The New Gastroenterologist

For the past 18 months, we’ve all been focused on defeating the COVID-19 pandemic and preparing for the effects of cancer screenings that were delayed or put off entirely. But COVID isn’t the only epidemic we’re facing in the United States. Obesity is the second leading cause of preventable death in the United States. and its related diseases account for $480.7 billion in direct health care costs, with an additional $1.24 trillion in indirect costs from lost economic productivity.

More than two in five Americans are obese and that number is predicted to grow to more than half of the U.S. population by 2030. Obesity is a risk factor for nonalcoholic fatty liver disease (NAFLD), a buildup of fat in the liver with little or no inflammation or cell damage that affects one in three (30%-37%) of adults in the U.S.

NAFLD can progress to nonalcoholic steatohepatitis (NASH), which affects about 1 in 10 (8%-12%) of adults in the U.S. NASH is fat in the liver with inflammation and cell damage, and it can lead to fibrosis and liver failure. The number of patients we see with NALFD and NASH continues to rise and it’s taking its toll. One in five people who have NASH will have the disease progress to liver cirrhosis. NASH is expected to be the leading cause of liver transplant in the U.S. for the next 5 years.
 

Stemming the tide of NAFLD and NASH

The best way to fight NAFLD and NASH is to prevent it in the first place by maintaining a healthy weight and exercising most days of the week. In terms of diet, limiting sugar and eating a diet rich in vegetables, whole grains, and healthy fats can prevent the factors that lead to liver disease.

If this were easy, we wouldn’t be facing the obesity epidemic that is plaguing the United States. One of the issues is that medicine has only recognized obesity as a disease for less than 10 years. We aren’t trained in medical school, residencies, or fellowships in managing obesity, beyond advising people to exercise and eat right. We know this doesn’t work.

That’s why many independent GI groups are exploring comprehensive weight management programs that take a holistic approach to weight management involving a team of health care providers and educators helping patients gradually exercise more and eat healthy while providing a social support system to lose weight and keep it off.
 

The best way to educate is to listen first

As gastroenterologists, we see many obesity-related issues and have an opportunity to intervene before other more serious issues show up – like cancer, hypertension, and stroke. And educating the public and primary care physicians is key to ensuring that patients who are high risk are screened for liver disease.

Some GI practices leverage awareness events such as International NASH Day in June, or National Liver Cancer Awareness Month in October, to provide primary care physicians and patients with educational materials about making healthier choices and what options are available to screen for NAFLD and NASH.

While the awareness events offer a ready-made context for outreach, the physicians in my practice work year-round to provide information on liver disease. When patients are brought in for issues that may indicate future problems, we look for signs of chronic liver disease and educate them and their family members about liver disease and cirrhosis.

Discussions of weight are very personal, and it’s important to approach the conversation with sensitivity. It’s also good to understand as best as possible any cultural implications of discussing a person’s weight to ensure that the patient or their family members are not embarrassed by the discussion. I find that oftentimes the best approach is to listen to the patient and hear what factors are influencing their ability to exercise and eat healthy foods so that you can work together to find the best solution.

It’s also important to recognize that racial disparities exist in many aspects of NAFLD, including prevalence, severity, genetic predisposition, and overall chance of recovery. For instance, Hispanics and Asian Americans have a higher prevalence of NAFLD, compared with other ethnic and racial groups.
 

Early detection is key

Screenings have become a lot simpler and more convenient. There are alternatives to the painful, expensive liver biopsy. There are blood biomarker tests designed to assess liver fibrosis in patients. Specialized vibration-controlled transient elastography, such as Fibroscan, can measure scarring and fat buildup in the liver. And because it’s noninvasive, it doesn’t come with the same risks as a traditional liver biopsy. It also costs about four or five times less, which is important in this era of value-based care.

These simple tests can be reassuring, or they can lead down another path of treating the disease, but not being screened at all can come at a steep price. Severe fibrosis can lead to cirrhosis, a dangerous condition where the liver can no longer function correctly. NAFLD and NASH can also lead to liver cancer.

There are some medications that are in phase 2 and some in phase 3 clinical trials that aim to reduce fatty liver by cutting down fibrosis and steatosis, and there are other medications that can be used to help with weight loss. But the reality is that lifestyle changes are currently the best way to reverse NAFLD or stop it from progressing to NASH or cirrhosis.
 

Join an innovative practice

For the next 20 years, the obesity epidemic will be the biggest issue facing our society and a major focus of our cancer prevention efforts. Early-career physicians who are looking to join an independent GI practice should ask questions to determine whether the partners in the practice are taking a comprehensive approach to treating issues of obesity, NAFLD, NASH, and liver disease. Discuss what steps the practice takes to educate primary care physicians and their patients about the dangers of NAFLD and NASH.

We’re looking for early-career physicians who are entrepreneurial, not just for the sake of the practice, but because the future is in digital technologies and chronic care management, such as Chronwell, that help people maintain health through remote care and coaching. We want people who are thinking about fixing the problems of today and tomorrow with new technologies and scalable solutions. Through education and new screening and treatment options, we can ensure that fewer people develop serious liver disease or cancer.
 

Dr. Sanjay Sandhir is a practicing gastroenterologist at Dayton Gastroenterology, One GI in Ohio and is an executive committee member of the Digestive Health Physicians Association. He has no conflicts to declare.

For the past 18 months, we’ve all been focused on defeating the COVID-19 pandemic and preparing for the effects of cancer screenings that were delayed or put off entirely. But COVID isn’t the only epidemic we’re facing in the United States. Obesity is the second leading cause of preventable death in the United States. and its related diseases account for $480.7 billion in direct health care costs, with an additional $1.24 trillion in indirect costs from lost economic productivity.

More than two in five Americans are obese and that number is predicted to grow to more than half of the U.S. population by 2030. Obesity is a risk factor for nonalcoholic fatty liver disease (NAFLD), a buildup of fat in the liver with little or no inflammation or cell damage that affects one in three (30%-37%) of adults in the U.S.

NAFLD can progress to nonalcoholic steatohepatitis (NASH), which affects about 1 in 10 (8%-12%) of adults in the U.S. NASH is fat in the liver with inflammation and cell damage, and it can lead to fibrosis and liver failure. The number of patients we see with NALFD and NASH continues to rise and it’s taking its toll. One in five people who have NASH will have the disease progress to liver cirrhosis. NASH is expected to be the leading cause of liver transplant in the U.S. for the next 5 years.
 

Stemming the tide of NAFLD and NASH

The best way to fight NAFLD and NASH is to prevent it in the first place by maintaining a healthy weight and exercising most days of the week. In terms of diet, limiting sugar and eating a diet rich in vegetables, whole grains, and healthy fats can prevent the factors that lead to liver disease.

If this were easy, we wouldn’t be facing the obesity epidemic that is plaguing the United States. One of the issues is that medicine has only recognized obesity as a disease for less than 10 years. We aren’t trained in medical school, residencies, or fellowships in managing obesity, beyond advising people to exercise and eat right. We know this doesn’t work.

That’s why many independent GI groups are exploring comprehensive weight management programs that take a holistic approach to weight management involving a team of health care providers and educators helping patients gradually exercise more and eat healthy while providing a social support system to lose weight and keep it off.
 

The best way to educate is to listen first

As gastroenterologists, we see many obesity-related issues and have an opportunity to intervene before other more serious issues show up – like cancer, hypertension, and stroke. And educating the public and primary care physicians is key to ensuring that patients who are high risk are screened for liver disease.

Some GI practices leverage awareness events such as International NASH Day in June, or National Liver Cancer Awareness Month in October, to provide primary care physicians and patients with educational materials about making healthier choices and what options are available to screen for NAFLD and NASH.

While the awareness events offer a ready-made context for outreach, the physicians in my practice work year-round to provide information on liver disease. When patients are brought in for issues that may indicate future problems, we look for signs of chronic liver disease and educate them and their family members about liver disease and cirrhosis.

Discussions of weight are very personal, and it’s important to approach the conversation with sensitivity. It’s also good to understand as best as possible any cultural implications of discussing a person’s weight to ensure that the patient or their family members are not embarrassed by the discussion. I find that oftentimes the best approach is to listen to the patient and hear what factors are influencing their ability to exercise and eat healthy foods so that you can work together to find the best solution.

It’s also important to recognize that racial disparities exist in many aspects of NAFLD, including prevalence, severity, genetic predisposition, and overall chance of recovery. For instance, Hispanics and Asian Americans have a higher prevalence of NAFLD, compared with other ethnic and racial groups.
 

Early detection is key

Screenings have become a lot simpler and more convenient. There are alternatives to the painful, expensive liver biopsy. There are blood biomarker tests designed to assess liver fibrosis in patients. Specialized vibration-controlled transient elastography, such as Fibroscan, can measure scarring and fat buildup in the liver. And because it’s noninvasive, it doesn’t come with the same risks as a traditional liver biopsy. It also costs about four or five times less, which is important in this era of value-based care.

These simple tests can be reassuring, or they can lead down another path of treating the disease, but not being screened at all can come at a steep price. Severe fibrosis can lead to cirrhosis, a dangerous condition where the liver can no longer function correctly. NAFLD and NASH can also lead to liver cancer.

There are some medications that are in phase 2 and some in phase 3 clinical trials that aim to reduce fatty liver by cutting down fibrosis and steatosis, and there are other medications that can be used to help with weight loss. But the reality is that lifestyle changes are currently the best way to reverse NAFLD or stop it from progressing to NASH or cirrhosis.
 

Join an innovative practice

For the next 20 years, the obesity epidemic will be the biggest issue facing our society and a major focus of our cancer prevention efforts. Early-career physicians who are looking to join an independent GI practice should ask questions to determine whether the partners in the practice are taking a comprehensive approach to treating issues of obesity, NAFLD, NASH, and liver disease. Discuss what steps the practice takes to educate primary care physicians and their patients about the dangers of NAFLD and NASH.

We’re looking for early-career physicians who are entrepreneurial, not just for the sake of the practice, but because the future is in digital technologies and chronic care management, such as Chronwell, that help people maintain health through remote care and coaching. We want people who are thinking about fixing the problems of today and tomorrow with new technologies and scalable solutions. Through education and new screening and treatment options, we can ensure that fewer people develop serious liver disease or cancer.
 

Dr. Sanjay Sandhir is a practicing gastroenterologist at Dayton Gastroenterology, One GI in Ohio and is an executive committee member of the Digestive Health Physicians Association. He has no conflicts to declare.

For the past 18 months, we’ve all been focused on defeating the COVID-19 pandemic and preparing for the effects of cancer screenings that were delayed or put off entirely. But COVID isn’t the only epidemic we’re facing in the United States. Obesity is the second leading cause of preventable death in the United States. and its related diseases account for $480.7 billion in direct health care costs, with an additional $1.24 trillion in indirect costs from lost economic productivity.

More than two in five Americans are obese and that number is predicted to grow to more than half of the U.S. population by 2030. Obesity is a risk factor for nonalcoholic fatty liver disease (NAFLD), a buildup of fat in the liver with little or no inflammation or cell damage that affects one in three (30%-37%) of adults in the U.S.

NAFLD can progress to nonalcoholic steatohepatitis (NASH), which affects about 1 in 10 (8%-12%) of adults in the U.S. NASH is fat in the liver with inflammation and cell damage, and it can lead to fibrosis and liver failure. The number of patients we see with NALFD and NASH continues to rise and it’s taking its toll. One in five people who have NASH will have the disease progress to liver cirrhosis. NASH is expected to be the leading cause of liver transplant in the U.S. for the next 5 years.
 

Stemming the tide of NAFLD and NASH

The best way to fight NAFLD and NASH is to prevent it in the first place by maintaining a healthy weight and exercising most days of the week. In terms of diet, limiting sugar and eating a diet rich in vegetables, whole grains, and healthy fats can prevent the factors that lead to liver disease.

If this were easy, we wouldn’t be facing the obesity epidemic that is plaguing the United States. One of the issues is that medicine has only recognized obesity as a disease for less than 10 years. We aren’t trained in medical school, residencies, or fellowships in managing obesity, beyond advising people to exercise and eat right. We know this doesn’t work.

That’s why many independent GI groups are exploring comprehensive weight management programs that take a holistic approach to weight management involving a team of health care providers and educators helping patients gradually exercise more and eat healthy while providing a social support system to lose weight and keep it off.
 

The best way to educate is to listen first

As gastroenterologists, we see many obesity-related issues and have an opportunity to intervene before other more serious issues show up – like cancer, hypertension, and stroke. And educating the public and primary care physicians is key to ensuring that patients who are high risk are screened for liver disease.

Some GI practices leverage awareness events such as International NASH Day in June, or National Liver Cancer Awareness Month in October, to provide primary care physicians and patients with educational materials about making healthier choices and what options are available to screen for NAFLD and NASH.

While the awareness events offer a ready-made context for outreach, the physicians in my practice work year-round to provide information on liver disease. When patients are brought in for issues that may indicate future problems, we look for signs of chronic liver disease and educate them and their family members about liver disease and cirrhosis.

Discussions of weight are very personal, and it’s important to approach the conversation with sensitivity. It’s also good to understand as best as possible any cultural implications of discussing a person’s weight to ensure that the patient or their family members are not embarrassed by the discussion. I find that oftentimes the best approach is to listen to the patient and hear what factors are influencing their ability to exercise and eat healthy foods so that you can work together to find the best solution.

It’s also important to recognize that racial disparities exist in many aspects of NAFLD, including prevalence, severity, genetic predisposition, and overall chance of recovery. For instance, Hispanics and Asian Americans have a higher prevalence of NAFLD, compared with other ethnic and racial groups.
 

Early detection is key

Screenings have become a lot simpler and more convenient. There are alternatives to the painful, expensive liver biopsy. There are blood biomarker tests designed to assess liver fibrosis in patients. Specialized vibration-controlled transient elastography, such as Fibroscan, can measure scarring and fat buildup in the liver. And because it’s noninvasive, it doesn’t come with the same risks as a traditional liver biopsy. It also costs about four or five times less, which is important in this era of value-based care.

These simple tests can be reassuring, or they can lead down another path of treating the disease, but not being screened at all can come at a steep price. Severe fibrosis can lead to cirrhosis, a dangerous condition where the liver can no longer function correctly. NAFLD and NASH can also lead to liver cancer.

There are some medications that are in phase 2 and some in phase 3 clinical trials that aim to reduce fatty liver by cutting down fibrosis and steatosis, and there are other medications that can be used to help with weight loss. But the reality is that lifestyle changes are currently the best way to reverse NAFLD or stop it from progressing to NASH or cirrhosis.
 

Join an innovative practice

For the next 20 years, the obesity epidemic will be the biggest issue facing our society and a major focus of our cancer prevention efforts. Early-career physicians who are looking to join an independent GI practice should ask questions to determine whether the partners in the practice are taking a comprehensive approach to treating issues of obesity, NAFLD, NASH, and liver disease. Discuss what steps the practice takes to educate primary care physicians and their patients about the dangers of NAFLD and NASH.

We’re looking for early-career physicians who are entrepreneurial, not just for the sake of the practice, but because the future is in digital technologies and chronic care management, such as Chronwell, that help people maintain health through remote care and coaching. We want people who are thinking about fixing the problems of today and tomorrow with new technologies and scalable solutions. Through education and new screening and treatment options, we can ensure that fewer people develop serious liver disease or cancer.
 

Dr. Sanjay Sandhir is a practicing gastroenterologist at Dayton Gastroenterology, One GI in Ohio and is an executive committee member of the Digestive Health Physicians Association. He has no conflicts to declare.

Even a decade ago, the idea of providers sharing clinical notes with patients was almost unfathomable to most in medicine. We have since seen a sea change regarding the need for transparency in health care, leading to dramatic legislative and policy shifts in recent years.

On April 5, 2021, the federal program rule on Interoperability, Information Blocking, and ONC Health IT Certification took effect, which implemented a part of the bipartisan 21st Century Cures Act of 2016 requiring most of a patient’s electronic health information (EHI) be made easily accessible free of charge and “without delay.”¹

Included in this defined set of EHI, known as the United States Core Data for Interoperability, are eight types of clinical notes that must be shared with patients, including: progress notes, history and physical notes, consultation notes, discharge summary notes, procedure notes, laboratory report narratives, imaging narratives, and pathology report narratives. Many clinicians viewed this federally mandated transition to note sharing with patients with concern, fearing increased documentation burdens, needless patient anxiety, and inevitable deluge of follow-up questions and requests for chart corrections.

In reality, the Health Insurance Portability and Accountability Act (HIPAA) granted virtually all patients the right to review a paper copy of their medical records, including all clinical notes, way back in 1996. Practically speaking, though, the multiple steps required to formally make these requests kept most patients from regularly accessing their health information.

The 21st Century Cures Act streamlines and modernizes this process by requiring electronic access. Certain note types, including psychotherapy notes, are exempt from this requirement. As has always been true since HIPAA was enacted, exceptions may be used for circumstances in which a clinician holds a reasonable belief that blocking information is necessary to prevent harm to a patient or another person or to protect an individual’s privacy. By continuing to allow for these exceptions, clinicians maintain the autonomy to block sharing of notes in the rare, complex situations in which doing so may truly be harmful.

And while the legal requirement to share most clinical notes is new, there is already a wealth of evidence from the earliest adopters (part of the OpenNotes movement) affirming the significant benefits from this practice – for patients and providers – with few negative effects on workflows or documentation patterns.² Findings published as early as 2012, and regularly since then, among OpenNotes adopters from a diverse set of health care institutions have shown access to notes improves patient engagement, activation, and communication, as well as patient and clinician satisfaction.³

Still, providers may argue, shouldn’t clinical notes be a space where providers are free to articulate uncertainties, work through clinical reasoning, and share subtle observations about a patient’s presentation and findings with colleagues without having to worry about alarming patients who may lack the background to understand medical nuances?

It’s a fine balance in certain situations since we want to document our objective clinical assessments and prognoses without needlessly upsetting our patients, especially when considering a potentially life-changing diagnosis. How do we continue offering hope to our patients while still respecting their autonomy and sharing their health information with them? There is no uniform approach or standard playbook to follow since each patient and clinical circumstance is unique.

Fundamentally, sharing clinical notes is about granting access to one’s own health information, promoting patient activation and engagement, and making health care more patient centered. As a clinician, it’s important to frame the conversations we have with our patients so they are not surprised or caught off guard by what we have written in our notes. If you had a difficult or contentious conversation, document it objectively and without bias. If you are discussing obesity, substance abuse, or mental health, do so respectfully, supportively, and without judgment. If one of the reasons you are doing a CT scan is to rule out pancreatic cancer, it’s hard to argue that the patient does not deserve to know that beforehand.

The OpenNotes experience to date has consistently shown that patients benefit from direct discussions and transparency, which can even motivate difficult behavior changes.⁴ As clinicians, we may have to make minor changes in how we document, such as using less medical jargon and fewer abbreviations, but based on data from the longest tenured participants in OpenNotes, these adjustments do not add to documentation burdens.⁵ An activated patient who is reading their notes is an engaged patient, one who will often collaborate more in their own care, offer additional insights, and feel more empowered to take responsibility for their own health.⁶

When surveyed, patients report that access to their clinical notes helps them feel more in control of their health by understanding their medical conditions better, which makes them feel more prepared for their visits.4 Studies have shown that patients forget between 40%-80% of the information communicated during a visit, making clinical notes a valuable reminder and reference. Over 75% of patients in one study reported that reading notes helped them better understand the meaning of results and the rationale for referrals and tests, which led to greater follow-through with their treatment plans and follow-up appointments.³ A remarkable 99% of patients in the same study reported feeling the same or better about their physician after reading their notes.

Sharing notes with patients also makes care safer and more equitable. A written record of a visit serves as an important source of information about why a medicine is prescribed, a reminder about additions or changes to a regimen, and potential adverse effects of medications. In the first OpenNotes study, which had more than 100 primary care physicians and 20,000 patients, 60%-78% of patients with access to their notes reported improved medication adherence.² A later study reported similar benefits, particularly among patients who identify as racial or ethnic minorities, non-native English speakers, and those with a high school education or less. These findings may reflect increased trust that comes with a more collaborative relationship between providers and patients. Patients who can read their notes also show a willingness to review their medication lists and report discrepancies and errors, making their care safer still.⁷

Conclusion

The move to widespread shared notes, though prompted by a federal mandate, is a critical step forward in patient activation, engagement, and satisfaction. Importantly, there is a large body of evidence showing multiple benefits, including better communication and safer and more equitable care at sites that have already been sharing notes for over a decade. When surveyed, both patients and providers who have been participating in shared notes believe the practice should continue.

In April 2021, we began a massive natural experiment in the U.S. with ubiquitous sharing of clinical notes, one that will help us learn more about how best to make our patients’ health information accessible, meaningful, and most meaningful in improving their overall health and well-being. Sharing notes with our patients is at once relatively easy to implement but complex in its implications and represents a significant paradigm shift in medicine toward a safer, more patient-centered approach. The evidence to date has shown that embracing shared notes promotes greater patient activation and engagement, and with it a more transparent and collaborative relationship between providers and patients that could lead to transformative benefits to the quality of the care we can achieve together.

Dr. Shah is an associate professor of medicine and pediatrics and associate chief medical information officer at University of Chicago Medicine. He has no disclosures

References

1. 21st Century Cures Act, HR 34, 114th Congress (2015). Accessed 2021 Sep 23. https://www.congress.gov/bill/114th-congress/house-bill/34.

2. Delbanco T et al. Ann Intern Med. 2012 Oct;157(7):461-70.

3. Bell S et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

4. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

5. DesRoches C et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Blease C et al. J Med Ethics. 2021 May. doi: 10.1136/medethics-2021-107275.

7. DesRoches C et al. Ann Intern Med. 2019 Jul 2;171(1):69-71.


 

Even a decade ago, the idea of providers sharing clinical notes with patients was almost unfathomable to most in medicine. We have since seen a sea change regarding the need for transparency in health care, leading to dramatic legislative and policy shifts in recent years.

On April 5, 2021, the federal program rule on Interoperability, Information Blocking, and ONC Health IT Certification took effect, which implemented a part of the bipartisan 21st Century Cures Act of 2016 requiring most of a patient’s electronic health information (EHI) be made easily accessible free of charge and “without delay.”¹

Included in this defined set of EHI, known as the United States Core Data for Interoperability, are eight types of clinical notes that must be shared with patients, including: progress notes, history and physical notes, consultation notes, discharge summary notes, procedure notes, laboratory report narratives, imaging narratives, and pathology report narratives. Many clinicians viewed this federally mandated transition to note sharing with patients with concern, fearing increased documentation burdens, needless patient anxiety, and inevitable deluge of follow-up questions and requests for chart corrections.

In reality, the Health Insurance Portability and Accountability Act (HIPAA) granted virtually all patients the right to review a paper copy of their medical records, including all clinical notes, way back in 1996. Practically speaking, though, the multiple steps required to formally make these requests kept most patients from regularly accessing their health information.

