vaccines. One of the major safety issues with this is that no physicians were involved in the administration of the vaccine, and it is unclear what training was given to the individuals injecting that vaccine. Finally, different places were interpreting the recommendations from ACIP on their own and not necessarily following the appropriate guidelines. All of these factors have further widened the health care disparity gap and made it difficult to provide the COVID vaccines in doctors’ offices.
 

Recommended next steps, solutions to problem

The question is what to do about this. The most important thing is to get the vaccines in arms so they can save lives. In addition, doctors need to be able to get the vaccines in their offices.

Many patients trust their physicians to advise them on what to do regarding health care. The majority of patients want to know if they should get the vaccine and ask for counseling. Physicians answering patients’ questions about vaccines is an important step in overcoming vaccine hesitancy.

Also, doctors need to be informed and supportive of the vaccine process.

The next step is the governmental aspect with those in power making sure that vaccines are accessible to all. Even if the vaccine cannot be given in the office, doctors should still be recommending that patients receive them. Plus, doctors should take every opportunity to ask about what vaccines their patients have received and encourage their patients to get vaccinated.

The COVID-19 vaccines are safe and effective and have been monitored for safety more than any other vaccine. There are multiple systems in place to look for any signals that could indicate an issue was caused by a COVID-19 vaccine. These vaccines can be administered with other vaccines, and there is a great opportunity for physicians to encourage patients to receive these life-saving vaccines.

While it may seem that the COVID-19 case counts are on the downslope, the importance of continuing to vaccinate is predicated on the very real concern that the disease is still circulating and the unvaccinated are still at risk for severe infection.

Dr. Goldman is immediate past governor of the Florida chapter of the American College of Physicians, a regent for the American College of Physicians, vice-president of the Florida Medical Association, and president of the Florida Medical Association Political Action Committee. You can reach Dr. Goldman at [email protected].

It would be overused and trite to say that the pandemic has drastically altered all of our lives and will cause lasting impact on how we function in society and medicine for years to come. While it seems that the current trend of the latest Omicron variant is on the downslope, the path to get to this point has been fraught with challenges that have struck at the very core of our society. As a primary care physician on the front lines seeing COVID patients, I have had to deal with not only the disease but the politics around it. As critical and life saving as the vaccines have been, many physicians have not been able to get access to these vaccines and give them to their patients. I am one of those physicians. I practice in Florida, and I still cannot give COVID vaccines in my office. 

I am a firm believer in the ability for physicians to be able to give all the necessary adult vaccines and provide them for their patients. The COVID vaccine exacerbated a majorly flawed system that further increased the health care disparities in the country. The current vaccine system for the majority of adult vaccines involves the physician’s being able to directly purchase supplies from the vaccine manufacturer, administer them to the patients, and be reimbursed.
 

Third parties can purchase vaccines at lower rates than those for physicians

The Affordable Care Act mandates that all vaccines approved by the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention must be covered. This allows for better access to care as physicians will be able to purchase, store, and deliver vaccines to their patients. The fallacy in this system is that third parties get involved and rebates or incentives are given to these groups to purchase vaccines at a rate lower than those for physicians.

In addition, many organizations can get access to vaccines before physicians and at a lower cost. That system was flawed to begin with and created a deterrent for access to care and physician involvement in the vaccination process. This was worsened by different states being given the ability to decide how vaccines would be distributed for COVID.

Many pharmacies were able to give out COVID vaccines while many physician offices still have not received access to any of the vaccines. One of the major safety issues with this is that no physicians were involved in the administration of the vaccine, and it is unclear what training was given to the individuals injecting that vaccine. Finally, different places were interpreting the recommendations from ACIP on their own and not necessarily following the appropriate guidelines. All of these factors have further widened the health care disparity gap and made it difficult to provide the COVID vaccines in doctors’ offices.
 

Recommended next steps, solutions to problem

The question is what to do about this. The most important thing is to get the vaccines in arms so they can save lives. In addition, doctors need to be able to get the vaccines in their offices.

Many patients trust their physicians to advise them on what to do regarding health care. The majority of patients want to know if they should get the vaccine and ask for counseling. Physicians answering patients’ questions about vaccines is an important step in overcoming vaccine hesitancy.

Also, doctors need to be informed and supportive of the vaccine process.

The next step is the governmental aspect with those in power making sure that vaccines are accessible to all. Even if the vaccine cannot be given in the office, doctors should still be recommending that patients receive them. Plus, doctors should take every opportunity to ask about what vaccines their patients have received and encourage their patients to get vaccinated.

The COVID-19 vaccines are safe and effective and have been monitored for safety more than any other vaccine. There are multiple systems in place to look for any signals that could indicate an issue was caused by a COVID-19 vaccine. These vaccines can be administered with other vaccines, and there is a great opportunity for physicians to encourage patients to receive these life-saving vaccines.

While it may seem that the COVID-19 case counts are on the downslope, the importance of continuing to vaccinate is predicated on the very real concern that the disease is still circulating and the unvaccinated are still at risk for severe infection.

Dr. Goldman is immediate past governor of the Florida chapter of the American College of Physicians, a regent for the American College of Physicians, vice-president of the Florida Medical Association, and president of the Florida Medical Association Political Action Committee. You can reach Dr. Goldman at [email protected].

It would be overused and trite to say that the pandemic has drastically altered all of our lives and will cause lasting impact on how we function in society and medicine for years to come. While it seems that the current trend of the latest Omicron variant is on the downslope, the path to get to this point has been fraught with challenges that have struck at the very core of our society. As a primary care physician on the front lines seeing COVID patients, I have had to deal with not only the disease but the politics around it. As critical and life saving as the vaccines have been, many physicians have not been able to get access to these vaccines and give them to their patients. I am one of those physicians. I practice in Florida, and I still cannot give COVID vaccines in my office. 

I am a firm believer in the ability for physicians to be able to give all the necessary adult vaccines and provide them for their patients. The COVID vaccine exacerbated a majorly flawed system that further increased the health care disparities in the country. The current vaccine system for the majority of adult vaccines involves the physician’s being able to directly purchase supplies from the vaccine manufacturer, administer them to the patients, and be reimbursed.
 

Third parties can purchase vaccines at lower rates than those for physicians

The Affordable Care Act mandates that all vaccines approved by the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention must be covered. This allows for better access to care as physicians will be able to purchase, store, and deliver vaccines to their patients. The fallacy in this system is that third parties get involved and rebates or incentives are given to these groups to purchase vaccines at a rate lower than those for physicians.

In addition, many organizations can get access to vaccines before physicians and at a lower cost. That system was flawed to begin with and created a deterrent for access to care and physician involvement in the vaccination process. This was worsened by different states being given the ability to decide how vaccines would be distributed for COVID.

Many pharmacies were able to give out COVID vaccines while many physician offices still have not received access to any of the vaccines. One of the major safety issues with this is that no physicians were involved in the administration of the vaccine, and it is unclear what training was given to the individuals injecting that vaccine. Finally, different places were interpreting the recommendations from ACIP on their own and not necessarily following the appropriate guidelines. All of these factors have further widened the health care disparity gap and made it difficult to provide the COVID vaccines in doctors’ offices.
 

Recommended next steps, solutions to problem

The question is what to do about this. The most important thing is to get the vaccines in arms so they can save lives. In addition, doctors need to be able to get the vaccines in their offices.

Many patients trust their physicians to advise them on what to do regarding health care. The majority of patients want to know if they should get the vaccine and ask for counseling. Physicians answering patients’ questions about vaccines is an important step in overcoming vaccine hesitancy.

Also, doctors need to be informed and supportive of the vaccine process.

The next step is the governmental aspect with those in power making sure that vaccines are accessible to all. Even if the vaccine cannot be given in the office, doctors should still be recommending that patients receive them. Plus, doctors should take every opportunity to ask about what vaccines their patients have received and encourage their patients to get vaccinated.

The COVID-19 vaccines are safe and effective and have been monitored for safety more than any other vaccine. There are multiple systems in place to look for any signals that could indicate an issue was caused by a COVID-19 vaccine. These vaccines can be administered with other vaccines, and there is a great opportunity for physicians to encourage patients to receive these life-saving vaccines.

While it may seem that the COVID-19 case counts are on the downslope, the importance of continuing to vaccinate is predicated on the very real concern that the disease is still circulating and the unvaccinated are still at risk for severe infection.

Dr. Goldman is immediate past governor of the Florida chapter of the American College of Physicians, a regent for the American College of Physicians, vice-president of the Florida Medical Association, and president of the Florida Medical Association Political Action Committee. You can reach Dr. Goldman at [email protected].

While evaluating an adolescent who had endured a several-day history of vomiting and diarrhea, I mentioned the likelihood of a viral causation, including SARS-CoV-2 infection. His well-informed mother responded, “He has no respiratory symptoms. Does COVID cause GI disease?”

Indeed, not only is the gastrointestinal tract a potential portal of entry of the virus but it may well be the site of mediation of both local and remote injury and thus a harbinger of more severe clinical phenotypes.

As we learn more about the clinical spectrum of COVID, it is becoming increasingly clear that certain features of GI tract involvement may allow us to establish a timeline of the clinical course and perhaps predict the outcome.
 

The GI tract’s involvement isn’t surprising

The ways in which the GI tract serves as a target organ of SARS-CoV-2 have been postulated in the literature. In part, this is related to the presence of abundant receptors for SARS-CoV-2 cell binding and internalization. The virus uses angiotensin-converting enzyme 2 receptors to enter various cells. These receptors are highly expressed on not only lung cells but also enterocytes. Binding of SARS-CoV-2 to ACE2 receptors allows GI involvement, leading to microscopic mucosal inflammation, increased permeability, and altered intestinal absorption.

The clinical GI manifestations of this include anorexia, nausea, vomiting, diarrhea, and abdominal pain, which may be the earliest, or sole, symptoms of COVID-19, often noted before the onset of fever or respiratory symptoms. In fact, John Ong, MBBS, and colleagues, in a discussion about patients with primary GI SARS-CoV-2 infection and symptoms, use the term “GI-COVID.”
 

Clinical course of GI manifestations

After SARS-CoV-2 exposure, adults most commonly present with respiratory symptoms, with GI symptoms reported in 10%-15% of cases. However, the overall incidence of GI involvement during SARS-CoV-2 infection varies according to age, with children more likely than adults to manifest intestinal symptoms.

There are also differences in incidence reported when comparing hospitalized with nonhospitalized individuals. In early reports from the onset of the COVID-19 pandemic, 11%-43% of hospitalized adult patients manifested GI symptoms. Of note, the presence of GI symptoms was associated with more severe disease and thus predictive of outcomes in those admitted to hospitals.

In a multicenter study that assessed pediatric inpatients with COVID-19, GI manifestations were present in 57% of patients and were the first manifestation in 14%. Adjusted by confounding factors, those with GI symptoms had a higher risk for pediatric intensive care unit admission. Patients admitted to the PICU also had higher serum C-reactive protein and aspartate aminotransferase values.
 

Emerging data on MIS-C

In previously healthy children and adolescents, the severe, life-threatening complication of multisystem inflammatory syndrome in children (MIS-C) may present 2-6 weeks after acute infection with SARS-CoV-2. MIS-C appears to be an immune activation syndrome and is presumed to be the delayed immunologic sequelae of mild/asymptomatic SARS-CoV-2 infection. This response manifests as hyperinflammation in conjunction with a peak in antibody production a few weeks later.

One report of 186 children with MIS-C in the United States noted that the involved organ system included the GI tract in 92%, followed by cardiovascular in 80%, hematologic in 76%, mucocutaneous in 74%, and respiratory in 70%. Affected children were hospitalized for a median of 7 days, with 80% requiring intensive care, 20% receiving mechanical ventilation, and 48% receiving vasoactive support; 2% died. In a similar study of patients hospitalized in New York, 88% had GI symptoms (abdominal pain, vomiting, and/or diarrhea). A retrospective chart review of patients with MIS-C found that the majority had GI symptoms with any portion of the GI tract potentially involved, but ileal and colonic inflammation predominated.

