Raising phototherapy thresholds and revising risk assessment are among the key changes in the American Academy of Pediatrics’ updated guidelines for managing hyperbilirubinemia in infants 35 weeks’ gestation and older.

“More than 80% of newborn infants will have some degree of jaundice,” Alex R. Kemper, MD, of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors wrote. Careful monitoring is needed manage high bilirubin concentrations and avoid acute bilirubin encephalopathy (ABE) and kernicterus, a disabling neurologic condition.

The current revision, published in Pediatrics, updates and replaces the 2004 AAP clinical practice guidelines for the management and prevention of hyperbilirubinemia in newborns of at least 35 weeks’ gestation.

The guideline committee reviewed evidence published since the previous guidelines were issued in 2004, and addressed similar issues of prevention, risk assessment, monitoring, and treatment.

A notable change from 2004 was the inclusion of a 2009 recommendation update for “universal predischarge bilirubin screening with measures of total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) linked to specific recommendations for follow-up,” the authors wrote.

In terms of prevention, recommendations include a direct antiglobulin test (DAT) for infants whose mother’s antibody screen was positive or unknown. In addition, exclusive breastfeeding is known to be associated with hyperbilirubinemia, but clinicians should support breastfeeding while monitoring for signs of hyperbilirubinemia because of suboptimal feeding, the authors noted. However, the guidelines recommend against oral supplementation with water or dextrose water to prevent hyperbilirubinemia.

For assessment and monitoring, the guidelines advise the use of total serum bilirubin (TSB) as the definitive test for hyperbilirubinemia to guide phototherapy and escalation of care, including exchange transfusion. “The presence of hyperbilirubinemia neurotoxicity risk factors lowers the threshold for treatment with phototherapy and the level at which care should be escalated,” the authors wrote. They also emphasized the need to consider glucose-6-phosphate dehydrogenase deficiency, a genetic condition that decreases protection against oxidative stress and has been identified as a leading cause of hazardous hyperbilirubinemia worldwide.

The guidelines recommend assessing all infants for jaundice at least every 12 hours after delivery until discharge, with TSB or TcB measured as soon as possible for those with suspected jaundice. The complete guidelines include charts for TSB levels to guide escalation of care. “Blood for TSB can be obtained at the time it is collected for newborn screening tests to avoid an additional heel stick,” the authors noted.

The rate of increase in TSB or TcB, if more than one measure is available, may identify infants at higher risk of hyperbilirubinemia, according to the guidelines, and a possible delay of hospital discharge may be needed for infants if appropriate follow-up is not feasible.

In terms of treatment, new evidence that bilirubin neurotoxicity does not occur until concentrations well above those given in the 2004 guidelines justified raising the treatment thresholds, although by a narrow range. “With the increased phototherapy thresholds, appropriately following the current guidelines including bilirubin screening during the birth hospitalization and timely postdischarge follow-up is important,” the authors wrote. The new thresholds, outlined in the complete guidelines, are based on gestational age, hyperbilirubinemia neurotoxicity risk factors, and the age of the infant in hours. However, infants may be treated at lower levels, based on individual circumstances, family preferences, and shared decision-making with clinicians. Home-based phototherapy may be used in some infants, but should not be used if there is a question about the device quality, delivery time, and ability of caregivers to use the device correctly.

“Discontinuing phototherapy is an option when the TSB has decreased by at least 2 mg/dL below the hour-specific threshold at the initiation of phototherapy,” and follow-up should be based on risk of rebound hyperbilirubinemia, according to the guidelines.

“This clinical practice guideline provides indications and approaches for phototherapy and escalation of care and when treatment and monitoring can be safely discontinued,” However, clinicians should understand the rationale for the recommendations and combine them with their clinical judgment, including shared decision-making when appropriate, the authors concluded.
 

Updated evidence supports escalating care

The take-home message for pediatricians is that neonatal hyperbilirubinemia is a very common finding, and complications are rare, but the condition can result in devastating life-long results, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Previous guidelines published in 2004 and updated in 2009 included evidence-based recommendations, but additional research was still needed to provide guidance for providers to prevent complications of hyperbilirubinemia,” said Dr. Haut, who was not involved in producing the guidelines.

“New data documenting additional risk factors, the importance of ongoing breastfeeding support, and addressing hyperbilirubinemia as an urgent problem” are additions to prevention methods in the latest published guidelines, she said.

“Acute encephalopathy and kernicterus can result from hyperbilirubinemia with severe and devastating neurologic effects, but are preventable by early identification and treatment,” said Dr. Haut. Therefore, “it is not surprising that the AAP utilized continuing and more recent evidence to support new recommendations. Both maternal and neonatal risk factors have long been considered in the development of neonatal hyperbilirubinemia, but recent recommendations incorporate additional risk factor evaluation and urgency in time to appropriate care. Detailed thresholds for phototherapy and exchange transfusion will benefit the families of full-term infants without other risk factors and escalate care for those neonates with risk factors.”

However, potential barriers to following the guidelines persist, Dr. Haut noted.

“Frequent infant follow-up can be challenging for busy primary care offices with outpatient laboratory results often taking much longer to obtain than in a hospital setting,” she said.

Also, “taking a newborn to the emergency department or an inpatient laboratory can be frightening for families with the risk of illness exposure. Frequent monitoring of serum bilirubin levels is disturbing for parents and inconvenient immediately postpartum,” Dr. Haut explained. “Few practices utilize transcutaneous bilirubin monitoring which may be one method of added screening.”

In addition, “despite the importance of breastfeeding, ongoing support is not readily available for mothers after hospital discharge. A lactation specialist in the office setting can take the burden off providers and add opportunity for family education.”

As for additional research, “continued evaluation of the comparison of transcutaneous bilirubin monitoring and serum levels along with the use of transcutaneous monitoring in facilities outside the hospital setting may be warranted,” Dr. Haut said. “Data collection on incidence and accompanying risk factors of neonates who develop acute hyperbilirubinemia encephalopathy and kernicterus is a long-term study opportunity.”

The guidelines received no external funding. Lead author Dr. Kemper had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Raising phototherapy thresholds and revising risk assessment are among the key changes in the American Academy of Pediatrics’ updated guidelines for managing hyperbilirubinemia in infants 35 weeks’ gestation and older.

“More than 80% of newborn infants will have some degree of jaundice,” Alex R. Kemper, MD, of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors wrote. Careful monitoring is needed manage high bilirubin concentrations and avoid acute bilirubin encephalopathy (ABE) and kernicterus, a disabling neurologic condition.

The current revision, published in Pediatrics, updates and replaces the 2004 AAP clinical practice guidelines for the management and prevention of hyperbilirubinemia in newborns of at least 35 weeks’ gestation.

The guideline committee reviewed evidence published since the previous guidelines were issued in 2004, and addressed similar issues of prevention, risk assessment, monitoring, and treatment.

A notable change from 2004 was the inclusion of a 2009 recommendation update for “universal predischarge bilirubin screening with measures of total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) linked to specific recommendations for follow-up,” the authors wrote.

In terms of prevention, recommendations include a direct antiglobulin test (DAT) for infants whose mother’s antibody screen was positive or unknown. In addition, exclusive breastfeeding is known to be associated with hyperbilirubinemia, but clinicians should support breastfeeding while monitoring for signs of hyperbilirubinemia because of suboptimal feeding, the authors noted. However, the guidelines recommend against oral supplementation with water or dextrose water to prevent hyperbilirubinemia.

For assessment and monitoring, the guidelines advise the use of total serum bilirubin (TSB) as the definitive test for hyperbilirubinemia to guide phototherapy and escalation of care, including exchange transfusion. “The presence of hyperbilirubinemia neurotoxicity risk factors lowers the threshold for treatment with phototherapy and the level at which care should be escalated,” the authors wrote. They also emphasized the need to consider glucose-6-phosphate dehydrogenase deficiency, a genetic condition that decreases protection against oxidative stress and has been identified as a leading cause of hazardous hyperbilirubinemia worldwide.

The guidelines recommend assessing all infants for jaundice at least every 12 hours after delivery until discharge, with TSB or TcB measured as soon as possible for those with suspected jaundice. The complete guidelines include charts for TSB levels to guide escalation of care. “Blood for TSB can be obtained at the time it is collected for newborn screening tests to avoid an additional heel stick,” the authors noted.

The rate of increase in TSB or TcB, if more than one measure is available, may identify infants at higher risk of hyperbilirubinemia, according to the guidelines, and a possible delay of hospital discharge may be needed for infants if appropriate follow-up is not feasible.

In terms of treatment, new evidence that bilirubin neurotoxicity does not occur until concentrations well above those given in the 2004 guidelines justified raising the treatment thresholds, although by a narrow range. “With the increased phototherapy thresholds, appropriately following the current guidelines including bilirubin screening during the birth hospitalization and timely postdischarge follow-up is important,” the authors wrote. The new thresholds, outlined in the complete guidelines, are based on gestational age, hyperbilirubinemia neurotoxicity risk factors, and the age of the infant in hours. However, infants may be treated at lower levels, based on individual circumstances, family preferences, and shared decision-making with clinicians. Home-based phototherapy may be used in some infants, but should not be used if there is a question about the device quality, delivery time, and ability of caregivers to use the device correctly.

“Discontinuing phototherapy is an option when the TSB has decreased by at least 2 mg/dL below the hour-specific threshold at the initiation of phototherapy,” and follow-up should be based on risk of rebound hyperbilirubinemia, according to the guidelines.

“This clinical practice guideline provides indications and approaches for phototherapy and escalation of care and when treatment and monitoring can be safely discontinued,” However, clinicians should understand the rationale for the recommendations and combine them with their clinical judgment, including shared decision-making when appropriate, the authors concluded.
 

Updated evidence supports escalating care

The take-home message for pediatricians is that neonatal hyperbilirubinemia is a very common finding, and complications are rare, but the condition can result in devastating life-long results, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Previous guidelines published in 2004 and updated in 2009 included evidence-based recommendations, but additional research was still needed to provide guidance for providers to prevent complications of hyperbilirubinemia,” said Dr. Haut, who was not involved in producing the guidelines.

“New data documenting additional risk factors, the importance of ongoing breastfeeding support, and addressing hyperbilirubinemia as an urgent problem” are additions to prevention methods in the latest published guidelines, she said.

“Acute encephalopathy and kernicterus can result from hyperbilirubinemia with severe and devastating neurologic effects, but are preventable by early identification and treatment,” said Dr. Haut. Therefore, “it is not surprising that the AAP utilized continuing and more recent evidence to support new recommendations. Both maternal and neonatal risk factors have long been considered in the development of neonatal hyperbilirubinemia, but recent recommendations incorporate additional risk factor evaluation and urgency in time to appropriate care. Detailed thresholds for phototherapy and exchange transfusion will benefit the families of full-term infants without other risk factors and escalate care for those neonates with risk factors.”

However, potential barriers to following the guidelines persist, Dr. Haut noted.

“Frequent infant follow-up can be challenging for busy primary care offices with outpatient laboratory results often taking much longer to obtain than in a hospital setting,” she said.

Also, “taking a newborn to the emergency department or an inpatient laboratory can be frightening for families with the risk of illness exposure. Frequent monitoring of serum bilirubin levels is disturbing for parents and inconvenient immediately postpartum,” Dr. Haut explained. “Few practices utilize transcutaneous bilirubin monitoring which may be one method of added screening.”

In addition, “despite the importance of breastfeeding, ongoing support is not readily available for mothers after hospital discharge. A lactation specialist in the office setting can take the burden off providers and add opportunity for family education.”

As for additional research, “continued evaluation of the comparison of transcutaneous bilirubin monitoring and serum levels along with the use of transcutaneous monitoring in facilities outside the hospital setting may be warranted,” Dr. Haut said. “Data collection on incidence and accompanying risk factors of neonates who develop acute hyperbilirubinemia encephalopathy and kernicterus is a long-term study opportunity.”

The guidelines received no external funding. Lead author Dr. Kemper had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Raising phototherapy thresholds and revising risk assessment are among the key changes in the American Academy of Pediatrics’ updated guidelines for managing hyperbilirubinemia in infants 35 weeks’ gestation and older.

“More than 80% of newborn infants will have some degree of jaundice,” Alex R. Kemper, MD, of Nationwide Children’s Hospital, Columbus, Ohio, and coauthors wrote. Careful monitoring is needed manage high bilirubin concentrations and avoid acute bilirubin encephalopathy (ABE) and kernicterus, a disabling neurologic condition.

The current revision, published in Pediatrics, updates and replaces the 2004 AAP clinical practice guidelines for the management and prevention of hyperbilirubinemia in newborns of at least 35 weeks’ gestation.

The guideline committee reviewed evidence published since the previous guidelines were issued in 2004, and addressed similar issues of prevention, risk assessment, monitoring, and treatment.

A notable change from 2004 was the inclusion of a 2009 recommendation update for “universal predischarge bilirubin screening with measures of total serum bilirubin (TSB) or transcutaneous bilirubin (TcB) linked to specific recommendations for follow-up,” the authors wrote.

In terms of prevention, recommendations include a direct antiglobulin test (DAT) for infants whose mother’s antibody screen was positive or unknown. In addition, exclusive breastfeeding is known to be associated with hyperbilirubinemia, but clinicians should support breastfeeding while monitoring for signs of hyperbilirubinemia because of suboptimal feeding, the authors noted. However, the guidelines recommend against oral supplementation with water or dextrose water to prevent hyperbilirubinemia.

For assessment and monitoring, the guidelines advise the use of total serum bilirubin (TSB) as the definitive test for hyperbilirubinemia to guide phototherapy and escalation of care, including exchange transfusion. “The presence of hyperbilirubinemia neurotoxicity risk factors lowers the threshold for treatment with phototherapy and the level at which care should be escalated,” the authors wrote. They also emphasized the need to consider glucose-6-phosphate dehydrogenase deficiency, a genetic condition that decreases protection against oxidative stress and has been identified as a leading cause of hazardous hyperbilirubinemia worldwide.

The guidelines recommend assessing all infants for jaundice at least every 12 hours after delivery until discharge, with TSB or TcB measured as soon as possible for those with suspected jaundice. The complete guidelines include charts for TSB levels to guide escalation of care. “Blood for TSB can be obtained at the time it is collected for newborn screening tests to avoid an additional heel stick,” the authors noted.

The rate of increase in TSB or TcB, if more than one measure is available, may identify infants at higher risk of hyperbilirubinemia, according to the guidelines, and a possible delay of hospital discharge may be needed for infants if appropriate follow-up is not feasible.

In terms of treatment, new evidence that bilirubin neurotoxicity does not occur until concentrations well above those given in the 2004 guidelines justified raising the treatment thresholds, although by a narrow range. “With the increased phototherapy thresholds, appropriately following the current guidelines including bilirubin screening during the birth hospitalization and timely postdischarge follow-up is important,” the authors wrote. The new thresholds, outlined in the complete guidelines, are based on gestational age, hyperbilirubinemia neurotoxicity risk factors, and the age of the infant in hours. However, infants may be treated at lower levels, based on individual circumstances, family preferences, and shared decision-making with clinicians. Home-based phototherapy may be used in some infants, but should not be used if there is a question about the device quality, delivery time, and ability of caregivers to use the device correctly.

“Discontinuing phototherapy is an option when the TSB has decreased by at least 2 mg/dL below the hour-specific threshold at the initiation of phototherapy,” and follow-up should be based on risk of rebound hyperbilirubinemia, according to the guidelines.

“This clinical practice guideline provides indications and approaches for phototherapy and escalation of care and when treatment and monitoring can be safely discontinued,” However, clinicians should understand the rationale for the recommendations and combine them with their clinical judgment, including shared decision-making when appropriate, the authors concluded.
 

Updated evidence supports escalating care

The take-home message for pediatricians is that neonatal hyperbilirubinemia is a very common finding, and complications are rare, but the condition can result in devastating life-long results, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Previous guidelines published in 2004 and updated in 2009 included evidence-based recommendations, but additional research was still needed to provide guidance for providers to prevent complications of hyperbilirubinemia,” said Dr. Haut, who was not involved in producing the guidelines.

“New data documenting additional risk factors, the importance of ongoing breastfeeding support, and addressing hyperbilirubinemia as an urgent problem” are additions to prevention methods in the latest published guidelines, she said.