The 21st Century Cures Act streamlines and modernizes this process by requiring electronic access. Certain note types, including psychotherapy notes, are exempt from this requirement. As has always been true since HIPAA was enacted, exceptions may be used for circumstances in which a clinician holds a reasonable belief that blocking information is necessary to prevent harm to a patient or another person or to protect an individual’s privacy. By continuing to allow for these exceptions, clinicians maintain the autonomy to block sharing of notes in the rare, complex situations in which doing so may truly be harmful.

And while the legal requirement to share most clinical notes is new, there is already a wealth of evidence from the earliest adopters (part of the OpenNotes movement) affirming the significant benefits from this practice – for patients and providers – with few negative effects on workflows or documentation patterns.² Findings published as early as 2012, and regularly since then, among OpenNotes adopters from a diverse set of health care institutions have shown access to notes improves patient engagement, activation, and communication, as well as patient and clinician satisfaction.³

Still, providers may argue, shouldn’t clinical notes be a space where providers are free to articulate uncertainties, work through clinical reasoning, and share subtle observations about a patient’s presentation and findings with colleagues without having to worry about alarming patients who may lack the background to understand medical nuances?

It’s a fine balance in certain situations since we want to document our objective clinical assessments and prognoses without needlessly upsetting our patients, especially when considering a potentially life-changing diagnosis. How do we continue offering hope to our patients while still respecting their autonomy and sharing their health information with them? There is no uniform approach or standard playbook to follow since each patient and clinical circumstance is unique.

Fundamentally, sharing clinical notes is about granting access to one’s own health information, promoting patient activation and engagement, and making health care more patient centered. As a clinician, it’s important to frame the conversations we have with our patients so they are not surprised or caught off guard by what we have written in our notes. If you had a difficult or contentious conversation, document it objectively and without bias. If you are discussing obesity, substance abuse, or mental health, do so respectfully, supportively, and without judgment. If one of the reasons you are doing a CT scan is to rule out pancreatic cancer, it’s hard to argue that the patient does not deserve to know that beforehand.

The OpenNotes experience to date has consistently shown that patients benefit from direct discussions and transparency, which can even motivate difficult behavior changes.⁴ As clinicians, we may have to make minor changes in how we document, such as using less medical jargon and fewer abbreviations, but based on data from the longest tenured participants in OpenNotes, these adjustments do not add to documentation burdens.⁵ An activated patient who is reading their notes is an engaged patient, one who will often collaborate more in their own care, offer additional insights, and feel more empowered to take responsibility for their own health.⁶

When surveyed, patients report that access to their clinical notes helps them feel more in control of their health by understanding their medical conditions better, which makes them feel more prepared for their visits.4 Studies have shown that patients forget between 40%-80% of the information communicated during a visit, making clinical notes a valuable reminder and reference. Over 75% of patients in one study reported that reading notes helped them better understand the meaning of results and the rationale for referrals and tests, which led to greater follow-through with their treatment plans and follow-up appointments.³ A remarkable 99% of patients in the same study reported feeling the same or better about their physician after reading their notes.

Sharing notes with patients also makes care safer and more equitable. A written record of a visit serves as an important source of information about why a medicine is prescribed, a reminder about additions or changes to a regimen, and potential adverse effects of medications. In the first OpenNotes study, which had more than 100 primary care physicians and 20,000 patients, 60%-78% of patients with access to their notes reported improved medication adherence.² A later study reported similar benefits, particularly among patients who identify as racial or ethnic minorities, non-native English speakers, and those with a high school education or less. These findings may reflect increased trust that comes with a more collaborative relationship between providers and patients. Patients who can read their notes also show a willingness to review their medication lists and report discrepancies and errors, making their care safer still.⁷

Conclusion

The move to widespread shared notes, though prompted by a federal mandate, is a critical step forward in patient activation, engagement, and satisfaction. Importantly, there is a large body of evidence showing multiple benefits, including better communication and safer and more equitable care at sites that have already been sharing notes for over a decade. When surveyed, both patients and providers who have been participating in shared notes believe the practice should continue.

In April 2021, we began a massive natural experiment in the U.S. with ubiquitous sharing of clinical notes, one that will help us learn more about how best to make our patients’ health information accessible, meaningful, and most meaningful in improving their overall health and well-being. Sharing notes with our patients is at once relatively easy to implement but complex in its implications and represents a significant paradigm shift in medicine toward a safer, more patient-centered approach. The evidence to date has shown that embracing shared notes promotes greater patient activation and engagement, and with it a more transparent and collaborative relationship between providers and patients that could lead to transformative benefits to the quality of the care we can achieve together.

Dr. Shah is an associate professor of medicine and pediatrics and associate chief medical information officer at University of Chicago Medicine. He has no disclosures

References

1. 21st Century Cures Act, HR 34, 114th Congress (2015). Accessed 2021 Sep 23. https://www.congress.gov/bill/114th-congress/house-bill/34.

2. Delbanco T et al. Ann Intern Med. 2012 Oct;157(7):461-70.

3. Bell S et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

4. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

5. DesRoches C et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Blease C et al. J Med Ethics. 2021 May. doi: 10.1136/medethics-2021-107275.

7. DesRoches C et al. Ann Intern Med. 2019 Jul 2;171(1):69-71.


 

Even a decade ago, the idea of providers sharing clinical notes with patients was almost unfathomable to most in medicine. We have since seen a sea change regarding the need for transparency in health care, leading to dramatic legislative and policy shifts in recent years.

On April 5, 2021, the federal program rule on Interoperability, Information Blocking, and ONC Health IT Certification took effect, which implemented a part of the bipartisan 21st Century Cures Act of 2016 requiring most of a patient’s electronic health information (EHI) be made easily accessible free of charge and “without delay.”¹

Included in this defined set of EHI, known as the United States Core Data for Interoperability, are eight types of clinical notes that must be shared with patients, including: progress notes, history and physical notes, consultation notes, discharge summary notes, procedure notes, laboratory report narratives, imaging narratives, and pathology report narratives. Many clinicians viewed this federally mandated transition to note sharing with patients with concern, fearing increased documentation burdens, needless patient anxiety, and inevitable deluge of follow-up questions and requests for chart corrections.

In reality, the Health Insurance Portability and Accountability Act (HIPAA) granted virtually all patients the right to review a paper copy of their medical records, including all clinical notes, way back in 1996. Practically speaking, though, the multiple steps required to formally make these requests kept most patients from regularly accessing their health information.

The 21st Century Cures Act streamlines and modernizes this process by requiring electronic access. Certain note types, including psychotherapy notes, are exempt from this requirement. As has always been true since HIPAA was enacted, exceptions may be used for circumstances in which a clinician holds a reasonable belief that blocking information is necessary to prevent harm to a patient or another person or to protect an individual’s privacy. By continuing to allow for these exceptions, clinicians maintain the autonomy to block sharing of notes in the rare, complex situations in which doing so may truly be harmful.

And while the legal requirement to share most clinical notes is new, there is already a wealth of evidence from the earliest adopters (part of the OpenNotes movement) affirming the significant benefits from this practice – for patients and providers – with few negative effects on workflows or documentation patterns.² Findings published as early as 2012, and regularly since then, among OpenNotes adopters from a diverse set of health care institutions have shown access to notes improves patient engagement, activation, and communication, as well as patient and clinician satisfaction.³

Still, providers may argue, shouldn’t clinical notes be a space where providers are free to articulate uncertainties, work through clinical reasoning, and share subtle observations about a patient’s presentation and findings with colleagues without having to worry about alarming patients who may lack the background to understand medical nuances?

It’s a fine balance in certain situations since we want to document our objective clinical assessments and prognoses without needlessly upsetting our patients, especially when considering a potentially life-changing diagnosis. How do we continue offering hope to our patients while still respecting their autonomy and sharing their health information with them? There is no uniform approach or standard playbook to follow since each patient and clinical circumstance is unique.

Fundamentally, sharing clinical notes is about granting access to one’s own health information, promoting patient activation and engagement, and making health care more patient centered. As a clinician, it’s important to frame the conversations we have with our patients so they are not surprised or caught off guard by what we have written in our notes. If you had a difficult or contentious conversation, document it objectively and without bias. If you are discussing obesity, substance abuse, or mental health, do so respectfully, supportively, and without judgment. If one of the reasons you are doing a CT scan is to rule out pancreatic cancer, it’s hard to argue that the patient does not deserve to know that beforehand.

The OpenNotes experience to date has consistently shown that patients benefit from direct discussions and transparency, which can even motivate difficult behavior changes.⁴ As clinicians, we may have to make minor changes in how we document, such as using less medical jargon and fewer abbreviations, but based on data from the longest tenured participants in OpenNotes, these adjustments do not add to documentation burdens.⁵ An activated patient who is reading their notes is an engaged patient, one who will often collaborate more in their own care, offer additional insights, and feel more empowered to take responsibility for their own health.⁶

When surveyed, patients report that access to their clinical notes helps them feel more in control of their health by understanding their medical conditions better, which makes them feel more prepared for their visits.4 Studies have shown that patients forget between 40%-80% of the information communicated during a visit, making clinical notes a valuable reminder and reference. Over 75% of patients in one study reported that reading notes helped them better understand the meaning of results and the rationale for referrals and tests, which led to greater follow-through with their treatment plans and follow-up appointments.³ A remarkable 99% of patients in the same study reported feeling the same or better about their physician after reading their notes.

Sharing notes with patients also makes care safer and more equitable. A written record of a visit serves as an important source of information about why a medicine is prescribed, a reminder about additions or changes to a regimen, and potential adverse effects of medications. In the first OpenNotes study, which had more than 100 primary care physicians and 20,000 patients, 60%-78% of patients with access to their notes reported improved medication adherence.² A later study reported similar benefits, particularly among patients who identify as racial or ethnic minorities, non-native English speakers, and those with a high school education or less. These findings may reflect increased trust that comes with a more collaborative relationship between providers and patients. Patients who can read their notes also show a willingness to review their medication lists and report discrepancies and errors, making their care safer still.⁷

Conclusion

The move to widespread shared notes, though prompted by a federal mandate, is a critical step forward in patient activation, engagement, and satisfaction. Importantly, there is a large body of evidence showing multiple benefits, including better communication and safer and more equitable care at sites that have already been sharing notes for over a decade. When surveyed, both patients and providers who have been participating in shared notes believe the practice should continue.

In April 2021, we began a massive natural experiment in the U.S. with ubiquitous sharing of clinical notes, one that will help us learn more about how best to make our patients’ health information accessible, meaningful, and most meaningful in improving their overall health and well-being. Sharing notes with our patients is at once relatively easy to implement but complex in its implications and represents a significant paradigm shift in medicine toward a safer, more patient-centered approach. The evidence to date has shown that embracing shared notes promotes greater patient activation and engagement, and with it a more transparent and collaborative relationship between providers and patients that could lead to transformative benefits to the quality of the care we can achieve together.

Dr. Shah is an associate professor of medicine and pediatrics and associate chief medical information officer at University of Chicago Medicine. He has no disclosures

References

1. 21st Century Cures Act, HR 34, 114th Congress (2015). Accessed 2021 Sep 23. https://www.congress.gov/bill/114th-congress/house-bill/34.

2. Delbanco T et al. Ann Intern Med. 2012 Oct;157(7):461-70.

3. Bell S et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

4. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

5. DesRoches C et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Blease C et al. J Med Ethics. 2021 May. doi: 10.1136/medethics-2021-107275.

7. DesRoches C et al. Ann Intern Med. 2019 Jul 2;171(1):69-71.


 

“Of all the forms of inequality, injustice in health is the most shocking and inhuman.” – Martin Luther King Jr., March 25, 1966. ¹

This single disparity – health care injustice – too often results in needless mental anguish, physical suffering, or death. In the spring of 2020, at the peak of the COVID-19 pandemic, the convergence of injustices in health care and policing led to the disproportionate preventable physical deaths of Black men and women. This became the watershed moment for 11 gastroenterologists and hepatologists who collectively grieved but heeded the call of social responsibility to form the Association of Black Gastroenterologists and Hepatologists.

The mission of ABGH is laser focused. It is to promote health equity in Black communities, advance science, and develop the careers of Black gastroenterologists, hepatologists, and scientists. The vision is to improve gastrointestinal health outcomes in Black communities; to develop the pipeline of Black gastroenterologists and hepatologists given that currently only 4% in the United States identify as Black; to foster networking, mentoring, and sponsorship among Black students, clinical trainees, gastroenterologists, and hepatologists; and to promote the scholarship of Black gastroenterologists and hepatologists.

Through community engagement, ABGH stands to empower the Black community with knowledge and choices, which inherently strengthens the physician-patient relationship. ABGH also exists to implement positive change in long term outcome statistics in Black communities. Black Americans are 20% more likely to be diagnosed with colorectal cancer and 40% more likely to die from the disease. In addition to colorectal cancer, rates of esophageal squamous cancer, as well as cancer of the small bowel and pancreas, are highest in Black people.² Through scientific research and clinical care, we aim to eradicate digestive health disparities. 

Yet in this space, we know first-hand that, in the United States, the wellness of a community is not measured by the medical fitness of its members alone but also by the availability of equitable opportunities for fulfillment of nonmedical but health-impacting social needs. These needs, also known as social determinants of health, are made inaccessible to vulnerable populations because of systemic racism. Importantly, we recognize that dismantling racist systems is not a singular effort, nor are we pioneers in this work, but we look forward to executing health equity goals collaboratively with our fellow gastrointestinal national societies and other leading community and grassroots organizations.

The founders of ABGH are a distinctive group of practicing gastroenterologists and hepatologists from across the United States with a strong track record in DEI work through their community, clinical, and research activities. The board of directors reflects only the depth of talent shared throughout the ABGH membership. The strength of the organization lies in its diverse and energetic constituents who all exemplify outstanding training and the readiness to redefine the standard of health care delivery to the Black community. From medical students to senior level gastroenterologists, we collectively embody a considerable momentum for formation of this organization at this point in our history.

ABGH fulfills a professional career development need for budding gastroenterologists not so readily available from other organizations. The compelling impact of representing the embodiment of what many of us were told we could not become is limitless. The personal and professional growth enabled by our networking and learning from each other is both motivating and empowering since, even after overcoming the obstacles needed to become a medical provider, Black professionals are often not afforded the bandwidth, range of emotion, and protection to reveal their specific needs. For this author personally, the ABGH provides a psychological safety that allows authentic self-identity without code-switching.³ Through this authenticity has arisen formidable strength, creativity, and productivity. The leadership and innovation cultivated in ABGH stands to benefit many generations to come, both within and outside the organization. 
 

Reflections from a junior member of ABGH: Dr. Kafayat Busari

My desire to pursue gastroenterology was bolstered by determination, curiosity, and passion, yet ironically was often met with skepticism by many in position to help advance this goal. Although projections of incertitude on members of a community that are often made to feel inadequate can diminish even the brightest of lights, conversely it can fuel the creation of an organization emboldened to specifically address GI-related health disparities. When I was a second-year internal medicine resident, I encountered a GI physician who told me GI “wasn’t something I wanted to do”—despite me expressing my interest.

Confused by the statement, I reached out to Renee L. Williams, MD, of NYU Langone Health, who I had met during my medical school training. She suggested I join a conference call later that week. On that call and the many that took place thereafter, I was introduced to Black gastroenterologists who are luminal disease experts, chair members, journal editors, transplant hepatologists, interventional endoscopists, researchers, and professors (in other words, GI professional leaders). My time on the initial call lasted perhaps less than 20 minutes, but the impact has been immeasurable. 

I was provided the emotional reassurance that GI was indeed for me and told “there’s always a seat, and if it feels like there’s not, we just need to get more chairs.” Little did I know, but those metaphorical chairs were being gathered so that I and other aspiring gastroenterologists will be able to sit comfortably at these tables one day. I was witnessing these GI professional leaders set in motion the beginning of what will undoubtedly be a pivotal component in the way I approach my career as a gastroenterologist. The experience reignited my mental determination to one day attain the level of success represented by the ABGH board members and to persevere in my quest to help redefine how Black medical students and residents serve their communities as physicians.

The creation of the ABGH could not have come at a better time in my training. In the wake of recent public protests for equity of African Americans within every institution (academia, housing, banks, policing, health care, and beyond), which were fundamentally built on racism, being a junior member of ABGH has not only given me a platform to speak my truth but has also provided me with tools to help others do so as well. As someone very passionate about research, primarily in colorectal cancer, I have been given an opportunity to connect with a dream team of mentors who have taken research ideas to new levels and have challenged me to dig deeper and expand my curiosity to investigate what still needs to be uncovered. It has created opportunity after opportunity for actively building relationships, leading to meaningful collaborations and the sharing of innovative ideas and discoveries. 

It is important to emphasize that ABGH is not an organization wanting to exclude themselves on the basis of ethnicity. ABGH is an example of how shared health goals within a medical discipline can be achieved when inclusion and equity is at the helm. ABGH led and represented events that raise awareness of diseases affecting all patients and aim to make the GI community more culturally competent. ABGH is future-oriented and embraces all members who align with the mission regardless of ethnicity, gender, orientation, or disability. The institution that is and will be the ABGH impresses upon me a feeling of excitement, gratitude, and humility. I look forward to continuing the mission created by the founding members and being to others what ABGH is to me. 

For more information on this organization, please visit blackingastro.org. 

Dr. Busari is a resident physician at Florida State University-SMH and a junior member of ABGH. Dr. Guillaume director of the Gastrointestinal Motility Center at Stony Brook (New York) University Hospital and an assistant professor of medicine at the Renaissance School of Medicine at Stony Brook University. They have no disclosures.
 

References 

1. Galarneau C. J Health Care Poor Underserved. 2018;29(1):5-8.

2. Ashktorab H et al. Gastroenterology. 2017 Oct;153(4):910-923.

3. Blanchard AK. N Engl J Med. 2021 Jun 10;384(23):e87.

“Of all the forms of inequality, injustice in health is the most shocking and inhuman.” – Martin Luther King Jr., March 25, 1966. ¹

This single disparity – health care injustice – too often results in needless mental anguish, physical suffering, or death. In the spring of 2020, at the peak of the COVID-19 pandemic, the convergence of injustices in health care and policing led to the disproportionate preventable physical deaths of Black men and women. This became the watershed moment for 11 gastroenterologists and hepatologists who collectively grieved but heeded the call of social responsibility to form the Association of Black Gastroenterologists and Hepatologists.

The mission of ABGH is laser focused. It is to promote health equity in Black communities, advance science, and develop the careers of Black gastroenterologists, hepatologists, and scientists. The vision is to improve gastrointestinal health outcomes in Black communities; to develop the pipeline of Black gastroenterologists and hepatologists given that currently only 4% in the United States identify as Black; to foster networking, mentoring, and sponsorship among Black students, clinical trainees, gastroenterologists, and hepatologists; and to promote the scholarship of Black gastroenterologists and hepatologists.

Through community engagement, ABGH stands to empower the Black community with knowledge and choices, which inherently strengthens the physician-patient relationship. ABGH also exists to implement positive change in long term outcome statistics in Black communities. Black Americans are 20% more likely to be diagnosed with colorectal cancer and 40% more likely to die from the disease. In addition to colorectal cancer, rates of esophageal squamous cancer, as well as cancer of the small bowel and pancreas, are highest in Black people.² Through scientific research and clinical care, we aim to eradicate digestive health disparities. 

Yet in this space, we know first-hand that, in the United States, the wellness of a community is not measured by the medical fitness of its members alone but also by the availability of equitable opportunities for fulfillment of nonmedical but health-impacting social needs. These needs, also known as social determinants of health, are made inaccessible to vulnerable populations because of systemic racism. Importantly, we recognize that dismantling racist systems is not a singular effort, nor are we pioneers in this work, but we look forward to executing health equity goals collaboratively with our fellow gastrointestinal national societies and other leading community and grassroots organizations.

The founders of ABGH are a distinctive group of practicing gastroenterologists and hepatologists from across the United States with a strong track record in DEI work through their community, clinical, and research activities. The board of directors reflects only the depth of talent shared throughout the ABGH membership. The strength of the organization lies in its diverse and energetic constituents who all exemplify outstanding training and the readiness to redefine the standard of health care delivery to the Black community. From medical students to senior level gastroenterologists, we collectively embody a considerable momentum for formation of this organization at this point in our history.

ABGH fulfills a professional career development need for budding gastroenterologists not so readily available from other organizations. The compelling impact of representing the embodiment of what many of us were told we could not become is limitless. The personal and professional growth enabled by our networking and learning from each other is both motivating and empowering since, even after overcoming the obstacles needed to become a medical provider, Black professionals are often not afforded the bandwidth, range of emotion, and protection to reveal their specific needs. For this author personally, the ABGH provides a psychological safety that allows authentic self-identity without code-switching.³ Through this authenticity has arisen formidable strength, creativity, and productivity. The leadership and innovation cultivated in ABGH stands to benefit many generations to come, both within and outside the organization. 
 

Reflections from a junior member of ABGH: Dr. Kafayat Busari

My desire to pursue gastroenterology was bolstered by determination, curiosity, and passion, yet ironically was often met with skepticism by many in position to help advance this goal. Although projections of incertitude on members of a community that are often made to feel inadequate can diminish even the brightest of lights, conversely it can fuel the creation of an organization emboldened to specifically address GI-related health disparities. When I was a second-year internal medicine resident, I encountered a GI physician who told me GI “wasn’t something I wanted to do”—despite me expressing my interest.

Confused by the statement, I reached out to Renee L. Williams, MD, of NYU Langone Health, who I had met during my medical school training. She suggested I join a conference call later that week. On that call and the many that took place thereafter, I was introduced to Black gastroenterologists who are luminal disease experts, chair members, journal editors, transplant hepatologists, interventional endoscopists, researchers, and professors (in other words, GI professional leaders). My time on the initial call lasted perhaps less than 20 minutes, but the impact has been immeasurable. 

I was provided the emotional reassurance that GI was indeed for me and told “there’s always a seat, and if it feels like there’s not, we just need to get more chairs.” Little did I know, but those metaphorical chairs were being gathered so that I and other aspiring gastroenterologists will be able to sit comfortably at these tables one day. I was witnessing these GI professional leaders set in motion the beginning of what will undoubtedly be a pivotal component in the way I approach my career as a gastroenterologist. The experience reignited my mental determination to one day attain the level of success represented by the ABGH board members and to persevere in my quest to help redefine how Black medical students and residents serve their communities as physicians.

The creation of the ABGH could not have come at a better time in my training. In the wake of recent public protests for equity of African Americans within every institution (academia, housing, banks, policing, health care, and beyond), which were fundamentally built on racism, being a junior member of ABGH has not only given me a platform to speak my truth but has also provided me with tools to help others do so as well. As someone very passionate about research, primarily in colorectal cancer, I have been given an opportunity to connect with a dream team of mentors who have taken research ideas to new levels and have challenged me to dig deeper and expand my curiosity to investigate what still needs to be uncovered. It has created opportunity after opportunity for actively building relationships, leading to meaningful collaborations and the sharing of innovative ideas and discoveries. 