Elizabeth Whittaker, MD, and colleagues described the clinical characteristics of children in eight hospitals in England who met criteria for MIS-C that were temporally associated with SARS-CoV-2. At presentation, all of the patients manifested fever and nonspecific GI symptoms, including vomiting (45%), abdominal pain (53%), and diarrhea (52%). During hospitalization, 50% developed shock with evidence of myocardial dysfunction.

Ermias D. Belay, MD, and colleagues described the clinical characteristics of a large cohort of patients with MIS-C that were reported to the U.S. Centers for Disease Control and Prevention. Of 1,733 patients identified, GI symptoms were reported in 53%-67%. Over half developed hypotension or shock and were admitted for intensive care. Younger children more frequently presented with abdominal pain in contrast with adolescents, who more frequently manifest respiratory symptoms.

In a multicenter retrospective study of Italian children with COVID-19 that was conducted from the onset of the pandemic to early 2021, GI symptoms were noted in 38%. These manifestations were mild and self-limiting, comparable to other viral intestinal infections. However, a subset of children (9.5%) had severe GI manifestations of MIS-C, defined as a medical and/or radiologic diagnosis of acute abdomen, appendicitis, intussusception, pancreatitis, abdominal fluid collection, or diffuse adenomesenteritis requiring surgical consultation. Overall, 42% of this group underwent surgery. The authors noted that the clinical presentation of abdominal pain, lymphopenia, and increased C-reactive protein and ferritin levels were associated with a 9- to 30-fold increased probability of these severe sequelae. In addition, the severity of the GI manifestations was correlated with age (5-10 years: overall response, 8.33; >10 years: OR, 6.37). Again, the presence of GI symptoms was a harbinger of hospitalization and PICU admission.

Given that GI symptoms are a common presentation of MIS-C, its diagnosis may be delayed as clinicians first consider other GI/viral infections, inflammatory bowel disease, or Kawasaki disease. Prompt identification of GI involvement and awareness of the potential outcomes may guide the management and improve the outcome.

These studies provide a clear picture of the differential presenting features of COVID-19 and MIS-C. Although there may be other environmental/genetic factors that govern the incidence, impact, and manifestations, COVID’s status as an ongoing pandemic gives these observations worldwide relevance. This is evident in a recent report documenting pronounced GI symptoms in African children with COVID-19.

It should be noted, however, that the published data cited here reflect the impact of the initial variants of SARS-CoV-2. The GI binding, effects, and aftermath of infection with the Delta and Omicron variants is not yet known.
 

Cause and effect, or simply coincidental?

Some insight into MIS-C pathogenesis was provided by Lael M. Yonker, MD, and colleagues in their analysis of biospecimens from 100 children: 19 with MIS-C, 26 with acute COVID-19, and 55 controls. They demonstrated that in children with MIS-C the prolonged presence of SARS-CoV-2 in the GI tract led to the release of zonulin, a biomarker of intestinal permeability, with subsequent trafficking of SARS-CoV-2 antigens into the bloodstream, leading to hyperinflammation. They were then able to decrease plasma SARS-CoV-2 spike antigen levels and inflammatory markers, with resulting clinical improvement after administration of larazotide, a zonulin antagonist.

These observations regarding the potential mechanism and triggers of MIS-C may offer biomarkers for early detection and/or strategies for prevention and treatment of MIS-C.
 

Bottom line

The GI tract is the target of an immune-mediated inflammatory response that is triggered by SARS-CoV-2, with MIS-C being the major manifestation of the resultant high degree of inflammation. These observations will allow an increased awareness of nonrespiratory symptoms of SARS-CoV-2 infection by clinicians working in emergency departments and primary care settings.

Clues that may enhance the ability of pediatric clinicians to recognize the potential for severe GI involvement include the occurrence of abdominal pain, leukopenia, and elevated inflammatory markers. Their presence should raise suspicion of MIS-C and lead to early evaluation.

Of note, COVID-19 mRNA vaccination is associated with a lower incidence of MIS-C in adolescents. This underscores the importance of COVID vaccination for all eligible children. Yet, we clearly have our work cut out for us. Of 107 children with MIS-C who were hospitalized in France, 31% were adolescents eligible for vaccination; however, none had been fully vaccinated. At the end of 2021, CDC data noted that less than 1% of vaccine-eligible children (12-17 years) were fully vaccinated.

The Pfizer-BioNTech vaccine is now authorized for receipt by children aged 5-11 years, the age group that is at highest risk for MIS-C. However, despite the approval of vaccines for these younger children, there is limited access in some parts of the United States at a time of rising incidence.

We look forward to broad availability of pediatric vaccination strategies. In addition, with the intense focus on safe and effective therapeutics for SARS-CoV-2 infection, we hope to soon have strategies to prevent and/or treat the life-threatening manifestations and long-term consequences of MIS-C. For example, the recently reported central role of the gut microbiota in immunity against SARS-CoV-2 infection offer the possibility that “microbiota modulation” may both reduce GI injury and enhance vaccine efficacy.

Dr. Balistreri has disclosed no relevant financial relationships.

William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; director emeritus, Pediatric Liver Care Center; medical director emeritus, liver transplantation; and professor, University of Cincinnati College of Medicine, department of pediatrics, Cincinnati Children’s Hospital Medical Center. He has served as director of the division of gastroenterology, hepatology, and nutrition at Cincinnati Children’s for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for this news organization. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. In his spare time, he coaches youth lacrosse.

A version of this article first appeared on Medscape.com.

While evaluating an adolescent who had endured a several-day history of vomiting and diarrhea, I mentioned the likelihood of a viral causation, including SARS-CoV-2 infection. His well-informed mother responded, “He has no respiratory symptoms. Does COVID cause GI disease?”

Indeed, not only is the gastrointestinal tract a potential portal of entry of the virus but it may well be the site of mediation of both local and remote injury and thus a harbinger of more severe clinical phenotypes.

As we learn more about the clinical spectrum of COVID, it is becoming increasingly clear that certain features of GI tract involvement may allow us to establish a timeline of the clinical course and perhaps predict the outcome.
 

The GI tract’s involvement isn’t surprising

The ways in which the GI tract serves as a target organ of SARS-CoV-2 have been postulated in the literature. In part, this is related to the presence of abundant receptors for SARS-CoV-2 cell binding and internalization. The virus uses angiotensin-converting enzyme 2 receptors to enter various cells. These receptors are highly expressed on not only lung cells but also enterocytes. Binding of SARS-CoV-2 to ACE2 receptors allows GI involvement, leading to microscopic mucosal inflammation, increased permeability, and altered intestinal absorption.

The clinical GI manifestations of this include anorexia, nausea, vomiting, diarrhea, and abdominal pain, which may be the earliest, or sole, symptoms of COVID-19, often noted before the onset of fever or respiratory symptoms. In fact, John Ong, MBBS, and colleagues, in a discussion about patients with primary GI SARS-CoV-2 infection and symptoms, use the term “GI-COVID.”
 

Clinical course of GI manifestations

After SARS-CoV-2 exposure, adults most commonly present with respiratory symptoms, with GI symptoms reported in 10%-15% of cases. However, the overall incidence of GI involvement during SARS-CoV-2 infection varies according to age, with children more likely than adults to manifest intestinal symptoms.

There are also differences in incidence reported when comparing hospitalized with nonhospitalized individuals. In early reports from the onset of the COVID-19 pandemic, 11%-43% of hospitalized adult patients manifested GI symptoms. Of note, the presence of GI symptoms was associated with more severe disease and thus predictive of outcomes in those admitted to hospitals.

In a multicenter study that assessed pediatric inpatients with COVID-19, GI manifestations were present in 57% of patients and were the first manifestation in 14%. Adjusted by confounding factors, those with GI symptoms had a higher risk for pediatric intensive care unit admission. Patients admitted to the PICU also had higher serum C-reactive protein and aspartate aminotransferase values.
 

Emerging data on MIS-C

In previously healthy children and adolescents, the severe, life-threatening complication of multisystem inflammatory syndrome in children (MIS-C) may present 2-6 weeks after acute infection with SARS-CoV-2. MIS-C appears to be an immune activation syndrome and is presumed to be the delayed immunologic sequelae of mild/asymptomatic SARS-CoV-2 infection. This response manifests as hyperinflammation in conjunction with a peak in antibody production a few weeks later.

One report of 186 children with MIS-C in the United States noted that the involved organ system included the GI tract in 92%, followed by cardiovascular in 80%, hematologic in 76%, mucocutaneous in 74%, and respiratory in 70%. Affected children were hospitalized for a median of 7 days, with 80% requiring intensive care, 20% receiving mechanical ventilation, and 48% receiving vasoactive support; 2% died. In a similar study of patients hospitalized in New York, 88% had GI symptoms (abdominal pain, vomiting, and/or diarrhea). A retrospective chart review of patients with MIS-C found that the majority had GI symptoms with any portion of the GI tract potentially involved, but ileal and colonic inflammation predominated.

Elizabeth Whittaker, MD, and colleagues described the clinical characteristics of children in eight hospitals in England who met criteria for MIS-C that were temporally associated with SARS-CoV-2. At presentation, all of the patients manifested fever and nonspecific GI symptoms, including vomiting (45%), abdominal pain (53%), and diarrhea (52%). During hospitalization, 50% developed shock with evidence of myocardial dysfunction.

Ermias D. Belay, MD, and colleagues described the clinical characteristics of a large cohort of patients with MIS-C that were reported to the U.S. Centers for Disease Control and Prevention. Of 1,733 patients identified, GI symptoms were reported in 53%-67%. Over half developed hypotension or shock and were admitted for intensive care. Younger children more frequently presented with abdominal pain in contrast with adolescents, who more frequently manifest respiratory symptoms.

In a multicenter retrospective study of Italian children with COVID-19 that was conducted from the onset of the pandemic to early 2021, GI symptoms were noted in 38%. These manifestations were mild and self-limiting, comparable to other viral intestinal infections. However, a subset of children (9.5%) had severe GI manifestations of MIS-C, defined as a medical and/or radiologic diagnosis of acute abdomen, appendicitis, intussusception, pancreatitis, abdominal fluid collection, or diffuse adenomesenteritis requiring surgical consultation. Overall, 42% of this group underwent surgery. The authors noted that the clinical presentation of abdominal pain, lymphopenia, and increased C-reactive protein and ferritin levels were associated with a 9- to 30-fold increased probability of these severe sequelae. In addition, the severity of the GI manifestations was correlated with age (5-10 years: overall response, 8.33; >10 years: OR, 6.37). Again, the presence of GI symptoms was a harbinger of hospitalization and PICU admission.

Given that GI symptoms are a common presentation of MIS-C, its diagnosis may be delayed as clinicians first consider other GI/viral infections, inflammatory bowel disease, or Kawasaki disease. Prompt identification of GI involvement and awareness of the potential outcomes may guide the management and improve the outcome.

These studies provide a clear picture of the differential presenting features of COVID-19 and MIS-C. Although there may be other environmental/genetic factors that govern the incidence, impact, and manifestations, COVID’s status as an ongoing pandemic gives these observations worldwide relevance. This is evident in a recent report documenting pronounced GI symptoms in African children with COVID-19.

It should be noted, however, that the published data cited here reflect the impact of the initial variants of SARS-CoV-2. The GI binding, effects, and aftermath of infection with the Delta and Omicron variants is not yet known.
 

Cause and effect, or simply coincidental?

