After 2 weeks of declines, the percentage of weekly COVID-19 cases occurring in children increased during the week ending Oct. 8, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

For the week, 14.6% of all COVID-19 cases reported in the United States occurred in children, after 2 consecutive weeks of declines that saw the proportion drop from 16.9% to 12.3%. The cumulative rate of child cases for the entire pandemic is 10.7%, with total child cases in the United States now up to 697,633 and cases among all ages at just over 6.5 million, the AAP and the CHA said Oct. 12 in their weekly COVID-19 report.

Nationally, there were 927 cases reported per 100,000 children as of Oct. 8, with rates at the state level varying from 176 per 100,000 in Vermont to 2,221 per 100,000 in North Dakota. Two other states were over 2,000 cases per 100,000 children: Tennessee (2,155) and South Carolina (2,116), based on data from the health departments of 49 states (New York does not report age distribution), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

Severe illness continues to be rare in children, and national (25 states and New York City) hospitalization rates dropped in the last week. The proportion of hospitalizations occurring in children slipped from a pandemic high of 1.8% the previous week to 1.7% during the week of Oct. 8, and the rate of hospitalizations for children with COVID-19 was down to 1.4% from 1.6% the week before and 1.9% on Sept. 3, the AAP and the CHA said.

Mortality data from 42 states and New York City also show a decline. For the third consecutive week, children represented just 0.06% of all COVID-19 deaths in the United States, down from a high of 0.07% on Sept. 17. Only 0.02% of all cases in children have resulted in death, and that figure has been dropping since early June, when it reached 0.06%, according to the AAP/CHA report. As of Oct. 8, there have been 115 total deaths reported in children.

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After 2 weeks of declines, the percentage of weekly COVID-19 cases occurring in children increased during the week ending Oct. 8, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

For the week, 14.6% of all COVID-19 cases reported in the United States occurred in children, after 2 consecutive weeks of declines that saw the proportion drop from 16.9% to 12.3%. The cumulative rate of child cases for the entire pandemic is 10.7%, with total child cases in the United States now up to 697,633 and cases among all ages at just over 6.5 million, the AAP and the CHA said Oct. 12 in their weekly COVID-19 report.

Nationally, there were 927 cases reported per 100,000 children as of Oct. 8, with rates at the state level varying from 176 per 100,000 in Vermont to 2,221 per 100,000 in North Dakota. Two other states were over 2,000 cases per 100,000 children: Tennessee (2,155) and South Carolina (2,116), based on data from the health departments of 49 states (New York does not report age distribution), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

Severe illness continues to be rare in children, and national (25 states and New York City) hospitalization rates dropped in the last week. The proportion of hospitalizations occurring in children slipped from a pandemic high of 1.8% the previous week to 1.7% during the week of Oct. 8, and the rate of hospitalizations for children with COVID-19 was down to 1.4% from 1.6% the week before and 1.9% on Sept. 3, the AAP and the CHA said.

Mortality data from 42 states and New York City also show a decline. For the third consecutive week, children represented just 0.06% of all COVID-19 deaths in the United States, down from a high of 0.07% on Sept. 17. Only 0.02% of all cases in children have resulted in death, and that figure has been dropping since early June, when it reached 0.06%, according to the AAP/CHA report. As of Oct. 8, there have been 115 total deaths reported in children.

[email protected]

After 2 weeks of declines, the percentage of weekly COVID-19 cases occurring in children increased during the week ending Oct. 8, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

For the week, 14.6% of all COVID-19 cases reported in the United States occurred in children, after 2 consecutive weeks of declines that saw the proportion drop from 16.9% to 12.3%. The cumulative rate of child cases for the entire pandemic is 10.7%, with total child cases in the United States now up to 697,633 and cases among all ages at just over 6.5 million, the AAP and the CHA said Oct. 12 in their weekly COVID-19 report.

Nationally, there were 927 cases reported per 100,000 children as of Oct. 8, with rates at the state level varying from 176 per 100,000 in Vermont to 2,221 per 100,000 in North Dakota. Two other states were over 2,000 cases per 100,000 children: Tennessee (2,155) and South Carolina (2,116), based on data from the health departments of 49 states (New York does not report age distribution), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

Severe illness continues to be rare in children, and national (25 states and New York City) hospitalization rates dropped in the last week. The proportion of hospitalizations occurring in children slipped from a pandemic high of 1.8% the previous week to 1.7% during the week of Oct. 8, and the rate of hospitalizations for children with COVID-19 was down to 1.4% from 1.6% the week before and 1.9% on Sept. 3, the AAP and the CHA said.

Mortality data from 42 states and New York City also show a decline. For the third consecutive week, children represented just 0.06% of all COVID-19 deaths in the United States, down from a high of 0.07% on Sept. 17. Only 0.02% of all cases in children have resulted in death, and that figure has been dropping since early June, when it reached 0.06%, according to the AAP/CHA report. As of Oct. 8, there have been 115 total deaths reported in children.

[email protected]

A diagnosis of acute myeloid leukemia (AML) is particularly challenging in older adults, whose age makes them highly susceptible to the disease and treatment-related toxicity. To help patients and practitioners navigate the clinical decision-making process, the American Society of Hematology convened a panel of experts who conducted a thorough review of the literature. The result of their work can be found in a new set of guidelines for the treatment of newly diagnosed AML in older adults.

In an interview, Mikkael Sekeres, MD, chair of the ASH AML guideline panel and director of the Leukemia Program at Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio, shared the rationale behind the panel’s key recommendations and the importance of keeping the patient’s goals in mind.

Question: What is the average life expectancy of a 75-year-old developing AML compared with someone of the same age without AML?

Dr. Sekeres: A 75-year-old developing AML has an average life expectancy measured in fewer than 6 months. Somebody who is 75 without leukemia in the United States has a life expectancy that can be measured in a decade or more. AML is a really serious diagnosis when someone is older and significantly truncates expected survival.

Q: What is the median age at AML diagnosis in the United States?

Dr. Sekeres: About 67 years.

Q: What are the biological underpinnings for poor outcomes in older AML patients?

Dr. Sekeres: There are a few of them. Older adults with AML tend to have a leukemia that has evolved from a known or unknown previous bone marrow condition such as myelodysplastic syndrome. Older adults also have worse genetics driving their leukemia, which makes the leukemia cells more resistant to chemotherapy. And the leukemia cells may even have drug efflux pumps that extrude chemotherapy that tries to enter the cell. Finally, older adults are more likely to have comorbidities that make their ability to tolerate chemotherapy much lower than for younger adults.

Q: In someone who is newly diagnosed with AML, what initial options are they routinely given?

Dr. Sekeres: For someone who is older, we divide those options into three main categories.

The first is to take intensive chemotherapy, which requires a 4-6 week hospitalization and has a chance of getting somebody who is older into a remission of approximately 50%-60%. But this also carries with it significant treatment-related mortality that may be as high as 10%-20%. So I have to look my older patients in the eyes when I talk about intensive chemotherapy and say, “There is a 1 in 10 or 1 in 5 chance that you might not make it out of the hospital alive.”

The second prong is lower-dose therapy. While the more-intensive therapy requiring hospitalization does have a low, but real, chance of curing that person, less-intensive therapy is not curative. Our best hope with less-intensive therapy is that our patients enter a remission and live longer. With less-intensive therapy, the chance that someone will go into remission is probably around 20%, but again it is not curative. The flip side to that is that it improves a person’s immediate quality of life because they’re not in the hospital for 4-6 weeks.

The final prong is to discuss palliative care or hospice upfront. We designed these guidelines to be focused on a patient’s goals of therapy and to constantly revisit those goals to make sure that the treatment options we are offering are aligning with them.

Q: The panel’s first recommendation is to offer antileukemic therapy over best supportive care in patients who are appropriate candidates. Can you provide some context for this recommendation?

Dr. Sekeres: Doesn’t that strike you as funny that we even have to make a recommendation about getting chemotherapy? Some database studies conducted over the past 2 decades show that, as recently as 15 years ago, only one-third of patients who were over the age of 65 years received any type of chemotherapy for AML. More recently, as we have had a few more drugs available that allow us to use lower-dose approaches, that number has crept up to probably about 50%. We still have half the patients offered no therapy at all. So we felt that we had to deliberately make a recommendation saying that, if it aligns with the patients’ goals, they should be offered chemotherapy.

Q: The second recommendation is that patients considered candidates for intensive antileukemic therapy should receive it over less-intensive antileukemic therapy. How did you get to that recommendation?

Dr. Sekeres: There is a debate in our field about whether older adults should be offered intensive inpatient chemotherapy at all or whether we should be treating all of them with less-intensive therapy. There is not a huge amount of high-quality studies out there to answer some of these questions, in particular whether intensive chemotherapy should be recommended over less-intensive therapy. But with the available evidence, what we believe is that patients live longer if they are offered intensive antileukemic chemotherapy. So again, if it aligns with a patient’s goals, we support that patient receiving more-intensive therapy in the hospital.

Q: What does the panel recommend for patients who achieve remission after at least a single cycle of intensive antileukemic therapy and who are not candidates for allogeneic hematopoietic stem cell transplantation?

Dr. Sekeres: Once again, this may seem at first blush to be an obvious recommendation. The standard treatment of someone who is younger with AML is to offer intensive inpatient chemotherapy to induce remission. This is followed by a few cycles of chemotherapy, mostly in an outpatient setting, to consolidate that remission.

Q: What is the underlying philosophy for this approach?

Dr. Sekeres: Every time we give chemotherapy, we probably get about a 3-4 log kill of leukemia cells. Imagine when patients first present with AML, they may have 10 billion leukemia cells in their body. We are reducing that 3-4 log with the first course of chemotherapy.

When we then look at a bone marrow biopsy, it may appear to be normal. When leukemia is at a lower level in the body, we simply can’t see it using standard techniques. But that doesn’t mean the leukemia is gone. For younger patients, we give another cycle of chemotherapy, then another, then another, and then even another to reduce the number of leukemia cells left over in the body until that person has a durable remission and hopefully cure.

For someone who is older, the data are less clear. While some studies have shown that, if you give too much chemotherapy after the initial course, it doesn’t help that much, there is a paucity of studies that show that any chemotherapy at all after the first induction course is helpful. Consequently, we have to use indirect data. Older people who are long-term survivors from their acute leukemia always seem to have gotten more than one course of chemotherapy. In other words, the initial course of chemotherapy that a patient receives in the hospital isn’t enough. They should receive more than that.

Q: What about older adults with AML considered appropriate for antileukemic therapy but not for intensive antileukemic therapy?

Dr. Sekeres: This again gets to the question of what are a patient’s goals. It takes a very involved conversation with patients at the time of their AML diagnosis to determine whether they would want to pursue an aggressive approach or a less-aggressive approach. If a patients want a less-aggressive approach, and want nothing to do with a hospital stay, then they are also prioritizing initial quality of life. In this recommendation, based on existing studies, we didn’t have a preference for which of the available less-aggressive chemotherapies a person selects.

There’s also debate about what to do in those considered appropriate for antileukemic therapy, such as hypomethylating agents (azacitidine and decitabine) or low-dose cytarabine, but not for intensive antileukemic therapy. What did the available evidence seem to indicate about this issue?

There has been a lot of studies trying to add two drugs together to see if those do better than one drug alone in patients who are older and who choose less-intensive therapy. The majority of those studies have shown no advantage to getting two drugs over one drug.

Our recommendation is that in these situations a patient gets one drug, not two, but there are a couple of caveats. One caveat is that there has been a small study showing the effectiveness of one of those low-dose chemotherapies combined with the drug glasdegib. The second caveat is that there have been results presented combining one of these low-dose chemotherapies with the drug venetoclax. One of those was a negative study, and another was a positive study showing a survival advantage to the combination vs. the low-dose therapy alone. We had to couch our recommendation a little bit because we knew this other study had been presented at a conference, but it hadn’t come out in final form yet. It did recently, however, and we will now revisit this recommendation.

The other complicated aspect to this is that we weren’t 100% convinced that the combination of venetoclax with one of these lower-dose therapies is truly less-intensive therapy. We think it is starting to creep up toward more-intensive chemotherapy, even though it is commonly given to patients in the outpatient setting. It gets into the very complicated area of what are we defining as more-intensive therapy and less-intensive therapy.

Q: Is there a recommended strategy for older adults with AML who achieve a response after receiving less-intensive therapy?

Dr. Sekeres: This is also challenging because there are no randomized studies in which patients received less-intensive therapy for a finite period of time vs. receiving those therapies ad infinitum. Given the lack of data and also given a lot of anecdotal data out there about patients who stopped a certain therapy and relapsed thereafter, we recommended that patients continue the less-intensive therapy ad infinitum. So as long as they are receiving a response to that therapy, they continue on the drug.

Q: Of course, there are also unique considerations faced by older patients who are no longer receiving antileukemic therapy and have moved on to receiving end-of-life care or hospice care. What advice do the guidelines offer in this situation?

Dr. Sekeres: There are a lot of aspects of these recommendations that I think are special. The first is the focus on patient goals of care at every point in these guidelines. The second is that the guidelines follow the real disease course and a real conversation that doctors and patients have at every step of the way to help guide the decisions that have to be made in real time.

A problem we have in the United States is that once patients enter a hospice, most will not allow blood transfusions. One reason is that some say it is antithetical to their philosophy and consider it aggressive care. The second reason is that, to be completely blunt, economically it doesn’t make sense for hospices to allow blood transfusions. The amount that they are reimbursed by Medicare is much lower than the cost of receiving blood in an infusion center.

We wanted to make a clear recommendation that we consider transfusions in a patient who is in a palliative care or hospice mode to be supportive and necessary, and that these should be provided to patients even if they are in hospice and, as always, if consistent with a patient’s goals of care.

Q: How does a patient’s age inform the discussion surrounding what intensity treatment to offer?

Dr. Sekeres: With younger adults, this is not as complicated a conversation. A younger person has a better chance of being cured with intensive chemotherapy and is much more likely to tolerate that intensive chemotherapy. For someone who is younger, we offer intensive chemotherapy and the chance of going into remission is higher, at 70%-80%. The chance of dying is lower, usually less than 5%. It is an easy decision to make.

For an older adult, the risk-benefit ratio shifts and it becomes a more complicated option. Less-intensive therapy or best supportive care or hospice become viable.

Q: Are there other factors confounding the treatment decision-making process in older adults with AML that practitioners should consider?

Dr. Sekeres: Someone who is older is making a different decision than I would. I have school-aged children and believe that my job as a parent is to successfully get them to adulthood, so I would take any treatment under the sun to make sure that happens. People who have lived a longer life than I have may have children and even grandchildren who are adults, and they might have different goals of care. My goals are not going to be the same as my patient’s goals.

It is also harder because patients who are older may feel that they have lived a good life and don’t need to go through heroic measures to try to be around as long as possible, and those goals may not align with the goals of that person’s children who want their parent to be around as long as possible. One of the confounding factors in this is navigating the different goals of the different family members.

Dr. Sekeres has disclosed no relevant financial relationships.
 

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

A diagnosis of acute myeloid leukemia (AML) is particularly challenging in older adults, whose age makes them highly susceptible to the disease and treatment-related toxicity. To help patients and practitioners navigate the clinical decision-making process, the American Society of Hematology convened a panel of experts who conducted a thorough review of the literature. The result of their work can be found in a new set of guidelines for the treatment of newly diagnosed AML in older adults.