“Acute encephalopathy and kernicterus can result from hyperbilirubinemia with severe and devastating neurologic effects, but are preventable by early identification and treatment,” said Dr. Haut. Therefore, “it is not surprising that the AAP utilized continuing and more recent evidence to support new recommendations. Both maternal and neonatal risk factors have long been considered in the development of neonatal hyperbilirubinemia, but recent recommendations incorporate additional risk factor evaluation and urgency in time to appropriate care. Detailed thresholds for phototherapy and exchange transfusion will benefit the families of full-term infants without other risk factors and escalate care for those neonates with risk factors.”

However, potential barriers to following the guidelines persist, Dr. Haut noted.

“Frequent infant follow-up can be challenging for busy primary care offices with outpatient laboratory results often taking much longer to obtain than in a hospital setting,” she said.

Also, “taking a newborn to the emergency department or an inpatient laboratory can be frightening for families with the risk of illness exposure. Frequent monitoring of serum bilirubin levels is disturbing for parents and inconvenient immediately postpartum,” Dr. Haut explained. “Few practices utilize transcutaneous bilirubin monitoring which may be one method of added screening.”

In addition, “despite the importance of breastfeeding, ongoing support is not readily available for mothers after hospital discharge. A lactation specialist in the office setting can take the burden off providers and add opportunity for family education.”

As for additional research, “continued evaluation of the comparison of transcutaneous bilirubin monitoring and serum levels along with the use of transcutaneous monitoring in facilities outside the hospital setting may be warranted,” Dr. Haut said. “Data collection on incidence and accompanying risk factors of neonates who develop acute hyperbilirubinemia encephalopathy and kernicterus is a long-term study opportunity.”

The guidelines received no external funding. Lead author Dr. Kemper had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Patients said they’d prefer fecal immunochemical test (FIT)–fecal DNA tests over any of the other colorectal cancer screening (CRC) modalities currently recommended by the U.S. Multi-Society Task Force, according to a study published in Clinical Gastroenterology and Hepatology.

Just over a third of American adults aged 40 and older who hadn’t yet been screened for CRC preferred the FIT–fecal DNA test every 3 years, whereas just one in seven respondents preferred a colonoscopy – considered the gold standard in colorectal cancer screening – every 10 years.

”When you talk to patients and to your friends and family members, people tend to think colonoscopy is synonymous with colon cancer screening, but we have lots of different tests,” senior author Christopher V. Almario, MD, MSHPM, of the department of medicine at the Karsh division of gastroenterology and hepatology, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Most people in general tend to prefer noninvasive stool tests, and when we try to predict who would prefer what, we actually couldn’t, so this is a very personal decision,” Dr. Almario said. “It’s important for clinicians to offer multiple choices to their patients, not to mention just colonoscopy. We have data from observing clinician-patient interactions showing that, a lot of times, colonoscopy is the only test that’s offered, despite there being multiple options.”

At the very least, Dr. Almario said, providers should offer patients a colonoscopy along with a noninvasive test, particularly a stool test, and discuss the two options, getting the patient’s input in terms of what they prefer. “The best test is the test that actually gets done,” he said.
 

Offering patients options

Reid M. Ness, MD, MPH, an associate professor of medicine in the division of gastroenterology, hepatology and nutrition at Vanderbilt University Medical Center in Nashville, was not involved with the study but wasn’t surprised at the findings since “most people wisely prefer to avoid invasive procedures,” he said in an interview. He agreed that many patients aren’t necessarily informed of all their options for screening.

“Many people who are now being offered colonoscopy as their only screening option may prefer a noninvasive option, such as FIT or multitarget stool DNA testing,” Dr. Ness said. “Also, people now refusing colonoscopy for colorectal cancer screening may instead accept FIT or multitarget stool DNA testing. It is difficult to know how many people now refusing colorectal cancer screening may have accepted screening if it had been offered differently.”

That’s precisely what Dr. Almario and his colleagues wanted to find out. They surveyed 1,000 people aged 40 and older who were at average risk for colorectal cancer to find out their preferences for different screening modalities and what features of different screening types they most valued. The researchers asked about the following screening tests recommended by the U.S. Multi-Society Task Force:

• FIT every year.
• FIT–fecal DNA every 3 years.
• Colon video capsule every 5 years.
• CT colonography every 5 years.
• Colonoscopy every 10 years.

The respondents who completed the online survey were recruited from a sample of more than 20 million people across the United States who have agreed to receive survey invitations. Respondents were excluded if they had a first-degree relative with colorectal cancer, had already undergone colorectal cancer screening or had been diagnosed with colon polyps, Crohn’s disease, or ulcerative colitis.

The respondents were split into those aged 40-49 (61% of the sample) who had not yet discussed colorectal cancer screening with their providers and those aged 50 and older, who might have already discussed it and declined. Eighty percent of the respondents were White, 6% were Black, 6% were Hispanic, 4% were Asian, and 3% reported another race/ethnicity. Just over half (52%) had at least two comorbidities. A quarter (25%) reported one comorbidity, and 22% reported none.



In thinking about the decision to get screened, respondents ranked the test type as the most important consideration, followed by the reduction in their chance of developing colorectal cancer and then frequency of the test. Lower priority on the list of considerations were their chances of a complication, bowel prep before the test, and required diet changes before the test.

The test preferred by the highest proportion of respondents was the FIT–fecal DNA test every 3 years, preferred by 35% of respondents, followed by the colon capsule video test every 5 years (28%). About one in seven respondents (14%) preferred a colonoscopy every 10 years, followed by the annual FIT (12%) and CT colonography every 5 years (11%). When limited only to the two tier 1–option tests – the annual FIT or a colonoscopy every 10 years – a substantial majority of the younger (69%) and older (77%) groups preferred the annual FIT.

”This finding is discordant with current CRC screening utilization in the United States where colonoscopy is the most commonly performed test, and this may partially explain our suboptimal screening rates,” the authors wrote. “Our findings suggest that screening programs should strongly consider a sequential-based strategy where FIT is offered first, and if declined then colonoscopy.”
 

Underlying factors

Dr. Ness said that many primary care providers might prefer to offer colonoscopies instead of annual FIT tests because it’s easier to track a test given every 10 years instead of every year or every 3 years.

“Providers across most of the U.S. are incentivized to recommend colonoscopy as the primary screening modality because the burden of follow-up on them is less,” Dr. Ness said. “They are able to justify this choice given colonoscopy remains the most accurate screening modality.”

Dr. Ness pointed to the programmatic screening program at Kaiser Permanente of Northern California health care system as a model for a program that utilizes FIT tests more often.

“The only way to accomplish an efficient and equitable colorectal cancer screening program is within the context of a national health service or plan,” Dr. Ness added. “Otherwise, the uninsured and underinsured will remain excluded from the benefits of colorectal cancer screening.”

Preferences did not differ a great deal between the age groups, with 35% of the younger group and 37% of the older group both preferring the FIT–fecal DNA tests every 3 years. Slightly more people in the 50+ age group preferred an annual fit (19% vs. 12%) as opposed to the colon capsule video every 5 years (28% of younger group vs. 23%) or colon CT scan every 5 years (11% of younger group vs. 8%), but the differences were statistically significant (P = .019).

In fact, “sociodemographic, clinical characteristics, and colorectal cancer screening knowledge, attitudes, and beliefs were not predictive of selecting FIT or colonoscopy,” the authors found. ”This demonstrates the individualized nature of decision making on colorectal cancer screening tests. Moreover, as most individuals preferred FIT, it again emphasizes the importance of sequential or choice-based strategies for colorectal cancer screening.”

However, one of the study’s notable limitations was its high proportion of White patients relative to other racial/ethnic groups, so additional research may illuminate whether different sociodemographic groups do have slight preferences for one test over another, Dr. Almario said. The advantage to colonoscopies, he noted, is that they only occur every 10 years and if polyps are discovered, they can be taken care of right away.

”You don’t have to think about it for a decade, which is certainly a pro for the colonoscopy,” Dr. Almario said. “The FIT test is obviously less invasive, but you have to do it every year for it to be an effective screening test.” He noted that some data have shown a drop-off in compliance over multiple years. “We certainly need more systems in place to remind patients and providers to do it annually so that we can see the ultimate screening benefit from doing that test specifically.”

“The most important point from the clinical perspective is, when we’re talking to patients about colon cancer screening, make sure to give them a choice,” Dr. Almario said. “We just can’t look at someone’s chart, their clinical characteristics or demographics, and predict what tests they would prefer. We need to ask them. We need to present them with the options, go over the pros and cons of colonoscopy, the pros and cons of the stool test, and ask the patient what they would prefer to do.”

The research was funded by the National Cancer Institute and the National Institutes of Health. One author served on an advisory board with Exact Sciences. The other authors and Dr. Ness had no disclosures.

Patients said they’d prefer fecal immunochemical test (FIT)–fecal DNA tests over any of the other colorectal cancer screening (CRC) modalities currently recommended by the U.S. Multi-Society Task Force, according to a study published in Clinical Gastroenterology and Hepatology.

Just over a third of American adults aged 40 and older who hadn’t yet been screened for CRC preferred the FIT–fecal DNA test every 3 years, whereas just one in seven respondents preferred a colonoscopy – considered the gold standard in colorectal cancer screening – every 10 years.

”When you talk to patients and to your friends and family members, people tend to think colonoscopy is synonymous with colon cancer screening, but we have lots of different tests,” senior author Christopher V. Almario, MD, MSHPM, of the department of medicine at the Karsh division of gastroenterology and hepatology, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Most people in general tend to prefer noninvasive stool tests, and when we try to predict who would prefer what, we actually couldn’t, so this is a very personal decision,” Dr. Almario said. “It’s important for clinicians to offer multiple choices to their patients, not to mention just colonoscopy. We have data from observing clinician-patient interactions showing that, a lot of times, colonoscopy is the only test that’s offered, despite there being multiple options.”

At the very least, Dr. Almario said, providers should offer patients a colonoscopy along with a noninvasive test, particularly a stool test, and discuss the two options, getting the patient’s input in terms of what they prefer. “The best test is the test that actually gets done,” he said.
 

Offering patients options

Reid M. Ness, MD, MPH, an associate professor of medicine in the division of gastroenterology, hepatology and nutrition at Vanderbilt University Medical Center in Nashville, was not involved with the study but wasn’t surprised at the findings since “most people wisely prefer to avoid invasive procedures,” he said in an interview. He agreed that many patients aren’t necessarily informed of all their options for screening.

“Many people who are now being offered colonoscopy as their only screening option may prefer a noninvasive option, such as FIT or multitarget stool DNA testing,” Dr. Ness said. “Also, people now refusing colonoscopy for colorectal cancer screening may instead accept FIT or multitarget stool DNA testing. It is difficult to know how many people now refusing colorectal cancer screening may have accepted screening if it had been offered differently.”

That’s precisely what Dr. Almario and his colleagues wanted to find out. They surveyed 1,000 people aged 40 and older who were at average risk for colorectal cancer to find out their preferences for different screening modalities and what features of different screening types they most valued. The researchers asked about the following screening tests recommended by the U.S. Multi-Society Task Force:

• FIT every year.
• FIT–fecal DNA every 3 years.
• Colon video capsule every 5 years.
• CT colonography every 5 years.
• Colonoscopy every 10 years.

The respondents who completed the online survey were recruited from a sample of more than 20 million people across the United States who have agreed to receive survey invitations. Respondents were excluded if they had a first-degree relative with colorectal cancer, had already undergone colorectal cancer screening or had been diagnosed with colon polyps, Crohn’s disease, or ulcerative colitis.

The respondents were split into those aged 40-49 (61% of the sample) who had not yet discussed colorectal cancer screening with their providers and those aged 50 and older, who might have already discussed it and declined. Eighty percent of the respondents were White, 6% were Black, 6% were Hispanic, 4% were Asian, and 3% reported another race/ethnicity. Just over half (52%) had at least two comorbidities. A quarter (25%) reported one comorbidity, and 22% reported none.



In thinking about the decision to get screened, respondents ranked the test type as the most important consideration, followed by the reduction in their chance of developing colorectal cancer and then frequency of the test. Lower priority on the list of considerations were their chances of a complication, bowel prep before the test, and required diet changes before the test.

The test preferred by the highest proportion of respondents was the FIT–fecal DNA test every 3 years, preferred by 35% of respondents, followed by the colon capsule video test every 5 years (28%). About one in seven respondents (14%) preferred a colonoscopy every 10 years, followed by the annual FIT (12%) and CT colonography every 5 years (11%). When limited only to the two tier 1–option tests – the annual FIT or a colonoscopy every 10 years – a substantial majority of the younger (69%) and older (77%) groups preferred the annual FIT.

”This finding is discordant with current CRC screening utilization in the United States where colonoscopy is the most commonly performed test, and this may partially explain our suboptimal screening rates,” the authors wrote. “Our findings suggest that screening programs should strongly consider a sequential-based strategy where FIT is offered first, and if declined then colonoscopy.”
 

Underlying factors

Dr. Ness said that many primary care providers might prefer to offer colonoscopies instead of annual FIT tests because it’s easier to track a test given every 10 years instead of every year or every 3 years.

“Providers across most of the U.S. are incentivized to recommend colonoscopy as the primary screening modality because the burden of follow-up on them is less,” Dr. Ness said. “They are able to justify this choice given colonoscopy remains the most accurate screening modality.”

Dr. Ness pointed to the programmatic screening program at Kaiser Permanente of Northern California health care system as a model for a program that utilizes FIT tests more often.

“The only way to accomplish an efficient and equitable colorectal cancer screening program is within the context of a national health service or plan,” Dr. Ness added. “Otherwise, the uninsured and underinsured will remain excluded from the benefits of colorectal cancer screening.”

Preferences did not differ a great deal between the age groups, with 35% of the younger group and 37% of the older group both preferring the FIT–fecal DNA tests every 3 years. Slightly more people in the 50+ age group preferred an annual fit (19% vs. 12%) as opposed to the colon capsule video every 5 years (28% of younger group vs. 23%) or colon CT scan every 5 years (11% of younger group vs. 8%), but the differences were statistically significant (P = .019).

In fact, “sociodemographic, clinical characteristics, and colorectal cancer screening knowledge, attitudes, and beliefs were not predictive of selecting FIT or colonoscopy,” the authors found. ”This demonstrates the individualized nature of decision making on colorectal cancer screening tests. Moreover, as most individuals preferred FIT, it again emphasizes the importance of sequential or choice-based strategies for colorectal cancer screening.”

However, one of the study’s notable limitations was its high proportion of White patients relative to other racial/ethnic groups, so additional research may illuminate whether different sociodemographic groups do have slight preferences for one test over another, Dr. Almario said. The advantage to colonoscopies, he noted, is that they only occur every 10 years and if polyps are discovered, they can be taken care of right away.

”You don’t have to think about it for a decade, which is certainly a pro for the colonoscopy,” Dr. Almario said. “The FIT test is obviously less invasive, but you have to do it every year for it to be an effective screening test.” He noted that some data have shown a drop-off in compliance over multiple years. “We certainly need more systems in place to remind patients and providers to do it annually so that we can see the ultimate screening benefit from doing that test specifically.”

“The most important point from the clinical perspective is, when we’re talking to patients about colon cancer screening, make sure to give them a choice,” Dr. Almario said. “We just can’t look at someone’s chart, their clinical characteristics or demographics, and predict what tests they would prefer. We need to ask them. We need to present them with the options, go over the pros and cons of colonoscopy, the pros and cons of the stool test, and ask the patient what they would prefer to do.”

The research was funded by the National Cancer Institute and the National Institutes of Health. One author served on an advisory board with Exact Sciences. The other authors and Dr. Ness had no disclosures.

Patients said they’d prefer fecal immunochemical test (FIT)–fecal DNA tests over any of the other colorectal cancer screening (CRC) modalities currently recommended by the U.S. Multi-Society Task Force, according to a study published in Clinical Gastroenterology and Hepatology.

Just over a third of American adults aged 40 and older who hadn’t yet been screened for CRC preferred the FIT–fecal DNA test every 3 years, whereas just one in seven respondents preferred a colonoscopy – considered the gold standard in colorectal cancer screening – every 10 years.