Some insight into MIS-C pathogenesis was provided by Lael M. Yonker, MD, and colleagues in their analysis of biospecimens from 100 children: 19 with MIS-C, 26 with acute COVID-19, and 55 controls. They demonstrated that in children with MIS-C the prolonged presence of SARS-CoV-2 in the GI tract led to the release of zonulin, a biomarker of intestinal permeability, with subsequent trafficking of SARS-CoV-2 antigens into the bloodstream, leading to hyperinflammation. They were then able to decrease plasma SARS-CoV-2 spike antigen levels and inflammatory markers, with resulting clinical improvement after administration of larazotide, a zonulin antagonist.

These observations regarding the potential mechanism and triggers of MIS-C may offer biomarkers for early detection and/or strategies for prevention and treatment of MIS-C.
 

Bottom line

The GI tract is the target of an immune-mediated inflammatory response that is triggered by SARS-CoV-2, with MIS-C being the major manifestation of the resultant high degree of inflammation. These observations will allow an increased awareness of nonrespiratory symptoms of SARS-CoV-2 infection by clinicians working in emergency departments and primary care settings.

Clues that may enhance the ability of pediatric clinicians to recognize the potential for severe GI involvement include the occurrence of abdominal pain, leukopenia, and elevated inflammatory markers. Their presence should raise suspicion of MIS-C and lead to early evaluation.

Of note, COVID-19 mRNA vaccination is associated with a lower incidence of MIS-C in adolescents. This underscores the importance of COVID vaccination for all eligible children. Yet, we clearly have our work cut out for us. Of 107 children with MIS-C who were hospitalized in France, 31% were adolescents eligible for vaccination; however, none had been fully vaccinated. At the end of 2021, CDC data noted that less than 1% of vaccine-eligible children (12-17 years) were fully vaccinated.

The Pfizer-BioNTech vaccine is now authorized for receipt by children aged 5-11 years, the age group that is at highest risk for MIS-C. However, despite the approval of vaccines for these younger children, there is limited access in some parts of the United States at a time of rising incidence.

We look forward to broad availability of pediatric vaccination strategies. In addition, with the intense focus on safe and effective therapeutics for SARS-CoV-2 infection, we hope to soon have strategies to prevent and/or treat the life-threatening manifestations and long-term consequences of MIS-C. For example, the recently reported central role of the gut microbiota in immunity against SARS-CoV-2 infection offer the possibility that “microbiota modulation” may both reduce GI injury and enhance vaccine efficacy.

Dr. Balistreri has disclosed no relevant financial relationships.

William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; director emeritus, Pediatric Liver Care Center; medical director emeritus, liver transplantation; and professor, University of Cincinnati College of Medicine, department of pediatrics, Cincinnati Children’s Hospital Medical Center. He has served as director of the division of gastroenterology, hepatology, and nutrition at Cincinnati Children’s for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for this news organization. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. In his spare time, he coaches youth lacrosse.

A version of this article first appeared on Medscape.com.

While evaluating an adolescent who had endured a several-day history of vomiting and diarrhea, I mentioned the likelihood of a viral causation, including SARS-CoV-2 infection. His well-informed mother responded, “He has no respiratory symptoms. Does COVID cause GI disease?”

Indeed, not only is the gastrointestinal tract a potential portal of entry of the virus but it may well be the site of mediation of both local and remote injury and thus a harbinger of more severe clinical phenotypes.

As we learn more about the clinical spectrum of COVID, it is becoming increasingly clear that certain features of GI tract involvement may allow us to establish a timeline of the clinical course and perhaps predict the outcome.
 

The GI tract’s involvement isn’t surprising

The ways in which the GI tract serves as a target organ of SARS-CoV-2 have been postulated in the literature. In part, this is related to the presence of abundant receptors for SARS-CoV-2 cell binding and internalization. The virus uses angiotensin-converting enzyme 2 receptors to enter various cells. These receptors are highly expressed on not only lung cells but also enterocytes. Binding of SARS-CoV-2 to ACE2 receptors allows GI involvement, leading to microscopic mucosal inflammation, increased permeability, and altered intestinal absorption.

The clinical GI manifestations of this include anorexia, nausea, vomiting, diarrhea, and abdominal pain, which may be the earliest, or sole, symptoms of COVID-19, often noted before the onset of fever or respiratory symptoms. In fact, John Ong, MBBS, and colleagues, in a discussion about patients with primary GI SARS-CoV-2 infection and symptoms, use the term “GI-COVID.”
 

Clinical course of GI manifestations

After SARS-CoV-2 exposure, adults most commonly present with respiratory symptoms, with GI symptoms reported in 10%-15% of cases. However, the overall incidence of GI involvement during SARS-CoV-2 infection varies according to age, with children more likely than adults to manifest intestinal symptoms.

There are also differences in incidence reported when comparing hospitalized with nonhospitalized individuals. In early reports from the onset of the COVID-19 pandemic, 11%-43% of hospitalized adult patients manifested GI symptoms. Of note, the presence of GI symptoms was associated with more severe disease and thus predictive of outcomes in those admitted to hospitals.

In a multicenter study that assessed pediatric inpatients with COVID-19, GI manifestations were present in 57% of patients and were the first manifestation in 14%. Adjusted by confounding factors, those with GI symptoms had a higher risk for pediatric intensive care unit admission. Patients admitted to the PICU also had higher serum C-reactive protein and aspartate aminotransferase values.
 

Emerging data on MIS-C

In previously healthy children and adolescents, the severe, life-threatening complication of multisystem inflammatory syndrome in children (MIS-C) may present 2-6 weeks after acute infection with SARS-CoV-2. MIS-C appears to be an immune activation syndrome and is presumed to be the delayed immunologic sequelae of mild/asymptomatic SARS-CoV-2 infection. This response manifests as hyperinflammation in conjunction with a peak in antibody production a few weeks later.

One report of 186 children with MIS-C in the United States noted that the involved organ system included the GI tract in 92%, followed by cardiovascular in 80%, hematologic in 76%, mucocutaneous in 74%, and respiratory in 70%. Affected children were hospitalized for a median of 7 days, with 80% requiring intensive care, 20% receiving mechanical ventilation, and 48% receiving vasoactive support; 2% died. In a similar study of patients hospitalized in New York, 88% had GI symptoms (abdominal pain, vomiting, and/or diarrhea). A retrospective chart review of patients with MIS-C found that the majority had GI symptoms with any portion of the GI tract potentially involved, but ileal and colonic inflammation predominated.

Elizabeth Whittaker, MD, and colleagues described the clinical characteristics of children in eight hospitals in England who met criteria for MIS-C that were temporally associated with SARS-CoV-2. At presentation, all of the patients manifested fever and nonspecific GI symptoms, including vomiting (45%), abdominal pain (53%), and diarrhea (52%). During hospitalization, 50% developed shock with evidence of myocardial dysfunction.

Ermias D. Belay, MD, and colleagues described the clinical characteristics of a large cohort of patients with MIS-C that were reported to the U.S. Centers for Disease Control and Prevention. Of 1,733 patients identified, GI symptoms were reported in 53%-67%. Over half developed hypotension or shock and were admitted for intensive care. Younger children more frequently presented with abdominal pain in contrast with adolescents, who more frequently manifest respiratory symptoms.

In a multicenter retrospective study of Italian children with COVID-19 that was conducted from the onset of the pandemic to early 2021, GI symptoms were noted in 38%. These manifestations were mild and self-limiting, comparable to other viral intestinal infections. However, a subset of children (9.5%) had severe GI manifestations of MIS-C, defined as a medical and/or radiologic diagnosis of acute abdomen, appendicitis, intussusception, pancreatitis, abdominal fluid collection, or diffuse adenomesenteritis requiring surgical consultation. Overall, 42% of this group underwent surgery. The authors noted that the clinical presentation of abdominal pain, lymphopenia, and increased C-reactive protein and ferritin levels were associated with a 9- to 30-fold increased probability of these severe sequelae. In addition, the severity of the GI manifestations was correlated with age (5-10 years: overall response, 8.33; >10 years: OR, 6.37). Again, the presence of GI symptoms was a harbinger of hospitalization and PICU admission.

Given that GI symptoms are a common presentation of MIS-C, its diagnosis may be delayed as clinicians first consider other GI/viral infections, inflammatory bowel disease, or Kawasaki disease. Prompt identification of GI involvement and awareness of the potential outcomes may guide the management and improve the outcome.

These studies provide a clear picture of the differential presenting features of COVID-19 and MIS-C. Although there may be other environmental/genetic factors that govern the incidence, impact, and manifestations, COVID’s status as an ongoing pandemic gives these observations worldwide relevance. This is evident in a recent report documenting pronounced GI symptoms in African children with COVID-19.

It should be noted, however, that the published data cited here reflect the impact of the initial variants of SARS-CoV-2. The GI binding, effects, and aftermath of infection with the Delta and Omicron variants is not yet known.
 

Cause and effect, or simply coincidental?

Some insight into MIS-C pathogenesis was provided by Lael M. Yonker, MD, and colleagues in their analysis of biospecimens from 100 children: 19 with MIS-C, 26 with acute COVID-19, and 55 controls. They demonstrated that in children with MIS-C the prolonged presence of SARS-CoV-2 in the GI tract led to the release of zonulin, a biomarker of intestinal permeability, with subsequent trafficking of SARS-CoV-2 antigens into the bloodstream, leading to hyperinflammation. They were then able to decrease plasma SARS-CoV-2 spike antigen levels and inflammatory markers, with resulting clinical improvement after administration of larazotide, a zonulin antagonist.

These observations regarding the potential mechanism and triggers of MIS-C may offer biomarkers for early detection and/or strategies for prevention and treatment of MIS-C.
 

Bottom line

The GI tract is the target of an immune-mediated inflammatory response that is triggered by SARS-CoV-2, with MIS-C being the major manifestation of the resultant high degree of inflammation. These observations will allow an increased awareness of nonrespiratory symptoms of SARS-CoV-2 infection by clinicians working in emergency departments and primary care settings.

Clues that may enhance the ability of pediatric clinicians to recognize the potential for severe GI involvement include the occurrence of abdominal pain, leukopenia, and elevated inflammatory markers. Their presence should raise suspicion of MIS-C and lead to early evaluation.

Of note, COVID-19 mRNA vaccination is associated with a lower incidence of MIS-C in adolescents. This underscores the importance of COVID vaccination for all eligible children. Yet, we clearly have our work cut out for us. Of 107 children with MIS-C who were hospitalized in France, 31% were adolescents eligible for vaccination; however, none had been fully vaccinated. At the end of 2021, CDC data noted that less than 1% of vaccine-eligible children (12-17 years) were fully vaccinated.

The Pfizer-BioNTech vaccine is now authorized for receipt by children aged 5-11 years, the age group that is at highest risk for MIS-C. However, despite the approval of vaccines for these younger children, there is limited access in some parts of the United States at a time of rising incidence.

We look forward to broad availability of pediatric vaccination strategies. In addition, with the intense focus on safe and effective therapeutics for SARS-CoV-2 infection, we hope to soon have strategies to prevent and/or treat the life-threatening manifestations and long-term consequences of MIS-C. For example, the recently reported central role of the gut microbiota in immunity against SARS-CoV-2 infection offer the possibility that “microbiota modulation” may both reduce GI injury and enhance vaccine efficacy.

Dr. Balistreri has disclosed no relevant financial relationships.

William F. Balistreri, MD, is the Dorothy M.M. Kersten Professor of Pediatrics; director emeritus, Pediatric Liver Care Center; medical director emeritus, liver transplantation; and professor, University of Cincinnati College of Medicine, department of pediatrics, Cincinnati Children’s Hospital Medical Center. He has served as director of the division of gastroenterology, hepatology, and nutrition at Cincinnati Children’s for 25 years and frequently covers gastroenterology, liver, and nutrition-related topics for this news organization. Dr Balistreri is currently editor-in-chief of the Journal of Pediatrics, having previously served as editor-in-chief of several journals and textbooks. He also became the first pediatrician to act as president of the American Association for the Study of Liver Diseases. In his spare time, he coaches youth lacrosse.

