Heavier smoking significantly increased mortality in adults with progressive fibrosing interstitial lung disease (PF-ILD), based on data from 377 individuals.

The negative impact of smoking on pulmonary diseases is well documented, but the specific impact on patients with PF-ILD has not been well studied, Mark Platenburg, MD, of St. Antonious Hospital, Nieuwegein, the Netherlands, and colleagues wrote in Respiratory Medicine .

GaryPhoto/ThinkStock

“Patients with PF-ILD or IPF [idiopathic pulmonary fibrosis] are prone to early mortality, indicating a need for prognostic [bio]marker studies for precision medicine,” they said.

The researchers identified adults older than 18 years with PF-ILD who were diagnosed at a single center. All study participants had at least 10% fibrosis, and showed either a decline of at least 10% in forced vital capacity, a 5.0%-9.9% relative FVC decline plus progressive respiratory symptoms and/or an increase in extent of fibrosis on subsequent high-resolution (HRCT progression), or progressive respiratory symptoms and HRCT progression over 24 months after ILD diagnosis.

Pack-years of smoking was a prognostic variable; the researchers also compared median transplant-free survival in heavy smokers and mild to moderate smokers. They also investigated the association between smoking quantity and emphysema in the study population.

Overall, the increased risk for mortality was 11%, 22%, and 44% in patients with 10, 20, and 40 pack-years of smoking, respectively.

Both the unadjusted and adjusted hazard ratio for pack-years were significant (1.014, P < .001 and 1.011, P = .022, respectively).

The median transplant-free survival of ever-smokers versus never-smokers with PF-ILD was 3.3 years versus 4.8 years; median transplant-free survival was 3.0 years for heavy smokers and 3.8 years for mild to moderate smokers. Similarly, median survival was 4.2 years in never-smokers versus 3.0 years in former smokers.

Emphysema was significantly more comment in heavy smokers, compared with never smokers and mild to moderate smokers (P < .001 for both).

“We observed a gradual decrease in survival starting from never to mild-moderate and subsequent heavy smokers supporting our finding that [pack-years] is an independent predictor for mortality in PF-ILD,” the researchers wrote. “This is an important message that clinicians could convey to their ILD patients, but also to patients at-risk for ILD.”

The study findings were limited by several factors, mainly the retrospective design, incomplete data for some patients, and lack of data on comorbidities, the researchers noted. However, the results strengthen the evidence for the detrimental effect of heavy smoking in PF-ILD, they said. Consequently, “efforts to reduce pack-years in those with, and at risk for, PF-ILD may translate into a survival benefit and should have high priority in clinical practice.”

The study was supported by grants from ZonMw TopZorg Care and TZO. The researchers had no financial conflicts to disclose.

Heavier smoking significantly increased mortality in adults with progressive fibrosing interstitial lung disease (PF-ILD), based on data from 377 individuals.

The negative impact of smoking on pulmonary diseases is well documented, but the specific impact on patients with PF-ILD has not been well studied, Mark Platenburg, MD, of St. Antonious Hospital, Nieuwegein, the Netherlands, and colleagues wrote in Respiratory Medicine .

GaryPhoto/ThinkStock

“Patients with PF-ILD or IPF [idiopathic pulmonary fibrosis] are prone to early mortality, indicating a need for prognostic [bio]marker studies for precision medicine,” they said.

The researchers identified adults older than 18 years with PF-ILD who were diagnosed at a single center. All study participants had at least 10% fibrosis, and showed either a decline of at least 10% in forced vital capacity, a 5.0%-9.9% relative FVC decline plus progressive respiratory symptoms and/or an increase in extent of fibrosis on subsequent high-resolution (HRCT progression), or progressive respiratory symptoms and HRCT progression over 24 months after ILD diagnosis.

Pack-years of smoking was a prognostic variable; the researchers also compared median transplant-free survival in heavy smokers and mild to moderate smokers. They also investigated the association between smoking quantity and emphysema in the study population.

Overall, the increased risk for mortality was 11%, 22%, and 44% in patients with 10, 20, and 40 pack-years of smoking, respectively.

Both the unadjusted and adjusted hazard ratio for pack-years were significant (1.014, P < .001 and 1.011, P = .022, respectively).

The median transplant-free survival of ever-smokers versus never-smokers with PF-ILD was 3.3 years versus 4.8 years; median transplant-free survival was 3.0 years for heavy smokers and 3.8 years for mild to moderate smokers. Similarly, median survival was 4.2 years in never-smokers versus 3.0 years in former smokers.

Emphysema was significantly more comment in heavy smokers, compared with never smokers and mild to moderate smokers (P < .001 for both).

“We observed a gradual decrease in survival starting from never to mild-moderate and subsequent heavy smokers supporting our finding that [pack-years] is an independent predictor for mortality in PF-ILD,” the researchers wrote. “This is an important message that clinicians could convey to their ILD patients, but also to patients at-risk for ILD.”

The study findings were limited by several factors, mainly the retrospective design, incomplete data for some patients, and lack of data on comorbidities, the researchers noted. However, the results strengthen the evidence for the detrimental effect of heavy smoking in PF-ILD, they said. Consequently, “efforts to reduce pack-years in those with, and at risk for, PF-ILD may translate into a survival benefit and should have high priority in clinical practice.”

The study was supported by grants from ZonMw TopZorg Care and TZO. The researchers had no financial conflicts to disclose.

Heavier smoking significantly increased mortality in adults with progressive fibrosing interstitial lung disease (PF-ILD), based on data from 377 individuals.

The negative impact of smoking on pulmonary diseases is well documented, but the specific impact on patients with PF-ILD has not been well studied, Mark Platenburg, MD, of St. Antonious Hospital, Nieuwegein, the Netherlands, and colleagues wrote in Respiratory Medicine .

GaryPhoto/ThinkStock

“Patients with PF-ILD or IPF [idiopathic pulmonary fibrosis] are prone to early mortality, indicating a need for prognostic [bio]marker studies for precision medicine,” they said.

The researchers identified adults older than 18 years with PF-ILD who were diagnosed at a single center. All study participants had at least 10% fibrosis, and showed either a decline of at least 10% in forced vital capacity, a 5.0%-9.9% relative FVC decline plus progressive respiratory symptoms and/or an increase in extent of fibrosis on subsequent high-resolution (HRCT progression), or progressive respiratory symptoms and HRCT progression over 24 months after ILD diagnosis.

Pack-years of smoking was a prognostic variable; the researchers also compared median transplant-free survival in heavy smokers and mild to moderate smokers. They also investigated the association between smoking quantity and emphysema in the study population.

Overall, the increased risk for mortality was 11%, 22%, and 44% in patients with 10, 20, and 40 pack-years of smoking, respectively.

Both the unadjusted and adjusted hazard ratio for pack-years were significant (1.014, P < .001 and 1.011, P = .022, respectively).

The median transplant-free survival of ever-smokers versus never-smokers with PF-ILD was 3.3 years versus 4.8 years; median transplant-free survival was 3.0 years for heavy smokers and 3.8 years for mild to moderate smokers. Similarly, median survival was 4.2 years in never-smokers versus 3.0 years in former smokers.

Emphysema was significantly more comment in heavy smokers, compared with never smokers and mild to moderate smokers (P < .001 for both).

“We observed a gradual decrease in survival starting from never to mild-moderate and subsequent heavy smokers supporting our finding that [pack-years] is an independent predictor for mortality in PF-ILD,” the researchers wrote. “This is an important message that clinicians could convey to their ILD patients, but also to patients at-risk for ILD.”

The study findings were limited by several factors, mainly the retrospective design, incomplete data for some patients, and lack of data on comorbidities, the researchers noted. However, the results strengthen the evidence for the detrimental effect of heavy smoking in PF-ILD, they said. Consequently, “efforts to reduce pack-years in those with, and at risk for, PF-ILD may translate into a survival benefit and should have high priority in clinical practice.”

The study was supported by grants from ZonMw TopZorg Care and TZO. The researchers had no financial conflicts to disclose.

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.

The nonprofit group Public Citizen has filed a petition with the U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA), arguing that the medication’s risks warrant additional safeguards.

Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).

Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.

Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
 

‘Widespread misuse’

There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.

Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.

“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”

This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.

It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.

As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
 

‘Unnoticed’ abuse

There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.

In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.

As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.

In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.

“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.

The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.

It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”

In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.

In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.

“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
 

FDA 2019 warning

In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.

These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.

The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.

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

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.

The nonprofit group Public Citizen has filed a petition with the U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA), arguing that the medication’s risks warrant additional safeguards.

Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).

Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.

Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
 

‘Widespread misuse’

There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.

Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.

“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”

This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.

It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.

As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
 

‘Unnoticed’ abuse

There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.

In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.

As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.

In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.

“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.

The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.

It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”

In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.

In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.

“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
 

FDA 2019 warning

In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.

These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.

The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.

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

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.

The nonprofit group Public Citizen has filed a petition with the U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA), arguing that the medication’s risks warrant additional safeguards.

Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).

Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.

Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
 

‘Widespread misuse’

There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.

Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.

“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”

This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.

It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.

As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
 

‘Unnoticed’ abuse

There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.

In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.

As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.

In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.

“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.

The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.

It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”

In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.

In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.

“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
 

FDA 2019 warning

In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.

These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.

The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.

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

As many in the world react with sanctions imposed on Russia after its invasion of Ukraine, the oncology community has now stepped into the fray.

All the large cancer organizations have put out statements in support of Ukraine, but one group has gone further and cut its ties with Russia.

“The international cancer specialist network, OncoAlert, severed all cooperation with doctors in Russia as part of the Western sanctions,” the group announced on its Twitter page, which is decorated with a blue and yellow ribbon and declares that it “stands with Ukraine.”

“The OncoAlert Network is nonpolitical but we cannot stand idle and not take a stand against this aggression toward our Ukrainian friends & colleagues,” the group said. “The network will be pulling out of ALL collaborations & congresses in Russia.”

Not surprisingly, the post was inundated with a barrage of inflammatory and politically laced tweets from Russian and Chinese users. Many of them repeated the same phrase about “violating the Hippocratic oath and the Geneva convention,” used foul language, and slammed the United States for past military actions in other parts of the world.

A prominent Russian oncologist also responded, posting a video in which he discussed the situation more coherently and without mudslinging or scripted phrases. Andrey Kaprin, MD, PhD, is chief oncologist of the Russian Federation as well as director general of the Federal State Budgetary Institution, NMRCC, of the Ministry of Health of the Russian Federation. He says they continue to maintain relations with the largest and best known oncologic organizations. “We haven’t felt any deterioration in our relationship yet, and of course, we hope that this won’t happen.”

Dr. Kaprin said he believes OncoAlert will return to cooperation with Russia, and that “reason will prevail.”

“No one is protected from cancer, not even doctors, and that is why there should be no politics here,” he said.

Dr. Kaprin was speaking from Russia state-affiliated media, so it was not an independent commentary. Several of the Twitter responses to his video, primarily from non-Russians, were less than complimentary.

One user replied: “Cancer is rife in the Kremlin.”

Another post pointed out the hypocrisy of Russians being upset that OncoAlert was cutting ties with them. “What about sick Ukrainian kids, having to shelter in hospital basement, not having lifesaving surgeries because Russia decided to invade a democratic country?”

And another post was not buying the story that “reason will prevail,” in that the doctor’s talk seemed to contradict the reality of the situation. “I guess for every child #Russia murders they get cut off a little more from the civilized world?”
 

Cancer patients vulnerable

The war in Ukraine is an “unfolding humanitarian emergency,” said the World Health Organization, and it has called on top-level officials involved in the Russian invasion to ensure access for delivery of essential medical, surgical, and trauma supplies to help the Ukrainian people and refugees in neighboring countries. A shortage of oxygen, insulin, cancer therapies, and other essential supplies will continue to grow more dire in the weeks and months ahead, WHO officials predict.

One of the more heartbreaking reports described how pediatric cancer patients have been moved to hospital basements that are serving as temporary bomb shelters. Hospital staff continue to try to provide limited treatment when possible, even though essential supplies are dwindling. 

“These children suffer more because they need to stay alive to fight with the cancer – and this fight cannot wait,” Lesia Lysytsia, MD, a doctor at Okhmatdyt, the country’s largest children’s hospital in Kyiv, said in an NBC news report.

For some children, the only treatment available is a basic form of chemotherapy, and at the Kyiv Regional Oncology Center, the situation became so dire for children in need of blood transfusions that physicians began to transfuse blood from parent to child.

“Our patients, they will die,” Dr. Lysytsia said. “We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren’t diagnosed of disease in time, how many patients died because they didn’t receive treatment. It’s an epic amount of people.”
 

Response from oncology community

Many of the large American oncology groups have issued strong statements expressing their support for Ukraine and offering assistance.

The American Cancer Society has partnered with the American Society of Clinical Oncology and the Sidney Kimmel Cancer Center–Jefferson Health to support all Ukrainian cancer patients and their families. The groups are engaging a network of oncologists and oncology nurses to provide support through the ACS Clinician Volunteer Corps.

The ACS and ASCO are making free cancer resources available in English, Ukrainian, Polish, and Russian through their patient information websites (available here and here), with additional patient education resources planned. 

The ACS noted that there are more than 179,000 newly diagnosed patients with cancer among the Ukrainian people “suffering from Russia’s unprovoked aggression.”

“Disruptions to cancer treatment pose a grave risk to the survival of Ukrainian patients with cancer,” commented Karen Knudsen, PhD, CEO at the ACS.

ASCO also issued its own statement, declaring that it stands with “our Ukrainian members, the worldwide oncology community, and health care providers around the globe in condemning Russia’s unprovoked war on Ukraine.”

The society notes that it represents oncology professionals in Ukraine and neighboring countries including Poland, Romania, Moldova, Slovakia, and Hungary, which are now receiving thousands of refugees from the Russian invasion.