”When you talk to patients and to your friends and family members, people tend to think colonoscopy is synonymous with colon cancer screening, but we have lots of different tests,” senior author Christopher V. Almario, MD, MSHPM, of the department of medicine at the Karsh division of gastroenterology and hepatology, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Most people in general tend to prefer noninvasive stool tests, and when we try to predict who would prefer what, we actually couldn’t, so this is a very personal decision,” Dr. Almario said. “It’s important for clinicians to offer multiple choices to their patients, not to mention just colonoscopy. We have data from observing clinician-patient interactions showing that, a lot of times, colonoscopy is the only test that’s offered, despite there being multiple options.”

At the very least, Dr. Almario said, providers should offer patients a colonoscopy along with a noninvasive test, particularly a stool test, and discuss the two options, getting the patient’s input in terms of what they prefer. “The best test is the test that actually gets done,” he said.
 

Offering patients options

Reid M. Ness, MD, MPH, an associate professor of medicine in the division of gastroenterology, hepatology and nutrition at Vanderbilt University Medical Center in Nashville, was not involved with the study but wasn’t surprised at the findings since “most people wisely prefer to avoid invasive procedures,” he said in an interview. He agreed that many patients aren’t necessarily informed of all their options for screening.

“Many people who are now being offered colonoscopy as their only screening option may prefer a noninvasive option, such as FIT or multitarget stool DNA testing,” Dr. Ness said. “Also, people now refusing colonoscopy for colorectal cancer screening may instead accept FIT or multitarget stool DNA testing. It is difficult to know how many people now refusing colorectal cancer screening may have accepted screening if it had been offered differently.”

That’s precisely what Dr. Almario and his colleagues wanted to find out. They surveyed 1,000 people aged 40 and older who were at average risk for colorectal cancer to find out their preferences for different screening modalities and what features of different screening types they most valued. The researchers asked about the following screening tests recommended by the U.S. Multi-Society Task Force:

• FIT every year.
• FIT–fecal DNA every 3 years.
• Colon video capsule every 5 years.
• CT colonography every 5 years.
• Colonoscopy every 10 years.

The respondents who completed the online survey were recruited from a sample of more than 20 million people across the United States who have agreed to receive survey invitations. Respondents were excluded if they had a first-degree relative with colorectal cancer, had already undergone colorectal cancer screening or had been diagnosed with colon polyps, Crohn’s disease, or ulcerative colitis.

The respondents were split into those aged 40-49 (61% of the sample) who had not yet discussed colorectal cancer screening with their providers and those aged 50 and older, who might have already discussed it and declined. Eighty percent of the respondents were White, 6% were Black, 6% were Hispanic, 4% were Asian, and 3% reported another race/ethnicity. Just over half (52%) had at least two comorbidities. A quarter (25%) reported one comorbidity, and 22% reported none.



In thinking about the decision to get screened, respondents ranked the test type as the most important consideration, followed by the reduction in their chance of developing colorectal cancer and then frequency of the test. Lower priority on the list of considerations were their chances of a complication, bowel prep before the test, and required diet changes before the test.

The test preferred by the highest proportion of respondents was the FIT–fecal DNA test every 3 years, preferred by 35% of respondents, followed by the colon capsule video test every 5 years (28%). About one in seven respondents (14%) preferred a colonoscopy every 10 years, followed by the annual FIT (12%) and CT colonography every 5 years (11%). When limited only to the two tier 1–option tests – the annual FIT or a colonoscopy every 10 years – a substantial majority of the younger (69%) and older (77%) groups preferred the annual FIT.

”This finding is discordant with current CRC screening utilization in the United States where colonoscopy is the most commonly performed test, and this may partially explain our suboptimal screening rates,” the authors wrote. “Our findings suggest that screening programs should strongly consider a sequential-based strategy where FIT is offered first, and if declined then colonoscopy.”
 

Underlying factors

Dr. Ness said that many primary care providers might prefer to offer colonoscopies instead of annual FIT tests because it’s easier to track a test given every 10 years instead of every year or every 3 years.

“Providers across most of the U.S. are incentivized to recommend colonoscopy as the primary screening modality because the burden of follow-up on them is less,” Dr. Ness said. “They are able to justify this choice given colonoscopy remains the most accurate screening modality.”

Dr. Ness pointed to the programmatic screening program at Kaiser Permanente of Northern California health care system as a model for a program that utilizes FIT tests more often.

“The only way to accomplish an efficient and equitable colorectal cancer screening program is within the context of a national health service or plan,” Dr. Ness added. “Otherwise, the uninsured and underinsured will remain excluded from the benefits of colorectal cancer screening.”

Preferences did not differ a great deal between the age groups, with 35% of the younger group and 37% of the older group both preferring the FIT–fecal DNA tests every 3 years. Slightly more people in the 50+ age group preferred an annual fit (19% vs. 12%) as opposed to the colon capsule video every 5 years (28% of younger group vs. 23%) or colon CT scan every 5 years (11% of younger group vs. 8%), but the differences were statistically significant (P = .019).

In fact, “sociodemographic, clinical characteristics, and colorectal cancer screening knowledge, attitudes, and beliefs were not predictive of selecting FIT or colonoscopy,” the authors found. ”This demonstrates the individualized nature of decision making on colorectal cancer screening tests. Moreover, as most individuals preferred FIT, it again emphasizes the importance of sequential or choice-based strategies for colorectal cancer screening.”

However, one of the study’s notable limitations was its high proportion of White patients relative to other racial/ethnic groups, so additional research may illuminate whether different sociodemographic groups do have slight preferences for one test over another, Dr. Almario said. The advantage to colonoscopies, he noted, is that they only occur every 10 years and if polyps are discovered, they can be taken care of right away.

”You don’t have to think about it for a decade, which is certainly a pro for the colonoscopy,” Dr. Almario said. “The FIT test is obviously less invasive, but you have to do it every year for it to be an effective screening test.” He noted that some data have shown a drop-off in compliance over multiple years. “We certainly need more systems in place to remind patients and providers to do it annually so that we can see the ultimate screening benefit from doing that test specifically.”

“The most important point from the clinical perspective is, when we’re talking to patients about colon cancer screening, make sure to give them a choice,” Dr. Almario said. “We just can’t look at someone’s chart, their clinical characteristics or demographics, and predict what tests they would prefer. We need to ask them. We need to present them with the options, go over the pros and cons of colonoscopy, the pros and cons of the stool test, and ask the patient what they would prefer to do.”

The research was funded by the National Cancer Institute and the National Institutes of Health. One author served on an advisory board with Exact Sciences. The other authors and Dr. Ness had no disclosures.

The White House declared monkeypox a public health emergency Aug. 4. There have been more than 6,600 reported cases of the disease in the United States, up from less than 5,000 cases reported last week.

“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Robert Fenton, who was named as the national monkeypox response coordinator this week, said at a news briefing Aug. 4.

Those who catch the virus usually have fever-like symptoms, followed by red lesions on the body that can raise and develop pus. Those at highest risk of monkeypox are gay and bisexual men, as well as men who have sex with other men. There are between 1.6 million and 1.7 million Americans in this high-risk group, Health and Human Services Secretary Xavier Becerra said at the briefing.

The Jynneos vaccine is being distributed to protect against monkeypox and can prevent severe symptoms. It’s mostly going to those with the greatest risk of catching the virus.

Last week, the Biden administration made over 1.1 million doses of the Jynneos vaccine available – of which over 600,000 doses have already been distributed across the country – and have secured over 6.9 million Jynneos doses altogether.

Around 786,000 vaccines have already been allocated, and the first doses were shipped this week. States will be able to order more doses beginning Aug. 15. If a state has used 90% or more of its vaccine supply, it will be eligible to order more doses before Aug. 15, according to Dawn O’Connell, JD, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.

An additional 150,000 doses will be added to the national stockpile in September, with more doses to come later this year, Ms. O’Connell says.

The administration is also stressing the importance of monkeypox testing and says it can now distribute 80,000 monkeypox tests per week.

An antiviral drug – known as TPOXX – is also available to treat severe cases of monkeypox. Around 1,700,000 doses are available in the Strategic National Stockpile, public health officials say.

“We are prepared to take our response to the next level, and we urge every American to take this seriously and to take responsibility to help us tackle this virus,” Secretary Becerra told reporters.

The White House says it will continue reaching out to doctors, public health partners, LGBTQ advocates, and other impacted communities.

“The public health emergency further raises awareness about monkeypox, which will encourage clinicians to test for it,” Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention, said at the briefing.

This week, President Joe Biden appointed a new White House monkeypox response team. Besides Mr. Fenton as the response coordinator, Demetre Daskalakis, MD, will serve as the White House national monkeypox response deputy coordinator. He is the director of the CDC’s Division of HIV Prevention.

“This virus is moving fast. This is a unique outbreak that is spreading faster than previous outbreaks,” Mr. Fenton told reporters Aug. 4. “That’s why the president asked me to explore everything we can do to combat monkeypox and protect communities at risk.”

This article was updated 8/4/22.

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

The White House declared monkeypox a public health emergency Aug. 4. There have been more than 6,600 reported cases of the disease in the United States, up from less than 5,000 cases reported last week.

“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Robert Fenton, who was named as the national monkeypox response coordinator this week, said at a news briefing Aug. 4.

Those who catch the virus usually have fever-like symptoms, followed by red lesions on the body that can raise and develop pus. Those at highest risk of monkeypox are gay and bisexual men, as well as men who have sex with other men. There are between 1.6 million and 1.7 million Americans in this high-risk group, Health and Human Services Secretary Xavier Becerra said at the briefing.

The Jynneos vaccine is being distributed to protect against monkeypox and can prevent severe symptoms. It’s mostly going to those with the greatest risk of catching the virus.

Last week, the Biden administration made over 1.1 million doses of the Jynneos vaccine available – of which over 600,000 doses have already been distributed across the country – and have secured over 6.9 million Jynneos doses altogether.

Around 786,000 vaccines have already been allocated, and the first doses were shipped this week. States will be able to order more doses beginning Aug. 15. If a state has used 90% or more of its vaccine supply, it will be eligible to order more doses before Aug. 15, according to Dawn O’Connell, JD, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.

An additional 150,000 doses will be added to the national stockpile in September, with more doses to come later this year, Ms. O’Connell says.

The administration is also stressing the importance of monkeypox testing and says it can now distribute 80,000 monkeypox tests per week.

An antiviral drug – known as TPOXX – is also available to treat severe cases of monkeypox. Around 1,700,000 doses are available in the Strategic National Stockpile, public health officials say.

“We are prepared to take our response to the next level, and we urge every American to take this seriously and to take responsibility to help us tackle this virus,” Secretary Becerra told reporters.

The White House says it will continue reaching out to doctors, public health partners, LGBTQ advocates, and other impacted communities.

“The public health emergency further raises awareness about monkeypox, which will encourage clinicians to test for it,” Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention, said at the briefing.

This week, President Joe Biden appointed a new White House monkeypox response team. Besides Mr. Fenton as the response coordinator, Demetre Daskalakis, MD, will serve as the White House national monkeypox response deputy coordinator. He is the director of the CDC’s Division of HIV Prevention.

“This virus is moving fast. This is a unique outbreak that is spreading faster than previous outbreaks,” Mr. Fenton told reporters Aug. 4. “That’s why the president asked me to explore everything we can do to combat monkeypox and protect communities at risk.”

This article was updated 8/4/22.

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

The White House declared monkeypox a public health emergency Aug. 4. There have been more than 6,600 reported cases of the disease in the United States, up from less than 5,000 cases reported last week.

“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Robert Fenton, who was named as the national monkeypox response coordinator this week, said at a news briefing Aug. 4.

Those who catch the virus usually have fever-like symptoms, followed by red lesions on the body that can raise and develop pus. Those at highest risk of monkeypox are gay and bisexual men, as well as men who have sex with other men. There are between 1.6 million and 1.7 million Americans in this high-risk group, Health and Human Services Secretary Xavier Becerra said at the briefing.

The Jynneos vaccine is being distributed to protect against monkeypox and can prevent severe symptoms. It’s mostly going to those with the greatest risk of catching the virus.

Last week, the Biden administration made over 1.1 million doses of the Jynneos vaccine available – of which over 600,000 doses have already been distributed across the country – and have secured over 6.9 million Jynneos doses altogether.

Around 786,000 vaccines have already been allocated, and the first doses were shipped this week. States will be able to order more doses beginning Aug. 15. If a state has used 90% or more of its vaccine supply, it will be eligible to order more doses before Aug. 15, according to Dawn O’Connell, JD, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.

An additional 150,000 doses will be added to the national stockpile in September, with more doses to come later this year, Ms. O’Connell says.

The administration is also stressing the importance of monkeypox testing and says it can now distribute 80,000 monkeypox tests per week.

An antiviral drug – known as TPOXX – is also available to treat severe cases of monkeypox. Around 1,700,000 doses are available in the Strategic National Stockpile, public health officials say.

“We are prepared to take our response to the next level, and we urge every American to take this seriously and to take responsibility to help us tackle this virus,” Secretary Becerra told reporters.

The White House says it will continue reaching out to doctors, public health partners, LGBTQ advocates, and other impacted communities.

“The public health emergency further raises awareness about monkeypox, which will encourage clinicians to test for it,” Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention, said at the briefing.

This week, President Joe Biden appointed a new White House monkeypox response team. Besides Mr. Fenton as the response coordinator, Demetre Daskalakis, MD, will serve as the White House national monkeypox response deputy coordinator. He is the director of the CDC’s Division of HIV Prevention.

“This virus is moving fast. This is a unique outbreak that is spreading faster than previous outbreaks,” Mr. Fenton told reporters Aug. 4. “That’s why the president asked me to explore everything we can do to combat monkeypox and protect communities at risk.”

This article was updated 8/4/22.

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

A new analysis projects steep increases by 2060 in the prevalence of cardiovascular (CV) risk factors and disease that will disproportionately affect non-White populations who have limited access to health care.

The study by Reza Mohebi, MD, Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues was published in the Journal of the American College of Cardiology.

“Even though several assumptions underlie these projections, the importance of this work cannot be overestimated,” Andreas P. Kalogeropoulos, MD, MPH, PhD, and Javed Butler, MD, MPH, MBA, wrote in an accompanying editorial. “The absolute numbers are staggering.”

From 2025 to 2060, the number of people with any one of four CV risk factors – type 2 diabetes, hypertension, dyslipidemia, and obesity – is projected to increase by 15.4 million, to 34.7 million.

And the number of people with of any one of four CV disease types – ischemic heart disease, heart failure, MI, and stroke – is projected to increase by 3.2 million, to 6.8 million.

Although the model predicts that the prevalence of CV risk factors will gradually decrease among White Americans, the highest prevalence of CV risk factors will be among the White population because of its overall size.

Conversely, the projected prevalence of CV risk factors is expected to increase in Black, Hispanic, Asian, and other race/ethnicity populations.

In parallel, the prevalence of CV disease is projected to decrease in the White population and increase among all other race/ethnicities, particularly in the Black and Hispanic populations.

Courtesy Massachusetts General Hospital

“Our results project a worrisome increase with a particularly ominous increase in risk factors and disease in our most vulnerable patients, including Blacks and Hispanics,” senior author James L. Januzzi Jr., MD, summarized in a video issued by the society.

“The steep rise in CV risk factors and disease reflects the generally higher prevalence in populations projected to increase in the United States, owing to immigration and growth, including Black or Hispanic individuals,” Dr. Januzzi, also from Massachusetts General and Harvard, said in an interview.

“The disproportionate size of the risk is expected in a sense, as minority populations are disproportionately disadvantaged with respect to their health care,” he said. “But whether it is expected or not, the increase in projected prevalence is, nonetheless, concerning and a call to action.”

This study identifies “areas of opportunity for change in the U.S. health care system,” he continued. “Business as usual will result in us encountering a huge number of individuals with CV risk factors and diseases.”

The results from the current analysis assume there will be no modification in health care policies or changes in access to care for at-risk populations, Dr. Mohebi and colleagues noted.

To “stem the rising tide of CV disease in at-risk individuals,” would require strategies such as “emphasis on education regarding CV risk factors, improving access to quality healthcare, and facilitating lower-cost access to effective therapies for treatment of CV risk factors,” according to the researchers.

“Such advances need to be applied in a more equitable way throughout the United States, however,” they cautioned.
 

Census plus NHANES data

The researchers used 2020 U.S. census data and projected growth and 2013-2018 U.S. National Health and Nutrition Survey data to estimate the number of people with CV risk factors and CV disease from 2025 to 2060.