A version of this article first appeared on Medscape.com.

The new year has already marked major progress for colorectal cancer (CRC) screening with the implementation of the Removing Barriers to Colorectal Cancer Screening Act by the Centers for Medicare & Medicaid Services, which will protect Medicare beneficiaries from an unexpected bill if a polyp is detected and removed during a screening colonoscopy, as well as new guidance from the federal government requiring private insurers to cover colonoscopy as a follow-up to a noninvasive CRC screening test without imposing cost sharing for patients.

Over the past decade, the AGA and other organizations have spent countless hours advocating for closing the gap. In September 2021, Dr. Inadomi and Dr. Lieberman, along with the American Cancer Society Cancer Action Network and Fight CRC, met with Assistant Secretary of Labor, Ali Khawar, and representatives from the U.S. Department of Health & Human Services and U.S. Department of Treasury to request they direct private health plans to cover colonoscopy after a positive noninvasive CRC screening. In January 2022, guidance from the United States Department of Labor, HHS, and the USDT clarified that private insurance plans must cover follow-up colonoscopies after a positive noninvasive stool test. In the Frequently Asked Questions (FAQs) about the Affordable Care Act Implementation, Part 51, the departments affirmed that a plan or issuer must cover and may not impose cost sharing with respect to a colonoscopy conducted after a positive noninvasive stool-based screening test or direct visualization screening test for colorectal cancer for individuals described in a U.S. Preventive Services Task Force (USPSTF) recommendation from May 18, 2021. As stated in that USPSTF recommendation, the follow-up colonoscopy is an integral part of the preventive screening without which the screening would not be complete . The follow-up colonoscopy after a positive noninvasive stool-based screening test or direct visualization screening test is therefore required to be covered without cost sharing in accordance with the requirements of Public Health Service Act section 2713 and its implementing regulations.

Dr. Brill is chief medical officer, Predictive Health, Phoenix. Dr. Lieberman is professor of medicine, division of gastroenterology and hepatology, Oregon Health & Science University, Portland, as well as a past president of the AGA. Dr. Brill discloses consulting for Accomplish Health, Alimetry, Allara Health, AnX Robotica, Arch Therapeutics, Biotax, Boomerang Medical, Brightline, Calyx, Capsovision, Check Cap, Clexio, Curology, Docbot, Echosens, Endogastric Solutions, evoEndo, Family First, FDNA, Food Marble, Freespira, Gala Therapeutics, Glaukos, gTech Medical, Gynesonics, Hbox, Hello Heart, HyGIeaCare, Innovative Health Solutions, IronRod Health, Johnson & Johnson, Lantheus, LeMinou, Lumen, Mainstay Medical, MaternaMed, Medtronic, Mightier, Motus GI, OncoSil Medical, Palette Life Sciences, Perry Health, Perspectum, Red Ventures, Reflexion, Respira Labs, Salaso, Smith+Nephew, SonarMD, Stage Zero Life Sciences, Steris, Sword Health, Tabula Rosa Health Care, Ultrasight, Vertos Medical, WL Gore, and holds options/warrants in Accomplish Health, AnX Robotica, Capsovision, Donsini Health, Hbox, Hello Heart, HyGIeaCare, Restech, Perry Health, StageZero Life Sciences, SonarMD. Dr. Lieberman is a consultant to Geneoscopy.

The new year has already marked major progress for colorectal cancer (CRC) screening with the implementation of the Removing Barriers to Colorectal Cancer Screening Act by the Centers for Medicare & Medicaid Services, which will protect Medicare beneficiaries from an unexpected bill if a polyp is detected and removed during a screening colonoscopy, as well as new guidance from the federal government requiring private insurers to cover colonoscopy as a follow-up to a noninvasive CRC screening test without imposing cost sharing for patients.

Over the past decade, the AGA and other organizations have spent countless hours advocating for closing the gap. In September 2021, Dr. Inadomi and Dr. Lieberman, along with the American Cancer Society Cancer Action Network and Fight CRC, met with Assistant Secretary of Labor, Ali Khawar, and representatives from the U.S. Department of Health & Human Services and U.S. Department of Treasury to request they direct private health plans to cover colonoscopy after a positive noninvasive CRC screening. In January 2022, guidance from the United States Department of Labor, HHS, and the USDT clarified that private insurance plans must cover follow-up colonoscopies after a positive noninvasive stool test. In the Frequently Asked Questions (FAQs) about the Affordable Care Act Implementation, Part 51, the departments affirmed that a plan or issuer must cover and may not impose cost sharing with respect to a colonoscopy conducted after a positive noninvasive stool-based screening test or direct visualization screening test for colorectal cancer for individuals described in a U.S. Preventive Services Task Force (USPSTF) recommendation from May 18, 2021. As stated in that USPSTF recommendation, the follow-up colonoscopy is an integral part of the preventive screening without which the screening would not be complete . The follow-up colonoscopy after a positive noninvasive stool-based screening test or direct visualization screening test is therefore required to be covered without cost sharing in accordance with the requirements of Public Health Service Act section 2713 and its implementing regulations.

Dr. Brill is chief medical officer, Predictive Health, Phoenix. Dr. Lieberman is professor of medicine, division of gastroenterology and hepatology, Oregon Health & Science University, Portland, as well as a past president of the AGA. Dr. Brill discloses consulting for Accomplish Health, Alimetry, Allara Health, AnX Robotica, Arch Therapeutics, Biotax, Boomerang Medical, Brightline, Calyx, Capsovision, Check Cap, Clexio, Curology, Docbot, Echosens, Endogastric Solutions, evoEndo, Family First, FDNA, Food Marble, Freespira, Gala Therapeutics, Glaukos, gTech Medical, Gynesonics, Hbox, Hello Heart, HyGIeaCare, Innovative Health Solutions, IronRod Health, Johnson & Johnson, Lantheus, LeMinou, Lumen, Mainstay Medical, MaternaMed, Medtronic, Mightier, Motus GI, OncoSil Medical, Palette Life Sciences, Perry Health, Perspectum, Red Ventures, Reflexion, Respira Labs, Salaso, Smith+Nephew, SonarMD, Stage Zero Life Sciences, Steris, Sword Health, Tabula Rosa Health Care, Ultrasight, Vertos Medical, WL Gore, and holds options/warrants in Accomplish Health, AnX Robotica, Capsovision, Donsini Health, Hbox, Hello Heart, HyGIeaCare, Restech, Perry Health, StageZero Life Sciences, SonarMD. Dr. Lieberman is a consultant to Geneoscopy.

The new year has already marked major progress for colorectal cancer (CRC) screening with the implementation of the Removing Barriers to Colorectal Cancer Screening Act by the Centers for Medicare & Medicaid Services, which will protect Medicare beneficiaries from an unexpected bill if a polyp is detected and removed during a screening colonoscopy, as well as new guidance from the federal government requiring private insurers to cover colonoscopy as a follow-up to a noninvasive CRC screening test without imposing cost sharing for patients.

Over the past decade, the AGA and other organizations have spent countless hours advocating for closing the gap. In September 2021, Dr. Inadomi and Dr. Lieberman, along with the American Cancer Society Cancer Action Network and Fight CRC, met with Assistant Secretary of Labor, Ali Khawar, and representatives from the U.S. Department of Health & Human Services and U.S. Department of Treasury to request they direct private health plans to cover colonoscopy after a positive noninvasive CRC screening. In January 2022, guidance from the United States Department of Labor, HHS, and the USDT clarified that private insurance plans must cover follow-up colonoscopies after a positive noninvasive stool test. In the Frequently Asked Questions (FAQs) about the Affordable Care Act Implementation, Part 51, the departments affirmed that a plan or issuer must cover and may not impose cost sharing with respect to a colonoscopy conducted after a positive noninvasive stool-based screening test or direct visualization screening test for colorectal cancer for individuals described in a U.S. Preventive Services Task Force (USPSTF) recommendation from May 18, 2021. As stated in that USPSTF recommendation, the follow-up colonoscopy is an integral part of the preventive screening without which the screening would not be complete . The follow-up colonoscopy after a positive noninvasive stool-based screening test or direct visualization screening test is therefore required to be covered without cost sharing in accordance with the requirements of Public Health Service Act section 2713 and its implementing regulations.

Dr. Brill is chief medical officer, Predictive Health, Phoenix. Dr. Lieberman is professor of medicine, division of gastroenterology and hepatology, Oregon Health & Science University, Portland, as well as a past president of the AGA. Dr. Brill discloses consulting for Accomplish Health, Alimetry, Allara Health, AnX Robotica, Arch Therapeutics, Biotax, Boomerang Medical, Brightline, Calyx, Capsovision, Check Cap, Clexio, Curology, Docbot, Echosens, Endogastric Solutions, evoEndo, Family First, FDNA, Food Marble, Freespira, Gala Therapeutics, Glaukos, gTech Medical, Gynesonics, Hbox, Hello Heart, HyGIeaCare, Innovative Health Solutions, IronRod Health, Johnson & Johnson, Lantheus, LeMinou, Lumen, Mainstay Medical, MaternaMed, Medtronic, Mightier, Motus GI, OncoSil Medical, Palette Life Sciences, Perry Health, Perspectum, Red Ventures, Reflexion, Respira Labs, Salaso, Smith+Nephew, SonarMD, Stage Zero Life Sciences, Steris, Sword Health, Tabula Rosa Health Care, Ultrasight, Vertos Medical, WL Gore, and holds options/warrants in Accomplish Health, AnX Robotica, Capsovision, Donsini Health, Hbox, Hello Heart, HyGIeaCare, Restech, Perry Health, StageZero Life Sciences, SonarMD. Dr. Lieberman is a consultant to Geneoscopy.

On the first Friday in March, it has become an annual tradition to dress in blue to promote colorectal cancer awareness. Twitter feeds are filled with photos of members of our gastroenterology community (sometimes entire endoscopy units!) swathed in various shades of blue. This tradition was started in the mid-2000’s by a patient diagnosed with early-onset colorectal cancer who planned a fund raiser at her daughter’s elementary school where students were encouraged to wear a blue outfit and make a $1 donation to support awareness of this deadly but preventable cancer. What was once a local effort has now grown into a national phenomenon, and a powerful opportunity for the medical community to educate patients, friends, and family regarding risk factors for colorectal cancer and the importance of timely and effective screening. But while raising awareness is vital, it is only an initial step in the complex process of optimizing delivery of screening services and improving cancer outcomes through prevention and early detection.

In this month’s issue of GIHN, we report on a study from Cancer demonstrating the effectiveness of Spanish-speaking patient navigators in boosting colorectal cancer screening rates among Hispanic patients. We also highlight a quality improvement initiative at a large academic medical center demonstrating the impact of an electronic “primer” message delivered through the patient portal on screening completion rates in a mailed fecal immunochemical test outreach program. Finally, in this month’s Practice Management Toolbox column, Dr. Brill and Dr. Lieberman advise us on how to prepare for upcoming coverage changes impacting screening colonoscopy – a result of AGA’s tireless efforts to eliminate financial barriers impeding access to colorectal cancer screening.

As always, thank you for being a dedicated reader and please stay safe out there. Better days are ahead.

Megan A. Adams, MD, JD, MSc
Editor in Chief

On the first Friday in March, it has become an annual tradition to dress in blue to promote colorectal cancer awareness. Twitter feeds are filled with photos of members of our gastroenterology community (sometimes entire endoscopy units!) swathed in various shades of blue. This tradition was started in the mid-2000’s by a patient diagnosed with early-onset colorectal cancer who planned a fund raiser at her daughter’s elementary school where students were encouraged to wear a blue outfit and make a $1 donation to support awareness of this deadly but preventable cancer. What was once a local effort has now grown into a national phenomenon, and a powerful opportunity for the medical community to educate patients, friends, and family regarding risk factors for colorectal cancer and the importance of timely and effective screening. But while raising awareness is vital, it is only an initial step in the complex process of optimizing delivery of screening services and improving cancer outcomes through prevention and early detection.

