Opinion

While many gastroenterologists may be comfortable with inflammatory bowel disease (IBD), most are not experts in women’s concerns about pregnancy. One study found that, although women with IBD may have concerns about the interplay of their disease and reproductive health, many have not had extensive conversations with their gastroenterologist about it. In fact, that same study found most women expect their gastroenterologist to initiate these conversations.

GI & Hepatology News sought input from a patient advocate about questions women with IBD often think about but may not always discuss with their gastroenterologists, and then solicited responses from thought leaders in IBD and pregnancy. In this roundtable discussion, Uma Mahadevan, MD, professor of medicine and the director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco; Marla C. Dubinsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York; and Sunanda V. Kane, MD, professor of medicine at Mayo Clinic in Rochester, Minn., share how they respond to these questions in their clinical practice.
 

What should a woman with IBD who is interested in having biological children in the future be thinking about now?

Dr. Mahadevan: Because active disease is associated with lower rates of conception and higher rates of pregnancy loss, women with IBD should first ensure they are in remission. I like to document endoscopic healing with a colonoscopy or sigmoidoscopy, but, if this has been done recently, a fecal calprotectin test can be helpful.

Women with IBD, particularly those with small bowel disease, are at risk for nutritional deficiencies, so prior to conception, I also check vitamin B-12, vitamin D, and iron, and repeat as needed. Zinc and folate can be considered. Those who are underweight should work with a nutritionist to ensure adequate caloric intake.

Dr. Dubinsky: I think it’s also important to stress the importance of taking their IBD medications because they can help patients achieve and maintain disease remission. Uncontrolled inflammation is a key risk factor for spontaneous abortion in the first trimester. Medication we would use in pregnancy is not putting them at risk for spontaneous abortion or congenital anomalies, which is what mothers to be are understandably most concerned about.

I am very honest and transparent with my patients: “About the only thing I need to take care of is you. If you are good, the baby is good.”

Dr. Kane: As Dr. Mahadevan mentioned, women with IBD are at higher risk for vitamin deficiencies, so those need to be corrected before conception. If they smoke, they should stop before conceiving.

There is no increased risk of infertility unless there has been a history of abdominal surgery.

Also, if women are not actively planning on getting pregnant, that would be important to share because some gastroenterologists will avoid certain effective medications if pregnancy is a possibility.

If a woman has had surgery for her IBD, could that make it harder for her to get pregnant?

Dr. Kane: Yes, it can because scar tissue may develop within the pelvis. However, if surgery is indicated to manage a patient’s IBD, then talk to the surgeon about ways that they might be able to reduce the risk of scar tissue formation.

Dr. Dubinsky: One thing to note is that almost all the data of infertility risk and scarring are based on open surgical techniques that involve dissection of the rectum. On the other hand, we don’t yet have enough prospective data on the impact of the modern era of laparoscopic surgery to suggest whether it affects fertility. More data is needed because providers may be giving women old information that is no longer relevant in the modern era.
 

If a woman is experiencing IBD symptoms, should she attempt to conceive?

Dr. Kane: Gastrointestinal symptoms in patients with IBD could be from active disease but also other things, so it’s important to have a thorough check-up to assess if there is active disease or not. Active disease can (but does not always) lead to a more complicated pregnancy, and conception is not recommended while a patient has active IBD.

Dr. Dubinsky: Although some patients feel an urgency to conceive regardless of disease activity, we need to do our due diligence and explain that we need to focus on getting them into the deepest remission possible, including endoscopic findings, biomarkers, and symptoms.

The most important gift you can give your future moms is to optimize the therapy they’re on before they conceive.
 

Is it important for someone who’s working with a gastroenterologist and an obstetrician to also work with a maternal-fetal medicine (MFM) specialist?

Dr. Kane: Having a diagnosis of IBD makes a woman’s pregnancy “high risk” because just having the diagnosis is associated with a higher risk of prematurity and small for gestational age – but importantly, not birth defects. A woman whose IBD is in remission should still have a discussion with an MFM specialist, just so everyone is on the same page.

Dr. Dubinsky: I refer to care with MFM specialists as “tighter monitoring.” I tell my patients that MFM specialists have managed many complex pregnancies and feel confident around the safety of their medications, understand the impact of when the baby may be exposed to certain medications, and will focus on following them more closely.
 

What are the risks of IBD medications during pregnancy and while breastfeeding? Should women stop their medications during pregnancy and breastfeeding?

Dr. Dubinsky: Organogenesis occurs in the first 10 weeks, so any medicines that cross the placenta during that time are up for discussion and debate. Methotrexate and the newer small molecules, such as Janus kinase (JAK) inhibitors and S1P receptor modulators, do cross the placenta during the first trimester and need to be discontinued before conception, sometimes as early as 3 months before conception.

However, biologics are very large proteins and do not cross the placenta until closer to week 27. We are not advocating stopping biologics in advance of conception, or during pregnancy, or during breastfeeding. There is more risk to stopping than continuing.

Dr. Mahadevan: Methotrexate should be stopped at least 3 months prior to conception and should not be taken during pregnancy.

There are limited antibiotic safety data in pregnancy for the longer periods of time used in IBD. I generally prefer amoxicillin/clavulanic acid over ciprofloxacin or metronidazole, but short term (less than 2 weeks) use of any of those three are not contraindicated.

Mesalamine agents and thiopurine monotherapy can be continued through pregnancy and breastfeeding.

Biologic agents, such as anti–tumor necrosis factor, anti-interleukin 23, anti-integrin, and biosimilars, can be continued through pregnancy and during breastfeeding. Given limited exposure in the first trimester, there is no evidence of increased risk of birth defects. As Dr. Dubinsky pointed out, there is active transfer, particularly in the third trimester and minimal transfer in breast milk, but this has not been associated with harm.

Lastly, small molecules, such as the JAK inhibitors tofacitinib and upadacitinib, as well as ozanimod, have virtually no human safety data during pregnancy, and animal data show harm. The use of these agents in pregnancy is not recommended.

Dr. Kane: As Dr. Dubinsky stated, most of the medications our patients take are low risk to continue through pregnancy if the patients are in remission. Although a woman “in remission” on steroids is not really in remission and should not get pregnant until she is on something else.

As far as breastfeeding goes, that should be stopped if the patient is on methotrexate, cyclosporine, or certain antibiotics. If she is on more than 20 mg of prednisone, this can pass to the infant, and a mother should not breastfeed.

Women should avoid fenugreek as a lactation aid, as that contains a compound that can promote bleeding. Lactation cookies are ok.

Otherwise, there are lots of potential benefits to breastfeeding, and I encourage it.
 

How is a flare treated if it occurs during pregnancy?

Dr. Dubinsky: A flare during pregnancy is treated the same as a flare outside of pregnancy. We want to use noninvasive ways to confirm it, but I think we don’t need to overly investigate in most of our women. If they’re already on a biologic, you may consider changing.

Some women may need corticosteroids. It’s not our favorite move, but there is an urgency to getting a flare under control during pregnancy because of possible complications.

Dr. Mahadevan: Some of this is contingent on when during pregnancy the flare occurs. A patient who has a flare at 38 weeks’ gestation will likely proceed with delivery and the flare will be dealt with separately. Someone at 8 weeks’ gestation is at high risk for pregnancy loss, so treatment should be quick and effective.

As does Dr. Dubinsky, I do try to avoid steroids if possible. For example, I would rather start an effective biologic right away than drag out steroids to see if they will respond.

Dr. Kane: I would add that, if a mother is losing weight, she might need to be hospitalized for additional nutritional support. If surgery is necessary, we usually try to time it for the second or third trimester.

What needs to be taken into consideration regarding mode of delivery? Also, if a woman has undergone prior surgeries, do they increase the risk of delivery complications?

For ulcerative colitis, mode of delivery is based on obstetric, not gastrointestinal, variables. For Crohn’s disease, if there is evidence of perianal disease, then a cesarean is appropriate.

If there is no history of perianal disease, then delivery is based on obstetric variables.

For a woman who has a J pouch, if possible, the surgeon who created it should be contacted to ask about the technical aspects of the pouch and how it lies in the pelvis.
 

What’s the risk of a postpartum flare if a woman’s IBD remains in clinical remission during pregnancy?

Dr. Mahadevan: There is no increased risk of postpartum flare if a woman continues her IBD medications after delivery. Many of the reports of flare are from stopping medications (mistakenly often) to breastfeed.

Dr. Kane: As Dr. Mahadevan said, the risk of a flare is usually because a woman stops taking her medications because she thinks that medication will be passed to the infant through breastfeeding, which in most cases is not true.

Otherwise, there is not an increased risk of a flare in a 12-month period. However, it is important to monitor for symptoms after delivery; the risk of a flare is not zero.
 

What symptoms should women watch out for after delivery that may indicate an uptick in disease activity?

Dr. Kane: The same symptoms as before they were pregnant. Diarrhea, abdominal pain, and rectal bleeding are not normal after delivery and should be considered signs of returning disease.

As a gastroenterologist, is there any additional advice you’d offer about conception, fertility, and pregnancy when treating women with IBD?

Dr. Mahadevan: Women with IBD should, when feasible, have a planned pregnancy when in documented remission and under the care of their gastroenterologists, obstetrician, and an MFM specialist. Life happens, and this is not always possible. That said, a woman with IBD has the same chance of getting pregnant as a woman of the same age without IBD, unless she has active disease or a history of pelvic surgery. Women with IBD in remission will generally have healthy pregnancies if they continue appropriate medications.

Dr. Kane: Agreed. The majority of women with IBD will have normal, healthy pregnancies. It is important for them to not stop their IBD therapy without talking to their gastroenterologist first. Well-intentioned but ignorant obstetricians or midwives may recommend stopping, but then panic when disease flares and the mother’s health is at risk. Active inflammation is the worst enemy to a pregnancy, not active therapy.

Dr. Dubinsky: One additional thing to consider is: How do we help women with IBD who have delivered meet the needs of their family and continue to stay on their meds and be in good inflammatory control?

For example, we can give the biologic in the hospital after they’ve had a cesarean or a vaginal delivery and before they leave. We know that that is safe, giving that to them before they leave the hospital is a huge value added.

Another thing is possibly changing their infusions to home infusions. That would be helpful for the moms as well.


Dr. Mahadevan reports being a consultant for AbbVie, Janssen, Pfizer, Gilead, Bristol-Myers Squibb, Takeda, Protagonist, Prometheus, and Boehringer Ingelheim. Dr. Dubinsky is a consultant for AbbVie, Arena, Bristol-Myers Squibb, Janssen, Eli Lilly, Takeda, and Prometheus BioSciences. She is a shareholder and CEO of a publicly traded company, Trellis Health. Dr. Kane is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Takeda, Seres Therapeutics, TechLab, United Healthcare, Predicta-Med, and InveniAI, and is the editor for the IBD section of UptoDate.
 

AGA Resource

Planning for a family can be challenging, and if your patient has IBD, there are additional factors to consider. The AGA IBD Parenthood Project is the “go-to” resource for everything patients need to know about IBD and pregnancy throughout all stages of family planning.

While many gastroenterologists may be comfortable with inflammatory bowel disease (IBD), most are not experts in women’s concerns about pregnancy. One study found that, although women with IBD may have concerns about the interplay of their disease and reproductive health, many have not had extensive conversations with their gastroenterologist about it. In fact, that same study found most women expect their gastroenterologist to initiate these conversations.

GI & Hepatology News sought input from a patient advocate about questions women with IBD often think about but may not always discuss with their gastroenterologists, and then solicited responses from thought leaders in IBD and pregnancy. In this roundtable discussion, Uma Mahadevan, MD, professor of medicine and the director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco; Marla C. Dubinsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York; and Sunanda V. Kane, MD, professor of medicine at Mayo Clinic in Rochester, Minn., share how they respond to these questions in their clinical practice.
 

What should a woman with IBD who is interested in having biological children in the future be thinking about now?

Dr. Mahadevan: Because active disease is associated with lower rates of conception and higher rates of pregnancy loss, women with IBD should first ensure they are in remission. I like to document endoscopic healing with a colonoscopy or sigmoidoscopy, but, if this has been done recently, a fecal calprotectin test can be helpful.

Women with IBD, particularly those with small bowel disease, are at risk for nutritional deficiencies, so prior to conception, I also check vitamin B-12, vitamin D, and iron, and repeat as needed. Zinc and folate can be considered. Those who are underweight should work with a nutritionist to ensure adequate caloric intake.

Dr. Dubinsky: I think it’s also important to stress the importance of taking their IBD medications because they can help patients achieve and maintain disease remission. Uncontrolled inflammation is a key risk factor for spontaneous abortion in the first trimester. Medication we would use in pregnancy is not putting them at risk for spontaneous abortion or congenital anomalies, which is what mothers to be are understandably most concerned about.

I am very honest and transparent with my patients: “About the only thing I need to take care of is you. If you are good, the baby is good.”

Dr. Kane: As Dr. Mahadevan mentioned, women with IBD are at higher risk for vitamin deficiencies, so those need to be corrected before conception. If they smoke, they should stop before conceiving.

There is no increased risk of infertility unless there has been a history of abdominal surgery.

Also, if women are not actively planning on getting pregnant, that would be important to share because some gastroenterologists will avoid certain effective medications if pregnancy is a possibility.

If a woman has had surgery for her IBD, could that make it harder for her to get pregnant?

Dr. Kane: Yes, it can because scar tissue may develop within the pelvis. However, if surgery is indicated to manage a patient’s IBD, then talk to the surgeon about ways that they might be able to reduce the risk of scar tissue formation.

Dr. Dubinsky: One thing to note is that almost all the data of infertility risk and scarring are based on open surgical techniques that involve dissection of the rectum. On the other hand, we don’t yet have enough prospective data on the impact of the modern era of laparoscopic surgery to suggest whether it affects fertility. More data is needed because providers may be giving women old information that is no longer relevant in the modern era.
 

If a woman is experiencing IBD symptoms, should she attempt to conceive?

Dr. Kane: Gastrointestinal symptoms in patients with IBD could be from active disease but also other things, so it’s important to have a thorough check-up to assess if there is active disease or not. Active disease can (but does not always) lead to a more complicated pregnancy, and conception is not recommended while a patient has active IBD.

Dr. Dubinsky: Although some patients feel an urgency to conceive regardless of disease activity, we need to do our due diligence and explain that we need to focus on getting them into the deepest remission possible, including endoscopic findings, biomarkers, and symptoms.

The most important gift you can give your future moms is to optimize the therapy they’re on before they conceive.
 

Is it important for someone who’s working with a gastroenterologist and an obstetrician to also work with a maternal-fetal medicine (MFM) specialist?

Dr. Kane: Having a diagnosis of IBD makes a woman’s pregnancy “high risk” because just having the diagnosis is associated with a higher risk of prematurity and small for gestational age – but importantly, not birth defects. A woman whose IBD is in remission should still have a discussion with an MFM specialist, just so everyone is on the same page.

Dr. Dubinsky: I refer to care with MFM specialists as “tighter monitoring.” I tell my patients that MFM specialists have managed many complex pregnancies and feel confident around the safety of their medications, understand the impact of when the baby may be exposed to certain medications, and will focus on following them more closely.
 

What are the risks of IBD medications during pregnancy and while breastfeeding? Should women stop their medications during pregnancy and breastfeeding?

Dr. Dubinsky: Organogenesis occurs in the first 10 weeks, so any medicines that cross the placenta during that time are up for discussion and debate. Methotrexate and the newer small molecules, such as Janus kinase (JAK) inhibitors and S1P receptor modulators, do cross the placenta during the first trimester and need to be discontinued before conception, sometimes as early as 3 months before conception.

However, biologics are very large proteins and do not cross the placenta until closer to week 27. We are not advocating stopping biologics in advance of conception, or during pregnancy, or during breastfeeding. There is more risk to stopping than continuing.

Dr. Mahadevan: Methotrexate should be stopped at least 3 months prior to conception and should not be taken during pregnancy.

There are limited antibiotic safety data in pregnancy for the longer periods of time used in IBD. I generally prefer amoxicillin/clavulanic acid over ciprofloxacin or metronidazole, but short term (less than 2 weeks) use of any of those three are not contraindicated.

Mesalamine agents and thiopurine monotherapy can be continued through pregnancy and breastfeeding.

Biologic agents, such as anti–tumor necrosis factor, anti-interleukin 23, anti-integrin, and biosimilars, can be continued through pregnancy and during breastfeeding. Given limited exposure in the first trimester, there is no evidence of increased risk of birth defects. As Dr. Dubinsky pointed out, there is active transfer, particularly in the third trimester and minimal transfer in breast milk, but this has not been associated with harm.

Lastly, small molecules, such as the JAK inhibitors tofacitinib and upadacitinib, as well as ozanimod, have virtually no human safety data during pregnancy, and animal data show harm. The use of these agents in pregnancy is not recommended.

Dr. Kane: As Dr. Dubinsky stated, most of the medications our patients take are low risk to continue through pregnancy if the patients are in remission. Although a woman “in remission” on steroids is not really in remission and should not get pregnant until she is on something else.

As far as breastfeeding goes, that should be stopped if the patient is on methotrexate, cyclosporine, or certain antibiotics. If she is on more than 20 mg of prednisone, this can pass to the infant, and a mother should not breastfeed.

Women should avoid fenugreek as a lactation aid, as that contains a compound that can promote bleeding. Lactation cookies are ok.

Otherwise, there are lots of potential benefits to breastfeeding, and I encourage it.
 

How is a flare treated if it occurs during pregnancy?

Dr. Dubinsky: A flare during pregnancy is treated the same as a flare outside of pregnancy. We want to use noninvasive ways to confirm it, but I think we don’t need to overly investigate in most of our women. If they’re already on a biologic, you may consider changing.

Some women may need corticosteroids. It’s not our favorite move, but there is an urgency to getting a flare under control during pregnancy because of possible complications.

Dr. Mahadevan: Some of this is contingent on when during pregnancy the flare occurs. A patient who has a flare at 38 weeks’ gestation will likely proceed with delivery and the flare will be dealt with separately. Someone at 8 weeks’ gestation is at high risk for pregnancy loss, so treatment should be quick and effective.

As does Dr. Dubinsky, I do try to avoid steroids if possible. For example, I would rather start an effective biologic right away than drag out steroids to see if they will respond.

Dr. Kane: I would add that, if a mother is losing weight, she might need to be hospitalized for additional nutritional support. If surgery is necessary, we usually try to time it for the second or third trimester.

What needs to be taken into consideration regarding mode of delivery? Also, if a woman has undergone prior surgeries, do they increase the risk of delivery complications?

For ulcerative colitis, mode of delivery is based on obstetric, not gastrointestinal, variables. For Crohn’s disease, if there is evidence of perianal disease, then a cesarean is appropriate.

If there is no history of perianal disease, then delivery is based on obstetric variables.

For a woman who has a J pouch, if possible, the surgeon who created it should be contacted to ask about the technical aspects of the pouch and how it lies in the pelvis.
 

