References

1. Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Finfection-control.html. Updated February 21, 2020. Accessed February 27, 2020.
2. Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html. Updated February 12, 2020. Accessed February 27, 2020.
3. Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for 2019 Novel Coronavirus (2019-nCoV). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html. Updated February 12, 2020. Accessed February 27, 2020.
4. Interim Guidance for Preventing the Spread of Coronavirus Disease 2019 (COVID-19) in Homes and Residential Communities. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html. Updated February 14, 2020. Accessed February 27, 2020.
5. World Health Organization. Coronavirus disease (COVID-2019) situation reports. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports. Updated February 26, 2020. Accessed February 27, 2020.
6. Coronavirus Disease 2019 (COVID-19) in the U.S. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Updated February 26, 2020. Accessed February 27, 2020.

ALSO, see last month’s audiocast: “Coronavirus outbreak: Putting it into perspective.”

References

1. Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Finfection-control.html. Updated February 21, 2020. Accessed February 27, 2020.
2. Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html. Updated February 12, 2020. Accessed February 27, 2020.
3. Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for 2019 Novel Coronavirus (2019-nCoV). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html. Updated February 12, 2020. Accessed February 27, 2020.
4. Interim Guidance for Preventing the Spread of Coronavirus Disease 2019 (COVID-19) in Homes and Residential Communities. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html. Updated February 14, 2020. Accessed February 27, 2020.
5. World Health Organization. Coronavirus disease (COVID-2019) situation reports. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports. Updated February 26, 2020. Accessed February 27, 2020.
6. Coronavirus Disease 2019 (COVID-19) in the U.S. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Updated February 26, 2020. Accessed February 27, 2020.

ALSO, see last month’s audiocast: “Coronavirus outbreak: Putting it into perspective.”

References

1. Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Finfection-control.html. Updated February 21, 2020. Accessed February 27, 2020.
2. Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html. Updated February 12, 2020. Accessed February 27, 2020.
3. Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for 2019 Novel Coronavirus (2019-nCoV). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html. Updated February 12, 2020. Accessed February 27, 2020.
4. Interim Guidance for Preventing the Spread of Coronavirus Disease 2019 (COVID-19) in Homes and Residential Communities. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html. Updated February 14, 2020. Accessed February 27, 2020.
5. World Health Organization. Coronavirus disease (COVID-2019) situation reports. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports. Updated February 26, 2020. Accessed February 27, 2020.
6. Coronavirus Disease 2019 (COVID-19) in the U.S. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Updated February 26, 2020. Accessed February 27, 2020.

ALSO, see last month’s audiocast: “Coronavirus outbreak: Putting it into perspective.”

As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.

Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.

Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.

Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.

“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”

Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.

Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.

The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.

No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.

Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.

Courtesy King County Public Health Department

Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.

“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.

Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.

Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.

“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.

“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.

• A man in his 50s, who was hospitalized and died at EvergreenHealth.

koakes@mdedge.com

As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.

Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.

Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.

Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.

“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”

Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.

Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.

The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.

No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.

Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.

Courtesy King County Public Health Department

Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.

“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.

Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.

Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.

“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.

“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.

• A man in his 50s, who was hospitalized and died at EvergreenHealth.

koakes@mdedge.com

As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.

Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.

Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.

Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.

“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”

Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.

Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.

The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.

No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.

Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.

Courtesy King County Public Health Department

Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.

“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.

Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.

Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.

“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.

“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.

• A man in his 50s, who was hospitalized and died at EvergreenHealth.

koakes@mdedge.com

NATIONAL HARBOR, MD. – Thermal injury of a patient’s esophagus during radiofrequency catheter ablation of atrial fibrillation is notorious as a relatively common and problematic complication of the procedure, but two new approaches showed promise for substantially cutting the risk of esophageal thermal injury and the potential for the most severe damage: perforation.

Mitchel L. Zoler/MDedge News

One of these innovations is intensive esophageal cooling with a commercially marketed, fluid-chilled catheter placed in a patient’s esophagus during radiofrequency catheter ablation that keeps the inner surface of the esophagus at 4°C. This approach cut the incidence of periprocedural episodes of endoscopically detected esophageal thermal injury from 20% among controls to 3% in patients who had esophageal cooling in a randomized study with 120 patients, Mark M. Gallagher, MD, said at the annual International AF Symposium. The same device can also maintain a temperature on the inner surface of the esophagus of 42 ° C in patients undergoing cryoablation of atrial fibrillation, noted Dr. Gallagher, a cardiac electrophysiologist at St. George’s University Hospitals in London.