It is important to emphasize that ABGH is not an organization wanting to exclude themselves on the basis of ethnicity. ABGH is an example of how shared health goals within a medical discipline can be achieved when inclusion and equity is at the helm. ABGH led and represented events that raise awareness of diseases affecting all patients and aim to make the GI community more culturally competent. ABGH is future-oriented and embraces all members who align with the mission regardless of ethnicity, gender, orientation, or disability. The institution that is and will be the ABGH impresses upon me a feeling of excitement, gratitude, and humility. I look forward to continuing the mission created by the founding members and being to others what ABGH is to me. 

For more information on this organization, please visit blackingastro.org. 

Dr. Busari is a resident physician at Florida State University-SMH and a junior member of ABGH. Dr. Guillaume director of the Gastrointestinal Motility Center at Stony Brook (New York) University Hospital and an assistant professor of medicine at the Renaissance School of Medicine at Stony Brook University. They have no disclosures.
 

References 

1. Galarneau C. J Health Care Poor Underserved. 2018;29(1):5-8.

2. Ashktorab H et al. Gastroenterology. 2017 Oct;153(4):910-923.

3. Blanchard AK. N Engl J Med. 2021 Jun 10;384(23):e87.

“Of all the forms of inequality, injustice in health is the most shocking and inhuman.” – Martin Luther King Jr., March 25, 1966. ¹

This single disparity – health care injustice – too often results in needless mental anguish, physical suffering, or death. In the spring of 2020, at the peak of the COVID-19 pandemic, the convergence of injustices in health care and policing led to the disproportionate preventable physical deaths of Black men and women. This became the watershed moment for 11 gastroenterologists and hepatologists who collectively grieved but heeded the call of social responsibility to form the Association of Black Gastroenterologists and Hepatologists.

The mission of ABGH is laser focused. It is to promote health equity in Black communities, advance science, and develop the careers of Black gastroenterologists, hepatologists, and scientists. The vision is to improve gastrointestinal health outcomes in Black communities; to develop the pipeline of Black gastroenterologists and hepatologists given that currently only 4% in the United States identify as Black; to foster networking, mentoring, and sponsorship among Black students, clinical trainees, gastroenterologists, and hepatologists; and to promote the scholarship of Black gastroenterologists and hepatologists.

Through community engagement, ABGH stands to empower the Black community with knowledge and choices, which inherently strengthens the physician-patient relationship. ABGH also exists to implement positive change in long term outcome statistics in Black communities. Black Americans are 20% more likely to be diagnosed with colorectal cancer and 40% more likely to die from the disease. In addition to colorectal cancer, rates of esophageal squamous cancer, as well as cancer of the small bowel and pancreas, are highest in Black people.² Through scientific research and clinical care, we aim to eradicate digestive health disparities. 

Yet in this space, we know first-hand that, in the United States, the wellness of a community is not measured by the medical fitness of its members alone but also by the availability of equitable opportunities for fulfillment of nonmedical but health-impacting social needs. These needs, also known as social determinants of health, are made inaccessible to vulnerable populations because of systemic racism. Importantly, we recognize that dismantling racist systems is not a singular effort, nor are we pioneers in this work, but we look forward to executing health equity goals collaboratively with our fellow gastrointestinal national societies and other leading community and grassroots organizations.

The founders of ABGH are a distinctive group of practicing gastroenterologists and hepatologists from across the United States with a strong track record in DEI work through their community, clinical, and research activities. The board of directors reflects only the depth of talent shared throughout the ABGH membership. The strength of the organization lies in its diverse and energetic constituents who all exemplify outstanding training and the readiness to redefine the standard of health care delivery to the Black community. From medical students to senior level gastroenterologists, we collectively embody a considerable momentum for formation of this organization at this point in our history.

ABGH fulfills a professional career development need for budding gastroenterologists not so readily available from other organizations. The compelling impact of representing the embodiment of what many of us were told we could not become is limitless. The personal and professional growth enabled by our networking and learning from each other is both motivating and empowering since, even after overcoming the obstacles needed to become a medical provider, Black professionals are often not afforded the bandwidth, range of emotion, and protection to reveal their specific needs. For this author personally, the ABGH provides a psychological safety that allows authentic self-identity without code-switching.³ Through this authenticity has arisen formidable strength, creativity, and productivity. The leadership and innovation cultivated in ABGH stands to benefit many generations to come, both within and outside the organization. 
 

Reflections from a junior member of ABGH: Dr. Kafayat Busari

My desire to pursue gastroenterology was bolstered by determination, curiosity, and passion, yet ironically was often met with skepticism by many in position to help advance this goal. Although projections of incertitude on members of a community that are often made to feel inadequate can diminish even the brightest of lights, conversely it can fuel the creation of an organization emboldened to specifically address GI-related health disparities. When I was a second-year internal medicine resident, I encountered a GI physician who told me GI “wasn’t something I wanted to do”—despite me expressing my interest.

Confused by the statement, I reached out to Renee L. Williams, MD, of NYU Langone Health, who I had met during my medical school training. She suggested I join a conference call later that week. On that call and the many that took place thereafter, I was introduced to Black gastroenterologists who are luminal disease experts, chair members, journal editors, transplant hepatologists, interventional endoscopists, researchers, and professors (in other words, GI professional leaders). My time on the initial call lasted perhaps less than 20 minutes, but the impact has been immeasurable. 

I was provided the emotional reassurance that GI was indeed for me and told “there’s always a seat, and if it feels like there’s not, we just need to get more chairs.” Little did I know, but those metaphorical chairs were being gathered so that I and other aspiring gastroenterologists will be able to sit comfortably at these tables one day. I was witnessing these GI professional leaders set in motion the beginning of what will undoubtedly be a pivotal component in the way I approach my career as a gastroenterologist. The experience reignited my mental determination to one day attain the level of success represented by the ABGH board members and to persevere in my quest to help redefine how Black medical students and residents serve their communities as physicians.

The creation of the ABGH could not have come at a better time in my training. In the wake of recent public protests for equity of African Americans within every institution (academia, housing, banks, policing, health care, and beyond), which were fundamentally built on racism, being a junior member of ABGH has not only given me a platform to speak my truth but has also provided me with tools to help others do so as well. As someone very passionate about research, primarily in colorectal cancer, I have been given an opportunity to connect with a dream team of mentors who have taken research ideas to new levels and have challenged me to dig deeper and expand my curiosity to investigate what still needs to be uncovered. It has created opportunity after opportunity for actively building relationships, leading to meaningful collaborations and the sharing of innovative ideas and discoveries. 

It is important to emphasize that ABGH is not an organization wanting to exclude themselves on the basis of ethnicity. ABGH is an example of how shared health goals within a medical discipline can be achieved when inclusion and equity is at the helm. ABGH led and represented events that raise awareness of diseases affecting all patients and aim to make the GI community more culturally competent. ABGH is future-oriented and embraces all members who align with the mission regardless of ethnicity, gender, orientation, or disability. The institution that is and will be the ABGH impresses upon me a feeling of excitement, gratitude, and humility. I look forward to continuing the mission created by the founding members and being to others what ABGH is to me. 

For more information on this organization, please visit blackingastro.org. 

Dr. Busari is a resident physician at Florida State University-SMH and a junior member of ABGH. Dr. Guillaume director of the Gastrointestinal Motility Center at Stony Brook (New York) University Hospital and an assistant professor of medicine at the Renaissance School of Medicine at Stony Brook University. They have no disclosures.
 

References 

1. Galarneau C. J Health Care Poor Underserved. 2018;29(1):5-8.

2. Ashktorab H et al. Gastroenterology. 2017 Oct;153(4):910-923.

3. Blanchard AK. N Engl J Med. 2021 Jun 10;384(23):e87.

In December 2019, cases of pulmonary infection secondary to a novel coronavirus, known as severe acute respiratory syndrome coronavirus 2, were first identified in the city of Wuhan, China.

The clinical disease caused by the virus, COVID-19, has resulted in a worldwide pandemic that has portended significant morbidity and mortality throughout the United States. Three highly efficacious COVID-19 vaccines have received emergency use authorization (EUA) by the Food and Drug Administration to help prevent COVID-19, all of which are effective at preventing severe COVID-19.^1-3 The Pfizer vaccine was given full FDA approval on Aug. 23, 2021.⁴

Patients with inflammatory bowel disease (IBD) are commonly treated with immune-modifying therapies that may increase their risk for serious and opportunistic infections. As such, there was concern at the beginning of the pandemic that patients with IBD may be at increased risk of contracting COVID-19 and/or developing severe disease (that is, ICU-level care, mechanical ventilation, and/or death). There is evidence that the incidence of COVID-19 in the IBD population is similar to that of the general population.^5-7 Furthermore, most patients with IBD are not at increased risk of severe disease, including those on biologic therapies. Several studies demonstrated that those on corticosteroids are at increased risk of severe COVID-19, while those on other immune-modifying therapies such as tumor necrosis factor inhibitors (anti-TNFs) are not at increased risk.^5,7-10 Patients with IBD with other well-known risk factors for severe disease include comorbidities such as diabetes and obesity.

It is known that patients with IBD on certain immune-modifying therapies such as anti-TNFs, especially those on combination therapy, may have a blunted immune response to certain vaccines.¹¹ Neither patients with IBD nor patients on immunosuppressive therapy were included in phase 3 clinical trials for COVID-19 vaccine development, contributing to uncertainty regarding the safety and efficacy in our patient population. The risk of adverse events following COVID-19 vaccination in the IBD population has been found to be similar to that of the general population.¹² It has also been reported that those who have had reactions to injectable therapies in the past may safely be vaccinated against COVID-19.^13,14 With regard to vaccine efficacy, initial studies, including ICARUS, PREVENT-COVID, and CORALE-IBD, have demonstrated that patients with IBD do indeed mount a humoral immune response to the vaccine, including those on immune-modifying therapies.^15-17 Nonhumoral aspects of immunity, such as cell-mediated immunity, have not yet been thoroughly evaluated. In addition, the risk of breakthrough COVID-19 infection after vaccination is low in patients with IBD, including those on immune-modifying therapy.^14-18 While initial studies are reassuring that the vast majority of patients with IBD are able to mount a vaccine response, future studies are needed to determine the effects of immune-modifying therapy on sustained antibody concentrations and other correlates of immunity.

For those who received the Pfizer or Moderna vaccines, on Aug. 12, 2021, the FDA amended their EUA to allow for an additional dose in the initial vaccination series for certain immunocompromised individuals, specifically solid organ transplant recipients or those with conditions that make them equally immunocompromised.¹⁹ Based on evidence suggesting that certain solid organ transplant recipients do not mount an immune response after completing a two-dose series, the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention on how to use vaccines, recommended that moderate to severely immunocompromised individuals should complete a three-dose series, with the third dose being given at least 28 days after the second dose.²⁰ This recommendation included those on high-dose corticosteroids defined as oral prednisone at least 20 mg/day, anti-TNFs and biosimilars, and antimetabolites such as azathioprine, mercaptopurine, and methotrexate.

It is worth noting that the role of the ACIP here was to consider the available evidence supporting the use of an additional dose and then make recommendations on which conditions may qualify; the ACIP was not able to provide recommendations for every disease state. At the time of writing this article, no recommendations have been made with regards to an additional dose of the Janssen vaccine. Likewise, in response to the ACIP recommendations, the Crohn’s & Colitis Foundation recommended an additional dose for patients with IBD on immune-modifying therapies.^21,22

Less than one week after the EUA amendment for an additional dose, the Department of Health & Human Services announced that booster shots would likely become available to the general population as early as the week of Sept. 20, 2021 and starting 8 months after an individual’s second dose.²³ Here, it is worth noting that an additional dose is distinct from a booster. An additional dose (or third dose here) refers to the initial vaccination series and is given when the standard schedule is thought to be insufficient in a certain patient population. In contrast, a booster dose is administered when the initial and sufficient immunity gained from a primary vaccination series has likely dissipated. The HHS acknowledged that boosters would likely be needed for those who received the Janssen vaccine but noted that further data and recommendations would be forthcoming.

To summarize, COVID-19 vaccines are safe and effective in the IBD population, and patients should be vaccinated at the earliest opportunity regardless of concurrent therapies. For those that received the Pfizer or Moderna vaccine, the ACIP recommended an additional dose in the initial vaccination series to be given at least 28 days after the second dose for those that are immunosuppressed. This recommendation was largely based off of transplant data. Reassuringly, the available data demonstrates a humoral immune response to a two-dose vaccination series in patients with IBD, including those on immune-modifying therapies. The Crohn’s & Colitis Foundation recommends that patients with IBD on immune-modifying therapy receive an additional dose (i.e., a three-dose series), which should be from the same manufacturer as the first two doses. In addition, at press time, HHS indicated that there will be a movement toward a booster dose for the general population in late September, which would also apply to patients with IBD. The ACIP has yet to comment on this change at the time of preparing this article, but the announcement indicated that a booster could be given “8 months after an individual’s second dose.” It is unclear how those who may receive a three-dose vaccination series will factor in, but it is possible that they would be eligible for a booster 8 months after their most recent dose. Gastroenterologists should also be aware that there is no role for serologic testing in the clinical setting because it has not been validated for such purposes and is primarily used in the research setting. Finally, it is paramount to emphasize that patients with IBD have historically had lower vaccination rates than the general population,²⁴ and we must take an active role in ensuring that our patients are immunized by addressing their concerns, communicating the risks of COVID-19 and the benefits of vaccination, providing information on how to get vaccinated, and strongly recommending vaccination.

• Patients with IBD should be vaccinated against COVID-19 regardless of concurrent therapies.
• Patients with IBD are not at increased risk of severe COVID-19.
• Patients with IBD, including those on immune-modifying therapies, mount a humoral immune response to the vaccine.
• Patients with IBD on immune-modifying therapies, who received either the Pfizer or Moderna vaccine, should receive a three-dose vaccination series, with the third dose at least 28 days after the second dose.
• Patients with IBD on biologic therapy can receive the third dose of the vaccine at any time point and should not interrupt biologic therapy.
• Boosters are likely to become available to the general public in September and would be given at least 8 months after an individual’s second dose.
• Recommendations regarding boosters for those who received a three-dose vaccination series are forthcoming.
• Recommendations regarding boosters and additional doses for those that received the Janssen vaccine are forthcoming.
• Gastroenterologists should take an active role in ensuring that their patients are vaccinated.

Dr. Schell is a second-year graduate student in the division of internal medicine at the University of Wisconsin–Madison. Dr. Caldera is an associate professor of medicine in the division of gastroenterology & hepatology at the University of Wisconsin–Madison. Dr. Schell has no conflicts of interest to disclose. Dr. Caldera has received research support from Takeda Pharmaceuticals and Sanofi. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene.

References

1. Sadoff J et al. N Engl J Med. 2021;384(23):2187-201.

2. Baden LR et al. N Engl J Med. 2021;384(5):403-16.

3. Polack FP et al. N Engl J Med. 2020;383:2603-15.

4. Johnson K et al. U.S. FDA aims to give full approval to Pfizer vaccine on Monday – NYT. Reuters. 2021 Aug 20. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-aims-give-full-nod-pfizers-covid-19-vaccine-monday-new-york-times-2021-08-20/.

5. Allocca M et al. J Clin Med. 2020 Oct;9(11):3533.

6. Monteleone G and Ardizzone S. J Crohns Colitis. 2020 Sep;14(9):1334-6.

7. Papa A et al. Am J Gastroenterol. 2020;115(10):1722-4.

8. Derikx LAAP et al. J Crohn’s Colitis. 2021 Apr 6;15(4):529-39.

9. Brenner EJ et al. Gastroenterology. 2020;159(2):481-91.

10. Ungaro RC et al. Gut. 2021;70(4):725-32.

11. Caldera F et al. Inflamm Bowel Dis. 2020;26(4):593-602.

12. Botwin GJ et al. Am J Gastroenterol. 2021. doi: 10.14309/ajg.0000000000001342.

13. Squire JD et al. Inflamm Bowel Dis. 2021 Jul 27;27(8):1358-60.

14. Hadi YB et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.014.

15. Wong S-Y et al. Gastroenterology. 2021;161:715-8.

16. Kappelman MD et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.016.

17. Pozdnyakova V et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.08.014.

18. Ben-Tov A et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.076.

19. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. FDA News Release. 2021. Accessed 2021 Aug 18. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised.

20. Centers for Disease Control and Prevention. COVID-19 Vaccines for Moderately to Severely Immunocompromised People. 2021. Accessed 2021 Aug 18. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

21. Allocca M et al. J Clin Med. 2020 Oct 31;9(11):3533.

22. Crohn’s & Colitis Foundation. COVID-19 Vaccines: Position Statements. IBD & Coronavirus. 2021. Accessed 2021 Aug 20. https://www.crohnscolitisfoundation.org/coronavirus/vaccine-position-statements.

23. Centers for Disease Control and Prevention. Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html.

24. Caldera F et al. Inflamm Bowel Dis. 2021;27(1):123-133.

In December 2019, cases of pulmonary infection secondary to a novel coronavirus, known as severe acute respiratory syndrome coronavirus 2, were first identified in the city of Wuhan, China.

The clinical disease caused by the virus, COVID-19, has resulted in a worldwide pandemic that has portended significant morbidity and mortality throughout the United States. Three highly efficacious COVID-19 vaccines have received emergency use authorization (EUA) by the Food and Drug Administration to help prevent COVID-19, all of which are effective at preventing severe COVID-19.^1-3 The Pfizer vaccine was given full FDA approval on Aug. 23, 2021.⁴

Patients with inflammatory bowel disease (IBD) are commonly treated with immune-modifying therapies that may increase their risk for serious and opportunistic infections. As such, there was concern at the beginning of the pandemic that patients with IBD may be at increased risk of contracting COVID-19 and/or developing severe disease (that is, ICU-level care, mechanical ventilation, and/or death). There is evidence that the incidence of COVID-19 in the IBD population is similar to that of the general population.^5-7 Furthermore, most patients with IBD are not at increased risk of severe disease, including those on biologic therapies. Several studies demonstrated that those on corticosteroids are at increased risk of severe COVID-19, while those on other immune-modifying therapies such as tumor necrosis factor inhibitors (anti-TNFs) are not at increased risk.^5,7-10 Patients with IBD with other well-known risk factors for severe disease include comorbidities such as diabetes and obesity.

It is known that patients with IBD on certain immune-modifying therapies such as anti-TNFs, especially those on combination therapy, may have a blunted immune response to certain vaccines.¹¹ Neither patients with IBD nor patients on immunosuppressive therapy were included in phase 3 clinical trials for COVID-19 vaccine development, contributing to uncertainty regarding the safety and efficacy in our patient population. The risk of adverse events following COVID-19 vaccination in the IBD population has been found to be similar to that of the general population.¹² It has also been reported that those who have had reactions to injectable therapies in the past may safely be vaccinated against COVID-19.^13,14 With regard to vaccine efficacy, initial studies, including ICARUS, PREVENT-COVID, and CORALE-IBD, have demonstrated that patients with IBD do indeed mount a humoral immune response to the vaccine, including those on immune-modifying therapies.^15-17 Nonhumoral aspects of immunity, such as cell-mediated immunity, have not yet been thoroughly evaluated. In addition, the risk of breakthrough COVID-19 infection after vaccination is low in patients with IBD, including those on immune-modifying therapy.^14-18 While initial studies are reassuring that the vast majority of patients with IBD are able to mount a vaccine response, future studies are needed to determine the effects of immune-modifying therapy on sustained antibody concentrations and other correlates of immunity.

For those who received the Pfizer or Moderna vaccines, on Aug. 12, 2021, the FDA amended their EUA to allow for an additional dose in the initial vaccination series for certain immunocompromised individuals, specifically solid organ transplant recipients or those with conditions that make them equally immunocompromised.¹⁹ Based on evidence suggesting that certain solid organ transplant recipients do not mount an immune response after completing a two-dose series, the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention on how to use vaccines, recommended that moderate to severely immunocompromised individuals should complete a three-dose series, with the third dose being given at least 28 days after the second dose.²⁰ This recommendation included those on high-dose corticosteroids defined as oral prednisone at least 20 mg/day, anti-TNFs and biosimilars, and antimetabolites such as azathioprine, mercaptopurine, and methotrexate.

It is worth noting that the role of the ACIP here was to consider the available evidence supporting the use of an additional dose and then make recommendations on which conditions may qualify; the ACIP was not able to provide recommendations for every disease state. At the time of writing this article, no recommendations have been made with regards to an additional dose of the Janssen vaccine. Likewise, in response to the ACIP recommendations, the Crohn’s & Colitis Foundation recommended an additional dose for patients with IBD on immune-modifying therapies.^21,22

Less than one week after the EUA amendment for an additional dose, the Department of Health & Human Services announced that booster shots would likely become available to the general population as early as the week of Sept. 20, 2021 and starting 8 months after an individual’s second dose.²³ Here, it is worth noting that an additional dose is distinct from a booster. An additional dose (or third dose here) refers to the initial vaccination series and is given when the standard schedule is thought to be insufficient in a certain patient population. In contrast, a booster dose is administered when the initial and sufficient immunity gained from a primary vaccination series has likely dissipated. The HHS acknowledged that boosters would likely be needed for those who received the Janssen vaccine but noted that further data and recommendations would be forthcoming.

To summarize, COVID-19 vaccines are safe and effective in the IBD population, and patients should be vaccinated at the earliest opportunity regardless of concurrent therapies. For those that received the Pfizer or Moderna vaccine, the ACIP recommended an additional dose in the initial vaccination series to be given at least 28 days after the second dose for those that are immunosuppressed. This recommendation was largely based off of transplant data. Reassuringly, the available data demonstrates a humoral immune response to a two-dose vaccination series in patients with IBD, including those on immune-modifying therapies. The Crohn’s & Colitis Foundation recommends that patients with IBD on immune-modifying therapy receive an additional dose (i.e., a three-dose series), which should be from the same manufacturer as the first two doses. In addition, at press time, HHS indicated that there will be a movement toward a booster dose for the general population in late September, which would also apply to patients with IBD. The ACIP has yet to comment on this change at the time of preparing this article, but the announcement indicated that a booster could be given “8 months after an individual’s second dose.” It is unclear how those who may receive a three-dose vaccination series will factor in, but it is possible that they would be eligible for a booster 8 months after their most recent dose. Gastroenterologists should also be aware that there is no role for serologic testing in the clinical setting because it has not been validated for such purposes and is primarily used in the research setting. Finally, it is paramount to emphasize that patients with IBD have historically had lower vaccination rates than the general population,²⁴ and we must take an active role in ensuring that our patients are immunized by addressing their concerns, communicating the risks of COVID-19 and the benefits of vaccination, providing information on how to get vaccinated, and strongly recommending vaccination.

• Patients with IBD should be vaccinated against COVID-19 regardless of concurrent therapies.
• Patients with IBD are not at increased risk of severe COVID-19.
• Patients with IBD, including those on immune-modifying therapies, mount a humoral immune response to the vaccine.
• Patients with IBD on immune-modifying therapies, who received either the Pfizer or Moderna vaccine, should receive a three-dose vaccination series, with the third dose at least 28 days after the second dose.
• Patients with IBD on biologic therapy can receive the third dose of the vaccine at any time point and should not interrupt biologic therapy.
• Boosters are likely to become available to the general public in September and would be given at least 8 months after an individual’s second dose.
• Recommendations regarding boosters for those who received a three-dose vaccination series are forthcoming.
• Recommendations regarding boosters and additional doses for those that received the Janssen vaccine are forthcoming.
• Gastroenterologists should take an active role in ensuring that their patients are vaccinated.