“We are hearing daily reports of cancer treatment interrupted by acts of war, including damage to medical facilities and shortages of critical supplies. Countless patients now need to find cancer care in new and unfamiliar surroundings with limited medical records and minimal resources,” the society commented.

The American Association for Cancer Research also issued a statement by President David A. Tuveson, MD, PhD, and CEO Margaret Foti, PhD, MD (hc). The organization has more than 50,000 members around the world, and they “stand in solidarity with the citizens of Ukraine during the Russian attack on their country.”

“This abhorrent war, which has been instigated by Russia’s leaders, is isolating and interrupting the lifesaving work of scientists and clinicians in Ukraine and Russia, threatening years of effective research collaborations and community building,” the AACR comments. “Limiting the exchange of innovative ideas, practices, and data across borders will significantly retard cancer research and have an adverse effect on public health.”

Perhaps the most subdued statement came from the European Society of Medical Oncology, in a brief release entitled: “Against Any War.” The society expressed profound sadness about the unfolding tragedy in Ukraine and the suffering of people. “We would like to confirm our solidarity and unconditioned support to all oncology professionals and cancer patients, with no geographical boundaries.”

ESMO also said that they were reviewing possibilities “to be of concrete help for our members and their patients, in collaboration with national and transnational oncology societies, as well as the International Cancer Foundation.”

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

As many in the world react with sanctions imposed on Russia after its invasion of Ukraine, the oncology community has now stepped into the fray.

All the large cancer organizations have put out statements in support of Ukraine, but one group has gone further and cut its ties with Russia.

“The international cancer specialist network, OncoAlert, severed all cooperation with doctors in Russia as part of the Western sanctions,” the group announced on its Twitter page, which is decorated with a blue and yellow ribbon and declares that it “stands with Ukraine.”

“The OncoAlert Network is nonpolitical but we cannot stand idle and not take a stand against this aggression toward our Ukrainian friends & colleagues,” the group said. “The network will be pulling out of ALL collaborations & congresses in Russia.”

Not surprisingly, the post was inundated with a barrage of inflammatory and politically laced tweets from Russian and Chinese users. Many of them repeated the same phrase about “violating the Hippocratic oath and the Geneva convention,” used foul language, and slammed the United States for past military actions in other parts of the world.

A prominent Russian oncologist also responded, posting a video in which he discussed the situation more coherently and without mudslinging or scripted phrases. Andrey Kaprin, MD, PhD, is chief oncologist of the Russian Federation as well as director general of the Federal State Budgetary Institution, NMRCC, of the Ministry of Health of the Russian Federation. He says they continue to maintain relations with the largest and best known oncologic organizations. “We haven’t felt any deterioration in our relationship yet, and of course, we hope that this won’t happen.”

Dr. Kaprin said he believes OncoAlert will return to cooperation with Russia, and that “reason will prevail.”

“No one is protected from cancer, not even doctors, and that is why there should be no politics here,” he said.

Dr. Kaprin was speaking from Russia state-affiliated media, so it was not an independent commentary. Several of the Twitter responses to his video, primarily from non-Russians, were less than complimentary.

One user replied: “Cancer is rife in the Kremlin.”

Another post pointed out the hypocrisy of Russians being upset that OncoAlert was cutting ties with them. “What about sick Ukrainian kids, having to shelter in hospital basement, not having lifesaving surgeries because Russia decided to invade a democratic country?”

And another post was not buying the story that “reason will prevail,” in that the doctor’s talk seemed to contradict the reality of the situation. “I guess for every child #Russia murders they get cut off a little more from the civilized world?”
 

Cancer patients vulnerable

The war in Ukraine is an “unfolding humanitarian emergency,” said the World Health Organization, and it has called on top-level officials involved in the Russian invasion to ensure access for delivery of essential medical, surgical, and trauma supplies to help the Ukrainian people and refugees in neighboring countries. A shortage of oxygen, insulin, cancer therapies, and other essential supplies will continue to grow more dire in the weeks and months ahead, WHO officials predict.

One of the more heartbreaking reports described how pediatric cancer patients have been moved to hospital basements that are serving as temporary bomb shelters. Hospital staff continue to try to provide limited treatment when possible, even though essential supplies are dwindling. 

“These children suffer more because they need to stay alive to fight with the cancer – and this fight cannot wait,” Lesia Lysytsia, MD, a doctor at Okhmatdyt, the country’s largest children’s hospital in Kyiv, said in an NBC news report.

For some children, the only treatment available is a basic form of chemotherapy, and at the Kyiv Regional Oncology Center, the situation became so dire for children in need of blood transfusions that physicians began to transfuse blood from parent to child.

“Our patients, they will die,” Dr. Lysytsia said. “We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren’t diagnosed of disease in time, how many patients died because they didn’t receive treatment. It’s an epic amount of people.”
 

Response from oncology community

Many of the large American oncology groups have issued strong statements expressing their support for Ukraine and offering assistance.

The American Cancer Society has partnered with the American Society of Clinical Oncology and the Sidney Kimmel Cancer Center–Jefferson Health to support all Ukrainian cancer patients and their families. The groups are engaging a network of oncologists and oncology nurses to provide support through the ACS Clinician Volunteer Corps.

The ACS and ASCO are making free cancer resources available in English, Ukrainian, Polish, and Russian through their patient information websites (available here and here), with additional patient education resources planned. 

The ACS noted that there are more than 179,000 newly diagnosed patients with cancer among the Ukrainian people “suffering from Russia’s unprovoked aggression.”

“Disruptions to cancer treatment pose a grave risk to the survival of Ukrainian patients with cancer,” commented Karen Knudsen, PhD, CEO at the ACS.

ASCO also issued its own statement, declaring that it stands with “our Ukrainian members, the worldwide oncology community, and health care providers around the globe in condemning Russia’s unprovoked war on Ukraine.”

The society notes that it represents oncology professionals in Ukraine and neighboring countries including Poland, Romania, Moldova, Slovakia, and Hungary, which are now receiving thousands of refugees from the Russian invasion.

“We are hearing daily reports of cancer treatment interrupted by acts of war, including damage to medical facilities and shortages of critical supplies. Countless patients now need to find cancer care in new and unfamiliar surroundings with limited medical records and minimal resources,” the society commented.

The American Association for Cancer Research also issued a statement by President David A. Tuveson, MD, PhD, and CEO Margaret Foti, PhD, MD (hc). The organization has more than 50,000 members around the world, and they “stand in solidarity with the citizens of Ukraine during the Russian attack on their country.”

“This abhorrent war, which has been instigated by Russia’s leaders, is isolating and interrupting the lifesaving work of scientists and clinicians in Ukraine and Russia, threatening years of effective research collaborations and community building,” the AACR comments. “Limiting the exchange of innovative ideas, practices, and data across borders will significantly retard cancer research and have an adverse effect on public health.”

Perhaps the most subdued statement came from the European Society of Medical Oncology, in a brief release entitled: “Against Any War.” The society expressed profound sadness about the unfolding tragedy in Ukraine and the suffering of people. “We would like to confirm our solidarity and unconditioned support to all oncology professionals and cancer patients, with no geographical boundaries.”

ESMO also said that they were reviewing possibilities “to be of concrete help for our members and their patients, in collaboration with national and transnational oncology societies, as well as the International Cancer Foundation.”

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

As many in the world react with sanctions imposed on Russia after its invasion of Ukraine, the oncology community has now stepped into the fray.

All the large cancer organizations have put out statements in support of Ukraine, but one group has gone further and cut its ties with Russia.

“The international cancer specialist network, OncoAlert, severed all cooperation with doctors in Russia as part of the Western sanctions,” the group announced on its Twitter page, which is decorated with a blue and yellow ribbon and declares that it “stands with Ukraine.”

“The OncoAlert Network is nonpolitical but we cannot stand idle and not take a stand against this aggression toward our Ukrainian friends & colleagues,” the group said. “The network will be pulling out of ALL collaborations & congresses in Russia.”

Not surprisingly, the post was inundated with a barrage of inflammatory and politically laced tweets from Russian and Chinese users. Many of them repeated the same phrase about “violating the Hippocratic oath and the Geneva convention,” used foul language, and slammed the United States for past military actions in other parts of the world.

A prominent Russian oncologist also responded, posting a video in which he discussed the situation more coherently and without mudslinging or scripted phrases. Andrey Kaprin, MD, PhD, is chief oncologist of the Russian Federation as well as director general of the Federal State Budgetary Institution, NMRCC, of the Ministry of Health of the Russian Federation. He says they continue to maintain relations with the largest and best known oncologic organizations. “We haven’t felt any deterioration in our relationship yet, and of course, we hope that this won’t happen.”

Dr. Kaprin said he believes OncoAlert will return to cooperation with Russia, and that “reason will prevail.”

“No one is protected from cancer, not even doctors, and that is why there should be no politics here,” he said.

Dr. Kaprin was speaking from Russia state-affiliated media, so it was not an independent commentary. Several of the Twitter responses to his video, primarily from non-Russians, were less than complimentary.

One user replied: “Cancer is rife in the Kremlin.”

Another post pointed out the hypocrisy of Russians being upset that OncoAlert was cutting ties with them. “What about sick Ukrainian kids, having to shelter in hospital basement, not having lifesaving surgeries because Russia decided to invade a democratic country?”

And another post was not buying the story that “reason will prevail,” in that the doctor’s talk seemed to contradict the reality of the situation. “I guess for every child #Russia murders they get cut off a little more from the civilized world?”
 

Cancer patients vulnerable

The war in Ukraine is an “unfolding humanitarian emergency,” said the World Health Organization, and it has called on top-level officials involved in the Russian invasion to ensure access for delivery of essential medical, surgical, and trauma supplies to help the Ukrainian people and refugees in neighboring countries. A shortage of oxygen, insulin, cancer therapies, and other essential supplies will continue to grow more dire in the weeks and months ahead, WHO officials predict.

One of the more heartbreaking reports described how pediatric cancer patients have been moved to hospital basements that are serving as temporary bomb shelters. Hospital staff continue to try to provide limited treatment when possible, even though essential supplies are dwindling. 

“These children suffer more because they need to stay alive to fight with the cancer – and this fight cannot wait,” Lesia Lysytsia, MD, a doctor at Okhmatdyt, the country’s largest children’s hospital in Kyiv, said in an NBC news report.

For some children, the only treatment available is a basic form of chemotherapy, and at the Kyiv Regional Oncology Center, the situation became so dire for children in need of blood transfusions that physicians began to transfuse blood from parent to child.

“Our patients, they will die,” Dr. Lysytsia said. “We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren’t diagnosed of disease in time, how many patients died because they didn’t receive treatment. It’s an epic amount of people.”
 

Response from oncology community

Many of the large American oncology groups have issued strong statements expressing their support for Ukraine and offering assistance.

The American Cancer Society has partnered with the American Society of Clinical Oncology and the Sidney Kimmel Cancer Center–Jefferson Health to support all Ukrainian cancer patients and their families. The groups are engaging a network of oncologists and oncology nurses to provide support through the ACS Clinician Volunteer Corps.

The ACS and ASCO are making free cancer resources available in English, Ukrainian, Polish, and Russian through their patient information websites (available here and here), with additional patient education resources planned. 

The ACS noted that there are more than 179,000 newly diagnosed patients with cancer among the Ukrainian people “suffering from Russia’s unprovoked aggression.”

“Disruptions to cancer treatment pose a grave risk to the survival of Ukrainian patients with cancer,” commented Karen Knudsen, PhD, CEO at the ACS.

ASCO also issued its own statement, declaring that it stands with “our Ukrainian members, the worldwide oncology community, and health care providers around the globe in condemning Russia’s unprovoked war on Ukraine.”

The society notes that it represents oncology professionals in Ukraine and neighboring countries including Poland, Romania, Moldova, Slovakia, and Hungary, which are now receiving thousands of refugees from the Russian invasion.

“We are hearing daily reports of cancer treatment interrupted by acts of war, including damage to medical facilities and shortages of critical supplies. Countless patients now need to find cancer care in new and unfamiliar surroundings with limited medical records and minimal resources,” the society commented.

The American Association for Cancer Research also issued a statement by President David A. Tuveson, MD, PhD, and CEO Margaret Foti, PhD, MD (hc). The organization has more than 50,000 members around the world, and they “stand in solidarity with the citizens of Ukraine during the Russian attack on their country.”

“This abhorrent war, which has been instigated by Russia’s leaders, is isolating and interrupting the lifesaving work of scientists and clinicians in Ukraine and Russia, threatening years of effective research collaborations and community building,” the AACR comments. “Limiting the exchange of innovative ideas, practices, and data across borders will significantly retard cancer research and have an adverse effect on public health.”

Perhaps the most subdued statement came from the European Society of Medical Oncology, in a brief release entitled: “Against Any War.” The society expressed profound sadness about the unfolding tragedy in Ukraine and the suffering of people. “We would like to confirm our solidarity and unconditioned support to all oncology professionals and cancer patients, with no geographical boundaries.”

ESMO also said that they were reviewing possibilities “to be of concrete help for our members and their patients, in collaboration with national and transnational oncology societies, as well as the International Cancer Foundation.”

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

The federal government’s efforts to thwart information blocking are underway. As such, physicians would do well to be standing at the ready when the information-blocking regulations, designed to ensure that patients can access their electronic health information (EHI), shift into full gear.

Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.

The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.

Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.

The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
 

Do the stats tell the story?

The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.

Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.

“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
 

A long time coming

The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.

The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.

Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.

“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
 

With education, more is better

These efforts, however, could be expanded, according to MGMA.

“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”

Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.

“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.

For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.

The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.

“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”

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

The federal government’s efforts to thwart information blocking are underway. As such, physicians would do well to be standing at the ready when the information-blocking regulations, designed to ensure that patients can access their electronic health information (EHI), shift into full gear.

Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.

The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.

Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.

The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
 

Do the stats tell the story?

The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.

Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.

“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
 

A long time coming

The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.

The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.

Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.

“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
 

With education, more is better

These efforts, however, could be expanded, according to MGMA.

“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”

Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.

“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.

For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.

The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.

“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”

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

The federal government’s efforts to thwart information blocking are underway. As such, physicians would do well to be standing at the ready when the information-blocking regulations, designed to ensure that patients can access their electronic health information (EHI), shift into full gear.

Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.

The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.

Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.

The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
 

Do the stats tell the story?

The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.

Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.

“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
 

A long time coming

The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.

The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.

Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.

“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
 

With education, more is better

These efforts, however, could be expanded, according to MGMA.

“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”

Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.

“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.

For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.

The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.

“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”

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

A high-fiber diet, especially one rich in soluble fiber, is linked to a lower risk of incident disabling dementia, new research shows.

Investigators administered a dietary survey to 3,700 healthy adults at midlife and then followed them for up to 20 years. They found that participants who consumed the most fiber had approximately a 25% lower risk of developing dementia in later life.

“This study showed that people with a high intake of dietary fiber, especially soluble fiber, have a lower risk of dementia,” study investigator Kazumasa Yamagishi, MD, PhD, professor, department of public health medicine, faculty of medicine and health, Services Research and Development Center, University of Tsukuba, Japan, said in an interview.

CDC/Debora Cartagena

“There are still many unknowns about the causes of dementia, and it is not appropriate to determine causality based on the results of a single cohort study. However, the results of this study can be said to be one of the findings that will lead to the prevention of dementia,” Dr. Yamagishi said.

The study was published online Feb. 6 in Nutritional Neuroscience.
 

Brain-gut interaction

Brain-gut interaction has recently received attention for its potential involvement in the development of dementia. “The concept of brain-gut interaction emerged from the idea that the central nervous system communicates bidirectionally with the gastrointestinal tract, suggesting that the gut microbiome may influence brain plasticity and cognitive function,” the authors wrote.

A diet high in soluble fiber attenuates neuroinflammation in mouse models. Other animal studies have suggested that insoluble fiber might also have a beneficial effect on the microbiome.

The researchers wanted to see whether dietary fiber intake – especially soluble fiber – is associated with a reduced risk of dementia. They also investigated whether there was any difference between dementia in patients with vs. without a history of stroke.

In a previous study, these same researchers reported an inverse association between eating beans, which are high in fiber, and risk of disabling dementia. In the current study, the researchers extended the analyses to dietary fiber intake of total, soluble, and insoluble fibers, as well as other fiber-containing foods, such potatoes, vegetables, and fruits. However, they distinguished potatoes from other vegetables because the composition of starch in potatoes differs.

“Dietary fiber is a nutrient found in grains, potatoes, vegetables, and fruits and is known to affect intestinal bacteria,” Dr. Yamagishi said. “Recently, some experimental studies have shown that intestinal bacteria may be involved in cognitive functions as well as diseases of the digestive tract. However, there have been no studies that have actually examined the relationship between dietary fiber intake and the subsequent risk of dementia in large numbers of general people.”

The researchers turned to participants in the Circulatory Risk in Communities Study (CIRCS), an ongoing dynamic community cohort study involving five communities in Japan. The current study focused on communities where disabling dementia surveillance is conducted.

Participants (n = 3,739) ranged in age from 40 to 64 years (mean age, 51 years) at the time they completed the 24-hour dietary recall survey, and they participated in annual health checkups from 1985 to 1999. Potential risk factors for disabling dementia were measured at the time the dietary surveys were conducted. Participants were then followed for a median of 19.7 years (1999-2020) to confirm incident, disabling dementia.

“Disabling dementia” was defined as dementia that required care under the National Long-Term Care Insurance System and was further categorized on the basis of having a history or not having a history of stroke.

The researchers divided participants into quartiles, based on the amount of total, soluble, and insoluble intake reported in their surveys. They found that men tended to consume less total fiber compared to women.
 

Unclear mechanism

During follow-up, 670 participants developed disabling dementia.

Total fiber intake was “inversely and linearly” associated with risk of incident dementia, the authors reported, with each successive quartile associated with a lower risk compared to the lowest quartile (P for trend = .03).

The association remained after adjustment for potential factors that might affect dementia onset, such as body mass index, systolic blood pressure, antihypertensive medication use, serum total cholesterol, cholesterol-lowering medication, and diabetes (P for trend = .05).

“The inverse association was more evident for soluble fiber intake and was confined to dementia without a history of stroke,” the authors reported. Moreover, potatoes, not vegetables or fruits, showed a similar association.

“The mechanisms are currently unknown but might involve the interactions that take place between the gut and the brain,” Dr. Yamagishi said in a release.

“One possibility is that soluble fiber regulates the composition of gut bacteria. This composition may affect neuroinflammation, which plays a role in the onset of dementia,” he suggested. “It’s also possible that dietary fiber may reduce other risk factors for dementia, such as body weight, blood pressure, lipids, and glucose levels.”

The authors noted several limitations. For example, they did not distinguish between Alzheimer’s and non-Alzheimer’s dementia. Moreover, they classified dietary habits on the basis of a single survey, and participants’ dietary patterns might have changed over the study period.

In addition, Dr. Yamagishi noted, it is “important to confirm the association in other populations.”
 

Balance is key

In an interview, Uma Naidoo, MD, director of nutritional and lifestyle psychiatry, Massachusetts General Hospital, and nutrition educator at Harvard Medical School, both in Boston, said the study “adds to the growing pool of evidence suggesting that a diet rich in colorful, plant-based foods can benefit our neurological and psychiatric health, especially as we age.”

Dr. Naidoo, a chef and the author of “This Is Your Brain on Food,” who was not involved in the study, continued, “In nutritional psychiatry, balance is key and therefore consuming a well-rounded diet including ample amounts of fiber – particularly from sources like steel-cut oats, beans, lentils, and numerous other fruits and vegetables – can be part of a healthy lifestyle and prevention against cognitive decline in later years.

“While the study authors admit to limitations within the study, in my opinion, eating healthier has so many mental and physical health benefits that it’s a nutritional psychiatry no-brainer,” she added.

The study was partly supported by Health and Labour Science Research Grants for Dementia from the Ministry of Health, Labour and Welfare of Japan; JSPS Kakenhi; FULLHAP; and the Osaka University International Joint Research Promotion Programme with University College London. The authors and Dr. Naidoo report no relevant financial relationships.

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

A high-fiber diet, especially one rich in soluble fiber, is linked to a lower risk of incident disabling dementia, new research shows.

Investigators administered a dietary survey to 3,700 healthy adults at midlife and then followed them for up to 20 years. They found that participants who consumed the most fiber had approximately a 25% lower risk of developing dementia in later life.

“This study showed that people with a high intake of dietary fiber, especially soluble fiber, have a lower risk of dementia,” study investigator Kazumasa Yamagishi, MD, PhD, professor, department of public health medicine, faculty of medicine and health, Services Research and Development Center, University of Tsukuba, Japan, said in an interview.

CDC/Debora Cartagena

“There are still many unknowns about the causes of dementia, and it is not appropriate to determine causality based on the results of a single cohort study. However, the results of this study can be said to be one of the findings that will lead to the prevention of dementia,” Dr. Yamagishi said.

The study was published online Feb. 6 in Nutritional Neuroscience.
 

Brain-gut interaction

Brain-gut interaction has recently received attention for its potential involvement in the development of dementia. “The concept of brain-gut interaction emerged from the idea that the central nervous system communicates bidirectionally with the gastrointestinal tract, suggesting that the gut microbiome may influence brain plasticity and cognitive function,” the authors wrote.

A diet high in soluble fiber attenuates neuroinflammation in mouse models. Other animal studies have suggested that insoluble fiber might also have a beneficial effect on the microbiome.

The researchers wanted to see whether dietary fiber intake – especially soluble fiber – is associated with a reduced risk of dementia. They also investigated whether there was any difference between dementia in patients with vs. without a history of stroke.

In a previous study, these same researchers reported an inverse association between eating beans, which are high in fiber, and risk of disabling dementia. In the current study, the researchers extended the analyses to dietary fiber intake of total, soluble, and insoluble fibers, as well as other fiber-containing foods, such potatoes, vegetables, and fruits. However, they distinguished potatoes from other vegetables because the composition of starch in potatoes differs.

“Dietary fiber is a nutrient found in grains, potatoes, vegetables, and fruits and is known to affect intestinal bacteria,” Dr. Yamagishi said. “Recently, some experimental studies have shown that intestinal bacteria may be involved in cognitive functions as well as diseases of the digestive tract. However, there have been no studies that have actually examined the relationship between dietary fiber intake and the subsequent risk of dementia in large numbers of general people.”

The researchers turned to participants in the Circulatory Risk in Communities Study (CIRCS), an ongoing dynamic community cohort study involving five communities in Japan. The current study focused on communities where disabling dementia surveillance is conducted.

Participants (n = 3,739) ranged in age from 40 to 64 years (mean age, 51 years) at the time they completed the 24-hour dietary recall survey, and they participated in annual health checkups from 1985 to 1999. Potential risk factors for disabling dementia were measured at the time the dietary surveys were conducted. Participants were then followed for a median of 19.7 years (1999-2020) to confirm incident, disabling dementia.

“Disabling dementia” was defined as dementia that required care under the National Long-Term Care Insurance System and was further categorized on the basis of having a history or not having a history of stroke.

The researchers divided participants into quartiles, based on the amount of total, soluble, and insoluble intake reported in their surveys. They found that men tended to consume less total fiber compared to women.
 

Unclear mechanism

During follow-up, 670 participants developed disabling dementia.

Total fiber intake was “inversely and linearly” associated with risk of incident dementia, the authors reported, with each successive quartile associated with a lower risk compared to the lowest quartile (P for trend = .03).

The association remained after adjustment for potential factors that might affect dementia onset, such as body mass index, systolic blood pressure, antihypertensive medication use, serum total cholesterol, cholesterol-lowering medication, and diabetes (P for trend = .05).

“The inverse association was more evident for soluble fiber intake and was confined to dementia without a history of stroke,” the authors reported. Moreover, potatoes, not vegetables or fruits, showed a similar association.

“The mechanisms are currently unknown but might involve the interactions that take place between the gut and the brain,” Dr. Yamagishi said in a release.

“One possibility is that soluble fiber regulates the composition of gut bacteria. This composition may affect neuroinflammation, which plays a role in the onset of dementia,” he suggested. “It’s also possible that dietary fiber may reduce other risk factors for dementia, such as body weight, blood pressure, lipids, and glucose levels.”

The authors noted several limitations. For example, they did not distinguish between Alzheimer’s and non-Alzheimer’s dementia. Moreover, they classified dietary habits on the basis of a single survey, and participants’ dietary patterns might have changed over the study period.

In addition, Dr. Yamagishi noted, it is “important to confirm the association in other populations.”
 

Balance is key

In an interview, Uma Naidoo, MD, director of nutritional and lifestyle psychiatry, Massachusetts General Hospital, and nutrition educator at Harvard Medical School, both in Boston, said the study “adds to the growing pool of evidence suggesting that a diet rich in colorful, plant-based foods can benefit our neurological and psychiatric health, especially as we age.”

Dr. Naidoo, a chef and the author of “This Is Your Brain on Food,” who was not involved in the study, continued, “In nutritional psychiatry, balance is key and therefore consuming a well-rounded diet including ample amounts of fiber – particularly from sources like steel-cut oats, beans, lentils, and numerous other fruits and vegetables – can be part of a healthy lifestyle and prevention against cognitive decline in later years.

“While the study authors admit to limitations within the study, in my opinion, eating healthier has so many mental and physical health benefits that it’s a nutritional psychiatry no-brainer,” she added.

The study was partly supported by Health and Labour Science Research Grants for Dementia from the Ministry of Health, Labour and Welfare of Japan; JSPS Kakenhi; FULLHAP; and the Osaka University International Joint Research Promotion Programme with University College London. The authors and Dr. Naidoo report no relevant financial relationships.

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

A high-fiber diet, especially one rich in soluble fiber, is linked to a lower risk of incident disabling dementia, new research shows.

Investigators administered a dietary survey to 3,700 healthy adults at midlife and then followed them for up to 20 years. They found that participants who consumed the most fiber had approximately a 25% lower risk of developing dementia in later life.

“This study showed that people with a high intake of dietary fiber, especially soluble fiber, have a lower risk of dementia,” study investigator Kazumasa Yamagishi, MD, PhD, professor, department of public health medicine, faculty of medicine and health, Services Research and Development Center, University of Tsukuba, Japan, said in an interview.

CDC/Debora Cartagena

“There are still many unknowns about the causes of dementia, and it is not appropriate to determine causality based on the results of a single cohort study. However, the results of this study can be said to be one of the findings that will lead to the prevention of dementia,” Dr. Yamagishi said.

The study was published online Feb. 6 in Nutritional Neuroscience.
 

Brain-gut interaction

Brain-gut interaction has recently received attention for its potential involvement in the development of dementia. “The concept of brain-gut interaction emerged from the idea that the central nervous system communicates bidirectionally with the gastrointestinal tract, suggesting that the gut microbiome may influence brain plasticity and cognitive function,” the authors wrote.

A diet high in soluble fiber attenuates neuroinflammation in mouse models. Other animal studies have suggested that insoluble fiber might also have a beneficial effect on the microbiome.

The researchers wanted to see whether dietary fiber intake – especially soluble fiber – is associated with a reduced risk of dementia. They also investigated whether there was any difference between dementia in patients with vs. without a history of stroke.