In this month’s issue of GIHN, we report on a study from Cancer demonstrating the effectiveness of Spanish-speaking patient navigators in boosting colorectal cancer screening rates among Hispanic patients. We also highlight a quality improvement initiative at a large academic medical center demonstrating the impact of an electronic “primer” message delivered through the patient portal on screening completion rates in a mailed fecal immunochemical test outreach program. Finally, in this month’s Practice Management Toolbox column, Dr. Brill and Dr. Lieberman advise us on how to prepare for upcoming coverage changes impacting screening colonoscopy – a result of AGA’s tireless efforts to eliminate financial barriers impeding access to colorectal cancer screening.

As always, thank you for being a dedicated reader and please stay safe out there. Better days are ahead.

Megan A. Adams, MD, JD, MSc
Editor in Chief

On the first Friday in March, it has become an annual tradition to dress in blue to promote colorectal cancer awareness. Twitter feeds are filled with photos of members of our gastroenterology community (sometimes entire endoscopy units!) swathed in various shades of blue. This tradition was started in the mid-2000’s by a patient diagnosed with early-onset colorectal cancer who planned a fund raiser at her daughter’s elementary school where students were encouraged to wear a blue outfit and make a $1 donation to support awareness of this deadly but preventable cancer. What was once a local effort has now grown into a national phenomenon, and a powerful opportunity for the medical community to educate patients, friends, and family regarding risk factors for colorectal cancer and the importance of timely and effective screening. But while raising awareness is vital, it is only an initial step in the complex process of optimizing delivery of screening services and improving cancer outcomes through prevention and early detection.

In this month’s issue of GIHN, we report on a study from Cancer demonstrating the effectiveness of Spanish-speaking patient navigators in boosting colorectal cancer screening rates among Hispanic patients. We also highlight a quality improvement initiative at a large academic medical center demonstrating the impact of an electronic “primer” message delivered through the patient portal on screening completion rates in a mailed fecal immunochemical test outreach program. Finally, in this month’s Practice Management Toolbox column, Dr. Brill and Dr. Lieberman advise us on how to prepare for upcoming coverage changes impacting screening colonoscopy – a result of AGA’s tireless efforts to eliminate financial barriers impeding access to colorectal cancer screening.

As always, thank you for being a dedicated reader and please stay safe out there. Better days are ahead.

Megan A. Adams, MD, JD, MSc
Editor in Chief

When we refer to “regular table salt,” it is most commonly in the form of sodium chloride, which is also a major constituent of packaged and ultraprocessed foods.

The best approach to finding the “healthiest salt” – which really means the lowest in sodium – is to look for the amount on the label. “Sodium-free” usually indicates less than 5 mg of sodium per serving, and “low-sodium” usually means 140 mg or less per serving. In contrast, regular table salt can contain as much as 560 mg of sodium in one serving.

Other en vogue salts, such as pink Himalayan salt, sea salt, and kosher salt, are high in sodium content – like regular table salt – but because of their larger crystal size, less sodium is delivered per serving.

Georges Lievre / Fotolia.com

FDA issues guidance on reducing salt

Currently, the U.S. sodium dietary guidelines for persons older than 14 stipulate 2,300 mg/d, which is equivalent to 1 teaspoon a day. However it is estimated that the average person in the United States consumes more than this – around 3,400 mg of sodium daily.

In October 2021, the U.S. Food and Drug Administration published guidance on voluntary sodium limitations in commercially processed, packaged, and prepared food. The FDA’s short-term approach is to slowly reduce exposure to sodium in processed and restaurant food by 2025, on the basis that people will eventually get used to less salt, as has happened in the United Kingdom and other countries.

Such strategies to reduce salt intake are now being used in national programs in several countries. Many of these successful initiatives include active engagement with the food industry to reduce the amount of sodium added to processed food, as well as public awareness campaigns to alert consumers to the dangers of eating too much salt. This includes increasing potassium in manufactured foods, primarily to target hypertension and heart disease, as described by Clare Farrand, MSc, BSc, and colleagues, in the Journal of Clinical Hypertension. The authors also make several recommendations regarding salt reduction policies:

• Food manufacturers should gradually reduce sodium in food to the lowest possible levels and explore the use of potassium-based sodium replacers to reduce sodium levels even further.
• Governments should continue to monitor sodium and potassium levels in processed foods.
• Further consideration may need to be given to how best to label salt substitutes (namely potassium) in processed foods to ensure that people who may be adversely affected are aware.
• Governments should systematically monitor potassium intake at the population level, including for specific susceptible groups.
• Governments should continue to systematically monitor sodium (salt) intake and iodine intake at the population level to adjust salt iodization over time as necessary, depending on observed salt intake in specific targeted groups, to ensure that they have sufficient but not excessive iodine intakes as salt intakes are reduced.
• Governments should consider opportunities for promoting and subsidizing salt substitutes, particularly in countries where salt added during cooking or at the table is the major source of salt in the diet.

The new FDA document includes 163 subcategories of foods in its voluntary salt reduction strategy.
 

Salt substitutes, high blood pressure, and mortality

Lowering sodium intake is almost certainly beneficial for persons with high blood pressure. In 2020, a review in Hypertension highlighted the benefit of salt substitutes in reducing hypertension, reporting that they lower systolic blood pressure by 5.58 mm Hg and diastolic blood pressure by 2.88 mm Hg.

And changes to dietary sodium intake can potentially reduce or obviate the need for medications for essential hypertension in some individuals. Although there are only a few studies on this topic, a study by Bruce Neal, MB, ChB, PhD, and colleagues, revealed a reduction in stroke, cardiovascular events, and deaths with the use of potassium-based salt substitutes.
 

Salt substitutes and sodium and potassium handling in the kidneys

Many studies have shown that potassium-rich salt substitutes are safe in individuals with normal kidney function, but are they safe and beneficial for people with chronic kidney disease (CKD)?

For anyone who is on a renal diet, potassium and sodium intake goals are limited according to their absolute level of kidney function.

There have been case reports of life-threatening blood potassium levels (hyperkalemia) due to potassium-rich salt substitutes in people with CKD, but no larger published studies on this topic can be found.

A diet modeling study by Rebecca Morrison and colleagues evaluated varying degrees of potassium-enriched salt substituted bread products and their impact on dietary intake in persons with CKD. They used dietary data from the National Nutrition and Physical Activity Survey 2011-2012 in Australia for 12,152 participants, 154 of whom had CKD. Replacing the sodium in bread with varying amounts of potassium chloride (20%, 30%, and 40%) would result in one-third of people with CKD exceeding the safe limits for dietary potassium consumption (31.8%, 32.6%, and 33%, respectively), they found.

“Potassium chloride substitution in staple foods such as bread and bread products have serious and potentially fatal consequences for people who need to restrict dietary potassium. Improved food labelling is required for consumers to avoid excessive consumption,” Ms. Morrison and colleagues concluded. They added that more studies are needed to further understand the risks of potassium dietary intake and hyperkalemia in CKD from potassium-based salt substitutes.

The American Heart Association recommends no more than 1,500 mg of sodium intake daily for persons with CKD, diabetes, or high blood pressure; those older than 51; and African American persons of any age.

The recommended daily intake of potassium in persons with CKD can range from 2,000 mg to 4,000 mg, depending on the individual and their degree of CKD. The potassium content in some salt substitutes varies from 440 mg to 2,800 mg per teaspoon.

The best recommendation for individuals with CKD and a goal to reduce their sodium intake is to use herbs and lower-sodium seasonings as a substitute, but these should always be reviewed with their physician and renal nutritionist.

Dr. Brookins is a board-certified nephrologist and internist practicing in Georgia. She is the founder and owner of Remote Renal Care, a telehealth kidney practice. She reported no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

When we refer to “regular table salt,” it is most commonly in the form of sodium chloride, which is also a major constituent of packaged and ultraprocessed foods.

The best approach to finding the “healthiest salt” – which really means the lowest in sodium – is to look for the amount on the label. “Sodium-free” usually indicates less than 5 mg of sodium per serving, and “low-sodium” usually means 140 mg or less per serving. In contrast, regular table salt can contain as much as 560 mg of sodium in one serving.

Other en vogue salts, such as pink Himalayan salt, sea salt, and kosher salt, are high in sodium content – like regular table salt – but because of their larger crystal size, less sodium is delivered per serving.

Georges Lievre / Fotolia.com

FDA issues guidance on reducing salt

Currently, the U.S. sodium dietary guidelines for persons older than 14 stipulate 2,300 mg/d, which is equivalent to 1 teaspoon a day. However it is estimated that the average person in the United States consumes more than this – around 3,400 mg of sodium daily.

In October 2021, the U.S. Food and Drug Administration published guidance on voluntary sodium limitations in commercially processed, packaged, and prepared food. The FDA’s short-term approach is to slowly reduce exposure to sodium in processed and restaurant food by 2025, on the basis that people will eventually get used to less salt, as has happened in the United Kingdom and other countries.

Such strategies to reduce salt intake are now being used in national programs in several countries. Many of these successful initiatives include active engagement with the food industry to reduce the amount of sodium added to processed food, as well as public awareness campaigns to alert consumers to the dangers of eating too much salt. This includes increasing potassium in manufactured foods, primarily to target hypertension and heart disease, as described by Clare Farrand, MSc, BSc, and colleagues, in the Journal of Clinical Hypertension. The authors also make several recommendations regarding salt reduction policies:

• Food manufacturers should gradually reduce sodium in food to the lowest possible levels and explore the use of potassium-based sodium replacers to reduce sodium levels even further.
• Governments should continue to monitor sodium and potassium levels in processed foods.
• Further consideration may need to be given to how best to label salt substitutes (namely potassium) in processed foods to ensure that people who may be adversely affected are aware.
• Governments should systematically monitor potassium intake at the population level, including for specific susceptible groups.
• Governments should continue to systematically monitor sodium (salt) intake and iodine intake at the population level to adjust salt iodization over time as necessary, depending on observed salt intake in specific targeted groups, to ensure that they have sufficient but not excessive iodine intakes as salt intakes are reduced.
• Governments should consider opportunities for promoting and subsidizing salt substitutes, particularly in countries where salt added during cooking or at the table is the major source of salt in the diet.

The new FDA document includes 163 subcategories of foods in its voluntary salt reduction strategy.
 

Salt substitutes, high blood pressure, and mortality

Lowering sodium intake is almost certainly beneficial for persons with high blood pressure. In 2020, a review in Hypertension highlighted the benefit of salt substitutes in reducing hypertension, reporting that they lower systolic blood pressure by 5.58 mm Hg and diastolic blood pressure by 2.88 mm Hg.

And changes to dietary sodium intake can potentially reduce or obviate the need for medications for essential hypertension in some individuals. Although there are only a few studies on this topic, a study by Bruce Neal, MB, ChB, PhD, and colleagues, revealed a reduction in stroke, cardiovascular events, and deaths with the use of potassium-based salt substitutes.
 

Salt substitutes and sodium and potassium handling in the kidneys

Many studies have shown that potassium-rich salt substitutes are safe in individuals with normal kidney function, but are they safe and beneficial for people with chronic kidney disease (CKD)?

For anyone who is on a renal diet, potassium and sodium intake goals are limited according to their absolute level of kidney function.

There have been case reports of life-threatening blood potassium levels (hyperkalemia) due to potassium-rich salt substitutes in people with CKD, but no larger published studies on this topic can be found.