Dr. Schell is a second-year graduate student in the division of internal medicine at the University of Wisconsin–Madison. Dr. Caldera is an associate professor of medicine in the division of gastroenterology & hepatology at the University of Wisconsin–Madison. Dr. Schell has no conflicts of interest to disclose. Dr. Caldera has received research support from Takeda Pharmaceuticals and Sanofi. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene.

References

1. Sadoff J et al. N Engl J Med. 2021;384(23):2187-201.

2. Baden LR et al. N Engl J Med. 2021;384(5):403-16.

3. Polack FP et al. N Engl J Med. 2020;383:2603-15.

4. Johnson K et al. U.S. FDA aims to give full approval to Pfizer vaccine on Monday – NYT. Reuters. 2021 Aug 20. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-aims-give-full-nod-pfizers-covid-19-vaccine-monday-new-york-times-2021-08-20/.

5. Allocca M et al. J Clin Med. 2020 Oct;9(11):3533.

6. Monteleone G and Ardizzone S. J Crohns Colitis. 2020 Sep;14(9):1334-6.

7. Papa A et al. Am J Gastroenterol. 2020;115(10):1722-4.

8. Derikx LAAP et al. J Crohn’s Colitis. 2021 Apr 6;15(4):529-39.

9. Brenner EJ et al. Gastroenterology. 2020;159(2):481-91.

10. Ungaro RC et al. Gut. 2021;70(4):725-32.

11. Caldera F et al. Inflamm Bowel Dis. 2020;26(4):593-602.

12. Botwin GJ et al. Am J Gastroenterol. 2021. doi: 10.14309/ajg.0000000000001342.

13. Squire JD et al. Inflamm Bowel Dis. 2021 Jul 27;27(8):1358-60.

14. Hadi YB et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.014.

15. Wong S-Y et al. Gastroenterology. 2021;161:715-8.

16. Kappelman MD et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.016.

17. Pozdnyakova V et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.08.014.

18. Ben-Tov A et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.076.

19. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. FDA News Release. 2021. Accessed 2021 Aug 18. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised.

20. Centers for Disease Control and Prevention. COVID-19 Vaccines for Moderately to Severely Immunocompromised People. 2021. Accessed 2021 Aug 18. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

21. Allocca M et al. J Clin Med. 2020 Oct 31;9(11):3533.

22. Crohn’s & Colitis Foundation. COVID-19 Vaccines: Position Statements. IBD & Coronavirus. 2021. Accessed 2021 Aug 20. https://www.crohnscolitisfoundation.org/coronavirus/vaccine-position-statements.

23. Centers for Disease Control and Prevention. Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html.

24. Caldera F et al. Inflamm Bowel Dis. 2021;27(1):123-133.

In December 2019, cases of pulmonary infection secondary to a novel coronavirus, known as severe acute respiratory syndrome coronavirus 2, were first identified in the city of Wuhan, China.

The clinical disease caused by the virus, COVID-19, has resulted in a worldwide pandemic that has portended significant morbidity and mortality throughout the United States. Three highly efficacious COVID-19 vaccines have received emergency use authorization (EUA) by the Food and Drug Administration to help prevent COVID-19, all of which are effective at preventing severe COVID-19.^1-3 The Pfizer vaccine was given full FDA approval on Aug. 23, 2021.⁴

Patients with inflammatory bowel disease (IBD) are commonly treated with immune-modifying therapies that may increase their risk for serious and opportunistic infections. As such, there was concern at the beginning of the pandemic that patients with IBD may be at increased risk of contracting COVID-19 and/or developing severe disease (that is, ICU-level care, mechanical ventilation, and/or death). There is evidence that the incidence of COVID-19 in the IBD population is similar to that of the general population.^5-7 Furthermore, most patients with IBD are not at increased risk of severe disease, including those on biologic therapies. Several studies demonstrated that those on corticosteroids are at increased risk of severe COVID-19, while those on other immune-modifying therapies such as tumor necrosis factor inhibitors (anti-TNFs) are not at increased risk.^5,7-10 Patients with IBD with other well-known risk factors for severe disease include comorbidities such as diabetes and obesity.

It is known that patients with IBD on certain immune-modifying therapies such as anti-TNFs, especially those on combination therapy, may have a blunted immune response to certain vaccines.¹¹ Neither patients with IBD nor patients on immunosuppressive therapy were included in phase 3 clinical trials for COVID-19 vaccine development, contributing to uncertainty regarding the safety and efficacy in our patient population. The risk of adverse events following COVID-19 vaccination in the IBD population has been found to be similar to that of the general population.¹² It has also been reported that those who have had reactions to injectable therapies in the past may safely be vaccinated against COVID-19.^13,14 With regard to vaccine efficacy, initial studies, including ICARUS, PREVENT-COVID, and CORALE-IBD, have demonstrated that patients with IBD do indeed mount a humoral immune response to the vaccine, including those on immune-modifying therapies.^15-17 Nonhumoral aspects of immunity, such as cell-mediated immunity, have not yet been thoroughly evaluated. In addition, the risk of breakthrough COVID-19 infection after vaccination is low in patients with IBD, including those on immune-modifying therapy.^14-18 While initial studies are reassuring that the vast majority of patients with IBD are able to mount a vaccine response, future studies are needed to determine the effects of immune-modifying therapy on sustained antibody concentrations and other correlates of immunity.

For those who received the Pfizer or Moderna vaccines, on Aug. 12, 2021, the FDA amended their EUA to allow for an additional dose in the initial vaccination series for certain immunocompromised individuals, specifically solid organ transplant recipients or those with conditions that make them equally immunocompromised.¹⁹ Based on evidence suggesting that certain solid organ transplant recipients do not mount an immune response after completing a two-dose series, the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention on how to use vaccines, recommended that moderate to severely immunocompromised individuals should complete a three-dose series, with the third dose being given at least 28 days after the second dose.²⁰ This recommendation included those on high-dose corticosteroids defined as oral prednisone at least 20 mg/day, anti-TNFs and biosimilars, and antimetabolites such as azathioprine, mercaptopurine, and methotrexate.

It is worth noting that the role of the ACIP here was to consider the available evidence supporting the use of an additional dose and then make recommendations on which conditions may qualify; the ACIP was not able to provide recommendations for every disease state. At the time of writing this article, no recommendations have been made with regards to an additional dose of the Janssen vaccine. Likewise, in response to the ACIP recommendations, the Crohn’s & Colitis Foundation recommended an additional dose for patients with IBD on immune-modifying therapies.^21,22

Less than one week after the EUA amendment for an additional dose, the Department of Health & Human Services announced that booster shots would likely become available to the general population as early as the week of Sept. 20, 2021 and starting 8 months after an individual’s second dose.²³ Here, it is worth noting that an additional dose is distinct from a booster. An additional dose (or third dose here) refers to the initial vaccination series and is given when the standard schedule is thought to be insufficient in a certain patient population. In contrast, a booster dose is administered when the initial and sufficient immunity gained from a primary vaccination series has likely dissipated. The HHS acknowledged that boosters would likely be needed for those who received the Janssen vaccine but noted that further data and recommendations would be forthcoming.

To summarize, COVID-19 vaccines are safe and effective in the IBD population, and patients should be vaccinated at the earliest opportunity regardless of concurrent therapies. For those that received the Pfizer or Moderna vaccine, the ACIP recommended an additional dose in the initial vaccination series to be given at least 28 days after the second dose for those that are immunosuppressed. This recommendation was largely based off of transplant data. Reassuringly, the available data demonstrates a humoral immune response to a two-dose vaccination series in patients with IBD, including those on immune-modifying therapies. The Crohn’s & Colitis Foundation recommends that patients with IBD on immune-modifying therapy receive an additional dose (i.e., a three-dose series), which should be from the same manufacturer as the first two doses. In addition, at press time, HHS indicated that there will be a movement toward a booster dose for the general population in late September, which would also apply to patients with IBD. The ACIP has yet to comment on this change at the time of preparing this article, but the announcement indicated that a booster could be given “8 months after an individual’s second dose.” It is unclear how those who may receive a three-dose vaccination series will factor in, but it is possible that they would be eligible for a booster 8 months after their most recent dose. Gastroenterologists should also be aware that there is no role for serologic testing in the clinical setting because it has not been validated for such purposes and is primarily used in the research setting. Finally, it is paramount to emphasize that patients with IBD have historically had lower vaccination rates than the general population,²⁴ and we must take an active role in ensuring that our patients are immunized by addressing their concerns, communicating the risks of COVID-19 and the benefits of vaccination, providing information on how to get vaccinated, and strongly recommending vaccination.

• Patients with IBD should be vaccinated against COVID-19 regardless of concurrent therapies.
• Patients with IBD are not at increased risk of severe COVID-19.
• Patients with IBD, including those on immune-modifying therapies, mount a humoral immune response to the vaccine.
• Patients with IBD on immune-modifying therapies, who received either the Pfizer or Moderna vaccine, should receive a three-dose vaccination series, with the third dose at least 28 days after the second dose.
• Patients with IBD on biologic therapy can receive the third dose of the vaccine at any time point and should not interrupt biologic therapy.
• Boosters are likely to become available to the general public in September and would be given at least 8 months after an individual’s second dose.
• Recommendations regarding boosters for those who received a three-dose vaccination series are forthcoming.
• Recommendations regarding boosters and additional doses for those that received the Janssen vaccine are forthcoming.
• Gastroenterologists should take an active role in ensuring that their patients are vaccinated.

Dr. Schell is a second-year graduate student in the division of internal medicine at the University of Wisconsin–Madison. Dr. Caldera is an associate professor of medicine in the division of gastroenterology & hepatology at the University of Wisconsin–Madison. Dr. Schell has no conflicts of interest to disclose. Dr. Caldera has received research support from Takeda Pharmaceuticals and Sanofi. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene.

References

1. Sadoff J et al. N Engl J Med. 2021;384(23):2187-201.

2. Baden LR et al. N Engl J Med. 2021;384(5):403-16.

3. Polack FP et al. N Engl J Med. 2020;383:2603-15.

4. Johnson K et al. U.S. FDA aims to give full approval to Pfizer vaccine on Monday – NYT. Reuters. 2021 Aug 20. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-aims-give-full-nod-pfizers-covid-19-vaccine-monday-new-york-times-2021-08-20/.

5. Allocca M et al. J Clin Med. 2020 Oct;9(11):3533.

6. Monteleone G and Ardizzone S. J Crohns Colitis. 2020 Sep;14(9):1334-6.

7. Papa A et al. Am J Gastroenterol. 2020;115(10):1722-4.

8. Derikx LAAP et al. J Crohn’s Colitis. 2021 Apr 6;15(4):529-39.

9. Brenner EJ et al. Gastroenterology. 2020;159(2):481-91.

10. Ungaro RC et al. Gut. 2021;70(4):725-32.

11. Caldera F et al. Inflamm Bowel Dis. 2020;26(4):593-602.

12. Botwin GJ et al. Am J Gastroenterol. 2021. doi: 10.14309/ajg.0000000000001342.

13. Squire JD et al. Inflamm Bowel Dis. 2021 Jul 27;27(8):1358-60.

14. Hadi YB et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.014.

15. Wong S-Y et al. Gastroenterology. 2021;161:715-8.

16. Kappelman MD et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.016.

17. Pozdnyakova V et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.08.014.

18. Ben-Tov A et al. Gastroenterology. 2021. doi: 10.1053/j.gastro.2021.06.076.

19. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. FDA News Release. 2021. Accessed 2021 Aug 18. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised.

20. Centers for Disease Control and Prevention. COVID-19 Vaccines for Moderately to Severely Immunocompromised People. 2021. Accessed 2021 Aug 18. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

21. Allocca M et al. J Clin Med. 2020 Oct 31;9(11):3533.

22. Crohn’s & Colitis Foundation. COVID-19 Vaccines: Position Statements. IBD & Coronavirus. 2021. Accessed 2021 Aug 20. https://www.crohnscolitisfoundation.org/coronavirus/vaccine-position-statements.

23. Centers for Disease Control and Prevention. Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html.

24. Caldera F et al. Inflamm Bowel Dis. 2021;27(1):123-133.

In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”

This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).¹ The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.

Thus far, few patients have been informed about the new regulation.² By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Currently, the rule requires that physicians allow automatic access, without charge, to a patient’s own personal health information, including clinical notes, medication lists, laboratory results, and other diagnostic reports. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.

The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.

With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.

There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.³ Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”⁴ While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.

The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.³

In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.⁵ One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”³

In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).⁶ The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.

Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,⁴ this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.⁵

Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.⁵ Patients report that they understand and value the information provided to them in their medical records,⁷ and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.⁸

Importantly, open notes can increase patient engagement and patients’ trust in their physicians,⁹ thereby improving the doctor-patient relationship.³ And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.³ Additionally, it is predicted that open notes may, in fact, decrease legal liability.⁹ By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.¹⁰

The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.⁵ Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.

Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.

This article was updated Sept. 9, 2021.

References

1. Fed Regist. 2020 May;85(85):25642-961.

2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.

3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.

4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.

5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access

7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.

8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.

In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”

This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).¹ The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.

Thus far, few patients have been informed about the new regulation.² By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Currently, the rule requires that physicians allow automatic access, without charge, to a patient’s own personal health information, including clinical notes, medication lists, laboratory results, and other diagnostic reports. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.

The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.

With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.

There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.³ Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”⁴ While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.

The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.³

In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.⁵ One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”³

In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).⁶ The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.

Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,⁴ this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.⁵

Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.⁵ Patients report that they understand and value the information provided to them in their medical records,⁷ and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.⁸

Importantly, open notes can increase patient engagement and patients’ trust in their physicians,⁹ thereby improving the doctor-patient relationship.³ And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.³ Additionally, it is predicted that open notes may, in fact, decrease legal liability.⁹ By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.¹⁰

The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.⁵ Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.

Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.

This article was updated Sept. 9, 2021.

References

1. Fed Regist. 2020 May;85(85):25642-961.

2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.

3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.

4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.

5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access

7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.

8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.

In July, I had my annual physical with my primary care physician, whose practice is based out of a large urban academic medical center. As she concluded my visit and directed me to the lab to have my blood work done, she said, “You’ll be receiving an automatic notice from MyChart by 9 am tomorrow that your medical records from today’s visit are available. I apologize if I have not yet had the opportunity to review them and enter my note, but you’ll get access to all of that, as well, as soon as it is in the system.”

This sort of interaction is increasingly common across the United States as health care institutions implement policies and procedures to comply with new regulations promulgated by the Office of the National Coordinator for Health Information Technology (ONC), which went into effect on April 5, 2021. These rules were promulgated in accordance with the 21st Century Cures Act of 2016 (Cures Act).¹ The regulations, known as the Interoperability, Information Blocking, and the ONC Health IT Certification Program, implement provisions of the Cures Act intended to “support the access, exchange, and use of electronic health information.” The rule is considered a significant step in the “open notes” movement, which is intended to make health care more transparent by enabling patients to access their medical records. The drafters of the ONC regulations have carved out certain exceptions to the information blocking rule. For example, one exception allows some patient information to be withheld where making that information available might cause physical harm to the patient or another person.

Thus far, few patients have been informed about the new regulation.² By forbidding “information blocking,” the rule enables patients to more easily access and control their health information. Currently, the rule requires that physicians allow automatic access, without charge, to a patient’s own personal health information, including clinical notes, medication lists, laboratory results, and other diagnostic reports. Records must be provided “without delay,” or at least as soon as the physician’s office receives an electronic copy. In 2022, it will be required that access to even more of a patient’s personal electronic health record be provided in real-time through a patient portal and that electronic health information be shareable across third-party apps.

The Cures Act and the regulations governing its implementation highlight the inherent tension between two core principles of bioethical inquiry: autonomy and beneficence. The first principle, autonomy, champions allowing patient access and control over their own personal information. Beneficence, which is often expressed as paternalism, ensures that the experts are able to analyze and interpret data so that patients are in the best position to then make informed decisions.

With these principles in mind, arguments against open notes have generally fallen into three related categories. First, critics worry that immediate access to one’s medical record will increase patient anxiety caused by feelings of being inundated with complex medical information that patients may be ill-equipped to analyze and understand. This is a common refrain any time policies are implemented to improve medical information sharing. For example, critics of direct-to-consumer genetic testing caution that permitting unfettered access to complex information, particularly without an intermediary to interpret the data, could lead to confusion and poor medical choices.

There may be validity to this claim. One study found that 3% of patients reported feeling very confused when granted access to their medical notes.³ Another study concluded that direct release of medical test results “sometimes leads to unnecessary anxiety.”⁴ While the drafters of the ONC regulations have carved out certain exceptions to the information blocking rule, those exceptions do not allow for withholding of information because of concerns about patient anxiety or psychological harms.

The second common critique of open notes is that requiring release of all clinical notes will lead to clinician self-censorship, effectively muzzling or silencing the experts whose responsibility it is to objectively interpret results in order to provide the best care for their patients. Some have expressed concern that clinicians will be forced to “code” their records to avoid addressing “sensitive” subjects that might make patients feel offended or judged. This, in turn, might lead to less complete, reliable, or useful clinician communication.³

In fact, open notes has led to changes in the documentation process for some clinicians. They have reported modifying the way they document patient visits by changing their use of critical language and sensitive information.⁵ One study found that open notes led physicians to adjust “their language to avoid being perceived as critical of patients; omitting certain terms, such as ‘noncompliant’ and ‘patient denies’; and modifying how they document sensitive information.”³

In response, experts recommend focusing on precise and empathetic patient notes; in other words, the clinician should not write something in the note that they would not say directly to the patient. For example, they recommend that clinicians use precise language (for example, identifying the patient’s BMI) rather than using terms that could be offensive (for example, labeling the patient as “obese”).⁶ The shift to more empathetic note-taking could be seen less as a burden and more as a valuable tool in the shared decision-making endeavor: It could allow physicians to document both their clinical judgments and the patient’s values and preferences, which could lead to better medical decision-making.

Third, critics of open notes point to concerns about the burden it places on clinicians’ already limited time. The ONC rule requires automatic release of test results regardless of whether the clinician has had the opportunity to review them and offer their interpretation and insight. Because physician interpretation of results has known benefits,⁴ this puts additional pressure on clinicians to review results and enter notes in a timely manner. But physicians have reported that often open notes necessitates that they spend more time on documentation than they would otherwise.⁵

Despite critiques of open notes, the benefits of allowing patients access to their medical records have been repeatedly demonstrated. And research has shown that patients benefit from accessing open notes by allowing them to access and control their own personal medical information.⁵ Patients report that they understand and value the information provided to them in their medical records,⁷ and they feel empowered to participate in their medical decision-making. In surveys, patients report that reading their doctors’ notes is useful for taking care of their health and for remembering their care plans, understanding why a medication was prescribed, and reinforcing the need to take their medications and adhere to treatment plans.⁸

Importantly, open notes can increase patient engagement and patients’ trust in their physicians,⁹ thereby improving the doctor-patient relationship.³ And allowing patients to share their medical records with care partners enables supported decision-making, particularly for older and chronically ill individuals.³ Additionally, it is predicted that open notes may, in fact, decrease legal liability.⁹ By improving both trust in the doctor-patient relationship and safety, some experts expect that legal claims against clinicians will, in turn, decrease.¹⁰

The modern practice of medicine necessitates a more empathetic approach to clinical note-taking, even in the absence of regulation requiring it. As the regulations implementing the Cures Act roll out, patients will have easier, and more immediate, access to their medical records. Despite earlier hesitancy, clinicians are steadily beginning to support sharing access to notes with patients.⁵ Change can be hard. But the change expected of clinicians because of these new regulations appears to be less onerous than originally anticipated.

Prof. Koch is codirector of Health Law & Policy Institute and assistant professor at the University of Houston Law Center, as well as director of law and ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She has no disclosures.

This article was updated Sept. 9, 2021.

References

1. Fed Regist. 2020 May;85(85):25642-961.

2. The Petrie-Flom Center Staff. “New Rule Puts Medical Data in Patients’ Hands.” Bill of Health. July 12, 2021. Accessed August 30, 2021. https://blog.petrieflom.law.harvard.edu/2021/07/12/new-rule-puts-medical-data-in-patients-hands/.

3. Blease C et al. Ann Intern Med. 2021 Jan;174(1):101-2.

4. Pillemer F et al. PLoS One. 2016 Jun. doi: 10.1371/journal.pone.0154743.

5. DesRoches CM et al. JAMA Netw Open. 2020 Mar. doi: 10.1001/jamanetworkopen.2020.1753.

6. Heath S. “Most Patients Understand Clinical Notes, Patient Data Access.” Patient Engagement HIT. July 29, 2020. Accessed August 30, 2021. https://patientengagementhit.com/news/most-patients-understand-clinical-notes-patient-data-access

7. Leveille SG et al. J Gen Intern Med. 2020 Dec;35(12):3510-6.

8. Walker J et al. J Med Internet Res. 2019 May. doi: 10.2196/13876.

9. Bell SK et al. BMJ Qual Saf. 2017 Apr;26(4):262-70.

10. Kachalia A, Mello MM. N Engl J Med. 2011 Apr;364(16):1564-72.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

Due to broad social changes and efforts from leaders in GI, there is renewed interest in family planning and parental leave policies for GI trainees. The American Board of Medical Specialties now permits trainees a minimum of 6 weeks away during training, without automatically requiring an extension of training time or completely depleting vacation time, for boards eligibility.^1,2 However, national and institutional guidance for family planning and pregnancy during GI fellowship is lacking. How can gastroenterology fellowship programs support fellows taking parental leave and enact fair policies? We review the scope of the problem, describe our experience in developing resources within our GI fellowship program, and highlight areas that require further development.

The scope of the issue

There is no national data yet on the number of GI fellows that are parents prior to starting fellowship or who become parents during fellowship. We estimate that approximately 25% of fellows enter training as parents or become parents during fellowship, although 40%-50% may have an intention to have children.^3,4 Fellows may be worried that they will “fall behind” or be perceived as less committed if they devote time to childrearing or take parental leave.^5-7 Indeed, worries about discrimination based on pregnancy and parental leave are borne out by the experiences of older physicians (in particular, female physicians).^8,9

State- and institution-specific benefits vary from program to program. Nationally, the Family and Medical Leave Act provides only unpaid leave and applies only to trainees who have been employed for greater than 12 months.¹⁰ Benefits may not always be well advertised, and even when they are, trainees (and attendings) may feel uncomfortable taking full advantage. One survey of GIs revealed that, although two-thirds believed that 6-8 weeks of maternity leave was inadequate, half took less than that amount due to fears about financial and professional consequences.⁸

Pregnancy during GI fellowship is a special concern. GI fellowship consists of long work hours, includes night call, and can be physically demanding. All three of these factors have been associated with preterm delivery, infertility, and miscarriage.^11,12 In addition, there are no guidelines for ergonomic adjustments or infection precautions for pregnant endoscopists. We have compiled information about infection prevention guidance in pregnancy (available from the authors on request) derived from guidance from the National Institute for Occupational Safety and Health, which recommends the same precautions for pregnant health care workers as for nonpregnant health care workers.¹³ In regards to SARS-CoV-2, we believe that the decision to perform procedures on patients with COVID-19 infection should be individualized, although vaccinated endoscopists should be reassured by the exceedingly low rates of infection after vaccination and with appropriate personal protective equipment. Radiation is yet another concern. There are limited data on radiation dosages incurred by workers in the endoscopy suite and no pregnancy-specific data, which may lead trainees to avoid fluoroscopic procedures and unnecessarily double up on lead gowns.^8,11,14-17

Breastfeeding accommodations, and access to lactation rooms for trainees, are required by federal law for a minimum of 12 months.¹⁸ Should a trainee choose to breastfeed, education of staff and attendings is critical because many may be unaware of the specific needs pertaining to lactation. Staff should be aware that 30-45 minutes are needed to prepare, pump, and store milk. Trainees should not be solely responsible for educating their attendings and staff.
 