In an interview, Mikkael Sekeres, MD, chair of the ASH AML guideline panel and director of the Leukemia Program at Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio, shared the rationale behind the panel’s key recommendations and the importance of keeping the patient’s goals in mind.

Question: What is the average life expectancy of a 75-year-old developing AML compared with someone of the same age without AML?

Dr. Sekeres: A 75-year-old developing AML has an average life expectancy measured in fewer than 6 months. Somebody who is 75 without leukemia in the United States has a life expectancy that can be measured in a decade or more. AML is a really serious diagnosis when someone is older and significantly truncates expected survival.

Q: What is the median age at AML diagnosis in the United States?

Dr. Sekeres: About 67 years.

Q: What are the biological underpinnings for poor outcomes in older AML patients?

Dr. Sekeres: There are a few of them. Older adults with AML tend to have a leukemia that has evolved from a known or unknown previous bone marrow condition such as myelodysplastic syndrome. Older adults also have worse genetics driving their leukemia, which makes the leukemia cells more resistant to chemotherapy. And the leukemia cells may even have drug efflux pumps that extrude chemotherapy that tries to enter the cell. Finally, older adults are more likely to have comorbidities that make their ability to tolerate chemotherapy much lower than for younger adults.

Q: In someone who is newly diagnosed with AML, what initial options are they routinely given?

Dr. Sekeres: For someone who is older, we divide those options into three main categories.

The first is to take intensive chemotherapy, which requires a 4-6 week hospitalization and has a chance of getting somebody who is older into a remission of approximately 50%-60%. But this also carries with it significant treatment-related mortality that may be as high as 10%-20%. So I have to look my older patients in the eyes when I talk about intensive chemotherapy and say, “There is a 1 in 10 or 1 in 5 chance that you might not make it out of the hospital alive.”

The second prong is lower-dose therapy. While the more-intensive therapy requiring hospitalization does have a low, but real, chance of curing that person, less-intensive therapy is not curative. Our best hope with less-intensive therapy is that our patients enter a remission and live longer. With less-intensive therapy, the chance that someone will go into remission is probably around 20%, but again it is not curative. The flip side to that is that it improves a person’s immediate quality of life because they’re not in the hospital for 4-6 weeks.

The final prong is to discuss palliative care or hospice upfront. We designed these guidelines to be focused on a patient’s goals of therapy and to constantly revisit those goals to make sure that the treatment options we are offering are aligning with them.

Q: The panel’s first recommendation is to offer antileukemic therapy over best supportive care in patients who are appropriate candidates. Can you provide some context for this recommendation?

Dr. Sekeres: Doesn’t that strike you as funny that we even have to make a recommendation about getting chemotherapy? Some database studies conducted over the past 2 decades show that, as recently as 15 years ago, only one-third of patients who were over the age of 65 years received any type of chemotherapy for AML. More recently, as we have had a few more drugs available that allow us to use lower-dose approaches, that number has crept up to probably about 50%. We still have half the patients offered no therapy at all. So we felt that we had to deliberately make a recommendation saying that, if it aligns with the patients’ goals, they should be offered chemotherapy.

Q: The second recommendation is that patients considered candidates for intensive antileukemic therapy should receive it over less-intensive antileukemic therapy. How did you get to that recommendation?

Dr. Sekeres: There is a debate in our field about whether older adults should be offered intensive inpatient chemotherapy at all or whether we should be treating all of them with less-intensive therapy. There is not a huge amount of high-quality studies out there to answer some of these questions, in particular whether intensive chemotherapy should be recommended over less-intensive therapy. But with the available evidence, what we believe is that patients live longer if they are offered intensive antileukemic chemotherapy. So again, if it aligns with a patient’s goals, we support that patient receiving more-intensive therapy in the hospital.

Q: What does the panel recommend for patients who achieve remission after at least a single cycle of intensive antileukemic therapy and who are not candidates for allogeneic hematopoietic stem cell transplantation?

Dr. Sekeres: Once again, this may seem at first blush to be an obvious recommendation. The standard treatment of someone who is younger with AML is to offer intensive inpatient chemotherapy to induce remission. This is followed by a few cycles of chemotherapy, mostly in an outpatient setting, to consolidate that remission.

Q: What is the underlying philosophy for this approach?

Dr. Sekeres: Every time we give chemotherapy, we probably get about a 3-4 log kill of leukemia cells. Imagine when patients first present with AML, they may have 10 billion leukemia cells in their body. We are reducing that 3-4 log with the first course of chemotherapy.

When we then look at a bone marrow biopsy, it may appear to be normal. When leukemia is at a lower level in the body, we simply can’t see it using standard techniques. But that doesn’t mean the leukemia is gone. For younger patients, we give another cycle of chemotherapy, then another, then another, and then even another to reduce the number of leukemia cells left over in the body until that person has a durable remission and hopefully cure.

For someone who is older, the data are less clear. While some studies have shown that, if you give too much chemotherapy after the initial course, it doesn’t help that much, there is a paucity of studies that show that any chemotherapy at all after the first induction course is helpful. Consequently, we have to use indirect data. Older people who are long-term survivors from their acute leukemia always seem to have gotten more than one course of chemotherapy. In other words, the initial course of chemotherapy that a patient receives in the hospital isn’t enough. They should receive more than that.

Q: What about older adults with AML considered appropriate for antileukemic therapy but not for intensive antileukemic therapy?

Dr. Sekeres: This again gets to the question of what are a patient’s goals. It takes a very involved conversation with patients at the time of their AML diagnosis to determine whether they would want to pursue an aggressive approach or a less-aggressive approach. If a patients want a less-aggressive approach, and want nothing to do with a hospital stay, then they are also prioritizing initial quality of life. In this recommendation, based on existing studies, we didn’t have a preference for which of the available less-aggressive chemotherapies a person selects.

There’s also debate about what to do in those considered appropriate for antileukemic therapy, such as hypomethylating agents (azacitidine and decitabine) or low-dose cytarabine, but not for intensive antileukemic therapy. What did the available evidence seem to indicate about this issue?

There has been a lot of studies trying to add two drugs together to see if those do better than one drug alone in patients who are older and who choose less-intensive therapy. The majority of those studies have shown no advantage to getting two drugs over one drug.

Our recommendation is that in these situations a patient gets one drug, not two, but there are a couple of caveats. One caveat is that there has been a small study showing the effectiveness of one of those low-dose chemotherapies combined with the drug glasdegib. The second caveat is that there have been results presented combining one of these low-dose chemotherapies with the drug venetoclax. One of those was a negative study, and another was a positive study showing a survival advantage to the combination vs. the low-dose therapy alone. We had to couch our recommendation a little bit because we knew this other study had been presented at a conference, but it hadn’t come out in final form yet. It did recently, however, and we will now revisit this recommendation.

The other complicated aspect to this is that we weren’t 100% convinced that the combination of venetoclax with one of these lower-dose therapies is truly less-intensive therapy. We think it is starting to creep up toward more-intensive chemotherapy, even though it is commonly given to patients in the outpatient setting. It gets into the very complicated area of what are we defining as more-intensive therapy and less-intensive therapy.

Q: Is there a recommended strategy for older adults with AML who achieve a response after receiving less-intensive therapy?

Dr. Sekeres: This is also challenging because there are no randomized studies in which patients received less-intensive therapy for a finite period of time vs. receiving those therapies ad infinitum. Given the lack of data and also given a lot of anecdotal data out there about patients who stopped a certain therapy and relapsed thereafter, we recommended that patients continue the less-intensive therapy ad infinitum. So as long as they are receiving a response to that therapy, they continue on the drug.

Q: Of course, there are also unique considerations faced by older patients who are no longer receiving antileukemic therapy and have moved on to receiving end-of-life care or hospice care. What advice do the guidelines offer in this situation?

Dr. Sekeres: There are a lot of aspects of these recommendations that I think are special. The first is the focus on patient goals of care at every point in these guidelines. The second is that the guidelines follow the real disease course and a real conversation that doctors and patients have at every step of the way to help guide the decisions that have to be made in real time.

A problem we have in the United States is that once patients enter a hospice, most will not allow blood transfusions. One reason is that some say it is antithetical to their philosophy and consider it aggressive care. The second reason is that, to be completely blunt, economically it doesn’t make sense for hospices to allow blood transfusions. The amount that they are reimbursed by Medicare is much lower than the cost of receiving blood in an infusion center.

We wanted to make a clear recommendation that we consider transfusions in a patient who is in a palliative care or hospice mode to be supportive and necessary, and that these should be provided to patients even if they are in hospice and, as always, if consistent with a patient’s goals of care.

Q: How does a patient’s age inform the discussion surrounding what intensity treatment to offer?

Dr. Sekeres: With younger adults, this is not as complicated a conversation. A younger person has a better chance of being cured with intensive chemotherapy and is much more likely to tolerate that intensive chemotherapy. For someone who is younger, we offer intensive chemotherapy and the chance of going into remission is higher, at 70%-80%. The chance of dying is lower, usually less than 5%. It is an easy decision to make.

For an older adult, the risk-benefit ratio shifts and it becomes a more complicated option. Less-intensive therapy or best supportive care or hospice become viable.

Q: Are there other factors confounding the treatment decision-making process in older adults with AML that practitioners should consider?

Dr. Sekeres: Someone who is older is making a different decision than I would. I have school-aged children and believe that my job as a parent is to successfully get them to adulthood, so I would take any treatment under the sun to make sure that happens. People who have lived a longer life than I have may have children and even grandchildren who are adults, and they might have different goals of care. My goals are not going to be the same as my patient’s goals.

It is also harder because patients who are older may feel that they have lived a good life and don’t need to go through heroic measures to try to be around as long as possible, and those goals may not align with the goals of that person’s children who want their parent to be around as long as possible. One of the confounding factors in this is navigating the different goals of the different family members.

Dr. Sekeres has disclosed no relevant financial relationships.
 

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

A diagnosis of acute myeloid leukemia (AML) is particularly challenging in older adults, whose age makes them highly susceptible to the disease and treatment-related toxicity. To help patients and practitioners navigate the clinical decision-making process, the American Society of Hematology convened a panel of experts who conducted a thorough review of the literature. The result of their work can be found in a new set of guidelines for the treatment of newly diagnosed AML in older adults.

In an interview, Mikkael Sekeres, MD, chair of the ASH AML guideline panel and director of the Leukemia Program at Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio, shared the rationale behind the panel’s key recommendations and the importance of keeping the patient’s goals in mind.

Question: What is the average life expectancy of a 75-year-old developing AML compared with someone of the same age without AML?

Dr. Sekeres: A 75-year-old developing AML has an average life expectancy measured in fewer than 6 months. Somebody who is 75 without leukemia in the United States has a life expectancy that can be measured in a decade or more. AML is a really serious diagnosis when someone is older and significantly truncates expected survival.

Q: What is the median age at AML diagnosis in the United States?

Dr. Sekeres: About 67 years.

Q: What are the biological underpinnings for poor outcomes in older AML patients?

Dr. Sekeres: There are a few of them. Older adults with AML tend to have a leukemia that has evolved from a known or unknown previous bone marrow condition such as myelodysplastic syndrome. Older adults also have worse genetics driving their leukemia, which makes the leukemia cells more resistant to chemotherapy. And the leukemia cells may even have drug efflux pumps that extrude chemotherapy that tries to enter the cell. Finally, older adults are more likely to have comorbidities that make their ability to tolerate chemotherapy much lower than for younger adults.

Q: In someone who is newly diagnosed with AML, what initial options are they routinely given?

Dr. Sekeres: For someone who is older, we divide those options into three main categories.

The first is to take intensive chemotherapy, which requires a 4-6 week hospitalization and has a chance of getting somebody who is older into a remission of approximately 50%-60%. But this also carries with it significant treatment-related mortality that may be as high as 10%-20%. So I have to look my older patients in the eyes when I talk about intensive chemotherapy and say, “There is a 1 in 10 or 1 in 5 chance that you might not make it out of the hospital alive.”

The second prong is lower-dose therapy. While the more-intensive therapy requiring hospitalization does have a low, but real, chance of curing that person, less-intensive therapy is not curative. Our best hope with less-intensive therapy is that our patients enter a remission and live longer. With less-intensive therapy, the chance that someone will go into remission is probably around 20%, but again it is not curative. The flip side to that is that it improves a person’s immediate quality of life because they’re not in the hospital for 4-6 weeks.

The final prong is to discuss palliative care or hospice upfront. We designed these guidelines to be focused on a patient’s goals of therapy and to constantly revisit those goals to make sure that the treatment options we are offering are aligning with them.

Q: The panel’s first recommendation is to offer antileukemic therapy over best supportive care in patients who are appropriate candidates. Can you provide some context for this recommendation?

Dr. Sekeres: Doesn’t that strike you as funny that we even have to make a recommendation about getting chemotherapy? Some database studies conducted over the past 2 decades show that, as recently as 15 years ago, only one-third of patients who were over the age of 65 years received any type of chemotherapy for AML. More recently, as we have had a few more drugs available that allow us to use lower-dose approaches, that number has crept up to probably about 50%. We still have half the patients offered no therapy at all. So we felt that we had to deliberately make a recommendation saying that, if it aligns with the patients’ goals, they should be offered chemotherapy.

Q: The second recommendation is that patients considered candidates for intensive antileukemic therapy should receive it over less-intensive antileukemic therapy. How did you get to that recommendation?

Dr. Sekeres: There is a debate in our field about whether older adults should be offered intensive inpatient chemotherapy at all or whether we should be treating all of them with less-intensive therapy. There is not a huge amount of high-quality studies out there to answer some of these questions, in particular whether intensive chemotherapy should be recommended over less-intensive therapy. But with the available evidence, what we believe is that patients live longer if they are offered intensive antileukemic chemotherapy. So again, if it aligns with a patient’s goals, we support that patient receiving more-intensive therapy in the hospital.

Q: What does the panel recommend for patients who achieve remission after at least a single cycle of intensive antileukemic therapy and who are not candidates for allogeneic hematopoietic stem cell transplantation?

Dr. Sekeres: Once again, this may seem at first blush to be an obvious recommendation. The standard treatment of someone who is younger with AML is to offer intensive inpatient chemotherapy to induce remission. This is followed by a few cycles of chemotherapy, mostly in an outpatient setting, to consolidate that remission.

Q: What is the underlying philosophy for this approach?

Dr. Sekeres: Every time we give chemotherapy, we probably get about a 3-4 log kill of leukemia cells. Imagine when patients first present with AML, they may have 10 billion leukemia cells in their body. We are reducing that 3-4 log with the first course of chemotherapy.

When we then look at a bone marrow biopsy, it may appear to be normal. When leukemia is at a lower level in the body, we simply can’t see it using standard techniques. But that doesn’t mean the leukemia is gone. For younger patients, we give another cycle of chemotherapy, then another, then another, and then even another to reduce the number of leukemia cells left over in the body until that person has a durable remission and hopefully cure.