The estimates are based on a growing population and a fixed frequency.

Changing demographic landscape

It is “striking” that the numbers of non-White individuals with CV risk factors is projected to surpass the number of White individuals over time, and the number of non-White individuals with CV disease will be almost as many as White individuals by the year 2060, the editorialists noted.

“From a policy perspective, this means that unless appropriate, targeted action is taken, disparities in the burden of cardiovascular disease are only going to be exacerbated over time,” wrote Dr. Kalogeropoulos, from Stony Brook (N.Y.) University, and Dr. Butler, from Baylor College of Medicine, Dallas.

“On the positive side,” they continued, “the absolute increase in the percent prevalence of cardiovascular risk factors and conditions is projected to lie within a manageable range,” assuming that specific prevention policies are implemented.

“This is an opportunity for professional societies, including the cardiovascular care community, to re-evaluate priorities and strategies, for both training and practice, to best match the growing demands of a changing demographic landscape in the United States,” Dr. Kalogeropoulos and Dr. Butler concluded.

Dr. Mohebi is supported by the Barry Fellowship. Dr. Januzzi is supported by the Hutter Family Professorship; is a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; has received grant support from Abbott Diagnostics, Applied Therapeutics, Innolife, and Novartis; has received consulting income from Abbott Diagnostics, Boehringer Ingelheim, Janssen, Novartis, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for AbbVie, Siemens, Takeda, and Vifor. Dr. Kalogeropoulos has received research funding from the National Heart, Lung, and Blood Institute; the American Heart Association; and the Centers for Disease Control and Prevention. Dr. Butler has been a consultant for numerous pharmaceutical companies.

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

A new analysis projects steep increases by 2060 in the prevalence of cardiovascular (CV) risk factors and disease that will disproportionately affect non-White populations who have limited access to health care.

The study by Reza Mohebi, MD, Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues was published in the Journal of the American College of Cardiology.

“Even though several assumptions underlie these projections, the importance of this work cannot be overestimated,” Andreas P. Kalogeropoulos, MD, MPH, PhD, and Javed Butler, MD, MPH, MBA, wrote in an accompanying editorial. “The absolute numbers are staggering.”

From 2025 to 2060, the number of people with any one of four CV risk factors – type 2 diabetes, hypertension, dyslipidemia, and obesity – is projected to increase by 15.4 million, to 34.7 million.

And the number of people with of any one of four CV disease types – ischemic heart disease, heart failure, MI, and stroke – is projected to increase by 3.2 million, to 6.8 million.

Although the model predicts that the prevalence of CV risk factors will gradually decrease among White Americans, the highest prevalence of CV risk factors will be among the White population because of its overall size.

Conversely, the projected prevalence of CV risk factors is expected to increase in Black, Hispanic, Asian, and other race/ethnicity populations.

In parallel, the prevalence of CV disease is projected to decrease in the White population and increase among all other race/ethnicities, particularly in the Black and Hispanic populations.

Courtesy Massachusetts General Hospital

“Our results project a worrisome increase with a particularly ominous increase in risk factors and disease in our most vulnerable patients, including Blacks and Hispanics,” senior author James L. Januzzi Jr., MD, summarized in a video issued by the society.

“The steep rise in CV risk factors and disease reflects the generally higher prevalence in populations projected to increase in the United States, owing to immigration and growth, including Black or Hispanic individuals,” Dr. Januzzi, also from Massachusetts General and Harvard, said in an interview.

“The disproportionate size of the risk is expected in a sense, as minority populations are disproportionately disadvantaged with respect to their health care,” he said. “But whether it is expected or not, the increase in projected prevalence is, nonetheless, concerning and a call to action.”

This study identifies “areas of opportunity for change in the U.S. health care system,” he continued. “Business as usual will result in us encountering a huge number of individuals with CV risk factors and diseases.”

The results from the current analysis assume there will be no modification in health care policies or changes in access to care for at-risk populations, Dr. Mohebi and colleagues noted.

To “stem the rising tide of CV disease in at-risk individuals,” would require strategies such as “emphasis on education regarding CV risk factors, improving access to quality healthcare, and facilitating lower-cost access to effective therapies for treatment of CV risk factors,” according to the researchers.

“Such advances need to be applied in a more equitable way throughout the United States, however,” they cautioned.
 

Census plus NHANES data

The researchers used 2020 U.S. census data and projected growth and 2013-2018 U.S. National Health and Nutrition Survey data to estimate the number of people with CV risk factors and CV disease from 2025 to 2060.

The estimates are based on a growing population and a fixed frequency.

Changing demographic landscape

It is “striking” that the numbers of non-White individuals with CV risk factors is projected to surpass the number of White individuals over time, and the number of non-White individuals with CV disease will be almost as many as White individuals by the year 2060, the editorialists noted.

“From a policy perspective, this means that unless appropriate, targeted action is taken, disparities in the burden of cardiovascular disease are only going to be exacerbated over time,” wrote Dr. Kalogeropoulos, from Stony Brook (N.Y.) University, and Dr. Butler, from Baylor College of Medicine, Dallas.

“On the positive side,” they continued, “the absolute increase in the percent prevalence of cardiovascular risk factors and conditions is projected to lie within a manageable range,” assuming that specific prevention policies are implemented.

“This is an opportunity for professional societies, including the cardiovascular care community, to re-evaluate priorities and strategies, for both training and practice, to best match the growing demands of a changing demographic landscape in the United States,” Dr. Kalogeropoulos and Dr. Butler concluded.

Dr. Mohebi is supported by the Barry Fellowship. Dr. Januzzi is supported by the Hutter Family Professorship; is a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; has received grant support from Abbott Diagnostics, Applied Therapeutics, Innolife, and Novartis; has received consulting income from Abbott Diagnostics, Boehringer Ingelheim, Janssen, Novartis, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for AbbVie, Siemens, Takeda, and Vifor. Dr. Kalogeropoulos has received research funding from the National Heart, Lung, and Blood Institute; the American Heart Association; and the Centers for Disease Control and Prevention. Dr. Butler has been a consultant for numerous pharmaceutical companies.

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

A new analysis projects steep increases by 2060 in the prevalence of cardiovascular (CV) risk factors and disease that will disproportionately affect non-White populations who have limited access to health care.

The study by Reza Mohebi, MD, Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues was published in the Journal of the American College of Cardiology.

“Even though several assumptions underlie these projections, the importance of this work cannot be overestimated,” Andreas P. Kalogeropoulos, MD, MPH, PhD, and Javed Butler, MD, MPH, MBA, wrote in an accompanying editorial. “The absolute numbers are staggering.”

From 2025 to 2060, the number of people with any one of four CV risk factors – type 2 diabetes, hypertension, dyslipidemia, and obesity – is projected to increase by 15.4 million, to 34.7 million.

And the number of people with of any one of four CV disease types – ischemic heart disease, heart failure, MI, and stroke – is projected to increase by 3.2 million, to 6.8 million.

Although the model predicts that the prevalence of CV risk factors will gradually decrease among White Americans, the highest prevalence of CV risk factors will be among the White population because of its overall size.

Conversely, the projected prevalence of CV risk factors is expected to increase in Black, Hispanic, Asian, and other race/ethnicity populations.

In parallel, the prevalence of CV disease is projected to decrease in the White population and increase among all other race/ethnicities, particularly in the Black and Hispanic populations.

Courtesy Massachusetts General Hospital

“Our results project a worrisome increase with a particularly ominous increase in risk factors and disease in our most vulnerable patients, including Blacks and Hispanics,” senior author James L. Januzzi Jr., MD, summarized in a video issued by the society.

“The steep rise in CV risk factors and disease reflects the generally higher prevalence in populations projected to increase in the United States, owing to immigration and growth, including Black or Hispanic individuals,” Dr. Januzzi, also from Massachusetts General and Harvard, said in an interview.

“The disproportionate size of the risk is expected in a sense, as minority populations are disproportionately disadvantaged with respect to their health care,” he said. “But whether it is expected or not, the increase in projected prevalence is, nonetheless, concerning and a call to action.”

This study identifies “areas of opportunity for change in the U.S. health care system,” he continued. “Business as usual will result in us encountering a huge number of individuals with CV risk factors and diseases.”

The results from the current analysis assume there will be no modification in health care policies or changes in access to care for at-risk populations, Dr. Mohebi and colleagues noted.

To “stem the rising tide of CV disease in at-risk individuals,” would require strategies such as “emphasis on education regarding CV risk factors, improving access to quality healthcare, and facilitating lower-cost access to effective therapies for treatment of CV risk factors,” according to the researchers.

“Such advances need to be applied in a more equitable way throughout the United States, however,” they cautioned.
 

Census plus NHANES data

The researchers used 2020 U.S. census data and projected growth and 2013-2018 U.S. National Health and Nutrition Survey data to estimate the number of people with CV risk factors and CV disease from 2025 to 2060.

The estimates are based on a growing population and a fixed frequency.

Changing demographic landscape

It is “striking” that the numbers of non-White individuals with CV risk factors is projected to surpass the number of White individuals over time, and the number of non-White individuals with CV disease will be almost as many as White individuals by the year 2060, the editorialists noted.

“From a policy perspective, this means that unless appropriate, targeted action is taken, disparities in the burden of cardiovascular disease are only going to be exacerbated over time,” wrote Dr. Kalogeropoulos, from Stony Brook (N.Y.) University, and Dr. Butler, from Baylor College of Medicine, Dallas.

“On the positive side,” they continued, “the absolute increase in the percent prevalence of cardiovascular risk factors and conditions is projected to lie within a manageable range,” assuming that specific prevention policies are implemented.

“This is an opportunity for professional societies, including the cardiovascular care community, to re-evaluate priorities and strategies, for both training and practice, to best match the growing demands of a changing demographic landscape in the United States,” Dr. Kalogeropoulos and Dr. Butler concluded.

Dr. Mohebi is supported by the Barry Fellowship. Dr. Januzzi is supported by the Hutter Family Professorship; is a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; has received grant support from Abbott Diagnostics, Applied Therapeutics, Innolife, and Novartis; has received consulting income from Abbott Diagnostics, Boehringer Ingelheim, Janssen, Novartis, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for AbbVie, Siemens, Takeda, and Vifor. Dr. Kalogeropoulos has received research funding from the National Heart, Lung, and Blood Institute; the American Heart Association; and the Centers for Disease Control and Prevention. Dr. Butler has been a consultant for numerous pharmaceutical companies.

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

Pulse oximetry is a vital monitoring tool in the ICU and in pulmonary medicine. Regrettably, re-emerging data show that pulse oximeters do not accurately measure blood oxygen levels in Black patients, presumably due to their skin tone. Patients with darker skin are, therefore, more likely to experience occult hypoxemia (i.e., low arterial oxygen saturation despite a seemingly normal pulse oximetry reading). While inaccuracy of pulse oximeter measurements in patients with darker skin has been recognized for decades, recent studies have highlighted this as an ongoing problem with potentially severe consequences for Black patients and other patients of color.

One recent study found that Black patients had almost three times the likelihood of occult hypoxemia compared with White patients (Sjoding, MW, et al. N Engl J Med. 2020;383[25]:2477-8).

Subsequent studies have confirmed this to be a widespread problem across various clinical settings in hundreds of hospitals (Wong AI, et al. JAMA Netw Open. 2021;4[11]:e2131674; Valbuena VS, et al. Chest. 2022;161[4]:971-8). A recent retrospective cohort study of patients with COVID-19 found that occult hypoxemia in Black and Hispanic patients was associated with delayed eligibility for potentially lifesaving COVID-19 therapies (Fawzy AF, et al. JAMA Intern Med. 2022; published online May 31, 2022).

Now that numerous studies have demonstrated the inaccuracy of pulse oximetry with the potential to cause harm to historically marginalized racial and ethnic groups, must we abandon the use of pulse oximetry? We would argue that pulse oximeters remain valuable tools, but for now, we must adapt our practice until better devices are widely adopted.

First, it is crucial that health professionals are aware that pulse oximeters may underestimate the true extent of hypoxemia for all patients, but particularly for patients with darker skin. Acknowledging this device flaw is essential to avoid harm to our patients.

Second, clinicians must have heightened skepticism for seemingly normal pulse oximetry values when caring for symptomatic patients at risk of occult hypoxemia.

Until better pulse oximeters are widely available, clinicians must consider workarounds aimed at ensuring timely identification of hypoxemia in Black patients and other patients of color.

These patients may need invasive monitoring of arterial oxygenation, including arterial blood gas checks or an arterial catheter. However, invasive monitoring comes at the cost of discomfort to patients and potential complications, such as vessel or nerve damage.

Invasive monitoring of patients at risk for occult hypoxemia is not an equitable or acceptable long-term solution for this problem. As advocates for patients, clinicians and professional organizations should lobby regulatory bodies to ensure pulse oximeters are accurate for all patients.

We must also call on government leaders to move this process forward. For example, in response to efforts by the United Kingdom’s Intensive Care Society, the Health Secretary of the UK, Sajid Javid, has called for a review of pulse oximeters as part of a larger review assessing structural issues in health care that lead to worse outcomes in racial and ethnic minorities (BBC News. https://www.bbc.com/news/uk-59363544. Published online Nov. 21, 2021).

Device companies are largely for-profit corporations with obligations to their shareholders. It seems that existing incentives are insufficient to motivate investment in less biased technology and real-world evaluations of their devices.

We previously called for buyers of pulse oximeters to change the incentives of device companies – that is, for “hospitals to commit to only purchasing pulse oximeters that have been shown to work equally well in patients of colour.” (Hidalgo DC, et al. Lancet Respir Med. 2021;9[4]:E37). And, indeed, we worry that hospitals are putting themselves at medicolegal risk by not raising their purchasing standards. Since it is now widely known that pulse oximeters are inaccurate in certain patients, could there be liability for hospitals that continue to use devices we know to be disproportionately inaccurate by race?

Pulse oximetry is a vital monitoring tool in the ICU and in pulmonary medicine. Regrettably, re-emerging data show that pulse oximeters do not accurately measure blood oxygen levels in Black patients, presumably due to their skin tone. Patients with darker skin are, therefore, more likely to experience occult hypoxemia (i.e., low arterial oxygen saturation despite a seemingly normal pulse oximetry reading). While inaccuracy of pulse oximeter measurements in patients with darker skin has been recognized for decades, recent studies have highlighted this as an ongoing problem with potentially severe consequences for Black patients and other patients of color.

One recent study found that Black patients had almost three times the likelihood of occult hypoxemia compared with White patients (Sjoding, MW, et al. N Engl J Med. 2020;383[25]:2477-8).

Subsequent studies have confirmed this to be a widespread problem across various clinical settings in hundreds of hospitals (Wong AI, et al. JAMA Netw Open. 2021;4[11]:e2131674; Valbuena VS, et al. Chest. 2022;161[4]:971-8). A recent retrospective cohort study of patients with COVID-19 found that occult hypoxemia in Black and Hispanic patients was associated with delayed eligibility for potentially lifesaving COVID-19 therapies (Fawzy AF, et al. JAMA Intern Med. 2022; published online May 31, 2022).

Now that numerous studies have demonstrated the inaccuracy of pulse oximetry with the potential to cause harm to historically marginalized racial and ethnic groups, must we abandon the use of pulse oximetry? We would argue that pulse oximeters remain valuable tools, but for now, we must adapt our practice until better devices are widely adopted.

First, it is crucial that health professionals are aware that pulse oximeters may underestimate the true extent of hypoxemia for all patients, but particularly for patients with darker skin. Acknowledging this device flaw is essential to avoid harm to our patients.

Second, clinicians must have heightened skepticism for seemingly normal pulse oximetry values when caring for symptomatic patients at risk of occult hypoxemia.

Until better pulse oximeters are widely available, clinicians must consider workarounds aimed at ensuring timely identification of hypoxemia in Black patients and other patients of color.

These patients may need invasive monitoring of arterial oxygenation, including arterial blood gas checks or an arterial catheter. However, invasive monitoring comes at the cost of discomfort to patients and potential complications, such as vessel or nerve damage.

Invasive monitoring of patients at risk for occult hypoxemia is not an equitable or acceptable long-term solution for this problem. As advocates for patients, clinicians and professional organizations should lobby regulatory bodies to ensure pulse oximeters are accurate for all patients.