In a previous study, these same researchers reported an inverse association between eating beans, which are high in fiber, and risk of disabling dementia. In the current study, the researchers extended the analyses to dietary fiber intake of total, soluble, and insoluble fibers, as well as other fiber-containing foods, such potatoes, vegetables, and fruits. However, they distinguished potatoes from other vegetables because the composition of starch in potatoes differs.

“Dietary fiber is a nutrient found in grains, potatoes, vegetables, and fruits and is known to affect intestinal bacteria,” Dr. Yamagishi said. “Recently, some experimental studies have shown that intestinal bacteria may be involved in cognitive functions as well as diseases of the digestive tract. However, there have been no studies that have actually examined the relationship between dietary fiber intake and the subsequent risk of dementia in large numbers of general people.”

The researchers turned to participants in the Circulatory Risk in Communities Study (CIRCS), an ongoing dynamic community cohort study involving five communities in Japan. The current study focused on communities where disabling dementia surveillance is conducted.

Participants (n = 3,739) ranged in age from 40 to 64 years (mean age, 51 years) at the time they completed the 24-hour dietary recall survey, and they participated in annual health checkups from 1985 to 1999. Potential risk factors for disabling dementia were measured at the time the dietary surveys were conducted. Participants were then followed for a median of 19.7 years (1999-2020) to confirm incident, disabling dementia.

“Disabling dementia” was defined as dementia that required care under the National Long-Term Care Insurance System and was further categorized on the basis of having a history or not having a history of stroke.

The researchers divided participants into quartiles, based on the amount of total, soluble, and insoluble intake reported in their surveys. They found that men tended to consume less total fiber compared to women.
 

Unclear mechanism

During follow-up, 670 participants developed disabling dementia.

Total fiber intake was “inversely and linearly” associated with risk of incident dementia, the authors reported, with each successive quartile associated with a lower risk compared to the lowest quartile (P for trend = .03).

The association remained after adjustment for potential factors that might affect dementia onset, such as body mass index, systolic blood pressure, antihypertensive medication use, serum total cholesterol, cholesterol-lowering medication, and diabetes (P for trend = .05).

“The inverse association was more evident for soluble fiber intake and was confined to dementia without a history of stroke,” the authors reported. Moreover, potatoes, not vegetables or fruits, showed a similar association.

“The mechanisms are currently unknown but might involve the interactions that take place between the gut and the brain,” Dr. Yamagishi said in a release.

“One possibility is that soluble fiber regulates the composition of gut bacteria. This composition may affect neuroinflammation, which plays a role in the onset of dementia,” he suggested. “It’s also possible that dietary fiber may reduce other risk factors for dementia, such as body weight, blood pressure, lipids, and glucose levels.”

The authors noted several limitations. For example, they did not distinguish between Alzheimer’s and non-Alzheimer’s dementia. Moreover, they classified dietary habits on the basis of a single survey, and participants’ dietary patterns might have changed over the study period.

In addition, Dr. Yamagishi noted, it is “important to confirm the association in other populations.”
 

Balance is key

In an interview, Uma Naidoo, MD, director of nutritional and lifestyle psychiatry, Massachusetts General Hospital, and nutrition educator at Harvard Medical School, both in Boston, said the study “adds to the growing pool of evidence suggesting that a diet rich in colorful, plant-based foods can benefit our neurological and psychiatric health, especially as we age.”

Dr. Naidoo, a chef and the author of “This Is Your Brain on Food,” who was not involved in the study, continued, “In nutritional psychiatry, balance is key and therefore consuming a well-rounded diet including ample amounts of fiber – particularly from sources like steel-cut oats, beans, lentils, and numerous other fruits and vegetables – can be part of a healthy lifestyle and prevention against cognitive decline in later years.

“While the study authors admit to limitations within the study, in my opinion, eating healthier has so many mental and physical health benefits that it’s a nutritional psychiatry no-brainer,” she added.

The study was partly supported by Health and Labour Science Research Grants for Dementia from the Ministry of Health, Labour and Welfare of Japan; JSPS Kakenhi; FULLHAP; and the Osaka University International Joint Research Promotion Programme with University College London. The authors and Dr. Naidoo report no relevant financial relationships.

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

Treatment for moderate to severe active ulcerative colitis (UC) has evolved, and with more effective treatment comes higher standards for disease control. 

The initial goal is clinical response, followed by clinical remission, endoscopic remission, and — the ultimate goal — histologic remission.  

The majority of UC medications have been studied for clinical and endoscopic remission. Recent clinical trials, however, have evaluated the emerging targeted therapies ustekinumab and ozanimod for histologic remission and found positive results.  

Dr Bincy Abraham, director of the Fondren Inflammatory Bowel Disease Program at Houston Methodist in Houston, Texas, reports on UC treatment milestones and how emerging targeted therapies can help achieve these goals. 

She also discusses patient monitoring to ensure response to therapy as well as medication adjustments should response prove inadequate. 

--

Professor of Clinical Medicine, Department of Internal Medicine and Gastroenterology; Director, Fondren Inflammatory Bowel Disease Program, Underwood Center for Digestive Disorders, Houston Methodist, Houston, Texas 

Bincy Abraham, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; BMS; Janssen; Pfizer; Takeda; Medtronic 

Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; BMS; Janssen; Pfizer; Takeda 

Received research grant from: Takeda; BMS; Genentech 

Treatment for moderate to severe active ulcerative colitis (UC) has evolved, and with more effective treatment comes higher standards for disease control. 

The initial goal is clinical response, followed by clinical remission, endoscopic remission, and — the ultimate goal — histologic remission.  

The majority of UC medications have been studied for clinical and endoscopic remission. Recent clinical trials, however, have evaluated the emerging targeted therapies ustekinumab and ozanimod for histologic remission and found positive results.  

Dr Bincy Abraham, director of the Fondren Inflammatory Bowel Disease Program at Houston Methodist in Houston, Texas, reports on UC treatment milestones and how emerging targeted therapies can help achieve these goals. 

She also discusses patient monitoring to ensure response to therapy as well as medication adjustments should response prove inadequate. 

--

Professor of Clinical Medicine, Department of Internal Medicine and Gastroenterology; Director, Fondren Inflammatory Bowel Disease Program, Underwood Center for Digestive Disorders, Houston Methodist, Houston, Texas 

Bincy Abraham, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; BMS; Janssen; Pfizer; Takeda; Medtronic 

Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; BMS; Janssen; Pfizer; Takeda 

Received research grant from: Takeda; BMS; Genentech 

Treatment for moderate to severe active ulcerative colitis (UC) has evolved, and with more effective treatment comes higher standards for disease control. 

The initial goal is clinical response, followed by clinical remission, endoscopic remission, and — the ultimate goal — histologic remission.  

The majority of UC medications have been studied for clinical and endoscopic remission. Recent clinical trials, however, have evaluated the emerging targeted therapies ustekinumab and ozanimod for histologic remission and found positive results.  

Dr Bincy Abraham, director of the Fondren Inflammatory Bowel Disease Program at Houston Methodist in Houston, Texas, reports on UC treatment milestones and how emerging targeted therapies can help achieve these goals. 

She also discusses patient monitoring to ensure response to therapy as well as medication adjustments should response prove inadequate. 

--

Professor of Clinical Medicine, Department of Internal Medicine and Gastroenterology; Director, Fondren Inflammatory Bowel Disease Program, Underwood Center for Digestive Disorders, Houston Methodist, Houston, Texas 

Bincy Abraham, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; BMS; Janssen; Pfizer; Takeda; Medtronic 

Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; BMS; Janssen; Pfizer; Takeda 

Received research grant from: Takeda; BMS; Genentech 

Combining individual schema and group schema therapy together appears to be the best approach for reducing symptoms of borderline personality disorder (BPD), new research suggests.

Schema is a form of psychotherapy that focuses on experiential approaches rather than on behavior change.

Courtesy University of Amsterdam

The findings from an international randomized controlled trial underscore the importance of offering both individual and group approaches to patients with BPD, study investigator Arnoud Arntz, PhD, professor in the department of clinical psychology at the University of Amsterdam, told this news organization.

“In the Netherlands, there’s a big push from mental health institutes to deliver treatments in group therapy [only] because people think it’s more cost-effective; but these findings question that idea,” Dr. Arntz said.

The findings were published online March 2 in JAMA Psychiatry.
 

Early childhood experiences

Patients with BPD exhibit extreme sensitivity to interpersonal slights, intense and volatile emotions, and impulsive behaviors. Many abuse drugs, self-harm, or attempt suicide.

Evidence-based guidelines recommend psychotherapy as the primary treatment for BPD.

Schema therapy uses techniques from traditional psychotherapy but focuses on an experiential strategy. It also delves into early childhood experiences, which is relevant because patients with BPD often experienced abuse or neglect early in life.

As well, with this approach, therapists take on a sort of parenting role with patients to try to meet needs “that were frustrated in childhood,” said Dr. Arntz.

Previous research has suggested both individual and group schema therapy help reduce BPD symptoms, but the effectiveness of combining these two approaches has been unclear.

The current study included 495 adult patients (mean age, 33.6 years; 86.2% women) enrolled at 15 sites in five countries: the Netherlands, England, Greece, Germany, and Australia. All participants had a Borderline Personality Disorder Severity Index IV (BPDSI-IV) score of more than 20.

The BPDSI-IV score ranges from 0 to 90, with a score of 15 being the cutoff for a BPD diagnosis.

Investigators randomly assigned participants to one of three arms: predominantly group schema therapy, combined individual and group schema therapy, and treatment as usual – which was the optimal psychological treatment available at the site.

The two schema therapy arms, whether group or individual, involved a similar number of sessions each week. However, the frequency was gradually reduced over the course of the study.
 

Improved severity

The primary outcome was change in BPD severity as assessed at baseline, 6 months, 12 months, 18 months, 24 months, and 36 months with the BPDSI-IV total score.

Researchers first compared both the group therapy and the combination therapy with treatment as usual and found that together, the two schema arms were superior for reducing total BPDSI-IV score, with a medium to large effect size (Cohen d, 0.73; 95% confidence interval, .29-1.18; P = .001).

The difference was significant at 1.5 years (mean difference, 2.38; 95% CI, .27-4.49; P = .03).

When the treatment arms were compared separately, the combination therapy was superior to both the group therapy (Cohen d, 0.84; 95% CI, .09-1.59; P = .03) and to treatment as usual (Cohen d, 1.14; 95% CI, .57-1.71; P < .001).

The effectiveness of the predominantly group therapy did not differ significantly from that of treatment as usual.

The difference in effectiveness of combined therapy compared with treatment as usual became significant at 1 year. It became significant at 2.5 years compared with predominantly group therapy.
 

Treatment retention

In both schema arms, session frequency was tapered to only once a month; and in year 3, no further treatment was offered. However, symptom improvement continued during years 2 and 3.

Dr. Arntz explained this could be because patients realized they could apply what they learned after therapy was discontinued, which boosted their self-confidence.

Treatment retention was greater with combined therapy compared to the other options.

There was also improvement in several secondary outcomes, including happiness and quality of life, in most patients. However, patterns of outcomes for societal and work functioning improved more for those in either arm that received schema therapy.

“Group therapy seems to offer something that is important for learning to cooperate with other people. At work, you often have to collaborate with people who are not necessarily your friends,” Dr. Arntz noted.

The number of suicide attempts declined over time, with the combination arm being significantly superior to treatment as usual. During the study period, three patients died from suicide: one from each treatment arm. Another death had an unknown cause.

Overall, the results suggest that group and individual sessions address different needs of patients, the investigators noted.

While patients may learn to get along with others in a group setting, they may be more comfortable discussing severe trauma or suicidal thoughts in one-on-one sessions with a therapist, they added.
 

Strengths, weaknesses

Commenting for this news organization, John M. Oldham, MD, Distinguished Emeritus Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, said the study had a number of strengths, including its size and “good, solid” methodology.

“This is another big study that demonstrates a well-established form of psychotherapy leads to effective improvement in patients with borderline,” said Dr. Oldham, who was not involved in the research.

However, he noted a number of study limitations. First, training for therapists to deliver schema therapy is not always readily available. In addition, schema therapists in the study “were pretty junior,” with some appearing to be “trained on the job,” he said.

Dr. Oldham noted that cost may be another deterrent to implementing this therapeutic approach. Only those with substantial financial resources could afford once-a-week group therapy and once-a-week individual therapy for 2 years, at least in the United States, he said.

Because patients had to be willing to undergo therapy for 2 years to be enrolled in the study, the results may not be generalizable to the entire BPD population, Dr. Oldham added. “Many borderline patients would turn around and walk out the door if asked to commit to that,” he said.

So the study population may be “better attuned and receptive to therapy” and less impaired compared to many patients with this condition, Dr. Oldham said.

He also said the study did not compare individual schema therapy alone with group schema alone.

Study sites were supported by the Netherlands Organization for Health Research and Development and the Netherlands Foundation for Mental Health Study; Else Kröner-Fresenius-Stiftung; Australian Rotary Health; Greek Society of Schema Therapy, First Department of Psychiatry of the Medical School of the University of Athens, and Institut für Verhaltenstherapie Ausbildung Hamburg; South London and Maudsley NHS Foundation Trust and the Research Center Experimental Psychopathology, Maastricht University and Bradford District Care NHS Foundation Trust. Dr. Arntz has received grants from the Netherlands Organization for Health Research and Development and the Netherlands Foundation for Mental Health. Dr. Oldham reported no relevant financial relationships.

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

Combining individual schema and group schema therapy together appears to be the best approach for reducing symptoms of borderline personality disorder (BPD), new research suggests.

Schema is a form of psychotherapy that focuses on experiential approaches rather than on behavior change.

Courtesy University of Amsterdam

The findings from an international randomized controlled trial underscore the importance of offering both individual and group approaches to patients with BPD, study investigator Arnoud Arntz, PhD, professor in the department of clinical psychology at the University of Amsterdam, told this news organization.