For someone who is older, the data are less clear. While some studies have shown that, if you give too much chemotherapy after the initial course, it doesn’t help that much, there is a paucity of studies that show that any chemotherapy at all after the first induction course is helpful. Consequently, we have to use indirect data. Older people who are long-term survivors from their acute leukemia always seem to have gotten more than one course of chemotherapy. In other words, the initial course of chemotherapy that a patient receives in the hospital isn’t enough. They should receive more than that.

Q: What about older adults with AML considered appropriate for antileukemic therapy but not for intensive antileukemic therapy?

Dr. Sekeres: This again gets to the question of what are a patient’s goals. It takes a very involved conversation with patients at the time of their AML diagnosis to determine whether they would want to pursue an aggressive approach or a less-aggressive approach. If a patients want a less-aggressive approach, and want nothing to do with a hospital stay, then they are also prioritizing initial quality of life. In this recommendation, based on existing studies, we didn’t have a preference for which of the available less-aggressive chemotherapies a person selects.

There’s also debate about what to do in those considered appropriate for antileukemic therapy, such as hypomethylating agents (azacitidine and decitabine) or low-dose cytarabine, but not for intensive antileukemic therapy. What did the available evidence seem to indicate about this issue?

There has been a lot of studies trying to add two drugs together to see if those do better than one drug alone in patients who are older and who choose less-intensive therapy. The majority of those studies have shown no advantage to getting two drugs over one drug.

Our recommendation is that in these situations a patient gets one drug, not two, but there are a couple of caveats. One caveat is that there has been a small study showing the effectiveness of one of those low-dose chemotherapies combined with the drug glasdegib. The second caveat is that there have been results presented combining one of these low-dose chemotherapies with the drug venetoclax. One of those was a negative study, and another was a positive study showing a survival advantage to the combination vs. the low-dose therapy alone. We had to couch our recommendation a little bit because we knew this other study had been presented at a conference, but it hadn’t come out in final form yet. It did recently, however, and we will now revisit this recommendation.

The other complicated aspect to this is that we weren’t 100% convinced that the combination of venetoclax with one of these lower-dose therapies is truly less-intensive therapy. We think it is starting to creep up toward more-intensive chemotherapy, even though it is commonly given to patients in the outpatient setting. It gets into the very complicated area of what are we defining as more-intensive therapy and less-intensive therapy.

Q: Is there a recommended strategy for older adults with AML who achieve a response after receiving less-intensive therapy?

Dr. Sekeres: This is also challenging because there are no randomized studies in which patients received less-intensive therapy for a finite period of time vs. receiving those therapies ad infinitum. Given the lack of data and also given a lot of anecdotal data out there about patients who stopped a certain therapy and relapsed thereafter, we recommended that patients continue the less-intensive therapy ad infinitum. So as long as they are receiving a response to that therapy, they continue on the drug.

Q: Of course, there are also unique considerations faced by older patients who are no longer receiving antileukemic therapy and have moved on to receiving end-of-life care or hospice care. What advice do the guidelines offer in this situation?

Dr. Sekeres: There are a lot of aspects of these recommendations that I think are special. The first is the focus on patient goals of care at every point in these guidelines. The second is that the guidelines follow the real disease course and a real conversation that doctors and patients have at every step of the way to help guide the decisions that have to be made in real time.

A problem we have in the United States is that once patients enter a hospice, most will not allow blood transfusions. One reason is that some say it is antithetical to their philosophy and consider it aggressive care. The second reason is that, to be completely blunt, economically it doesn’t make sense for hospices to allow blood transfusions. The amount that they are reimbursed by Medicare is much lower than the cost of receiving blood in an infusion center.

We wanted to make a clear recommendation that we consider transfusions in a patient who is in a palliative care or hospice mode to be supportive and necessary, and that these should be provided to patients even if they are in hospice and, as always, if consistent with a patient’s goals of care.

Q: How does a patient’s age inform the discussion surrounding what intensity treatment to offer?

Dr. Sekeres: With younger adults, this is not as complicated a conversation. A younger person has a better chance of being cured with intensive chemotherapy and is much more likely to tolerate that intensive chemotherapy. For someone who is younger, we offer intensive chemotherapy and the chance of going into remission is higher, at 70%-80%. The chance of dying is lower, usually less than 5%. It is an easy decision to make.

For an older adult, the risk-benefit ratio shifts and it becomes a more complicated option. Less-intensive therapy or best supportive care or hospice become viable.

Q: Are there other factors confounding the treatment decision-making process in older adults with AML that practitioners should consider?

Dr. Sekeres: Someone who is older is making a different decision than I would. I have school-aged children and believe that my job as a parent is to successfully get them to adulthood, so I would take any treatment under the sun to make sure that happens. People who have lived a longer life than I have may have children and even grandchildren who are adults, and they might have different goals of care. My goals are not going to be the same as my patient’s goals.

It is also harder because patients who are older may feel that they have lived a good life and don’t need to go through heroic measures to try to be around as long as possible, and those goals may not align with the goals of that person’s children who want their parent to be around as long as possible. One of the confounding factors in this is navigating the different goals of the different family members.

Dr. Sekeres has disclosed no relevant financial relationships.
 

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

A vaginal ring that can be reused for up to 1 year and a progestin-only pill (POP) with a wider window for missed pills are 2 of the novel contraceptive products introduced to the market this year. In addition, an ongoing study of the levonorgestrel 52-mg intrauterine system (IUS) continues to provide evidence on its extended duration of use, now approved through 6 years.

The segesterone acetate (SA) and ethinyl estradiol (EE) vaginal ring (Annovera) is new among contraceptive options. Segesterone acetate is a novel progestin that can be used only via nonoral routes; it binds specifically to progesterone receptors without estrogenic or antiandrogen effects.¹ Unlike the etonogestrel and ethinyl estradiol ring (NuvaRing; for which generic products became available this past year), which is used for 1 cycle and then thrown away, the SA/EE ring is effective for 13 consecutive cycles. It does not require refrigeration when not in use.² Because a single ring can be used for 13 cycles, users in locations without laws that mandate a 12-month supply of pills, patches, and rings need less frequent visits to the pharmacy or clinic.

Progestin-only contraceptive pills are an important option for patients who desire hormonal contraception and have contraindications to estrogen, such as migraines with aura, cardiovascular risk factors, and being in the early postpartum period.³ In the United States, current POPs contain norethindrone, which has a 3-hour window for missed pills⁴; a desogestrel-only pill available outside the United States has a 12-hour window.⁵ Both are provided as a 28-day pill pack for continuous use, and both result in undesirable bleeding patterns in some users.

The prolonged half-life of drospirenone, another progestin, gives it the potential to increase reliability in the setting of missed or delayed pills and improve bleeding patterns. A new POP contraceptive contains drospirenone (Slynd) and is available in a 28-day pack with a 24-day supply of hormone and a 4-day supply of placebo; it provides a window for missed pill use similar to that for combined hormonal contraception (CHC) as well as a placebo period for a timed withdrawal bleed.^6,7

Liletta is a well-known levonorgestrel 52-mg IUS that was first approved by the US Food and Drug Administration (FDA) in 2015. An ongoing clinical trial has been the basis for approval of this IUS for use in increasing durations, from 3 years initially to 4 and then 5 years. The newest data indicate efficacy up to 6 years.⁸

Continue to: Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile...

Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile 

Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7:e1054-e1064. 

Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99:323-328. 

Archer and colleagues reported the results of 2 pivotal multicenter, open-label, phase 3 trials, which included 2,265 users, conducted to evaluate efficacy and return to menses or pregnancy after use of the 1-year (13 cycles) SA/EE contraceptive vaginal system (CVS). 

Details of the efficacy study 

The study included 1,130 women in a US-only study and 1,135 women in an international study with sites in the United States, Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, and Sweden. Participants used the CVS for 21 days followed by a 7-day use-free interval for up to 13 consecutive cycles; they were instructed not to remove the CVS for more than 2 hours during the 21 days of use. 

Primary and secondary efficacy outcomes were calculated using the Pearl Index and an intention-to-treat Kaplan-Meier life table, respectively. At the end of the study, users who desired not to continue hormonal contraception or to become pregnant were followed up for 6 months to evaluate return to menses or pregnancy. 

Year-long effectiveness 

The investigators reported an overall Pearl index of 2.98 (95% confidence interval [CI], 2.13-4.06) and a Kaplan-Meier life table cumulative efficacy rate of 97.5% (FIGURE 1), consistent with other recently approved CHC methods. Women from non-European sites, who primarily were US participants, had a Pearl Index of 3.25 (95% CI, 2.35-4.37), and participants from the European sites had a Pearl Index of 0.47 (95% CI, 0.03-2.07). Importantly, CVS removal had a significant impact on efficacy, with a Pearl Index of 5.98 (95% CI, 2.46-9.27) in users reporting CVS removals for longer than 2 hours, suggesting escape ovulation with improper use. The Pearl Index was highest in users aged 18 to 19 years and was not affected by body mass index (BMI), although 91% of users had a BMI of 29.0 kg/m² or lower. 

There was no trend for a change in pregnancy risk across 13 cycles, providing evidence of CVS efficacy throughout a full year's use. The follow-up portion of the study included 290 users who were not continuing hormonal contraception at study end; all follow-up participants reported return to menses after method discontinuation. 

Clinical safety data 

To evaluate safety outcomes from clinical studies on the CVS containing SA/EE, Gemzell-Danielsson and colleagues analyzed 9 studies. Most of the data were derived from 2 phase 3, multicenter trials (as discussed above), with supporting evidence from 7 other studies. 

Adverse events reported 

Among 2,308 CVS users in the phase 3 trials, 87% reported at least 1 adverse effect, with most of mild or moderate severity. These included headache, 26%; nausea, 18%; vaginal discharge, 10%; and metrorrhagia, 7%. Overall, 12% of CVS users discontinued use due to an adverse effect. Two percent of users experienced severe adverse effects, including venous thromboembolism (VTE), allergic reaction, gallbladder disease, and spontaneous abortion. 

In the US-only phase 3 trial, 2 VTE events occurred in the first 6 months in women with baseline BMI greater than 29.0 kg/m²; therefore, enrollment of patients with a BMI greater than 29.0 kg/m² was halted and current users meeting that criteria were discontinued. Notably, no cases of VTE occurred in studies with a segesterone acetate-only CVS; this suggests that risk can be attributed to the estrogen component. Overall, 4 nonfatal VTEs occurred, all among the 1,536 women enrolled in the phase 3 trials (4 of 1,536 [0.3%]); at least 3 of these cases occurred in users with VTE risk factors (TABLE 1). The estimated VTE rate in CVS users with a BMI greater than 29.0 kg/m2 is 10.8/10,000 women-years (95% CI, 8.9-13.1). 

Complete expulsion of the CVS occurred in 7% of cycles and partial expulsion in 19.5% of cycles; users reported expulsion more frequently in the first cycle, most (about 70%) of which were partial expulsions. Of the laboratory values and vital signs studied, including weight, users had no clinically relevant changes from baseline.

Continue to: New drospirenone pill is an effective POP option...

New drospirenone pill is an effective POP option 

Kimble T, Burke AE, Barnhart KT, et al. A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. Contracept X. 2020;2:100020. 

Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98:1549-1557. 

In a prospective, single-arm, multicenter phase 3 trial in the United States, Kimble and colleagues evaluated the efficacy and safety of an oral drospirenone POP in a cyclic 24-day hormone/4-day placebo regimen. The trial included 1,006 users. No BMI cutoff was used, and about one-third of study participants were obese (BMI >30.0 kg/m²). Women were instructed to take a missed tablet as soon as remembered if within 24 hours or with the next scheduled dose if more than 24 hours late. 

Contraceptive effectiveness 

The Pearl Index for nonbreastfeeding users aged 35 years or younger with pregnancies confirmed by a quantitative serum ß-human chorionic gonadotropin test (915 users) was 2.9 (95% CI, 1.5-5.1). Of note, 2 out of 15 on-treatment pregnancies were excluded from this calculation because of protocol site violations, as were 3 pregnancies that were unconfirmed. In the modified full analysis set of 915 users, 36% were obese (BMI≥30 kg/m²), and the Pearl Index was noted to be unaffected by BMI (TABLE 2). 

While 61% of women reported adverse effects, more than 95% of these were mild or moderate in intensity, including headache, nausea, dysmenorrhea, metrorrhagia, and breast pain. No VTE occurred. The frequency of hyperkalemia was 0.5%, and there was no evidence of hypotension, which is significant due to the antimineralocorticoid activity of drospirenone. All cases of hyperkalemia were considered mild, and all women were asymptomatic. There were no clinically relevant changes in body weight, gynecologic exam, or other laboratory values. 

With increased cycles of use, the number of days with bleeding or spotting generally decreased and amenorrhea increased. However, in cycles 11 to 13, 41.6% of users still had unscheduled bleeding (reduced from 57.0% at cycles 2-4), and 29.0% had scheduled bleeding (decreased from 44% at cycles 2-4) (FIGURE 2). With these bleeding patterns, 86.2% of users agreed or strongly agreed that they were satisfied with the product. 

European multicenter study of drospironene 

In a European investigation, Palacios and colleagues pooled and analyzed data from 2 phase 3 multicenter trials to assess the efficacy, tolerability, and safety of the same drospirenone-only pill (24 days of drospironene 4 mg and 4 days of placebo) in 1,571 users. No BMI cutoff was used, but overall only 71 participants (4.6%) were obese. One study included desogestrel 0.075 mg (in a regimen of 28 active pills) as a comparator for safety. 

The overall Pearl Index for users 35 years or younger (1,251 users) was 1.0 (95% CI, 0.4-2.0). The "method failure Pearl Index" in users 35 years or younger, which included all pregnancies during "perfect medication cycles," was 1.3 (95% CI, 0.5-2.5). 

The most common adverse effects were acne (6.6% in study 1 and 4.4% in study 2), headache (4.5% in study 1), and irregular bleeding (4.4% in study 2). No cases of VTE occurred; there was 1 case of asymptomatic hyperkalemia. Additional laboratory values and vital signs showed no significant changes. The trend in bleeding was similar to that in the US studies, but it is interesting to note that there were significantly lower rates of unscheduled bleeding or spotting in drospirenone users than in desogestrel users (67.9% vs 86.5%, respectively; P<.001).

Continue to: Evidence supports 6 years' use of a levonorgestrel 52-mg IUS...

Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52-mg intrauterine system. Contraception. 2020;101:159-161. 

Two levonorgestrel 52-mg IUS products are on the market, both of which were approved for 5 years of use. The ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) is an ongoing phase 3 trial to assess the safety and efficacy of a levonorgestrel 52-mg IUS (Liletta) for up to 10 years of use in US women. Westhoff and colleagues presented the data used for this IUS to gain approval for 6 years of use as of October 2019. The report included safety information for all users, with use exceeding 8 years in 122 participants. 

In year 6 of the ongoing trial, there were no on-treatment pregnancies with a 6-year life table pregnancy rate of 0.87 (95% CI, 0.44-1.70). Forty percent of users reported amenorrhea in the 90 days preceding the end of year 6, consistent with prior data after 3 years of use (FIGURE 3). The most common adverse effects over 6 or more years of use were bacterial vulvovaginal infections and urinary tract infections. 