Our Experience in Creating a Policy

We developed a formal fellowship program policy on parental leave and pregnancy in the setting of a broader discussion about fellow workload and wellness. We agreed that trainees should be allowed to make changes to their schedule with co-fellows as needed for medical appointments or procedures and that our backup policy should be flexible enough to provide spot coverage for unexpected complications and family emergencies. We also incorporated a GI psychologist to provide wellness resources and suggestions for reducing burnout for our fellows.

We strove to follow certain principles in creating this policy. Trainees who are parents should have a comparable clinical experience to their nonparenting colleagues and should take the lead in rearranging their own schedule. Nonbirthing parents, adopting parents, and parents using surrogacy should be included in any parental leave policy. Fellowship leaders have an important responsibility in helping fellows proactively plan to meet requirements for graduation and maximize learning and exposure (Figure). We also recognized the importance of equitable coverage. For example, there is sometimes a perception that fellows with children “burden” fellows who are not parents.^3,19 On the other hand, fellows without children may feel that they are called on more than their colleagues with children to cover those with childcare issues. In addition, as a recent study of general surgery residency program directors indicates, there are complex interpersonal issues that play into a colleague’s willingness to provide coverage.²⁰ It behooves program leadership to be cognizant of group dynamics that might cause conflict over what should be a straightforward coverage situation.

We first researched national and societal guidelines if available, as well as our institution’s graduate medical education (GME) website. We categorized benefits by whether they were federal, state-mandated, or institutional. It is important to note that any concerns about trainee salaries should be discussed with one’s GME office to ensure the leave policy is in accordance with federal funding policies.²¹ We solicited experiences and advice from former and current fellows who had gone through, or were planning, pregnancy and parental leave. A few faculty members volunteered to serve as a resource for fellows; these “ambassadors” discussed their experiences during a lunchtime panel, as well as offered to provide one-on-one advice and participate in future panels. We also reached out to our infection control experts to review the literature and federal policies on infections of special consideration during pregnancy and endoscopy. As for radiation safety, given the importance of education and active monitoring, we offer the option of reaching out to our radiation safety officer for individualized counseling.²²

Based on these efforts, we drafted a written policy designed for pregnant fellows and fellows planning parental leave on expectations for the program and fellows, benefits, and advice, including childcare options, lactation room locations, and financial planning tips. We shared this document with fellows and incorporated feedback. As a “living document” it is subject to change and will be updated as needed (at least annually).
 

Additional planning considerations for fellows

Research childcare options (ideally 6 months or more before leave).

• Start to explore your institution’s resources for leave and childcare options (daycare waitlists may be greater than 1 year in some cities).

Inform your program director (4-5 months before leave).

• Consider informing your program director about pregnancy at the beginning of the second trimester.
• Discuss Accreditation Council for Graduate Medical Education requirements and scheduling responsibilities.
• Explicitly discuss whether you plan to graduate on time or extend fellowship.

Inform your colleagues and patients (at least 3-4 months before leave).

• If comfortable, consider getting advice from a co-fellow and/or faculty mentor parent to facilitate transition to parenthood.
• When you feel ready, begin trading rotations and calls with co-fellows. If you have a results inbox or pager, discuss who can help cover those during your leave.
• Inform research collaborators about your leave and make preparations to keep projects progressing during your leave.
• If you have “active” clinic patients, when appropriate, begin to inform them that you will be away and provide reassurance that a colleague will be covering you. Leave clear plans with contingencies for these patients in your last progress notes.

Complete institutional paperwork and map out facilities (at least 2-3 months before leave).

• Review your options for using time toward leave, including vacation, research, or Family and Medical Leave Act–provided leave (unpaid), and what paperwork you need to fill out.
• Contact your payroll and/or human resources office to inform them of birth/adoption.
• Research potential program parental benefits, such as dependent daycare and/or health care flexible spending accounts.
• If choosing to breastfeed, explore the lactation rooms that are closest to your workroom and endoscopy suite and determine how much time you will need to set aside for pumping.

Be prepared to make adjustments as needed.

• Endoscopy-heavy rotations may be more difficult in the third trimester of pregnancy.
• Make contingency plans for early or late delivery dates, as well as if you undergo a cesarean that requires additional recovery time.
• Consider scheduling elective rotations (research, clinic) toward the end of leave and for the first month of “return to work.”
• If you plan to join limited clinic or outpatient endoscopy blocks later in your leave, make early arrangements to work regularly with these attendings.

Conclusion

Trainee needs assessments in gastroenterology fellowship similar to those in other specialties should be performed, and are in fact underway.^19,23,24 There is a lack of data regarding the availability of fellowship program guidance and, specifically, adherence to required policies, and more data from program directors at a national level need to be collected.²⁰ We recommend that programs engage in identifying specific needs at their institutions with the goal of eventually sharing this knowledge with other programs. Gastroenterology society recommendations for performing endoscopy while pregnant, with regard to ergonomics, infection control, and radiation exposure, would be instrumental. GI fellowships should consolidate institutional knowledge and engage key stakeholders – including trainees, prior trainees, occupational safety experts, radiation safety offices, wellness experts, and GME – to create program-specific policies that are flexible but rigorous and generous but equitable.

Dr. Liu and Dr. Summa are gastroenterology fellows at Northwestern University, Chicago. Dr. Patel is an assistant professor of medicine and a gastroenterology fellowship assistant program director at Northwestern University, Chicago. Dr. Donnan and Dr. Guentner are assistant professors of medicine at Northwestern University. Dr. Kia is an assistant professor of medicine and the gastroenterology fellowship program director at Northwestern University. They have no conflicts of interest to disclose. The authors would like to thank Michelle Clermont, MD, and Maureen K. Bolon, MD, for their discussion and assistance during the drafting of this article.

References

1. Section on Medical Students, Residents, and Fellowship Trainees; Committee on Early Childhood. Pediatrics. 2013;131(2):387-90.

2. American Board of Medical Specialties. ABMS Announces Progressive Leave Policy for Residents and Fellows. July 13, 2020. Accessed May 1, 2021. https://www.abms.org/news-events/abms-announces-progressive-leave-policy-for-residents-and-fellows/.

3. Magudia K et al. J Grad Med Educ. 2020;12(2):162-7.

4. Blair JE et al. Acad Med. 2016;91(7):972-8.

5. Feld LD. Am J Gastroenterol. 2021;116(3):505-8.

6. Roubaud MS. Plast Reconstr Surg Glob Open. 2019. doi: 10.1097/GOX.0000000000002104.

7. Price J, Dunbar K. Gastrointest Endosc. 2009;69(1):121-3.

8. David YN et al. Gastrointest Endosc. 2020;91(6):AB75-AB76.

9. Webb AMB et al. Acad Med J Assoc Am Med Coll. 2019;94(11):1631-4.

10. Weinstein DF et al. N Engl J Med. 2019 Sep 12;381(11):995-7.

11. Anderson M, Goldman RH. JAMA Surg. 2020;155(3):243-9.

12. Palmer KT et al. Occup Environ Med. 2013;70(4):213-22.

13. Siegel JD et al; Healthcare Infection, Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). 2007. Last reviewed July 22, 2019. Accessed April 28, 2021. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html

14. David YN et al. Am J Gastroenterol. 2021;116(3):539-50.

15. Sethi S et al. Dig Dis Sci. 2019;64(9):2455-66.

16. Alzimami K et al. Gastroenterol Res Pract. 2013;2013:587574.

17. Hayashi S et al. World J Clin Cases. 2018;6(16):1087-93.

18. U.S. Department of Labor, Wage and Hour Division. “Frequently Asked Questions – Break Time for Nursing Mothers.” Accessed May 1, 2021. https://www.dol.gov/agencies/whd/nursing-mothers/faq.

19. Mwakyanjala EJ et al. J Am Heart Assoc. 2019. doi: 10.1161/JAHA.119.012137.

20. Castillo-Angeles M et al. JAMA Surg. 2021 Jul 1;156(7):647-53.

21. Prasad S et al. J Grad Med Educ. 2021 Jun;13(3):349-54.

22. Ho IKH et al. Am J Gastroenterol. 2014;109(8):1180-94.

23. Sherbaf FG et al. AJNR Am J Neuroradiol. 2020;41(8):1348-54.

24. Altieri MS et al. JAMA Surg. 2019;154(10):952-58.

AGA journals’ reach record-high Impact Factors

AGA is proud to announce that its journals have maintained their exceptional standing in the field of gastroenterology and hepatology, based on Impact Factor. The Impact Factor is a measure of the frequency with which articles published in the previous 2 years are cited and is commonly used to rank the significance of journals within their fields.

Gastroenterology, AGA’s flagship journal, received a record-high Impact Factor of 22.682, a substantial increase from its 2019 Impact Factor of 17.37. Gastroenterology maintains its position among an elite group of journals focused on publishing original research, spanning basic to clinical, in our field. Co–Editors in Chief (EICs) Richard M. Peek Jr., MD, and Douglas A. Corley, MD, PhD, remarked, “We would like to thank our entire board of editors and reviewers, as well as the incredible AGA editorial staff, for their exceptional work in this challenging pandemic year as we continue to publish articles and reviews of outstanding quality that are widely used by our readership. It is an honor to be part of such a remarkable team.”

Clinical Gastroenterology and Hepatology (CGH), AGA’s clinically focused journal, also reached a record high with an Impact Factor of 11.382, pulling ahead as the field’s top exclusively clinically oriented journal. This puts CGH at a rank of 8th among 92 journals in the field. Fasiha Kanwal, MD, MSHS, EIC of CGH, noted, “We are delighted that CGH remains in a strong position in the top 10 GI journals in terms of Impact Factor. On behalf of the CGH board of editors, I want to extend a warm and most heartfelt thanks to our authors, reviewers, and readers!  We would not have been able to achieve this milestone without your support, contributions, and the faith that you place in us.”

To round things out, Cellular and Molecular Gastroenterology and Hepatology (CMGH), AGA’s basic and translational open-access journal also reached a record high with an Impact Factor of 9.225, placing it 13th, and second among nonclinical journals in that topic area. EICs Klaus Kaestner, PhD, and Michael Pack, MD, stated, “As co-EICs of CMGH, we send congratulations to the journal’s board of editors, editorial board, reviewers, and superb editorial staff on this year’s Impact Factor. We are honored to work with these outstanding colleagues and to provide our readership with highly impactful and cutting-edge research and review articles.”

In its online announcement, AGA congratulates and thanks the boards of all three journals for their editorial leadership. We also thank our authors, readers, and reviewers for their continued support of AGA’s journals. We look forward to continuing to push the envelope in scientific publishing in the upcoming year.
 

AGA journals select new editorial fellows

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), Cellular and Molecular Gastroenterology and Hepatology (CMGH), and Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) recently selected the recipients of their editorial fellowships, which will run from July 2021 through June 2022. The AGA editorial fellowship program is in its 4th year. 

• Amisha Ahuja, MD (Gastroenterology)
• Helenie Kefalalkes, MD (Gastroenterology)
• Katherine Falloon, MD (CGH)
• Judy Trieu, MD, MPH (CGH)
• Lindsey Kennedy, PhD (CMGH)
• Vivian Ortiz, MD (CMGH)  
• Sagarika Satyavada, MD (TIGE)
• Eric Swei, MD (TIGE)

Gain perspectives, insights, and experience in diagnostic and therapeutic GI care

Accurately diagnosing and treating GI disorders such as irritable bowel syndrome, inflammatory bowel disease, or eosinophilic esophagitis are challenging for any health care practitioners. Why not be the advanced practice provider (APP) in your practice that others look to for providing the best course of action for patients? The all-virtual 2021 Principles of GI for the NP and PA, Aug. 14-15, 2021, explores these GI conditions in detail, as well as colorectal cancer and disorders of the liver and pancreas, to give you a foundation in which to provide superlative patient care.

The virtual format also offers a safe and affordable forum for learning from your home or office as the impact of the COVID-19 pandemic continues to be felt throughout 2021. You’ll also benefit from on-demand access for 2 years after the live course so you can reference and refresh what you learned.

Take the opportunity to refine your skills and improve your patient care outcomes. 
 

Honor your peers with an AGA Recognition Award

When you think about outstanding GI educators, clinicians, investigators, and mentors, who comes to mind?  

Share your appreciation by nominating your colleagues for a prestigious 2022 AGA Recognition Award! 

Make your nominee stand out by sharing specific examples of how they have devoted themselves to eradicating the world of digestive disease, demonstrated innovation in bettering our community, and made a lasting impact, all of which exemplifies an outstanding AGA member. 

Need some inspiration? Read about our 2021 winners before submitting your nomination. 

AGA journals’ reach record-high Impact Factors

AGA is proud to announce that its journals have maintained their exceptional standing in the field of gastroenterology and hepatology, based on Impact Factor. The Impact Factor is a measure of the frequency with which articles published in the previous 2 years are cited and is commonly used to rank the significance of journals within their fields.

Gastroenterology, AGA’s flagship journal, received a record-high Impact Factor of 22.682, a substantial increase from its 2019 Impact Factor of 17.37. Gastroenterology maintains its position among an elite group of journals focused on publishing original research, spanning basic to clinical, in our field. Co–Editors in Chief (EICs) Richard M. Peek Jr., MD, and Douglas A. Corley, MD, PhD, remarked, “We would like to thank our entire board of editors and reviewers, as well as the incredible AGA editorial staff, for their exceptional work in this challenging pandemic year as we continue to publish articles and reviews of outstanding quality that are widely used by our readership. It is an honor to be part of such a remarkable team.”

Clinical Gastroenterology and Hepatology (CGH), AGA’s clinically focused journal, also reached a record high with an Impact Factor of 11.382, pulling ahead as the field’s top exclusively clinically oriented journal. This puts CGH at a rank of 8th among 92 journals in the field. Fasiha Kanwal, MD, MSHS, EIC of CGH, noted, “We are delighted that CGH remains in a strong position in the top 10 GI journals in terms of Impact Factor. On behalf of the CGH board of editors, I want to extend a warm and most heartfelt thanks to our authors, reviewers, and readers!  We would not have been able to achieve this milestone without your support, contributions, and the faith that you place in us.”

To round things out, Cellular and Molecular Gastroenterology and Hepatology (CMGH), AGA’s basic and translational open-access journal also reached a record high with an Impact Factor of 9.225, placing it 13th, and second among nonclinical journals in that topic area. EICs Klaus Kaestner, PhD, and Michael Pack, MD, stated, “As co-EICs of CMGH, we send congratulations to the journal’s board of editors, editorial board, reviewers, and superb editorial staff on this year’s Impact Factor. We are honored to work with these outstanding colleagues and to provide our readership with highly impactful and cutting-edge research and review articles.”

In its online announcement, AGA congratulates and thanks the boards of all three journals for their editorial leadership. We also thank our authors, readers, and reviewers for their continued support of AGA’s journals. We look forward to continuing to push the envelope in scientific publishing in the upcoming year.
 

AGA journals select new editorial fellows

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), Cellular and Molecular Gastroenterology and Hepatology (CMGH), and Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) recently selected the recipients of their editorial fellowships, which will run from July 2021 through June 2022. The AGA editorial fellowship program is in its 4th year. 

• Amisha Ahuja, MD (Gastroenterology)
• Helenie Kefalalkes, MD (Gastroenterology)
• Katherine Falloon, MD (CGH)
• Judy Trieu, MD, MPH (CGH)
• Lindsey Kennedy, PhD (CMGH)
• Vivian Ortiz, MD (CMGH)  
• Sagarika Satyavada, MD (TIGE)
• Eric Swei, MD (TIGE)

Gain perspectives, insights, and experience in diagnostic and therapeutic GI care

Accurately diagnosing and treating GI disorders such as irritable bowel syndrome, inflammatory bowel disease, or eosinophilic esophagitis are challenging for any health care practitioners. Why not be the advanced practice provider (APP) in your practice that others look to for providing the best course of action for patients? The all-virtual 2021 Principles of GI for the NP and PA, Aug. 14-15, 2021, explores these GI conditions in detail, as well as colorectal cancer and disorders of the liver and pancreas, to give you a foundation in which to provide superlative patient care.

The virtual format also offers a safe and affordable forum for learning from your home or office as the impact of the COVID-19 pandemic continues to be felt throughout 2021. You’ll also benefit from on-demand access for 2 years after the live course so you can reference and refresh what you learned.

Take the opportunity to refine your skills and improve your patient care outcomes. 
 

Honor your peers with an AGA Recognition Award

When you think about outstanding GI educators, clinicians, investigators, and mentors, who comes to mind?  

Share your appreciation by nominating your colleagues for a prestigious 2022 AGA Recognition Award! 

Make your nominee stand out by sharing specific examples of how they have devoted themselves to eradicating the world of digestive disease, demonstrated innovation in bettering our community, and made a lasting impact, all of which exemplifies an outstanding AGA member. 

Need some inspiration? Read about our 2021 winners before submitting your nomination. 

AGA journals’ reach record-high Impact Factors

AGA is proud to announce that its journals have maintained their exceptional standing in the field of gastroenterology and hepatology, based on Impact Factor. The Impact Factor is a measure of the frequency with which articles published in the previous 2 years are cited and is commonly used to rank the significance of journals within their fields.

Gastroenterology, AGA’s flagship journal, received a record-high Impact Factor of 22.682, a substantial increase from its 2019 Impact Factor of 17.37. Gastroenterology maintains its position among an elite group of journals focused on publishing original research, spanning basic to clinical, in our field. Co–Editors in Chief (EICs) Richard M. Peek Jr., MD, and Douglas A. Corley, MD, PhD, remarked, “We would like to thank our entire board of editors and reviewers, as well as the incredible AGA editorial staff, for their exceptional work in this challenging pandemic year as we continue to publish articles and reviews of outstanding quality that are widely used by our readership. It is an honor to be part of such a remarkable team.”

Clinical Gastroenterology and Hepatology (CGH), AGA’s clinically focused journal, also reached a record high with an Impact Factor of 11.382, pulling ahead as the field’s top exclusively clinically oriented journal. This puts CGH at a rank of 8th among 92 journals in the field. Fasiha Kanwal, MD, MSHS, EIC of CGH, noted, “We are delighted that CGH remains in a strong position in the top 10 GI journals in terms of Impact Factor. On behalf of the CGH board of editors, I want to extend a warm and most heartfelt thanks to our authors, reviewers, and readers!  We would not have been able to achieve this milestone without your support, contributions, and the faith that you place in us.”

To round things out, Cellular and Molecular Gastroenterology and Hepatology (CMGH), AGA’s basic and translational open-access journal also reached a record high with an Impact Factor of 9.225, placing it 13th, and second among nonclinical journals in that topic area. EICs Klaus Kaestner, PhD, and Michael Pack, MD, stated, “As co-EICs of CMGH, we send congratulations to the journal’s board of editors, editorial board, reviewers, and superb editorial staff on this year’s Impact Factor. We are honored to work with these outstanding colleagues and to provide our readership with highly impactful and cutting-edge research and review articles.”

In its online announcement, AGA congratulates and thanks the boards of all three journals for their editorial leadership. We also thank our authors, readers, and reviewers for their continued support of AGA’s journals. We look forward to continuing to push the envelope in scientific publishing in the upcoming year.
 

AGA journals select new editorial fellows

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), Cellular and Molecular Gastroenterology and Hepatology (CMGH), and Techniques and Innovations in Gastrointestinal Endoscopy (TIGE) recently selected the recipients of their editorial fellowships, which will run from July 2021 through June 2022. The AGA editorial fellowship program is in its 4th year. 

• Amisha Ahuja, MD (Gastroenterology)
• Helenie Kefalalkes, MD (Gastroenterology)
• Katherine Falloon, MD (CGH)
• Judy Trieu, MD, MPH (CGH)
• Lindsey Kennedy, PhD (CMGH)
• Vivian Ortiz, MD (CMGH)  
• Sagarika Satyavada, MD (TIGE)
• Eric Swei, MD (TIGE)

Gain perspectives, insights, and experience in diagnostic and therapeutic GI care

Accurately diagnosing and treating GI disorders such as irritable bowel syndrome, inflammatory bowel disease, or eosinophilic esophagitis are challenging for any health care practitioners. Why not be the advanced practice provider (APP) in your practice that others look to for providing the best course of action for patients? The all-virtual 2021 Principles of GI for the NP and PA, Aug. 14-15, 2021, explores these GI conditions in detail, as well as colorectal cancer and disorders of the liver and pancreas, to give you a foundation in which to provide superlative patient care.

The virtual format also offers a safe and affordable forum for learning from your home or office as the impact of the COVID-19 pandemic continues to be felt throughout 2021. You’ll also benefit from on-demand access for 2 years after the live course so you can reference and refresh what you learned.

Take the opportunity to refine your skills and improve your patient care outcomes. 
 

Honor your peers with an AGA Recognition Award

When you think about outstanding GI educators, clinicians, investigators, and mentors, who comes to mind?  

Share your appreciation by nominating your colleagues for a prestigious 2022 AGA Recognition Award! 

Make your nominee stand out by sharing specific examples of how they have devoted themselves to eradicating the world of digestive disease, demonstrated innovation in bettering our community, and made a lasting impact, all of which exemplifies an outstanding AGA member. 

Need some inspiration? Read about our 2021 winners before submitting your nomination. 

Dear colleagues,

I’m thrilled to introduce the August edition of The New Gastroenterologist, which features an excellent line-up of articles! Summer has been in full swing, and gradually, we eased into aspects of our prepandemic routine. The fear, caution, and isolation that characterized the last year and a half was less pervasive, and the ability to reconnect in person felt both refreshing and liberating. While new threats of variants and rising infection rates have emerged, there is hope that, with the availability of vaccines, the worst of the pandemic may still be behind us.

One of the most difficult aspects of treating patients with inflammatory bowel disease is acute pain management. Dr. Jami Kinnucan and Dr. Mehwish Ahmed (University of Michigan) outline an expert approach on differentiating between visceral and somatic pain and how to manage each accordingly.