What’s the risk of a postpartum flare if a woman’s IBD remains in clinical remission during pregnancy?

Dr. Mahadevan: There is no increased risk of postpartum flare if a woman continues her IBD medications after delivery. Many of the reports of flare are from stopping medications (mistakenly often) to breastfeed.

Dr. Kane: As Dr. Mahadevan said, the risk of a flare is usually because a woman stops taking her medications because she thinks that medication will be passed to the infant through breastfeeding, which in most cases is not true.

Otherwise, there is not an increased risk of a flare in a 12-month period. However, it is important to monitor for symptoms after delivery; the risk of a flare is not zero.
 

What symptoms should women watch out for after delivery that may indicate an uptick in disease activity?

Dr. Kane: The same symptoms as before they were pregnant. Diarrhea, abdominal pain, and rectal bleeding are not normal after delivery and should be considered signs of returning disease.

As a gastroenterologist, is there any additional advice you’d offer about conception, fertility, and pregnancy when treating women with IBD?

Dr. Mahadevan: Women with IBD should, when feasible, have a planned pregnancy when in documented remission and under the care of their gastroenterologists, obstetrician, and an MFM specialist. Life happens, and this is not always possible. That said, a woman with IBD has the same chance of getting pregnant as a woman of the same age without IBD, unless she has active disease or a history of pelvic surgery. Women with IBD in remission will generally have healthy pregnancies if they continue appropriate medications.

Dr. Kane: Agreed. The majority of women with IBD will have normal, healthy pregnancies. It is important for them to not stop their IBD therapy without talking to their gastroenterologist first. Well-intentioned but ignorant obstetricians or midwives may recommend stopping, but then panic when disease flares and the mother’s health is at risk. Active inflammation is the worst enemy to a pregnancy, not active therapy.

Dr. Dubinsky: One additional thing to consider is: How do we help women with IBD who have delivered meet the needs of their family and continue to stay on their meds and be in good inflammatory control?

For example, we can give the biologic in the hospital after they’ve had a cesarean or a vaginal delivery and before they leave. We know that that is safe, giving that to them before they leave the hospital is a huge value added.

Another thing is possibly changing their infusions to home infusions. That would be helpful for the moms as well.


Dr. Mahadevan reports being a consultant for AbbVie, Janssen, Pfizer, Gilead, Bristol-Myers Squibb, Takeda, Protagonist, Prometheus, and Boehringer Ingelheim. Dr. Dubinsky is a consultant for AbbVie, Arena, Bristol-Myers Squibb, Janssen, Eli Lilly, Takeda, and Prometheus BioSciences. She is a shareholder and CEO of a publicly traded company, Trellis Health. Dr. Kane is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Takeda, Seres Therapeutics, TechLab, United Healthcare, Predicta-Med, and InveniAI, and is the editor for the IBD section of UptoDate.
 

AGA Resource

Planning for a family can be challenging, and if your patient has IBD, there are additional factors to consider. The AGA IBD Parenthood Project is the “go-to” resource for everything patients need to know about IBD and pregnancy throughout all stages of family planning.

While many gastroenterologists may be comfortable with inflammatory bowel disease (IBD), most are not experts in women’s concerns about pregnancy. One study found that, although women with IBD may have concerns about the interplay of their disease and reproductive health, many have not had extensive conversations with their gastroenterologist about it. In fact, that same study found most women expect their gastroenterologist to initiate these conversations.

GI & Hepatology News sought input from a patient advocate about questions women with IBD often think about but may not always discuss with their gastroenterologists, and then solicited responses from thought leaders in IBD and pregnancy. In this roundtable discussion, Uma Mahadevan, MD, professor of medicine and the director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco; Marla C. Dubinsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York; and Sunanda V. Kane, MD, professor of medicine at Mayo Clinic in Rochester, Minn., share how they respond to these questions in their clinical practice.
 

What should a woman with IBD who is interested in having biological children in the future be thinking about now?

Dr. Mahadevan: Because active disease is associated with lower rates of conception and higher rates of pregnancy loss, women with IBD should first ensure they are in remission. I like to document endoscopic healing with a colonoscopy or sigmoidoscopy, but, if this has been done recently, a fecal calprotectin test can be helpful.

Women with IBD, particularly those with small bowel disease, are at risk for nutritional deficiencies, so prior to conception, I also check vitamin B-12, vitamin D, and iron, and repeat as needed. Zinc and folate can be considered. Those who are underweight should work with a nutritionist to ensure adequate caloric intake.

Dr. Dubinsky: I think it’s also important to stress the importance of taking their IBD medications because they can help patients achieve and maintain disease remission. Uncontrolled inflammation is a key risk factor for spontaneous abortion in the first trimester. Medication we would use in pregnancy is not putting them at risk for spontaneous abortion or congenital anomalies, which is what mothers to be are understandably most concerned about.

I am very honest and transparent with my patients: “About the only thing I need to take care of is you. If you are good, the baby is good.”

Dr. Kane: As Dr. Mahadevan mentioned, women with IBD are at higher risk for vitamin deficiencies, so those need to be corrected before conception. If they smoke, they should stop before conceiving.

There is no increased risk of infertility unless there has been a history of abdominal surgery.

Also, if women are not actively planning on getting pregnant, that would be important to share because some gastroenterologists will avoid certain effective medications if pregnancy is a possibility.

If a woman has had surgery for her IBD, could that make it harder for her to get pregnant?

Dr. Kane: Yes, it can because scar tissue may develop within the pelvis. However, if surgery is indicated to manage a patient’s IBD, then talk to the surgeon about ways that they might be able to reduce the risk of scar tissue formation.

Dr. Dubinsky: One thing to note is that almost all the data of infertility risk and scarring are based on open surgical techniques that involve dissection of the rectum. On the other hand, we don’t yet have enough prospective data on the impact of the modern era of laparoscopic surgery to suggest whether it affects fertility. More data is needed because providers may be giving women old information that is no longer relevant in the modern era.
 

If a woman is experiencing IBD symptoms, should she attempt to conceive?

Dr. Kane: Gastrointestinal symptoms in patients with IBD could be from active disease but also other things, so it’s important to have a thorough check-up to assess if there is active disease or not. Active disease can (but does not always) lead to a more complicated pregnancy, and conception is not recommended while a patient has active IBD.

Dr. Dubinsky: Although some patients feel an urgency to conceive regardless of disease activity, we need to do our due diligence and explain that we need to focus on getting them into the deepest remission possible, including endoscopic findings, biomarkers, and symptoms.

The most important gift you can give your future moms is to optimize the therapy they’re on before they conceive.
 

Is it important for someone who’s working with a gastroenterologist and an obstetrician to also work with a maternal-fetal medicine (MFM) specialist?

Dr. Kane: Having a diagnosis of IBD makes a woman’s pregnancy “high risk” because just having the diagnosis is associated with a higher risk of prematurity and small for gestational age – but importantly, not birth defects. A woman whose IBD is in remission should still have a discussion with an MFM specialist, just so everyone is on the same page.

Dr. Dubinsky: I refer to care with MFM specialists as “tighter monitoring.” I tell my patients that MFM specialists have managed many complex pregnancies and feel confident around the safety of their medications, understand the impact of when the baby may be exposed to certain medications, and will focus on following them more closely.
 

What are the risks of IBD medications during pregnancy and while breastfeeding? Should women stop their medications during pregnancy and breastfeeding?

Dr. Dubinsky: Organogenesis occurs in the first 10 weeks, so any medicines that cross the placenta during that time are up for discussion and debate. Methotrexate and the newer small molecules, such as Janus kinase (JAK) inhibitors and S1P receptor modulators, do cross the placenta during the first trimester and need to be discontinued before conception, sometimes as early as 3 months before conception.

However, biologics are very large proteins and do not cross the placenta until closer to week 27. We are not advocating stopping biologics in advance of conception, or during pregnancy, or during breastfeeding. There is more risk to stopping than continuing.

Dr. Mahadevan: Methotrexate should be stopped at least 3 months prior to conception and should not be taken during pregnancy.

There are limited antibiotic safety data in pregnancy for the longer periods of time used in IBD. I generally prefer amoxicillin/clavulanic acid over ciprofloxacin or metronidazole, but short term (less than 2 weeks) use of any of those three are not contraindicated.

Mesalamine agents and thiopurine monotherapy can be continued through pregnancy and breastfeeding.

Biologic agents, such as anti–tumor necrosis factor, anti-interleukin 23, anti-integrin, and biosimilars, can be continued through pregnancy and during breastfeeding. Given limited exposure in the first trimester, there is no evidence of increased risk of birth defects. As Dr. Dubinsky pointed out, there is active transfer, particularly in the third trimester and minimal transfer in breast milk, but this has not been associated with harm.

Lastly, small molecules, such as the JAK inhibitors tofacitinib and upadacitinib, as well as ozanimod, have virtually no human safety data during pregnancy, and animal data show harm. The use of these agents in pregnancy is not recommended.

Dr. Kane: As Dr. Dubinsky stated, most of the medications our patients take are low risk to continue through pregnancy if the patients are in remission. Although a woman “in remission” on steroids is not really in remission and should not get pregnant until she is on something else.

As far as breastfeeding goes, that should be stopped if the patient is on methotrexate, cyclosporine, or certain antibiotics. If she is on more than 20 mg of prednisone, this can pass to the infant, and a mother should not breastfeed.

Women should avoid fenugreek as a lactation aid, as that contains a compound that can promote bleeding. Lactation cookies are ok.

Otherwise, there are lots of potential benefits to breastfeeding, and I encourage it.
 

How is a flare treated if it occurs during pregnancy?

Dr. Dubinsky: A flare during pregnancy is treated the same as a flare outside of pregnancy. We want to use noninvasive ways to confirm it, but I think we don’t need to overly investigate in most of our women. If they’re already on a biologic, you may consider changing.

Some women may need corticosteroids. It’s not our favorite move, but there is an urgency to getting a flare under control during pregnancy because of possible complications.

Dr. Mahadevan: Some of this is contingent on when during pregnancy the flare occurs. A patient who has a flare at 38 weeks’ gestation will likely proceed with delivery and the flare will be dealt with separately. Someone at 8 weeks’ gestation is at high risk for pregnancy loss, so treatment should be quick and effective.

As does Dr. Dubinsky, I do try to avoid steroids if possible. For example, I would rather start an effective biologic right away than drag out steroids to see if they will respond.

Dr. Kane: I would add that, if a mother is losing weight, she might need to be hospitalized for additional nutritional support. If surgery is necessary, we usually try to time it for the second or third trimester.

What needs to be taken into consideration regarding mode of delivery? Also, if a woman has undergone prior surgeries, do they increase the risk of delivery complications?

For ulcerative colitis, mode of delivery is based on obstetric, not gastrointestinal, variables. For Crohn’s disease, if there is evidence of perianal disease, then a cesarean is appropriate.

If there is no history of perianal disease, then delivery is based on obstetric variables.

For a woman who has a J pouch, if possible, the surgeon who created it should be contacted to ask about the technical aspects of the pouch and how it lies in the pelvis.
 

What’s the risk of a postpartum flare if a woman’s IBD remains in clinical remission during pregnancy?

Dr. Mahadevan: There is no increased risk of postpartum flare if a woman continues her IBD medications after delivery. Many of the reports of flare are from stopping medications (mistakenly often) to breastfeed.

Dr. Kane: As Dr. Mahadevan said, the risk of a flare is usually because a woman stops taking her medications because she thinks that medication will be passed to the infant through breastfeeding, which in most cases is not true.

Otherwise, there is not an increased risk of a flare in a 12-month period. However, it is important to monitor for symptoms after delivery; the risk of a flare is not zero.
 

What symptoms should women watch out for after delivery that may indicate an uptick in disease activity?

Dr. Kane: The same symptoms as before they were pregnant. Diarrhea, abdominal pain, and rectal bleeding are not normal after delivery and should be considered signs of returning disease.

As a gastroenterologist, is there any additional advice you’d offer about conception, fertility, and pregnancy when treating women with IBD?

Dr. Mahadevan: Women with IBD should, when feasible, have a planned pregnancy when in documented remission and under the care of their gastroenterologists, obstetrician, and an MFM specialist. Life happens, and this is not always possible. That said, a woman with IBD has the same chance of getting pregnant as a woman of the same age without IBD, unless she has active disease or a history of pelvic surgery. Women with IBD in remission will generally have healthy pregnancies if they continue appropriate medications.

Dr. Kane: Agreed. The majority of women with IBD will have normal, healthy pregnancies. It is important for them to not stop their IBD therapy without talking to their gastroenterologist first. Well-intentioned but ignorant obstetricians or midwives may recommend stopping, but then panic when disease flares and the mother’s health is at risk. Active inflammation is the worst enemy to a pregnancy, not active therapy.

Dr. Dubinsky: One additional thing to consider is: How do we help women with IBD who have delivered meet the needs of their family and continue to stay on their meds and be in good inflammatory control?

For example, we can give the biologic in the hospital after they’ve had a cesarean or a vaginal delivery and before they leave. We know that that is safe, giving that to them before they leave the hospital is a huge value added.

Another thing is possibly changing their infusions to home infusions. That would be helpful for the moms as well.


Dr. Mahadevan reports being a consultant for AbbVie, Janssen, Pfizer, Gilead, Bristol-Myers Squibb, Takeda, Protagonist, Prometheus, and Boehringer Ingelheim. Dr. Dubinsky is a consultant for AbbVie, Arena, Bristol-Myers Squibb, Janssen, Eli Lilly, Takeda, and Prometheus BioSciences. She is a shareholder and CEO of a publicly traded company, Trellis Health. Dr. Kane is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Takeda, Seres Therapeutics, TechLab, United Healthcare, Predicta-Med, and InveniAI, and is the editor for the IBD section of UptoDate.
 

AGA Resource

Planning for a family can be challenging, and if your patient has IBD, there are additional factors to consider. The AGA IBD Parenthood Project is the “go-to” resource for everything patients need to know about IBD and pregnancy throughout all stages of family planning.

While many gastroenterologists may be comfortable with inflammatory bowel disease (IBD), most are not experts in women’s concerns about pregnancy. One study found that, although women with IBD may have concerns about the interplay of their disease and reproductive health, many have not had extensive conversations with their gastroenterologist about it. In fact, that same study found most women expect their gastroenterologist to initiate these conversations.

GI & Hepatology News sought input from a patient advocate about questions women with IBD often think about but may not always discuss with their gastroenterologists, and then solicited responses from thought leaders in IBD and pregnancy. In this roundtable discussion, Uma Mahadevan, MD, professor of medicine and the director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco; Marla C. Dubinsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York; and Sunanda V. Kane, MD, professor of medicine at Mayo Clinic in Rochester, Minn., share how they respond to these questions in their clinical practice.
 

What should a woman with IBD who is interested in having biological children in the future be thinking about now?

Dr. Mahadevan: Because active disease is associated with lower rates of conception and higher rates of pregnancy loss, women with IBD should first ensure they are in remission. I like to document endoscopic healing with a colonoscopy or sigmoidoscopy, but, if this has been done recently, a fecal calprotectin test can be helpful.

Women with IBD, particularly those with small bowel disease, are at risk for nutritional deficiencies, so prior to conception, I also check vitamin B-12, vitamin D, and iron, and repeat as needed. Zinc and folate can be considered. Those who are underweight should work with a nutritionist to ensure adequate caloric intake.

Dr. Dubinsky: I think it’s also important to stress the importance of taking their IBD medications because they can help patients achieve and maintain disease remission. Uncontrolled inflammation is a key risk factor for spontaneous abortion in the first trimester. Medication we would use in pregnancy is not putting them at risk for spontaneous abortion or congenital anomalies, which is what mothers to be are understandably most concerned about.

I am very honest and transparent with my patients: “About the only thing I need to take care of is you. If you are good, the baby is good.”

Dr. Kane: As Dr. Mahadevan mentioned, women with IBD are at higher risk for vitamin deficiencies so those need to be corrected before conception. If they smoke, they should stop before conceiving.

There is no increased risk of infertility unless there has been a history of abdominal surgery.

Also, if women are not actively planning on getting pregnant, that would be important to share because some gastroenterologists will avoid certain effective medications if pregnancy is a possibility.

If a woman has had surgery for her IBD, could that make it harder for her to get pregnant?

Dr. Kane: Yes, it can because scar tissue may develop within the pelvis. However, if surgery is indicated to manage a patient’s IBD, then talk to the surgeon about ways that they might be able to reduce the risk of scar tissue formation.

Dr. Dubinsky: One thing to note is that almost all the data of infertility risk and scarring are based on open surgical techniques that involve dissection of the rectum. On the other hand, we don’t yet have enough prospective data on the impact of the modern era of laparoscopic surgery to suggest whether it affects fertility. More data is needed because providers may be giving women old information that is no longer relevant in the modern era.
 

If a woman is experiencing IBD symptoms, should she attempt to conceive?

Dr. Kane: Gastrointestinal symptoms in patients with IBD could be from active disease but also other things, so it’s important to have a thorough check-up to assess if there is active disease or not. Active disease can (but does not always) lead to a more complicated pregnancy, and conception is not recommended while a patient has active IBD.

Dr. Dubinsky: Although some patients feel an urgency to conceive regardless of disease activity, we need to do our due diligence and explain that we need to focus on getting them into the deepest remission possible, including endoscopic findings, biomarkers, and symptoms.

The most important gift you can give your future moms is to optimize the therapy they’re on before they conceive.
 

Is it important for someone who’s working with a gastroenterologist and an obstetrician to also work with a maternal-fetal medicine (MFM) specialist?

Dr. Kane: Having a diagnosis of IBD makes a woman’s pregnancy “high risk” because just having the diagnosis is associated with a higher risk of prematurity and small for gestational age – but importantly, not birth defects. A woman whose IBD is in remission should still have a discussion with an MFM specialist, just so everyone is on the same page.

Dr. Dubinsky: I refer to care with MFM specialists as “tighter monitoring.” I tell my patients that MFM specialists have managed many complex pregnancies and feel confident around the safety of their medications, understand the impact of when the baby may be exposed to certain medications, and will focus on following them more closely.
 

What are the risks of IBD medications during pregnancy and while breastfeeding? Should women stop their medications during pregnancy and breastfeeding?

Dr. Dubinsky: Organogenesis occurs in the first 10 weeks, so any medicines that cross the placenta during that time are up for discussion and debate. Methotrexate and the newer small molecules, such as Janus kinase (JAK) inhibitors and S1P receptor modulators, do cross the placenta during the first trimester and need to be discontinued before conception, sometimes as early as 3 months before conception.

However, biologics are very large proteins and do not cross the placenta until closer to week 27. We are not advocating stopping biologics in advance of conception, or during pregnancy, or during breastfeeding. There is more risk to stopping than continuing.

Dr. Mahadevan: Methotrexate should be stopped at least 3 months prior to conception and should not be taken during pregnancy.

There are limited antibiotic safety data in pregnancy for the longer periods of time used in IBD. I generally prefer amoxicillin/clavulanic acid over ciprofloxacin or metronidazole, but short term (less than 2 weeks) use of any of those three are not contraindicated.