“In the Netherlands, there’s a big push from mental health institutes to deliver treatments in group therapy [only] because people think it’s more cost-effective; but these findings question that idea,” Dr. Arntz said.

The findings were published online March 2 in JAMA Psychiatry.
 

Early childhood experiences

Patients with BPD exhibit extreme sensitivity to interpersonal slights, intense and volatile emotions, and impulsive behaviors. Many abuse drugs, self-harm, or attempt suicide.

Evidence-based guidelines recommend psychotherapy as the primary treatment for BPD.

Schema therapy uses techniques from traditional psychotherapy but focuses on an experiential strategy. It also delves into early childhood experiences, which is relevant because patients with BPD often experienced abuse or neglect early in life.

As well, with this approach, therapists take on a sort of parenting role with patients to try to meet needs “that were frustrated in childhood,” said Dr. Arntz.

Previous research has suggested both individual and group schema therapy help reduce BPD symptoms, but the effectiveness of combining these two approaches has been unclear.

The current study included 495 adult patients (mean age, 33.6 years; 86.2% women) enrolled at 15 sites in five countries: the Netherlands, England, Greece, Germany, and Australia. All participants had a Borderline Personality Disorder Severity Index IV (BPDSI-IV) score of more than 20.

The BPDSI-IV score ranges from 0 to 90, with a score of 15 being the cutoff for a BPD diagnosis.

Investigators randomly assigned participants to one of three arms: predominantly group schema therapy, combined individual and group schema therapy, and treatment as usual – which was the optimal psychological treatment available at the site.

The two schema therapy arms, whether group or individual, involved a similar number of sessions each week. However, the frequency was gradually reduced over the course of the study.
 

Improved severity

The primary outcome was change in BPD severity as assessed at baseline, 6 months, 12 months, 18 months, 24 months, and 36 months with the BPDSI-IV total score.

Researchers first compared both the group therapy and the combination therapy with treatment as usual and found that together, the two schema arms were superior for reducing total BPDSI-IV score, with a medium to large effect size (Cohen d, 0.73; 95% confidence interval, .29-1.18; P = .001).

The difference was significant at 1.5 years (mean difference, 2.38; 95% CI, .27-4.49; P = .03).

When the treatment arms were compared separately, the combination therapy was superior to both the group therapy (Cohen d, 0.84; 95% CI, .09-1.59; P = .03) and to treatment as usual (Cohen d, 1.14; 95% CI, .57-1.71; P < .001).

The effectiveness of the predominantly group therapy did not differ significantly from that of treatment as usual.

The difference in effectiveness of combined therapy compared with treatment as usual became significant at 1 year. It became significant at 2.5 years compared with predominantly group therapy.
 

Treatment retention

In both schema arms, session frequency was tapered to only once a month; and in year 3, no further treatment was offered. However, symptom improvement continued during years 2 and 3.

Dr. Arntz explained this could be because patients realized they could apply what they learned after therapy was discontinued, which boosted their self-confidence.

Treatment retention was greater with combined therapy compared to the other options.

There was also improvement in several secondary outcomes, including happiness and quality of life, in most patients. However, patterns of outcomes for societal and work functioning improved more for those in either arm that received schema therapy.

“Group therapy seems to offer something that is important for learning to cooperate with other people. At work, you often have to collaborate with people who are not necessarily your friends,” Dr. Arntz noted.

The number of suicide attempts declined over time, with the combination arm being significantly superior to treatment as usual. During the study period, three patients died from suicide: one from each treatment arm. Another death had an unknown cause.

Overall, the results suggest that group and individual sessions address different needs of patients, the investigators noted.

While patients may learn to get along with others in a group setting, they may be more comfortable discussing severe trauma or suicidal thoughts in one-on-one sessions with a therapist, they added.
 

Strengths, weaknesses

Commenting for this news organization, John M. Oldham, MD, Distinguished Emeritus Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, said the study had a number of strengths, including its size and “good, solid” methodology.

“This is another big study that demonstrates a well-established form of psychotherapy leads to effective improvement in patients with borderline,” said Dr. Oldham, who was not involved in the research.

However, he noted a number of study limitations. First, training for therapists to deliver schema therapy is not always readily available. In addition, schema therapists in the study “were pretty junior,” with some appearing to be “trained on the job,” he said.

Dr. Oldham noted that cost may be another deterrent to implementing this therapeutic approach. Only those with substantial financial resources could afford once-a-week group therapy and once-a-week individual therapy for 2 years, at least in the United States, he said.

Because patients had to be willing to undergo therapy for 2 years to be enrolled in the study, the results may not be generalizable to the entire BPD population, Dr. Oldham added. “Many borderline patients would turn around and walk out the door if asked to commit to that,” he said.

So the study population may be “better attuned and receptive to therapy” and less impaired compared to many patients with this condition, Dr. Oldham said.

He also said the study did not compare individual schema therapy alone with group schema alone.

Study sites were supported by the Netherlands Organization for Health Research and Development and the Netherlands Foundation for Mental Health Study; Else Kröner-Fresenius-Stiftung; Australian Rotary Health; Greek Society of Schema Therapy, First Department of Psychiatry of the Medical School of the University of Athens, and Institut für Verhaltenstherapie Ausbildung Hamburg; South London and Maudsley NHS Foundation Trust and the Research Center Experimental Psychopathology, Maastricht University and Bradford District Care NHS Foundation Trust. Dr. Arntz has received grants from the Netherlands Organization for Health Research and Development and the Netherlands Foundation for Mental Health. Dr. Oldham reported no relevant financial relationships.

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

Combining individual schema and group schema therapy together appears to be the best approach for reducing symptoms of borderline personality disorder (BPD), new research suggests.

Schema is a form of psychotherapy that focuses on experiential approaches rather than on behavior change.

Courtesy University of Amsterdam

The findings from an international randomized controlled trial underscore the importance of offering both individual and group approaches to patients with BPD, study investigator Arnoud Arntz, PhD, professor in the department of clinical psychology at the University of Amsterdam, told this news organization.

“In the Netherlands, there’s a big push from mental health institutes to deliver treatments in group therapy [only] because people think it’s more cost-effective; but these findings question that idea,” Dr. Arntz said.

The findings were published online March 2 in JAMA Psychiatry.
 

Early childhood experiences

Patients with BPD exhibit extreme sensitivity to interpersonal slights, intense and volatile emotions, and impulsive behaviors. Many abuse drugs, self-harm, or attempt suicide.

Evidence-based guidelines recommend psychotherapy as the primary treatment for BPD.

Schema therapy uses techniques from traditional psychotherapy but focuses on an experiential strategy. It also delves into early childhood experiences, which is relevant because patients with BPD often experienced abuse or neglect early in life.

As well, with this approach, therapists take on a sort of parenting role with patients to try to meet needs “that were frustrated in childhood,” said Dr. Arntz.

Previous research has suggested both individual and group schema therapy help reduce BPD symptoms, but the effectiveness of combining these two approaches has been unclear.

The current study included 495 adult patients (mean age, 33.6 years; 86.2% women) enrolled at 15 sites in five countries: the Netherlands, England, Greece, Germany, and Australia. All participants had a Borderline Personality Disorder Severity Index IV (BPDSI-IV) score of more than 20.

The BPDSI-IV score ranges from 0 to 90, with a score of 15 being the cutoff for a BPD diagnosis.

Investigators randomly assigned participants to one of three arms: predominantly group schema therapy, combined individual and group schema therapy, and treatment as usual – which was the optimal psychological treatment available at the site.

The two schema therapy arms, whether group or individual, involved a similar number of sessions each week. However, the frequency was gradually reduced over the course of the study.
 

Improved severity

The primary outcome was change in BPD severity as assessed at baseline, 6 months, 12 months, 18 months, 24 months, and 36 months with the BPDSI-IV total score.

Researchers first compared both the group therapy and the combination therapy with treatment as usual and found that together, the two schema arms were superior for reducing total BPDSI-IV score, with a medium to large effect size (Cohen d, 0.73; 95% confidence interval, .29-1.18; P = .001).

The difference was significant at 1.5 years (mean difference, 2.38; 95% CI, .27-4.49; P = .03).

When the treatment arms were compared separately, the combination therapy was superior to both the group therapy (Cohen d, 0.84; 95% CI, .09-1.59; P = .03) and to treatment as usual (Cohen d, 1.14; 95% CI, .57-1.71; P < .001).

The effectiveness of the predominantly group therapy did not differ significantly from that of treatment as usual.

The difference in effectiveness of combined therapy compared with treatment as usual became significant at 1 year. It became significant at 2.5 years compared with predominantly group therapy.
 

Treatment retention

In both schema arms, session frequency was tapered to only once a month; and in year 3, no further treatment was offered. However, symptom improvement continued during years 2 and 3.

Dr. Arntz explained this could be because patients realized they could apply what they learned after therapy was discontinued, which boosted their self-confidence.

Treatment retention was greater with combined therapy compared to the other options.

There was also improvement in several secondary outcomes, including happiness and quality of life, in most patients. However, patterns of outcomes for societal and work functioning improved more for those in either arm that received schema therapy.

“Group therapy seems to offer something that is important for learning to cooperate with other people. At work, you often have to collaborate with people who are not necessarily your friends,” Dr. Arntz noted.

The number of suicide attempts declined over time, with the combination arm being significantly superior to treatment as usual. During the study period, three patients died from suicide: one from each treatment arm. Another death had an unknown cause.

Overall, the results suggest that group and individual sessions address different needs of patients, the investigators noted.

While patients may learn to get along with others in a group setting, they may be more comfortable discussing severe trauma or suicidal thoughts in one-on-one sessions with a therapist, they added.
 

Strengths, weaknesses

Commenting for this news organization, John M. Oldham, MD, Distinguished Emeritus Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, said the study had a number of strengths, including its size and “good, solid” methodology.

“This is another big study that demonstrates a well-established form of psychotherapy leads to effective improvement in patients with borderline,” said Dr. Oldham, who was not involved in the research.

However, he noted a number of study limitations. First, training for therapists to deliver schema therapy is not always readily available. In addition, schema therapists in the study “were pretty junior,” with some appearing to be “trained on the job,” he said.

Dr. Oldham noted that cost may be another deterrent to implementing this therapeutic approach. Only those with substantial financial resources could afford once-a-week group therapy and once-a-week individual therapy for 2 years, at least in the United States, he said.

Because patients had to be willing to undergo therapy for 2 years to be enrolled in the study, the results may not be generalizable to the entire BPD population, Dr. Oldham added. “Many borderline patients would turn around and walk out the door if asked to commit to that,” he said.

So the study population may be “better attuned and receptive to therapy” and less impaired compared to many patients with this condition, Dr. Oldham said.

He also said the study did not compare individual schema therapy alone with group schema alone.

Study sites were supported by the Netherlands Organization for Health Research and Development and the Netherlands Foundation for Mental Health Study; Else Kröner-Fresenius-Stiftung; Australian Rotary Health; Greek Society of Schema Therapy, First Department of Psychiatry of the Medical School of the University of Athens, and Institut für Verhaltenstherapie Ausbildung Hamburg; South London and Maudsley NHS Foundation Trust and the Research Center Experimental Psychopathology, Maastricht University and Bradford District Care NHS Foundation Trust. Dr. Arntz has received grants from the Netherlands Organization for Health Research and Development and the Netherlands Foundation for Mental Health. Dr. Oldham reported no relevant financial relationships.

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

Six key bacterial species of the gut microbiome have been identified as predictors of the development of type 2 diabetes, according to results from a 15-year follow-up study of more than 5,000 people in Finland.

“We are not aware of previous long-term prospective studies of the associations between type 2 diabetes and the gut microbiome similar to the current study,” stated the authors of the study, published online Jan. 31, 2022, in Diabetes Care.

Though requiring further validation, the results “build on and extend previous mainly cross-sectional evidence and further support links between dietary habits, metabolic diseases, and type 2 diabetes that are modulated by the gut microbiome,” the authors wrote.

The findings are from a prospective study of data on fecal samples from 5,572 people in Finland in 2002 in the FINRISK 2002 population cohort. In 2017, the samples were sent for sequencing as follow-up.

Of note, the study excluded people with prevalent diabetes at baseline, including those being treated with antidiabetic drugs such as metformin.
 

Four species, two clusters associated with type 2 diabetes development

Over a median follow-up of 15.8 years, 432 (7.8%) participants went on to have a diagnosis of type 2 diabetes, and the presence of four species and two clusters at baseline were significantly associated with the development of type 2 diabetes.

The four species include Clostridium citroniae (hazard ratio, 1.21; unadjusted P = .02), C. bolteae (HR, 1.20; unadjusted P = .01), Tyzzerella nexilis (HR, 1.17; unadjusted P = .03), and Ruminococcus gnavus (HR, 1.17; P = .04).

And the two positively associated clusters mostly consisted of the same species (both HR, 1.18).

Importantly, the associations were nearly the same among participants in eastern and western Finland, which are known for having unique genetic as well as lifestyle differences that impact morbidity and mortality.

“Three of these taxa could be clustered together by proportional abundance in both geographic areas, and combined abundance of the four taxa was also predictive of incident type 2 diabetes,” the authors wrote.

They noted that the identified species have been previously associated with type 2 diabetes and appear to be linked in some ways to the quality of diet and with other metabolic diseases, such as fatty liver disease.

C. citroniae, for instance, has been associated with trimethylamine N-oxide (TMAO), a compound likely linked to the intake of red meat, and the authors noted that a direct association between red meat intake and type 2 diabetes risk has been known for more than 15 years.

TMAO has also been associated with adipose tissue inflammation and impeded hepatic insulin signaling, which are all involved in increased insulin resistance, high blood glucose levels, and type 2 diabetes, the authors explained.