The diagnosis of microscopic colitis can be elusive because colonic mucosa typically appears endoscopically normal and the pathognomonic findings are histologic. Management can also be challenging given the frequently relapsing and remitting nature of its clinical course. The “In Focus” feature for August, written by Dr. June Tome, Dr. Amrit Kamboj, and Dr. Darrell Pardi (Mayo Clinic), is an absolute must-read as it provides a detailed review on the diagnosis, management, and therapeutic options for microscopic colitis.

As gastroenterologists, we are often asked to place percutaneous endoscopic gastrostomy (PEG) tubes. This can be a difficult situation to navigate especially when the indication or timing of placement seems questionable. In our ethics case for this quarter, Dr. David Seres and Dr. Jane Cowan (Columbia University) unpack the ethical considerations of PEG tube placement in order to facilitate discharge to subacute nursing facilities.

Months in quarantine have incited many to crave larger living spaces, lending to a chaotic housing market. Jon Solitro (FinancialMD) offers sound financial advice for physicians interested purchasing a home – including factors to consider when choosing a home, how much to spend, and whether or not to consider a doctor’s loan.

Success in research can be particularly difficult for fellows and early career gastroenterologists as they juggle the many responsibilities inherent to busy training programs or adjust to independent practice. Dr. Dionne Rebello and Dr. Michelle Long (Boston University) compile a list of incredibly helpful tips on how to optimize productivity. For those interested in ways to harness experiences in clinical medicine into health technology, Dr. Simon Matthews (Johns Hopkins) discusses his role as chief medical officer in a health tech start-up in our postfellowship pathways section.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. George Dickstein (Greater Boston Gastroenterology), nicely summarizes lessons learned from the pandemic and how a practice can be adequately prepared for a post-pandemic surge of procedures.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Stay well,

Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

I’m thrilled to introduce the August edition of The New Gastroenterologist, which features an excellent line-up of articles! Summer has been in full swing, and gradually, we eased into aspects of our prepandemic routine. The fear, caution, and isolation that characterized the last year and a half was less pervasive, and the ability to reconnect in person felt both refreshing and liberating. While new threats of variants and rising infection rates have emerged, there is hope that, with the availability of vaccines, the worst of the pandemic may still be behind us.

One of the most difficult aspects of treating patients with inflammatory bowel disease is acute pain management. Dr. Jami Kinnucan and Dr. Mehwish Ahmed (University of Michigan) outline an expert approach on differentiating between visceral and somatic pain and how to manage each accordingly.

The diagnosis of microscopic colitis can be elusive because colonic mucosa typically appears endoscopically normal and the pathognomonic findings are histologic. Management can also be challenging given the frequently relapsing and remitting nature of its clinical course. The “In Focus” feature for August, written by Dr. June Tome, Dr. Amrit Kamboj, and Dr. Darrell Pardi (Mayo Clinic), is an absolute must-read as it provides a detailed review on the diagnosis, management, and therapeutic options for microscopic colitis.

As gastroenterologists, we are often asked to place percutaneous endoscopic gastrostomy (PEG) tubes. This can be a difficult situation to navigate especially when the indication or timing of placement seems questionable. In our ethics case for this quarter, Dr. David Seres and Dr. Jane Cowan (Columbia University) unpack the ethical considerations of PEG tube placement in order to facilitate discharge to subacute nursing facilities.

Months in quarantine have incited many to crave larger living spaces, lending to a chaotic housing market. Jon Solitro (FinancialMD) offers sound financial advice for physicians interested purchasing a home – including factors to consider when choosing a home, how much to spend, and whether or not to consider a doctor’s loan.

Success in research can be particularly difficult for fellows and early career gastroenterologists as they juggle the many responsibilities inherent to busy training programs or adjust to independent practice. Dr. Dionne Rebello and Dr. Michelle Long (Boston University) compile a list of incredibly helpful tips on how to optimize productivity. For those interested in ways to harness experiences in clinical medicine into health technology, Dr. Simon Matthews (Johns Hopkins) discusses his role as chief medical officer in a health tech start-up in our postfellowship pathways section.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. George Dickstein (Greater Boston Gastroenterology), nicely summarizes lessons learned from the pandemic and how a practice can be adequately prepared for a post-pandemic surge of procedures.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Stay well,

Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

I’m thrilled to introduce the August edition of The New Gastroenterologist, which features an excellent line-up of articles! Summer has been in full swing, and gradually, we eased into aspects of our prepandemic routine. The fear, caution, and isolation that characterized the last year and a half was less pervasive, and the ability to reconnect in person felt both refreshing and liberating. While new threats of variants and rising infection rates have emerged, there is hope that, with the availability of vaccines, the worst of the pandemic may still be behind us.

One of the most difficult aspects of treating patients with inflammatory bowel disease is acute pain management. Dr. Jami Kinnucan and Dr. Mehwish Ahmed (University of Michigan) outline an expert approach on differentiating between visceral and somatic pain and how to manage each accordingly.

The diagnosis of microscopic colitis can be elusive because colonic mucosa typically appears endoscopically normal and the pathognomonic findings are histologic. Management can also be challenging given the frequently relapsing and remitting nature of its clinical course. The “In Focus” feature for August, written by Dr. June Tome, Dr. Amrit Kamboj, and Dr. Darrell Pardi (Mayo Clinic), is an absolute must-read as it provides a detailed review on the diagnosis, management, and therapeutic options for microscopic colitis.

As gastroenterologists, we are often asked to place percutaneous endoscopic gastrostomy (PEG) tubes. This can be a difficult situation to navigate especially when the indication or timing of placement seems questionable. In our ethics case for this quarter, Dr. David Seres and Dr. Jane Cowan (Columbia University) unpack the ethical considerations of PEG tube placement in order to facilitate discharge to subacute nursing facilities.

Months in quarantine have incited many to crave larger living spaces, lending to a chaotic housing market. Jon Solitro (FinancialMD) offers sound financial advice for physicians interested purchasing a home – including factors to consider when choosing a home, how much to spend, and whether or not to consider a doctor’s loan.

Success in research can be particularly difficult for fellows and early career gastroenterologists as they juggle the many responsibilities inherent to busy training programs or adjust to independent practice. Dr. Dionne Rebello and Dr. Michelle Long (Boston University) compile a list of incredibly helpful tips on how to optimize productivity. For those interested in ways to harness experiences in clinical medicine into health technology, Dr. Simon Matthews (Johns Hopkins) discusses his role as chief medical officer in a health tech start-up in our postfellowship pathways section.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. George Dickstein (Greater Boston Gastroenterology), nicely summarizes lessons learned from the pandemic and how a practice can be adequately prepared for a post-pandemic surge of procedures.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Stay well,

Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Microscopic colitis is an inflammatory disease of the colon and a frequent cause of chronic or recurrent watery diarrhea, particularly in older persons. MC consists of two subtypes, collagenous colitis (CC) and lymphocytic colitis (LC). While the primary symptom is diarrhea, other signs and symptoms such as abdominal pain, weight loss, and dehydration or electrolyte abnormalities may also be present depending on disease severity.¹ In MC, the colonic mucosa usually appears normal on colonoscopy, and the diagnosis is made by histologic findings of intraepithelial lymphocytosis with (CC) or without (LC) a prominent subepithelial collagen band. The management approaches to CC and LC are similar and should be directed based on the severity of symptoms.² We review the epidemiology, risk factors, pathophysiology, diagnosis, and clinical management for this condition, as well as novel therapeutic approaches.

Epidemiology

Although the incidence of MC increased in the late twentieth century, more recently, it has stabilized with an estimated incidence varying from 1 to 25 per 100,000 person-years.^3-5 A recent meta-analysis revealed a pooled incidence of 4.85 per 100,000 persons for LC and 4.14 per 100,000 persons for CC.6 Proposed explanations for the rising incidence in the late twentieth century include improved clinical awareness of the disease, possible increased use of drugs associated with MC, and increased performance of diagnostic colonoscopies for chronic diarrhea. Since MC is now well-recognized, the recent plateau in incidence rates may reflect decreased detection bias.

The prevalence of MC ranges from 10%-20% in patients undergoing colonoscopy for chronic watery diarrhea.^6,7 The prevalence of LC is approximately 63.1 cases per 100,000 person-years and, for CC, is 49.2 cases per 100,000 person-years.^6-8 Recent studies have demonstrated increasing prevalence of MC likely resulting from an aging population.^9,10
 

Risk stratification

Female gender, increasing age, concomitant autoimmune disease, and the use of certain drugs, including NSAIDs, proton pump inhibitors (PPIs), statins, and selective serotonin reuptake inhibitors (SSRIs), have been associated with an increased risk of MC.^11,12 Autoimmune disorders, including celiac disease (CD), rheumatoid arthritis, hypothyroidism, and hyperthyroidism, are more common in patients with MC. The association with CD, in particular, is clinically important, as CD is associated with a 50-70 times greater risk of MC, and 2%-9% of patients with MC have CD.^13,14

Several medications have been associated with MC. In a British multicenter prospective study, MC was associated with the use of NSAIDs, PPIs, and SSRIs;¹⁵ however, recent studies have questioned the association of MC with some of these medications, which might worsen diarrhea but not actually cause MC.¹⁶

An additional risk factor for MC is smoking. A recent meta-analysis demonstrated that current and former smokers had an increased risk of MC (odds ratio, 2.99; 95% confidence interval, 2.15-4.15 and OR, 1.63; 95% CI, 1.37-1.94, respectively), compared with nonsmokers.¹⁷ Smokers develop MC at a younger age, and smoking is associated with increased disease severity and decreased likelihood of attaining remission.^18,19

Pathogenesis

The pathogenesis of MC remains largely unknown, although there are several hypotheses. The leading proposed mechanisms include reaction to luminal antigens, dysregulated collagen metabolism, genetic predisposition, autoimmunity, and bile acid malabsorption.

MC may be caused by abnormal epithelial barrier function, leading to increased permeability and reaction to luminal antigens, including dietary antigens, certain drugs, and bacterial products, ^20,21 which themselves lead to the immune dysregulation and intestinal inflammation seen in MC. This mechanism may explain the association of several drugs with MC. Histological changes resembling LC are reported in patients with CD who consume gluten; however, large population-based studies have not found specific dietary associations with the development of MC.²²

Another potential mechanism of MC is dysregulated collagen deposition. Collagen accumulation in the subepithelial layer in CC may result from increased levels of fibroblast growth factor, transforming growth factor–beta and vascular endothelial growth factor.²³ Nonetheless, studies have not found an association between the severity of diarrhea in patients with CC and the thickness of the subepithelial collagen band.

Thirdly, autoimmunity and genetic predisposition have been postulated in the pathogenesis of MC. As previously discussed, MC is associated with several autoimmune diseases and predominantly occurs in women, a distinctive feature of autoimmune disorders. Several studies have demonstrated an association between MC and HLA-DQ2 and -DQ3 haplotypes,²⁴ as well as potential polymorphisms in the serotonin transporter gene promoter.²⁵ It is important to note, however, that only a few familial cases of MC have been reported to date.²⁶

Lastly, bile acid malabsorption may play a role in the etiology of MC. Histologic findings of inflammation, along with villous atrophy and collagen deposition, have been reported in the ileum of patients with MC;^27,28 however, because patients with MC without bile acid malabsorption may also respond to bile acid binders such as cholestyramine, these findings unlikely to be the sole mechanism explaining the development of the disease.

Despite the different proposed mechanisms for the pathogenesis of MC, no definite conclusions can be drawn because of the limited size of these studies and their often conflicting results.

Vidyard Video

Clinical features

Clinicians should suspect MC in patients with chronic or recurrent watery diarrhea, particularly in older persons. Other risk factors include female gender, use of certain culprit medications, smoking, and presence of other autoimmune diseases. The clinical manifestations of MC subtypes LC and CC are similar with no significant clinical differences.^1,2 In addition to diarrhea, patients with MC may have abdominal pain, fatigue, and dehydration or electrolyte abnormalities depending on disease severity. Patients may also present with fecal urgency, incontinence, and nocturnal stools. Quality of life is often reduced in these patients, predominantly in those with severe or refractory symptoms.^29,30 The natural course of MC is highly variable, with some patients achieving spontaneous resolution after one episode and others developing chronic symptoms.

Diagnosis

The differential diagnosis of chronic watery diarrhea is broad and includes malabsorption/maldigestion, inflammatory bowel disease (IBD), irritable bowel syndrome, and medication side effects. In addition, although gastrointestinal infections typically cause acute or subacute diarrhea, some can present with chronic diarrhea. Malabsorption/maldigestion may occur because of CD, lactose intolerance, and pancreatic insufficiency, among other conditions. A thorough history, regarding recent antibiotic and medication use, travel, and immunosuppression, should be obtained in patients with chronic diarrhea. Additionally, laboratory and endoscopic evaluation with random biopsies of the colon can further help differentiate these diseases from MC. A few studies suggest fecal calprotectin may be used to differentiate MC from other noninflammatory conditions such as irritable bowel syndrome, as well as to monitor disease activity. This test is not expected to distinguish MC from other inflammatory causes of diarrhea, such as IBD, and therefore, its role in clinical practice is uncertain.³¹

 

 

The diagnosis of MC is made by biopsy of the colonic mucosa demonstrating characteristic pathologic features.³² Unlike in diseases such as Crohn’s disease or ulcerative colitis, the colon usually appears normal in MC, although mild nonspecific changes, such as erythema or edema, may be visualized. There is no consensus on the ideal location to obtain biopsies for MC or whether biopsies from both the left and the right colon are required.^2,33 The procedure of choice for the diagnosis of MC is colonoscopy with random biopsies taken throughout the colon. More limited evaluation by flexible sigmoidoscopy with biopsies may miss cases of MC as inflammation and collagen thickening are not necessarily uniform throughout the colon; however, in a patient that has undergone a recent colonoscopy for colon cancer screening without colon biopsies, a flexible sigmoidoscopy may be a reasonable next test for evaluation of MC, provided biopsies are obtained above the rectosigmoid colon.³⁴

Courtesy Dr. Catherine Hagen/Mayo Clinic

The MC subtypes are differentiated based on histology. The hallmark of LC is less than 20 intraepithelial lymphocytes per 100 surface epithelial cells (normal, less than 5) (Figure 1A). CC is characterized by a thickened subepithelial collagen band greater than 7-10 micrometers (normal, less than 5) (Figure 1B). For a subgroup of patients with milder abnormalities that do not meet these histological criteria, the terms “microscopic colitis, not otherwise specified” or “microscopic colitis, incomplete” may be used.³⁵ These patients often respond to standard treatments for MC. There is an additional subset of patients with biopsy demonstrating features of both CC and LC simultaneously, as well as patients transitioning from one MC subtype to another over time.^32,35

Courtesy Dr. Catherine Hagen/Mayo Clinic

 

Management approach

The first step in management of patients with MC includes stopping culprit medications if there is a temporal relationship between the initiation of the medication and the onset of diarrhea, as well as encouraging smoking cessation. These steps alone, however, are unlikely to achieve clinical remission in most patients. A stepwise pharmacological approach is used in the management of MC based on disease severity (Figure 2). For patients with mild symptoms, antidiarrheal medications, such as loperamide, may be helpful.³⁶ Long-term use of loperamide at therapeutic doses no greater than 16 mg daily appears to be safe if required to maintain symptom response. For those with persistent symptoms despite antidiarrheal medications, bismuth subsalicylate at three 262 mg tablets three times daily for 6-8 weeks can be considered. Long-term use of bismuth subsalicylate is not advised, especially at this dose, because of possible neurotoxicity.³⁷

For patients refractory to the above treatments or those with moderate-to-severe symptoms, an 8-week course of budesonide at 9 mg daily is the first-line treatment.³⁸ The dose was tapered before discontinuation in some studies but not in others. Both strategies appear effective. A recent meta-analysis of nine randomized trials demonstrated pooled ORs of 7.34 (95% CI, 4.08-13.19) and 8.35 (95% CI, 4.14-16.85) for response to budesonide induction and maintenance, respectively.³⁹

Cholestyramine is another medication considered in the management of MC and warrants further investigation. To date, no randomized clinical trials have been conducted to evaluate bile acid sequestrants in MC, but they should be considered before placing patients on immunosuppressive medications. Some providers use mesalamine in this setting, although mesalamine is inferior to budesonide in the induction of clinical remission in MC.⁴⁰

Despite high rates of response to budesonide, relapse after discontinuation is frequent (60%-80%), and time to relapse is variable^41,42 The American Gastroenterological Association recommends budesonide for maintenance of remission in patients with recurrence following discontinuation of induction therapy. The lowest effective dose that maintains resolution of symptoms should be prescribed, ideally at 6 mg daily or lower.³⁸ Although budesonide has a greater first-pass metabolism, compared with other glucocorticoids, patients should be monitored for possible side effects including hypertension, diabetes, and osteoporosis, as well as ophthalmologic disease, including cataracts and glaucoma.

For those who are intolerant to budesonide or have refractory symptoms, concomitant disorders such as CD that may be contributing to symptoms must be excluded. Immunosuppressive medications – such as thiopurines and biologic agents, including tumor necrosis factor–alpha inhibitors or vedolizumab – may be considered in refractory cases.^43,44 Of note, there are limited studies evaluating the use of these medications for MC. Lastly, surgeries including ileostomy with or without colectomy have been performed in the most severe cases for resistant disease that has failed numerous pharmacological therapies.⁴⁵

Patients should be counseled that, while symptoms from MC can be quite bothersome and disabling, there appears to be a normal life expectancy and no association between MC and colon cancer, unlike with other inflammatory conditions of the colon such as IBD.^46,47

 

 

Conclusion and future outlook

As a common cause of chronic watery diarrhea, MC will be commonly encountered in primary care and gastroenterology practices. The diagnosis should be suspected in patients presenting with chronic or recurrent watery diarrhea, especially with female gender, autoimmune disease, and increasing age. The management of MC requires an algorithmic approach directed by symptom severity, with a subgroup of patients requiring maintenance therapy for relapsing symptoms. The care of patients with MC will continue to evolve in the future. Further work is needed to explore long-term safety outcomes with budesonide and the role of immunomodulators and newer biologic agents for patients with complex, refractory disease.

Dr. Tome is with the department of internal medicine at the Mayo Clinic, Rochester, Minn. Dr. Kamboj, and Dr. Pardi are with the division of gastroenterology and hepatology at the Mayo Clinic. Dr. Pardi has grant funding from Pfizer, Vedanta, Seres, Finch, Applied Molecular Transport, and Takeda and has consulted for Vedanta and Otsuka. The other authors have no conflicts of interest to report.

References

1. Nyhlin N et al. Aliment Pharmacol Ther. 2014;39:963-72.

2. Miehlke S et al. United European Gastroenterol J. 2020;20-8.

3. Pardi DS et al. Gut. 2007;56:504-8.

4. Fernández-Bañares F et al. J Crohn’s Colitis.2016;10(7):805-11.

5. Gentile NM et al. Clin Gastroenterol Hepatol. 2014;12(5):838-42.

6. Tong J et al. Am J Gastroenterol. 2015;110:265-76.

7. Olesen M et al. Gut. 2004;53(3):346-50.

8. Bergman D et al. Aliment Pharmacol Ther. 2019;49(11):1395-400.

9. Guagnozzi D et al. Dig Liver Dis. 2012;44(5):384-8.

10. Münch A et al. J Crohns Colitis. 2012;6(9):932-45.

11. Macaigne G et al. Am J Gastroenterol. 2014; 09(9):1461-70.

12. Verhaegh BP et al. Aliment Pharmacol Ther. 2016;43(9):1004-13.

13. Stewart M et al. Aliment Pharmacol Ther. 2011;33(12):1340-9.

14. Green PHR et al. Clin Gastroenterol Hepatol. 2009;7(11):1210-6.

15. Masclee GM et al. Am J Gastroenterol. 2015;110:749-59.

16. Zylberberg H et al. Ailment Pharmacol Ther. 2021 Jun;53(11)1209-15.

17. Jaruvongvanich V et al. Inflamm Bowel Dis. 2019;25(4):672-8.

18. Fernández-Bañares F et al. Inflamm Bowel Dis. 2013; 19(7):1470-6.

19. Yen EF et al. Inflamm Bowel Dis. 2012;18(10):1835-41.

20. Barmeyer C et al. J Gastroenterol. 2017;52(10):1090-100.

21. Morgan DM et al. Clin Gastroenterol Hepatol. 2020;18(4):984-6.

22. Larsson JK et al. Eur J Clin Nutr. 2016;70:1309-17.

23. Madisch A et al.. Inflamm Bowel Dis. 2011;17(11):2295-8.

24. Stahl E et al. Gastroenterology. 2020;159(2):549-61.

25. Sikander A et al. Dig Dis Sci. 2015; 60:887-94.

26. Abdo AA et al. Can J Gastroenterol. 2001;15(5):341-3.

27. Fernandez-Bañares F et al. Dig Dis Sci.2001;46(10):2231-8.

28. Lyutakov I et al. Eur J Gastroenterol Hepatol. 2021;1;33(3):380-7.

29. Hjortswang H et al. Dig Liver Dis. 2011 Feb;43(2):102-9.

30. Cotter TG= et al. Gut. 2018;67(3):441-6.

31. Von Arnim U et al. Clin Exp Gastroenterol. 2016;9:97-103.

32. Langner C et al. Histopathology. 2015;66:613-26.

33. ASGE Standards of Practice Committee and Sharaf RN et al. Gastrointest Endosc. 2013;78:216-24.

34. Macaigne G et al. Clin Res Hepatol Gastroenterol. 2017;41(3):333-40.

35. Bjørnbak C et al. Aliment Pharmacol Ther. 2011;34(10):1225-34.

36. Pardi DS et al. Gastroenterology. 2016;150(1):247-74.

37. Masannat Y and Nazer E. West Virginia Med J. 2013;109(3):32-4.

38. Nguyen GC et al. Gastroenterology. 2016; 150(1):242-6.

39. Sebastian S et al. Eur J Gastroenterol Hepatol. 2019 Aug;31(8):919-27.

40. Miehlke S et al. Gastroenterology. 2014;146(5):1222-30.

41. Gentile NM et al. Am J Gastroenterol. 2013;108:256-9.

42. Münch A et al. Gut. 2016; 65(1):47-56.

43. Cotter TG et al. Aliment Pharmacol Ther. 2017; 46(2):169-74.

44. Esteve M et al. J Crohns Colitis. 2011;5(6):612-8.

45. Cottreau J et al. Clin J Gastroenterol. 2016;9:140-4.

46. Kamboj AK et al. Program No. P1876. ACG 2018 Annual Scientific Meeting Abstracts. Philadelphia, Pennsylvania: American College of Gastroenterology.

47. Yen EF et al. Dig Dis Sci. 2012;57:161-9.

Microscopic colitis is an inflammatory disease of the colon and a frequent cause of chronic or recurrent watery diarrhea, particularly in older persons. MC consists of two subtypes, collagenous colitis (CC) and lymphocytic colitis (LC). While the primary symptom is diarrhea, other signs and symptoms such as abdominal pain, weight loss, and dehydration or electrolyte abnormalities may also be present depending on disease severity.¹ In MC, the colonic mucosa usually appears normal on colonoscopy, and the diagnosis is made by histologic findings of intraepithelial lymphocytosis with (CC) or without (LC) a prominent subepithelial collagen band. The management approaches to CC and LC are similar and should be directed based on the severity of symptoms.² We review the epidemiology, risk factors, pathophysiology, diagnosis, and clinical management for this condition, as well as novel therapeutic approaches.