Mesalamine agents and thiopurine monotherapy can be continued through pregnancy and breastfeeding.

Biologic agents, such as anti–tumor necrosis factor, anti-interleukin 23, anti-integrin, and biosimilars, can be continued through pregnancy and during breastfeeding. Given limited exposure in the first trimester, there is no evidence of increased risk of birth defects. As Dr. Dubinsky pointed out, there is active transfer, particularly in the third trimester and minimal transfer in breast milk, but this has not been associated with harm.

Lastly, small molecules, such as the JAK inhibitors tofacitinib and upadacitinib, as well as ozanimod, have virtually no human safety data during pregnancy, and animal data show harm. The use of these agents in pregnancy is not recommended.

Dr. Kane: As Dr. Dubinsky stated, most of the medications our patients take are low risk to continue through pregnancy if the patients are in remission. Although a woman “in remission” on steroids is not really in remission and should not get pregnant until she is on something else.

As far as breastfeeding goes, that should be stopped if the patient is on methotrexate, cyclosporine, or certain antibiotics. If she is on more than 20 mg of prednisone this can pass to the infant, and a mother should not breastfeed.

Women should avoid fenugreek as a lactation aid, as that contains a compound that can promote bleeding. Lactation cookies are ok.

Otherwise, there are lots of potential benefits to breastfeeding, and I encourage it.
 

How is a flare treated if it occurs during pregnancy?

Dr. Dubinsky: A flare during pregnancy is treated the same as a flare outside of pregnancy. We want to use noninvasive ways to confirm it, but I think we don’t need to overly investigate in most of our women. If they’re already on a biologic, you may consider changing.

Some women may need corticosteroids. It’s not our favorite move, but there is an urgency to getting a flare under control during pregnancy because of possible complications.

Dr. Mahadevan: Some of this is contingent on when during pregnancy the flare occurs. A patient who has a flare at 38 weeks’ gestation will likely proceed with delivery and the flare will be dealt with separately. Someone at 8 weeks’ gestation is at high risk for pregnancy loss, so treatment should be quick and effective.

As does Dr. Dubinsky, I do try to avoid steroids if possible. For example, I would rather start an effective biologic right away than drag out steroids to see if they will respond.

Dr. Kane: I would add that, if a mother is losing weight, she might need to be hospitalized for additional nutritional support. If surgery is necessary, we usually try to time it for the second or third trimester.

What needs to be taken into consideration regarding mode of delivery? Also, if a woman has undergone prior surgeries, do they increase the risk of delivery complications?

For ulcerative colitis, mode of delivery is based on obstetric, not gastrointestinal, variables. For Crohn’s disease, if there is evidence of perianal disease, then a cesarean is appropriate.

If there is no history of perianal disease, then delivery is based on obstetric variables.

For a woman who has a J pouch, if possible, the surgeon who created it should be contacted to ask about the technical aspects of the pouch and how it lies in the pelvis.
 

What’s the risk of a postpartum flare if a woman’s IBD remains in clinical remission during pregnancy?

Dr. Mahadevan: There is no increased risk of postpartum flare if a woman continues her IBD medications after delivery. Many of the reports of flare are from stopping medications (mistakenly often) to breastfeed.

Dr. Kane: As Dr. Mahadevan said, the risk of a flare is usually because a woman stops taking her medications because she thinks that medication will be passed to the infant through breastfeeding, which in most cases is not true.

Otherwise, there is not an increased risk of a flare in a 12-month period. However, it is important to monitor for symptoms after delivery; the risk of a flare is not zero.
 

What symptoms should women watch out for after delivery that may indicate an uptick in disease activity?

Dr. Kane: The same symptoms as before they were pregnant. Diarrhea, abdominal pain, and rectal bleeding are not normal after delivery and should be considered signs of returning disease.

As a gastroenterologist, is there any additional advice you’d offer about conception, fertility, and pregnancy when treating women with IBD?

Dr. Mahadevan: Women with IBD should, when feasible, have a planned pregnancy when in documented remission and under the care of their gastroenterologists, obstetrician, and an MFM specialist. Life happens, and this is not always possible. That said, a woman with IBD has the same chance of getting pregnant as a woman of the same age without IBD, unless she has active disease or a history of pelvic surgery. Women with IBD in remission will generally have healthy pregnancies if they continue appropriate medications.

Dr. Kane: Agreed. The majority of women with IBD will have normal, healthy pregnancies. It is important for them to not stop their IBD therapy without talking to their gastroenterologist first. Well-intentioned but ignorant obstetricians or midwives may recommend stopping, but then panic when disease flares and the mother’s health is at risk. Active inflammation is the worst enemy to a pregnancy, not active therapy.

Dr. Dubinsky: One additional thing to consider is: How do we help women with IBD who have delivered meet the needs of their family and continue to stay on their meds and be in good inflammatory control?

For example, we can give the biologic in the hospital after they’ve had a cesarean or a vaginal delivery and before they leave. We know that that is safe, giving that to them before they leave the hospital is a huge value added.

Another thing is possibly changing their infusions to home infusions. That would be helpful for the moms as well.

Dr. Mahadevan reports being a consultant for AbbVie, Janssen, Pfizer, Gilead, Bristol-Myers Squibb, Takeda, Protagonist, Prometheus, and Boehringer Ingelheim. Dr. Dubinsky is a consultant for AbbVie, Arena, Bristol-Myers Squibb, Janssen, Eli Lilly, Takeda, and Prometheus BioSciences. She is a shareholder and CEO of a publicly traded company, Trellis Health. Dr. Kane is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Takeda, Seres Therapeutics, TechLab, United Healthcare, Predicta-Med, and InveniAI, and is the editor for the IBD section of UptoDate.

While many gastroenterologists may be comfortable with inflammatory bowel disease (IBD), most are not experts in women’s concerns about pregnancy. One study found that, although women with IBD may have concerns about the interplay of their disease and reproductive health, many have not had extensive conversations with their gastroenterologist about it. In fact, that same study found most women expect their gastroenterologist to initiate these conversations.

GI & Hepatology News sought input from a patient advocate about questions women with IBD often think about but may not always discuss with their gastroenterologists, and then solicited responses from thought leaders in IBD and pregnancy. In this roundtable discussion, Uma Mahadevan, MD, professor of medicine and the director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco; Marla C. Dubinsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York; and Sunanda V. Kane, MD, professor of medicine at Mayo Clinic in Rochester, Minn., share how they respond to these questions in their clinical practice.
 

What should a woman with IBD who is interested in having biological children in the future be thinking about now?

Dr. Mahadevan: Because active disease is associated with lower rates of conception and higher rates of pregnancy loss, women with IBD should first ensure they are in remission. I like to document endoscopic healing with a colonoscopy or sigmoidoscopy, but, if this has been done recently, a fecal calprotectin test can be helpful.

Women with IBD, particularly those with small bowel disease, are at risk for nutritional deficiencies, so prior to conception, I also check vitamin B-12, vitamin D, and iron, and repeat as needed. Zinc and folate can be considered. Those who are underweight should work with a nutritionist to ensure adequate caloric intake.

Dr. Dubinsky: I think it’s also important to stress the importance of taking their IBD medications because they can help patients achieve and maintain disease remission. Uncontrolled inflammation is a key risk factor for spontaneous abortion in the first trimester. Medication we would use in pregnancy is not putting them at risk for spontaneous abortion or congenital anomalies, which is what mothers to be are understandably most concerned about.

I am very honest and transparent with my patients: “About the only thing I need to take care of is you. If you are good, the baby is good.”

Dr. Kane: As Dr. Mahadevan mentioned, women with IBD are at higher risk for vitamin deficiencies so those need to be corrected before conception. If they smoke, they should stop before conceiving.

There is no increased risk of infertility unless there has been a history of abdominal surgery.

Also, if women are not actively planning on getting pregnant, that would be important to share because some gastroenterologists will avoid certain effective medications if pregnancy is a possibility.

If a woman has had surgery for her IBD, could that make it harder for her to get pregnant?

Dr. Kane: Yes, it can because scar tissue may develop within the pelvis. However, if surgery is indicated to manage a patient’s IBD, then talk to the surgeon about ways that they might be able to reduce the risk of scar tissue formation.

Dr. Dubinsky: One thing to note is that almost all the data of infertility risk and scarring are based on open surgical techniques that involve dissection of the rectum. On the other hand, we don’t yet have enough prospective data on the impact of the modern era of laparoscopic surgery to suggest whether it affects fertility. More data is needed because providers may be giving women old information that is no longer relevant in the modern era.
 

If a woman is experiencing IBD symptoms, should she attempt to conceive?

Dr. Kane: Gastrointestinal symptoms in patients with IBD could be from active disease but also other things, so it’s important to have a thorough check-up to assess if there is active disease or not. Active disease can (but does not always) lead to a more complicated pregnancy, and conception is not recommended while a patient has active IBD.

Dr. Dubinsky: Although some patients feel an urgency to conceive regardless of disease activity, we need to do our due diligence and explain that we need to focus on getting them into the deepest remission possible, including endoscopic findings, biomarkers, and symptoms.

The most important gift you can give your future moms is to optimize the therapy they’re on before they conceive.
 

Is it important for someone who’s working with a gastroenterologist and an obstetrician to also work with a maternal-fetal medicine (MFM) specialist?

Dr. Kane: Having a diagnosis of IBD makes a woman’s pregnancy “high risk” because just having the diagnosis is associated with a higher risk of prematurity and small for gestational age – but importantly, not birth defects. A woman whose IBD is in remission should still have a discussion with an MFM specialist, just so everyone is on the same page.

Dr. Dubinsky: I refer to care with MFM specialists as “tighter monitoring.” I tell my patients that MFM specialists have managed many complex pregnancies and feel confident around the safety of their medications, understand the impact of when the baby may be exposed to certain medications, and will focus on following them more closely.
 

What are the risks of IBD medications during pregnancy and while breastfeeding? Should women stop their medications during pregnancy and breastfeeding?

Dr. Dubinsky: Organogenesis occurs in the first 10 weeks, so any medicines that cross the placenta during that time are up for discussion and debate. Methotrexate and the newer small molecules, such as Janus kinase (JAK) inhibitors and S1P receptor modulators, do cross the placenta during the first trimester and need to be discontinued before conception, sometimes as early as 3 months before conception.

However, biologics are very large proteins and do not cross the placenta until closer to week 27. We are not advocating stopping biologics in advance of conception, or during pregnancy, or during breastfeeding. There is more risk to stopping than continuing.

Dr. Mahadevan: Methotrexate should be stopped at least 3 months prior to conception and should not be taken during pregnancy.

There are limited antibiotic safety data in pregnancy for the longer periods of time used in IBD. I generally prefer amoxicillin/clavulanic acid over ciprofloxacin or metronidazole, but short term (less than 2 weeks) use of any of those three are not contraindicated.

Mesalamine agents and thiopurine monotherapy can be continued through pregnancy and breastfeeding.

Biologic agents, such as anti–tumor necrosis factor, anti-interleukin 23, anti-integrin, and biosimilars, can be continued through pregnancy and during breastfeeding. Given limited exposure in the first trimester, there is no evidence of increased risk of birth defects. As Dr. Dubinsky pointed out, there is active transfer, particularly in the third trimester and minimal transfer in breast milk, but this has not been associated with harm.

Lastly, small molecules, such as the JAK inhibitors tofacitinib and upadacitinib, as well as ozanimod, have virtually no human safety data during pregnancy, and animal data show harm. The use of these agents in pregnancy is not recommended.

Dr. Kane: As Dr. Dubinsky stated, most of the medications our patients take are low risk to continue through pregnancy if the patients are in remission. Although a woman “in remission” on steroids is not really in remission and should not get pregnant until she is on something else.

As far as breastfeeding goes, that should be stopped if the patient is on methotrexate, cyclosporine, or certain antibiotics. If she is on more than 20 mg of prednisone this can pass to the infant, and a mother should not breastfeed.

Women should avoid fenugreek as a lactation aid, as that contains a compound that can promote bleeding. Lactation cookies are ok.

Otherwise, there are lots of potential benefits to breastfeeding, and I encourage it.
 

How is a flare treated if it occurs during pregnancy?

Dr. Dubinsky: A flare during pregnancy is treated the same as a flare outside of pregnancy. We want to use noninvasive ways to confirm it, but I think we don’t need to overly investigate in most of our women. If they’re already on a biologic, you may consider changing.

Some women may need corticosteroids. It’s not our favorite move, but there is an urgency to getting a flare under control during pregnancy because of possible complications.

Dr. Mahadevan: Some of this is contingent on when during pregnancy the flare occurs. A patient who has a flare at 38 weeks’ gestation will likely proceed with delivery and the flare will be dealt with separately. Someone at 8 weeks’ gestation is at high risk for pregnancy loss, so treatment should be quick and effective.

As does Dr. Dubinsky, I do try to avoid steroids if possible. For example, I would rather start an effective biologic right away than drag out steroids to see if they will respond.

Dr. Kane: I would add that, if a mother is losing weight, she might need to be hospitalized for additional nutritional support. If surgery is necessary, we usually try to time it for the second or third trimester.

What needs to be taken into consideration regarding mode of delivery? Also, if a woman has undergone prior surgeries, do they increase the risk of delivery complications?

For ulcerative colitis, mode of delivery is based on obstetric, not gastrointestinal, variables. For Crohn’s disease, if there is evidence of perianal disease, then a cesarean is appropriate.

If there is no history of perianal disease, then delivery is based on obstetric variables.

For a woman who has a J pouch, if possible, the surgeon who created it should be contacted to ask about the technical aspects of the pouch and how it lies in the pelvis.
 

What’s the risk of a postpartum flare if a woman’s IBD remains in clinical remission during pregnancy?

Dr. Mahadevan: There is no increased risk of postpartum flare if a woman continues her IBD medications after delivery. Many of the reports of flare are from stopping medications (mistakenly often) to breastfeed.

Dr. Kane: As Dr. Mahadevan said, the risk of a flare is usually because a woman stops taking her medications because she thinks that medication will be passed to the infant through breastfeeding, which in most cases is not true.

Otherwise, there is not an increased risk of a flare in a 12-month period. However, it is important to monitor for symptoms after delivery; the risk of a flare is not zero.
 

What symptoms should women watch out for after delivery that may indicate an uptick in disease activity?

Dr. Kane: The same symptoms as before they were pregnant. Diarrhea, abdominal pain, and rectal bleeding are not normal after delivery and should be considered signs of returning disease.

As a gastroenterologist, is there any additional advice you’d offer about conception, fertility, and pregnancy when treating women with IBD?

Dr. Mahadevan: Women with IBD should, when feasible, have a planned pregnancy when in documented remission and under the care of their gastroenterologists, obstetrician, and an MFM specialist. Life happens, and this is not always possible. That said, a woman with IBD has the same chance of getting pregnant as a woman of the same age without IBD, unless she has active disease or a history of pelvic surgery. Women with IBD in remission will generally have healthy pregnancies if they continue appropriate medications.

Dr. Kane: Agreed. The majority of women with IBD will have normal, healthy pregnancies. It is important for them to not stop their IBD therapy without talking to their gastroenterologist first. Well-intentioned but ignorant obstetricians or midwives may recommend stopping, but then panic when disease flares and the mother’s health is at risk. Active inflammation is the worst enemy to a pregnancy, not active therapy.

Dr. Dubinsky: One additional thing to consider is: How do we help women with IBD who have delivered meet the needs of their family and continue to stay on their meds and be in good inflammatory control?

For example, we can give the biologic in the hospital after they’ve had a cesarean or a vaginal delivery and before they leave. We know that that is safe, giving that to them before they leave the hospital is a huge value added.

Another thing is possibly changing their infusions to home infusions. That would be helpful for the moms as well.

Dr. Mahadevan reports being a consultant for AbbVie, Janssen, Pfizer, Gilead, Bristol-Myers Squibb, Takeda, Protagonist, Prometheus, and Boehringer Ingelheim. Dr. Dubinsky is a consultant for AbbVie, Arena, Bristol-Myers Squibb, Janssen, Eli Lilly, Takeda, and Prometheus BioSciences. She is a shareholder and CEO of a publicly traded company, Trellis Health. Dr. Kane is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Takeda, Seres Therapeutics, TechLab, United Healthcare, Predicta-Med, and InveniAI, and is the editor for the IBD section of UptoDate.

While many gastroenterologists may be comfortable with inflammatory bowel disease (IBD), most are not experts in women’s concerns about pregnancy. One study found that, although women with IBD may have concerns about the interplay of their disease and reproductive health, many have not had extensive conversations with their gastroenterologist about it. In fact, that same study found most women expect their gastroenterologist to initiate these conversations.

GI & Hepatology News sought input from a patient advocate about questions women with IBD often think about but may not always discuss with their gastroenterologists, and then solicited responses from thought leaders in IBD and pregnancy. In this roundtable discussion, Uma Mahadevan, MD, professor of medicine and the director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco; Marla C. Dubinsky, MD, professor of medicine at the Icahn School of Medicine at Mount Sinai, New York; and Sunanda V. Kane, MD, professor of medicine at Mayo Clinic in Rochester, Minn., share how they respond to these questions in their clinical practice.
 

What should a woman with IBD who is interested in having biological children in the future be thinking about now?

Dr. Mahadevan: Because active disease is associated with lower rates of conception and higher rates of pregnancy loss, women with IBD should first ensure they are in remission. I like to document endoscopic healing with a colonoscopy or sigmoidoscopy, but, if this has been done recently, a fecal calprotectin test can be helpful.

Women with IBD, particularly those with small bowel disease, are at risk for nutritional deficiencies, so prior to conception, I also check vitamin B-12, vitamin D, and iron, and repeat as needed. Zinc and folate can be considered. Those who are underweight should work with a nutritionist to ensure adequate caloric intake.

Dr. Dubinsky: I think it’s also important to stress the importance of taking their IBD medications because they can help patients achieve and maintain disease remission. Uncontrolled inflammation is a key risk factor for spontaneous abortion in the first trimester. Medication we would use in pregnancy is not putting them at risk for spontaneous abortion or congenital anomalies, which is what mothers to be are understandably most concerned about.

I am very honest and transparent with my patients: “About the only thing I need to take care of is you. If you are good, the baby is good.”

Dr. Kane: As Dr. Mahadevan mentioned, women with IBD are at higher risk for vitamin deficiencies so those need to be corrected before conception. If they smoke, they should stop before conceiving.

There is no increased risk of infertility unless there has been a history of abdominal surgery.

Also, if women are not actively planning on getting pregnant, that would be important to share because some gastroenterologists will avoid certain effective medications if pregnancy is a possibility.

If a woman has had surgery for her IBD, could that make it harder for her to get pregnant?

Dr. Kane: Yes, it can because scar tissue may develop within the pelvis. However, if surgery is indicated to manage a patient’s IBD, then talk to the surgeon about ways that they might be able to reduce the risk of scar tissue formation.