A diet modeling study by Rebecca Morrison and colleagues evaluated varying degrees of potassium-enriched salt substituted bread products and their impact on dietary intake in persons with CKD. They used dietary data from the National Nutrition and Physical Activity Survey 2011-2012 in Australia for 12,152 participants, 154 of whom had CKD. Replacing the sodium in bread with varying amounts of potassium chloride (20%, 30%, and 40%) would result in one-third of people with CKD exceeding the safe limits for dietary potassium consumption (31.8%, 32.6%, and 33%, respectively), they found.

“Potassium chloride substitution in staple foods such as bread and bread products have serious and potentially fatal consequences for people who need to restrict dietary potassium. Improved food labelling is required for consumers to avoid excessive consumption,” Ms. Morrison and colleagues concluded. They added that more studies are needed to further understand the risks of potassium dietary intake and hyperkalemia in CKD from potassium-based salt substitutes.

The American Heart Association recommends no more than 1,500 mg of sodium intake daily for persons with CKD, diabetes, or high blood pressure; those older than 51; and African American persons of any age.

The recommended daily intake of potassium in persons with CKD can range from 2,000 mg to 4,000 mg, depending on the individual and their degree of CKD. The potassium content in some salt substitutes varies from 440 mg to 2,800 mg per teaspoon.

The best recommendation for individuals with CKD and a goal to reduce their sodium intake is to use herbs and lower-sodium seasonings as a substitute, but these should always be reviewed with their physician and renal nutritionist.

Dr. Brookins is a board-certified nephrologist and internist practicing in Georgia. She is the founder and owner of Remote Renal Care, a telehealth kidney practice. She reported no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

When we refer to “regular table salt,” it is most commonly in the form of sodium chloride, which is also a major constituent of packaged and ultraprocessed foods.

The best approach to finding the “healthiest salt” – which really means the lowest in sodium – is to look for the amount on the label. “Sodium-free” usually indicates less than 5 mg of sodium per serving, and “low-sodium” usually means 140 mg or less per serving. In contrast, regular table salt can contain as much as 560 mg of sodium in one serving.

Other en vogue salts, such as pink Himalayan salt, sea salt, and kosher salt, are high in sodium content – like regular table salt – but because of their larger crystal size, less sodium is delivered per serving.

Georges Lievre / Fotolia.com

FDA issues guidance on reducing salt

Currently, the U.S. sodium dietary guidelines for persons older than 14 stipulate 2,300 mg/d, which is equivalent to 1 teaspoon a day. However it is estimated that the average person in the United States consumes more than this – around 3,400 mg of sodium daily.

In October 2021, the U.S. Food and Drug Administration published guidance on voluntary sodium limitations in commercially processed, packaged, and prepared food. The FDA’s short-term approach is to slowly reduce exposure to sodium in processed and restaurant food by 2025, on the basis that people will eventually get used to less salt, as has happened in the United Kingdom and other countries.

Such strategies to reduce salt intake are now being used in national programs in several countries. Many of these successful initiatives include active engagement with the food industry to reduce the amount of sodium added to processed food, as well as public awareness campaigns to alert consumers to the dangers of eating too much salt. This includes increasing potassium in manufactured foods, primarily to target hypertension and heart disease, as described by Clare Farrand, MSc, BSc, and colleagues, in the Journal of Clinical Hypertension. The authors also make several recommendations regarding salt reduction policies:

• Food manufacturers should gradually reduce sodium in food to the lowest possible levels and explore the use of potassium-based sodium replacers to reduce sodium levels even further.
• Governments should continue to monitor sodium and potassium levels in processed foods.
• Further consideration may need to be given to how best to label salt substitutes (namely potassium) in processed foods to ensure that people who may be adversely affected are aware.
• Governments should systematically monitor potassium intake at the population level, including for specific susceptible groups.
• Governments should continue to systematically monitor sodium (salt) intake and iodine intake at the population level to adjust salt iodization over time as necessary, depending on observed salt intake in specific targeted groups, to ensure that they have sufficient but not excessive iodine intakes as salt intakes are reduced.
• Governments should consider opportunities for promoting and subsidizing salt substitutes, particularly in countries where salt added during cooking or at the table is the major source of salt in the diet.

The new FDA document includes 163 subcategories of foods in its voluntary salt reduction strategy.
 

Salt substitutes, high blood pressure, and mortality

Lowering sodium intake is almost certainly beneficial for persons with high blood pressure. In 2020, a review in Hypertension highlighted the benefit of salt substitutes in reducing hypertension, reporting that they lower systolic blood pressure by 5.58 mm Hg and diastolic blood pressure by 2.88 mm Hg.

And changes to dietary sodium intake can potentially reduce or obviate the need for medications for essential hypertension in some individuals. Although there are only a few studies on this topic, a study by Bruce Neal, MB, ChB, PhD, and colleagues, revealed a reduction in stroke, cardiovascular events, and deaths with the use of potassium-based salt substitutes.
 

Salt substitutes and sodium and potassium handling in the kidneys

Many studies have shown that potassium-rich salt substitutes are safe in individuals with normal kidney function, but are they safe and beneficial for people with chronic kidney disease (CKD)?

For anyone who is on a renal diet, potassium and sodium intake goals are limited according to their absolute level of kidney function.

There have been case reports of life-threatening blood potassium levels (hyperkalemia) due to potassium-rich salt substitutes in people with CKD, but no larger published studies on this topic can be found.

A diet modeling study by Rebecca Morrison and colleagues evaluated varying degrees of potassium-enriched salt substituted bread products and their impact on dietary intake in persons with CKD. They used dietary data from the National Nutrition and Physical Activity Survey 2011-2012 in Australia for 12,152 participants, 154 of whom had CKD. Replacing the sodium in bread with varying amounts of potassium chloride (20%, 30%, and 40%) would result in one-third of people with CKD exceeding the safe limits for dietary potassium consumption (31.8%, 32.6%, and 33%, respectively), they found.

“Potassium chloride substitution in staple foods such as bread and bread products have serious and potentially fatal consequences for people who need to restrict dietary potassium. Improved food labelling is required for consumers to avoid excessive consumption,” Ms. Morrison and colleagues concluded. They added that more studies are needed to further understand the risks of potassium dietary intake and hyperkalemia in CKD from potassium-based salt substitutes.

The American Heart Association recommends no more than 1,500 mg of sodium intake daily for persons with CKD, diabetes, or high blood pressure; those older than 51; and African American persons of any age.

The recommended daily intake of potassium in persons with CKD can range from 2,000 mg to 4,000 mg, depending on the individual and their degree of CKD. The potassium content in some salt substitutes varies from 440 mg to 2,800 mg per teaspoon.

The best recommendation for individuals with CKD and a goal to reduce their sodium intake is to use herbs and lower-sodium seasonings as a substitute, but these should always be reviewed with their physician and renal nutritionist.

Dr. Brookins is a board-certified nephrologist and internist practicing in Georgia. She is the founder and owner of Remote Renal Care, a telehealth kidney practice. She reported no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

The choice of entry point for gynecologic laparoscopy is critical, considering that most laparoscopic injuries occur during initial entry into the abdomen. In addition, different abdominal access points may have differing utility and efficacy depending on the patient. (The overall rate of injuries to abdominal viscera and blood vessels at the time of entry is an estimated 1 per 1,000 cases.¹)

The most conventional entry point for gynecologic laparoscopic surgeries has been the umbilicus, but there are contraindications to this choice and situations in which it may not be the best access site. It is important to have knowledge of alternate entry points and techniques that consider the patient’s current pathology, anatomy, and most importantly, surgical history to better facilitate a safe initial entry.

Courtesy Dr. Kirsten J. Sasaki

The left upper quadrant (LUQ) has been described as a preferred alternate site to the umbilicus, and some gynecologic surgeons even consider it as a routine mode of entry.² In our practice, LUQ entry is a safe and commonly used technique that is chosen primarily based on a patient’s history of a midline vertical incision, the presence of abdominal mesh from a prior umbilical hernia repair, or repeated cesarean sections.

Our technique for LUQ entry is a modification of the traditional approach that employs Palmer’s point – the entry point described by Raoul Palmer, MD, in 1974 as 3-4 cm below the left subcostal margin at the midclavicular line.³ We choose to enter at the midclavicular level and directly under the last rib.
 

When the umbilicus is problematic

The umbilicus is a favored entry point not only for its operative access to pelvic structures but also because – in the absence of obesity – it has no or little subcutaneous fat and, therefore, provides the shortest distance from skin to peritoneum.

Courtesy Dr. Mary (Molly) McKenna

However, adhesive disease from a prior laparotomy involving the umbilicus is a risk factor for bowel injury during umbilical entry (direct trocar, Veress needle, or open technique). In a 1995 review of 360 women undergoing operative laparoscopy after a previous laparotomy, Brill et al. reported umbilical adhesions in 27% of those with prior horizontal suprapubic (Pfannenstiel) incisions, in 55% of those with prior incisions in the midline below the umbilicus, and 67% of those with prior midline incisions above the umbilicus.⁴

Of the 259 patients whose prior laparotomy was for gynecologic surgery (as opposed to obstetric or general surgery) adhesions were present in 70% of those who had midline incisions. (Direct injury to adherent omentum and bowel occurred during laparoscopic procedures in 21% of all women.)

Since the Brill paper, other studies have similarly reported significant adhesion rate, especially after midline incisions. For instance, one French study of patients undergoing laparoscopy reported umbilical adhesions in 51.7% of 89 patients who had previous laparotomy with a midline incision.⁵

Prior umbilical laparoscopy is not a risk factor for umbilical entry unless a hernia repair with mesh was performed at the umbilicus. Umbilical adhesions have been reported to occur in up to 15% of women who have had prior laparoscopic surgery, with more adhesions associated with larger trocar use (specifically 12-mm trocars).¹ Still, the rate of those adhesions was very low.

Obesity is not necessarily a contraindication to umbilical entry; however, it can make successful entry more difficult, particularly in those with central obesity and a thicker layer of subcutaneous fat. It can be difficult in such cases to know when peritoneal access is achieved. Extra-long Veress needles or trocars may be needed, and it is important to enter the abdomen at a 90° angle to minimize risk to the great vessel vasculature.

LUQ entry is often a reliable alternative when central obesity is significant or when umbilical access proves to be difficult. Certainly, the subcutaneous fat layer is thinner at the LUQ than at the umbilicus, and in patients whose umbilicus is pulled very caudal because of a large pannus, the LUQ will also provide a better location for visualization of pelvic anatomy and for easier entry.

We still use umbilical entry in most patients with obesity, but if we are unsuccessful after two to three attempts, we proceed to the LUQ (barring any contraindications to this site).
 

LUQ entry: Our approach, contraindications

By entering at the midclavicular level and directly under the bottom of the rib cage, rather than 2-3 cm below the last rib as in traditional Palmer’s point LUQ entry, we benefit from the tenting up of the peritoneum by the last rib. Having space between the peritoneum and underlying omentum and stomach can facilitate an easier entry, as shown in the video.

Courtesy Kirsten J. Sasaki

We primarily utilize the Veress needle for entry. The needle is inserted directly perpendicular to the fascia, or at a slight angle toward the umbilicus. After the abdomen is insufflated to 15 mm Hg, we proceed with a visual peritoneal entry using a 5-mm trocar with a clear tip, which allows us to visualize both layers of fascia, and subsequently the peritoneum, as the trocar is advanced.

The fascia is not fused, so we can expect to feel three “pops” as the needle (or trocar) passes through the aponeuroses of the internal and external obliques, the aponeuroses of the internal oblique and transversus, and the peritoneum.