Long-term IUS effectiveness 

Overall, in users aged 16 to 35 years, 72% discontinued study participation, most frequently due to an adverse event (19.2%) or to seeking pregnancy (15.5%). Through 6 or more years of use, overall discontinuation rates for expulsion (4.0%) and bleeding symptoms (2.3%) were very low, with 2 expulsions occurring in year 6 and only 1 participant discontinuing in year 6 for a bleeding symptom. These findings are consistent with those found at 5 years of IUS use and are representative of continued efficacy as well as overall low frequency of new significant events with extended use.¹¹

A vaginal ring that can be reused for up to 1 year and a progestin-only pill (POP) with a wider window for missed pills are 2 of the novel contraceptive products introduced to the market this year. In addition, an ongoing study of the levonorgestrel 52-mg intrauterine system (IUS) continues to provide evidence on its extended duration of use, now approved through 6 years.

The segesterone acetate (SA) and ethinyl estradiol (EE) vaginal ring (Annovera) is new among contraceptive options. Segesterone acetate is a novel progestin that can be used only via nonoral routes; it binds specifically to progesterone receptors without estrogenic or antiandrogen effects.¹ Unlike the etonogestrel and ethinyl estradiol ring (NuvaRing; for which generic products became available this past year), which is used for 1 cycle and then thrown away, the SA/EE ring is effective for 13 consecutive cycles. It does not require refrigeration when not in use.² Because a single ring can be used for 13 cycles, users in locations without laws that mandate a 12-month supply of pills, patches, and rings need less frequent visits to the pharmacy or clinic.

Progestin-only contraceptive pills are an important option for patients who desire hormonal contraception and have contraindications to estrogen, such as migraines with aura, cardiovascular risk factors, and being in the early postpartum period.³ In the United States, current POPs contain norethindrone, which has a 3-hour window for missed pills⁴; a desogestrel-only pill available outside the United States has a 12-hour window.⁵ Both are provided as a 28-day pill pack for continuous use, and both result in undesirable bleeding patterns in some users.

The prolonged half-life of drospirenone, another progestin, gives it the potential to increase reliability in the setting of missed or delayed pills and improve bleeding patterns. A new POP contraceptive contains drospirenone (Slynd) and is available in a 28-day pack with a 24-day supply of hormone and a 4-day supply of placebo; it provides a window for missed pill use similar to that for combined hormonal contraception (CHC) as well as a placebo period for a timed withdrawal bleed.^6,7

Liletta is a well-known levonorgestrel 52-mg IUS that was first approved by the US Food and Drug Administration (FDA) in 2015. An ongoing clinical trial has been the basis for approval of this IUS for use in increasing durations, from 3 years initially to 4 and then 5 years. The newest data indicate efficacy up to 6 years.⁸

Continue to: Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile...

Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile 

Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7:e1054-e1064. 

Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99:323-328. 

Archer and colleagues reported the results of 2 pivotal multicenter, open-label, phase 3 trials, which included 2,265 users, conducted to evaluate efficacy and return to menses or pregnancy after use of the 1-year (13 cycles) SA/EE contraceptive vaginal system (CVS). 

Details of the efficacy study 

The study included 1,130 women in a US-only study and 1,135 women in an international study with sites in the United States, Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, and Sweden. Participants used the CVS for 21 days followed by a 7-day use-free interval for up to 13 consecutive cycles; they were instructed not to remove the CVS for more than 2 hours during the 21 days of use. 

Primary and secondary efficacy outcomes were calculated using the Pearl Index and an intention-to-treat Kaplan-Meier life table, respectively. At the end of the study, users who desired not to continue hormonal contraception or to become pregnant were followed up for 6 months to evaluate return to menses or pregnancy. 

Year-long effectiveness 

The investigators reported an overall Pearl index of 2.98 (95% confidence interval [CI], 2.13-4.06) and a Kaplan-Meier life table cumulative efficacy rate of 97.5% (FIGURE 1), consistent with other recently approved CHC methods. Women from non-European sites, who primarily were US participants, had a Pearl Index of 3.25 (95% CI, 2.35-4.37), and participants from the European sites had a Pearl Index of 0.47 (95% CI, 0.03-2.07). Importantly, CVS removal had a significant impact on efficacy, with a Pearl Index of 5.98 (95% CI, 2.46-9.27) in users reporting CVS removals for longer than 2 hours, suggesting escape ovulation with improper use. The Pearl Index was highest in users aged 18 to 19 years and was not affected by body mass index (BMI), although 91% of users had a BMI of 29.0 kg/m² or lower. 

There was no trend for a change in pregnancy risk across 13 cycles, providing evidence of CVS efficacy throughout a full year's use. The follow-up portion of the study included 290 users who were not continuing hormonal contraception at study end; all follow-up participants reported return to menses after method discontinuation. 

Clinical safety data 

To evaluate safety outcomes from clinical studies on the CVS containing SA/EE, Gemzell-Danielsson and colleagues analyzed 9 studies. Most of the data were derived from 2 phase 3, multicenter trials (as discussed above), with supporting evidence from 7 other studies. 

Adverse events reported 

Among 2,308 CVS users in the phase 3 trials, 87% reported at least 1 adverse effect, with most of mild or moderate severity. These included headache, 26%; nausea, 18%; vaginal discharge, 10%; and metrorrhagia, 7%. Overall, 12% of CVS users discontinued use due to an adverse effect. Two percent of users experienced severe adverse effects, including venous thromboembolism (VTE), allergic reaction, gallbladder disease, and spontaneous abortion. 

In the US-only phase 3 trial, 2 VTE events occurred in the first 6 months in women with baseline BMI greater than 29.0 kg/m²; therefore, enrollment of patients with a BMI greater than 29.0 kg/m² was halted and current users meeting that criteria were discontinued. Notably, no cases of VTE occurred in studies with a segesterone acetate-only CVS; this suggests that risk can be attributed to the estrogen component. Overall, 4 nonfatal VTEs occurred, all among the 1,536 women enrolled in the phase 3 trials (4 of 1,536 [0.3%]); at least 3 of these cases occurred in users with VTE risk factors (TABLE 1). The estimated VTE rate in CVS users with a BMI greater than 29.0 kg/m2 is 10.8/10,000 women-years (95% CI, 8.9-13.1). 

Complete expulsion of the CVS occurred in 7% of cycles and partial expulsion in 19.5% of cycles; users reported expulsion more frequently in the first cycle, most (about 70%) of which were partial expulsions. Of the laboratory values and vital signs studied, including weight, users had no clinically relevant changes from baseline.

Continue to: New drospirenone pill is an effective POP option...

New drospirenone pill is an effective POP option 

Kimble T, Burke AE, Barnhart KT, et al. A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. Contracept X. 2020;2:100020. 

Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98:1549-1557. 

In a prospective, single-arm, multicenter phase 3 trial in the United States, Kimble and colleagues evaluated the efficacy and safety of an oral drospirenone POP in a cyclic 24-day hormone/4-day placebo regimen. The trial included 1,006 users. No BMI cutoff was used, and about one-third of study participants were obese (BMI >30.0 kg/m²). Women were instructed to take a missed tablet as soon as remembered if within 24 hours or with the next scheduled dose if more than 24 hours late. 

Contraceptive effectiveness 

The Pearl Index for nonbreastfeeding users aged 35 years or younger with pregnancies confirmed by a quantitative serum ß-human chorionic gonadotropin test (915 users) was 2.9 (95% CI, 1.5-5.1). Of note, 2 out of 15 on-treatment pregnancies were excluded from this calculation because of protocol site violations, as were 3 pregnancies that were unconfirmed. In the modified full analysis set of 915 users, 36% were obese (BMI≥30 kg/m²), and the Pearl Index was noted to be unaffected by BMI (TABLE 2). 

While 61% of women reported adverse effects, more than 95% of these were mild or moderate in intensity, including headache, nausea, dysmenorrhea, metrorrhagia, and breast pain. No VTE occurred. The frequency of hyperkalemia was 0.5%, and there was no evidence of hypotension, which is significant due to the antimineralocorticoid activity of drospirenone. All cases of hyperkalemia were considered mild, and all women were asymptomatic. There were no clinically relevant changes in body weight, gynecologic exam, or other laboratory values. 

With increased cycles of use, the number of days with bleeding or spotting generally decreased and amenorrhea increased. However, in cycles 11 to 13, 41.6% of users still had unscheduled bleeding (reduced from 57.0% at cycles 2-4), and 29.0% had scheduled bleeding (decreased from 44% at cycles 2-4) (FIGURE 2). With these bleeding patterns, 86.2% of users agreed or strongly agreed that they were satisfied with the product. 

European multicenter study of drospironene 

In a European investigation, Palacios and colleagues pooled and analyzed data from 2 phase 3 multicenter trials to assess the efficacy, tolerability, and safety of the same drospirenone-only pill (24 days of drospironene 4 mg and 4 days of placebo) in 1,571 users. No BMI cutoff was used, but overall only 71 participants (4.6%) were obese. One study included desogestrel 0.075 mg (in a regimen of 28 active pills) as a comparator for safety. 

The overall Pearl Index for users 35 years or younger (1,251 users) was 1.0 (95% CI, 0.4-2.0). The "method failure Pearl Index" in users 35 years or younger, which included all pregnancies during "perfect medication cycles," was 1.3 (95% CI, 0.5-2.5). 

The most common adverse effects were acne (6.6% in study 1 and 4.4% in study 2), headache (4.5% in study 1), and irregular bleeding (4.4% in study 2). No cases of VTE occurred; there was 1 case of asymptomatic hyperkalemia. Additional laboratory values and vital signs showed no significant changes. The trend in bleeding was similar to that in the US studies, but it is interesting to note that there were significantly lower rates of unscheduled bleeding or spotting in drospirenone users than in desogestrel users (67.9% vs 86.5%, respectively; P<.001).

Continue to: Evidence supports 6 years' use of a levonorgestrel 52-mg IUS...

Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52-mg intrauterine system. Contraception. 2020;101:159-161. 

Two levonorgestrel 52-mg IUS products are on the market, both of which were approved for 5 years of use. The ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) is an ongoing phase 3 trial to assess the safety and efficacy of a levonorgestrel 52-mg IUS (Liletta) for up to 10 years of use in US women. Westhoff and colleagues presented the data used for this IUS to gain approval for 6 years of use as of October 2019. The report included safety information for all users, with use exceeding 8 years in 122 participants. 

In year 6 of the ongoing trial, there were no on-treatment pregnancies with a 6-year life table pregnancy rate of 0.87 (95% CI, 0.44-1.70). Forty percent of users reported amenorrhea in the 90 days preceding the end of year 6, consistent with prior data after 3 years of use (FIGURE 3). The most common adverse effects over 6 or more years of use were bacterial vulvovaginal infections and urinary tract infections. 

Long-term IUS effectiveness 

Overall, in users aged 16 to 35 years, 72% discontinued study participation, most frequently due to an adverse event (19.2%) or to seeking pregnancy (15.5%). Through 6 or more years of use, overall discontinuation rates for expulsion (4.0%) and bleeding symptoms (2.3%) were very low, with 2 expulsions occurring in year 6 and only 1 participant discontinuing in year 6 for a bleeding symptom. These findings are consistent with those found at 5 years of IUS use and are representative of continued efficacy as well as overall low frequency of new significant events with extended use.¹¹

A vaginal ring that can be reused for up to 1 year and a progestin-only pill (POP) with a wider window for missed pills are 2 of the novel contraceptive products introduced to the market this year. In addition, an ongoing study of the levonorgestrel 52-mg intrauterine system (IUS) continues to provide evidence on its extended duration of use, now approved through 6 years.

The segesterone acetate (SA) and ethinyl estradiol (EE) vaginal ring (Annovera) is new among contraceptive options. Segesterone acetate is a novel progestin that can be used only via nonoral routes; it binds specifically to progesterone receptors without estrogenic or antiandrogen effects.¹ Unlike the etonogestrel and ethinyl estradiol ring (NuvaRing; for which generic products became available this past year), which is used for 1 cycle and then thrown away, the SA/EE ring is effective for 13 consecutive cycles. It does not require refrigeration when not in use.² Because a single ring can be used for 13 cycles, users in locations without laws that mandate a 12-month supply of pills, patches, and rings need less frequent visits to the pharmacy or clinic.

Progestin-only contraceptive pills are an important option for patients who desire hormonal contraception and have contraindications to estrogen, such as migraines with aura, cardiovascular risk factors, and being in the early postpartum period.³ In the United States, current POPs contain norethindrone, which has a 3-hour window for missed pills⁴; a desogestrel-only pill available outside the United States has a 12-hour window.⁵ Both are provided as a 28-day pill pack for continuous use, and both result in undesirable bleeding patterns in some users.

The prolonged half-life of drospirenone, another progestin, gives it the potential to increase reliability in the setting of missed or delayed pills and improve bleeding patterns. A new POP contraceptive contains drospirenone (Slynd) and is available in a 28-day pack with a 24-day supply of hormone and a 4-day supply of placebo; it provides a window for missed pill use similar to that for combined hormonal contraception (CHC) as well as a placebo period for a timed withdrawal bleed.^6,7

Liletta is a well-known levonorgestrel 52-mg IUS that was first approved by the US Food and Drug Administration (FDA) in 2015. An ongoing clinical trial has been the basis for approval of this IUS for use in increasing durations, from 3 years initially to 4 and then 5 years. The newest data indicate efficacy up to 6 years.⁸

Continue to: Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile...

Combined hormonal vaginal system provides a year's contraception with an acceptable safety profile 

Archer DF, Merkatz RB, Bahamondes L, et al. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019;7:e1054-e1064. 

Gemzell-Danielsson K, Sitruk-Ware R, Creinin MD, et al. Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation. Contraception. 2019;99:323-328. 

Archer and colleagues reported the results of 2 pivotal multicenter, open-label, phase 3 trials, which included 2,265 users, conducted to evaluate efficacy and return to menses or pregnancy after use of the 1-year (13 cycles) SA/EE contraceptive vaginal system (CVS). 

Details of the efficacy study 

The study included 1,130 women in a US-only study and 1,135 women in an international study with sites in the United States, Australia, Brazil, Chile, Dominican Republic, Finland, Hungary, and Sweden. Participants used the CVS for 21 days followed by a 7-day use-free interval for up to 13 consecutive cycles; they were instructed not to remove the CVS for more than 2 hours during the 21 days of use. 

Primary and secondary efficacy outcomes were calculated using the Pearl Index and an intention-to-treat Kaplan-Meier life table, respectively. At the end of the study, users who desired not to continue hormonal contraception or to become pregnant were followed up for 6 months to evaluate return to menses or pregnancy. 

Year-long effectiveness 

The investigators reported an overall Pearl index of 2.98 (95% confidence interval [CI], 2.13-4.06) and a Kaplan-Meier life table cumulative efficacy rate of 97.5% (FIGURE 1), consistent with other recently approved CHC methods. Women from non-European sites, who primarily were US participants, had a Pearl Index of 3.25 (95% CI, 2.35-4.37), and participants from the European sites had a Pearl Index of 0.47 (95% CI, 0.03-2.07). Importantly, CVS removal had a significant impact on efficacy, with a Pearl Index of 5.98 (95% CI, 2.46-9.27) in users reporting CVS removals for longer than 2 hours, suggesting escape ovulation with improper use. The Pearl Index was highest in users aged 18 to 19 years and was not affected by body mass index (BMI), although 91% of users had a BMI of 29.0 kg/m² or lower. 