Dr. Dubinsky: One thing to note is that almost all the data of infertility risk and scarring are based on open surgical techniques that involve dissection of the rectum. On the other hand, we don’t yet have enough prospective data on the impact of the modern era of laparoscopic surgery to suggest whether it affects fertility. More data is needed because providers may be giving women old information that is no longer relevant in the modern era.
 

If a woman is experiencing IBD symptoms, should she attempt to conceive?

Dr. Kane: Gastrointestinal symptoms in patients with IBD could be from active disease but also other things, so it’s important to have a thorough check-up to assess if there is active disease or not. Active disease can (but does not always) lead to a more complicated pregnancy, and conception is not recommended while a patient has active IBD.

Dr. Dubinsky: Although some patients feel an urgency to conceive regardless of disease activity, we need to do our due diligence and explain that we need to focus on getting them into the deepest remission possible, including endoscopic findings, biomarkers, and symptoms.

The most important gift you can give your future moms is to optimize the therapy they’re on before they conceive.
 

Is it important for someone who’s working with a gastroenterologist and an obstetrician to also work with a maternal-fetal medicine (MFM) specialist?

Dr. Kane: Having a diagnosis of IBD makes a woman’s pregnancy “high risk” because just having the diagnosis is associated with a higher risk of prematurity and small for gestational age – but importantly, not birth defects. A woman whose IBD is in remission should still have a discussion with an MFM specialist, just so everyone is on the same page.

Dr. Dubinsky: I refer to care with MFM specialists as “tighter monitoring.” I tell my patients that MFM specialists have managed many complex pregnancies and feel confident around the safety of their medications, understand the impact of when the baby may be exposed to certain medications, and will focus on following them more closely.
 

What are the risks of IBD medications during pregnancy and while breastfeeding? Should women stop their medications during pregnancy and breastfeeding?

Dr. Dubinsky: Organogenesis occurs in the first 10 weeks, so any medicines that cross the placenta during that time are up for discussion and debate. Methotrexate and the newer small molecules, such as Janus kinase (JAK) inhibitors and S1P receptor modulators, do cross the placenta during the first trimester and need to be discontinued before conception, sometimes as early as 3 months before conception.

However, biologics are very large proteins and do not cross the placenta until closer to week 27. We are not advocating stopping biologics in advance of conception, or during pregnancy, or during breastfeeding. There is more risk to stopping than continuing.

Dr. Mahadevan: Methotrexate should be stopped at least 3 months prior to conception and should not be taken during pregnancy.

There are limited antibiotic safety data in pregnancy for the longer periods of time used in IBD. I generally prefer amoxicillin/clavulanic acid over ciprofloxacin or metronidazole, but short term (less than 2 weeks) use of any of those three are not contraindicated.

Mesalamine agents and thiopurine monotherapy can be continued through pregnancy and breastfeeding.

Biologic agents, such as anti–tumor necrosis factor, anti-interleukin 23, anti-integrin, and biosimilars, can be continued through pregnancy and during breastfeeding. Given limited exposure in the first trimester, there is no evidence of increased risk of birth defects. As Dr. Dubinsky pointed out, there is active transfer, particularly in the third trimester and minimal transfer in breast milk, but this has not been associated with harm.

Lastly, small molecules, such as the JAK inhibitors tofacitinib and upadacitinib, as well as ozanimod, have virtually no human safety data during pregnancy, and animal data show harm. The use of these agents in pregnancy is not recommended.

Dr. Kane: As Dr. Dubinsky stated, most of the medications our patients take are low risk to continue through pregnancy if the patients are in remission. Although a woman “in remission” on steroids is not really in remission and should not get pregnant until she is on something else.

As far as breastfeeding goes, that should be stopped if the patient is on methotrexate, cyclosporine, or certain antibiotics. If she is on more than 20 mg of prednisone this can pass to the infant, and a mother should not breastfeed.

Women should avoid fenugreek as a lactation aid, as that contains a compound that can promote bleeding. Lactation cookies are ok.

Otherwise, there are lots of potential benefits to breastfeeding, and I encourage it.
 

How is a flare treated if it occurs during pregnancy?

Dr. Dubinsky: A flare during pregnancy is treated the same as a flare outside of pregnancy. We want to use noninvasive ways to confirm it, but I think we don’t need to overly investigate in most of our women. If they’re already on a biologic, you may consider changing.

Some women may need corticosteroids. It’s not our favorite move, but there is an urgency to getting a flare under control during pregnancy because of possible complications.

Dr. Mahadevan: Some of this is contingent on when during pregnancy the flare occurs. A patient who has a flare at 38 weeks’ gestation will likely proceed with delivery and the flare will be dealt with separately. Someone at 8 weeks’ gestation is at high risk for pregnancy loss, so treatment should be quick and effective.

As does Dr. Dubinsky, I do try to avoid steroids if possible. For example, I would rather start an effective biologic right away than drag out steroids to see if they will respond.

Dr. Kane: I would add that, if a mother is losing weight, she might need to be hospitalized for additional nutritional support. If surgery is necessary, we usually try to time it for the second or third trimester.

What needs to be taken into consideration regarding mode of delivery? Also, if a woman has undergone prior surgeries, do they increase the risk of delivery complications?

For ulcerative colitis, mode of delivery is based on obstetric, not gastrointestinal, variables. For Crohn’s disease, if there is evidence of perianal disease, then a cesarean is appropriate.

If there is no history of perianal disease, then delivery is based on obstetric variables.

For a woman who has a J pouch, if possible, the surgeon who created it should be contacted to ask about the technical aspects of the pouch and how it lies in the pelvis.
 

What’s the risk of a postpartum flare if a woman’s IBD remains in clinical remission during pregnancy?

Dr. Mahadevan: There is no increased risk of postpartum flare if a woman continues her IBD medications after delivery. Many of the reports of flare are from stopping medications (mistakenly often) to breastfeed.

Dr. Kane: As Dr. Mahadevan said, the risk of a flare is usually because a woman stops taking her medications because she thinks that medication will be passed to the infant through breastfeeding, which in most cases is not true.

Otherwise, there is not an increased risk of a flare in a 12-month period. However, it is important to monitor for symptoms after delivery; the risk of a flare is not zero.
 

What symptoms should women watch out for after delivery that may indicate an uptick in disease activity?

Dr. Kane: The same symptoms as before they were pregnant. Diarrhea, abdominal pain, and rectal bleeding are not normal after delivery and should be considered signs of returning disease.

As a gastroenterologist, is there any additional advice you’d offer about conception, fertility, and pregnancy when treating women with IBD?

Dr. Mahadevan: Women with IBD should, when feasible, have a planned pregnancy when in documented remission and under the care of their gastroenterologists, obstetrician, and an MFM specialist. Life happens, and this is not always possible. That said, a woman with IBD has the same chance of getting pregnant as a woman of the same age without IBD, unless she has active disease or a history of pelvic surgery. Women with IBD in remission will generally have healthy pregnancies if they continue appropriate medications.

Dr. Kane: Agreed. The majority of women with IBD will have normal, healthy pregnancies. It is important for them to not stop their IBD therapy without talking to their gastroenterologist first. Well-intentioned but ignorant obstetricians or midwives may recommend stopping, but then panic when disease flares and the mother’s health is at risk. Active inflammation is the worst enemy to a pregnancy, not active therapy.

Dr. Dubinsky: One additional thing to consider is: How do we help women with IBD who have delivered meet the needs of their family and continue to stay on their meds and be in good inflammatory control?

For example, we can give the biologic in the hospital after they’ve had a cesarean or a vaginal delivery and before they leave. We know that that is safe, giving that to them before they leave the hospital is a huge value added.

Another thing is possibly changing their infusions to home infusions. That would be helpful for the moms as well.

Dr. Mahadevan reports being a consultant for AbbVie, Janssen, Pfizer, Gilead, Bristol-Myers Squibb, Takeda, Protagonist, Prometheus, and Boehringer Ingelheim. Dr. Dubinsky is a consultant for AbbVie, Arena, Bristol-Myers Squibb, Janssen, Eli Lilly, Takeda, and Prometheus BioSciences. She is a shareholder and CEO of a publicly traded company, Trellis Health. Dr. Kane is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Janssen, Takeda, Seres Therapeutics, TechLab, United Healthcare, Predicta-Med, and InveniAI, and is the editor for the IBD section of UptoDate.

Meditation has become a popular practice in the United States over the last decade. It is not limited to adults, but can be learned and practiced by children and teenagers also. Variants are being used in many schools as parts of a social and emotional learning curriculum, and different kinds of mindfulness practices are common parts of psychological treatments. In this month’s column, we will review the evidence that supports the efficacy of a meditation practice to treat the mental health problems that are common in children and adolescents, and review how it might be a useful adjunct to the screening, education, and treatments that you offer your young patients.

There are many different types of meditation practices, but the unifying feature is known as mindfulness. Most broadly, mindfulness refers to a state of nonjudgmental awareness of one’s thoughts, feelings, or sensations. A mindfulness meditation practice involves physical stillness and focused attention, typically on the physical sensations of one’s breath. When thoughts, feelings, or physical sensations intrude on the stillness, one learns to cultivate a nonjudgmental awareness of those experiences without disrupting the state of quiet concentration. It could be said that meditation is easy to learn and difficult to master, and that is why it should be practiced regularly. Part of its growing popularity has undoubtedly been served by the ease with which people can access a variety of guided meditations (through apps, YouTube, and beyond) that make it relatively easy to access a variety of methods to learn how to practice mindfulness meditation.

The benefits of meditation in adults are well-established, including lower blood pressure, lower rates of heart disease, lower markers of inflammation, better sleep, and self-described levels of well-being. Meditation appears to be especially effective at mitigating the cardiovascular, metabolic, autoimmune, and inflammatory consequences of high-stress or unhealthy lifestyles in adults. Children and adolescents typically do not suffer from these diseases, but there is growing evidence that mindfulness practices can improve self-reported stress management skills, well-being, and sleep in young people; skills that can protect their physical and mental health. In addition, there is some evidence that mindfulness can be effective as a treatment for the common psychiatric illnesses of youth.
 

Anxiety

There is robust evidence for the efficacy of mindfulness-based interventions (including a regular mindfulness meditation practice) in the treatment of anxiety disorders in youth. Multiple studies and meta-analyses have demonstrated significant and sustained improvement in anxiety symptoms in these young patients. This makes sense when one considers that most psychotherapy treatments for anxiety include the cultivation of self-awareness and the ability to recognize the feelings of anxiety. This is critical as youth with anxiety disorders often mistake these feelings for facts. The treatment then shifts toward practice tolerating these feelings to help children develop an appreciation that they can face and manage anxiety and that it does not need to be avoided. Part of tolerating these feelings includes building skills to facilitate calm and physical relaxation in the face of these anxious feelings.

This is the core of exposure-based psychotherapies. Mindfulness practices echo the cultivation of self-awareness with focus and physical calm. Studies have shown that mindfulness-based interventions have significant and lasting effects on the symptoms of anxiety disorders in youth, including those youth with comorbid ADHD and learning disabilities. It is important to be aware that, for youth who have experienced trauma, mindfulness meditation can trigger a flood of re-experiencing phenomena, and it is important that those youth also are receiving treatment for PTSD.
 

Depression

There is evidence that some of the symptoms that occur as part of depression in adolescents improve with mindfulness-based interventions. In particular, symptoms of anger, irritability, disruptive behaviors, suicidality, and even impulsive self-injury improve with mindfulness-based interventions. Dialectical behavioral therapy (DBT) and acceptance and commitment therapy (ACT) have the nonjudgmental self-awareness of mindfulness built in as a component of the therapy. But mindfulness practices without explicit cognitive and behavioral components of psychotherapy for depression are not effective as stand-alone treatment of major depressive disorder in youth.

Multiple meta-analyses have demonstrated that stimulant treatment is more effective than behavioral or environmental interventions in the treatment of ADHD in children and adolescents, and combined treatments have not shown substantial additional improvement over medications alone in randomized controlled studies. But there is a lot of interest in finding effective treatments beyond medications that will help children with ADHD build important cognitive and behavioral skills that may lag developmentally.

Now there is an emerging body of evidence indicating that mindfulness skills in children with ADHD are quite effective for improving their sustained attention, social skills, behavioral control, and even hyperactivity. Additionally, methods to teach mindfulness skills to children who struggle with stillness and focused attention have been developed for these studies (“mindful martial arts”). Again, this intervention has not yet shown the same level of efficacy as medication treatments for ADHD symptoms, but it has demonstrated promise in early trials. Interestingly, it has also shown promise as a component of parenting interventions for youth with ADHD.

You do not need to wait for decisive evidence from randomized controlled trials to recommend mindfulness training for your patients with anxiety, ADHD, or even depression. Indeed, this practice alone may be adequate as a treatment for mild to moderate anxiety disorders. But you can also recommend it as an empowering and effective adjunctive treatment for almost every psychiatric illness and subclinical syndrome, and one that is affordable and easy for families to access. It would be valuable for you to recommend that your patients and their parents both try a mindfulness practice alongside your recommendations about healthy sleep, exercise, and nutrition. There are free apps such as Smiling Mind, Sound Mind, and Thrive Global that families can try together. Some children may need to move physically to be able to practice mindfulness, so yoga or walking meditations can be a better practice for them. When parents can try mindfulness practice alongside their children, it will facilitate their child’s efforts to develop these skills, and the improved sleep, focus, and stress management skills in parents can make a significant difference in the health and well-being of the whole family.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

Meditation has become a popular practice in the United States over the last decade. It is not limited to adults, but can be learned and practiced by children and teenagers also. Variants are being used in many schools as parts of a social and emotional learning curriculum, and different kinds of mindfulness practices are common parts of psychological treatments. In this month’s column, we will review the evidence that supports the efficacy of a meditation practice to treat the mental health problems that are common in children and adolescents, and review how it might be a useful adjunct to the screening, education, and treatments that you offer your young patients.

There are many different types of meditation practices, but the unifying feature is known as mindfulness. Most broadly, mindfulness refers to a state of nonjudgmental awareness of one’s thoughts, feelings, or sensations. A mindfulness meditation practice involves physical stillness and focused attention, typically on the physical sensations of one’s breath. When thoughts, feelings, or physical sensations intrude on the stillness, one learns to cultivate a nonjudgmental awareness of those experiences without disrupting the state of quiet concentration. It could be said that meditation is easy to learn and difficult to master, and that is why it should be practiced regularly. Part of its growing popularity has undoubtedly been served by the ease with which people can access a variety of guided meditations (through apps, YouTube, and beyond) that make it relatively easy to access a variety of methods to learn how to practice mindfulness meditation.

The benefits of meditation in adults are well-established, including lower blood pressure, lower rates of heart disease, lower markers of inflammation, better sleep, and self-described levels of well-being. Meditation appears to be especially effective at mitigating the cardiovascular, metabolic, autoimmune, and inflammatory consequences of high-stress or unhealthy lifestyles in adults. Children and adolescents typically do not suffer from these diseases, but there is growing evidence that mindfulness practices can improve self-reported stress management skills, well-being, and sleep in young people; skills that can protect their physical and mental health. In addition, there is some evidence that mindfulness can be effective as a treatment for the common psychiatric illnesses of youth.
 

Anxiety

There is robust evidence for the efficacy of mindfulness-based interventions (including a regular mindfulness meditation practice) in the treatment of anxiety disorders in youth. Multiple studies and meta-analyses have demonstrated significant and sustained improvement in anxiety symptoms in these young patients. This makes sense when one considers that most psychotherapy treatments for anxiety include the cultivation of self-awareness and the ability to recognize the feelings of anxiety. This is critical as youth with anxiety disorders often mistake these feelings for facts. The treatment then shifts toward practice tolerating these feelings to help children develop an appreciation that they can face and manage anxiety and that it does not need to be avoided. Part of tolerating these feelings includes building skills to facilitate calm and physical relaxation in the face of these anxious feelings.

This is the core of exposure-based psychotherapies. Mindfulness practices echo the cultivation of self-awareness with focus and physical calm. Studies have shown that mindfulness-based interventions have significant and lasting effects on the symptoms of anxiety disorders in youth, including those youth with comorbid ADHD and learning disabilities. It is important to be aware that, for youth who have experienced trauma, mindfulness meditation can trigger a flood of re-experiencing phenomena, and it is important that those youth also are receiving treatment for PTSD.
 

Depression

There is evidence that some of the symptoms that occur as part of depression in adolescents improve with mindfulness-based interventions. In particular, symptoms of anger, irritability, disruptive behaviors, suicidality, and even impulsive self-injury improve with mindfulness-based interventions. Dialectical behavioral therapy (DBT) and acceptance and commitment therapy (ACT) have the nonjudgmental self-awareness of mindfulness built in as a component of the therapy. But mindfulness practices without explicit cognitive and behavioral components of psychotherapy for depression are not effective as stand-alone treatment of major depressive disorder in youth.

Multiple meta-analyses have demonstrated that stimulant treatment is more effective than behavioral or environmental interventions in the treatment of ADHD in children and adolescents, and combined treatments have not shown substantial additional improvement over medications alone in randomized controlled studies. But there is a lot of interest in finding effective treatments beyond medications that will help children with ADHD build important cognitive and behavioral skills that may lag developmentally.

Now there is an emerging body of evidence indicating that mindfulness skills in children with ADHD are quite effective for improving their sustained attention, social skills, behavioral control, and even hyperactivity. Additionally, methods to teach mindfulness skills to children who struggle with stillness and focused attention have been developed for these studies (“mindful martial arts”). Again, this intervention has not yet shown the same level of efficacy as medication treatments for ADHD symptoms, but it has demonstrated promise in early trials. Interestingly, it has also shown promise as a component of parenting interventions for youth with ADHD.

You do not need to wait for decisive evidence from randomized controlled trials to recommend mindfulness training for your patients with anxiety, ADHD, or even depression. Indeed, this practice alone may be adequate as a treatment for mild to moderate anxiety disorders. But you can also recommend it as an empowering and effective adjunctive treatment for almost every psychiatric illness and subclinical syndrome, and one that is affordable and easy for families to access. It would be valuable for you to recommend that your patients and their parents both try a mindfulness practice alongside your recommendations about healthy sleep, exercise, and nutrition. There are free apps such as Smiling Mind, Sound Mind, and Thrive Global that families can try together. Some children may need to move physically to be able to practice mindfulness, so yoga or walking meditations can be a better practice for them. When parents can try mindfulness practice alongside their children, it will facilitate their child’s efforts to develop these skills, and the improved sleep, focus, and stress management skills in parents can make a significant difference in the health and well-being of the whole family.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

Meditation has become a popular practice in the United States over the last decade. It is not limited to adults, but can be learned and practiced by children and teenagers also. Variants are being used in many schools as parts of a social and emotional learning curriculum, and different kinds of mindfulness practices are common parts of psychological treatments. In this month’s column, we will review the evidence that supports the efficacy of a meditation practice to treat the mental health problems that are common in children and adolescents, and review how it might be a useful adjunct to the screening, education, and treatments that you offer your young patients.