R. gnavus has been previously associated with obesity in humans and animals. And the bacterial species is also “potentially related to glucose metabolism regulation and linked to increases in inflammatory cytokines, both of which are related to type 2 diabetes pathophysiology,” the authors reported.
 

Stepping stone toward improved prediction

Coauthor Teemu J. Niiranen, MD, PhD, of the division of medicine, Turku (Finland) University Hospital, noted that, while prior studies have linked type 2 diabetes with distinctive characteristics of gut microbiome composition, most studies have not included prospective data, and long-term studies have been lacking.

Furthermore, many of the studies could have been confounded by the use of antidiabetic drugs that could influence gut microbiome composition, including metformin, which was excluded in the current study.

“We avoid several of the biases related to cross-sectional studies, such as the confounding effects of diabetes medications,” Dr. Niiranen said in an interview.

“We also know the temporal sequence of the exposure and the outcome, and that the changes in the gut microbiome preceded the development of diabetes,” he said. “All in all, a cohort study like this provides a much greater level of evidence than cross-sectional studies.”

Dr. Niiranen noted, however, that “although we demonstrate that certain gut microbiome changes are associated with greater risk of future diabetes, we are still quite far from clinical use.”

In addition to needing to replicate the results in other ethnic groups and locations, “we would need to find optimal clinical cutoffs for clinical decision-making and demonstrate the amount increase in predictive ability, compared with conventional diabetes risk factors,” he said.

The study nevertheless “serves as a stepping stone toward the goal of improved prediction and the development of effective treatments for type 2 diabetes through modification of the gut microbiome,” the authors wrote.

Other research has shed light on gut bacteria that appear to be linked to the prevention rather than the development of diabetes, identifying species that help produce butyrate, a short-chain fatty acid that may in fact provide protection against type 2 diabetes.

And additional research does suggest potential clinical implications. Efforts to improve insulin sensitivity via the gut through fecal microbial transplantation are also making headway, with an oral capsule formulation showing benefit among patients with severe obesity.

The research was funded in part by grants from the Finnish Cultural Foundation, the Finnish Foundation for Cardiovascular Research, the Emil Aaltonen Foundation, the Finnish Medical Foundation, the Sigrid Jusélius Foundation, and the Academy of Finland.

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

Six key bacterial species of the gut microbiome have been identified as predictors of the development of type 2 diabetes, according to results from a 15-year follow-up study of more than 5,000 people in Finland.

“We are not aware of previous long-term prospective studies of the associations between type 2 diabetes and the gut microbiome similar to the current study,” stated the authors of the study, published online Jan. 31, 2022, in Diabetes Care.

Though requiring further validation, the results “build on and extend previous mainly cross-sectional evidence and further support links between dietary habits, metabolic diseases, and type 2 diabetes that are modulated by the gut microbiome,” the authors wrote.

The findings are from a prospective study of data on fecal samples from 5,572 people in Finland in 2002 in the FINRISK 2002 population cohort. In 2017, the samples were sent for sequencing as follow-up.

Of note, the study excluded people with prevalent diabetes at baseline, including those being treated with antidiabetic drugs such as metformin.
 

Four species, two clusters associated with type 2 diabetes development

Over a median follow-up of 15.8 years, 432 (7.8%) participants went on to have a diagnosis of type 2 diabetes, and the presence of four species and two clusters at baseline were significantly associated with the development of type 2 diabetes.

The four species include Clostridium citroniae (hazard ratio, 1.21; unadjusted P = .02), C. bolteae (HR, 1.20; unadjusted P = .01), Tyzzerella nexilis (HR, 1.17; unadjusted P = .03), and Ruminococcus gnavus (HR, 1.17; P = .04).

And the two positively associated clusters mostly consisted of the same species (both HR, 1.18).

Importantly, the associations were nearly the same among participants in eastern and western Finland, which are known for having unique genetic as well as lifestyle differences that impact morbidity and mortality.

“Three of these taxa could be clustered together by proportional abundance in both geographic areas, and combined abundance of the four taxa was also predictive of incident type 2 diabetes,” the authors wrote.

They noted that the identified species have been previously associated with type 2 diabetes and appear to be linked in some ways to the quality of diet and with other metabolic diseases, such as fatty liver disease.

C. citroniae, for instance, has been associated with trimethylamine N-oxide (TMAO), a compound likely linked to the intake of red meat, and the authors noted that a direct association between red meat intake and type 2 diabetes risk has been known for more than 15 years.

TMAO has also been associated with adipose tissue inflammation and impeded hepatic insulin signaling, which are all involved in increased insulin resistance, high blood glucose levels, and type 2 diabetes, the authors explained.

R. gnavus has been previously associated with obesity in humans and animals. And the bacterial species is also “potentially related to glucose metabolism regulation and linked to increases in inflammatory cytokines, both of which are related to type 2 diabetes pathophysiology,” the authors reported.
 

Stepping stone toward improved prediction

Coauthor Teemu J. Niiranen, MD, PhD, of the division of medicine, Turku (Finland) University Hospital, noted that, while prior studies have linked type 2 diabetes with distinctive characteristics of gut microbiome composition, most studies have not included prospective data, and long-term studies have been lacking.

Furthermore, many of the studies could have been confounded by the use of antidiabetic drugs that could influence gut microbiome composition, including metformin, which was excluded in the current study.

“We avoid several of the biases related to cross-sectional studies, such as the confounding effects of diabetes medications,” Dr. Niiranen said in an interview.

“We also know the temporal sequence of the exposure and the outcome, and that the changes in the gut microbiome preceded the development of diabetes,” he said. “All in all, a cohort study like this provides a much greater level of evidence than cross-sectional studies.”

Dr. Niiranen noted, however, that “although we demonstrate that certain gut microbiome changes are associated with greater risk of future diabetes, we are still quite far from clinical use.”

In addition to needing to replicate the results in other ethnic groups and locations, “we would need to find optimal clinical cutoffs for clinical decision-making and demonstrate the amount increase in predictive ability, compared with conventional diabetes risk factors,” he said.

The study nevertheless “serves as a stepping stone toward the goal of improved prediction and the development of effective treatments for type 2 diabetes through modification of the gut microbiome,” the authors wrote.

Other research has shed light on gut bacteria that appear to be linked to the prevention rather than the development of diabetes, identifying species that help produce butyrate, a short-chain fatty acid that may in fact provide protection against type 2 diabetes.

And additional research does suggest potential clinical implications. Efforts to improve insulin sensitivity via the gut through fecal microbial transplantation are also making headway, with an oral capsule formulation showing benefit among patients with severe obesity.

The research was funded in part by grants from the Finnish Cultural Foundation, the Finnish Foundation for Cardiovascular Research, the Emil Aaltonen Foundation, the Finnish Medical Foundation, the Sigrid Jusélius Foundation, and the Academy of Finland.

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

Six key bacterial species of the gut microbiome have been identified as predictors of the development of type 2 diabetes, according to results from a 15-year follow-up study of more than 5,000 people in Finland.

“We are not aware of previous long-term prospective studies of the associations between type 2 diabetes and the gut microbiome similar to the current study,” stated the authors of the study, published online Jan. 31, 2022, in Diabetes Care.

Though requiring further validation, the results “build on and extend previous mainly cross-sectional evidence and further support links between dietary habits, metabolic diseases, and type 2 diabetes that are modulated by the gut microbiome,” the authors wrote.

The findings are from a prospective study of data on fecal samples from 5,572 people in Finland in 2002 in the FINRISK 2002 population cohort. In 2017, the samples were sent for sequencing as follow-up.

Of note, the study excluded people with prevalent diabetes at baseline, including those being treated with antidiabetic drugs such as metformin.
 

Four species, two clusters associated with type 2 diabetes development

Over a median follow-up of 15.8 years, 432 (7.8%) participants went on to have a diagnosis of type 2 diabetes, and the presence of four species and two clusters at baseline were significantly associated with the development of type 2 diabetes.

The four species include Clostridium citroniae (hazard ratio, 1.21; unadjusted P = .02), C. bolteae (HR, 1.20; unadjusted P = .01), Tyzzerella nexilis (HR, 1.17; unadjusted P = .03), and Ruminococcus gnavus (HR, 1.17; P = .04).

And the two positively associated clusters mostly consisted of the same species (both HR, 1.18).

Importantly, the associations were nearly the same among participants in eastern and western Finland, which are known for having unique genetic as well as lifestyle differences that impact morbidity and mortality.

“Three of these taxa could be clustered together by proportional abundance in both geographic areas, and combined abundance of the four taxa was also predictive of incident type 2 diabetes,” the authors wrote.

They noted that the identified species have been previously associated with type 2 diabetes and appear to be linked in some ways to the quality of diet and with other metabolic diseases, such as fatty liver disease.

C. citroniae, for instance, has been associated with trimethylamine N-oxide (TMAO), a compound likely linked to the intake of red meat, and the authors noted that a direct association between red meat intake and type 2 diabetes risk has been known for more than 15 years.

TMAO has also been associated with adipose tissue inflammation and impeded hepatic insulin signaling, which are all involved in increased insulin resistance, high blood glucose levels, and type 2 diabetes, the authors explained.

R. gnavus has been previously associated with obesity in humans and animals. And the bacterial species is also “potentially related to glucose metabolism regulation and linked to increases in inflammatory cytokines, both of which are related to type 2 diabetes pathophysiology,” the authors reported.
 

Stepping stone toward improved prediction

Coauthor Teemu J. Niiranen, MD, PhD, of the division of medicine, Turku (Finland) University Hospital, noted that, while prior studies have linked type 2 diabetes with distinctive characteristics of gut microbiome composition, most studies have not included prospective data, and long-term studies have been lacking.

Furthermore, many of the studies could have been confounded by the use of antidiabetic drugs that could influence gut microbiome composition, including metformin, which was excluded in the current study.

“We avoid several of the biases related to cross-sectional studies, such as the confounding effects of diabetes medications,” Dr. Niiranen said in an interview.

“We also know the temporal sequence of the exposure and the outcome, and that the changes in the gut microbiome preceded the development of diabetes,” he said. “All in all, a cohort study like this provides a much greater level of evidence than cross-sectional studies.”

Dr. Niiranen noted, however, that “although we demonstrate that certain gut microbiome changes are associated with greater risk of future diabetes, we are still quite far from clinical use.”

In addition to needing to replicate the results in other ethnic groups and locations, “we would need to find optimal clinical cutoffs for clinical decision-making and demonstrate the amount increase in predictive ability, compared with conventional diabetes risk factors,” he said.

The study nevertheless “serves as a stepping stone toward the goal of improved prediction and the development of effective treatments for type 2 diabetes through modification of the gut microbiome,” the authors wrote.

Other research has shed light on gut bacteria that appear to be linked to the prevention rather than the development of diabetes, identifying species that help produce butyrate, a short-chain fatty acid that may in fact provide protection against type 2 diabetes.

And additional research does suggest potential clinical implications. Efforts to improve insulin sensitivity via the gut through fecal microbial transplantation are also making headway, with an oral capsule formulation showing benefit among patients with severe obesity.

The research was funded in part by grants from the Finnish Cultural Foundation, the Finnish Foundation for Cardiovascular Research, the Emil Aaltonen Foundation, the Finnish Medical Foundation, the Sigrid Jusélius Foundation, and the Academy of Finland.

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

The currently available two-dose COVID-19 vaccines were not effective in preventing symptomatic disease caused by the Omicron variant, as determined on the basis of data from more than 800,000 Omicron-infected individuals.

Early laboratory data suggested a substantially lower neutralizing antibody response to the Omicron variant, compared with both the original COVID-19 strain and the Delta variant, write Nick Andrews, PhD, of the United Kingdom Health Security Agency, London, and colleagues.

Vaccines have shown high levels of effectiveness against symptomatic disease and severe disease and death resulting from the original COVID-19 virus and the Alpha variant and modest effectiveness against the Beta and Delta variants, they say.

“Neutralizing antibodies correlate with protection against reinfection and vaccine effectiveness against infection; therefore, reduced vaccine effectiveness against the omicron variant is anticipated on the basis of these early laboratory findings,” they explain.

In a study published in the New England Journal of Medicine, the researchers identified 886,774 adults aged 18 years and older who had been infected with the Omicron variant, 204,154 who had been infected with the Delta variant, and 1,572,621 symptomatic control patients who tested negative for COVID-19 between Nov. 27, 2021, and Jan. 12, 2022. The participants had been vaccinated with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine, plus a booster given at least 175 days after a second dose, after Sept. 13, 2021.

Vaccine effectiveness was calculated after primary immunization at weeks 2-4, 5-9, 10-14, 15-19, 20-24, and 25 or longer after the second dose, and at 2-4, 5-9, and 10 or more weeks after boosters.

Omicron infections that occurred starting 14 or more days after a booster occurred a median of 39 days after the booster.

“Vaccine effectiveness was lower for the Omicron variant than for the Delta variant at all intervals after vaccination and for all combinations of primary courses and booster doses investigated,” the researchers write.

Individuals who received two doses of ChAdOx1 nCoV-19 had almost no protection against symptomatic disease caused by Omicron from 20-24 weeks after the second dose. For individuals who received two doses of BNT162b2, effectiveness was 65.5% 2-4 weeks after the second dose, but effectiveness declined to 15.4% after 15-19 weeks and to 8.8% after 25 or more weeks. For individuals who received two doses of mRNA-1273, vaccine effectiveness was 75.1% after 2-4 weeks, but effectiveness declined to 14.9% after 25 or more weeks.

Boosters created a short-term improvement in vaccine effectiveness against the Omicron variant, but this effect also declined over time.

Among individuals who received primary doses of ChAdOx1 nCoV-19, vaccine effectiveness increased to 62.4% 2-4 weeks after a BNT162b2 booster, then declined to 39.6% after 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 70.1% at 2-4 weeks and decreased to 60.9% at 5-9 weeks.