While successful peritoneal entry with umbilical access is generally confirmed with an intraperitoneal pressure measuring less than 7 mm Hg (which varies depending on abdominal wall thickness and adiposity), we have found that the opening pressure with LUQ entry is slightly higher. A recently published Canadian guideline for gynecologic laparoscopic entry recommends that an initial Veress intraperitoneal pressure of 10 mm Hg or below be considered an indicator of successful entry, regardless of the patient’s body habitus.¹

LUQ entry can be helpful for surgeries involving large pelvic masses, for which there is little or no space to enter at the umbilicus or to optimally view the pathology. Utilizing the LUQ not only allows for an unobstructed entry and optimal viewing but also may become an extra operative port that can be used for the camera, allowing both surgeons to operate with two hands – a four-port technique. It also allows the surgeon to use a larger diameter port at the umbilicus without concern for cosmetics.

Additionally, there is a school of thought that LUQ entry is overall more successful, requiring less conversion to alternative sites and fewer attempts. This success may result from the presence of less adhesive disease in the LUQ, as well as clearer visualization of the anatomy while entering and confidence in entering the intraperitoneal space.

A prerequisite for LUQ entry is that the stomach be decompressed through placement of an oral gastric or nasogastric tube and suctioning of all gastric contents. An inability to decompress the stomach is a contraindication to LUQ entry, as is a history of splenectomy, an enlarged liver, gastric bypass surgery, or upper abdominal surgery.
 

Entry techniques, alternate sites

No single entry site or technique has been proven to be universally safer than another. A 2019 Cochrane review of laparoscopic entry techniques noted an advantage of direct trocar entry over Veress-needle entry for failed entry but concluded that, overall, evidence was insufficient to support the use of one entry technique over another to decrease complication rates.⁶

A more recently published review of randomized controlled trials, Cochrane reviews, and older descriptive accounts similarly concluded that, between the Veress needle (the oldest described technique), direct trocar insertion, and open entry (Hasson), there is no good evidence to suggest that any of these methods is universally superior.² Surgeon comfort is, therefore, an important factor.

Regarding entry sites, we advocate use of the LUQ as an advantageous alternative site for access, but there are several other approaches described in the literature. These include right upper quadrant entry; the Lee Huang point, which is about 10 cm below the xiphoid; and uncommonly, vaginal, either posterior to the uterus into the pouch of Douglas or through the uterine fundus.²

The right upper quadrant approach is included in a recent video review in the Journal of Minimally Invasive Gynecology of safe entry techniques, along with umbilicus, LUQ, and supraumbilical entry.⁷

Another described entry site is the “Jain point,” located at the intersection of a vertical line drawn 2.5 cm medial to the anterior superior iliac spine, up to the level of the umbilicus, and a horizontal line at the upper margin of the umbilicus. In a retrospective study of 7,802 cases involving this method, the authors reported only one significant entry complication. Patients in the study had a wide range of BMIs and previous surgeries.⁸

With respect to entry techniques, we facilitate the Veress entry technique described by Frank E. Loeffler, MD, in the mid-1970s, unless there are contraindications such as second-trimester pregnancy. For umbilical entry, we first use a Kocher clamp to grasp the base of the umbilicus and then evert it. Using two towel clips, the surgeon and assistant apply countertraction by grasping the skin and fat on either side of the umbilicus. A horizontal incision is then made directly on the base of the umbilicus. The towel clips are used to elevate the anterior abdominal wall, and the Veress needle is attached to insufflation tubing, then inserted into the abdomen.

Alternatively, direct entry involves incising the skin, placing a laparoscope in a visual entry trocar, and directly visualizing each layer as the abdomen is entered. Once the trocar is intraperitoneal, insufflation is started.

In open laparoscopic/Hasson entry, the umbilical skin is incised, and the subcutaneous fat is dissected down until the rectal fascia is visualized. The fascia is then incised, the peritoneum is entered bluntly, and the Hasson trocar is placed. Insufflation is attached, and the laparoscope is inserted.
 

Dr. Sasaki is a partner, and Dr. McKenna is an AAGL MIGS fellow, in the private practice of Charles E. Miller, MD, & Associates in Chicago. They reported that they have no disclosures.

References

1. Vilos GA et al. J Obstet Gyneacol Can. 2021;43(3):376-89.

2. Recknagel JD and Goodman LR. J Minim Invasive Gynecol. 2021;28(3):467-74.

3. Palmer R. J Reprod Med. 1974;13:1-5.

4. Brill AI et al. Obstet Gynecol. 1995;85(2):269-72.

5. Audebert AJ and Gomel V. Fertil Steril. 2000;73(3):631-5.

6. Ahmad G et al. Cochrane Database of Systematic Reviews. 2019;1:CD006583.

7. Patzkowsky KE et al. J. Minim Invasive Gynecol. 2021;28(3):386.

8. Nutan J et al. Updates in Surgery. 2021;73(6):2321-9.

The choice of entry point for gynecologic laparoscopy is critical, considering that most laparoscopic injuries occur during initial entry into the abdomen. In addition, different abdominal access points may have differing utility and efficacy depending on the patient. (The overall rate of injuries to abdominal viscera and blood vessels at the time of entry is an estimated 1 per 1,000 cases.¹)

The most conventional entry point for gynecologic laparoscopic surgeries has been the umbilicus, but there are contraindications to this choice and situations in which it may not be the best access site. It is important to have knowledge of alternate entry points and techniques that consider the patient’s current pathology, anatomy, and most importantly, surgical history to better facilitate a safe initial entry.

Courtesy Dr. Kirsten J. Sasaki

The left upper quadrant (LUQ) has been described as a preferred alternate site to the umbilicus, and some gynecologic surgeons even consider it as a routine mode of entry.² In our practice, LUQ entry is a safe and commonly used technique that is chosen primarily based on a patient’s history of a midline vertical incision, the presence of abdominal mesh from a prior umbilical hernia repair, or repeated cesarean sections.

Our technique for LUQ entry is a modification of the traditional approach that employs Palmer’s point – the entry point described by Raoul Palmer, MD, in 1974 as 3-4 cm below the left subcostal margin at the midclavicular line.³ We choose to enter at the midclavicular level and directly under the last rib.
 

When the umbilicus is problematic

The umbilicus is a favored entry point not only for its operative access to pelvic structures but also because – in the absence of obesity – it has no or little subcutaneous fat and, therefore, provides the shortest distance from skin to peritoneum.

Courtesy Dr. Mary (Molly) McKenna

However, adhesive disease from a prior laparotomy involving the umbilicus is a risk factor for bowel injury during umbilical entry (direct trocar, Veress needle, or open technique). In a 1995 review of 360 women undergoing operative laparoscopy after a previous laparotomy, Brill et al. reported umbilical adhesions in 27% of those with prior horizontal suprapubic (Pfannenstiel) incisions, in 55% of those with prior incisions in the midline below the umbilicus, and 67% of those with prior midline incisions above the umbilicus.⁴

Of the 259 patients whose prior laparotomy was for gynecologic surgery (as opposed to obstetric or general surgery) adhesions were present in 70% of those who had midline incisions. (Direct injury to adherent omentum and bowel occurred during laparoscopic procedures in 21% of all women.)

Since the Brill paper, other studies have similarly reported significant adhesion rate, especially after midline incisions. For instance, one French study of patients undergoing laparoscopy reported umbilical adhesions in 51.7% of 89 patients who had previous laparotomy with a midline incision.⁵

Prior umbilical laparoscopy is not a risk factor for umbilical entry unless a hernia repair with mesh was performed at the umbilicus. Umbilical adhesions have been reported to occur in up to 15% of women who have had prior laparoscopic surgery, with more adhesions associated with larger trocar use (specifically 12-mm trocars).¹ Still, the rate of those adhesions was very low.

Obesity is not necessarily a contraindication to umbilical entry; however, it can make successful entry more difficult, particularly in those with central obesity and a thicker layer of subcutaneous fat. It can be difficult in such cases to know when peritoneal access is achieved. Extra-long Veress needles or trocars may be needed, and it is important to enter the abdomen at a 90° angle to minimize risk to the great vessel vasculature.

LUQ entry is often a reliable alternative when central obesity is significant or when umbilical access proves to be difficult. Certainly, the subcutaneous fat layer is thinner at the LUQ than at the umbilicus, and in patients whose umbilicus is pulled very caudal because of a large pannus, the LUQ will also provide a better location for visualization of pelvic anatomy and for easier entry.

We still use umbilical entry in most patients with obesity, but if we are unsuccessful after two to three attempts, we proceed to the LUQ (barring any contraindications to this site).
 

LUQ entry: Our approach, contraindications

By entering at the midclavicular level and directly under the bottom of the rib cage, rather than 2-3 cm below the last rib as in traditional Palmer’s point LUQ entry, we benefit from the tenting up of the peritoneum by the last rib. Having space between the peritoneum and underlying omentum and stomach can facilitate an easier entry, as shown in the video.

Courtesy Kirsten J. Sasaki

We primarily utilize the Veress needle for entry. The needle is inserted directly perpendicular to the fascia, or at a slight angle toward the umbilicus. After the abdomen is insufflated to 15 mm Hg, we proceed with a visual peritoneal entry using a 5-mm trocar with a clear tip, which allows us to visualize both layers of fascia, and subsequently the peritoneum, as the trocar is advanced.

The fascia is not fused, so we can expect to feel three “pops” as the needle (or trocar) passes through the aponeuroses of the internal and external obliques, the aponeuroses of the internal oblique and transversus, and the peritoneum.

While successful peritoneal entry with umbilical access is generally confirmed with an intraperitoneal pressure measuring less than 7 mm Hg (which varies depending on abdominal wall thickness and adiposity), we have found that the opening pressure with LUQ entry is slightly higher. A recently published Canadian guideline for gynecologic laparoscopic entry recommends that an initial Veress intraperitoneal pressure of 10 mm Hg or below be considered an indicator of successful entry, regardless of the patient’s body habitus.¹

LUQ entry can be helpful for surgeries involving large pelvic masses, for which there is little or no space to enter at the umbilicus or to optimally view the pathology. Utilizing the LUQ not only allows for an unobstructed entry and optimal viewing but also may become an extra operative port that can be used for the camera, allowing both surgeons to operate with two hands – a four-port technique. It also allows the surgeon to use a larger diameter port at the umbilicus without concern for cosmetics.

Additionally, there is a school of thought that LUQ entry is overall more successful, requiring less conversion to alternative sites and fewer attempts. This success may result from the presence of less adhesive disease in the LUQ, as well as clearer visualization of the anatomy while entering and confidence in entering the intraperitoneal space.

A prerequisite for LUQ entry is that the stomach be decompressed through placement of an oral gastric or nasogastric tube and suctioning of all gastric contents. An inability to decompress the stomach is a contraindication to LUQ entry, as is a history of splenectomy, an enlarged liver, gastric bypass surgery, or upper abdominal surgery.
 

Entry techniques, alternate sites

No single entry site or technique has been proven to be universally safer than another. A 2019 Cochrane review of laparoscopic entry techniques noted an advantage of direct trocar entry over Veress-needle entry for failed entry but concluded that, overall, evidence was insufficient to support the use of one entry technique over another to decrease complication rates.⁶

A more recently published review of randomized controlled trials, Cochrane reviews, and older descriptive accounts similarly concluded that, between the Veress needle (the oldest described technique), direct trocar insertion, and open entry (Hasson), there is no good evidence to suggest that any of these methods is universally superior.² Surgeon comfort is, therefore, an important factor.