There are many different types of meditation practices, but the unifying feature is known as mindfulness. Most broadly, mindfulness refers to a state of nonjudgmental awareness of one’s thoughts, feelings, or sensations. A mindfulness meditation practice involves physical stillness and focused attention, typically on the physical sensations of one’s breath. When thoughts, feelings, or physical sensations intrude on the stillness, one learns to cultivate a nonjudgmental awareness of those experiences without disrupting the state of quiet concentration. It could be said that meditation is easy to learn and difficult to master, and that is why it should be practiced regularly. Part of its growing popularity has undoubtedly been served by the ease with which people can access a variety of guided meditations (through apps, YouTube, and beyond) that make it relatively easy to access a variety of methods to learn how to practice mindfulness meditation.

The benefits of meditation in adults are well-established, including lower blood pressure, lower rates of heart disease, lower markers of inflammation, better sleep, and self-described levels of well-being. Meditation appears to be especially effective at mitigating the cardiovascular, metabolic, autoimmune, and inflammatory consequences of high-stress or unhealthy lifestyles in adults. Children and adolescents typically do not suffer from these diseases, but there is growing evidence that mindfulness practices can improve self-reported stress management skills, well-being, and sleep in young people; skills that can protect their physical and mental health. In addition, there is some evidence that mindfulness can be effective as a treatment for the common psychiatric illnesses of youth.
 

Anxiety

There is robust evidence for the efficacy of mindfulness-based interventions (including a regular mindfulness meditation practice) in the treatment of anxiety disorders in youth. Multiple studies and meta-analyses have demonstrated significant and sustained improvement in anxiety symptoms in these young patients. This makes sense when one considers that most psychotherapy treatments for anxiety include the cultivation of self-awareness and the ability to recognize the feelings of anxiety. This is critical as youth with anxiety disorders often mistake these feelings for facts. The treatment then shifts toward practice tolerating these feelings to help children develop an appreciation that they can face and manage anxiety and that it does not need to be avoided. Part of tolerating these feelings includes building skills to facilitate calm and physical relaxation in the face of these anxious feelings.

This is the core of exposure-based psychotherapies. Mindfulness practices echo the cultivation of self-awareness with focus and physical calm. Studies have shown that mindfulness-based interventions have significant and lasting effects on the symptoms of anxiety disorders in youth, including those youth with comorbid ADHD and learning disabilities. It is important to be aware that, for youth who have experienced trauma, mindfulness meditation can trigger a flood of re-experiencing phenomena, and it is important that those youth also are receiving treatment for PTSD.
 

Depression

There is evidence that some of the symptoms that occur as part of depression in adolescents improve with mindfulness-based interventions. In particular, symptoms of anger, irritability, disruptive behaviors, suicidality, and even impulsive self-injury improve with mindfulness-based interventions. Dialectical behavioral therapy (DBT) and acceptance and commitment therapy (ACT) have the nonjudgmental self-awareness of mindfulness built in as a component of the therapy. But mindfulness practices without explicit cognitive and behavioral components of psychotherapy for depression are not effective as stand-alone treatment of major depressive disorder in youth.

Multiple meta-analyses have demonstrated that stimulant treatment is more effective than behavioral or environmental interventions in the treatment of ADHD in children and adolescents, and combined treatments have not shown substantial additional improvement over medications alone in randomized controlled studies. But there is a lot of interest in finding effective treatments beyond medications that will help children with ADHD build important cognitive and behavioral skills that may lag developmentally.

Now there is an emerging body of evidence indicating that mindfulness skills in children with ADHD are quite effective for improving their sustained attention, social skills, behavioral control, and even hyperactivity. Additionally, methods to teach mindfulness skills to children who struggle with stillness and focused attention have been developed for these studies (“mindful martial arts”). Again, this intervention has not yet shown the same level of efficacy as medication treatments for ADHD symptoms, but it has demonstrated promise in early trials. Interestingly, it has also shown promise as a component of parenting interventions for youth with ADHD.

You do not need to wait for decisive evidence from randomized controlled trials to recommend mindfulness training for your patients with anxiety, ADHD, or even depression. Indeed, this practice alone may be adequate as a treatment for mild to moderate anxiety disorders. But you can also recommend it as an empowering and effective adjunctive treatment for almost every psychiatric illness and subclinical syndrome, and one that is affordable and easy for families to access. It would be valuable for you to recommend that your patients and their parents both try a mindfulness practice alongside your recommendations about healthy sleep, exercise, and nutrition. There are free apps such as Smiling Mind, Sound Mind, and Thrive Global that families can try together. Some children may need to move physically to be able to practice mindfulness, so yoga or walking meditations can be a better practice for them. When parents can try mindfulness practice alongside their children, it will facilitate their child’s efforts to develop these skills, and the improved sleep, focus, and stress management skills in parents can make a significant difference in the health and well-being of the whole family.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

On March 26, 2022, Hawaii became the last state in the United States to lift its indoor mask mandate. By the time the current school year started, there were essentially no public school mask mandates either.

Whether you viewed the mask as an emblem of stalwart defiance against a rampaging virus, or a scarlet letter emblematic of the overreaches of public policy, you probably aren’t seeing them much anymore.

And yet, the debate about masks still rages. Who was right, who was wrong? Who trusted science, and what does the science even say? If we brought our country into marriage counseling, would we be told it is time to move on?  To look forward, not backward? To plan for our bright future together?

Perhaps. But this question isn’t really moot just because masks have largely disappeared in the United States. Variants may emerge that lead to more infection waves – and other pandemics may occur in the future. And so I think it is important to discuss a study that, with quite rigorous analysis, attempts to answer the following question: Did masking in schools lower students’ and teachers’ risk of COVID?

We are talking about this study, appearing in the New England Journal of Medicine. The short version goes like this.

Researchers had access to two important sources of data. One – an accounting of all the teachers and students (more than 300,000 of them) in 79 public, noncharter school districts in Eastern Massachusetts who tested positive for COVID every week. Two – the date that each of those school districts lifted their mask mandates or (in the case of two districts) didn’t.

Right away, I’m sure you’re thinking of potential issues. Districts that kept masks even when the statewide ban was lifted are likely quite a bit different from districts that dropped masks right away. You’re right, of course – hold on to that thought; we’ll get there.

But first – the big question – would districts that kept their masks on longer do better when it comes to the rate of COVID infection?

When everyone was masking, COVID case rates were pretty similar. Statewide mandates are lifted in late February – and most school districts remove their mandates within a few weeks – the black line are the two districts (Boston and Chelsea) where mask mandates remained in place.

As time marched on, the case rates in the various districts spread out – with districts that kept masks on longer doing better than those that took them off, and districts that kept masks on the whole time doing best of all.

Prior to the mask mandate lifting, you see very similar COVID rates in districts that would eventually remove the mandate and those that would not, with a bit of noise around the initial Omicron wave which saw just a huge amount of people get infected.

And then, after the mandate was lifted, separation. Districts that held on to masks longer had lower rates of COVID infection.

In all, over the 15-weeks of the study, there were roughly 12,000 extra cases of COVID in the mask-free school districts, which corresponds to about 35% of the total COVID burden during that time. And, yes, kids do well with COVID – on average. But 12,000 extra cases is enough to translate into a significant number of important clinical outcomes – think hospitalizations and post-COVID syndromes. And of course, maybe most importantly, missed school days. Positive kids were not allowed in class no matter what district they were in.

Okay – I promised we’d address confounders. This was not a cluster-randomized trial, where some school districts had their mandates removed based on the vicissitudes of a virtual coin flip, as much as many of us would have been interested to see that. The decision to remove masks was up to the various school boards – and they had a lot of pressure on them from many different directions. But all we need to worry about is whether any of those things that pressure a school board to keep masks on would ALSO lead to fewer COVID cases. That’s how confounders work, and how you can get false results in a study like this.

And yes – districts that kept the masks on longer were different than those who took them right off. But check out how they were different.

The districts that kept masks on longer had more low-income students. More Black and Latino students. More students per classroom. These are all risk factors that increase the risk of COVID infection. In other words, the confounding here goes in the opposite direction of the results. If anything, these factors should make you more certain that masking works.

The authors also adjusted for other factors – the community transmission of COVID-19, vaccination rates, school district sizes, and so on. No major change in the results.

One concern I addressed to Dr. Ellie Murray, the biostatistician on the study – could districts that removed masks simply have been testing more to compensate, leading to increased capturing of cases?

If anything, the schools that kept masks on were testing more than the schools that took them off – again that would tend to imply that the results are even stronger than what was reported.

Is this a perfect study? Of course not – it’s one study, it’s from one state. And the relatively large effects from keeping masks on for one or 2 weeks require us to really embrace the concept of exponential growth of infections, but, if COVID has taught us anything, it is that small changes in initial conditions can have pretty big effects.

My daughter, who goes to a public school here in Connecticut, unmasked, was home with COVID this past week. She’s fine. But you know what? She missed a week of school. I worked from home to be with her – though I didn’t test positive. And that is a real cost to both of us that I think we need to consider when we consider the value of masks. Yes, they’re annoying – but if they keep kids in school, might they be worth it? Perhaps not for now, as cases aren’t surging. But in the future, be it a particularly concerning variant, or a whole new pandemic, we should not discount the simple, cheap, and apparently beneficial act of wearing masks to decrease transmission.

Dr. Perry Wilson is an associate professor of medicine and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

On March 26, 2022, Hawaii became the last state in the United States to lift its indoor mask mandate. By the time the current school year started, there were essentially no public school mask mandates either.

Whether you viewed the mask as an emblem of stalwart defiance against a rampaging virus, or a scarlet letter emblematic of the overreaches of public policy, you probably aren’t seeing them much anymore.

And yet, the debate about masks still rages. Who was right, who was wrong? Who trusted science, and what does the science even say? If we brought our country into marriage counseling, would we be told it is time to move on?  To look forward, not backward? To plan for our bright future together?

Perhaps. But this question isn’t really moot just because masks have largely disappeared in the United States. Variants may emerge that lead to more infection waves – and other pandemics may occur in the future. And so I think it is important to discuss a study that, with quite rigorous analysis, attempts to answer the following question: Did masking in schools lower students’ and teachers’ risk of COVID?

We are talking about this study, appearing in the New England Journal of Medicine. The short version goes like this.

Researchers had access to two important sources of data. One – an accounting of all the teachers and students (more than 300,000 of them) in 79 public, noncharter school districts in Eastern Massachusetts who tested positive for COVID every week. Two – the date that each of those school districts lifted their mask mandates or (in the case of two districts) didn’t.

Right away, I’m sure you’re thinking of potential issues. Districts that kept masks even when the statewide ban was lifted are likely quite a bit different from districts that dropped masks right away. You’re right, of course – hold on to that thought; we’ll get there.

But first – the big question – would districts that kept their masks on longer do better when it comes to the rate of COVID infection?

When everyone was masking, COVID case rates were pretty similar. Statewide mandates are lifted in late February – and most school districts remove their mandates within a few weeks – the black line are the two districts (Boston and Chelsea) where mask mandates remained in place.

As time marched on, the case rates in the various districts spread out – with districts that kept masks on longer doing better than those that took them off, and districts that kept masks on the whole time doing best of all.

Prior to the mask mandate lifting, you see very similar COVID rates in districts that would eventually remove the mandate and those that would not, with a bit of noise around the initial Omicron wave which saw just a huge amount of people get infected.

And then, after the mandate was lifted, separation. Districts that held on to masks longer had lower rates of COVID infection.

In all, over the 15-weeks of the study, there were roughly 12,000 extra cases of COVID in the mask-free school districts, which corresponds to about 35% of the total COVID burden during that time. And, yes, kids do well with COVID – on average. But 12,000 extra cases is enough to translate into a significant number of important clinical outcomes – think hospitalizations and post-COVID syndromes. And of course, maybe most importantly, missed school days. Positive kids were not allowed in class no matter what district they were in.

Okay – I promised we’d address confounders. This was not a cluster-randomized trial, where some school districts had their mandates removed based on the vicissitudes of a virtual coin flip, as much as many of us would have been interested to see that. The decision to remove masks was up to the various school boards – and they had a lot of pressure on them from many different directions. But all we need to worry about is whether any of those things that pressure a school board to keep masks on would ALSO lead to fewer COVID cases. That’s how confounders work, and how you can get false results in a study like this.

And yes – districts that kept the masks on longer were different than those who took them right off. But check out how they were different.

The districts that kept masks on longer had more low-income students. More Black and Latino students. More students per classroom. These are all risk factors that increase the risk of COVID infection. In other words, the confounding here goes in the opposite direction of the results. If anything, these factors should make you more certain that masking works.

The authors also adjusted for other factors – the community transmission of COVID-19, vaccination rates, school district sizes, and so on. No major change in the results.

One concern I addressed to Dr. Ellie Murray, the biostatistician on the study – could districts that removed masks simply have been testing more to compensate, leading to increased capturing of cases?

If anything, the schools that kept masks on were testing more than the schools that took them off – again that would tend to imply that the results are even stronger than what was reported.

Is this a perfect study? Of course not – it’s one study, it’s from one state. And the relatively large effects from keeping masks on for one or 2 weeks require us to really embrace the concept of exponential growth of infections, but, if COVID has taught us anything, it is that small changes in initial conditions can have pretty big effects.

My daughter, who goes to a public school here in Connecticut, unmasked, was home with COVID this past week. She’s fine. But you know what? She missed a week of school. I worked from home to be with her – though I didn’t test positive. And that is a real cost to both of us that I think we need to consider when we consider the value of masks. Yes, they’re annoying – but if they keep kids in school, might they be worth it? Perhaps not for now, as cases aren’t surging. But in the future, be it a particularly concerning variant, or a whole new pandemic, we should not discount the simple, cheap, and apparently beneficial act of wearing masks to decrease transmission.

Dr. Perry Wilson is an associate professor of medicine and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

On March 26, 2022, Hawaii became the last state in the United States to lift its indoor mask mandate. By the time the current school year started, there were essentially no public school mask mandates either.

Whether you viewed the mask as an emblem of stalwart defiance against a rampaging virus, or a scarlet letter emblematic of the overreaches of public policy, you probably aren’t seeing them much anymore.

And yet, the debate about masks still rages. Who was right, who was wrong? Who trusted science, and what does the science even say? If we brought our country into marriage counseling, would we be told it is time to move on?  To look forward, not backward? To plan for our bright future together?

Perhaps. But this question isn’t really moot just because masks have largely disappeared in the United States. Variants may emerge that lead to more infection waves – and other pandemics may occur in the future. And so I think it is important to discuss a study that, with quite rigorous analysis, attempts to answer the following question: Did masking in schools lower students’ and teachers’ risk of COVID?

We are talking about this study, appearing in the New England Journal of Medicine. The short version goes like this.

Researchers had access to two important sources of data. One – an accounting of all the teachers and students (more than 300,000 of them) in 79 public, noncharter school districts in Eastern Massachusetts who tested positive for COVID every week. Two – the date that each of those school districts lifted their mask mandates or (in the case of two districts) didn’t.

Right away, I’m sure you’re thinking of potential issues. Districts that kept masks even when the statewide ban was lifted are likely quite a bit different from districts that dropped masks right away. You’re right, of course – hold on to that thought; we’ll get there.

But first – the big question – would districts that kept their masks on longer do better when it comes to the rate of COVID infection?

When everyone was masking, COVID case rates were pretty similar. Statewide mandates are lifted in late February – and most school districts remove their mandates within a few weeks – the black line are the two districts (Boston and Chelsea) where mask mandates remained in place.

As time marched on, the case rates in the various districts spread out – with districts that kept masks on longer doing better than those that took them off, and districts that kept masks on the whole time doing best of all.

Prior to the mask mandate lifting, you see very similar COVID rates in districts that would eventually remove the mandate and those that would not, with a bit of noise around the initial Omicron wave which saw just a huge amount of people get infected.

And then, after the mandate was lifted, separation. Districts that held on to masks longer had lower rates of COVID infection.

In all, over the 15-weeks of the study, there were roughly 12,000 extra cases of COVID in the mask-free school districts, which corresponds to about 35% of the total COVID burden during that time. And, yes, kids do well with COVID – on average. But 12,000 extra cases is enough to translate into a significant number of important clinical outcomes – think hospitalizations and post-COVID syndromes. And of course, maybe most importantly, missed school days. Positive kids were not allowed in class no matter what district they were in.

Okay – I promised we’d address confounders. This was not a cluster-randomized trial, where some school districts had their mandates removed based on the vicissitudes of a virtual coin flip, as much as many of us would have been interested to see that. The decision to remove masks was up to the various school boards – and they had a lot of pressure on them from many different directions. But all we need to worry about is whether any of those things that pressure a school board to keep masks on would ALSO lead to fewer COVID cases. That’s how confounders work, and how you can get false results in a study like this.

And yes – districts that kept the masks on longer were different than those who took them right off. But check out how they were different.

The districts that kept masks on longer had more low-income students. More Black and Latino students. More students per classroom. These are all risk factors that increase the risk of COVID infection. In other words, the confounding here goes in the opposite direction of the results. If anything, these factors should make you more certain that masking works.

The authors also adjusted for other factors – the community transmission of COVID-19, vaccination rates, school district sizes, and so on. No major change in the results.

One concern I addressed to Dr. Ellie Murray, the biostatistician on the study – could districts that removed masks simply have been testing more to compensate, leading to increased capturing of cases?

If anything, the schools that kept masks on were testing more than the schools that took them off – again that would tend to imply that the results are even stronger than what was reported.

Is this a perfect study? Of course not – it’s one study, it’s from one state. And the relatively large effects from keeping masks on for one or 2 weeks require us to really embrace the concept of exponential growth of infections, but, if COVID has taught us anything, it is that small changes in initial conditions can have pretty big effects.

My daughter, who goes to a public school here in Connecticut, unmasked, was home with COVID this past week. She’s fine. But you know what? She missed a week of school. I worked from home to be with her – though I didn’t test positive. And that is a real cost to both of us that I think we need to consider when we consider the value of masks. Yes, they’re annoying – but if they keep kids in school, might they be worth it? Perhaps not for now, as cases aren’t surging. But in the future, be it a particularly concerning variant, or a whole new pandemic, we should not discount the simple, cheap, and apparently beneficial act of wearing masks to decrease transmission.

Dr. Perry Wilson is an associate professor of medicine and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He disclosed no relevant conflicts of interest.

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

Dear Colleagues,

We have a mismatch. The evidence supporting treatment for Paxlovid is compelling for people aged 60 or over, but the older patients in the United States are much less likely to be treated. Not only was there a randomized, placebo-controlled trial of high-risk patients which showed 89% reduction of hospitalizations and deaths (median age, 45), but there have been multiple real-world effectiveness studies subsequently published that have partitioned the benefit for age 65 or older, such as the ones from Israel and Hong Kong (age 60+). Overall, the real-world effectiveness in the first month after treatment is at least as good, if not better, than in the high-risk randomized trial.