There was no trend for a change in pregnancy risk across 13 cycles, providing evidence of CVS efficacy throughout a full year's use. The follow-up portion of the study included 290 users who were not continuing hormonal contraception at study end; all follow-up participants reported return to menses after method discontinuation. 

Clinical safety data 

To evaluate safety outcomes from clinical studies on the CVS containing SA/EE, Gemzell-Danielsson and colleagues analyzed 9 studies. Most of the data were derived from 2 phase 3, multicenter trials (as discussed above), with supporting evidence from 7 other studies. 

Adverse events reported 

Among 2,308 CVS users in the phase 3 trials, 87% reported at least 1 adverse effect, with most of mild or moderate severity. These included headache, 26%; nausea, 18%; vaginal discharge, 10%; and metrorrhagia, 7%. Overall, 12% of CVS users discontinued use due to an adverse effect. Two percent of users experienced severe adverse effects, including venous thromboembolism (VTE), allergic reaction, gallbladder disease, and spontaneous abortion. 

In the US-only phase 3 trial, 2 VTE events occurred in the first 6 months in women with baseline BMI greater than 29.0 kg/m²; therefore, enrollment of patients with a BMI greater than 29.0 kg/m² was halted and current users meeting that criteria were discontinued. Notably, no cases of VTE occurred in studies with a segesterone acetate-only CVS; this suggests that risk can be attributed to the estrogen component. Overall, 4 nonfatal VTEs occurred, all among the 1,536 women enrolled in the phase 3 trials (4 of 1,536 [0.3%]); at least 3 of these cases occurred in users with VTE risk factors (TABLE 1). The estimated VTE rate in CVS users with a BMI greater than 29.0 kg/m2 is 10.8/10,000 women-years (95% CI, 8.9-13.1). 

Complete expulsion of the CVS occurred in 7% of cycles and partial expulsion in 19.5% of cycles; users reported expulsion more frequently in the first cycle, most (about 70%) of which were partial expulsions. Of the laboratory values and vital signs studied, including weight, users had no clinically relevant changes from baseline.

Continue to: New drospirenone pill is an effective POP option...

New drospirenone pill is an effective POP option 

Kimble T, Burke AE, Barnhart KT, et al. A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen. Contracept X. 2020;2:100020. 

Palacios S, Colli E, Regidor PA. Multicenter, phase III trials on the contraceptive efficacy, tolerability and safety of a new drospirenone-only pill. Acta Obstet Gynecol Scand. 2019;98:1549-1557. 

In a prospective, single-arm, multicenter phase 3 trial in the United States, Kimble and colleagues evaluated the efficacy and safety of an oral drospirenone POP in a cyclic 24-day hormone/4-day placebo regimen. The trial included 1,006 users. No BMI cutoff was used, and about one-third of study participants were obese (BMI >30.0 kg/m²). Women were instructed to take a missed tablet as soon as remembered if within 24 hours or with the next scheduled dose if more than 24 hours late. 

Contraceptive effectiveness 

The Pearl Index for nonbreastfeeding users aged 35 years or younger with pregnancies confirmed by a quantitative serum ß-human chorionic gonadotropin test (915 users) was 2.9 (95% CI, 1.5-5.1). Of note, 2 out of 15 on-treatment pregnancies were excluded from this calculation because of protocol site violations, as were 3 pregnancies that were unconfirmed. In the modified full analysis set of 915 users, 36% were obese (BMI≥30 kg/m²), and the Pearl Index was noted to be unaffected by BMI (TABLE 2). 

While 61% of women reported adverse effects, more than 95% of these were mild or moderate in intensity, including headache, nausea, dysmenorrhea, metrorrhagia, and breast pain. No VTE occurred. The frequency of hyperkalemia was 0.5%, and there was no evidence of hypotension, which is significant due to the antimineralocorticoid activity of drospirenone. All cases of hyperkalemia were considered mild, and all women were asymptomatic. There were no clinically relevant changes in body weight, gynecologic exam, or other laboratory values. 

With increased cycles of use, the number of days with bleeding or spotting generally decreased and amenorrhea increased. However, in cycles 11 to 13, 41.6% of users still had unscheduled bleeding (reduced from 57.0% at cycles 2-4), and 29.0% had scheduled bleeding (decreased from 44% at cycles 2-4) (FIGURE 2). With these bleeding patterns, 86.2% of users agreed or strongly agreed that they were satisfied with the product. 

European multicenter study of drospironene 

In a European investigation, Palacios and colleagues pooled and analyzed data from 2 phase 3 multicenter trials to assess the efficacy, tolerability, and safety of the same drospirenone-only pill (24 days of drospironene 4 mg and 4 days of placebo) in 1,571 users. No BMI cutoff was used, but overall only 71 participants (4.6%) were obese. One study included desogestrel 0.075 mg (in a regimen of 28 active pills) as a comparator for safety. 

The overall Pearl Index for users 35 years or younger (1,251 users) was 1.0 (95% CI, 0.4-2.0). The "method failure Pearl Index" in users 35 years or younger, which included all pregnancies during "perfect medication cycles," was 1.3 (95% CI, 0.5-2.5). 

The most common adverse effects were acne (6.6% in study 1 and 4.4% in study 2), headache (4.5% in study 1), and irregular bleeding (4.4% in study 2). No cases of VTE occurred; there was 1 case of asymptomatic hyperkalemia. Additional laboratory values and vital signs showed no significant changes. The trend in bleeding was similar to that in the US studies, but it is interesting to note that there were significantly lower rates of unscheduled bleeding or spotting in drospirenone users than in desogestrel users (67.9% vs 86.5%, respectively; P<.001).

Continue to: Evidence supports 6 years' use of a levonorgestrel 52-mg IUS...

Westhoff CL, Keder LM, Gangestad A, et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52-mg intrauterine system. Contraception. 2020;101:159-161. 

Two levonorgestrel 52-mg IUS products are on the market, both of which were approved for 5 years of use. The ACCESS IUS study (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) is an ongoing phase 3 trial to assess the safety and efficacy of a levonorgestrel 52-mg IUS (Liletta) for up to 10 years of use in US women. Westhoff and colleagues presented the data used for this IUS to gain approval for 6 years of use as of October 2019. The report included safety information for all users, with use exceeding 8 years in 122 participants. 

In year 6 of the ongoing trial, there were no on-treatment pregnancies with a 6-year life table pregnancy rate of 0.87 (95% CI, 0.44-1.70). Forty percent of users reported amenorrhea in the 90 days preceding the end of year 6, consistent with prior data after 3 years of use (FIGURE 3). The most common adverse effects over 6 or more years of use were bacterial vulvovaginal infections and urinary tract infections. 

Long-term IUS effectiveness 

Overall, in users aged 16 to 35 years, 72% discontinued study participation, most frequently due to an adverse event (19.2%) or to seeking pregnancy (15.5%). Through 6 or more years of use, overall discontinuation rates for expulsion (4.0%) and bleeding symptoms (2.3%) were very low, with 2 expulsions occurring in year 6 and only 1 participant discontinuing in year 6 for a bleeding symptom. These findings are consistent with those found at 5 years of IUS use and are representative of continued efficacy as well as overall low frequency of new significant events with extended use.¹¹

Gastroenterology

July 2020

Role of cannabis and its derivatives in gastrointestinal and hepatic disease. Jonathan Gotfried et al. 2020 July;159(1):62-80. doi: 10.1053/j.gastro.2020.03.087 

Effects of blended (yellow) vs forced coagulation (blue) currents on adverse events, complete resection, or polyp recurrence after polypectomy in a large randomized trial. Heiko Pohl et al. 2020 July;159(1):119-28.e2. doi: 10.1053/j.gastro.2020.03.014 

Calculating the starting age for screening in relatives of patients with colorectal cancer based on data from large nationwide data sets.
Yu Tian et al. July 2020;159(1):159-168.e3. doi: 10.1053/j.gastro.2020.03.063 



August 2020

Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with inflammatory bowel diseases: results from an international registry. Erica J. Brenner et al. 2020 Aug 159;(2):481-91.e3. doi: 10.1053/j.gastro.2020.05.032 

Collagenous colitis is associated with HLA signature and shares genetic risks with other immune-mediated diseases. Eli Stahl et al. 2020 Aug;159(2):549-61.e8. doi: 10.1053/j.gastro.2020.04.063 

Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Alessandro Repici et al. 2020 Aug;159(2):512-20.e7. doi: 10.1053/j.gastro.2020.04.062 


September 2020

Dietary inflammatory potential and risk of Crohn’s disease and ulcerative colitis. Chun-Han Lo et al. 2020 Sept;159(3):p873-83.e1. doi: 10.1053/j.gastro.2020.05.011 

Rates of incomplete resection of 1- to 20-mm colorectal polyps: A systematic review and meta-analysis. Roupen Djinbachian et al. 2020 Sept;159(3):904-14.e12. doi: 10.1053/j.gastro.2020.05.018 
 

Clinical Gastroenterology and Hepatology

August 2020

Prevalence and characteristics of avoidant/restrictive food intake disorder in adult neurogastroenterology patients. Helen Burton Murray et al. 2020 Aug;18(9):1995-2002.e1. doi: 10.1016/j.cgh.2019.10.030 

Ten things every gastroenterologist should know about antireflux surgery. Steven Park et al. 2020 Aug;18(9):1923-9. doi: 10.1016/j.cgh.2020.02.041 

Biopsies from ascending and descending colon are sufficient for diagnosis of microscopic colitis. Boris Virine et al. 2020 Aug;18(9):2003-9. doi: 10.1016/j.cgh.2020.02.036 



September 2020

Association between endoscopist annual procedure volume and colonoscopy quality: Systematic review and meta-analysis. Nauzer Forbes et al. 2020 Sept:18(10):2192-208.e12. doi: 10.1016/j.cgh.2020.03.046 

Plans to reactivate gastroenterology practices following the COVID-19 pandemic: A survey of North American centers. Vladimir M. Kushnir et al on Behalf of the North American Alliance for the Study of Digestive Manifestations of COVID-19. 2020 Sept;18(10):2287-94.e1. doi: 10.1016/j.cgh.2020.05.030 

Cost effectiveness of different strategies for detecting cirrhosis in patients with nonalcoholic fatty liver disease based on United States health care system. Eduardo Vilar-Gomez et al. 2020 Sept;18(10):2305-14.e12. doi: 10.1016/j.cgh.2020.04.017 

October 2020

AGA Clinical Practice Update on young adult–onset colorectal cancer diagnosis and management: Expert review. Lisa A. Boardman et al. 2020 Oct:18(11):2415-24. doi: 10.1016/j.cgh.2020.05.058 

Frequency of eating disorder pathology among patients with chronic constipation and contribution of gastrointestinal-specific anxiety. Helen Burton Murray et al. 2020 Oct;18(11):2471-8. doi: 10.1016/j.cgh.2019.12.030 

Correction of dyssynergic defecation, but not fiber supplementation, reduces symptoms of functional dyspepsia in patients with constipation in a randomized trial. Jose-Walter Huaman et al. 2020 Oct;18(11):2463-70.e1. doi: 10.1016/j.cgh.2019.11.048 

Cellular and Molecular Gastroenterology and Hepatology

A new treatment for chronic hepatitis B and D offers novel insights into obesity and hepatic steatosis. Robert Schierwagen et al. 2020;10(3):649-51. doi: 10.1016/j.jcmgh.2020.05.011 
 

Techniques and Innovations in Gastrointestinal Endoscopy

The impact of endoscopic submucosal dissection for gastric adenocarcinomas in the United States. Shria Kumar et al. 2020 July:22(3):93-8. doi: 10.1016/j.tige.2020.03.009 

Gastroenterology

July 2020

Role of cannabis and its derivatives in gastrointestinal and hepatic disease. Jonathan Gotfried et al. 2020 July;159(1):62-80. doi: 10.1053/j.gastro.2020.03.087 

Effects of blended (yellow) vs forced coagulation (blue) currents on adverse events, complete resection, or polyp recurrence after polypectomy in a large randomized trial. Heiko Pohl et al. 2020 July;159(1):119-28.e2. doi: 10.1053/j.gastro.2020.03.014 

Calculating the starting age for screening in relatives of patients with colorectal cancer based on data from large nationwide data sets.
Yu Tian et al. July 2020;159(1):159-168.e3. doi: 10.1053/j.gastro.2020.03.063 



August 2020

Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with inflammatory bowel diseases: results from an international registry. Erica J. Brenner et al. 2020 Aug 159;(2):481-91.e3. doi: 10.1053/j.gastro.2020.05.032 

Collagenous colitis is associated with HLA signature and shares genetic risks with other immune-mediated diseases. Eli Stahl et al. 2020 Aug;159(2):549-61.e8. doi: 10.1053/j.gastro.2020.04.063 

Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Alessandro Repici et al. 2020 Aug;159(2):512-20.e7. doi: 10.1053/j.gastro.2020.04.062 


September 2020

Dietary inflammatory potential and risk of Crohn’s disease and ulcerative colitis. Chun-Han Lo et al. 2020 Sept;159(3):p873-83.e1. doi: 10.1053/j.gastro.2020.05.011 

Rates of incomplete resection of 1- to 20-mm colorectal polyps: A systematic review and meta-analysis. Roupen Djinbachian et al. 2020 Sept;159(3):904-14.e12. doi: 10.1053/j.gastro.2020.05.018 
 

Clinical Gastroenterology and Hepatology

August 2020

Prevalence and characteristics of avoidant/restrictive food intake disorder in adult neurogastroenterology patients. Helen Burton Murray et al. 2020 Aug;18(9):1995-2002.e1. doi: 10.1016/j.cgh.2019.10.030 

Ten things every gastroenterologist should know about antireflux surgery. Steven Park et al. 2020 Aug;18(9):1923-9. doi: 10.1016/j.cgh.2020.02.041 

Biopsies from ascending and descending colon are sufficient for diagnosis of microscopic colitis. Boris Virine et al. 2020 Aug;18(9):2003-9. doi: 10.1016/j.cgh.2020.02.036 



September 2020

Association between endoscopist annual procedure volume and colonoscopy quality: Systematic review and meta-analysis. Nauzer Forbes et al. 2020 Sept:18(10):2192-208.e12. doi: 10.1016/j.cgh.2020.03.046 

Plans to reactivate gastroenterology practices following the COVID-19 pandemic: A survey of North American centers. Vladimir M. Kushnir et al on Behalf of the North American Alliance for the Study of Digestive Manifestations of COVID-19. 2020 Sept;18(10):2287-94.e1. doi: 10.1016/j.cgh.2020.05.030 

Cost effectiveness of different strategies for detecting cirrhosis in patients with nonalcoholic fatty liver disease based on United States health care system. Eduardo Vilar-Gomez et al. 2020 Sept;18(10):2305-14.e12. doi: 10.1016/j.cgh.2020.04.017 

October 2020

AGA Clinical Practice Update on young adult–onset colorectal cancer diagnosis and management: Expert review. Lisa A. Boardman et al. 2020 Oct:18(11):2415-24. doi: 10.1016/j.cgh.2020.05.058 