We must also call on government leaders to move this process forward. For example, in response to efforts by the United Kingdom’s Intensive Care Society, the Health Secretary of the UK, Sajid Javid, has called for a review of pulse oximeters as part of a larger review assessing structural issues in health care that lead to worse outcomes in racial and ethnic minorities (BBC News. https://www.bbc.com/news/uk-59363544. Published online Nov. 21, 2021).

Device companies are largely for-profit corporations with obligations to their shareholders. It seems that existing incentives are insufficient to motivate investment in less biased technology and real-world evaluations of their devices.

We previously called for buyers of pulse oximeters to change the incentives of device companies – that is, for “hospitals to commit to only purchasing pulse oximeters that have been shown to work equally well in patients of colour.” (Hidalgo DC, et al. Lancet Respir Med. 2021;9[4]:E37). And, indeed, we worry that hospitals are putting themselves at medicolegal risk by not raising their purchasing standards. Since it is now widely known that pulse oximeters are inaccurate in certain patients, could there be liability for hospitals that continue to use devices we know to be disproportionately inaccurate by race?

Pulse oximetry is a vital monitoring tool in the ICU and in pulmonary medicine. Regrettably, re-emerging data show that pulse oximeters do not accurately measure blood oxygen levels in Black patients, presumably due to their skin tone. Patients with darker skin are, therefore, more likely to experience occult hypoxemia (i.e., low arterial oxygen saturation despite a seemingly normal pulse oximetry reading). While inaccuracy of pulse oximeter measurements in patients with darker skin has been recognized for decades, recent studies have highlighted this as an ongoing problem with potentially severe consequences for Black patients and other patients of color.

One recent study found that Black patients had almost three times the likelihood of occult hypoxemia compared with White patients (Sjoding, MW, et al. N Engl J Med. 2020;383[25]:2477-8).

Subsequent studies have confirmed this to be a widespread problem across various clinical settings in hundreds of hospitals (Wong AI, et al. JAMA Netw Open. 2021;4[11]:e2131674; Valbuena VS, et al. Chest. 2022;161[4]:971-8). A recent retrospective cohort study of patients with COVID-19 found that occult hypoxemia in Black and Hispanic patients was associated with delayed eligibility for potentially lifesaving COVID-19 therapies (Fawzy AF, et al. JAMA Intern Med. 2022; published online May 31, 2022).

Now that numerous studies have demonstrated the inaccuracy of pulse oximetry with the potential to cause harm to historically marginalized racial and ethnic groups, must we abandon the use of pulse oximetry? We would argue that pulse oximeters remain valuable tools, but for now, we must adapt our practice until better devices are widely adopted.

First, it is crucial that health professionals are aware that pulse oximeters may underestimate the true extent of hypoxemia for all patients, but particularly for patients with darker skin. Acknowledging this device flaw is essential to avoid harm to our patients.

Second, clinicians must have heightened skepticism for seemingly normal pulse oximetry values when caring for symptomatic patients at risk of occult hypoxemia.

Until better pulse oximeters are widely available, clinicians must consider workarounds aimed at ensuring timely identification of hypoxemia in Black patients and other patients of color.

These patients may need invasive monitoring of arterial oxygenation, including arterial blood gas checks or an arterial catheter. However, invasive monitoring comes at the cost of discomfort to patients and potential complications, such as vessel or nerve damage.

Invasive monitoring of patients at risk for occult hypoxemia is not an equitable or acceptable long-term solution for this problem. As advocates for patients, clinicians and professional organizations should lobby regulatory bodies to ensure pulse oximeters are accurate for all patients.

We must also call on government leaders to move this process forward. For example, in response to efforts by the United Kingdom’s Intensive Care Society, the Health Secretary of the UK, Sajid Javid, has called for a review of pulse oximeters as part of a larger review assessing structural issues in health care that lead to worse outcomes in racial and ethnic minorities (BBC News. https://www.bbc.com/news/uk-59363544. Published online Nov. 21, 2021).

Device companies are largely for-profit corporations with obligations to their shareholders. It seems that existing incentives are insufficient to motivate investment in less biased technology and real-world evaluations of their devices.

We previously called for buyers of pulse oximeters to change the incentives of device companies – that is, for “hospitals to commit to only purchasing pulse oximeters that have been shown to work equally well in patients of colour.” (Hidalgo DC, et al. Lancet Respir Med. 2021;9[4]:E37). And, indeed, we worry that hospitals are putting themselves at medicolegal risk by not raising their purchasing standards. Since it is now widely known that pulse oximeters are inaccurate in certain patients, could there be liability for hospitals that continue to use devices we know to be disproportionately inaccurate by race?

The Pulmonary Fibrosis Foundation (PFF) has launched a new initiative in which they hope to capture a far more diverse representation of patients with pulmonary fibrosis (PF) than the current registry allows them to do, a press release from the PFF indicated.

“The existing registry we have – the PFF Patient Registry – is limited to our care centers, which are primarily academic clinical institutions and we have only a few thousand patients within that registry,” Junelle Speller, MBA, vice president of the PFF Registry, told this news organization.

“We wanted to go beyond these care centers and capture patients in community centers, and in rural settings to provide a more complete understanding of patients with this disease and, of course, have a larger sample size,” she added.

“So, the major impetus behind the PFF Community Registry was to gather a more diverse representative sample of PF patients across all parts of the United States and, most importantly, accelerate the research on PF toward improving earlier diagnosis, treatment, and outcomes for these patients,” Ms. Speller said.
 

Passive versus active

The PFF Community Registry differs in its structure and purpose from the PFF Patient Registry, as Ms. Speller explained. First, the PFF Patient Registry, established in 2016, is “passive” in its nature in that whatever information is entered into a patient’s electronic medical record or clinical chart on a routine office visit is abstracted and captured in the registry. By contrast, the PFF Community Registry is asking for self-reported data from patients, “so it’s more of an ‘active’ registry and will give us a chance to have a bidirectional connection with participants, provide email updates and newsletters, and give patients an opportunity to participate in future studies within the registry as well as in clinical trials,” she noted.

The two registries still overlap in that both capture demographic data on patients’ medical and family histories as well as any medications patients may be taking, but the Community Registry will also capture information with respect to education, employment, patient-reported outcomes, and quality of life metrics. “It will also let us know how patients feel about continued education on the disease itself and patient participation in support groups,” Ms. Speller observed.

The Community Registry will also collect information from lung transplant recipients who have had PF or any other form of interstitial lung disease (ILD) as well as information from caregivers and family members affected by the patient’s disease. As Ms. Speller noted, both PF and other forms of ILD (of which there are more than 200 types) are all characterized by inflammation or scarring in the lung. “Patients are often misdiagnosed, and it can take months, even years, to identify the disease,” Ms. Speller said.

From there, it can be a very long and difficult road ahead, with no cure in sight, although several antifibrotic drugs do help slow disease progression. Typically, onset is around the age of 60 and symptoms include chronic dry cough, fatigue, shortness of breath, weakness, discomfort in the chest, and sometimes unexplained weight loss. Some patients do have a history of smoking, but not all, Ms. Speller noted. So far, registry data suggest PF largely occurs in White patients.

“We’re very excited about the Community Registry, particularly about reaching into communities that we haven’t been able to reach with our existing registry,” Ms. Speller noted. “The rural population in particular is often underserved, so we are really looking forward to capturing data from these patients as well as those from community centers within smaller and larger cities,” she observed.

“A powerful aspect of the Community Registry is that we can use the information gained from it to understand the experience of individuals living with PF, and how it impacts their lives and those of their families and caregivers,” Kevin Flaherty, MD, steering committee chair, PFF Registry, said in a statement.

“Researchers can also look at the data to better understand fibrotic lung diseases and learn about effective approaches to improve patient care,” he added.

Patients who wish to join the PFF Community Registry can sign up at pffregistry.org. To learn more about PF and its risk factors, readers are invited to visit www.AboutPF.org. More than 250,000 patients in the United States are living with either PF or other types of ILD.

Ms. Speller and Dr. Flaherty disclosed no financial conflicts of interest. The PFF Registry is supported by its founding partner, Genentech, Visionary Partner, United Therapeutics, and its sustaining partner, Boehringer Ingelheim, as well as many donors.

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

This article was updated 8/8/22.

The Pulmonary Fibrosis Foundation (PFF) has launched a new initiative in which they hope to capture a far more diverse representation of patients with pulmonary fibrosis (PF) than the current registry allows them to do, a press release from the PFF indicated.

“The existing registry we have – the PFF Patient Registry – is limited to our care centers, which are primarily academic clinical institutions and we have only a few thousand patients within that registry,” Junelle Speller, MBA, vice president of the PFF Registry, told this news organization.

“We wanted to go beyond these care centers and capture patients in community centers, and in rural settings to provide a more complete understanding of patients with this disease and, of course, have a larger sample size,” she added.

“So, the major impetus behind the PFF Community Registry was to gather a more diverse representative sample of PF patients across all parts of the United States and, most importantly, accelerate the research on PF toward improving earlier diagnosis, treatment, and outcomes for these patients,” Ms. Speller said.
 

Passive versus active

The PFF Community Registry differs in its structure and purpose from the PFF Patient Registry, as Ms. Speller explained. First, the PFF Patient Registry, established in 2016, is “passive” in its nature in that whatever information is entered into a patient’s electronic medical record or clinical chart on a routine office visit is abstracted and captured in the registry. By contrast, the PFF Community Registry is asking for self-reported data from patients, “so it’s more of an ‘active’ registry and will give us a chance to have a bidirectional connection with participants, provide email updates and newsletters, and give patients an opportunity to participate in future studies within the registry as well as in clinical trials,” she noted.

The two registries still overlap in that both capture demographic data on patients’ medical and family histories as well as any medications patients may be taking, but the Community Registry will also capture information with respect to education, employment, patient-reported outcomes, and quality of life metrics. “It will also let us know how patients feel about continued education on the disease itself and patient participation in support groups,” Ms. Speller observed.

The Community Registry will also collect information from lung transplant recipients who have had PF or any other form of interstitial lung disease (ILD) as well as information from caregivers and family members affected by the patient’s disease. As Ms. Speller noted, both PF and other forms of ILD (of which there are more than 200 types) are all characterized by inflammation or scarring in the lung. “Patients are often misdiagnosed, and it can take months, even years, to identify the disease,” Ms. Speller said.

From there, it can be a very long and difficult road ahead, with no cure in sight, although several antifibrotic drugs do help slow disease progression. Typically, onset is around the age of 60 and symptoms include chronic dry cough, fatigue, shortness of breath, weakness, discomfort in the chest, and sometimes unexplained weight loss. Some patients do have a history of smoking, but not all, Ms. Speller noted. So far, registry data suggest PF largely occurs in White patients.

“We’re very excited about the Community Registry, particularly about reaching into communities that we haven’t been able to reach with our existing registry,” Ms. Speller noted. “The rural population in particular is often underserved, so we are really looking forward to capturing data from these patients as well as those from community centers within smaller and larger cities,” she observed.

“A powerful aspect of the Community Registry is that we can use the information gained from it to understand the experience of individuals living with PF, and how it impacts their lives and those of their families and caregivers,” Kevin Flaherty, MD, steering committee chair, PFF Registry, said in a statement.

“Researchers can also look at the data to better understand fibrotic lung diseases and learn about effective approaches to improve patient care,” he added.

Patients who wish to join the PFF Community Registry can sign up at pffregistry.org. To learn more about PF and its risk factors, readers are invited to visit www.AboutPF.org. More than 250,000 patients in the United States are living with either PF or other types of ILD.

Ms. Speller and Dr. Flaherty disclosed no financial conflicts of interest. The PFF Registry is supported by its founding partner, Genentech, Visionary Partner, United Therapeutics, and its sustaining partner, Boehringer Ingelheim, as well as many donors.

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

This article was updated 8/8/22.

The Pulmonary Fibrosis Foundation (PFF) has launched a new initiative in which they hope to capture a far more diverse representation of patients with pulmonary fibrosis (PF) than the current registry allows them to do, a press release from the PFF indicated.

“The existing registry we have – the PFF Patient Registry – is limited to our care centers, which are primarily academic clinical institutions and we have only a few thousand patients within that registry,” Junelle Speller, MBA, vice president of the PFF Registry, told this news organization.

“We wanted to go beyond these care centers and capture patients in community centers, and in rural settings to provide a more complete understanding of patients with this disease and, of course, have a larger sample size,” she added.

“So, the major impetus behind the PFF Community Registry was to gather a more diverse representative sample of PF patients across all parts of the United States and, most importantly, accelerate the research on PF toward improving earlier diagnosis, treatment, and outcomes for these patients,” Ms. Speller said.
 

Passive versus active

The PFF Community Registry differs in its structure and purpose from the PFF Patient Registry, as Ms. Speller explained. First, the PFF Patient Registry, established in 2016, is “passive” in its nature in that whatever information is entered into a patient’s electronic medical record or clinical chart on a routine office visit is abstracted and captured in the registry. By contrast, the PFF Community Registry is asking for self-reported data from patients, “so it’s more of an ‘active’ registry and will give us a chance to have a bidirectional connection with participants, provide email updates and newsletters, and give patients an opportunity to participate in future studies within the registry as well as in clinical trials,” she noted.

The two registries still overlap in that both capture demographic data on patients’ medical and family histories as well as any medications patients may be taking, but the Community Registry will also capture information with respect to education, employment, patient-reported outcomes, and quality of life metrics. “It will also let us know how patients feel about continued education on the disease itself and patient participation in support groups,” Ms. Speller observed.

The Community Registry will also collect information from lung transplant recipients who have had PF or any other form of interstitial lung disease (ILD) as well as information from caregivers and family members affected by the patient’s disease. As Ms. Speller noted, both PF and other forms of ILD (of which there are more than 200 types) are all characterized by inflammation or scarring in the lung. “Patients are often misdiagnosed, and it can take months, even years, to identify the disease,” Ms. Speller said.

From there, it can be a very long and difficult road ahead, with no cure in sight, although several antifibrotic drugs do help slow disease progression. Typically, onset is around the age of 60 and symptoms include chronic dry cough, fatigue, shortness of breath, weakness, discomfort in the chest, and sometimes unexplained weight loss. Some patients do have a history of smoking, but not all, Ms. Speller noted. So far, registry data suggest PF largely occurs in White patients.

“We’re very excited about the Community Registry, particularly about reaching into communities that we haven’t been able to reach with our existing registry,” Ms. Speller noted. “The rural population in particular is often underserved, so we are really looking forward to capturing data from these patients as well as those from community centers within smaller and larger cities,” she observed.

“A powerful aspect of the Community Registry is that we can use the information gained from it to understand the experience of individuals living with PF, and how it impacts their lives and those of their families and caregivers,” Kevin Flaherty, MD, steering committee chair, PFF Registry, said in a statement.

“Researchers can also look at the data to better understand fibrotic lung diseases and learn about effective approaches to improve patient care,” he added.

Patients who wish to join the PFF Community Registry can sign up at pffregistry.org. To learn more about PF and its risk factors, readers are invited to visit www.AboutPF.org. More than 250,000 patients in the United States are living with either PF or other types of ILD.

Ms. Speller and Dr. Flaherty disclosed no financial conflicts of interest. The PFF Registry is supported by its founding partner, Genentech, Visionary Partner, United Therapeutics, and its sustaining partner, Boehringer Ingelheim, as well as many donors.

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

This article was updated 8/8/22.

Over the last several years, hundreds of millions of dollars have been spent on robotic bronchoscopy systems in the United States. The release of robotic scopes was made to great fanfare, translating into the market being infiltrated with these systems. With base costs in the hundreds of thousands of dollars, robotic bronchoscope systems are easily the most expensive singular capital investment in the bronchoscopy suite. I frequently get asked questions from those who have not yet made that purchase: “Should I buy a robot?” “How could I justify a new robot purchase to my hospital?” “Is the hype real?” These are complex questions to answer. Before one can answer, I think it’s best to look back on the last 2 decades of bronchoscopy for peripheral lung nodules to get a better understanding of the value proposition robotic bronchoscopes may offer.