But it’s more likely in the United States for a person age 45-50 to get Paxlovid over people age 80 or older. Why? We’re doing the current survey to find out, but the most likely reasons include (1) lack of confidence of benefit; (2) medication interactions; and (3) concerns over rebound.

Let me address each of these briefly. The lack of confidence in benefit stems from the fact that the initial high-risk trial was in unvaccinated individuals. That concern can now be put aside because all of the several real-world studies confirming the protective benefit against hospitalizations and deaths are in people who have been vaccinated, and a significant proportion received booster shots.

The potential medication interactions due to the ritonavir component of the Paxlovid drug combination, attributable to its cytochrome P450 3A4 inhibition, have been unduly emphasized. There are many drug-interaction checkers for Paxlovid, but this one from the University of Liverpool is user friendly, color- and icon-coded, and shows that the vast majority of interactions can be sidestepped by discontinuing the medication of concern for the length of the Paxlovid treatment, 5 days. The simple chart is provided in my recent substack newsletter.

As far as rebound, this problem has unfortunately been exaggerated because of lack of prospective systematic studies and appreciation that a positive test of clinical symptom rebound can occur without Paxlovid. There are soon to be multiple reports that the incidence of Paxlovid rebound is fairly low, in the range of 10%. That concern should not be a reason to withhold treatment.

Now the plot thickens. A new preprint report from the Veterans Health Administration, the largest health care system in the United States, looks at 90-day outcomes of about 9,000 Paxlovid-treated patients and approximately 47,000 controls. Not only was there a 26% reduction in long COVID, but of the breakdown of 12 organs/systems and symptoms, 10 of 12 were significantly reduced with Paxlovid, including pulmonary embolism, deep vein thrombosis, and neurocognitive impairment. There was also a 48% reduction in death and a 30% reduction in hospitalizations after the first 30 days. I have reviewed all of these data and put them in context in a recent newsletter. A key point is that the magnitude of benefit was unaffected by vaccination or booster status, or prior COVID infections, or unvaccinated status. Also, it was the same for men and women, as well as for age > 70 and age < 60. These findings all emphasize a new reason to be using Paxlovid therapy, and if replicated, Paxlovid may even be indicated for younger patients (who are at low risk for hospitalizations and deaths but at increased risk for long COVID).

In summary, for older patients, we should be thinking of why we should be using Paxlovid rather than the reason not to treat. We’ll be interested in the survey results to understand the mismatch better, and we look forward to your ideas and feedback to make better use of this treatment for the people who need it the most.

Sincerely yours, Eric J. Topol, MD

Dr. Topol reports no conflicts of interest with Pfizer; he receives no honoraria or speaker fees, does not serve in an advisory role, and has no financial association with the company.

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

Dear Colleagues,

We have a mismatch. The evidence supporting treatment for Paxlovid is compelling for people aged 60 or over, but the older patients in the United States are much less likely to be treated. Not only was there a randomized, placebo-controlled trial of high-risk patients which showed 89% reduction of hospitalizations and deaths (median age, 45), but there have been multiple real-world effectiveness studies subsequently published that have partitioned the benefit for age 65 or older, such as the ones from Israel and Hong Kong (age 60+). Overall, the real-world effectiveness in the first month after treatment is at least as good, if not better, than in the high-risk randomized trial.

But it’s more likely in the United States for a person age 45-50 to get Paxlovid over people age 80 or older. Why? We’re doing the current survey to find out, but the most likely reasons include (1) lack of confidence of benefit; (2) medication interactions; and (3) concerns over rebound.

Let me address each of these briefly. The lack of confidence in benefit stems from the fact that the initial high-risk trial was in unvaccinated individuals. That concern can now be put aside because all of the several real-world studies confirming the protective benefit against hospitalizations and deaths are in people who have been vaccinated, and a significant proportion received booster shots.

The potential medication interactions due to the ritonavir component of the Paxlovid drug combination, attributable to its cytochrome P450 3A4 inhibition, have been unduly emphasized. There are many drug-interaction checkers for Paxlovid, but this one from the University of Liverpool is user friendly, color- and icon-coded, and shows that the vast majority of interactions can be sidestepped by discontinuing the medication of concern for the length of the Paxlovid treatment, 5 days. The simple chart is provided in my recent substack newsletter.

As far as rebound, this problem has unfortunately been exaggerated because of lack of prospective systematic studies and appreciation that a positive test of clinical symptom rebound can occur without Paxlovid. There are soon to be multiple reports that the incidence of Paxlovid rebound is fairly low, in the range of 10%. That concern should not be a reason to withhold treatment.

Now the plot thickens. A new preprint report from the Veterans Health Administration, the largest health care system in the United States, looks at 90-day outcomes of about 9,000 Paxlovid-treated patients and approximately 47,000 controls. Not only was there a 26% reduction in long COVID, but of the breakdown of 12 organs/systems and symptoms, 10 of 12 were significantly reduced with Paxlovid, including pulmonary embolism, deep vein thrombosis, and neurocognitive impairment. There was also a 48% reduction in death and a 30% reduction in hospitalizations after the first 30 days. I have reviewed all of these data and put them in context in a recent newsletter. A key point is that the magnitude of benefit was unaffected by vaccination or booster status, or prior COVID infections, or unvaccinated status. Also, it was the same for men and women, as well as for age > 70 and age < 60. These findings all emphasize a new reason to be using Paxlovid therapy, and if replicated, Paxlovid may even be indicated for younger patients (who are at low risk for hospitalizations and deaths but at increased risk for long COVID).

In summary, for older patients, we should be thinking of why we should be using Paxlovid rather than the reason not to treat. We’ll be interested in the survey results to understand the mismatch better, and we look forward to your ideas and feedback to make better use of this treatment for the people who need it the most.

Sincerely yours, Eric J. Topol, MD

Dr. Topol reports no conflicts of interest with Pfizer; he receives no honoraria or speaker fees, does not serve in an advisory role, and has no financial association with the company.

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

Dear Colleagues,

We have a mismatch. The evidence supporting treatment for Paxlovid is compelling for people aged 60 or over, but the older patients in the United States are much less likely to be treated. Not only was there a randomized, placebo-controlled trial of high-risk patients which showed 89% reduction of hospitalizations and deaths (median age, 45), but there have been multiple real-world effectiveness studies subsequently published that have partitioned the benefit for age 65 or older, such as the ones from Israel and Hong Kong (age 60+). Overall, the real-world effectiveness in the first month after treatment is at least as good, if not better, than in the high-risk randomized trial.

But it’s more likely in the United States for a person age 45-50 to get Paxlovid over people age 80 or older. Why? We’re doing the current survey to find out, but the most likely reasons include (1) lack of confidence of benefit; (2) medication interactions; and (3) concerns over rebound.

Let me address each of these briefly. The lack of confidence in benefit stems from the fact that the initial high-risk trial was in unvaccinated individuals. That concern can now be put aside because all of the several real-world studies confirming the protective benefit against hospitalizations and deaths are in people who have been vaccinated, and a significant proportion received booster shots.

The potential medication interactions due to the ritonavir component of the Paxlovid drug combination, attributable to its cytochrome P450 3A4 inhibition, have been unduly emphasized. There are many drug-interaction checkers for Paxlovid, but this one from the University of Liverpool is user friendly, color- and icon-coded, and shows that the vast majority of interactions can be sidestepped by discontinuing the medication of concern for the length of the Paxlovid treatment, 5 days. The simple chart is provided in my recent substack newsletter.

As far as rebound, this problem has unfortunately been exaggerated because of lack of prospective systematic studies and appreciation that a positive test of clinical symptom rebound can occur without Paxlovid. There are soon to be multiple reports that the incidence of Paxlovid rebound is fairly low, in the range of 10%. That concern should not be a reason to withhold treatment.

Now the plot thickens. A new preprint report from the Veterans Health Administration, the largest health care system in the United States, looks at 90-day outcomes of about 9,000 Paxlovid-treated patients and approximately 47,000 controls. Not only was there a 26% reduction in long COVID, but of the breakdown of 12 organs/systems and symptoms, 10 of 12 were significantly reduced with Paxlovid, including pulmonary embolism, deep vein thrombosis, and neurocognitive impairment. There was also a 48% reduction in death and a 30% reduction in hospitalizations after the first 30 days. I have reviewed all of these data and put them in context in a recent newsletter. A key point is that the magnitude of benefit was unaffected by vaccination or booster status, or prior COVID infections, or unvaccinated status. Also, it was the same for men and women, as well as for age > 70 and age < 60. These findings all emphasize a new reason to be using Paxlovid therapy, and if replicated, Paxlovid may even be indicated for younger patients (who are at low risk for hospitalizations and deaths but at increased risk for long COVID).

In summary, for older patients, we should be thinking of why we should be using Paxlovid rather than the reason not to treat. We’ll be interested in the survey results to understand the mismatch better, and we look forward to your ideas and feedback to make better use of this treatment for the people who need it the most.

Sincerely yours, Eric J. Topol, MD

Dr. Topol reports no conflicts of interest with Pfizer; he receives no honoraria or speaker fees, does not serve in an advisory role, and has no financial association with the company.

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

An 18-year-old woman with Crohn’s disease (diagnosed 3 years ago) came to my office for advice regarding management of osteoporosis. Her bone density was low for her age, and she had three low-impact fractures of her long bones in the preceding 4 years.

Loss of weight after the onset of Crohn’s disease, subsequent loss of periods, inflammation associated with her underlying diagnosis, and early treatment with glucocorticoids (known to have deleterious effects on bone) were believed to have caused osteoporosis in this young woman.

A few months previously, she was switched to a medication that doesn’t impair bone health and glucocorticoids were discontinued; her weight began to improve, and her Crohn’s disease was now in remission. Her menses had resumed about 3 months before her visit to my clinic after a prolonged period without periods. She was on calcium and vitamin D supplements, with normal levels of vitamin D.

After reading that exercise was good for bones, she asked me about it. Were there specific types of exercise that would help optimize her chances of improving her bone health?

Many factors determine bone health including (but not limited to) genetics, nutritional status, exercise activity (with mechanical loading of bones), macro- and micronutrient intake, hormonal status, chronic inflammation and other disease states, and medication use.

Exercise certainly has beneficial effects on bone. Bone-loading activities increase bone formation through the activation of certain cells in bone called osteocytes, which serve as mechanosensors and sense bone loading. Osteocytes make a hormone called sclerostin, which typically inhibits bone formation. When osteocytes sense bone-loading activities, sclerostin secretion reduces, allowing for increased bone formation.

Consistent with this, investigators in Canada have demonstrated greater increases in bone density and strength in schoolchildren who engage in moderate to vigorous physical activity, particularly bone-loading exercise, during the school day, compared with those who don’t (J Bone Miner Res. 2007 Mar;22[3]:434-46; J Bone Miner Res. 2017 Jul;32[7]:1525-36). In females, normal levels of estrogen seem necessary for osteocytes to bring about these effects after bone-loading activities. This is probably one of several reasons why athletes who lose their periods (indicative of low estrogen levels) and develop low bone density with an increased risk for fracture even when they are still at a normal weight (J Clin Endocrinol Metab. 2018 Jun 1;103[6]:2392-402; Med Sci Sports Exerc. 2015 Aug;47[8]:1577-86).

One concern around prescribing bone-loading activity or exercise to persons with osteoporosis is whether it would increase the risk for fracture from the impact on fragile bone. The extent of bone loading safe for fragile bone can be difficult to determine. Furthermore, excessive exercise may worsen bone health by causing weight loss or loss of periods in women. Very careful monitoring may be necessary to ensure that energy balance is maintained. Therefore, the nature and volume of exercise should be discussed with one’s doctor or physical therapist as well as a dietitian (if the patient is seeing one).

In patients with osteoporosis, high-impact activities such as jumping; repetitive impact activities such as running or jogging; and bending and twisting activities such as touching one’s toes, golf, tennis, and bowling aren’t recommended because they increase the risk for fracture. Even yoga poses should be discussed, because some may increase the risk for compression fractures of the vertebrae in the spine.

Strength and resistance training are generally believed to be good for bones. Strength training involves activities that build muscle strength and mass. Resistance training builds muscle strength, mass, and endurance by making muscles work against some form of resistance. Such activities include weight training with free weights or weight machines, use of resistance bands, and use of one’s own body to strengthen major muscle groups (such as through push-ups, squats, lunges, and gluteus maximus extension).

Some amount of weight-bearing aerobic training is also recommended, including walking, low-impact aerobics, the elliptical, and stair-climbing. Non–weight-bearing activities, such as swimming and cycling, typically don’t contribute to improving bone density.

In older individuals with osteoporosis, agility exercises are particularly useful to reduce the fall risk (J Am Geriatr Soc. 2004 May;52[5]:657-65; CMAJ. 2002 Oct 29;167[9]:997-1004). These can be structured to improve hand-eye coordination, foot-eye coordination, static and dynamic balance, and reaction time. Agility exercises with resistance training help improve bone density in older women.

An optimal exercise regimen includes a combination of strength and resistance training; weight-bearing aerobic training; and exercises that build flexibility, stability, and balance. A doctor, physical therapist, or trainer with expertise in the right combination of exercises should be consulted to ensure optimal effects on bone and general health.

In those at risk for overexercising to the point that they start to lose weight or lose their periods, and certainly in all women with disordered eating patterns, a dietitian should be part of the decision team to ensure that energy balance is maintained. In this group, particularly in very-low-weight women with eating disorders, exercise activity is often limited until they reach a healthier weight, and ideally after their menses resume.

For my patient with Crohn’s disease, I recommended that she see a physical therapist and a dietitian for guidance about a graded increase in exercise activity and an exercise regimen that would work best for her. I assess her bone density annually using dual-energy x-ray absorptiometry. Her bone density has gradually improved with the combination of weight gain, resumption of menses, medications for Crohn’s disease that do not affect bone deleteriously, remission of Crohn’s disease, and her exercise regimen.

Dr. Misra is chief of the division of pediatric endocrinology at Mass General Hospital for Children and professor in the department of pediatrics at Harvard Medical School, both in Boston. She reported conflicts of interest with AbbVie, Sanofi, and Ipsen.

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

An 18-year-old woman with Crohn’s disease (diagnosed 3 years ago) came to my office for advice regarding management of osteoporosis. Her bone density was low for her age, and she had three low-impact fractures of her long bones in the preceding 4 years.

Loss of weight after the onset of Crohn’s disease, subsequent loss of periods, inflammation associated with her underlying diagnosis, and early treatment with glucocorticoids (known to have deleterious effects on bone) were believed to have caused osteoporosis in this young woman.

A few months previously, she was switched to a medication that doesn’t impair bone health and glucocorticoids were discontinued; her weight began to improve, and her Crohn’s disease was now in remission. Her menses had resumed about 3 months before her visit to my clinic after a prolonged period without periods. She was on calcium and vitamin D supplements, with normal levels of vitamin D.

After reading that exercise was good for bones, she asked me about it. Were there specific types of exercise that would help optimize her chances of improving her bone health?

Many factors determine bone health including (but not limited to) genetics, nutritional status, exercise activity (with mechanical loading of bones), macro- and micronutrient intake, hormonal status, chronic inflammation and other disease states, and medication use.

Exercise certainly has beneficial effects on bone. Bone-loading activities increase bone formation through the activation of certain cells in bone called osteocytes, which serve as mechanosensors and sense bone loading. Osteocytes make a hormone called sclerostin, which typically inhibits bone formation. When osteocytes sense bone-loading activities, sclerostin secretion reduces, allowing for increased bone formation.

Consistent with this, investigators in Canada have demonstrated greater increases in bone density and strength in schoolchildren who engage in moderate to vigorous physical activity, particularly bone-loading exercise, during the school day, compared with those who don’t (J Bone Miner Res. 2007 Mar;22[3]:434-46; J Bone Miner Res. 2017 Jul;32[7]:1525-36). In females, normal levels of estrogen seem necessary for osteocytes to bring about these effects after bone-loading activities. This is probably one of several reasons why athletes who lose their periods (indicative of low estrogen levels) and develop low bone density with an increased risk for fracture even when they are still at a normal weight (J Clin Endocrinol Metab. 2018 Jun 1;103[6]:2392-402; Med Sci Sports Exerc. 2015 Aug;47[8]:1577-86).

One concern around prescribing bone-loading activity or exercise to persons with osteoporosis is whether it would increase the risk for fracture from the impact on fragile bone. The extent of bone loading safe for fragile bone can be difficult to determine. Furthermore, excessive exercise may worsen bone health by causing weight loss or loss of periods in women. Very careful monitoring may be necessary to ensure that energy balance is maintained. Therefore, the nature and volume of exercise should be discussed with one’s doctor or physical therapist as well as a dietitian (if the patient is seeing one).

In patients with osteoporosis, high-impact activities such as jumping; repetitive impact activities such as running or jogging; and bending and twisting activities such as touching one’s toes, golf, tennis, and bowling aren’t recommended because they increase the risk for fracture. Even yoga poses should be discussed, because some may increase the risk for compression fractures of the vertebrae in the spine.

Strength and resistance training are generally believed to be good for bones. Strength training involves activities that build muscle strength and mass. Resistance training builds muscle strength, mass, and endurance by making muscles work against some form of resistance. Such activities include weight training with free weights or weight machines, use of resistance bands, and use of one’s own body to strengthen major muscle groups (such as through push-ups, squats, lunges, and gluteus maximus extension).

Some amount of weight-bearing aerobic training is also recommended, including walking, low-impact aerobics, the elliptical, and stair-climbing. Non–weight-bearing activities, such as swimming and cycling, typically don’t contribute to improving bone density.

In older individuals with osteoporosis, agility exercises are particularly useful to reduce the fall risk (J Am Geriatr Soc. 2004 May;52[5]:657-65; CMAJ. 2002 Oct 29;167[9]:997-1004). These can be structured to improve hand-eye coordination, foot-eye coordination, static and dynamic balance, and reaction time. Agility exercises with resistance training help improve bone density in older women.

An optimal exercise regimen includes a combination of strength and resistance training; weight-bearing aerobic training; and exercises that build flexibility, stability, and balance. A doctor, physical therapist, or trainer with expertise in the right combination of exercises should be consulted to ensure optimal effects on bone and general health.

In those at risk for overexercising to the point that they start to lose weight or lose their periods, and certainly in all women with disordered eating patterns, a dietitian should be part of the decision team to ensure that energy balance is maintained. In this group, particularly in very-low-weight women with eating disorders, exercise activity is often limited until they reach a healthier weight, and ideally after their menses resume.

For my patient with Crohn’s disease, I recommended that she see a physical therapist and a dietitian for guidance about a graded increase in exercise activity and an exercise regimen that would work best for her. I assess her bone density annually using dual-energy x-ray absorptiometry. Her bone density has gradually improved with the combination of weight gain, resumption of menses, medications for Crohn’s disease that do not affect bone deleteriously, remission of Crohn’s disease, and her exercise regimen.