Frequency of eating disorder pathology among patients with chronic constipation and contribution of gastrointestinal-specific anxiety. Helen Burton Murray et al. 2020 Oct;18(11):2471-8. doi: 10.1016/j.cgh.2019.12.030 

Correction of dyssynergic defecation, but not fiber supplementation, reduces symptoms of functional dyspepsia in patients with constipation in a randomized trial. Jose-Walter Huaman et al. 2020 Oct;18(11):2463-70.e1. doi: 10.1016/j.cgh.2019.11.048 

Cellular and Molecular Gastroenterology and Hepatology

A new treatment for chronic hepatitis B and D offers novel insights into obesity and hepatic steatosis. Robert Schierwagen et al. 2020;10(3):649-51. doi: 10.1016/j.jcmgh.2020.05.011 
 

Techniques and Innovations in Gastrointestinal Endoscopy

The impact of endoscopic submucosal dissection for gastric adenocarcinomas in the United States. Shria Kumar et al. 2020 July:22(3):93-8. doi: 10.1016/j.tige.2020.03.009 

Gastroenterology

July 2020

Role of cannabis and its derivatives in gastrointestinal and hepatic disease. Jonathan Gotfried et al. 2020 July;159(1):62-80. doi: 10.1053/j.gastro.2020.03.087 

Effects of blended (yellow) vs forced coagulation (blue) currents on adverse events, complete resection, or polyp recurrence after polypectomy in a large randomized trial. Heiko Pohl et al. 2020 July;159(1):119-28.e2. doi: 10.1053/j.gastro.2020.03.014 

Calculating the starting age for screening in relatives of patients with colorectal cancer based on data from large nationwide data sets.
Yu Tian et al. July 2020;159(1):159-168.e3. doi: 10.1053/j.gastro.2020.03.063 



August 2020

Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with inflammatory bowel diseases: results from an international registry. Erica J. Brenner et al. 2020 Aug 159;(2):481-91.e3. doi: 10.1053/j.gastro.2020.05.032 

Collagenous colitis is associated with HLA signature and shares genetic risks with other immune-mediated diseases. Eli Stahl et al. 2020 Aug;159(2):549-61.e8. doi: 10.1053/j.gastro.2020.04.063 

Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Alessandro Repici et al. 2020 Aug;159(2):512-20.e7. doi: 10.1053/j.gastro.2020.04.062 


September 2020

Dietary inflammatory potential and risk of Crohn’s disease and ulcerative colitis. Chun-Han Lo et al. 2020 Sept;159(3):p873-83.e1. doi: 10.1053/j.gastro.2020.05.011 

Rates of incomplete resection of 1- to 20-mm colorectal polyps: A systematic review and meta-analysis. Roupen Djinbachian et al. 2020 Sept;159(3):904-14.e12. doi: 10.1053/j.gastro.2020.05.018 
 

Clinical Gastroenterology and Hepatology

August 2020

Prevalence and characteristics of avoidant/restrictive food intake disorder in adult neurogastroenterology patients. Helen Burton Murray et al. 2020 Aug;18(9):1995-2002.e1. doi: 10.1016/j.cgh.2019.10.030 

Ten things every gastroenterologist should know about antireflux surgery. Steven Park et al. 2020 Aug;18(9):1923-9. doi: 10.1016/j.cgh.2020.02.041 

Biopsies from ascending and descending colon are sufficient for diagnosis of microscopic colitis. Boris Virine et al. 2020 Aug;18(9):2003-9. doi: 10.1016/j.cgh.2020.02.036 



September 2020

Association between endoscopist annual procedure volume and colonoscopy quality: Systematic review and meta-analysis. Nauzer Forbes et al. 2020 Sept:18(10):2192-208.e12. doi: 10.1016/j.cgh.2020.03.046 

Plans to reactivate gastroenterology practices following the COVID-19 pandemic: A survey of North American centers. Vladimir M. Kushnir et al on Behalf of the North American Alliance for the Study of Digestive Manifestations of COVID-19. 2020 Sept;18(10):2287-94.e1. doi: 10.1016/j.cgh.2020.05.030 

Cost effectiveness of different strategies for detecting cirrhosis in patients with nonalcoholic fatty liver disease based on United States health care system. Eduardo Vilar-Gomez et al. 2020 Sept;18(10):2305-14.e12. doi: 10.1016/j.cgh.2020.04.017 

October 2020

AGA Clinical Practice Update on young adult–onset colorectal cancer diagnosis and management: Expert review. Lisa A. Boardman et al. 2020 Oct:18(11):2415-24. doi: 10.1016/j.cgh.2020.05.058 

Frequency of eating disorder pathology among patients with chronic constipation and contribution of gastrointestinal-specific anxiety. Helen Burton Murray et al. 2020 Oct;18(11):2471-8. doi: 10.1016/j.cgh.2019.12.030 

Correction of dyssynergic defecation, but not fiber supplementation, reduces symptoms of functional dyspepsia in patients with constipation in a randomized trial. Jose-Walter Huaman et al. 2020 Oct;18(11):2463-70.e1. doi: 10.1016/j.cgh.2019.11.048 

Cellular and Molecular Gastroenterology and Hepatology

A new treatment for chronic hepatitis B and D offers novel insights into obesity and hepatic steatosis. Robert Schierwagen et al. 2020;10(3):649-51. doi: 10.1016/j.jcmgh.2020.05.011 
 

Techniques and Innovations in Gastrointestinal Endoscopy

The impact of endoscopic submucosal dissection for gastric adenocarcinomas in the United States. Shria Kumar et al. 2020 July:22(3):93-8. doi: 10.1016/j.tige.2020.03.009 

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

Receive $300,000 for your research in health disparities

Applications for the research scholar award are due by Nov. 9, 2020.

The American Gastroenterological Association Research Foundation is pleased to announce an important addition to its prestigious awards portfolio. The AGA Research Scholar Award in Digestive Disease Health Disparities supports early-career faculty dedicated to investigating digestive diseases or disorders that disproportionately affect racial or ethnic minority populations in North America.

Applicants must have a full-time faculty (or equivalent) position and may be performing any type of research (clinical, basic, or translational). Awardees will receive a total of $300,000 over 3 years with funding to commence in July 2021. The deadline to apply is Nov. 9, 2020.

This award is just one example of how AGA is helping to improve patient care for those who need it most. Support AGA Giving Day and learn more about the AGA Equity Project – a multiyear effort spanning all aspects of our organization to achieve equity and eradicate disparities in digestive diseases.
 

Save the date for DDW Virtual™

In 2021, Digestive Disease Week^® moves online as a fully virtual meeting with slightly new dates: May 21-23, 2021.

For more than 50 years, the digestive disease community has connected over the best science, education, and networking at DDW, and we’re confident this year will be no exception. In fact, we’re excited by opportunities the new format provides to learn, share, and connect with each other.

Watch the DDW website for more information as it becomes available. In the meantime, check out our FAQs about DDW Virtual™. If you have a question we didn’t answer, please submit a ticket to our help desk. 

DDW is jointly sponsored by AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
 

Virtual 2021 Crohn’s & Colitis Congress® now open for registration

Help forge the roadmap to advance prevention, treatments, and cures for all patients living with inflammatory bowel disease (IBD).

Join the Crohn’s & Colitis Foundation, AGA, and a true community of friends and colleagues at the premier conference on IBD. The fourth annual Crohn’s & Colitis Congress^®, taking place virtually Jan. 21-24, 2021, is now open for registration.

The 2021 Crohn’s & Colitis Congress virtual experience will look a little different but will still bring you all the benefits and quality programming you have come to expect. The Congress will offer 4 days of learning, with more than 100 speakers and more than 200 expected abstracts – all from the safety of your home or work. Now at an even more affordable price, access from anywhere, and the ability to hear from the top leaders in the IBD field – this is a unique opportunity to join us as we come together virtually.

By moving our event online, we can now pass on greater savings to you. Registration for the conference provides you with substantial savings over last year and access to all sessions and networking opportunities. This virtual experience will bring our community of IBD professionals together in an engaging, interactive setting which will include breakout rooms, receptions, and much more.

The 2021 congress committee chair David T. Rubin, MD, AGAF, University of Chicago, and cochair Bruce E. Sands, MD, MS, AGAF, Icahn School of Medicine at Mount Sinai, New York, lead a faculty that includes thought leaders in the fields of GI, research investigation, surgery, pediatrics, advanced practice, IBD nursing, diet and nutrition, mental health, radiology, pathology, and more.

Register and get inspired to improve skills and patient outcomes, learn practical information you can immediately implement, hear what’s on the horizon in potential IBD treatments, discover fresh perspectives from multidisciplinary faculty and attendees.

You don’t want to miss the 2021 Crohn’s & Colitis Congress, connecting virtually on Jan. 21-24, 2021.

Register today to save before the early bird deadline of Friday, Nov. 6.

Learn more, submit an abstract, and register by visiting crohnscolitiscongress.org.
 

AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation

About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.

AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.

“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”

This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD and immunocompromised status, who are typically excluded from FMT clinical trials.

“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.
 

AGA raises concerns about recent executive order

We are speaking out to ensure a brighter and more equitable future.

AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.

We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.

As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.

By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.

AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.

Our commitment to this issue is manifest in the AGA Equity Project.

Receive $300,000 for your research in health disparities

Applications for the research scholar award are due by Nov. 9, 2020.

The American Gastroenterological Association Research Foundation is pleased to announce an important addition to its prestigious awards portfolio. The AGA Research Scholar Award in Digestive Disease Health Disparities supports early-career faculty dedicated to investigating digestive diseases or disorders that disproportionately affect racial or ethnic minority populations in North America.

Applicants must have a full-time faculty (or equivalent) position and may be performing any type of research (clinical, basic, or translational). Awardees will receive a total of $300,000 over 3 years with funding to commence in July 2021. The deadline to apply is Nov. 9, 2020.

This award is just one example of how AGA is helping to improve patient care for those who need it most. Support AGA Giving Day and learn more about the AGA Equity Project – a multiyear effort spanning all aspects of our organization to achieve equity and eradicate disparities in digestive diseases.
 

Save the date for DDW Virtual™

In 2021, Digestive Disease Week^® moves online as a fully virtual meeting with slightly new dates: May 21-23, 2021.

For more than 50 years, the digestive disease community has connected over the best science, education, and networking at DDW, and we’re confident this year will be no exception. In fact, we’re excited by opportunities the new format provides to learn, share, and connect with each other.

Watch the DDW website for more information as it becomes available. In the meantime, check out our FAQs about DDW Virtual™. If you have a question we didn’t answer, please submit a ticket to our help desk. 

DDW is jointly sponsored by AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
 

Virtual 2021 Crohn’s & Colitis Congress® now open for registration

Help forge the roadmap to advance prevention, treatments, and cures for all patients living with inflammatory bowel disease (IBD).

Join the Crohn’s & Colitis Foundation, AGA, and a true community of friends and colleagues at the premier conference on IBD. The fourth annual Crohn’s & Colitis Congress^®, taking place virtually Jan. 21-24, 2021, is now open for registration.

The 2021 Crohn’s & Colitis Congress virtual experience will look a little different but will still bring you all the benefits and quality programming you have come to expect. The Congress will offer 4 days of learning, with more than 100 speakers and more than 200 expected abstracts – all from the safety of your home or work. Now at an even more affordable price, access from anywhere, and the ability to hear from the top leaders in the IBD field – this is a unique opportunity to join us as we come together virtually.

By moving our event online, we can now pass on greater savings to you. Registration for the conference provides you with substantial savings over last year and access to all sessions and networking opportunities. This virtual experience will bring our community of IBD professionals together in an engaging, interactive setting which will include breakout rooms, receptions, and much more.

The 2021 congress committee chair David T. Rubin, MD, AGAF, University of Chicago, and cochair Bruce E. Sands, MD, MS, AGAF, Icahn School of Medicine at Mount Sinai, New York, lead a faculty that includes thought leaders in the fields of GI, research investigation, surgery, pediatrics, advanced practice, IBD nursing, diet and nutrition, mental health, radiology, pathology, and more.

Register and get inspired to improve skills and patient outcomes, learn practical information you can immediately implement, hear what’s on the horizon in potential IBD treatments, discover fresh perspectives from multidisciplinary faculty and attendees.

You don’t want to miss the 2021 Crohn’s & Colitis Congress, connecting virtually on Jan. 21-24, 2021.

Register today to save before the early bird deadline of Friday, Nov. 6.

Learn more, submit an abstract, and register by visiting crohnscolitiscongress.org.
 

AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation

About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.

AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.

“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”

This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD and immunocompromised status, who are typically excluded from FMT clinical trials.

“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.
 

AGA raises concerns about recent executive order

We are speaking out to ensure a brighter and more equitable future.

AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.

We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.

As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.

By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.

AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.

Our commitment to this issue is manifest in the AGA Equity Project.

Receive $300,000 for your research in health disparities

Applications for the research scholar award are due by Nov. 9, 2020.

The American Gastroenterological Association Research Foundation is pleased to announce an important addition to its prestigious awards portfolio. The AGA Research Scholar Award in Digestive Disease Health Disparities supports early-career faculty dedicated to investigating digestive diseases or disorders that disproportionately affect racial or ethnic minority populations in North America.

Applicants must have a full-time faculty (or equivalent) position and may be performing any type of research (clinical, basic, or translational). Awardees will receive a total of $300,000 over 3 years with funding to commence in July 2021. The deadline to apply is Nov. 9, 2020.

This award is just one example of how AGA is helping to improve patient care for those who need it most. Support AGA Giving Day and learn more about the AGA Equity Project – a multiyear effort spanning all aspects of our organization to achieve equity and eradicate disparities in digestive diseases.
 

Save the date for DDW Virtual™

In 2021, Digestive Disease Week^® moves online as a fully virtual meeting with slightly new dates: May 21-23, 2021.

For more than 50 years, the digestive disease community has connected over the best science, education, and networking at DDW, and we’re confident this year will be no exception. In fact, we’re excited by opportunities the new format provides to learn, share, and connect with each other.

Watch the DDW website for more information as it becomes available. In the meantime, check out our FAQs about DDW Virtual™. If you have a question we didn’t answer, please submit a ticket to our help desk. 

DDW is jointly sponsored by AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
 

Virtual 2021 Crohn’s & Colitis Congress® now open for registration

Help forge the roadmap to advance prevention, treatments, and cures for all patients living with inflammatory bowel disease (IBD).

Join the Crohn’s & Colitis Foundation, AGA, and a true community of friends and colleagues at the premier conference on IBD. The fourth annual Crohn’s & Colitis Congress^®, taking place virtually Jan. 21-24, 2021, is now open for registration.

The 2021 Crohn’s & Colitis Congress virtual experience will look a little different but will still bring you all the benefits and quality programming you have come to expect. The Congress will offer 4 days of learning, with more than 100 speakers and more than 200 expected abstracts – all from the safety of your home or work. Now at an even more affordable price, access from anywhere, and the ability to hear from the top leaders in the IBD field – this is a unique opportunity to join us as we come together virtually.

By moving our event online, we can now pass on greater savings to you. Registration for the conference provides you with substantial savings over last year and access to all sessions and networking opportunities. This virtual experience will bring our community of IBD professionals together in an engaging, interactive setting which will include breakout rooms, receptions, and much more.