A second approach to cutting esophageal damage focuses on modifying the energy delivery with a radiofrequency ablation method known as high-power short-duration (HPSD). As the name says, this strategy uses a relatively high level of radiofrequency energy, 50 watts in the reported experience, for the brief interval of about 7 seconds, ideally delivering an overall Ablation Index of at least 350 but below 360, said Thomas Deneke, MD, an electrophysiologist, professor, and cochief of cardiology at the Heart Center in Bad Neustadt, Germany.

Dr. Deneke and his associates in Bad Neustadt began using this HPSD approach in mid-2019, and by early 2020 they had data from 179 patients who underwent first-time catheter ablation of atrial fibrillation (AFib), all of whom had undergone routine esophageal endoscopy 1-3 days after their treatment. Eight patients (4%) showed evidence of endoscopically detected esophageal lesions (EDEL), including three patients (2%) with an actual esophageal ulcer, and one (0.6%) who developed a perforation that healed after 52 days, Dr. Deneke reported. An additional 55 patients underwent a redo catheter ablation procedure using the HPSD method during this period, and in that group follow-up endoscopy in all patients showed EDEL in two patients (4%). In contrast, during Jan. 2012–May 2019, the same German center treated 2,102 patients who had a first radiofrequency catheter ablation using convention energy levels and treatment times, which resulted in 291 patients having an EDEL (14%), including 94 (4%) with an ulcer, and six patients (0.3%) with an esophageal perforation, he said.

Mitchel L. Zoler/MDedge News

His center’s recent safety experience with HPSD radiofrequncy ablation, compared with the historical controls, suggests that this technique can produce a substantial reduction in esophageal thermal injury, but HPSD has not completely eliminated the risk and hence there is need for continued alertness for this potential complication Dr. Deneke concluded. The HPSD method is also limited by having “a very narrow window” between efficacy at an Ablation Index of 350 and safety when the index remains below 360, he added.

The randomized study that Dr. Gallagher ran at St. George’s followed an analysis he and his associates recently published that suggested efficacy using esophageal cooling in prior reports when the data combined in a meta-analysis (J Interv Card Electrophysiol. 2019 Nov 22. doi: 10.1007/s10840-019-00661-5). They also concluded that the clinical setting required a temperature control device with an enhanced capacity for rapid cooling, which prior studies had lacked. So they turned to a Food and Drug Administration–approved catheter designed for placement in the esophagus for the purpose of either whole-body cooling or warming.

The study randomized a total of 187 patients, but collected follow-up endoscopy at 5-7 days after the ablation procedure on 120 patients, of whom 60 received esophageal cooling and 60 did not. The types of ablations performed on patients in the two study arms were similar, and use of esophageal cooling had no impact on treatment duration or efficacy, either acute and longer term, Dr. Gallagher reported.

Cooling had a marked and statistically significant impact on endoscopically detected thermal injury. Although two patients in the group that underwent cooling had injuries, in one of these cases the injury involved a protocol violation: Radiofrequency ablation mistakenly occurred after the cooling device shut off, and it was during this period when the injury happened. In the second case of thermal injury, blinded scoring judged the injury as grade 2 in severity – an erosion of less than 5 mm – on a nine-item scale that ranged from zero to grade 6, the most severe level denoting a fistula. By contrast, among the 12 patients with thermal injury in the nonprotected subgroup, one patient had a grade 5a lesion denoting a deep ulcer, one had a 4b denoting a superficial ulcer with a clot, and four had a 4a lesion defined as a clean superficial ulcer.

“This is really effective. It’s the first study to show reduced damage without affecting ablation efficacy,” Dr. Gallagher said. He plans to now use this method of esophageal protection routinely for his AFib ablation patients who pay privately, and for patients insured under the national U.K. system once this coverage is approved. Dr. Deneke expressed his interest in also using this approach to esophageal protection, but noted that currently he did not have access to the cooling catheter that Dr. Gallagher used because of regulatory constraints.