Among individuals who received primary doses of BNT162b2, vaccine effectiveness increased to 67.2% 2-4 weeks after a BNT162b2 booster, then declined to 45.7% at 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 73.9% at 2-4 weeks, then declined to 64.4% at 5-9 weeks.

Among individuals who received primary doses of mRNA-1273, vaccine effectiveness increased to 64.9% 2-4 weeks after a BNT162b2 booster and 66.3% 2-4 weeks after an mRNA-1273 booster.

The study findings were limited by potential confounding from study participants who had traveled and may have had different levels of vaccine coverage and by the inability to break down estimates on the basis of age and clinical risk that might affect vaccine effectiveness, the researchers note. Other limitations include a lack of data on vaccine effectiveness for a longer period after boosters, they say.

However, the results are consistent with neutralization data for the Omicron variant in studies from the United Kingdom, South Africa, and Germany, they write. “Our findings support maximizing coverage with third doses of vaccine in highly vaccinated populations such as in the United Kingdom. Further follow-up will be needed to assess protection against severe disease and the duration of protection after booster vaccination,” they conclude.
 

Focus on severe disease prevention

Paul Offit, MD, of the University of Pennsylvania, Philadelphia, addressed the topic of vaccine effectiveness in an op-ed published on March 4 in The Philadelphia Inquirer. The following is adapted from the op-ed, with his permission.

“The goal of the COVID vaccine – as is true for all vaccines – is to prevent serious illness,” Dr. Offit wrote.

“For most people with normal immune systems, two doses of mRNA vaccines appear to do exactly that. But not everyone,” wrote Dr. Offit, who serves as director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and also serves on the Food and Drug Administration’s Vaccine Advisory Committee. “Three doses are required to induce high levels of protection against serious illness for people over 65 years of age or for people with other conditions that make them vulnerable, which can be anything from being overweight to having cancer. For people who are immune compromised, four doses might be required,” he noted.

Frequent vaccine boosting, although it may help prevent milder cases of COVID-19, such as those seen with the Omicron variant, is impractical, Dr. Offit emphasized. Instead, a newer, variant-specific vaccine might be needed if a variant emerges that overrides the protection against severe disease currently afforded by the available vaccines, he said. “But we’re not there yet. For now, we are going to have to realize that it is virtually impossible to prevent mild COVID without frequent boosting. So, let’s learn to accept that the goal of COVID vaccines is to prevent severe and not mild illness and stop talking about frequent boosting. Otherwise, we will never be able to live our lives as before,” he wrote.

The study was supported by the U.K. Health Security Agency. The researchers and Dr. Offit have disclosed no relevant financial relationships.

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

The currently available two-dose COVID-19 vaccines were not effective in preventing symptomatic disease caused by the Omicron variant, as determined on the basis of data from more than 800,000 Omicron-infected individuals.

Early laboratory data suggested a substantially lower neutralizing antibody response to the Omicron variant, compared with both the original COVID-19 strain and the Delta variant, write Nick Andrews, PhD, of the United Kingdom Health Security Agency, London, and colleagues.

Vaccines have shown high levels of effectiveness against symptomatic disease and severe disease and death resulting from the original COVID-19 virus and the Alpha variant and modest effectiveness against the Beta and Delta variants, they say.

“Neutralizing antibodies correlate with protection against reinfection and vaccine effectiveness against infection; therefore, reduced vaccine effectiveness against the omicron variant is anticipated on the basis of these early laboratory findings,” they explain.

In a study published in the New England Journal of Medicine, the researchers identified 886,774 adults aged 18 years and older who had been infected with the Omicron variant, 204,154 who had been infected with the Delta variant, and 1,572,621 symptomatic control patients who tested negative for COVID-19 between Nov. 27, 2021, and Jan. 12, 2022. The participants had been vaccinated with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine, plus a booster given at least 175 days after a second dose, after Sept. 13, 2021.

Vaccine effectiveness was calculated after primary immunization at weeks 2-4, 5-9, 10-14, 15-19, 20-24, and 25 or longer after the second dose, and at 2-4, 5-9, and 10 or more weeks after boosters.

Omicron infections that occurred starting 14 or more days after a booster occurred a median of 39 days after the booster.

“Vaccine effectiveness was lower for the Omicron variant than for the Delta variant at all intervals after vaccination and for all combinations of primary courses and booster doses investigated,” the researchers write.

Individuals who received two doses of ChAdOx1 nCoV-19 had almost no protection against symptomatic disease caused by Omicron from 20-24 weeks after the second dose. For individuals who received two doses of BNT162b2, effectiveness was 65.5% 2-4 weeks after the second dose, but effectiveness declined to 15.4% after 15-19 weeks and to 8.8% after 25 or more weeks. For individuals who received two doses of mRNA-1273, vaccine effectiveness was 75.1% after 2-4 weeks, but effectiveness declined to 14.9% after 25 or more weeks.

Boosters created a short-term improvement in vaccine effectiveness against the Omicron variant, but this effect also declined over time.

Among individuals who received primary doses of ChAdOx1 nCoV-19, vaccine effectiveness increased to 62.4% 2-4 weeks after a BNT162b2 booster, then declined to 39.6% after 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 70.1% at 2-4 weeks and decreased to 60.9% at 5-9 weeks.

Among individuals who received primary doses of BNT162b2, vaccine effectiveness increased to 67.2% 2-4 weeks after a BNT162b2 booster, then declined to 45.7% at 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 73.9% at 2-4 weeks, then declined to 64.4% at 5-9 weeks.

Among individuals who received primary doses of mRNA-1273, vaccine effectiveness increased to 64.9% 2-4 weeks after a BNT162b2 booster and 66.3% 2-4 weeks after an mRNA-1273 booster.

The study findings were limited by potential confounding from study participants who had traveled and may have had different levels of vaccine coverage and by the inability to break down estimates on the basis of age and clinical risk that might affect vaccine effectiveness, the researchers note. Other limitations include a lack of data on vaccine effectiveness for a longer period after boosters, they say.

However, the results are consistent with neutralization data for the Omicron variant in studies from the United Kingdom, South Africa, and Germany, they write. “Our findings support maximizing coverage with third doses of vaccine in highly vaccinated populations such as in the United Kingdom. Further follow-up will be needed to assess protection against severe disease and the duration of protection after booster vaccination,” they conclude.
 

Focus on severe disease prevention

Paul Offit, MD, of the University of Pennsylvania, Philadelphia, addressed the topic of vaccine effectiveness in an op-ed published on March 4 in The Philadelphia Inquirer. The following is adapted from the op-ed, with his permission.

“The goal of the COVID vaccine – as is true for all vaccines – is to prevent serious illness,” Dr. Offit wrote.

“For most people with normal immune systems, two doses of mRNA vaccines appear to do exactly that. But not everyone,” wrote Dr. Offit, who serves as director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and also serves on the Food and Drug Administration’s Vaccine Advisory Committee. “Three doses are required to induce high levels of protection against serious illness for people over 65 years of age or for people with other conditions that make them vulnerable, which can be anything from being overweight to having cancer. For people who are immune compromised, four doses might be required,” he noted.

Frequent vaccine boosting, although it may help prevent milder cases of COVID-19, such as those seen with the Omicron variant, is impractical, Dr. Offit emphasized. Instead, a newer, variant-specific vaccine might be needed if a variant emerges that overrides the protection against severe disease currently afforded by the available vaccines, he said. “But we’re not there yet. For now, we are going to have to realize that it is virtually impossible to prevent mild COVID without frequent boosting. So, let’s learn to accept that the goal of COVID vaccines is to prevent severe and not mild illness and stop talking about frequent boosting. Otherwise, we will never be able to live our lives as before,” he wrote.

The study was supported by the U.K. Health Security Agency. The researchers and Dr. Offit have disclosed no relevant financial relationships.

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

The currently available two-dose COVID-19 vaccines were not effective in preventing symptomatic disease caused by the Omicron variant, as determined on the basis of data from more than 800,000 Omicron-infected individuals.

Early laboratory data suggested a substantially lower neutralizing antibody response to the Omicron variant, compared with both the original COVID-19 strain and the Delta variant, write Nick Andrews, PhD, of the United Kingdom Health Security Agency, London, and colleagues.

Vaccines have shown high levels of effectiveness against symptomatic disease and severe disease and death resulting from the original COVID-19 virus and the Alpha variant and modest effectiveness against the Beta and Delta variants, they say.

“Neutralizing antibodies correlate with protection against reinfection and vaccine effectiveness against infection; therefore, reduced vaccine effectiveness against the omicron variant is anticipated on the basis of these early laboratory findings,” they explain.

In a study published in the New England Journal of Medicine, the researchers identified 886,774 adults aged 18 years and older who had been infected with the Omicron variant, 204,154 who had been infected with the Delta variant, and 1,572,621 symptomatic control patients who tested negative for COVID-19 between Nov. 27, 2021, and Jan. 12, 2022. The participants had been vaccinated with two doses of BNT162b2 (Pfizer–BioNTech), ChAdOx1 nCoV-19 (AstraZeneca), or mRNA-1273 (Moderna) vaccine, plus a booster given at least 175 days after a second dose, after Sept. 13, 2021.

Vaccine effectiveness was calculated after primary immunization at weeks 2-4, 5-9, 10-14, 15-19, 20-24, and 25 or longer after the second dose, and at 2-4, 5-9, and 10 or more weeks after boosters.

Omicron infections that occurred starting 14 or more days after a booster occurred a median of 39 days after the booster.

“Vaccine effectiveness was lower for the Omicron variant than for the Delta variant at all intervals after vaccination and for all combinations of primary courses and booster doses investigated,” the researchers write.

Individuals who received two doses of ChAdOx1 nCoV-19 had almost no protection against symptomatic disease caused by Omicron from 20-24 weeks after the second dose. For individuals who received two doses of BNT162b2, effectiveness was 65.5% 2-4 weeks after the second dose, but effectiveness declined to 15.4% after 15-19 weeks and to 8.8% after 25 or more weeks. For individuals who received two doses of mRNA-1273, vaccine effectiveness was 75.1% after 2-4 weeks, but effectiveness declined to 14.9% after 25 or more weeks.

Boosters created a short-term improvement in vaccine effectiveness against the Omicron variant, but this effect also declined over time.

Among individuals who received primary doses of ChAdOx1 nCoV-19, vaccine effectiveness increased to 62.4% 2-4 weeks after a BNT162b2 booster, then declined to 39.6% after 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 70.1% at 2-4 weeks and decreased to 60.9% at 5-9 weeks.

Among individuals who received primary doses of BNT162b2, vaccine effectiveness increased to 67.2% 2-4 weeks after a BNT162b2 booster, then declined to 45.7% at 10 or more weeks. After an mRNA-1273 booster, vaccine effectiveness increased to 73.9% at 2-4 weeks, then declined to 64.4% at 5-9 weeks.

Among individuals who received primary doses of mRNA-1273, vaccine effectiveness increased to 64.9% 2-4 weeks after a BNT162b2 booster and 66.3% 2-4 weeks after an mRNA-1273 booster.

The study findings were limited by potential confounding from study participants who had traveled and may have had different levels of vaccine coverage and by the inability to break down estimates on the basis of age and clinical risk that might affect vaccine effectiveness, the researchers note. Other limitations include a lack of data on vaccine effectiveness for a longer period after boosters, they say.

However, the results are consistent with neutralization data for the Omicron variant in studies from the United Kingdom, South Africa, and Germany, they write. “Our findings support maximizing coverage with third doses of vaccine in highly vaccinated populations such as in the United Kingdom. Further follow-up will be needed to assess protection against severe disease and the duration of protection after booster vaccination,” they conclude.
 

Focus on severe disease prevention

Paul Offit, MD, of the University of Pennsylvania, Philadelphia, addressed the topic of vaccine effectiveness in an op-ed published on March 4 in The Philadelphia Inquirer. The following is adapted from the op-ed, with his permission.

“The goal of the COVID vaccine – as is true for all vaccines – is to prevent serious illness,” Dr. Offit wrote.

“For most people with normal immune systems, two doses of mRNA vaccines appear to do exactly that. But not everyone,” wrote Dr. Offit, who serves as director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and also serves on the Food and Drug Administration’s Vaccine Advisory Committee. “Three doses are required to induce high levels of protection against serious illness for people over 65 years of age or for people with other conditions that make them vulnerable, which can be anything from being overweight to having cancer. For people who are immune compromised, four doses might be required,” he noted.

Frequent vaccine boosting, although it may help prevent milder cases of COVID-19, such as those seen with the Omicron variant, is impractical, Dr. Offit emphasized. Instead, a newer, variant-specific vaccine might be needed if a variant emerges that overrides the protection against severe disease currently afforded by the available vaccines, he said. “But we’re not there yet. For now, we are going to have to realize that it is virtually impossible to prevent mild COVID without frequent boosting. So, let’s learn to accept that the goal of COVID vaccines is to prevent severe and not mild illness and stop talking about frequent boosting. Otherwise, we will never be able to live our lives as before,” he wrote.

The study was supported by the U.K. Health Security Agency. The researchers and Dr. Offit have disclosed no relevant financial relationships.

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

Evidence summary

Time to delivery is shortened with combined therapy

Two recent high-quality meta-analyses investigated the effect of adding oxytocin to transcervical Foley balloon placement for cervical dilation. A network meta-analysis, including 30 RCTs (with 6465 pregnant patients), examined the efficacy of multiple combinations of cervical ripening methods.¹ A subset of 7 trials (n = 1313) compared oxytocin infusion with transcervical Foley (inflated to 30-60 mL) to Foley alone. Patients were at > 24 weeks’ gestation with a live fetus and undergoing elective or medical induction of labor; exclusion criteria were standard contraindications to vaginal delivery.