Epidemiology

Although the incidence of MC increased in the late twentieth century, more recently, it has stabilized with an estimated incidence varying from 1 to 25 per 100,000 person-years.^3-5 A recent meta-analysis revealed a pooled incidence of 4.85 per 100,000 persons for LC and 4.14 per 100,000 persons for CC.6 Proposed explanations for the rising incidence in the late twentieth century include improved clinical awareness of the disease, possible increased use of drugs associated with MC, and increased performance of diagnostic colonoscopies for chronic diarrhea. Since MC is now well-recognized, the recent plateau in incidence rates may reflect decreased detection bias.

The prevalence of MC ranges from 10%-20% in patients undergoing colonoscopy for chronic watery diarrhea.^6,7 The prevalence of LC is approximately 63.1 cases per 100,000 person-years and, for CC, is 49.2 cases per 100,000 person-years.^6-8 Recent studies have demonstrated increasing prevalence of MC likely resulting from an aging population.^9,10
 

Risk stratification

Female gender, increasing age, concomitant autoimmune disease, and the use of certain drugs, including NSAIDs, proton pump inhibitors (PPIs), statins, and selective serotonin reuptake inhibitors (SSRIs), have been associated with an increased risk of MC.^11,12 Autoimmune disorders, including celiac disease (CD), rheumatoid arthritis, hypothyroidism, and hyperthyroidism, are more common in patients with MC. The association with CD, in particular, is clinically important, as CD is associated with a 50-70 times greater risk of MC, and 2%-9% of patients with MC have CD.^13,14

Several medications have been associated with MC. In a British multicenter prospective study, MC was associated with the use of NSAIDs, PPIs, and SSRIs;¹⁵ however, recent studies have questioned the association of MC with some of these medications, which might worsen diarrhea but not actually cause MC.¹⁶

An additional risk factor for MC is smoking. A recent meta-analysis demonstrated that current and former smokers had an increased risk of MC (odds ratio, 2.99; 95% confidence interval, 2.15-4.15 and OR, 1.63; 95% CI, 1.37-1.94, respectively), compared with nonsmokers.¹⁷ Smokers develop MC at a younger age, and smoking is associated with increased disease severity and decreased likelihood of attaining remission.^18,19

Pathogenesis

The pathogenesis of MC remains largely unknown, although there are several hypotheses. The leading proposed mechanisms include reaction to luminal antigens, dysregulated collagen metabolism, genetic predisposition, autoimmunity, and bile acid malabsorption.

MC may be caused by abnormal epithelial barrier function, leading to increased permeability and reaction to luminal antigens, including dietary antigens, certain drugs, and bacterial products, ^20,21 which themselves lead to the immune dysregulation and intestinal inflammation seen in MC. This mechanism may explain the association of several drugs with MC. Histological changes resembling LC are reported in patients with CD who consume gluten; however, large population-based studies have not found specific dietary associations with the development of MC.²²

Another potential mechanism of MC is dysregulated collagen deposition. Collagen accumulation in the subepithelial layer in CC may result from increased levels of fibroblast growth factor, transforming growth factor–beta and vascular endothelial growth factor.²³ Nonetheless, studies have not found an association between the severity of diarrhea in patients with CC and the thickness of the subepithelial collagen band.

Thirdly, autoimmunity and genetic predisposition have been postulated in the pathogenesis of MC. As previously discussed, MC is associated with several autoimmune diseases and predominantly occurs in women, a distinctive feature of autoimmune disorders. Several studies have demonstrated an association between MC and HLA-DQ2 and -DQ3 haplotypes,²⁴ as well as potential polymorphisms in the serotonin transporter gene promoter.²⁵ It is important to note, however, that only a few familial cases of MC have been reported to date.²⁶

Lastly, bile acid malabsorption may play a role in the etiology of MC. Histologic findings of inflammation, along with villous atrophy and collagen deposition, have been reported in the ileum of patients with MC;^27,28 however, because patients with MC without bile acid malabsorption may also respond to bile acid binders such as cholestyramine, these findings unlikely to be the sole mechanism explaining the development of the disease.

Despite the different proposed mechanisms for the pathogenesis of MC, no definite conclusions can be drawn because of the limited size of these studies and their often conflicting results.

Vidyard Video

Clinical features

Clinicians should suspect MC in patients with chronic or recurrent watery diarrhea, particularly in older persons. Other risk factors include female gender, use of certain culprit medications, smoking, and presence of other autoimmune diseases. The clinical manifestations of MC subtypes LC and CC are similar with no significant clinical differences.^1,2 In addition to diarrhea, patients with MC may have abdominal pain, fatigue, and dehydration or electrolyte abnormalities depending on disease severity. Patients may also present with fecal urgency, incontinence, and nocturnal stools. Quality of life is often reduced in these patients, predominantly in those with severe or refractory symptoms.^29,30 The natural course of MC is highly variable, with some patients achieving spontaneous resolution after one episode and others developing chronic symptoms.

Diagnosis

The differential diagnosis of chronic watery diarrhea is broad and includes malabsorption/maldigestion, inflammatory bowel disease (IBD), irritable bowel syndrome, and medication side effects. In addition, although gastrointestinal infections typically cause acute or subacute diarrhea, some can present with chronic diarrhea. Malabsorption/maldigestion may occur because of CD, lactose intolerance, and pancreatic insufficiency, among other conditions. A thorough history, regarding recent antibiotic and medication use, travel, and immunosuppression, should be obtained in patients with chronic diarrhea. Additionally, laboratory and endoscopic evaluation with random biopsies of the colon can further help differentiate these diseases from MC. A few studies suggest fecal calprotectin may be used to differentiate MC from other noninflammatory conditions such as irritable bowel syndrome, as well as to monitor disease activity. This test is not expected to distinguish MC from other inflammatory causes of diarrhea, such as IBD, and therefore, its role in clinical practice is uncertain.³¹

 

 

The diagnosis of MC is made by biopsy of the colonic mucosa demonstrating characteristic pathologic features.³² Unlike in diseases such as Crohn’s disease or ulcerative colitis, the colon usually appears normal in MC, although mild nonspecific changes, such as erythema or edema, may be visualized. There is no consensus on the ideal location to obtain biopsies for MC or whether biopsies from both the left and the right colon are required.^2,33 The procedure of choice for the diagnosis of MC is colonoscopy with random biopsies taken throughout the colon. More limited evaluation by flexible sigmoidoscopy with biopsies may miss cases of MC as inflammation and collagen thickening are not necessarily uniform throughout the colon; however, in a patient that has undergone a recent colonoscopy for colon cancer screening without colon biopsies, a flexible sigmoidoscopy may be a reasonable next test for evaluation of MC, provided biopsies are obtained above the rectosigmoid colon.³⁴

Courtesy Dr. Catherine Hagen/Mayo Clinic

The MC subtypes are differentiated based on histology. The hallmark of LC is less than 20 intraepithelial lymphocytes per 100 surface epithelial cells (normal, less than 5) (Figure 1A). CC is characterized by a thickened subepithelial collagen band greater than 7-10 micrometers (normal, less than 5) (Figure 1B). For a subgroup of patients with milder abnormalities that do not meet these histological criteria, the terms “microscopic colitis, not otherwise specified” or “microscopic colitis, incomplete” may be used.³⁵ These patients often respond to standard treatments for MC. There is an additional subset of patients with biopsy demonstrating features of both CC and LC simultaneously, as well as patients transitioning from one MC subtype to another over time.^32,35

Courtesy Dr. Catherine Hagen/Mayo Clinic

 

Management approach

The first step in management of patients with MC includes stopping culprit medications if there is a temporal relationship between the initiation of the medication and the onset of diarrhea, as well as encouraging smoking cessation. These steps alone, however, are unlikely to achieve clinical remission in most patients. A stepwise pharmacological approach is used in the management of MC based on disease severity (Figure 2). For patients with mild symptoms, antidiarrheal medications, such as loperamide, may be helpful.³⁶ Long-term use of loperamide at therapeutic doses no greater than 16 mg daily appears to be safe if required to maintain symptom response. For those with persistent symptoms despite antidiarrheal medications, bismuth subsalicylate at three 262 mg tablets three times daily for 6-8 weeks can be considered. Long-term use of bismuth subsalicylate is not advised, especially at this dose, because of possible neurotoxicity.³⁷

For patients refractory to the above treatments or those with moderate-to-severe symptoms, an 8-week course of budesonide at 9 mg daily is the first-line treatment.³⁸ The dose was tapered before discontinuation in some studies but not in others. Both strategies appear effective. A recent meta-analysis of nine randomized trials demonstrated pooled ORs of 7.34 (95% CI, 4.08-13.19) and 8.35 (95% CI, 4.14-16.85) for response to budesonide induction and maintenance, respectively.³⁹

Cholestyramine is another medication considered in the management of MC and warrants further investigation. To date, no randomized clinical trials have been conducted to evaluate bile acid sequestrants in MC, but they should be considered before placing patients on immunosuppressive medications. Some providers use mesalamine in this setting, although mesalamine is inferior to budesonide in the induction of clinical remission in MC.⁴⁰

Despite high rates of response to budesonide, relapse after discontinuation is frequent (60%-80%), and time to relapse is variable^41,42 The American Gastroenterological Association recommends budesonide for maintenance of remission in patients with recurrence following discontinuation of induction therapy. The lowest effective dose that maintains resolution of symptoms should be prescribed, ideally at 6 mg daily or lower.³⁸ Although budesonide has a greater first-pass metabolism, compared with other glucocorticoids, patients should be monitored for possible side effects including hypertension, diabetes, and osteoporosis, as well as ophthalmologic disease, including cataracts and glaucoma.

For those who are intolerant to budesonide or have refractory symptoms, concomitant disorders such as CD that may be contributing to symptoms must be excluded. Immunosuppressive medications – such as thiopurines and biologic agents, including tumor necrosis factor–alpha inhibitors or vedolizumab – may be considered in refractory cases.^43,44 Of note, there are limited studies evaluating the use of these medications for MC. Lastly, surgeries including ileostomy with or without colectomy have been performed in the most severe cases for resistant disease that has failed numerous pharmacological therapies.⁴⁵

Patients should be counseled that, while symptoms from MC can be quite bothersome and disabling, there appears to be a normal life expectancy and no association between MC and colon cancer, unlike with other inflammatory conditions of the colon such as IBD.^46,47

 

 

Conclusion and future outlook

As a common cause of chronic watery diarrhea, MC will be commonly encountered in primary care and gastroenterology practices. The diagnosis should be suspected in patients presenting with chronic or recurrent watery diarrhea, especially with female gender, autoimmune disease, and increasing age. The management of MC requires an algorithmic approach directed by symptom severity, with a subgroup of patients requiring maintenance therapy for relapsing symptoms. The care of patients with MC will continue to evolve in the future. Further work is needed to explore long-term safety outcomes with budesonide and the role of immunomodulators and newer biologic agents for patients with complex, refractory disease.

Dr. Tome is with the department of internal medicine at the Mayo Clinic, Rochester, Minn. Dr. Kamboj, and Dr. Pardi are with the division of gastroenterology and hepatology at the Mayo Clinic. Dr. Pardi has grant funding from Pfizer, Vedanta, Seres, Finch, Applied Molecular Transport, and Takeda and has consulted for Vedanta and Otsuka. The other authors have no conflicts of interest to report.

References

1. Nyhlin N et al. Aliment Pharmacol Ther. 2014;39:963-72.

2. Miehlke S et al. United European Gastroenterol J. 2020;20-8.

3. Pardi DS et al. Gut. 2007;56:504-8.

4. Fernández-Bañares F et al. J Crohn’s Colitis.2016;10(7):805-11.

5. Gentile NM et al. Clin Gastroenterol Hepatol. 2014;12(5):838-42.

6. Tong J et al. Am J Gastroenterol. 2015;110:265-76.

7. Olesen M et al. Gut. 2004;53(3):346-50.

8. Bergman D et al. Aliment Pharmacol Ther. 2019;49(11):1395-400.

9. Guagnozzi D et al. Dig Liver Dis. 2012;44(5):384-8.

10. Münch A et al. J Crohns Colitis. 2012;6(9):932-45.

11. Macaigne G et al. Am J Gastroenterol. 2014; 09(9):1461-70.

12. Verhaegh BP et al. Aliment Pharmacol Ther. 2016;43(9):1004-13.

13. Stewart M et al. Aliment Pharmacol Ther. 2011;33(12):1340-9.

14. Green PHR et al. Clin Gastroenterol Hepatol. 2009;7(11):1210-6.

15. Masclee GM et al. Am J Gastroenterol. 2015;110:749-59.

16. Zylberberg H et al. Ailment Pharmacol Ther. 2021 Jun;53(11)1209-15.

17. Jaruvongvanich V et al. Inflamm Bowel Dis. 2019;25(4):672-8.

18. Fernández-Bañares F et al. Inflamm Bowel Dis. 2013; 19(7):1470-6.

19. Yen EF et al. Inflamm Bowel Dis. 2012;18(10):1835-41.

20. Barmeyer C et al. J Gastroenterol. 2017;52(10):1090-100.

21. Morgan DM et al. Clin Gastroenterol Hepatol. 2020;18(4):984-6.

22. Larsson JK et al. Eur J Clin Nutr. 2016;70:1309-17.

23. Madisch A et al.. Inflamm Bowel Dis. 2011;17(11):2295-8.

24. Stahl E et al. Gastroenterology. 2020;159(2):549-61.

25. Sikander A et al. Dig Dis Sci. 2015; 60:887-94.

26. Abdo AA et al. Can J Gastroenterol. 2001;15(5):341-3.

27. Fernandez-Bañares F et al. Dig Dis Sci.2001;46(10):2231-8.

28. Lyutakov I et al. Eur J Gastroenterol Hepatol. 2021;1;33(3):380-7.

29. Hjortswang H et al. Dig Liver Dis. 2011 Feb;43(2):102-9.

30. Cotter TG= et al. Gut. 2018;67(3):441-6.

31. Von Arnim U et al. Clin Exp Gastroenterol. 2016;9:97-103.

32. Langner C et al. Histopathology. 2015;66:613-26.

33. ASGE Standards of Practice Committee and Sharaf RN et al. Gastrointest Endosc. 2013;78:216-24.

34. Macaigne G et al. Clin Res Hepatol Gastroenterol. 2017;41(3):333-40.

35. Bjørnbak C et al. Aliment Pharmacol Ther. 2011;34(10):1225-34.

36. Pardi DS et al. Gastroenterology. 2016;150(1):247-74.

37. Masannat Y and Nazer E. West Virginia Med J. 2013;109(3):32-4.

38. Nguyen GC et al. Gastroenterology. 2016; 150(1):242-6.

39. Sebastian S et al. Eur J Gastroenterol Hepatol. 2019 Aug;31(8):919-27.

40. Miehlke S et al. Gastroenterology. 2014;146(5):1222-30.

41. Gentile NM et al. Am J Gastroenterol. 2013;108:256-9.

42. Münch A et al. Gut. 2016; 65(1):47-56.

43. Cotter TG et al. Aliment Pharmacol Ther. 2017; 46(2):169-74.

44. Esteve M et al. J Crohns Colitis. 2011;5(6):612-8.

45. Cottreau J et al. Clin J Gastroenterol. 2016;9:140-4.

46. Kamboj AK et al. Program No. P1876. ACG 2018 Annual Scientific Meeting Abstracts. Philadelphia, Pennsylvania: American College of Gastroenterology.

47. Yen EF et al. Dig Dis Sci. 2012;57:161-9.

Microscopic colitis is an inflammatory disease of the colon and a frequent cause of chronic or recurrent watery diarrhea, particularly in older persons. MC consists of two subtypes, collagenous colitis (CC) and lymphocytic colitis (LC). While the primary symptom is diarrhea, other signs and symptoms such as abdominal pain, weight loss, and dehydration or electrolyte abnormalities may also be present depending on disease severity.¹ In MC, the colonic mucosa usually appears normal on colonoscopy, and the diagnosis is made by histologic findings of intraepithelial lymphocytosis with (CC) or without (LC) a prominent subepithelial collagen band. The management approaches to CC and LC are similar and should be directed based on the severity of symptoms.² We review the epidemiology, risk factors, pathophysiology, diagnosis, and clinical management for this condition, as well as novel therapeutic approaches.

Epidemiology

Although the incidence of MC increased in the late twentieth century, more recently, it has stabilized with an estimated incidence varying from 1 to 25 per 100,000 person-years.^3-5 A recent meta-analysis revealed a pooled incidence of 4.85 per 100,000 persons for LC and 4.14 per 100,000 persons for CC.6 Proposed explanations for the rising incidence in the late twentieth century include improved clinical awareness of the disease, possible increased use of drugs associated with MC, and increased performance of diagnostic colonoscopies for chronic diarrhea. Since MC is now well-recognized, the recent plateau in incidence rates may reflect decreased detection bias.

The prevalence of MC ranges from 10%-20% in patients undergoing colonoscopy for chronic watery diarrhea.^6,7 The prevalence of LC is approximately 63.1 cases per 100,000 person-years and, for CC, is 49.2 cases per 100,000 person-years.^6-8 Recent studies have demonstrated increasing prevalence of MC likely resulting from an aging population.^9,10
 

Risk stratification

Female gender, increasing age, concomitant autoimmune disease, and the use of certain drugs, including NSAIDs, proton pump inhibitors (PPIs), statins, and selective serotonin reuptake inhibitors (SSRIs), have been associated with an increased risk of MC.^11,12 Autoimmune disorders, including celiac disease (CD), rheumatoid arthritis, hypothyroidism, and hyperthyroidism, are more common in patients with MC. The association with CD, in particular, is clinically important, as CD is associated with a 50-70 times greater risk of MC, and 2%-9% of patients with MC have CD.^13,14

Several medications have been associated with MC. In a British multicenter prospective study, MC was associated with the use of NSAIDs, PPIs, and SSRIs;¹⁵ however, recent studies have questioned the association of MC with some of these medications, which might worsen diarrhea but not actually cause MC.¹⁶

An additional risk factor for MC is smoking. A recent meta-analysis demonstrated that current and former smokers had an increased risk of MC (odds ratio, 2.99; 95% confidence interval, 2.15-4.15 and OR, 1.63; 95% CI, 1.37-1.94, respectively), compared with nonsmokers.¹⁷ Smokers develop MC at a younger age, and smoking is associated with increased disease severity and decreased likelihood of attaining remission.^18,19

Pathogenesis

The pathogenesis of MC remains largely unknown, although there are several hypotheses. The leading proposed mechanisms include reaction to luminal antigens, dysregulated collagen metabolism, genetic predisposition, autoimmunity, and bile acid malabsorption.

MC may be caused by abnormal epithelial barrier function, leading to increased permeability and reaction to luminal antigens, including dietary antigens, certain drugs, and bacterial products, ^20,21 which themselves lead to the immune dysregulation and intestinal inflammation seen in MC. This mechanism may explain the association of several drugs with MC. Histological changes resembling LC are reported in patients with CD who consume gluten; however, large population-based studies have not found specific dietary associations with the development of MC.²²

Another potential mechanism of MC is dysregulated collagen deposition. Collagen accumulation in the subepithelial layer in CC may result from increased levels of fibroblast growth factor, transforming growth factor–beta and vascular endothelial growth factor.²³ Nonetheless, studies have not found an association between the severity of diarrhea in patients with CC and the thickness of the subepithelial collagen band.

Thirdly, autoimmunity and genetic predisposition have been postulated in the pathogenesis of MC. As previously discussed, MC is associated with several autoimmune diseases and predominantly occurs in women, a distinctive feature of autoimmune disorders. Several studies have demonstrated an association between MC and HLA-DQ2 and -DQ3 haplotypes,²⁴ as well as potential polymorphisms in the serotonin transporter gene promoter.²⁵ It is important to note, however, that only a few familial cases of MC have been reported to date.²⁶

Lastly, bile acid malabsorption may play a role in the etiology of MC. Histologic findings of inflammation, along with villous atrophy and collagen deposition, have been reported in the ileum of patients with MC;^27,28 however, because patients with MC without bile acid malabsorption may also respond to bile acid binders such as cholestyramine, these findings unlikely to be the sole mechanism explaining the development of the disease.

Despite the different proposed mechanisms for the pathogenesis of MC, no definite conclusions can be drawn because of the limited size of these studies and their often conflicting results.

Vidyard Video

Clinical features

Clinicians should suspect MC in patients with chronic or recurrent watery diarrhea, particularly in older persons. Other risk factors include female gender, use of certain culprit medications, smoking, and presence of other autoimmune diseases. The clinical manifestations of MC subtypes LC and CC are similar with no significant clinical differences.^1,2 In addition to diarrhea, patients with MC may have abdominal pain, fatigue, and dehydration or electrolyte abnormalities depending on disease severity. Patients may also present with fecal urgency, incontinence, and nocturnal stools. Quality of life is often reduced in these patients, predominantly in those with severe or refractory symptoms.^29,30 The natural course of MC is highly variable, with some patients achieving spontaneous resolution after one episode and others developing chronic symptoms.