The 2021 congress committee chair David T. Rubin, MD, AGAF, University of Chicago, and cochair Bruce E. Sands, MD, MS, AGAF, Icahn School of Medicine at Mount Sinai, New York, lead a faculty that includes thought leaders in the fields of GI, research investigation, surgery, pediatrics, advanced practice, IBD nursing, diet and nutrition, mental health, radiology, pathology, and more.

Register and get inspired to improve skills and patient outcomes, learn practical information you can immediately implement, hear what’s on the horizon in potential IBD treatments, discover fresh perspectives from multidisciplinary faculty and attendees.

You don’t want to miss the 2021 Crohn’s & Colitis Congress, connecting virtually on Jan. 21-24, 2021.

Register today to save before the early bird deadline of Friday, Nov. 6.

Learn more, submit an abstract, and register by visiting crohnscolitiscongress.org.
 

AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation

About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.

AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.

“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”

This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD and immunocompromised status, who are typically excluded from FMT clinical trials.

“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.
 

AGA raises concerns about recent executive order

We are speaking out to ensure a brighter and more equitable future.

AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.

We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.

As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.

By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.

AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.

Our commitment to this issue is manifest in the AGA Equity Project.

I read, with great interest, Dr. Farford’s thorough review article “Diabetic retinopathy: the FP’s role in preserving vision” (J Fam Pract. 2020;69:120-126). I am a family physician with ophthalmology training. For more than 20 years, I have regularly performed dilated eye exams and reviewed nonmydriatic fundus photos for uninsured patients with diabetic retinopathy (DR) at the community health clinic where I work. The burden of visual loss from poorly controlled diabetes is staggering.

I do, however, want to point out some inaccuracies in the labeling of 2 of the photos included in Table 1.

• The photo labeled “Severe NPDR [nonproliferative DR]”—Figure 1A—actually shows an eye that has been treated with panretinal photocoagulation (multiple laser scars present in all quadrants) with nice regression of DR. Along the superior temporal arcade there is fibrosis, which likely represents regression of vitreal neovascularization or resolution of vitreal hemorrhage. There is little apparent active DR in this photo. The caption indicated the presence of intraretinal microvascular abnormalities; however, while these abnormalities may be present, they are not evident due to the photo resolution.   
• The photo labeled “Proliferative diabetic retinopathy”—Figure 2a—does not show evidence of neovascularization of the disc or the retina. This photo would be more accurately labeled “severe DR with likely clinically significant macular edema.”

The 2 photos shown here, from my photo collection, are perhaps more instructive:

• FIGURE 1B is an example of severe NPDR and maculopathy (this eye has undergone previous panretinal photocoagulation, a treatment option for severe NPDR and proliferative DR [defined as new vessel growth or neovascularization]).
• FIGURE 2b is an example of proliferative DR with vitreal hemorrhage that can lead to irreversible visual loss via traction retinal detachment. 

I appreciate your efforts in publishing Dr. Farford’s article. DR is a broad, complicated topic, and this informative article will help many FPs.

Kenneth Libre, MD
Central City Community Health Center
Salt Lake City, UT

I read, with great interest, Dr. Farford’s thorough review article “Diabetic retinopathy: the FP’s role in preserving vision” (J Fam Pract. 2020;69:120-126). I am a family physician with ophthalmology training. For more than 20 years, I have regularly performed dilated eye exams and reviewed nonmydriatic fundus photos for uninsured patients with diabetic retinopathy (DR) at the community health clinic where I work. The burden of visual loss from poorly controlled diabetes is staggering.

I do, however, want to point out some inaccuracies in the labeling of 2 of the photos included in Table 1.

• The photo labeled “Severe NPDR [nonproliferative DR]”—Figure 1A—actually shows an eye that has been treated with panretinal photocoagulation (multiple laser scars present in all quadrants) with nice regression of DR. Along the superior temporal arcade there is fibrosis, which likely represents regression of vitreal neovascularization or resolution of vitreal hemorrhage. There is little apparent active DR in this photo. The caption indicated the presence of intraretinal microvascular abnormalities; however, while these abnormalities may be present, they are not evident due to the photo resolution.   
• The photo labeled “Proliferative diabetic retinopathy”—Figure 2a—does not show evidence of neovascularization of the disc or the retina. This photo would be more accurately labeled “severe DR with likely clinically significant macular edema.”

The 2 photos shown here, from my photo collection, are perhaps more instructive:

• FIGURE 1B is an example of severe NPDR and maculopathy (this eye has undergone previous panretinal photocoagulation, a treatment option for severe NPDR and proliferative DR [defined as new vessel growth or neovascularization]).
• FIGURE 2b is an example of proliferative DR with vitreal hemorrhage that can lead to irreversible visual loss via traction retinal detachment. 

I appreciate your efforts in publishing Dr. Farford’s article. DR is a broad, complicated topic, and this informative article will help many FPs.

Kenneth Libre, MD
Central City Community Health Center
Salt Lake City, UT

I read, with great interest, Dr. Farford’s thorough review article “Diabetic retinopathy: the FP’s role in preserving vision” (J Fam Pract. 2020;69:120-126). I am a family physician with ophthalmology training. For more than 20 years, I have regularly performed dilated eye exams and reviewed nonmydriatic fundus photos for uninsured patients with diabetic retinopathy (DR) at the community health clinic where I work. The burden of visual loss from poorly controlled diabetes is staggering.

I do, however, want to point out some inaccuracies in the labeling of 2 of the photos included in Table 1.

• The photo labeled “Severe NPDR [nonproliferative DR]”—Figure 1A—actually shows an eye that has been treated with panretinal photocoagulation (multiple laser scars present in all quadrants) with nice regression of DR. Along the superior temporal arcade there is fibrosis, which likely represents regression of vitreal neovascularization or resolution of vitreal hemorrhage. There is little apparent active DR in this photo. The caption indicated the presence of intraretinal microvascular abnormalities; however, while these abnormalities may be present, they are not evident due to the photo resolution.   
• The photo labeled “Proliferative diabetic retinopathy”—Figure 2a—does not show evidence of neovascularization of the disc or the retina. This photo would be more accurately labeled “severe DR with likely clinically significant macular edema.”

The 2 photos shown here, from my photo collection, are perhaps more instructive:

• FIGURE 1B is an example of severe NPDR and maculopathy (this eye has undergone previous panretinal photocoagulation, a treatment option for severe NPDR and proliferative DR [defined as new vessel growth or neovascularization]).
• FIGURE 2b is an example of proliferative DR with vitreal hemorrhage that can lead to irreversible visual loss via traction retinal detachment. 

I appreciate your efforts in publishing Dr. Farford’s article. DR is a broad, complicated topic, and this informative article will help many FPs.

Kenneth Libre, MD
Central City Community Health Center
Salt Lake City, UT

Thanks to Dr. Linn et al for “Tips and tools for safe opioid prescribing” (J Fam Pract. 2020;69:280-292), which addressed an important topic: the risks of, and poor evidence for, chronic opioids in noncancer pain.

We should not be starting people on opioids for knee and back pain.

Pain management is challenging, and it is easy to prescribe opioids from a desire to help. However, we must translate the evidence of chronic opioids’ poor benefit and real harms into practice. No studies show a long-term benefit of opioids for chronic noncancer pain, but they do demonstrate abundant findings of harm. As a family medicine community, we should be practicing at the highest level of evidence and addressing legacy opioid prescribing for chronic noncancer pain.

Increasing opioid doses for pain only offers short-term benefits and can result in rapid tolerance and withdrawal. We should not be starting people on opioids for knee and back pain. We do not need more ways to initiate opioids or tables on how to dose long-acting opioids—drugs that increase mortality.¹ Let’s stop using poorly validated tools like DIRE to ignore the evidence against opioids (validated with 61 retrospective chart reviews; 81% sensitivity, 76% specificity for predicting efficacy of opioids).^2,3

A 2018 randomized controlled trial of 240 patients with back, knee, or hip osteoarthritis found opioids were not superior to nonopioid medication for pain-related function at 12 months and had more adverse effects.⁴ A 2015 systematic review concluded there was insufficient evidence of long-term benefits of opioids but a dose-dependent risk of serious harm.⁵ Just 1 year of taking low-dose opioids can increase the risk of opioid use disorder by 0.7%, compared with 0.004% with no opioids.⁵

Practical approaches exist. Excellent examples of modern pain care have been developed by the Department of Veterans Affairs/Department of Defense, the Department of Health and Human Services, and state-level initiatives such as the Oregon Pain Guidance.^6-8 All use a similar clinical algorithm (FIGURE). If pain is poorly controlled, a slow medically supervised tapering of opioids is indicated.

Start the pain management conversation by saying: “I’ve been thinking a lot about your chronic pain and how best to help you with it. I worry that opioids are causing more harm than good now.”

It can be challenging to raise the subject of opioid tapering with patients; I use Stanford’s BRAVO method to guide these conversations.^9,10 At my facility, we are tapering about 50 legacy opioid patients, and most are surprised to find that their pain is the same or better with reduced to no opioids, with fewer adverse effects. Many are happier on sublingual buprenorphine, a safer opioid analgesic.¹¹ The algorithm shown in the FIGURE and the BRAVO method should be more widely used within our specialty for a safe and patient-centered approach to chronic pain. 

Above all, let the patient know that you are with them on this journey to safe pain management. Start the conversation: “I’ve been thinking a lot about your chronic pain and how best to help you with it. Our understanding of what opioids do for pain has changed, and I worry they’re causing more harm than good now. This is a scary thing to talk about, but I’ll be with you every step of the way.”

Matt Perez, MD
Neighborcare Health
Seattle

Thanks to Dr. Linn et al for “Tips and tools for safe opioid prescribing” (J Fam Pract. 2020;69:280-292), which addressed an important topic: the risks of, and poor evidence for, chronic opioids in noncancer pain.

We should not be starting people on opioids for knee and back pain.

Pain management is challenging, and it is easy to prescribe opioids from a desire to help. However, we must translate the evidence of chronic opioids’ poor benefit and real harms into practice. No studies show a long-term benefit of opioids for chronic noncancer pain, but they do demonstrate abundant findings of harm. As a family medicine community, we should be practicing at the highest level of evidence and addressing legacy opioid prescribing for chronic noncancer pain.

Increasing opioid doses for pain only offers short-term benefits and can result in rapid tolerance and withdrawal. We should not be starting people on opioids for knee and back pain. We do not need more ways to initiate opioids or tables on how to dose long-acting opioids—drugs that increase mortality.¹ Let’s stop using poorly validated tools like DIRE to ignore the evidence against opioids (validated with 61 retrospective chart reviews; 81% sensitivity, 76% specificity for predicting efficacy of opioids).^2,3

A 2018 randomized controlled trial of 240 patients with back, knee, or hip osteoarthritis found opioids were not superior to nonopioid medication for pain-related function at 12 months and had more adverse effects.⁴ A 2015 systematic review concluded there was insufficient evidence of long-term benefits of opioids but a dose-dependent risk of serious harm.⁵ Just 1 year of taking low-dose opioids can increase the risk of opioid use disorder by 0.7%, compared with 0.004% with no opioids.⁵

Practical approaches exist. Excellent examples of modern pain care have been developed by the Department of Veterans Affairs/Department of Defense, the Department of Health and Human Services, and state-level initiatives such as the Oregon Pain Guidance.^6-8 All use a similar clinical algorithm (FIGURE). If pain is poorly controlled, a slow medically supervised tapering of opioids is indicated.

Start the pain management conversation by saying: “I’ve been thinking a lot about your chronic pain and how best to help you with it. I worry that opioids are causing more harm than good now.”

It can be challenging to raise the subject of opioid tapering with patients; I use Stanford’s BRAVO method to guide these conversations.^9,10 At my facility, we are tapering about 50 legacy opioid patients, and most are surprised to find that their pain is the same or better with reduced to no opioids, with fewer adverse effects. Many are happier on sublingual buprenorphine, a safer opioid analgesic.¹¹ The algorithm shown in the FIGURE and the BRAVO method should be more widely used within our specialty for a safe and patient-centered approach to chronic pain. 

Above all, let the patient know that you are with them on this journey to safe pain management. Start the conversation: “I’ve been thinking a lot about your chronic pain and how best to help you with it. Our understanding of what opioids do for pain has changed, and I worry they’re causing more harm than good now. This is a scary thing to talk about, but I’ll be with you every step of the way.”

Matt Perez, MD
Neighborcare Health
Seattle

Thanks to Dr. Linn et al for “Tips and tools for safe opioid prescribing” (J Fam Pract. 2020;69:280-292), which addressed an important topic: the risks of, and poor evidence for, chronic opioids in noncancer pain.

We should not be starting people on opioids for knee and back pain.

Pain management is challenging, and it is easy to prescribe opioids from a desire to help. However, we must translate the evidence of chronic opioids’ poor benefit and real harms into practice. No studies show a long-term benefit of opioids for chronic noncancer pain, but they do demonstrate abundant findings of harm. As a family medicine community, we should be practicing at the highest level of evidence and addressing legacy opioid prescribing for chronic noncancer pain.

Increasing opioid doses for pain only offers short-term benefits and can result in rapid tolerance and withdrawal. We should not be starting people on opioids for knee and back pain. We do not need more ways to initiate opioids or tables on how to dose long-acting opioids—drugs that increase mortality.¹ Let’s stop using poorly validated tools like DIRE to ignore the evidence against opioids (validated with 61 retrospective chart reviews; 81% sensitivity, 76% specificity for predicting efficacy of opioids).^2,3

A 2018 randomized controlled trial of 240 patients with back, knee, or hip osteoarthritis found opioids were not superior to nonopioid medication for pain-related function at 12 months and had more adverse effects.⁴ A 2015 systematic review concluded there was insufficient evidence of long-term benefits of opioids but a dose-dependent risk of serious harm.⁵ Just 1 year of taking low-dose opioids can increase the risk of opioid use disorder by 0.7%, compared with 0.004% with no opioids.⁵

Practical approaches exist. Excellent examples of modern pain care have been developed by the Department of Veterans Affairs/Department of Defense, the Department of Health and Human Services, and state-level initiatives such as the Oregon Pain Guidance.^6-8 All use a similar clinical algorithm (FIGURE). If pain is poorly controlled, a slow medically supervised tapering of opioids is indicated.

Start the pain management conversation by saying: “I’ve been thinking a lot about your chronic pain and how best to help you with it. I worry that opioids are causing more harm than good now.”

It can be challenging to raise the subject of opioid tapering with patients; I use Stanford’s BRAVO method to guide these conversations.^9,10 At my facility, we are tapering about 50 legacy opioid patients, and most are surprised to find that their pain is the same or better with reduced to no opioids, with fewer adverse effects. Many are happier on sublingual buprenorphine, a safer opioid analgesic.¹¹ The algorithm shown in the FIGURE and the BRAVO method should be more widely used within our specialty for a safe and patient-centered approach to chronic pain. 

Above all, let the patient know that you are with them on this journey to safe pain management. Start the conversation: “I’ve been thinking a lot about your chronic pain and how best to help you with it. Our understanding of what opioids do for pain has changed, and I worry they’re causing more harm than good now. This is a scary thing to talk about, but I’ll be with you every step of the way.”