Compared to Foley alone, Foley plus oxytocin reduced both the time to the primary outcome of vaginal delivery (mean duration [MD] = –4.2 h; 95% CI, –1.9 to –6.5) and the time to overall (vaginal and cesarean) delivery (MD = –3.1 h; 95% CI, –1.5 to –4.6). There were no differences in rates of cesarean section, chorioamnionitis, epidural use, or neonatal intensive care unit admission. This analysis did not stratify by parity.¹

In a standard meta-analysis, researchers identified 6 RCTs (N = 1133) comparing transcervical Foley balloon and oxytocin to Foley balloon alone for cervical ripening in pregnant patients at > 23 weeks’ gestation (1 trial was limited to patients at > 37 weeks’ gestation).² Foley balloons were inflated with 30 to 60 mL saline, and oxytocin infusions started at 1 to 2 mU/min and were titrated up to 10 to 40 mU/min. Balloon time was usually 12 hours, but not always stated.

The authors found no statistically significant difference in cesarean rates (the primary outcome) between Foley plus oxytocin vs Foley alone (relative risk [RR] = 0.91; 95% CI, 0.76-1.1). Overall delivery within 12 hours was more likely with combined therapy (RR of remaining pregnant = 0.46; 95% CI, 0.34-0.63), but delivery at 24 hours was not (RR = 0.94; 95% CI, 0.92-1.05). However, in a sub-analysis by parity, nulliparous women who received combined therapy had higher overall delivery rates in 24 hours than did multiparous women (RR = 0.77; 95% CI, 0.62-0.97).²

Adding oxytocin may allow shorter transcervical balloon times

One recent RCT (N = 177) compared labor induction with oxytocin and a single trans-cervical balloon (Cook catheter with only the intrauterine balloon inflated) removed at either 6 or 12 hours.³ Patients were pregnant women (mean age, 31 years) with a term singleton vertex pregnancy, a Bishop score ≤ 6, and no contraindications to vaginal delivery. All patients received a balloon inflated to 60 mL with an oxytocin infusion (2-30 mU/min). The intervention group had the balloon removed at 6 hours, while the control group had it removed at 12 hours.

The mean Bishop score changed by 6 points in each group. Time to overall delivery (the primary outcome) was significantly shorter with 6 hours of balloon time than with 12 hours (19.2 vs 24.3 h; P < .04). Overall delivery within 24 hours was also significantly more likely in the 6-hour group (67.4% vs 47.4%; P < .01), although vaginal delivery in 24 hours did not change (74% vs 59%; P = .07). No differences were seen in cesarean delivery rates or maternal or neonatal morbidity rates.

A look at fixed-dose vs titrated oxytocin

Another RCT (N = 116) examined the effectiveness of cervical ripening using a Foley balloon plus either fixed-dose or titrated low-dose oxytocin.⁴ Patients (mean age, 26 years) had singleton pregnancies at ≥ 37 weeks’ gestation with a Bishop score < 6 and presented for induction of labor. Foley balloons were inflated to 30 mL, and patients received either a fixed oxytocin infusion of 2 mU/min or a titrated infusion starting at 1 mU/min, increasing by 2 mU/min every 30 minutes to a maximum of 20 mU/min.

Continue to: Thre was no statistically...

High-quality evidence shows that the addition of oxytocin to balloon cervical ripening shortens the time to delivery.

There was no statistically significant difference in median time from Foley placement to overall delivery (the primary outcome) between the fixed low-dose and incremental low-dose groups in either nulliparous women (24 vs 19 h; P = .18) or multiparous women (16 vs 12 h; P = .68). The authors acknowledged the study may have been underpowered to detect a true difference.

Recommendations from others

A 2009 Practice Bulletin from the American College of Obstetricians and Gynecologists (ACOG) recommended the Foley catheter as a reasonable and effective alternative to prostaglandins for cervical ripening and the induction of labor (based on good-quality evidence).⁵ The guideline stated that Foley catheter placement before oxytocin induction reduced both the duration of labor and risk of cesarean delivery, but that the use of oxytocin along with a Foley catheter did not appear to shorten the time to delivery.

Editor’s takeaway

High-quality evidence shows us that the addition of oxytocin to balloon cervical ripening shortens the time to delivery. This newer evidence may prompt an update to the 2009 ACOG statement.

Evidence summary

Time to delivery is shortened with combined therapy

Two recent high-quality meta-analyses investigated the effect of adding oxytocin to transcervical Foley balloon placement for cervical dilation. A network meta-analysis, including 30 RCTs (with 6465 pregnant patients), examined the efficacy of multiple combinations of cervical ripening methods.¹ A subset of 7 trials (n = 1313) compared oxytocin infusion with transcervical Foley (inflated to 30-60 mL) to Foley alone. Patients were at > 24 weeks’ gestation with a live fetus and undergoing elective or medical induction of labor; exclusion criteria were standard contraindications to vaginal delivery.

Compared to Foley alone, Foley plus oxytocin reduced both the time to the primary outcome of vaginal delivery (mean duration [MD] = –4.2 h; 95% CI, –1.9 to –6.5) and the time to overall (vaginal and cesarean) delivery (MD = –3.1 h; 95% CI, –1.5 to –4.6). There were no differences in rates of cesarean section, chorioamnionitis, epidural use, or neonatal intensive care unit admission. This analysis did not stratify by parity.¹

In a standard meta-analysis, researchers identified 6 RCTs (N = 1133) comparing transcervical Foley balloon and oxytocin to Foley balloon alone for cervical ripening in pregnant patients at > 23 weeks’ gestation (1 trial was limited to patients at > 37 weeks’ gestation).² Foley balloons were inflated with 30 to 60 mL saline, and oxytocin infusions started at 1 to 2 mU/min and were titrated up to 10 to 40 mU/min. Balloon time was usually 12 hours, but not always stated.

The authors found no statistically significant difference in cesarean rates (the primary outcome) between Foley plus oxytocin vs Foley alone (relative risk [RR] = 0.91; 95% CI, 0.76-1.1). Overall delivery within 12 hours was more likely with combined therapy (RR of remaining pregnant = 0.46; 95% CI, 0.34-0.63), but delivery at 24 hours was not (RR = 0.94; 95% CI, 0.92-1.05). However, in a sub-analysis by parity, nulliparous women who received combined therapy had higher overall delivery rates in 24 hours than did multiparous women (RR = 0.77; 95% CI, 0.62-0.97).²

Adding oxytocin may allow shorter transcervical balloon times

One recent RCT (N = 177) compared labor induction with oxytocin and a single trans-cervical balloon (Cook catheter with only the intrauterine balloon inflated) removed at either 6 or 12 hours.³ Patients were pregnant women (mean age, 31 years) with a term singleton vertex pregnancy, a Bishop score ≤ 6, and no contraindications to vaginal delivery. All patients received a balloon inflated to 60 mL with an oxytocin infusion (2-30 mU/min). The intervention group had the balloon removed at 6 hours, while the control group had it removed at 12 hours.

The mean Bishop score changed by 6 points in each group. Time to overall delivery (the primary outcome) was significantly shorter with 6 hours of balloon time than with 12 hours (19.2 vs 24.3 h; P < .04). Overall delivery within 24 hours was also significantly more likely in the 6-hour group (67.4% vs 47.4%; P < .01), although vaginal delivery in 24 hours did not change (74% vs 59%; P = .07). No differences were seen in cesarean delivery rates or maternal or neonatal morbidity rates.

A look at fixed-dose vs titrated oxytocin

Another RCT (N = 116) examined the effectiveness of cervical ripening using a Foley balloon plus either fixed-dose or titrated low-dose oxytocin.⁴ Patients (mean age, 26 years) had singleton pregnancies at ≥ 37 weeks’ gestation with a Bishop score < 6 and presented for induction of labor. Foley balloons were inflated to 30 mL, and patients received either a fixed oxytocin infusion of 2 mU/min or a titrated infusion starting at 1 mU/min, increasing by 2 mU/min every 30 minutes to a maximum of 20 mU/min.

Continue to: Thre was no statistically...

High-quality evidence shows that the addition of oxytocin to balloon cervical ripening shortens the time to delivery.

There was no statistically significant difference in median time from Foley placement to overall delivery (the primary outcome) between the fixed low-dose and incremental low-dose groups in either nulliparous women (24 vs 19 h; P = .18) or multiparous women (16 vs 12 h; P = .68). The authors acknowledged the study may have been underpowered to detect a true difference.

Recommendations from others

A 2009 Practice Bulletin from the American College of Obstetricians and Gynecologists (ACOG) recommended the Foley catheter as a reasonable and effective alternative to prostaglandins for cervical ripening and the induction of labor (based on good-quality evidence).⁵ The guideline stated that Foley catheter placement before oxytocin induction reduced both the duration of labor and risk of cesarean delivery, but that the use of oxytocin along with a Foley catheter did not appear to shorten the time to delivery.

Editor’s takeaway

High-quality evidence shows us that the addition of oxytocin to balloon cervical ripening shortens the time to delivery. This newer evidence may prompt an update to the 2009 ACOG statement.

Evidence summary

Time to delivery is shortened with combined therapy

Two recent high-quality meta-analyses investigated the effect of adding oxytocin to transcervical Foley balloon placement for cervical dilation. A network meta-analysis, including 30 RCTs (with 6465 pregnant patients), examined the efficacy of multiple combinations of cervical ripening methods.¹ A subset of 7 trials (n = 1313) compared oxytocin infusion with transcervical Foley (inflated to 30-60 mL) to Foley alone. Patients were at > 24 weeks’ gestation with a live fetus and undergoing elective or medical induction of labor; exclusion criteria were standard contraindications to vaginal delivery.

Compared to Foley alone, Foley plus oxytocin reduced both the time to the primary outcome of vaginal delivery (mean duration [MD] = –4.2 h; 95% CI, –1.9 to –6.5) and the time to overall (vaginal and cesarean) delivery (MD = –3.1 h; 95% CI, –1.5 to –4.6). There were no differences in rates of cesarean section, chorioamnionitis, epidural use, or neonatal intensive care unit admission. This analysis did not stratify by parity.¹

In a standard meta-analysis, researchers identified 6 RCTs (N = 1133) comparing transcervical Foley balloon and oxytocin to Foley balloon alone for cervical ripening in pregnant patients at > 23 weeks’ gestation (1 trial was limited to patients at > 37 weeks’ gestation).² Foley balloons were inflated with 30 to 60 mL saline, and oxytocin infusions started at 1 to 2 mU/min and were titrated up to 10 to 40 mU/min. Balloon time was usually 12 hours, but not always stated.

The authors found no statistically significant difference in cesarean rates (the primary outcome) between Foley plus oxytocin vs Foley alone (relative risk [RR] = 0.91; 95% CI, 0.76-1.1). Overall delivery within 12 hours was more likely with combined therapy (RR of remaining pregnant = 0.46; 95% CI, 0.34-0.63), but delivery at 24 hours was not (RR = 0.94; 95% CI, 0.92-1.05). However, in a sub-analysis by parity, nulliparous women who received combined therapy had higher overall delivery rates in 24 hours than did multiparous women (RR = 0.77; 95% CI, 0.62-0.97).²

Adding oxytocin may allow shorter transcervical balloon times

One recent RCT (N = 177) compared labor induction with oxytocin and a single trans-cervical balloon (Cook catheter with only the intrauterine balloon inflated) removed at either 6 or 12 hours.³ Patients were pregnant women (mean age, 31 years) with a term singleton vertex pregnancy, a Bishop score ≤ 6, and no contraindications to vaginal delivery. All patients received a balloon inflated to 60 mL with an oxytocin infusion (2-30 mU/min). The intervention group had the balloon removed at 6 hours, while the control group had it removed at 12 hours.

The mean Bishop score changed by 6 points in each group. Time to overall delivery (the primary outcome) was significantly shorter with 6 hours of balloon time than with 12 hours (19.2 vs 24.3 h; P < .04). Overall delivery within 24 hours was also significantly more likely in the 6-hour group (67.4% vs 47.4%; P < .01), although vaginal delivery in 24 hours did not change (74% vs 59%; P = .07). No differences were seen in cesarean delivery rates or maternal or neonatal morbidity rates.

A look at fixed-dose vs titrated oxytocin

Another RCT (N = 116) examined the effectiveness of cervical ripening using a Foley balloon plus either fixed-dose or titrated low-dose oxytocin.⁴ Patients (mean age, 26 years) had singleton pregnancies at ≥ 37 weeks’ gestation with a Bishop score < 6 and presented for induction of labor. Foley balloons were inflated to 30 mL, and patients received either a fixed oxytocin infusion of 2 mU/min or a titrated infusion starting at 1 mU/min, increasing by 2 mU/min every 30 minutes to a maximum of 20 mU/min.

Continue to: Thre was no statistically...

High-quality evidence shows that the addition of oxytocin to balloon cervical ripening shortens the time to delivery.

There was no statistically significant difference in median time from Foley placement to overall delivery (the primary outcome) between the fixed low-dose and incremental low-dose groups in either nulliparous women (24 vs 19 h; P = .18) or multiparous women (16 vs 12 h; P = .68). The authors acknowledged the study may have been underpowered to detect a true difference.

Recommendations from others

A 2009 Practice Bulletin from the American College of Obstetricians and Gynecologists (ACOG) recommended the Foley catheter as a reasonable and effective alternative to prostaglandins for cervical ripening and the induction of labor (based on good-quality evidence).⁵ The guideline stated that Foley catheter placement before oxytocin induction reduced both the duration of labor and risk of cesarean delivery, but that the use of oxytocin along with a Foley catheter did not appear to shorten the time to delivery.

Editor’s takeaway

High-quality evidence shows us that the addition of oxytocin to balloon cervical ripening shortens the time to delivery. This newer evidence may prompt an update to the 2009 ACOG statement.