Dr. Misra is chief of the division of pediatric endocrinology at Mass General Hospital for Children and professor in the department of pediatrics at Harvard Medical School, both in Boston. She reported conflicts of interest with AbbVie, Sanofi, and Ipsen.

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

An 18-year-old woman with Crohn’s disease (diagnosed 3 years ago) came to my office for advice regarding management of osteoporosis. Her bone density was low for her age, and she had three low-impact fractures of her long bones in the preceding 4 years.

Loss of weight after the onset of Crohn’s disease, subsequent loss of periods, inflammation associated with her underlying diagnosis, and early treatment with glucocorticoids (known to have deleterious effects on bone) were believed to have caused osteoporosis in this young woman.

A few months previously, she was switched to a medication that doesn’t impair bone health and glucocorticoids were discontinued; her weight began to improve, and her Crohn’s disease was now in remission. Her menses had resumed about 3 months before her visit to my clinic after a prolonged period without periods. She was on calcium and vitamin D supplements, with normal levels of vitamin D.

After reading that exercise was good for bones, she asked me about it. Were there specific types of exercise that would help optimize her chances of improving her bone health?

Many factors determine bone health including (but not limited to) genetics, nutritional status, exercise activity (with mechanical loading of bones), macro- and micronutrient intake, hormonal status, chronic inflammation and other disease states, and medication use.

Exercise certainly has beneficial effects on bone. Bone-loading activities increase bone formation through the activation of certain cells in bone called osteocytes, which serve as mechanosensors and sense bone loading. Osteocytes make a hormone called sclerostin, which typically inhibits bone formation. When osteocytes sense bone-loading activities, sclerostin secretion reduces, allowing for increased bone formation.

Consistent with this, investigators in Canada have demonstrated greater increases in bone density and strength in schoolchildren who engage in moderate to vigorous physical activity, particularly bone-loading exercise, during the school day, compared with those who don’t (J Bone Miner Res. 2007 Mar;22[3]:434-46; J Bone Miner Res. 2017 Jul;32[7]:1525-36). In females, normal levels of estrogen seem necessary for osteocytes to bring about these effects after bone-loading activities. This is probably one of several reasons why athletes who lose their periods (indicative of low estrogen levels) and develop low bone density with an increased risk for fracture even when they are still at a normal weight (J Clin Endocrinol Metab. 2018 Jun 1;103[6]:2392-402; Med Sci Sports Exerc. 2015 Aug;47[8]:1577-86).

One concern around prescribing bone-loading activity or exercise to persons with osteoporosis is whether it would increase the risk for fracture from the impact on fragile bone. The extent of bone loading safe for fragile bone can be difficult to determine. Furthermore, excessive exercise may worsen bone health by causing weight loss or loss of periods in women. Very careful monitoring may be necessary to ensure that energy balance is maintained. Therefore, the nature and volume of exercise should be discussed with one’s doctor or physical therapist as well as a dietitian (if the patient is seeing one).

In patients with osteoporosis, high-impact activities such as jumping; repetitive impact activities such as running or jogging; and bending and twisting activities such as touching one’s toes, golf, tennis, and bowling aren’t recommended because they increase the risk for fracture. Even yoga poses should be discussed, because some may increase the risk for compression fractures of the vertebrae in the spine.

Strength and resistance training are generally believed to be good for bones. Strength training involves activities that build muscle strength and mass. Resistance training builds muscle strength, mass, and endurance by making muscles work against some form of resistance. Such activities include weight training with free weights or weight machines, use of resistance bands, and use of one’s own body to strengthen major muscle groups (such as through push-ups, squats, lunges, and gluteus maximus extension).

Some amount of weight-bearing aerobic training is also recommended, including walking, low-impact aerobics, the elliptical, and stair-climbing. Non–weight-bearing activities, such as swimming and cycling, typically don’t contribute to improving bone density.

In older individuals with osteoporosis, agility exercises are particularly useful to reduce the fall risk (J Am Geriatr Soc. 2004 May;52[5]:657-65; CMAJ. 2002 Oct 29;167[9]:997-1004). These can be structured to improve hand-eye coordination, foot-eye coordination, static and dynamic balance, and reaction time. Agility exercises with resistance training help improve bone density in older women.

An optimal exercise regimen includes a combination of strength and resistance training; weight-bearing aerobic training; and exercises that build flexibility, stability, and balance. A doctor, physical therapist, or trainer with expertise in the right combination of exercises should be consulted to ensure optimal effects on bone and general health.

In those at risk for overexercising to the point that they start to lose weight or lose their periods, and certainly in all women with disordered eating patterns, a dietitian should be part of the decision team to ensure that energy balance is maintained. In this group, particularly in very-low-weight women with eating disorders, exercise activity is often limited until they reach a healthier weight, and ideally after their menses resume.

For my patient with Crohn’s disease, I recommended that she see a physical therapist and a dietitian for guidance about a graded increase in exercise activity and an exercise regimen that would work best for her. I assess her bone density annually using dual-energy x-ray absorptiometry. Her bone density has gradually improved with the combination of weight gain, resumption of menses, medications for Crohn’s disease that do not affect bone deleteriously, remission of Crohn’s disease, and her exercise regimen.

Dr. Misra is chief of the division of pediatric endocrinology at Mass General Hospital for Children and professor in the department of pediatrics at Harvard Medical School, both in Boston. She reported conflicts of interest with AbbVie, Sanofi, and Ipsen.

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

I put a Christmas tree up early in November.

It’s not like it’s a real tree, or even a fancy one. For that matter, I’m Jewish.

Growing up in the 1970s one thing that could be relied on every year was the Charlie Brown Christmas special. It never changed. By age 5 you knew most of the lines, and loved the highlight when Charlie Brown brings home the saddest-looking tree ever, which collapses when he puts a single bauble on it.

Courtesy Dr. Allan M. Block

Years ago, my kids gave me a Charlie Brown tree as a gift. It even plays the late Vince Guaraldi’s immortal Peanuts theme when you push a button. I forgot about it for a few years, then discovered it, and immediately brought it to my office.

I’m not a fan of holiday creep, where they move up earlier in the year, so I used to put it up after Thanksgiving. But we close the office 2-3 weeks later for the rest of the year. I like the tree, my staff likes the tree, and my patients like the tree, so I just started putting it up in early November so we can enjoy it for a month.

It’s whimsical and brings back memories of innocence, childhood, and (of course) Peanuts. It sets a cheerful tone when you see it there. Very few of my patients can resist pressing the button and playing the music as they go by.

The start of a new year is a relatively arbitrary date, chosen long ago. But its approach is always a reminder that life goes on. We continue our trips around the sun. Good times and bad times come and go, but time never stops.

In bad years the tree reminds me that it’s coming to an end, and to look toward the next. In good years it reminds me that it’s time to be ready for the surprises of the coming one. With the stresses of the holidays and things (like getting taxes ready) that the year’s end brings, as well as the routine daily challenges of any medical practice, the Charlie Brown Christmas is a reminder to keep a sense of humor.

In mid-December, after the patients are done for the last day of the year, I quietly put it away. It’s a vaguely somber moment, but at the same time I’m glad to know I now have 2-3 weeks of home time. It mostly involves working at my desk and returning phone calls, but there’s also time to relax with my kids, do jigsaw puzzles, and enjoy the Phoenix winter weather as a break before the next round starts.

To those who disagree with my choice of decoration or its timing, I simply respond: “Good grief!”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I put a Christmas tree up early in November.

It’s not like it’s a real tree, or even a fancy one. For that matter, I’m Jewish.

Growing up in the 1970s one thing that could be relied on every year was the Charlie Brown Christmas special. It never changed. By age 5 you knew most of the lines, and loved the highlight when Charlie Brown brings home the saddest-looking tree ever, which collapses when he puts a single bauble on it.

Courtesy Dr. Allan M. Block

Years ago, my kids gave me a Charlie Brown tree as a gift. It even plays the late Vince Guaraldi’s immortal Peanuts theme when you push a button. I forgot about it for a few years, then discovered it, and immediately brought it to my office.

I’m not a fan of holiday creep, where they move up earlier in the year, so I used to put it up after Thanksgiving. But we close the office 2-3 weeks later for the rest of the year. I like the tree, my staff likes the tree, and my patients like the tree, so I just started putting it up in early November so we can enjoy it for a month.

It’s whimsical and brings back memories of innocence, childhood, and (of course) Peanuts. It sets a cheerful tone when you see it there. Very few of my patients can resist pressing the button and playing the music as they go by.

The start of a new year is a relatively arbitrary date, chosen long ago. But its approach is always a reminder that life goes on. We continue our trips around the sun. Good times and bad times come and go, but time never stops.

In bad years the tree reminds me that it’s coming to an end, and to look toward the next. In good years it reminds me that it’s time to be ready for the surprises of the coming one. With the stresses of the holidays and things (like getting taxes ready) that the year’s end brings, as well as the routine daily challenges of any medical practice, the Charlie Brown Christmas is a reminder to keep a sense of humor.

In mid-December, after the patients are done for the last day of the year, I quietly put it away. It’s a vaguely somber moment, but at the same time I’m glad to know I now have 2-3 weeks of home time. It mostly involves working at my desk and returning phone calls, but there’s also time to relax with my kids, do jigsaw puzzles, and enjoy the Phoenix winter weather as a break before the next round starts.

To those who disagree with my choice of decoration or its timing, I simply respond: “Good grief!”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I put a Christmas tree up early in November.

It’s not like it’s a real tree, or even a fancy one. For that matter, I’m Jewish.

Growing up in the 1970s one thing that could be relied on every year was the Charlie Brown Christmas special. It never changed. By age 5 you knew most of the lines, and loved the highlight when Charlie Brown brings home the saddest-looking tree ever, which collapses when he puts a single bauble on it.

Courtesy Dr. Allan M. Block

Years ago, my kids gave me a Charlie Brown tree as a gift. It even plays the late Vince Guaraldi’s immortal Peanuts theme when you push a button. I forgot about it for a few years, then discovered it, and immediately brought it to my office.

I’m not a fan of holiday creep, where they move up earlier in the year, so I used to put it up after Thanksgiving. But we close the office 2-3 weeks later for the rest of the year. I like the tree, my staff likes the tree, and my patients like the tree, so I just started putting it up in early November so we can enjoy it for a month.

It’s whimsical and brings back memories of innocence, childhood, and (of course) Peanuts. It sets a cheerful tone when you see it there. Very few of my patients can resist pressing the button and playing the music as they go by.

The start of a new year is a relatively arbitrary date, chosen long ago. But its approach is always a reminder that life goes on. We continue our trips around the sun. Good times and bad times come and go, but time never stops.

In bad years the tree reminds me that it’s coming to an end, and to look toward the next. In good years it reminds me that it’s time to be ready for the surprises of the coming one. With the stresses of the holidays and things (like getting taxes ready) that the year’s end brings, as well as the routine daily challenges of any medical practice, the Charlie Brown Christmas is a reminder to keep a sense of humor.

In mid-December, after the patients are done for the last day of the year, I quietly put it away. It’s a vaguely somber moment, but at the same time I’m glad to know I now have 2-3 weeks of home time. It mostly involves working at my desk and returning phone calls, but there’s also time to relax with my kids, do jigsaw puzzles, and enjoy the Phoenix winter weather as a break before the next round starts.

To those who disagree with my choice of decoration or its timing, I simply respond: “Good grief!”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Obsessive-compulsive disorder (OCD) affects 1-2% of the population. The disorder is characterized by recurrent intrusive unwanted thoughts (obsessions) that cause significant distress and anxiety, and behavioral or mental rituals (compulsions) that are performed to reduce distress stemming from obsessions. OCD may onset at any time in life, but most commonly begins in childhood or in early adulthood.

Cognitive behavioral therapy (CBT) with exposure and response prevention is an empirically based and highly effective treatment for OCD. However, most youth with OCD do not receive any treatment, which is related to a shortage of mental health care providers with expertise in assessment and treatment of the disorder, and misdiagnosis of the disorder is all too prevalent.

Aside from the subjective emotional toll associated with OCD, individuals living with this disorder frequently experience interpersonal, academic, and vocational impairments. Nevertheless, OCD is often overlooked or misdiagnosed. This may be more pronounced in youth with OCD, particularly in primary health care settings and large nonspecialized medical institutions. In fact, research indicates that pediatric OCD is often underrecognized even among mental health professionals. This situation is not new, and in fact the National Institute for Health and Care Excellence (NICE) in the United Kingdom stated that there is an urgent need to develop brief reliable screeners for OCD nearly 20 years ago.

Although there were several attempts to develop brief screening scales for adults and youth with OCD, none of them were found to be suitable for use as rapid screening tools in nonspecialized settings. One of the primary reasons is that OCD is associated with different “themes” or dimensions. For example, a child with OCD may engage in cleaning rituals because the context (or dimension) of their obsessions is contamination concerns. Another child with OCD, who may suffer from similar overall symptom severity, may primarily engage in checking rituals which are related with obsessions associated with fear of being responsible for harm. Therefore, one child with OCD may score very high on items assessing one dimension (e.g., contamination concerns), but very low on another dimension (e.g., harm obsessions).

This results in a known challenge in the assessment and psychometrics of self-report (as opposed to clinician administered) measures of OCD. Secondly, development of such measures requires very large carefully screened samples of individuals with OCD, with other disorders, and those without a known psychological disorder – which may be more challenging than requiring adult participants.

In order to address the urgent need for an ultrabrief measure for youth with OCD, we formed an international collaboration with the goal of developing a reliable ultrabrief self-report screening scale for this population. To accomplish this, we harmonized data from several sites that included three samples of carefully screened youths with OCD, with other disorders, and without known disorders who completed multiple self-report questionnaires, including the 21-item Obsessive-Compulsive Inventory – Child Version (OCI-CV).

Utilizing psychometric analyses including factor analyses, invariance analyses, and item response theory methodologies, we were able to develop an ultrabrief measure extracted from the OCI-CV: the 5-item Obsessive-Compulsive Inventory – Child Version (OCI-CV-5). This very brief self-report measure was found to have very good psychometric properties including a sensitive and specific clinical cutoff score. Youth who score at or above the cutoff score are nearly 21 times more likely to meet criteria for OCD.

This measure corresponds to a need to rapidly screen for OCD in children in nonspecialized settings, including community mental health clinics, primary care settings, and pediatric treatment facilities. However, it is important to note it is not a diagnostic measure. The measure is intended to identify youth who should be referred to a mental health care professional to conduct a diagnostic interview.

Dr. Abramovitch is a clinical psychologist and neuropsychologist based in Austin, Tex., and an associate professor at Texas State University. Dr. Abramowitz is professor and director of clinical training in the Anxiety and Stress Lab at University of North Carolina at Chapel Hill. Dr. McKay is professor of psychology at Fordham University, Bronx, N.Y.

Obsessive-compulsive disorder (OCD) affects 1-2% of the population. The disorder is characterized by recurrent intrusive unwanted thoughts (obsessions) that cause significant distress and anxiety, and behavioral or mental rituals (compulsions) that are performed to reduce distress stemming from obsessions. OCD may onset at any time in life, but most commonly begins in childhood or in early adulthood.

Cognitive behavioral therapy (CBT) with exposure and response prevention is an empirically based and highly effective treatment for OCD. However, most youth with OCD do not receive any treatment, which is related to a shortage of mental health care providers with expertise in assessment and treatment of the disorder, and misdiagnosis of the disorder is all too prevalent.

Aside from the subjective emotional toll associated with OCD, individuals living with this disorder frequently experience interpersonal, academic, and vocational impairments. Nevertheless, OCD is often overlooked or misdiagnosed. This may be more pronounced in youth with OCD, particularly in primary health care settings and large nonspecialized medical institutions. In fact, research indicates that pediatric OCD is often underrecognized even among mental health professionals. This situation is not new, and in fact the National Institute for Health and Care Excellence (NICE) in the United Kingdom stated that there is an urgent need to develop brief reliable screeners for OCD nearly 20 years ago.

Although there were several attempts to develop brief screening scales for adults and youth with OCD, none of them were found to be suitable for use as rapid screening tools in nonspecialized settings. One of the primary reasons is that OCD is associated with different “themes” or dimensions. For example, a child with OCD may engage in cleaning rituals because the context (or dimension) of their obsessions is contamination concerns. Another child with OCD, who may suffer from similar overall symptom severity, may primarily engage in checking rituals which are related with obsessions associated with fear of being responsible for harm. Therefore, one child with OCD may score very high on items assessing one dimension (e.g., contamination concerns), but very low on another dimension (e.g., harm obsessions).

This results in a known challenge in the assessment and psychometrics of self-report (as opposed to clinician administered) measures of OCD. Secondly, development of such measures requires very large carefully screened samples of individuals with OCD, with other disorders, and those without a known psychological disorder – which may be more challenging than requiring adult participants.

In order to address the urgent need for an ultrabrief measure for youth with OCD, we formed an international collaboration with the goal of developing a reliable ultrabrief self-report screening scale for this population. To accomplish this, we harmonized data from several sites that included three samples of carefully screened youths with OCD, with other disorders, and without known disorders who completed multiple self-report questionnaires, including the 21-item Obsessive-Compulsive Inventory – Child Version (OCI-CV).

Utilizing psychometric analyses including factor analyses, invariance analyses, and item response theory methodologies, we were able to develop an ultrabrief measure extracted from the OCI-CV: the 5-item Obsessive-Compulsive Inventory – Child Version (OCI-CV-5). This very brief self-report measure was found to have very good psychometric properties including a sensitive and specific clinical cutoff score. Youth who score at or above the cutoff score are nearly 21 times more likely to meet criteria for OCD.

This measure corresponds to a need to rapidly screen for OCD in children in nonspecialized settings, including community mental health clinics, primary care settings, and pediatric treatment facilities. However, it is important to note it is not a diagnostic measure. The measure is intended to identify youth who should be referred to a mental health care professional to conduct a diagnostic interview.

Dr. Abramovitch is a clinical psychologist and neuropsychologist based in Austin, Tex., and an associate professor at Texas State University. Dr. Abramowitz is professor and director of clinical training in the Anxiety and Stress Lab at University of North Carolina at Chapel Hill. Dr. McKay is professor of psychology at Fordham University, Bronx, N.Y.

Obsessive-compulsive disorder (OCD) affects 1-2% of the population. The disorder is characterized by recurrent intrusive unwanted thoughts (obsessions) that cause significant distress and anxiety, and behavioral or mental rituals (compulsions) that are performed to reduce distress stemming from obsessions. OCD may onset at any time in life, but most commonly begins in childhood or in early adulthood.

Cognitive behavioral therapy (CBT) with exposure and response prevention is an empirically based and highly effective treatment for OCD. However, most youth with OCD do not receive any treatment, which is related to a shortage of mental health care providers with expertise in assessment and treatment of the disorder, and misdiagnosis of the disorder is all too prevalent.