Guided bronchoscopy for lung nodules has significantly evolved over the past 2 decades, shifting diagnostic procedures from interventional radiologist to the pulmonologist. Some of these advances were based in redesigns of the bronchoscope (ultrathin bronchoscopy) or application of technology to the bronchoscope (radial EBUS, virtual bronchoscopy); but, these were not broadly applicable to the pulmonology community at large. It was not until the development of electromagnetic navigational bronchoscopy (ENB) that widespread adoption of bronchoscopy for lung nodules occurred. By and large, ENB fueled a rapid expansion of nodule bronchoscopy, mainly due to its ease of use and novel approach. Initial studies of ENB had impressive results; however, studies were criticized for having small numbers, inadequate follow-up, spurious definitions of yield, and that they were being done at highly specialized centers. The NAVIGATE trial was launched to address these criticisms among “real world” conditions. Sponsored by Medtronic, it studied ENB (superDimension platform, v6.0 or higher) across 29 academic and medical centers in the United States, enrolling over 1,000 patients (Folch EE, et al. J Thorac Oncol. 2019;14[3]:445-58. Epub 2018 Nov 23), and reported a diagnostic yield of 73%.

This led to a drive to improve upon yield, resulting in development of new technologies specifically designed to address some of the factors thought associated with diminished yield, and, out of this, robotic bronchoscopy was born. These factors included CT scan-body registration divergence, deflection of the extended working channel (EWC) by rigid biopsy tools, and inability to accurately “aim” the EWC-biopsy tool at the nodule; these were especially problematic in nodules not associated with airways. Robotic scopes were specifically designed to reach into the peripheral lung airways similar to an EWC, but with better structural integrity and steerability. This tip integrity would resist tool-related displacement, and steerability would allow for improved targeting of nodules during the biopsy.

There are two robots approved by the FDA at the time of this writing (Auris Monarch, Intuitive Ion), with a third awaiting FDA clearance (Noah Galaxy). In general, though the engineering of the robotic scopes to improve structural tip integrity are similar, the approach to navigation and targeting vary significantly. The Monarch platform uses electromagnetic guidance, similar to other traditional ENB platforms. The Ion platform does not use ENB; instead, it uses fiberoptic shape sensing technology, which analyzes the shape and orientation of the scope to provide location information. There are potential advantages to shape sensing, the most notable being the absence of electromagnetics; this allows for use of fluoroscopy during the procedure, which otherwise would have interfered with ENB-based navigation. There are other subtle differences between the two robots. The Monarch uses a scope-in-scope design, with a robotic scope contained within a robotic sheath; the Ion uses a single robotic scope. The Ion scope diameter is 3.5 mm, whereas the Monarch diameter is 4.4 mm; this may be a potential advantage when having to navigate through smaller airways.

So, which robot is better suited to reach peripheral nodules more consistently and accurately? I get asked this question a lot, since I have both platforms at my institution. But, answering with my own opinion based on my institution’s anecdotal experience would be irresponsible. I’m more of a “what does the data show?” person. Luckily, we do have clinical trials in both robot technologies. It should be noted here that there will likely never be a head-to-head randomized trial, so evaluating published studies with each platform is going to be the best method we have for comparison going forward, albeit an imperfect one. It should also be noted that many of the early robotic bronchoscopy trials have to be looked at with caution, as yield definitions tended not to be conservative and/or the follow-up of non-malignant was not robust. With that in mind, let’s review representative high-quality studies for each platform.

The best study to date using the Ion platform came out of Memorial Sloan Kettering Cancer Center (Kalchiem-Dekel O, et al. Chest. 2022;161[2];572-82). This single-site study reported on 159 nodule biopsies, with the primary outcome being diagnostic yield. The patients had 1 year of follow-up, and the definition of yield was conservative. The average lesion size was 18 mm, and nodule locations and characteristics were representative of real-world conditions. Overall diagnostic yield was 81.7%; however, it dropped to under 70% for nodules under 20 mm in size.

The largest study to date using the Monarch platform was also a single center study, this from the University of Chicago (Agrawal, et al. Ann Thorac Surg. 2022 Jan 17;S0003-4975(22)00042-X. Online ahead of print). This study included 124 nodules with at least 12 months of follow-up; diagnostic yield definition was conservative. Median nodule size was 20.5 mm, with distribution and characteristics representative of real-world conditions. Overall accuracy was 77%, and, similar to the Ion study, dropped to under 70% when nodule size was smaller than 20 mm.

Overall, both robot studies seemed to show a modest improvement in diagnostic yield when compared with ENB, and their outcomes were overall similar. It is important to remember that these were studies of each center’s first experiences with early versions of each technology; over time, the technology will continue to improve, as will operator skill and experience, and with that, perhaps improvements in yield will be seen, as well.

Interestingly, both studies evaluated target localization using radial EBUS (rEBUS), which also allowed for airway-nodule relationships to be reported. In Kalchiem-Dekel’s study, 85% of cases used rEBUS to determine localization, and, of these, 91.2% of cases showed accurate localization. In Agrawal’s study, rEBUS was used in all cases with a reported localization of 94%. In both, yield did not seem to be affected by airway-nodule relationships, perhaps explained by more robust tip control of the robotic scope. However, localization did not equate to yield in all cases, which brings up a very important question: Can the yield of robotic bronchoscopy be further improved with better real-time on-board imaging, such as CBCT scanning or C-arm based tomography? Currently, there is a study using 3D technology (Cios 3D Mobile Spin) in conjunction with the Ion platform to evaluate this.

So, let’s circle back to where we started. I think if you look at the totality of the data, it is clear that the robotic platforms currently offer a modest improvement in diagnostic yield over traditional ENB, with individual performances that are somewhat equivalent despite differences in design and operation. But does this improvement in yield justify the cost? Individual hospitals will have to make that decision. The capital cost and per-use price of the scope is significant, which has to be balanced against each center’s current performance with non-robotic bronchoscopy.

To date, there have been over 25,000 robotic procedures performed in the United States, so enthusiasm across diverse centers is being maintained. Whether this enthusiasm is driven by yield or novelty, or both, I’m not sure. With other nonrobotic platforms having reached, or soon to reach, the market, this is a good time to be in the business of bronchoscopy.

Dr. Cicenia is in the Section of Bronchoscopy at Cleveland Clinic’s Respiratory Institute, Cleveland, Ohio.

Over the last several years, hundreds of millions of dollars have been spent on robotic bronchoscopy systems in the United States. The release of robotic scopes was made to great fanfare, translating into the market being infiltrated with these systems. With base costs in the hundreds of thousands of dollars, robotic bronchoscope systems are easily the most expensive singular capital investment in the bronchoscopy suite. I frequently get asked questions from those who have not yet made that purchase: “Should I buy a robot?” “How could I justify a new robot purchase to my hospital?” “Is the hype real?” These are complex questions to answer. Before one can answer, I think it’s best to look back on the last 2 decades of bronchoscopy for peripheral lung nodules to get a better understanding of the value proposition robotic bronchoscopes may offer.

Guided bronchoscopy for lung nodules has significantly evolved over the past 2 decades, shifting diagnostic procedures from interventional radiologist to the pulmonologist. Some of these advances were based in redesigns of the bronchoscope (ultrathin bronchoscopy) or application of technology to the bronchoscope (radial EBUS, virtual bronchoscopy); but, these were not broadly applicable to the pulmonology community at large. It was not until the development of electromagnetic navigational bronchoscopy (ENB) that widespread adoption of bronchoscopy for lung nodules occurred. By and large, ENB fueled a rapid expansion of nodule bronchoscopy, mainly due to its ease of use and novel approach. Initial studies of ENB had impressive results; however, studies were criticized for having small numbers, inadequate follow-up, spurious definitions of yield, and that they were being done at highly specialized centers. The NAVIGATE trial was launched to address these criticisms among “real world” conditions. Sponsored by Medtronic, it studied ENB (superDimension platform, v6.0 or higher) across 29 academic and medical centers in the United States, enrolling over 1,000 patients (Folch EE, et al. J Thorac Oncol. 2019;14[3]:445-58. Epub 2018 Nov 23), and reported a diagnostic yield of 73%.

This led to a drive to improve upon yield, resulting in development of new technologies specifically designed to address some of the factors thought associated with diminished yield, and, out of this, robotic bronchoscopy was born. These factors included CT scan-body registration divergence, deflection of the extended working channel (EWC) by rigid biopsy tools, and inability to accurately “aim” the EWC-biopsy tool at the nodule; these were especially problematic in nodules not associated with airways. Robotic scopes were specifically designed to reach into the peripheral lung airways similar to an EWC, but with better structural integrity and steerability. This tip integrity would resist tool-related displacement, and steerability would allow for improved targeting of nodules during the biopsy.

There are two robots approved by the FDA at the time of this writing (Auris Monarch, Intuitive Ion), with a third awaiting FDA clearance (Noah Galaxy). In general, though the engineering of the robotic scopes to improve structural tip integrity are similar, the approach to navigation and targeting vary significantly. The Monarch platform uses electromagnetic guidance, similar to other traditional ENB platforms. The Ion platform does not use ENB; instead, it uses fiberoptic shape sensing technology, which analyzes the shape and orientation of the scope to provide location information. There are potential advantages to shape sensing, the most notable being the absence of electromagnetics; this allows for use of fluoroscopy during the procedure, which otherwise would have interfered with ENB-based navigation. There are other subtle differences between the two robots. The Monarch uses a scope-in-scope design, with a robotic scope contained within a robotic sheath; the Ion uses a single robotic scope. The Ion scope diameter is 3.5 mm, whereas the Monarch diameter is 4.4 mm; this may be a potential advantage when having to navigate through smaller airways.

So, which robot is better suited to reach peripheral nodules more consistently and accurately? I get asked this question a lot, since I have both platforms at my institution. But, answering with my own opinion based on my institution’s anecdotal experience would be irresponsible. I’m more of a “what does the data show?” person. Luckily, we do have clinical trials in both robot technologies. It should be noted here that there will likely never be a head-to-head randomized trial, so evaluating published studies with each platform is going to be the best method we have for comparison going forward, albeit an imperfect one. It should also be noted that many of the early robotic bronchoscopy trials have to be looked at with caution, as yield definitions tended not to be conservative and/or the follow-up of non-malignant was not robust. With that in mind, let’s review representative high-quality studies for each platform.

The best study to date using the Ion platform came out of Memorial Sloan Kettering Cancer Center (Kalchiem-Dekel O, et al. Chest. 2022;161[2];572-82). This single-site study reported on 159 nodule biopsies, with the primary outcome being diagnostic yield. The patients had 1 year of follow-up, and the definition of yield was conservative. The average lesion size was 18 mm, and nodule locations and characteristics were representative of real-world conditions. Overall diagnostic yield was 81.7%; however, it dropped to under 70% for nodules under 20 mm in size.

The largest study to date using the Monarch platform was also a single center study, this from the University of Chicago (Agrawal, et al. Ann Thorac Surg. 2022 Jan 17;S0003-4975(22)00042-X. Online ahead of print). This study included 124 nodules with at least 12 months of follow-up; diagnostic yield definition was conservative. Median nodule size was 20.5 mm, with distribution and characteristics representative of real-world conditions. Overall accuracy was 77%, and, similar to the Ion study, dropped to under 70% when nodule size was smaller than 20 mm.

Overall, both robot studies seemed to show a modest improvement in diagnostic yield when compared with ENB, and their outcomes were overall similar. It is important to remember that these were studies of each center’s first experiences with early versions of each technology; over time, the technology will continue to improve, as will operator skill and experience, and with that, perhaps improvements in yield will be seen, as well.

Interestingly, both studies evaluated target localization using radial EBUS (rEBUS), which also allowed for airway-nodule relationships to be reported. In Kalchiem-Dekel’s study, 85% of cases used rEBUS to determine localization, and, of these, 91.2% of cases showed accurate localization. In Agrawal’s study, rEBUS was used in all cases with a reported localization of 94%. In both, yield did not seem to be affected by airway-nodule relationships, perhaps explained by more robust tip control of the robotic scope. However, localization did not equate to yield in all cases, which brings up a very important question: Can the yield of robotic bronchoscopy be further improved with better real-time on-board imaging, such as CBCT scanning or C-arm based tomography? Currently, there is a study using 3D technology (Cios 3D Mobile Spin) in conjunction with the Ion platform to evaluate this.

So, let’s circle back to where we started. I think if you look at the totality of the data, it is clear that the robotic platforms currently offer a modest improvement in diagnostic yield over traditional ENB, with individual performances that are somewhat equivalent despite differences in design and operation. But does this improvement in yield justify the cost? Individual hospitals will have to make that decision. The capital cost and per-use price of the scope is significant, which has to be balanced against each center’s current performance with non-robotic bronchoscopy.

To date, there have been over 25,000 robotic procedures performed in the United States, so enthusiasm across diverse centers is being maintained. Whether this enthusiasm is driven by yield or novelty, or both, I’m not sure. With other nonrobotic platforms having reached, or soon to reach, the market, this is a good time to be in the business of bronchoscopy.

Dr. Cicenia is in the Section of Bronchoscopy at Cleveland Clinic’s Respiratory Institute, Cleveland, Ohio.

Over the last several years, hundreds of millions of dollars have been spent on robotic bronchoscopy systems in the United States. The release of robotic scopes was made to great fanfare, translating into the market being infiltrated with these systems. With base costs in the hundreds of thousands of dollars, robotic bronchoscope systems are easily the most expensive singular capital investment in the bronchoscopy suite. I frequently get asked questions from those who have not yet made that purchase: “Should I buy a robot?” “How could I justify a new robot purchase to my hospital?” “Is the hype real?” These are complex questions to answer. Before one can answer, I think it’s best to look back on the last 2 decades of bronchoscopy for peripheral lung nodules to get a better understanding of the value proposition robotic bronchoscopes may offer.

Guided bronchoscopy for lung nodules has significantly evolved over the past 2 decades, shifting diagnostic procedures from interventional radiologist to the pulmonologist. Some of these advances were based in redesigns of the bronchoscope (ultrathin bronchoscopy) or application of technology to the bronchoscope (radial EBUS, virtual bronchoscopy); but, these were not broadly applicable to the pulmonology community at large. It was not until the development of electromagnetic navigational bronchoscopy (ENB) that widespread adoption of bronchoscopy for lung nodules occurred. By and large, ENB fueled a rapid expansion of nodule bronchoscopy, mainly due to its ease of use and novel approach. Initial studies of ENB had impressive results; however, studies were criticized for having small numbers, inadequate follow-up, spurious definitions of yield, and that they were being done at highly specialized centers. The NAVIGATE trial was launched to address these criticisms among “real world” conditions. Sponsored by Medtronic, it studied ENB (superDimension platform, v6.0 or higher) across 29 academic and medical centers in the United States, enrolling over 1,000 patients (Folch EE, et al. J Thorac Oncol. 2019;14[3]:445-58. Epub 2018 Nov 23), and reported a diagnostic yield of 73%.

This led to a drive to improve upon yield, resulting in development of new technologies specifically designed to address some of the factors thought associated with diminished yield, and, out of this, robotic bronchoscopy was born. These factors included CT scan-body registration divergence, deflection of the extended working channel (EWC) by rigid biopsy tools, and inability to accurately “aim” the EWC-biopsy tool at the nodule; these were especially problematic in nodules not associated with airways. Robotic scopes were specifically designed to reach into the peripheral lung airways similar to an EWC, but with better structural integrity and steerability. This tip integrity would resist tool-related displacement, and steerability would allow for improved targeting of nodules during the biopsy.

There are two robots approved by the FDA at the time of this writing (Auris Monarch, Intuitive Ion), with a third awaiting FDA clearance (Noah Galaxy). In general, though the engineering of the robotic scopes to improve structural tip integrity are similar, the approach to navigation and targeting vary significantly. The Monarch platform uses electromagnetic guidance, similar to other traditional ENB platforms. The Ion platform does not use ENB; instead, it uses fiberoptic shape sensing technology, which analyzes the shape and orientation of the scope to provide location information. There are potential advantages to shape sensing, the most notable being the absence of electromagnetics; this allows for use of fluoroscopy during the procedure, which otherwise would have interfered with ENB-based navigation. There are other subtle differences between the two robots. The Monarch uses a scope-in-scope design, with a robotic scope contained within a robotic sheath; the Ion uses a single robotic scope. The Ion scope diameter is 3.5 mm, whereas the Monarch diameter is 4.4 mm; this may be a potential advantage when having to navigate through smaller airways.