Diagnosis

The differential diagnosis of chronic watery diarrhea is broad and includes malabsorption/maldigestion, inflammatory bowel disease (IBD), irritable bowel syndrome, and medication side effects. In addition, although gastrointestinal infections typically cause acute or subacute diarrhea, some can present with chronic diarrhea. Malabsorption/maldigestion may occur because of CD, lactose intolerance, and pancreatic insufficiency, among other conditions. A thorough history, regarding recent antibiotic and medication use, travel, and immunosuppression, should be obtained in patients with chronic diarrhea. Additionally, laboratory and endoscopic evaluation with random biopsies of the colon can further help differentiate these diseases from MC. A few studies suggest fecal calprotectin may be used to differentiate MC from other noninflammatory conditions such as irritable bowel syndrome, as well as to monitor disease activity. This test is not expected to distinguish MC from other inflammatory causes of diarrhea, such as IBD, and therefore, its role in clinical practice is uncertain.³¹

 

 

The diagnosis of MC is made by biopsy of the colonic mucosa demonstrating characteristic pathologic features.³² Unlike in diseases such as Crohn’s disease or ulcerative colitis, the colon usually appears normal in MC, although mild nonspecific changes, such as erythema or edema, may be visualized. There is no consensus on the ideal location to obtain biopsies for MC or whether biopsies from both the left and the right colon are required.^2,33 The procedure of choice for the diagnosis of MC is colonoscopy with random biopsies taken throughout the colon. More limited evaluation by flexible sigmoidoscopy with biopsies may miss cases of MC as inflammation and collagen thickening are not necessarily uniform throughout the colon; however, in a patient that has undergone a recent colonoscopy for colon cancer screening without colon biopsies, a flexible sigmoidoscopy may be a reasonable next test for evaluation of MC, provided biopsies are obtained above the rectosigmoid colon.³⁴

Courtesy Dr. Catherine Hagen/Mayo Clinic

The MC subtypes are differentiated based on histology. The hallmark of LC is less than 20 intraepithelial lymphocytes per 100 surface epithelial cells (normal, less than 5) (Figure 1A). CC is characterized by a thickened subepithelial collagen band greater than 7-10 micrometers (normal, less than 5) (Figure 1B). For a subgroup of patients with milder abnormalities that do not meet these histological criteria, the terms “microscopic colitis, not otherwise specified” or “microscopic colitis, incomplete” may be used.³⁵ These patients often respond to standard treatments for MC. There is an additional subset of patients with biopsy demonstrating features of both CC and LC simultaneously, as well as patients transitioning from one MC subtype to another over time.^32,35

Courtesy Dr. Catherine Hagen/Mayo Clinic

 

Management approach

The first step in management of patients with MC includes stopping culprit medications if there is a temporal relationship between the initiation of the medication and the onset of diarrhea, as well as encouraging smoking cessation. These steps alone, however, are unlikely to achieve clinical remission in most patients. A stepwise pharmacological approach is used in the management of MC based on disease severity (Figure 2). For patients with mild symptoms, antidiarrheal medications, such as loperamide, may be helpful.³⁶ Long-term use of loperamide at therapeutic doses no greater than 16 mg daily appears to be safe if required to maintain symptom response. For those with persistent symptoms despite antidiarrheal medications, bismuth subsalicylate at three 262 mg tablets three times daily for 6-8 weeks can be considered. Long-term use of bismuth subsalicylate is not advised, especially at this dose, because of possible neurotoxicity.³⁷

For patients refractory to the above treatments or those with moderate-to-severe symptoms, an 8-week course of budesonide at 9 mg daily is the first-line treatment.³⁸ The dose was tapered before discontinuation in some studies but not in others. Both strategies appear effective. A recent meta-analysis of nine randomized trials demonstrated pooled ORs of 7.34 (95% CI, 4.08-13.19) and 8.35 (95% CI, 4.14-16.85) for response to budesonide induction and maintenance, respectively.³⁹

Cholestyramine is another medication considered in the management of MC and warrants further investigation. To date, no randomized clinical trials have been conducted to evaluate bile acid sequestrants in MC, but they should be considered before placing patients on immunosuppressive medications. Some providers use mesalamine in this setting, although mesalamine is inferior to budesonide in the induction of clinical remission in MC.⁴⁰

Despite high rates of response to budesonide, relapse after discontinuation is frequent (60%-80%), and time to relapse is variable^41,42 The American Gastroenterological Association recommends budesonide for maintenance of remission in patients with recurrence following discontinuation of induction therapy. The lowest effective dose that maintains resolution of symptoms should be prescribed, ideally at 6 mg daily or lower.³⁸ Although budesonide has a greater first-pass metabolism, compared with other glucocorticoids, patients should be monitored for possible side effects including hypertension, diabetes, and osteoporosis, as well as ophthalmologic disease, including cataracts and glaucoma.

For those who are intolerant to budesonide or have refractory symptoms, concomitant disorders such as CD that may be contributing to symptoms must be excluded. Immunosuppressive medications – such as thiopurines and biologic agents, including tumor necrosis factor–alpha inhibitors or vedolizumab – may be considered in refractory cases.^43,44 Of note, there are limited studies evaluating the use of these medications for MC. Lastly, surgeries including ileostomy with or without colectomy have been performed in the most severe cases for resistant disease that has failed numerous pharmacological therapies.⁴⁵

Patients should be counseled that, while symptoms from MC can be quite bothersome and disabling, there appears to be a normal life expectancy and no association between MC and colon cancer, unlike with other inflammatory conditions of the colon such as IBD.^46,47

 

 

Conclusion and future outlook

As a common cause of chronic watery diarrhea, MC will be commonly encountered in primary care and gastroenterology practices. The diagnosis should be suspected in patients presenting with chronic or recurrent watery diarrhea, especially with female gender, autoimmune disease, and increasing age. The management of MC requires an algorithmic approach directed by symptom severity, with a subgroup of patients requiring maintenance therapy for relapsing symptoms. The care of patients with MC will continue to evolve in the future. Further work is needed to explore long-term safety outcomes with budesonide and the role of immunomodulators and newer biologic agents for patients with complex, refractory disease.

Dr. Tome is with the department of internal medicine at the Mayo Clinic, Rochester, Minn. Dr. Kamboj, and Dr. Pardi are with the division of gastroenterology and hepatology at the Mayo Clinic. Dr. Pardi has grant funding from Pfizer, Vedanta, Seres, Finch, Applied Molecular Transport, and Takeda and has consulted for Vedanta and Otsuka. The other authors have no conflicts of interest to report.

References

1. Nyhlin N et al. Aliment Pharmacol Ther. 2014;39:963-72.

2. Miehlke S et al. United European Gastroenterol J. 2020;20-8.

3. Pardi DS et al. Gut. 2007;56:504-8.

4. Fernández-Bañares F et al. J Crohn’s Colitis.2016;10(7):805-11.

5. Gentile NM et al. Clin Gastroenterol Hepatol. 2014;12(5):838-42.

6. Tong J et al. Am J Gastroenterol. 2015;110:265-76.

7. Olesen M et al. Gut. 2004;53(3):346-50.

8. Bergman D et al. Aliment Pharmacol Ther. 2019;49(11):1395-400.

9. Guagnozzi D et al. Dig Liver Dis. 2012;44(5):384-8.

10. Münch A et al. J Crohns Colitis. 2012;6(9):932-45.

11. Macaigne G et al. Am J Gastroenterol. 2014; 09(9):1461-70.

12. Verhaegh BP et al. Aliment Pharmacol Ther. 2016;43(9):1004-13.

13. Stewart M et al. Aliment Pharmacol Ther. 2011;33(12):1340-9.

14. Green PHR et al. Clin Gastroenterol Hepatol. 2009;7(11):1210-6.

15. Masclee GM et al. Am J Gastroenterol. 2015;110:749-59.

16. Zylberberg H et al. Ailment Pharmacol Ther. 2021 Jun;53(11)1209-15.

17. Jaruvongvanich V et al. Inflamm Bowel Dis. 2019;25(4):672-8.

18. Fernández-Bañares F et al. Inflamm Bowel Dis. 2013; 19(7):1470-6.

19. Yen EF et al. Inflamm Bowel Dis. 2012;18(10):1835-41.

20. Barmeyer C et al. J Gastroenterol. 2017;52(10):1090-100.

21. Morgan DM et al. Clin Gastroenterol Hepatol. 2020;18(4):984-6.

22. Larsson JK et al. Eur J Clin Nutr. 2016;70:1309-17.

23. Madisch A et al.. Inflamm Bowel Dis. 2011;17(11):2295-8.

24. Stahl E et al. Gastroenterology. 2020;159(2):549-61.

25. Sikander A et al. Dig Dis Sci. 2015; 60:887-94.

26. Abdo AA et al. Can J Gastroenterol. 2001;15(5):341-3.

27. Fernandez-Bañares F et al. Dig Dis Sci.2001;46(10):2231-8.

28. Lyutakov I et al. Eur J Gastroenterol Hepatol. 2021;1;33(3):380-7.

29. Hjortswang H et al. Dig Liver Dis. 2011 Feb;43(2):102-9.

30. Cotter TG= et al. Gut. 2018;67(3):441-6.

31. Von Arnim U et al. Clin Exp Gastroenterol. 2016;9:97-103.

32. Langner C et al. Histopathology. 2015;66:613-26.

33. ASGE Standards of Practice Committee and Sharaf RN et al. Gastrointest Endosc. 2013;78:216-24.

34. Macaigne G et al. Clin Res Hepatol Gastroenterol. 2017;41(3):333-40.

35. Bjørnbak C et al. Aliment Pharmacol Ther. 2011;34(10):1225-34.

36. Pardi DS et al. Gastroenterology. 2016;150(1):247-74.

37. Masannat Y and Nazer E. West Virginia Med J. 2013;109(3):32-4.

38. Nguyen GC et al. Gastroenterology. 2016; 150(1):242-6.

39. Sebastian S et al. Eur J Gastroenterol Hepatol. 2019 Aug;31(8):919-27.

40. Miehlke S et al. Gastroenterology. 2014;146(5):1222-30.

41. Gentile NM et al. Am J Gastroenterol. 2013;108:256-9.

42. Münch A et al. Gut. 2016; 65(1):47-56.

43. Cotter TG et al. Aliment Pharmacol Ther. 2017; 46(2):169-74.

44. Esteve M et al. J Crohns Colitis. 2011;5(6):612-8.

45. Cottreau J et al. Clin J Gastroenterol. 2016;9:140-4.

46. Kamboj AK et al. Program No. P1876. ACG 2018 Annual Scientific Meeting Abstracts. Philadelphia, Pennsylvania: American College of Gastroenterology.

47. Yen EF et al. Dig Dis Sci. 2012;57:161-9.

Gastroenterology

May 2021
Understanding GI Twitter and its major contributors. Elfanagely Y et al. Gastroenterology. 2021 May;160(6):1917-21. doi: 10.1053/j.gastro.2021.01.232.

Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection. Saha S et al. Gastroenterology. 2021 May;160(6):1961-9.e3. doi: 10.1053/j.gastro.2021.01.010.

How to incorporate health equity training into gastroenterology and hepatology fellowships. Lee-Allen J, Shah BJ. Gastroenterology. 2021 May;160(6):1924-8. doi: 10.1053/j.gastro.2021.03.018.

Functional dyspepsia and gastroparesis in tertiary care are interchangeable syndromes with common clinical and pathologic features. Pasricha PJ et al. Gastroenterology. 2021 May;160(6):2006-17. doi: 10.1053/j.gastro.2021.01.230.

June 2021
How to manage the large nonpedunculated colorectal polyp. Shahidi N, Bourke MJ. Gastroenterology. 2021 Jun;160(7):2239-43.e1. doi: 10.1053/j.gastro.2021.04.029.

Mortality, reoperation, and hospital stay within 90 days of primary and secondary antireflux surgery in a population-based multinational study. Yanes M et al. Gastroenterology. 2021 Jun;160(7):2283-90. doi: 10.1053/j.gastro.2021.02.022.

Endoscopic submucosal dissection in north america: A large prospective multicenter study. Draganov PV et al. Gastroenterology. 2021 Jun;160(7):2317-27.e2. doi: 10.1053/j.gastro.2021.02.036.

July 2021
Gluten degradation, pharmacokinetics, safety, and tolerability of TAK-062, an engineered enzyme to treat celiac disease. Pultz IG et al. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019.

Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Meserve J et al. Gastroenterology. 2021 Jul;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020.

Ethnicity associations with food sensitization are mediated by gut microbiota development in the first year of life. Tun Hm et al. Gastroenterology. 2021 Jul;161(1):94-106. doi: 10.1053/j.gastro.2021.03.016.

How to incorporate bariatric training into your fellowship program. Jirapinyo P, Thompson CC. Gastroenterology. 2019 Jul;157(1):9-13. doi: 10.1053/j.gastro.2019.05.034.

CGH

May 2021
Intestinal failure: What all gastroenterologists should know. Jansson-Knodell CL et al. Clin Gastroenterol Hepatol. 2021 May;19(5):885-8. doi: 10.1016/j.cgh.2021.01.038.

When and how to use endoscopic tattooing in the colon: An international Delphi agreement. Medina-Prado L et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1038-50. doi: 10.1016/j.cgh.2021.01.024.

Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-57.e2. doi: 10.1016/j.cgh.2020.09.055.

June 2021
GA Clinical Practice Update on management of bleeding gastric varices: Expert review. Henry Z et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-107.e1. doi: 10.1016/j.cgh.2021.01.027.

Inter- and intra-individual variation, and limited prognostic utility, of serum alkaline phosphatase in a trial of patients with primary sclerosing cholangitis

Palak J. Trivedi PJ et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1248-57. doi: 10.1016/j.cgh.2020.07.032.

Low-fat, high-fiber diet reduces markers of inflammation and dysbiosis and improves quality of life in patients with ulcerative colitis. Julia Fritsch J et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-99.e30. doi: 10.1016/j.cgh.2020.05.026.

July 2021
Scoping out a better parental leave policy for gastroenterology fellows. Wegermann K. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1307-9. doi: 10.1016/j.cgh.2021.01.040.

An impetus for change: How COVID-19 will transform the delivery of GI health care. Leiman DA et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1310-1313. doi: 10.1016/j.cgh.2021.03.042.

Untangling nonerosive reflux disease from functional heartburn. Patel D et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1314-26. doi: 10.1016/j.cgh.2020.03.057.
 

AGA Clinical Practice Update on chemoprevention for colorectal neoplasia: Expert review. Liang PS et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1327-36. doi: 10.1016/j.cgh.2021.02.014.
 

CMGH

Drug inhibition of SARS-CoV-2 replication in human pluripotent stem cell–derived intestinal organoids. Krüger J et al. Cell Mol Gastroenterol Hepatol. 2021;11(4):935-48. doi: 10.1016/j.jcmgh.2020.11.003.
 

TIGE

Virtual interviews during the COVID-19 Pandemic: A survey of advanced endoscopy fellowship applicants and programs. Amrit K. Kamboj AK et al. Tech Innov Gastrointest Endosc. 2021;23(2):159-68. doi: 10.1016/j.tige.2021.02.001.

Triage of general gastrointestinal endoscopic procedures during the COVID-19 pandemic: Results from a national Delphi consensus panel. Feuerstein JD et al. Tech Innov Gastrointest Endosc. 2021;23(2):113-21. doi: 10.1016/j.tige.2020.12.005.

Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding. Marya NB et al. Tech Innov Gastrointest Endosc. 2021;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.

Gastroenterology

May 2021
Understanding GI Twitter and its major contributors. Elfanagely Y et al. Gastroenterology. 2021 May;160(6):1917-21. doi: 10.1053/j.gastro.2021.01.232.

Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection. Saha S et al. Gastroenterology. 2021 May;160(6):1961-9.e3. doi: 10.1053/j.gastro.2021.01.010.

How to incorporate health equity training into gastroenterology and hepatology fellowships. Lee-Allen J, Shah BJ. Gastroenterology. 2021 May;160(6):1924-8. doi: 10.1053/j.gastro.2021.03.018.

Functional dyspepsia and gastroparesis in tertiary care are interchangeable syndromes with common clinical and pathologic features. Pasricha PJ et al. Gastroenterology. 2021 May;160(6):2006-17. doi: 10.1053/j.gastro.2021.01.230.

June 2021
How to manage the large nonpedunculated colorectal polyp. Shahidi N, Bourke MJ. Gastroenterology. 2021 Jun;160(7):2239-43.e1. doi: 10.1053/j.gastro.2021.04.029.

Mortality, reoperation, and hospital stay within 90 days of primary and secondary antireflux surgery in a population-based multinational study. Yanes M et al. Gastroenterology. 2021 Jun;160(7):2283-90. doi: 10.1053/j.gastro.2021.02.022.

Endoscopic submucosal dissection in north america: A large prospective multicenter study. Draganov PV et al. Gastroenterology. 2021 Jun;160(7):2317-27.e2. doi: 10.1053/j.gastro.2021.02.036.

July 2021
Gluten degradation, pharmacokinetics, safety, and tolerability of TAK-062, an engineered enzyme to treat celiac disease. Pultz IG et al. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019.

Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Meserve J et al. Gastroenterology. 2021 Jul;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020.

Ethnicity associations with food sensitization are mediated by gut microbiota development in the first year of life. Tun Hm et al. Gastroenterology. 2021 Jul;161(1):94-106. doi: 10.1053/j.gastro.2021.03.016.

How to incorporate bariatric training into your fellowship program. Jirapinyo P, Thompson CC. Gastroenterology. 2019 Jul;157(1):9-13. doi: 10.1053/j.gastro.2019.05.034.

CGH

May 2021
Intestinal failure: What all gastroenterologists should know. Jansson-Knodell CL et al. Clin Gastroenterol Hepatol. 2021 May;19(5):885-8. doi: 10.1016/j.cgh.2021.01.038.

When and how to use endoscopic tattooing in the colon: An international Delphi agreement. Medina-Prado L et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1038-50. doi: 10.1016/j.cgh.2021.01.024.

Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-57.e2. doi: 10.1016/j.cgh.2020.09.055.

June 2021
GA Clinical Practice Update on management of bleeding gastric varices: Expert review. Henry Z et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-107.e1. doi: 10.1016/j.cgh.2021.01.027.

Inter- and intra-individual variation, and limited prognostic utility, of serum alkaline phosphatase in a trial of patients with primary sclerosing cholangitis

Palak J. Trivedi PJ et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1248-57. doi: 10.1016/j.cgh.2020.07.032.

Low-fat, high-fiber diet reduces markers of inflammation and dysbiosis and improves quality of life in patients with ulcerative colitis. Julia Fritsch J et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-99.e30. doi: 10.1016/j.cgh.2020.05.026.

July 2021
Scoping out a better parental leave policy for gastroenterology fellows. Wegermann K. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1307-9. doi: 10.1016/j.cgh.2021.01.040.

An impetus for change: How COVID-19 will transform the delivery of GI health care. Leiman DA et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1310-1313. doi: 10.1016/j.cgh.2021.03.042.

Untangling nonerosive reflux disease from functional heartburn. Patel D et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1314-26. doi: 10.1016/j.cgh.2020.03.057.
 

AGA Clinical Practice Update on chemoprevention for colorectal neoplasia: Expert review. Liang PS et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1327-36. doi: 10.1016/j.cgh.2021.02.014.
 

CMGH

Drug inhibition of SARS-CoV-2 replication in human pluripotent stem cell–derived intestinal organoids. Krüger J et al. Cell Mol Gastroenterol Hepatol. 2021;11(4):935-48. doi: 10.1016/j.jcmgh.2020.11.003.
 

TIGE

Virtual interviews during the COVID-19 Pandemic: A survey of advanced endoscopy fellowship applicants and programs. Amrit K. Kamboj AK et al. Tech Innov Gastrointest Endosc. 2021;23(2):159-68. doi: 10.1016/j.tige.2021.02.001.

Triage of general gastrointestinal endoscopic procedures during the COVID-19 pandemic: Results from a national Delphi consensus panel. Feuerstein JD et al. Tech Innov Gastrointest Endosc. 2021;23(2):113-21. doi: 10.1016/j.tige.2020.12.005.

Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding. Marya NB et al. Tech Innov Gastrointest Endosc. 2021;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.

Gastroenterology

May 2021
Understanding GI Twitter and its major contributors. Elfanagely Y et al. Gastroenterology. 2021 May;160(6):1917-21. doi: 10.1053/j.gastro.2021.01.232.

Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection. Saha S et al. Gastroenterology. 2021 May;160(6):1961-9.e3. doi: 10.1053/j.gastro.2021.01.010.

How to incorporate health equity training into gastroenterology and hepatology fellowships. Lee-Allen J, Shah BJ. Gastroenterology. 2021 May;160(6):1924-8. doi: 10.1053/j.gastro.2021.03.018.

Functional dyspepsia and gastroparesis in tertiary care are interchangeable syndromes with common clinical and pathologic features. Pasricha PJ et al. Gastroenterology. 2021 May;160(6):2006-17. doi: 10.1053/j.gastro.2021.01.230.

June 2021
How to manage the large nonpedunculated colorectal polyp. Shahidi N, Bourke MJ. Gastroenterology. 2021 Jun;160(7):2239-43.e1. doi: 10.1053/j.gastro.2021.04.029.

Mortality, reoperation, and hospital stay within 90 days of primary and secondary antireflux surgery in a population-based multinational study. Yanes M et al. Gastroenterology. 2021 Jun;160(7):2283-90. doi: 10.1053/j.gastro.2021.02.022.

Endoscopic submucosal dissection in north america: A large prospective multicenter study. Draganov PV et al. Gastroenterology. 2021 Jun;160(7):2317-27.e2. doi: 10.1053/j.gastro.2021.02.036.

July 2021
Gluten degradation, pharmacokinetics, safety, and tolerability of TAK-062, an engineered enzyme to treat celiac disease. Pultz IG et al. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019.

Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Meserve J et al. Gastroenterology. 2021 Jul;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020.

Ethnicity associations with food sensitization are mediated by gut microbiota development in the first year of life. Tun Hm et al. Gastroenterology. 2021 Jul;161(1):94-106. doi: 10.1053/j.gastro.2021.03.016.

How to incorporate bariatric training into your fellowship program. Jirapinyo P, Thompson CC. Gastroenterology. 2019 Jul;157(1):9-13. doi: 10.1053/j.gastro.2019.05.034.

CGH

May 2021
Intestinal failure: What all gastroenterologists should know. Jansson-Knodell CL et al. Clin Gastroenterol Hepatol. 2021 May;19(5):885-8. doi: 10.1016/j.cgh.2021.01.038.

When and how to use endoscopic tattooing in the colon: An international Delphi agreement. Medina-Prado L et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1038-50. doi: 10.1016/j.cgh.2021.01.024.

Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-57.e2. doi: 10.1016/j.cgh.2020.09.055.

June 2021
GA Clinical Practice Update on management of bleeding gastric varices: Expert review. Henry Z et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-107.e1. doi: 10.1016/j.cgh.2021.01.027.

Inter- and intra-individual variation, and limited prognostic utility, of serum alkaline phosphatase in a trial of patients with primary sclerosing cholangitis

Palak J. Trivedi PJ et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1248-57. doi: 10.1016/j.cgh.2020.07.032.

Low-fat, high-fiber diet reduces markers of inflammation and dysbiosis and improves quality of life in patients with ulcerative colitis. Julia Fritsch J et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-99.e30. doi: 10.1016/j.cgh.2020.05.026.

July 2021
Scoping out a better parental leave policy for gastroenterology fellows. Wegermann K. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1307-9. doi: 10.1016/j.cgh.2021.01.040.

An impetus for change: How COVID-19 will transform the delivery of GI health care. Leiman DA et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1310-1313. doi: 10.1016/j.cgh.2021.03.042.

Untangling nonerosive reflux disease from functional heartburn. Patel D et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1314-26. doi: 10.1016/j.cgh.2020.03.057.
 

AGA Clinical Practice Update on chemoprevention for colorectal neoplasia: Expert review. Liang PS et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1327-36. doi: 10.1016/j.cgh.2021.02.014.
 

CMGH

Drug inhibition of SARS-CoV-2 replication in human pluripotent stem cell–derived intestinal organoids. Krüger J et al. Cell Mol Gastroenterol Hepatol. 2021;11(4):935-48. doi: 10.1016/j.jcmgh.2020.11.003.
 

TIGE

Virtual interviews during the COVID-19 Pandemic: A survey of advanced endoscopy fellowship applicants and programs. Amrit K. Kamboj AK et al. Tech Innov Gastrointest Endosc. 2021;23(2):159-68. doi: 10.1016/j.tige.2021.02.001.

Triage of general gastrointestinal endoscopic procedures during the COVID-19 pandemic: Results from a national Delphi consensus panel. Feuerstein JD et al. Tech Innov Gastrointest Endosc. 2021;23(2):113-21. doi: 10.1016/j.tige.2020.12.005.

Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding. Marya NB et al. Tech Innov Gastrointest Endosc. 2021;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.