Regarding entry sites, we advocate use of the LUQ as an advantageous alternative site for access, but there are several other approaches described in the literature. These include right upper quadrant entry; the Lee Huang point, which is about 10 cm below the xiphoid; and uncommonly, vaginal, either posterior to the uterus into the pouch of Douglas or through the uterine fundus.²

The right upper quadrant approach is included in a recent video review in the Journal of Minimally Invasive Gynecology of safe entry techniques, along with umbilicus, LUQ, and supraumbilical entry.⁷

Another described entry site is the “Jain point,” located at the intersection of a vertical line drawn 2.5 cm medial to the anterior superior iliac spine, up to the level of the umbilicus, and a horizontal line at the upper margin of the umbilicus. In a retrospective study of 7,802 cases involving this method, the authors reported only one significant entry complication. Patients in the study had a wide range of BMIs and previous surgeries.⁸

With respect to entry techniques, we facilitate the Veress entry technique described by Frank E. Loeffler, MD, in the mid-1970s, unless there are contraindications such as second-trimester pregnancy. For umbilical entry, we first use a Kocher clamp to grasp the base of the umbilicus and then evert it. Using two towel clips, the surgeon and assistant apply countertraction by grasping the skin and fat on either side of the umbilicus. A horizontal incision is then made directly on the base of the umbilicus. The towel clips are used to elevate the anterior abdominal wall, and the Veress needle is attached to insufflation tubing, then inserted into the abdomen.

Alternatively, direct entry involves incising the skin, placing a laparoscope in a visual entry trocar, and directly visualizing each layer as the abdomen is entered. Once the trocar is intraperitoneal, insufflation is started.

In open laparoscopic/Hasson entry, the umbilical skin is incised, and the subcutaneous fat is dissected down until the rectal fascia is visualized. The fascia is then incised, the peritoneum is entered bluntly, and the Hasson trocar is placed. Insufflation is attached, and the laparoscope is inserted.
 

Dr. Sasaki is a partner, and Dr. McKenna is an AAGL MIGS fellow, in the private practice of Charles E. Miller, MD, & Associates in Chicago. They reported that they have no disclosures.

References

1. Vilos GA et al. J Obstet Gyneacol Can. 2021;43(3):376-89.

2. Recknagel JD and Goodman LR. J Minim Invasive Gynecol. 2021;28(3):467-74.

3. Palmer R. J Reprod Med. 1974;13:1-5.

4. Brill AI et al. Obstet Gynecol. 1995;85(2):269-72.

5. Audebert AJ and Gomel V. Fertil Steril. 2000;73(3):631-5.

6. Ahmad G et al. Cochrane Database of Systematic Reviews. 2019;1:CD006583.

7. Patzkowsky KE et al. J. Minim Invasive Gynecol. 2021;28(3):386.

8. Nutan J et al. Updates in Surgery. 2021;73(6):2321-9.

The choice of entry point for gynecologic laparoscopy is critical, considering that most laparoscopic injuries occur during initial entry into the abdomen. In addition, different abdominal access points may have differing utility and efficacy depending on the patient. (The overall rate of injuries to abdominal viscera and blood vessels at the time of entry is an estimated 1 per 1,000 cases.¹)

The most conventional entry point for gynecologic laparoscopic surgeries has been the umbilicus, but there are contraindications to this choice and situations in which it may not be the best access site. It is important to have knowledge of alternate entry points and techniques that consider the patient’s current pathology, anatomy, and most importantly, surgical history to better facilitate a safe initial entry.

Courtesy Dr. Kirsten J. Sasaki

The left upper quadrant (LUQ) has been described as a preferred alternate site to the umbilicus, and some gynecologic surgeons even consider it as a routine mode of entry.² In our practice, LUQ entry is a safe and commonly used technique that is chosen primarily based on a patient’s history of a midline vertical incision, the presence of abdominal mesh from a prior umbilical hernia repair, or repeated cesarean sections.

Our technique for LUQ entry is a modification of the traditional approach that employs Palmer’s point – the entry point described by Raoul Palmer, MD, in 1974 as 3-4 cm below the left subcostal margin at the midclavicular line.³ We choose to enter at the midclavicular level and directly under the last rib.
 

When the umbilicus is problematic

The umbilicus is a favored entry point not only for its operative access to pelvic structures but also because – in the absence of obesity – it has no or little subcutaneous fat and, therefore, provides the shortest distance from skin to peritoneum.

Courtesy Dr. Mary (Molly) McKenna

However, adhesive disease from a prior laparotomy involving the umbilicus is a risk factor for bowel injury during umbilical entry (direct trocar, Veress needle, or open technique). In a 1995 review of 360 women undergoing operative laparoscopy after a previous laparotomy, Brill et al. reported umbilical adhesions in 27% of those with prior horizontal suprapubic (Pfannenstiel) incisions, in 55% of those with prior incisions in the midline below the umbilicus, and 67% of those with prior midline incisions above the umbilicus.⁴

Of the 259 patients whose prior laparotomy was for gynecologic surgery (as opposed to obstetric or general surgery) adhesions were present in 70% of those who had midline incisions. (Direct injury to adherent omentum and bowel occurred during laparoscopic procedures in 21% of all women.)

Since the Brill paper, other studies have similarly reported significant adhesion rate, especially after midline incisions. For instance, one French study of patients undergoing laparoscopy reported umbilical adhesions in 51.7% of 89 patients who had previous laparotomy with a midline incision.⁵

Prior umbilical laparoscopy is not a risk factor for umbilical entry unless a hernia repair with mesh was performed at the umbilicus. Umbilical adhesions have been reported to occur in up to 15% of women who have had prior laparoscopic surgery, with more adhesions associated with larger trocar use (specifically 12-mm trocars).¹ Still, the rate of those adhesions was very low.

Obesity is not necessarily a contraindication to umbilical entry; however, it can make successful entry more difficult, particularly in those with central obesity and a thicker layer of subcutaneous fat. It can be difficult in such cases to know when peritoneal access is achieved. Extra-long Veress needles or trocars may be needed, and it is important to enter the abdomen at a 90° angle to minimize risk to the great vessel vasculature.

LUQ entry is often a reliable alternative when central obesity is significant or when umbilical access proves to be difficult. Certainly, the subcutaneous fat layer is thinner at the LUQ than at the umbilicus, and in patients whose umbilicus is pulled very caudal because of a large pannus, the LUQ will also provide a better location for visualization of pelvic anatomy and for easier entry.

We still use umbilical entry in most patients with obesity, but if we are unsuccessful after two to three attempts, we proceed to the LUQ (barring any contraindications to this site).
 

LUQ entry: Our approach, contraindications

By entering at the midclavicular level and directly under the bottom of the rib cage, rather than 2-3 cm below the last rib as in traditional Palmer’s point LUQ entry, we benefit from the tenting up of the peritoneum by the last rib. Having space between the peritoneum and underlying omentum and stomach can facilitate an easier entry, as shown in the video.

Courtesy Kirsten J. Sasaki

We primarily utilize the Veress needle for entry. The needle is inserted directly perpendicular to the fascia, or at a slight angle toward the umbilicus. After the abdomen is insufflated to 15 mm Hg, we proceed with a visual peritoneal entry using a 5-mm trocar with a clear tip, which allows us to visualize both layers of fascia, and subsequently the peritoneum, as the trocar is advanced.

The fascia is not fused, so we can expect to feel three “pops” as the needle (or trocar) passes through the aponeuroses of the internal and external obliques, the aponeuroses of the internal oblique and transversus, and the peritoneum.

While successful peritoneal entry with umbilical access is generally confirmed with an intraperitoneal pressure measuring less than 7 mm Hg (which varies depending on abdominal wall thickness and adiposity), we have found that the opening pressure with LUQ entry is slightly higher. A recently published Canadian guideline for gynecologic laparoscopic entry recommends that an initial Veress intraperitoneal pressure of 10 mm Hg or below be considered an indicator of successful entry, regardless of the patient’s body habitus.¹

LUQ entry can be helpful for surgeries involving large pelvic masses, for which there is little or no space to enter at the umbilicus or to optimally view the pathology. Utilizing the LUQ not only allows for an unobstructed entry and optimal viewing but also may become an extra operative port that can be used for the camera, allowing both surgeons to operate with two hands – a four-port technique. It also allows the surgeon to use a larger diameter port at the umbilicus without concern for cosmetics.

Additionally, there is a school of thought that LUQ entry is overall more successful, requiring less conversion to alternative sites and fewer attempts. This success may result from the presence of less adhesive disease in the LUQ, as well as clearer visualization of the anatomy while entering and confidence in entering the intraperitoneal space.

A prerequisite for LUQ entry is that the stomach be decompressed through placement of an oral gastric or nasogastric tube and suctioning of all gastric contents. An inability to decompress the stomach is a contraindication to LUQ entry, as is a history of splenectomy, an enlarged liver, gastric bypass surgery, or upper abdominal surgery.
 

Entry techniques, alternate sites

No single entry site or technique has been proven to be universally safer than another. A 2019 Cochrane review of laparoscopic entry techniques noted an advantage of direct trocar entry over Veress-needle entry for failed entry but concluded that, overall, evidence was insufficient to support the use of one entry technique over another to decrease complication rates.⁶

A more recently published review of randomized controlled trials, Cochrane reviews, and older descriptive accounts similarly concluded that, between the Veress needle (the oldest described technique), direct trocar insertion, and open entry (Hasson), there is no good evidence to suggest that any of these methods is universally superior.² Surgeon comfort is, therefore, an important factor.

Regarding entry sites, we advocate use of the LUQ as an advantageous alternative site for access, but there are several other approaches described in the literature. These include right upper quadrant entry; the Lee Huang point, which is about 10 cm below the xiphoid; and uncommonly, vaginal, either posterior to the uterus into the pouch of Douglas or through the uterine fundus.²

The right upper quadrant approach is included in a recent video review in the Journal of Minimally Invasive Gynecology of safe entry techniques, along with umbilicus, LUQ, and supraumbilical entry.⁷

Another described entry site is the “Jain point,” located at the intersection of a vertical line drawn 2.5 cm medial to the anterior superior iliac spine, up to the level of the umbilicus, and a horizontal line at the upper margin of the umbilicus. In a retrospective study of 7,802 cases involving this method, the authors reported only one significant entry complication. Patients in the study had a wide range of BMIs and previous surgeries.⁸

With respect to entry techniques, we facilitate the Veress entry technique described by Frank E. Loeffler, MD, in the mid-1970s, unless there are contraindications such as second-trimester pregnancy. For umbilical entry, we first use a Kocher clamp to grasp the base of the umbilicus and then evert it. Using two towel clips, the surgeon and assistant apply countertraction by grasping the skin and fat on either side of the umbilicus. A horizontal incision is then made directly on the base of the umbilicus. The towel clips are used to elevate the anterior abdominal wall, and the Veress needle is attached to insufflation tubing, then inserted into the abdomen.

Alternatively, direct entry involves incising the skin, placing a laparoscope in a visual entry trocar, and directly visualizing each layer as the abdomen is entered. Once the trocar is intraperitoneal, insufflation is started.

In open laparoscopic/Hasson entry, the umbilical skin is incised, and the subcutaneous fat is dissected down until the rectal fascia is visualized. The fascia is then incised, the peritoneum is entered bluntly, and the Hasson trocar is placed. Insufflation is attached, and the laparoscope is inserted.
 

Dr. Sasaki is a partner, and Dr. McKenna is an AAGL MIGS fellow, in the private practice of Charles E. Miller, MD, & Associates in Chicago. They reported that they have no disclosures.

References

1. Vilos GA et al. J Obstet Gyneacol Can. 2021;43(3):376-89.

2. Recknagel JD and Goodman LR. J Minim Invasive Gynecol. 2021;28(3):467-74.

3. Palmer R. J Reprod Med. 1974;13:1-5.

4. Brill AI et al. Obstet Gynecol. 1995;85(2):269-72.

5. Audebert AJ and Gomel V. Fertil Steril. 2000;73(3):631-5.

6. Ahmad G et al. Cochrane Database of Systematic Reviews. 2019;1:CD006583.

7. Patzkowsky KE et al. J. Minim Invasive Gynecol. 2021;28(3):386.

8. Nutan J et al. Updates in Surgery. 2021;73(6):2321-9.