Aside from the subjective emotional toll associated with OCD, individuals living with this disorder frequently experience interpersonal, academic, and vocational impairments. Nevertheless, OCD is often overlooked or misdiagnosed. This may be more pronounced in youth with OCD, particularly in primary health care settings and large nonspecialized medical institutions. In fact, research indicates that pediatric OCD is often underrecognized even among mental health professionals. This situation is not new, and in fact the National Institute for Health and Care Excellence (NICE) in the United Kingdom stated that there is an urgent need to develop brief reliable screeners for OCD nearly 20 years ago.

Although there were several attempts to develop brief screening scales for adults and youth with OCD, none of them were found to be suitable for use as rapid screening tools in nonspecialized settings. One of the primary reasons is that OCD is associated with different “themes” or dimensions. For example, a child with OCD may engage in cleaning rituals because the context (or dimension) of their obsessions is contamination concerns. Another child with OCD, who may suffer from similar overall symptom severity, may primarily engage in checking rituals which are related with obsessions associated with fear of being responsible for harm. Therefore, one child with OCD may score very high on items assessing one dimension (e.g., contamination concerns), but very low on another dimension (e.g., harm obsessions).

This results in a known challenge in the assessment and psychometrics of self-report (as opposed to clinician administered) measures of OCD. Secondly, development of such measures requires very large carefully screened samples of individuals with OCD, with other disorders, and those without a known psychological disorder – which may be more challenging than requiring adult participants.

In order to address the urgent need for an ultrabrief measure for youth with OCD, we formed an international collaboration with the goal of developing a reliable ultrabrief self-report screening scale for this population. To accomplish this, we harmonized data from several sites that included three samples of carefully screened youths with OCD, with other disorders, and without known disorders who completed multiple self-report questionnaires, including the 21-item Obsessive-Compulsive Inventory – Child Version (OCI-CV).

Utilizing psychometric analyses including factor analyses, invariance analyses, and item response theory methodologies, we were able to develop an ultrabrief measure extracted from the OCI-CV: the 5-item Obsessive-Compulsive Inventory – Child Version (OCI-CV-5). This very brief self-report measure was found to have very good psychometric properties including a sensitive and specific clinical cutoff score. Youth who score at or above the cutoff score are nearly 21 times more likely to meet criteria for OCD.

This measure corresponds to a need to rapidly screen for OCD in children in nonspecialized settings, including community mental health clinics, primary care settings, and pediatric treatment facilities. However, it is important to note it is not a diagnostic measure. The measure is intended to identify youth who should be referred to a mental health care professional to conduct a diagnostic interview.

Dr. Abramovitch is a clinical psychologist and neuropsychologist based in Austin, Tex., and an associate professor at Texas State University. Dr. Abramowitz is professor and director of clinical training in the Anxiety and Stress Lab at University of North Carolina at Chapel Hill. Dr. McKay is professor of psychology at Fordham University, Bronx, N.Y.

The correct answer is (D), molluscum contagiosum. Upon surgical excision, the pathology indicated the lesion was consistent with molluscum contagiosum.

Molluscum contagiosum is a benign skin disorder caused by a pox virus and is frequently seen in children. This disease is transmitted primarily through direct skin contact with an infected individual.¹ Contaminated fomites have been suggested as another source of infection.² The typical lesion appears dome-shaped, round, and pinkish-purple in color.¹ The incubation period ranges from 2 weeks to 6 months and is typically self-limited in immunocompetent hosts; however, in immunocompromised persons, molluscum contagiosum lesions may present atypically such that they are larger in size and/or resemble malignancies, such as basal cell carcinoma or keratoacanthoma (for single lesions), or other infectious diseases, such as cryptococcosis and histoplasmosis (for more numerous lesions).^{3,4 A} giant atypical molluscum contagiosum is rarely seen in healthy individuals.
 

What’s on the differential?

The recent episode of bleeding raises concern for other neoplastic processes of the skin including squamous cell carcinoma or basal cell carcinoma as well as cutaneous metastatic rhabdoid tumor, given the patient’s history.

Eruptive keratoacanthomas are also reported in patients taking nivolumab, an anti-PD-1 immunotherapy, which the patient has received for treatment of his recurrent metastatic rhabdoid tumor.⁵ More common entities such as a pyogenic granuloma or verruca are also included on the differential. The initial presentation of the lesion, however, is more consistent with the pearly umbilicated papules associated with molluscum contagiosum.

Comments from Dr. Eichenfield

This is a very hard diagnosis to make with the clinical findings and history.

Molluscum contagiosum infections are common, but with this patient’s medical history, biopsy and excision with pathologic examination was an appropriate approach to make a certain diagnosis.

Ms. Moyal is a research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego.

References

1. Brown J et al. Int J Dermatol. 2006 Feb;45(2):93-9.

2. Hanson D and Diven DG. Dermatol Online J. 2003 Mar;9(2).

3. Badri T and Gandhi GR. Molluscum contagiosum. 2022. In: StatPearls [Internet]. Treasure Island, Fla.: StatPearls Publishing.

4. Schwartz JJ and Myskowski PL. J Am Acad Dermatol. 1992 Oct 1;27(4):583-8.

5. Antonov NK et al. JAAD Case Rep. 2019 Apr 5;5(4):342-5.

The correct answer is (D), molluscum contagiosum. Upon surgical excision, the pathology indicated the lesion was consistent with molluscum contagiosum.

Molluscum contagiosum is a benign skin disorder caused by a pox virus and is frequently seen in children. This disease is transmitted primarily through direct skin contact with an infected individual.¹ Contaminated fomites have been suggested as another source of infection.² The typical lesion appears dome-shaped, round, and pinkish-purple in color.¹ The incubation period ranges from 2 weeks to 6 months and is typically self-limited in immunocompetent hosts; however, in immunocompromised persons, molluscum contagiosum lesions may present atypically such that they are larger in size and/or resemble malignancies, such as basal cell carcinoma or keratoacanthoma (for single lesions), or other infectious diseases, such as cryptococcosis and histoplasmosis (for more numerous lesions).^{3,4 A} giant atypical molluscum contagiosum is rarely seen in healthy individuals.
 

What’s on the differential?

The recent episode of bleeding raises concern for other neoplastic processes of the skin including squamous cell carcinoma or basal cell carcinoma as well as cutaneous metastatic rhabdoid tumor, given the patient’s history.

Eruptive keratoacanthomas are also reported in patients taking nivolumab, an anti-PD-1 immunotherapy, which the patient has received for treatment of his recurrent metastatic rhabdoid tumor.⁵ More common entities such as a pyogenic granuloma or verruca are also included on the differential. The initial presentation of the lesion, however, is more consistent with the pearly umbilicated papules associated with molluscum contagiosum.

Comments from Dr. Eichenfield

This is a very hard diagnosis to make with the clinical findings and history.

Molluscum contagiosum infections are common, but with this patient’s medical history, biopsy and excision with pathologic examination was an appropriate approach to make a certain diagnosis.

Ms. Moyal is a research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego.

References

1. Brown J et al. Int J Dermatol. 2006 Feb;45(2):93-9.

2. Hanson D and Diven DG. Dermatol Online J. 2003 Mar;9(2).

3. Badri T and Gandhi GR. Molluscum contagiosum. 2022. In: StatPearls [Internet]. Treasure Island, Fla.: StatPearls Publishing.

4. Schwartz JJ and Myskowski PL. J Am Acad Dermatol. 1992 Oct 1;27(4):583-8.

5. Antonov NK et al. JAAD Case Rep. 2019 Apr 5;5(4):342-5.

The correct answer is (D), molluscum contagiosum. Upon surgical excision, the pathology indicated the lesion was consistent with molluscum contagiosum.

Molluscum contagiosum is a benign skin disorder caused by a pox virus and is frequently seen in children. This disease is transmitted primarily through direct skin contact with an infected individual.¹ Contaminated fomites have been suggested as another source of infection.² The typical lesion appears dome-shaped, round, and pinkish-purple in color.¹ The incubation period ranges from 2 weeks to 6 months and is typically self-limited in immunocompetent hosts; however, in immunocompromised persons, molluscum contagiosum lesions may present atypically such that they are larger in size and/or resemble malignancies, such as basal cell carcinoma or keratoacanthoma (for single lesions), or other infectious diseases, such as cryptococcosis and histoplasmosis (for more numerous lesions).^{3,4 A} giant atypical molluscum contagiosum is rarely seen in healthy individuals.
 

What’s on the differential?

The recent episode of bleeding raises concern for other neoplastic processes of the skin including squamous cell carcinoma or basal cell carcinoma as well as cutaneous metastatic rhabdoid tumor, given the patient’s history.

Eruptive keratoacanthomas are also reported in patients taking nivolumab, an anti-PD-1 immunotherapy, which the patient has received for treatment of his recurrent metastatic rhabdoid tumor.⁵ More common entities such as a pyogenic granuloma or verruca are also included on the differential. The initial presentation of the lesion, however, is more consistent with the pearly umbilicated papules associated with molluscum contagiosum.

Comments from Dr. Eichenfield

This is a very hard diagnosis to make with the clinical findings and history.

Molluscum contagiosum infections are common, but with this patient’s medical history, biopsy and excision with pathologic examination was an appropriate approach to make a certain diagnosis.

Ms. Moyal is a research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego.

References

1. Brown J et al. Int J Dermatol. 2006 Feb;45(2):93-9.

2. Hanson D and Diven DG. Dermatol Online J. 2003 Mar;9(2).

3. Badri T and Gandhi GR. Molluscum contagiosum. 2022. In: StatPearls [Internet]. Treasure Island, Fla.: StatPearls Publishing.

4. Schwartz JJ and Myskowski PL. J Am Acad Dermatol. 1992 Oct 1;27(4):583-8.

5. Antonov NK et al. JAAD Case Rep. 2019 Apr 5;5(4):342-5.

Primary care and family physicians operate on the front lines of health care, working tirelessly to serve patients and their families. However, many primary care practices are operating on tight margins and cannot sustain additional financial hits. As we continue to navigate a pandemic that has altered our health care landscape, we traveled to Capitol Hill to urge Congress to act on two critical issues: Medicare payment reform and streamlining administrative burden for physicians.

The current Medicare system for compensating physicians jeopardizes access to primary care. Family physicians, along with other primary care clinicians, are facing significant cuts in payments and rising inflation that threaten our ability to care for patients.

Each of us has experienced the effects of this pincer in devastating ways – from the independent clinicians who have been forced to sell their practices to hospitals or large health systems, to the physicians who are retiring early, leaving their practices, or even closing them because they can’t afford to keep their doors open.

Practices also struggle to cover the rising costs of staff wages, leasing space, and purchasing supplies and equipment, leaving little room for innovation or investments to transition into new payment models. Meanwhile, hospitals, skilled nursing facilities, ambulatory surgery centers, and other Medicare providers receive annual payment increases to account for rising costs.

Insufficient Medicare payments also challenge practices that serve many publicly insured patients. If practices cannot cover their expenses, they may be forced to turn away new Medicare and Medicaid patients – something that goes against the core tenets of our health care system.

Fortunately, we have some solutions. We’re asking Congress to pass the Supporting Medicare Providers Act of 2022, which calls for a 4.42% positive adjustment to the Medicare Physician Fee Schedule (MPFS) conversion factor for 2023 to offset the statutory reduction triggered by budget neutrality rules.

We also are calling on lawmakers to end the statutory freeze on annual updates to the MPFS and enact a positive annual update to the conversion factor based on the Medicare Economic Index. This critical relief would stave off the most immediate cuts while giving us more time to work with Congress on comprehensive reforms to the Medicare physician payment system.

As many practices struggle to operate, burnout among primary care physicians has also increased, with research showing that 66% of primary care physicians reported frequent burnout symptoms in 2021. Streamlining prior authorizations – a cumbersome process that requires physicians to obtain preapproval for treatments or tests before providing care to patients, and can risk patients’ access to timely care – is one way to reduce burden and alleviate burnout.

According to the American Medical Association, 82% of physicians report that prior authorization can lead to patients abandoning care, and 93% believe that prior authorization delays access to necessary care.

All of us have had patients whose care has been affected by these delays, including difficulty in getting necessary medications filled or having medical procedures postponed. Moreover, primary care physicians and their staff spend hours each week completing paperwork and communicating with insurers to ensure that their patients can access the treatments and services they need.

That is why we’re urging the Senate to pass the Improving Seniors’ Timely Access to Care Act, which would streamline the prior authorization process in the Medicare Advantage program.

As family physicians, we are in a unique position to help improve our patients’ health and their quality of life. But we can’t do this alone. We need the support of policy makers to make patient health and primary care a national priority.

Dr. Iroku-Malize is a family physician in Long Island, New York, and President of the American Academy of Family Physicians. Dr. Ransone is a family physician in Deltaville, Va., and board chair, immediate past president of the AAFP. Dr. Furr is a family physician in Jackson, Ala., and President-elect of the AAFP. They reported no conflicts of interest.

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

Primary care and family physicians operate on the front lines of health care, working tirelessly to serve patients and their families. However, many primary care practices are operating on tight margins and cannot sustain additional financial hits. As we continue to navigate a pandemic that has altered our health care landscape, we traveled to Capitol Hill to urge Congress to act on two critical issues: Medicare payment reform and streamlining administrative burden for physicians.

The current Medicare system for compensating physicians jeopardizes access to primary care. Family physicians, along with other primary care clinicians, are facing significant cuts in payments and rising inflation that threaten our ability to care for patients.

Each of us has experienced the effects of this pincer in devastating ways – from the independent clinicians who have been forced to sell their practices to hospitals or large health systems, to the physicians who are retiring early, leaving their practices, or even closing them because they can’t afford to keep their doors open.

Practices also struggle to cover the rising costs of staff wages, leasing space, and purchasing supplies and equipment, leaving little room for innovation or investments to transition into new payment models. Meanwhile, hospitals, skilled nursing facilities, ambulatory surgery centers, and other Medicare providers receive annual payment increases to account for rising costs.

Insufficient Medicare payments also challenge practices that serve many publicly insured patients. If practices cannot cover their expenses, they may be forced to turn away new Medicare and Medicaid patients – something that goes against the core tenets of our health care system.

Fortunately, we have some solutions. We’re asking Congress to pass the Supporting Medicare Providers Act of 2022, which calls for a 4.42% positive adjustment to the Medicare Physician Fee Schedule (MPFS) conversion factor for 2023 to offset the statutory reduction triggered by budget neutrality rules.

We also are calling on lawmakers to end the statutory freeze on annual updates to the MPFS and enact a positive annual update to the conversion factor based on the Medicare Economic Index. This critical relief would stave off the most immediate cuts while giving us more time to work with Congress on comprehensive reforms to the Medicare physician payment system.

As many practices struggle to operate, burnout among primary care physicians has also increased, with research showing that 66% of primary care physicians reported frequent burnout symptoms in 2021. Streamlining prior authorizations – a cumbersome process that requires physicians to obtain preapproval for treatments or tests before providing care to patients, and can risk patients’ access to timely care – is one way to reduce burden and alleviate burnout.

According to the American Medical Association, 82% of physicians report that prior authorization can lead to patients abandoning care, and 93% believe that prior authorization delays access to necessary care.

All of us have had patients whose care has been affected by these delays, including difficulty in getting necessary medications filled or having medical procedures postponed. Moreover, primary care physicians and their staff spend hours each week completing paperwork and communicating with insurers to ensure that their patients can access the treatments and services they need.

That is why we’re urging the Senate to pass the Improving Seniors’ Timely Access to Care Act, which would streamline the prior authorization process in the Medicare Advantage program.

As family physicians, we are in a unique position to help improve our patients’ health and their quality of life. But we can’t do this alone. We need the support of policy makers to make patient health and primary care a national priority.

Dr. Iroku-Malize is a family physician in Long Island, New York, and President of the American Academy of Family Physicians. Dr. Ransone is a family physician in Deltaville, Va., and board chair, immediate past president of the AAFP. Dr. Furr is a family physician in Jackson, Ala., and President-elect of the AAFP. They reported no conflicts of interest.

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

Primary care and family physicians operate on the front lines of health care, working tirelessly to serve patients and their families. However, many primary care practices are operating on tight margins and cannot sustain additional financial hits. As we continue to navigate a pandemic that has altered our health care landscape, we traveled to Capitol Hill to urge Congress to act on two critical issues: Medicare payment reform and streamlining administrative burden for physicians.

The current Medicare system for compensating physicians jeopardizes access to primary care. Family physicians, along with other primary care clinicians, are facing significant cuts in payments and rising inflation that threaten our ability to care for patients.

Each of us has experienced the effects of this pincer in devastating ways – from the independent clinicians who have been forced to sell their practices to hospitals or large health systems, to the physicians who are retiring early, leaving their practices, or even closing them because they can’t afford to keep their doors open.

Practices also struggle to cover the rising costs of staff wages, leasing space, and purchasing supplies and equipment, leaving little room for innovation or investments to transition into new payment models. Meanwhile, hospitals, skilled nursing facilities, ambulatory surgery centers, and other Medicare providers receive annual payment increases to account for rising costs.

Insufficient Medicare payments also challenge practices that serve many publicly insured patients. If practices cannot cover their expenses, they may be forced to turn away new Medicare and Medicaid patients – something that goes against the core tenets of our health care system.

Fortunately, we have some solutions. We’re asking Congress to pass the Supporting Medicare Providers Act of 2022, which calls for a 4.42% positive adjustment to the Medicare Physician Fee Schedule (MPFS) conversion factor for 2023 to offset the statutory reduction triggered by budget neutrality rules.

We also are calling on lawmakers to end the statutory freeze on annual updates to the MPFS and enact a positive annual update to the conversion factor based on the Medicare Economic Index. This critical relief would stave off the most immediate cuts while giving us more time to work with Congress on comprehensive reforms to the Medicare physician payment system.

As many practices struggle to operate, burnout among primary care physicians has also increased, with research showing that 66% of primary care physicians reported frequent burnout symptoms in 2021. Streamlining prior authorizations – a cumbersome process that requires physicians to obtain preapproval for treatments or tests before providing care to patients, and can risk patients’ access to timely care – is one way to reduce burden and alleviate burnout.

According to the American Medical Association, 82% of physicians report that prior authorization can lead to patients abandoning care, and 93% believe that prior authorization delays access to necessary care.

All of us have had patients whose care has been affected by these delays, including difficulty in getting necessary medications filled or having medical procedures postponed. Moreover, primary care physicians and their staff spend hours each week completing paperwork and communicating with insurers to ensure that their patients can access the treatments and services they need.

That is why we’re urging the Senate to pass the Improving Seniors’ Timely Access to Care Act, which would streamline the prior authorization process in the Medicare Advantage program.

As family physicians, we are in a unique position to help improve our patients’ health and their quality of life. But we can’t do this alone. We need the support of policy makers to make patient health and primary care a national priority.

Dr. Iroku-Malize is a family physician in Long Island, New York, and President of the American Academy of Family Physicians. Dr. Ransone is a family physician in Deltaville, Va., and board chair, immediate past president of the AAFP. Dr. Furr is a family physician in Jackson, Ala., and President-elect of the AAFP. They reported no conflicts of interest.

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