So, which robot is better suited to reach peripheral nodules more consistently and accurately? I get asked this question a lot, since I have both platforms at my institution. But, answering with my own opinion based on my institution’s anecdotal experience would be irresponsible. I’m more of a “what does the data show?” person. Luckily, we do have clinical trials in both robot technologies. It should be noted here that there will likely never be a head-to-head randomized trial, so evaluating published studies with each platform is going to be the best method we have for comparison going forward, albeit an imperfect one. It should also be noted that many of the early robotic bronchoscopy trials have to be looked at with caution, as yield definitions tended not to be conservative and/or the follow-up of non-malignant was not robust. With that in mind, let’s review representative high-quality studies for each platform.

The best study to date using the Ion platform came out of Memorial Sloan Kettering Cancer Center (Kalchiem-Dekel O, et al. Chest. 2022;161[2];572-82). This single-site study reported on 159 nodule biopsies, with the primary outcome being diagnostic yield. The patients had 1 year of follow-up, and the definition of yield was conservative. The average lesion size was 18 mm, and nodule locations and characteristics were representative of real-world conditions. Overall diagnostic yield was 81.7%; however, it dropped to under 70% for nodules under 20 mm in size.

The largest study to date using the Monarch platform was also a single center study, this from the University of Chicago (Agrawal, et al. Ann Thorac Surg. 2022 Jan 17;S0003-4975(22)00042-X. Online ahead of print). This study included 124 nodules with at least 12 months of follow-up; diagnostic yield definition was conservative. Median nodule size was 20.5 mm, with distribution and characteristics representative of real-world conditions. Overall accuracy was 77%, and, similar to the Ion study, dropped to under 70% when nodule size was smaller than 20 mm.

Overall, both robot studies seemed to show a modest improvement in diagnostic yield when compared with ENB, and their outcomes were overall similar. It is important to remember that these were studies of each center’s first experiences with early versions of each technology; over time, the technology will continue to improve, as will operator skill and experience, and with that, perhaps improvements in yield will be seen, as well.

Interestingly, both studies evaluated target localization using radial EBUS (rEBUS), which also allowed for airway-nodule relationships to be reported. In Kalchiem-Dekel’s study, 85% of cases used rEBUS to determine localization, and, of these, 91.2% of cases showed accurate localization. In Agrawal’s study, rEBUS was used in all cases with a reported localization of 94%. In both, yield did not seem to be affected by airway-nodule relationships, perhaps explained by more robust tip control of the robotic scope. However, localization did not equate to yield in all cases, which brings up a very important question: Can the yield of robotic bronchoscopy be further improved with better real-time on-board imaging, such as CBCT scanning or C-arm based tomography? Currently, there is a study using 3D technology (Cios 3D Mobile Spin) in conjunction with the Ion platform to evaluate this.

So, let’s circle back to where we started. I think if you look at the totality of the data, it is clear that the robotic platforms currently offer a modest improvement in diagnostic yield over traditional ENB, with individual performances that are somewhat equivalent despite differences in design and operation. But does this improvement in yield justify the cost? Individual hospitals will have to make that decision. The capital cost and per-use price of the scope is significant, which has to be balanced against each center’s current performance with non-robotic bronchoscopy.

To date, there have been over 25,000 robotic procedures performed in the United States, so enthusiasm across diverse centers is being maintained. Whether this enthusiasm is driven by yield or novelty, or both, I’m not sure. With other nonrobotic platforms having reached, or soon to reach, the market, this is a good time to be in the business of bronchoscopy.

Dr. Cicenia is in the Section of Bronchoscopy at Cleveland Clinic’s Respiratory Institute, Cleveland, Ohio.

New COVID-19 vaccine boosters, targeting new Omicron strains of the virus, are expected to roll out across the United States in September – a month ahead of schedule, the Biden administration announced this week.

Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the “bivalent” booster, which includes the original “ancestral” virus strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a $3.2 billion U.S. agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.

About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.

Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines – now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.

For a preview of what to expect from the CDC and FDA, this news organization spoke with Keri Althoff, PhD, an epidemiologist at Johns Hopkins University, Baltimore.
 

Q: Based on what we know now, who should be getting one of these new bivalent boosters?A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.

Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you’re X amount of months or more from your second booster; or X amount of months or more from your first booster, if you’ve only had one.

Q: What about pregnant women or those being treated for chronic health conditions?A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.

Q: And for children?A: That’s a good question. It’s something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they’re X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].

As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall. But there are questions as to whether or not that is going to happen.

Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?A: I don’t think they will likely make that a requirement – to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.

Q: Are there any new risks associated with these boosters, since they were developed so rapidly?A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.

Q: Some health experts are concerned “vaccine fatigue” will have an impact on the booster campaign. What’s your take?A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we’re doing is really priming the immune system.

We’re trying to expedite the process of getting people’s immune system up to speed so that when the virus comes our way – as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities – we’re able to get the highest level of population immunity, you don’t end up in the hospital.

Q: What other challenges do you see in persuading Americans to get another round of boosters?A: One of the things that I’ve been hearing a lot, which I get very nervous about, is people saying: “Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn’t feel like much to me, and so I’m not going to be boosted anymore.” We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we’re seeing hundreds of deaths every day.

There are consequences, even if it isn’t in severity of disease, meaning hospitalization and death. And let’s not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don’t mistake that for “I don’t need another one.”

Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?A: It’s all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.

Q: There haven’t been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?A: There have been some studies – some great studies – looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say: “Okay, this is what we know about the safety and effectiveness of the prior vaccines ... and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?”

Q: How long will the new boosters’ protections last – do we know yet?A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron specific, and then we have something totally new emerge ... we have to be more nimble because the variants are outpacing what we’re able to do.

This turns out to be a bit of a game of probability – the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.

Q: What about a combined flu-COVID vaccine; is that on the horizon?A: My children, who like most children do not like vaccines, always tell me: “Mom, why can’t they just put the influenza vaccine and the COVID vaccine into the same shot?” And I’m like: “Oh, from your lips to some scientist’s ears.”

At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.

Q: If you’ve received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it’s actually encouraged. So that’s not going to change with the bivalent booster.

Q: Is it okay to get a flu shot and a COVID booster at the same time, as the Centers for Disease Control and Prevention has recommended with past vaccines?A: I don’t anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.

I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.

Q: Once you’re fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission – you know who is ill with COVID in your kids’ schools, you know in your workplace and when people go out – that still signals there’s some increases in the circulation of virus. So, look at that to understand what your risk is.

If you know someone or have a colleague who is currently pregnant or immune suppressed, think about how you can protect them with mask-wearing, even if it’s just when you’re in one-on-one closed-door meetings with that individual.

So, your masking question is an important one, and it’s important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don’t bring anything to here.

The high-level community risk nationwide is high right now. COVID is here.

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

New COVID-19 vaccine boosters, targeting new Omicron strains of the virus, are expected to roll out across the United States in September – a month ahead of schedule, the Biden administration announced this week.

Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the “bivalent” booster, which includes the original “ancestral” virus strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a $3.2 billion U.S. agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.

About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.

Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines – now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.

For a preview of what to expect from the CDC and FDA, this news organization spoke with Keri Althoff, PhD, an epidemiologist at Johns Hopkins University, Baltimore.
 

Q: Based on what we know now, who should be getting one of these new bivalent boosters?A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.

Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you’re X amount of months or more from your second booster; or X amount of months or more from your first booster, if you’ve only had one.

Q: What about pregnant women or those being treated for chronic health conditions?A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.

Q: And for children?A: That’s a good question. It’s something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they’re X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].

As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall. But there are questions as to whether or not that is going to happen.

Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?A: I don’t think they will likely make that a requirement – to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.

Q: Are there any new risks associated with these boosters, since they were developed so rapidly?A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.

Q: Some health experts are concerned “vaccine fatigue” will have an impact on the booster campaign. What’s your take?A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we’re doing is really priming the immune system.

We’re trying to expedite the process of getting people’s immune system up to speed so that when the virus comes our way – as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities – we’re able to get the highest level of population immunity, you don’t end up in the hospital.

Q: What other challenges do you see in persuading Americans to get another round of boosters?A: One of the things that I’ve been hearing a lot, which I get very nervous about, is people saying: “Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn’t feel like much to me, and so I’m not going to be boosted anymore.” We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we’re seeing hundreds of deaths every day.

There are consequences, even if it isn’t in severity of disease, meaning hospitalization and death. And let’s not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don’t mistake that for “I don’t need another one.”

Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?A: It’s all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.

Q: There haven’t been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?A: There have been some studies – some great studies – looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say: “Okay, this is what we know about the safety and effectiveness of the prior vaccines ... and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?”

Q: How long will the new boosters’ protections last – do we know yet?A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron specific, and then we have something totally new emerge ... we have to be more nimble because the variants are outpacing what we’re able to do.

This turns out to be a bit of a game of probability – the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.

Q: What about a combined flu-COVID vaccine; is that on the horizon?A: My children, who like most children do not like vaccines, always tell me: “Mom, why can’t they just put the influenza vaccine and the COVID vaccine into the same shot?” And I’m like: “Oh, from your lips to some scientist’s ears.”

At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.

Q: If you’ve received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it’s actually encouraged. So that’s not going to change with the bivalent booster.

Q: Is it okay to get a flu shot and a COVID booster at the same time, as the Centers for Disease Control and Prevention has recommended with past vaccines?A: I don’t anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.

I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.

Q: Once you’re fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission – you know who is ill with COVID in your kids’ schools, you know in your workplace and when people go out – that still signals there’s some increases in the circulation of virus. So, look at that to understand what your risk is.

If you know someone or have a colleague who is currently pregnant or immune suppressed, think about how you can protect them with mask-wearing, even if it’s just when you’re in one-on-one closed-door meetings with that individual.

So, your masking question is an important one, and it’s important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don’t bring anything to here.

The high-level community risk nationwide is high right now. COVID is here.

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

New COVID-19 vaccine boosters, targeting new Omicron strains of the virus, are expected to roll out across the United States in September – a month ahead of schedule, the Biden administration announced this week.

Moderna has signed a $1.74 billion federal contract to supply 66 million initial doses of the “bivalent” booster, which includes the original “ancestral” virus strain and elements of the Omicron BA.4 and BA.5 variants. Pfizer also announced a $3.2 billion U.S. agreement for another 105 million shots. Both vaccine suppliers have signed options to provide millions more boosters in the months ahead.

About 83.5% of Americans have received at least one COVID-19 shot, with 71.5% fully vaccinated with the initial series, 48% receiving one booster shot, and 31% two boosters, according to the CDC. With about 130,000 new COVID cases per day, and about 440 deaths, officials say the updated boosters may help rein in those figures by targeting the highly transmissible and widely circulating Omicron strains.

Federal health officials are still hammering out details of guidelines and recommendations of who should get the boosters, which are expected to come from the CDC and FDA. For now, authorities have decided not to expand eligibility for second boosters of the existing vaccines – now recommended only for adults over 50 and those 12 and older with immune deficiencies. Children 5 through 11 are advised to receive a single booster, 5 months after their initial vaccine series.

For a preview of what to expect from the CDC and FDA, this news organization spoke with Keri Althoff, PhD, an epidemiologist at Johns Hopkins University, Baltimore.
 

Q: Based on what we know now, who should be getting one of these new bivalent boosters?A: Of course, there is a process here regarding the specific recommendations, but it appears there will likely be a recommendation for all individuals to get this bivalent booster, similar to the first booster. And there will likely be a recommended time frame as to time since the last booster.

Right now, we have a recommendation for adults over the age of 50 or adults who are at higher risk for severe COVID-related illness [to get] a second booster. For them, there will probably be a timeline that says you should get the booster if you’re X amount of months or more from your second booster; or X amount of months or more from your first booster, if you’ve only had one.

Q: What about pregnant women or those being treated for chronic health conditions?A: I would imagine that once this bivalent booster becomes available, it will be recommended for all adults.

Q: And for children?A: That’s a good question. It’s something I have been digging into, [and] I think parents are really interested in this. Most kids, 5 and above, are supposed to be boosted with one shot right now, if they’re X amount of days from their primary vaccine series. Of course those 6 months to 4.99 years are not yet eligible [for boosters].

As a parent, I would love to see my children become eligible for the bivalent booster. It would be great if these boosters are conveying some additional protection that the kids could get access to before we send them off to school this fall. But there are questions as to whether or not that is going to happen.

Q: If you never received a booster, but only the preliminary vaccine series, do you need to get those earlier boosters before having the new bivalent booster shot?A: I don’t think they will likely make that a requirement – to restrict the bivalent booster only to those who are already boosted or up to date on their vaccines at the time the bivalent booster becomes available. But that will be up to the [CDC] vaccine recommendation committee to decide.

Q: Are there any new risks associated with these boosters, since they were developed so rapidly?A: No. We continue to monitor this technology, and with all the mRNA vaccines that have been delivered, you have seen all that monitoring play out with the detection, for example, of different forms of inflammation of the heart tissue and who that may impact. So, those monitoring systems work, and they work really, really well, so we can detect those things. And we know these vaccines are definitely safe.

Q: Some health experts are concerned “vaccine fatigue” will have an impact on the booster campaign. What’s your take?A: We have seen this fatigue in the proportion of individuals who are boosted with a first booster and even boosted with a second. But having those earlier boosters along with this new bivalent booster is important, because essentially, what we’re doing is really priming the immune system.

We’re trying to expedite the process of getting people’s immune system up to speed so that when the virus comes our way – as we know it will, because [of] these Omicron strains that are highly infectious and really whipping through our communities – we’re able to get the highest level of population immunity, you don’t end up in the hospital.

Q: What other challenges do you see in persuading Americans to get another round of boosters?A: One of the things that I’ve been hearing a lot, which I get very nervous about, is people saying: “Oh, I got fully vaccinated, I did or did not get the booster, and I had COVID anyway and it was really nothing, it didn’t feel like much to me, and so I’m not going to be boosted anymore.” We are not in a place quite yet where those guidelines are being rolled back in any way, shape, or form. We still have highly vulnerable people to severe disease and death in our communities, and we’re seeing hundreds of deaths every day.

There are consequences, even if it isn’t in severity of disease, meaning hospitalization and death. And let’s not let the actual quality of the vaccine being so successful that it can keep you out of the hospital. Don’t mistake that for “I don’t need another one.”

Q: Unlike the flu shot, which is reformulated each year to match circulating strains, the new COVID boosters offer protection against older strains as well as the newer ones. Why?A: It’s all about creating a broader immune response in individuals so that as more strains emerge, which they likely will, we can create a broader population immune response [to all strains]. Our individual bodies are seeing differences in these strains through vaccination that helps everyone stay healthy.

Q: There haven’t been clinical trials of these new mRNA boosters. How strong is the evidence that they will be effective against the emerging Omicron variants?A: There have been some studies – some great studies – looking at things like neutralizing antibodies, which we use as a surrogate for clinical trials. But that is not the same as studying the outcome of interest, which would be hospitalizations. So, part of the challenge is to be able to say: “Okay, this is what we know about the safety and effectiveness of the prior vaccines ... and how can we relate that to outcomes with these new boosters at an earlier stage [before] clinical data is available?”

Q: How long will the new boosters’ protections last – do we know yet?A: That timing is still a question, but of course what plays a big role in that is what COVID strains are circulating. If we prep these boosters that are Omicron specific, and then we have something totally new emerge ... we have to be more nimble because the variants are outpacing what we’re able to do.

This turns out to be a bit of a game of probability – the more infection we have, the more replication of the virus; the more replication, the more opportunity for mutations and subsequent variants.

Q: What about a combined flu-COVID vaccine; is that on the horizon?A: My children, who like most children do not like vaccines, always tell me: “Mom, why can’t they just put the influenza vaccine and the COVID vaccine into the same shot?” And I’m like: “Oh, from your lips to some scientist’s ears.”

At a time like this, where mRNA technology has totally disrupted what we can do with vaccines, in such a good way, I think we should push for the limits, because that would be incredible.

Q: If you’ve received a non-mRNA COVID vaccine, like those produced by Johnson & Johnson and Novavax, should you also get an mRNA booster?A: Right now, the CDC guidelines do state that if your primary vaccine series was not with an mRNA vaccine then being boosted with an mRNA is a fine thing to do, and it’s actually encouraged. So that’s not going to change with the bivalent booster.