Matt Perez, MD
Neighborcare Health
Seattle

Statistics tell the tale of immigrants in the American health care workforce in broad strokes. In an interview, though, one hospitalist shared the particulars of his professional and personal journey since arriving in the United States from India 15 years ago.

Mihir Patel, MD, MPH, FHM, came to the United States in 2005 to complete a Master’s in Public Health. Fifteen years later, he is still waiting for the green card that signifies U.S. permanent residency status. The paperwork for the application, he said, was completed in 2012. Since then, he’s been renewing his H-1B visa every three years, and he has no expectation that anything will change soon.

“If you are from India, which has a significant backlog of green cards – up to 50 years…you just wait forever,” he said. “Many people even die waiting for their green card to arrive.”

Arriving on a student visa, Dr. Patel completed his MPH in 2008 and began an internal medicine residency that same year, holding a J-1 visa for the 3 years of his US residency program.

“Post-residency, I started working in a rural hospital in an underserved area of northeast Tennessee as a hospitalist,” thus completing the 3 years of service in a rural underserved area that’s a requirement for J-1 visa holders, said Dr. Patel. “I loved this rural community hospital so much that I ended up staying there for 6 years. During my work at this rural hospital, I was able to enjoy the autonomy of managing a small ICU, doing both critical care procedures and management of intubated critical patients while working as a hospitalist,” he said. Dr. Patel served as chief of staff at the hospital for two years, and also served on the board of directors for his 400-physician medical group.

“I was a proud member of this rural community – Rogersville,” said Dr. Patel. Although he and his wife, who was completing her hospitalist residency, lived in Johnson City, Tenn., “I did not mind driving 120 miles round trip every day to go to my small-town hospital for 6 years,” he said.

Spending this time in rural Tennessee allowed Dr. Patel to finish the requirements necessary for the Physician National Interest Waiver and submit his application for permanent residency. The waiver, though, doesn’t give him priority status in the waiting list for permanent residency status.

After a stint in northern California to be closer to extended family, the pull of “beautiful northeast Tennesse and the rural community” was too strong, so Dr. Patel and his family moved back to Johnson City in 2018.

Reauthorizing the H1-B visa program

SHM has been advocating to improve the H1-B visa system for years, Dr. Patel said, The Fairness for High Skilled Immigrants Act passed the U.S. House of Representatives with bipartisan support, and the Society is advocating for its passage in the Senate.

The Fairness for High-Skilled Immigrants Act (S. 386) simplifies the employment-based immigration system by removing per-country caps, converting the employment-based immigration system into a “first-come, first serve” system that does not discriminate on country of origin. The act will also help alleviate the decades-long green card and permanent residency application backlogs.

Dr. Patel emphasized the importance of action by Congress to reauthorize the physician visa waiver program and expediting physician permanent residency. “This is a crisis and we are all physicians who are ready to serve, regardless of our country of origin. Please let us help this great nation by giving us freedom from visa restrictions and providing security for our families.

“During wartime, all frontline soldiers are naturalized and given citizenship by presidential mandate; this is more than war and we are not asking for citizenship – but at least give us a green card which we have already satisfied all requirements for. If not now, then when?” he asked.

Statistics tell the tale of immigrants in the American health care workforce in broad strokes. In an interview, though, one hospitalist shared the particulars of his professional and personal journey since arriving in the United States from India 15 years ago.

Mihir Patel, MD, MPH, FHM, came to the United States in 2005 to complete a Master’s in Public Health. Fifteen years later, he is still waiting for the green card that signifies U.S. permanent residency status. The paperwork for the application, he said, was completed in 2012. Since then, he’s been renewing his H-1B visa every three years, and he has no expectation that anything will change soon.

“If you are from India, which has a significant backlog of green cards – up to 50 years…you just wait forever,” he said. “Many people even die waiting for their green card to arrive.”

Arriving on a student visa, Dr. Patel completed his MPH in 2008 and began an internal medicine residency that same year, holding a J-1 visa for the 3 years of his US residency program.

“Post-residency, I started working in a rural hospital in an underserved area of northeast Tennessee as a hospitalist,” thus completing the 3 years of service in a rural underserved area that’s a requirement for J-1 visa holders, said Dr. Patel. “I loved this rural community hospital so much that I ended up staying there for 6 years. During my work at this rural hospital, I was able to enjoy the autonomy of managing a small ICU, doing both critical care procedures and management of intubated critical patients while working as a hospitalist,” he said. Dr. Patel served as chief of staff at the hospital for two years, and also served on the board of directors for his 400-physician medical group.

“I was a proud member of this rural community – Rogersville,” said Dr. Patel. Although he and his wife, who was completing her hospitalist residency, lived in Johnson City, Tenn., “I did not mind driving 120 miles round trip every day to go to my small-town hospital for 6 years,” he said.

Spending this time in rural Tennessee allowed Dr. Patel to finish the requirements necessary for the Physician National Interest Waiver and submit his application for permanent residency. The waiver, though, doesn’t give him priority status in the waiting list for permanent residency status.

After a stint in northern California to be closer to extended family, the pull of “beautiful northeast Tennesse and the rural community” was too strong, so Dr. Patel and his family moved back to Johnson City in 2018.

Reauthorizing the H1-B visa program

SHM has been advocating to improve the H1-B visa system for years, Dr. Patel said, The Fairness for High Skilled Immigrants Act passed the U.S. House of Representatives with bipartisan support, and the Society is advocating for its passage in the Senate.

The Fairness for High-Skilled Immigrants Act (S. 386) simplifies the employment-based immigration system by removing per-country caps, converting the employment-based immigration system into a “first-come, first serve” system that does not discriminate on country of origin. The act will also help alleviate the decades-long green card and permanent residency application backlogs.

Dr. Patel emphasized the importance of action by Congress to reauthorize the physician visa waiver program and expediting physician permanent residency. “This is a crisis and we are all physicians who are ready to serve, regardless of our country of origin. Please let us help this great nation by giving us freedom from visa restrictions and providing security for our families.

“During wartime, all frontline soldiers are naturalized and given citizenship by presidential mandate; this is more than war and we are not asking for citizenship – but at least give us a green card which we have already satisfied all requirements for. If not now, then when?” he asked.

Statistics tell the tale of immigrants in the American health care workforce in broad strokes. In an interview, though, one hospitalist shared the particulars of his professional and personal journey since arriving in the United States from India 15 years ago.

Mihir Patel, MD, MPH, FHM, came to the United States in 2005 to complete a Master’s in Public Health. Fifteen years later, he is still waiting for the green card that signifies U.S. permanent residency status. The paperwork for the application, he said, was completed in 2012. Since then, he’s been renewing his H-1B visa every three years, and he has no expectation that anything will change soon.

“If you are from India, which has a significant backlog of green cards – up to 50 years…you just wait forever,” he said. “Many people even die waiting for their green card to arrive.”

Arriving on a student visa, Dr. Patel completed his MPH in 2008 and began an internal medicine residency that same year, holding a J-1 visa for the 3 years of his US residency program.

“Post-residency, I started working in a rural hospital in an underserved area of northeast Tennessee as a hospitalist,” thus completing the 3 years of service in a rural underserved area that’s a requirement for J-1 visa holders, said Dr. Patel. “I loved this rural community hospital so much that I ended up staying there for 6 years. During my work at this rural hospital, I was able to enjoy the autonomy of managing a small ICU, doing both critical care procedures and management of intubated critical patients while working as a hospitalist,” he said. Dr. Patel served as chief of staff at the hospital for two years, and also served on the board of directors for his 400-physician medical group.

“I was a proud member of this rural community – Rogersville,” said Dr. Patel. Although he and his wife, who was completing her hospitalist residency, lived in Johnson City, Tenn., “I did not mind driving 120 miles round trip every day to go to my small-town hospital for 6 years,” he said.

Spending this time in rural Tennessee allowed Dr. Patel to finish the requirements necessary for the Physician National Interest Waiver and submit his application for permanent residency. The waiver, though, doesn’t give him priority status in the waiting list for permanent residency status.

After a stint in northern California to be closer to extended family, the pull of “beautiful northeast Tennesse and the rural community” was too strong, so Dr. Patel and his family moved back to Johnson City in 2018.

Reauthorizing the H1-B visa program

SHM has been advocating to improve the H1-B visa system for years, Dr. Patel said, The Fairness for High Skilled Immigrants Act passed the U.S. House of Representatives with bipartisan support, and the Society is advocating for its passage in the Senate.

The Fairness for High-Skilled Immigrants Act (S. 386) simplifies the employment-based immigration system by removing per-country caps, converting the employment-based immigration system into a “first-come, first serve” system that does not discriminate on country of origin. The act will also help alleviate the decades-long green card and permanent residency application backlogs.

Dr. Patel emphasized the importance of action by Congress to reauthorize the physician visa waiver program and expediting physician permanent residency. “This is a crisis and we are all physicians who are ready to serve, regardless of our country of origin. Please let us help this great nation by giving us freedom from visa restrictions and providing security for our families.

“During wartime, all frontline soldiers are naturalized and given citizenship by presidential mandate; this is more than war and we are not asking for citizenship – but at least give us a green card which we have already satisfied all requirements for. If not now, then when?” he asked.

Four years ago, just prior to the 2016 presidential election, I mentioned the Choosing Wisely campaign in my JFP editorial.¹ I said that family physicians should do their part in controlling health care costs by carefully selecting tests and treatments that are known to be effective and avoiding those that are not. This remains as true now as it was then.

The Choosing Wisely campaign was sparked by a family physician, Dr. Howard Brody, in the context of national health care reform. In a 2010 New England Journal of Medicine editorial, he challenged physicians to do their part in controlling health care costs by not ordering tests and treatments that have no value for patients.² At that time, it was estimated that a third of tests and treatments ordered by US physicians were of marginal or no value.³

Here are 5 more recommendations from the Choosing Wisely list of tests and treatments to avoid ordering for your patients.

Dr. Brody’s editorial caught the attention of the National Physicians Alliance and eventually many other physician organizations. In 2012, the American Board of Internal Medicine Foundation launched the Choosing Wisely initiative; today, the campaign Web site, choosingwisely.org, has a wealth of information and practice recommendations from 78 medical specialty organizations, including the American Academy of Family Physicians (AAFP).

In this month’s issue of JFP, Dr. Kate Rowland has summarized 10 of the most important Choosing Wisely recommendations that apply to family physicians and other primary care clinicians. Here are 5 more recommendations from the Choosing Wisely list of tests and treatments to avoid ordering for your patients:

1. Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer.
2. Don’t routinely screen for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam. For men who want PSA screening, it should be performed only after engaging in shared decision-making.
3. Don’t order annual electrocardiograms or any other cardiac screening for low-risk patients without symptoms.
4. Don’t routinely prescribe antibiotics for otitis media in children ages 2 to 12 years with nonsevere symptoms when observation is reasonable.
5. Don’t use dual-energy x-ray absorptiometry screening for osteoporosis in women younger than 65 or men younger than 70 with no risk factors.

In total, AAFP lists 18 recommendations (2 additional recommendations have been withdrawn, based on updated evidence) on the Choosing Wisely Web site. I encourage you to review them to see if you should change any of your current patient recommendations.

Four years ago, just prior to the 2016 presidential election, I mentioned the Choosing Wisely campaign in my JFP editorial.¹ I said that family physicians should do their part in controlling health care costs by carefully selecting tests and treatments that are known to be effective and avoiding those that are not. This remains as true now as it was then.

The Choosing Wisely campaign was sparked by a family physician, Dr. Howard Brody, in the context of national health care reform. In a 2010 New England Journal of Medicine editorial, he challenged physicians to do their part in controlling health care costs by not ordering tests and treatments that have no value for patients.² At that time, it was estimated that a third of tests and treatments ordered by US physicians were of marginal or no value.³

Here are 5 more recommendations from the Choosing Wisely list of tests and treatments to avoid ordering for your patients.

Dr. Brody’s editorial caught the attention of the National Physicians Alliance and eventually many other physician organizations. In 2012, the American Board of Internal Medicine Foundation launched the Choosing Wisely initiative; today, the campaign Web site, choosingwisely.org, has a wealth of information and practice recommendations from 78 medical specialty organizations, including the American Academy of Family Physicians (AAFP).

In this month’s issue of JFP, Dr. Kate Rowland has summarized 10 of the most important Choosing Wisely recommendations that apply to family physicians and other primary care clinicians. Here are 5 more recommendations from the Choosing Wisely list of tests and treatments to avoid ordering for your patients:

1. Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer.
2. Don’t routinely screen for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam. For men who want PSA screening, it should be performed only after engaging in shared decision-making.
3. Don’t order annual electrocardiograms or any other cardiac screening for low-risk patients without symptoms.
4. Don’t routinely prescribe antibiotics for otitis media in children ages 2 to 12 years with nonsevere symptoms when observation is reasonable.
5. Don’t use dual-energy x-ray absorptiometry screening for osteoporosis in women younger than 65 or men younger than 70 with no risk factors.

In total, AAFP lists 18 recommendations (2 additional recommendations have been withdrawn, based on updated evidence) on the Choosing Wisely Web site. I encourage you to review them to see if you should change any of your current patient recommendations.

Four years ago, just prior to the 2016 presidential election, I mentioned the Choosing Wisely campaign in my JFP editorial.¹ I said that family physicians should do their part in controlling health care costs by carefully selecting tests and treatments that are known to be effective and avoiding those that are not. This remains as true now as it was then.

The Choosing Wisely campaign was sparked by a family physician, Dr. Howard Brody, in the context of national health care reform. In a 2010 New England Journal of Medicine editorial, he challenged physicians to do their part in controlling health care costs by not ordering tests and treatments that have no value for patients.² At that time, it was estimated that a third of tests and treatments ordered by US physicians were of marginal or no value.³

Here are 5 more recommendations from the Choosing Wisely list of tests and treatments to avoid ordering for your patients.

Dr. Brody’s editorial caught the attention of the National Physicians Alliance and eventually many other physician organizations. In 2012, the American Board of Internal Medicine Foundation launched the Choosing Wisely initiative; today, the campaign Web site, choosingwisely.org, has a wealth of information and practice recommendations from 78 medical specialty organizations, including the American Academy of Family Physicians (AAFP).

In this month’s issue of JFP, Dr. Kate Rowland has summarized 10 of the most important Choosing Wisely recommendations that apply to family physicians and other primary care clinicians. Here are 5 more recommendations from the Choosing Wisely list of tests and treatments to avoid ordering for your patients:

1. Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer.
2. Don’t routinely screen for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam. For men who want PSA screening, it should be performed only after engaging in shared decision-making.
3. Don’t order annual electrocardiograms or any other cardiac screening for low-risk patients without symptoms.
4. Don’t routinely prescribe antibiotics for otitis media in children ages 2 to 12 years with nonsevere symptoms when observation is reasonable.
5. Don’t use dual-energy x-ray absorptiometry screening for osteoporosis in women younger than 65 or men younger than 70 with no risk factors.

In total, AAFP lists 18 recommendations (2 additional recommendations have been withdrawn, based on updated evidence) on the Choosing Wisely Web site. I encourage you to review them to see if you should change any of your current patient recommendations.