Q: Is it okay to get a flu shot and a COVID booster at the same time, as the Centers for Disease Control and Prevention has recommended with past vaccines?A: I don’t anticipate there being recommendations against that. But I would also say watch for the recommendations that come out this fall on the bivalent boosters.

I do hope in the recommendations the CDC makes about the COVID boosters, they will say think about also getting your influenza vaccine, too. You could also get your COVID booster first, then by October get your influenza vaccine.

Q: Once you’re fully boosted, is it safe to stop wearing a mask, social distancing, avoiding crowded indoor spaces, and taking other precautions to avoid COVID-19?A: The virus is going to do what it does, which is infect whomever it can, and make them sick. So, if you see a lot of community transmission – you know who is ill with COVID in your kids’ schools, you know in your workplace and when people go out – that still signals there’s some increases in the circulation of virus. So, look at that to understand what your risk is.

If you know someone or have a colleague who is currently pregnant or immune suppressed, think about how you can protect them with mask-wearing, even if it’s just when you’re in one-on-one closed-door meetings with that individual.

So, your masking question is an important one, and it’s important for people to continue to hang onto those masks and wear them the week before you go see Grandma, for instance, to further reduce your risk so you don’t bring anything to here.

The high-level community risk nationwide is high right now. COVID is here.

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

The RNA interference (RNAi) therapeutic patisiran (Onpattro, Alnylam Pharmaceuticals) led to statistically significant improvement in functional capacity and quality of life in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy in the phase 3 APOLLO-B study, according to topline results released Aug. 3.

“We are thrilled that APOLLO-B successfully met all its major objectives, which we believe for the first time validates the hypothesis that TTR silencing by an RNAi therapeutic can be an effective approach for treating the cardiomyopathy of ATTR amyloidosis,” Pushkal Garg, MD, Alnylam chief medical officer, said in a news release.

The Food and Drug Administration approved patisiran in 2018 for polyneuropathy caused by hereditary ATTR in adults on the basis of results of the APOLLO phase 3 trial, as reported by this news organization.

APOLLO-B enrolled 360 adults with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 centers in 21 countries. Half were randomly allocated to 0.3 mg/kg of patisiran or placebo administered intravenously every 3 weeks for 12 months.

The study met the primary endpoint of a statistically significant improvement from baseline in the 6-minute walk test at 12 months compared with placebo (P = .0162), the company said.

The study also met the first secondary endpoint of a statistically significant improvement from baseline in quality of life compared with placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (P = .0397).

The patisiran and placebo groups had similar frequencies of adverse events (91% and 94%, respectively) and serious adverse events (34% and 35%, respectively).

“ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure, affecting greater than 250,000 patients around the world. These patients have limited treatment options, and disease progression is common. As such, we are encouraged to see the potential of patisiran to improve the functional capacity and quality of life of patients living with this fatal, multisystem disease,” Dr. Garg said in the release.

Full results from APOLLO-B will be presented at a late-breaker session at the 18th International Symposium on Amyloidosis in September in Heidelberg, Germany.

Based on these results, the company plans to file a supplementary new drug application (sNDA) for patisiran for this indication with the FDA later this year, the release noted.

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

The RNA interference (RNAi) therapeutic patisiran (Onpattro, Alnylam Pharmaceuticals) led to statistically significant improvement in functional capacity and quality of life in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy in the phase 3 APOLLO-B study, according to topline results released Aug. 3.

“We are thrilled that APOLLO-B successfully met all its major objectives, which we believe for the first time validates the hypothesis that TTR silencing by an RNAi therapeutic can be an effective approach for treating the cardiomyopathy of ATTR amyloidosis,” Pushkal Garg, MD, Alnylam chief medical officer, said in a news release.

The Food and Drug Administration approved patisiran in 2018 for polyneuropathy caused by hereditary ATTR in adults on the basis of results of the APOLLO phase 3 trial, as reported by this news organization.

APOLLO-B enrolled 360 adults with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 centers in 21 countries. Half were randomly allocated to 0.3 mg/kg of patisiran or placebo administered intravenously every 3 weeks for 12 months.

The study met the primary endpoint of a statistically significant improvement from baseline in the 6-minute walk test at 12 months compared with placebo (P = .0162), the company said.

The study also met the first secondary endpoint of a statistically significant improvement from baseline in quality of life compared with placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (P = .0397).

The patisiran and placebo groups had similar frequencies of adverse events (91% and 94%, respectively) and serious adverse events (34% and 35%, respectively).

“ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure, affecting greater than 250,000 patients around the world. These patients have limited treatment options, and disease progression is common. As such, we are encouraged to see the potential of patisiran to improve the functional capacity and quality of life of patients living with this fatal, multisystem disease,” Dr. Garg said in the release.

Full results from APOLLO-B will be presented at a late-breaker session at the 18th International Symposium on Amyloidosis in September in Heidelberg, Germany.

Based on these results, the company plans to file a supplementary new drug application (sNDA) for patisiran for this indication with the FDA later this year, the release noted.

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

The RNA interference (RNAi) therapeutic patisiran (Onpattro, Alnylam Pharmaceuticals) led to statistically significant improvement in functional capacity and quality of life in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy in the phase 3 APOLLO-B study, according to topline results released Aug. 3.

“We are thrilled that APOLLO-B successfully met all its major objectives, which we believe for the first time validates the hypothesis that TTR silencing by an RNAi therapeutic can be an effective approach for treating the cardiomyopathy of ATTR amyloidosis,” Pushkal Garg, MD, Alnylam chief medical officer, said in a news release.

The Food and Drug Administration approved patisiran in 2018 for polyneuropathy caused by hereditary ATTR in adults on the basis of results of the APOLLO phase 3 trial, as reported by this news organization.

APOLLO-B enrolled 360 adults with ATTR amyloidosis (hereditary or wild-type) with cardiomyopathy at 69 centers in 21 countries. Half were randomly allocated to 0.3 mg/kg of patisiran or placebo administered intravenously every 3 weeks for 12 months.

The study met the primary endpoint of a statistically significant improvement from baseline in the 6-minute walk test at 12 months compared with placebo (P = .0162), the company said.

The study also met the first secondary endpoint of a statistically significant improvement from baseline in quality of life compared with placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (P = .0397).

The patisiran and placebo groups had similar frequencies of adverse events (91% and 94%, respectively) and serious adverse events (34% and 35%, respectively).

“ATTR amyloidosis with cardiomyopathy is an increasingly recognized cause of heart failure, affecting greater than 250,000 patients around the world. These patients have limited treatment options, and disease progression is common. As such, we are encouraged to see the potential of patisiran to improve the functional capacity and quality of life of patients living with this fatal, multisystem disease,” Dr. Garg said in the release.

Full results from APOLLO-B will be presented at a late-breaker session at the 18th International Symposium on Amyloidosis in September in Heidelberg, Germany.

Based on these results, the company plans to file a supplementary new drug application (sNDA) for patisiran for this indication with the FDA later this year, the release noted.

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

A newly developed artificial intelligence (AI) model accurately evaluated endoscopic images from patients with ulcerative colitis (UC), according to new research. The AI could even distinguish between all four Mayo endoscopic subscore (MES) levels of disease activity, which is a first among similar AI models, the researchers noted.

Although management of UC involves disease activity monitoring and prompt response with appropriate therapy, endoscopic assessment has shown significant intra- and interobserver variation, thereby reducing the reliability of individual evaluations. Techniques that use AI may eliminate observer variation and aid in distinguishing between all levels of endoscopic activity with good accuracy.

“However, up until now, only a few computer-assisted diagnostic tools have been available for UC, and none are capable of distinguishing between all levels of endoscopic activity with sufficient accuracy,” wrote study authors Bobby Lo, MD, of the Copenhagen University Hospital Hvidovre, and colleagues, who published their findings in The American Journal of Gastroenterology. The researchers believe their new AI could optimize and standardize the assessment of UC severity measured by MES, regardless of the operator’s level of expertise.

The researchers extracted 1,484 unique endoscopic images from 467 patients with UC (median age, 45 years; 45.3% male) who had undergone a colonoscopy or sigmoidoscopy. Images of healthy colon mucosa were also extracted from a colorectal cancer surveillance program “to adequately reflect the distribution in the clinic,” the researchers wrote.

Two experts blinded for clinical details or other identifying information separately scored all images according to the MES. A third expert, blinded to results from the initial two experts, also scored the images in case of disagreement between the first sets of scores. Nearly half of the images (47.3%) were classified as normal, while 26.0% were deemed MES 1 (mild activity), 20.2% were classified as MES 2 (moderate activity), and 6.5% were classified as MES 3 (severe activity).

All endoscopic images were randomly split into a training dataset (85%) and a testing dataset (15%) with stratified sampling. Several convolutional neural networks architectures were considered for automatically classifying the severity of UC. The investigators used a fivefold cross-validation of the training data to develop and select the optimal final model. Subsequently, the investigators then used unseen test datasets to evaluate the model.

The final chosen model was the EfficientNetB2, given the superiority of its mean accuracy during cross-validation. This model, according to the researchers, is able to “process images significantly faster and requires less computing power than InceptionNetV3,” which was the other model evaluated in the study.

The test accuracy of the final model in distinguishing between all categories of MES was 0.84. The investigators evaluated the model on binary tasks of distinguishing MES 0 versus MES 1-3 and MES 0-1 versus 2-3. They found the model achieved accuracies of 0.94 and 0.93 and areas under the receiver operating characteristic curves of 0.997 and 0.998, respectively.

According to the researchers, they used 10-fold fewer images in this study than have been used in similar studies but noted that the developed model demonstrated an accuracy of around 0.74 “even when using images from another cohort” that had lower image quality. The investigators added that the model could have achieved better results if more data were available, citing this as a limitation of the study.

“In conclusion, we have developed a deep learning model that exceeded previously reported results in classifying endoscopic images from UC patients. This may automate and optimize the evaluation of disease severity in both clinical and academic settings and ideally in clinical trials,” they wrote.“Finally, this study serves as a stepping stone for future projects, including the use of video material and the assessment of long-term outcomes.”

The authors reported no relevant conflicts of interest.

A newly developed artificial intelligence (AI) model accurately evaluated endoscopic images from patients with ulcerative colitis (UC), according to new research. The AI could even distinguish between all four Mayo endoscopic subscore (MES) levels of disease activity, which is a first among similar AI models, the researchers noted.

Although management of UC involves disease activity monitoring and prompt response with appropriate therapy, endoscopic assessment has shown significant intra- and interobserver variation, thereby reducing the reliability of individual evaluations. Techniques that use AI may eliminate observer variation and aid in distinguishing between all levels of endoscopic activity with good accuracy.

“However, up until now, only a few computer-assisted diagnostic tools have been available for UC, and none are capable of distinguishing between all levels of endoscopic activity with sufficient accuracy,” wrote study authors Bobby Lo, MD, of the Copenhagen University Hospital Hvidovre, and colleagues, who published their findings in The American Journal of Gastroenterology. The researchers believe their new AI could optimize and standardize the assessment of UC severity measured by MES, regardless of the operator’s level of expertise.

The researchers extracted 1,484 unique endoscopic images from 467 patients with UC (median age, 45 years; 45.3% male) who had undergone a colonoscopy or sigmoidoscopy. Images of healthy colon mucosa were also extracted from a colorectal cancer surveillance program “to adequately reflect the distribution in the clinic,” the researchers wrote.

Two experts blinded for clinical details or other identifying information separately scored all images according to the MES. A third expert, blinded to results from the initial two experts, also scored the images in case of disagreement between the first sets of scores. Nearly half of the images (47.3%) were classified as normal, while 26.0% were deemed MES 1 (mild activity), 20.2% were classified as MES 2 (moderate activity), and 6.5% were classified as MES 3 (severe activity).

All endoscopic images were randomly split into a training dataset (85%) and a testing dataset (15%) with stratified sampling. Several convolutional neural networks architectures were considered for automatically classifying the severity of UC. The investigators used a fivefold cross-validation of the training data to develop and select the optimal final model. Subsequently, the investigators then used unseen test datasets to evaluate the model.

The final chosen model was the EfficientNetB2, given the superiority of its mean accuracy during cross-validation. This model, according to the researchers, is able to “process images significantly faster and requires less computing power than InceptionNetV3,” which was the other model evaluated in the study.

The test accuracy of the final model in distinguishing between all categories of MES was 0.84. The investigators evaluated the model on binary tasks of distinguishing MES 0 versus MES 1-3 and MES 0-1 versus 2-3. They found the model achieved accuracies of 0.94 and 0.93 and areas under the receiver operating characteristic curves of 0.997 and 0.998, respectively.

According to the researchers, they used 10-fold fewer images in this study than have been used in similar studies but noted that the developed model demonstrated an accuracy of around 0.74 “even when using images from another cohort” that had lower image quality. The investigators added that the model could have achieved better results if more data were available, citing this as a limitation of the study.

“In conclusion, we have developed a deep learning model that exceeded previously reported results in classifying endoscopic images from UC patients. This may automate and optimize the evaluation of disease severity in both clinical and academic settings and ideally in clinical trials,” they wrote.“Finally, this study serves as a stepping stone for future projects, including the use of video material and the assessment of long-term outcomes.”

The authors reported no relevant conflicts of interest.

A newly developed artificial intelligence (AI) model accurately evaluated endoscopic images from patients with ulcerative colitis (UC), according to new research. The AI could even distinguish between all four Mayo endoscopic subscore (MES) levels of disease activity, which is a first among similar AI models, the researchers noted.

Although management of UC involves disease activity monitoring and prompt response with appropriate therapy, endoscopic assessment has shown significant intra- and interobserver variation, thereby reducing the reliability of individual evaluations. Techniques that use AI may eliminate observer variation and aid in distinguishing between all levels of endoscopic activity with good accuracy.

“However, up until now, only a few computer-assisted diagnostic tools have been available for UC, and none are capable of distinguishing between all levels of endoscopic activity with sufficient accuracy,” wrote study authors Bobby Lo, MD, of the Copenhagen University Hospital Hvidovre, and colleagues, who published their findings in The American Journal of Gastroenterology. The researchers believe their new AI could optimize and standardize the assessment of UC severity measured by MES, regardless of the operator’s level of expertise.

The researchers extracted 1,484 unique endoscopic images from 467 patients with UC (median age, 45 years; 45.3% male) who had undergone a colonoscopy or sigmoidoscopy. Images of healthy colon mucosa were also extracted from a colorectal cancer surveillance program “to adequately reflect the distribution in the clinic,” the researchers wrote.

Two experts blinded for clinical details or other identifying information separately scored all images according to the MES. A third expert, blinded to results from the initial two experts, also scored the images in case of disagreement between the first sets of scores. Nearly half of the images (47.3%) were classified as normal, while 26.0% were deemed MES 1 (mild activity), 20.2% were classified as MES 2 (moderate activity), and 6.5% were classified as MES 3 (severe activity).

All endoscopic images were randomly split into a training dataset (85%) and a testing dataset (15%) with stratified sampling. Several convolutional neural networks architectures were considered for automatically classifying the severity of UC. The investigators used a fivefold cross-validation of the training data to develop and select the optimal final model. Subsequently, the investigators then used unseen test datasets to evaluate the model.

The final chosen model was the EfficientNetB2, given the superiority of its mean accuracy during cross-validation. This model, according to the researchers, is able to “process images significantly faster and requires less computing power than InceptionNetV3,” which was the other model evaluated in the study.

The test accuracy of the final model in distinguishing between all categories of MES was 0.84. The investigators evaluated the model on binary tasks of distinguishing MES 0 versus MES 1-3 and MES 0-1 versus 2-3. They found the model achieved accuracies of 0.94 and 0.93 and areas under the receiver operating characteristic curves of 0.997 and 0.998, respectively.

According to the researchers, they used 10-fold fewer images in this study than have been used in similar studies but noted that the developed model demonstrated an accuracy of around 0.74 “even when using images from another cohort” that had lower image quality. The investigators added that the model could have achieved better results if more data were available, citing this as a limitation of the study.

“In conclusion, we have developed a deep learning model that exceeded previously reported results in classifying endoscopic images from UC patients. This may automate and optimize the evaluation of disease severity in both clinical and academic settings and ideally in clinical trials,” they wrote.“Finally, this study serves as a stepping stone for future projects, including the use of video material and the assessment of long-term outcomes.”

The authors reported no relevant conflicts of interest.