The esophageal cooling study was sponsored by Attune Medical, which markets the cooling device. Dr. Gallagher has received research funding from Attune Medical, and has received honoraria as a speaker on behalf of Biosense Webster and Medtronic. Dr. Deneke has been a speaker on behalf of Abbott, Biosense Webster, Biotronik, and Boston Scientific, and his institution has received research funding from Biosense Webster and Securus/Boston Scientific.

mzoler@mdedge.com

NATIONAL HARBOR, MD. – Thermal injury of a patient’s esophagus during radiofrequency catheter ablation of atrial fibrillation is notorious as a relatively common and problematic complication of the procedure, but two new approaches showed promise for substantially cutting the risk of esophageal thermal injury and the potential for the most severe damage: perforation.

Mitchel L. Zoler/MDedge News

One of these innovations is intensive esophageal cooling with a commercially marketed, fluid-chilled catheter placed in a patient’s esophagus during radiofrequency catheter ablation that keeps the inner surface of the esophagus at 4°C. This approach cut the incidence of periprocedural episodes of endoscopically detected esophageal thermal injury from 20% among controls to 3% in patients who had esophageal cooling in a randomized study with 120 patients, Mark M. Gallagher, MD, said at the annual International AF Symposium. The same device can also maintain a temperature on the inner surface of the esophagus of 42 ° C in patients undergoing cryoablation of atrial fibrillation, noted Dr. Gallagher, a cardiac electrophysiologist at St. George’s University Hospitals in London.

A second approach to cutting esophageal damage focuses on modifying the energy delivery with a radiofrequency ablation method known as high-power short-duration (HPSD). As the name says, this strategy uses a relatively high level of radiofrequency energy, 50 watts in the reported experience, for the brief interval of about 7 seconds, ideally delivering an overall Ablation Index of at least 350 but below 360, said Thomas Deneke, MD, an electrophysiologist, professor, and cochief of cardiology at the Heart Center in Bad Neustadt, Germany.

Dr. Deneke and his associates in Bad Neustadt began using this HPSD approach in mid-2019, and by early 2020 they had data from 179 patients who underwent first-time catheter ablation of atrial fibrillation (AFib), all of whom had undergone routine esophageal endoscopy 1-3 days after their treatment. Eight patients (4%) showed evidence of endoscopically detected esophageal lesions (EDEL), including three patients (2%) with an actual esophageal ulcer, and one (0.6%) who developed a perforation that healed after 52 days, Dr. Deneke reported. An additional 55 patients underwent a redo catheter ablation procedure using the HPSD method during this period, and in that group follow-up endoscopy in all patients showed EDEL in two patients (4%). In contrast, during Jan. 2012–May 2019, the same German center treated 2,102 patients who had a first radiofrequency catheter ablation using convention energy levels and treatment times, which resulted in 291 patients having an EDEL (14%), including 94 (4%) with an ulcer, and six patients (0.3%) with an esophageal perforation, he said.

Mitchel L. Zoler/MDedge News

His center’s recent safety experience with HPSD radiofrequncy ablation, compared with the historical controls, suggests that this technique can produce a substantial reduction in esophageal thermal injury, but HPSD has not completely eliminated the risk and hence there is need for continued alertness for this potential complication Dr. Deneke concluded. The HPSD method is also limited by having “a very narrow window” between efficacy at an Ablation Index of 350 and safety when the index remains below 360, he added.

The randomized study that Dr. Gallagher ran at St. George’s followed an analysis he and his associates recently published that suggested efficacy using esophageal cooling in prior reports when the data combined in a meta-analysis (J Interv Card Electrophysiol. 2019 Nov 22. doi: 10.1007/s10840-019-00661-5). They also concluded that the clinical setting required a temperature control device with an enhanced capacity for rapid cooling, which prior studies had lacked. So they turned to a Food and Drug Administration–approved catheter designed for placement in the esophagus for the purpose of either whole-body cooling or warming.

The study randomized a total of 187 patients, but collected follow-up endoscopy at 5-7 days after the ablation procedure on 120 patients, of whom 60 received esophageal cooling and 60 did not. The types of ablations performed on patients in the two study arms were similar, and use of esophageal cooling had no impact on treatment duration or efficacy, either acute and longer term, Dr. Gallagher reported.

Cooling had a marked and statistically significant impact on endoscopically detected thermal injury. Although two patients in the group that underwent cooling had injuries, in one of these cases the injury involved a protocol violation: Radiofrequency ablation mistakenly occurred after the cooling device shut off, and it was during this period when the injury happened. In the second case of thermal injury, blinded scoring judged the injury as grade 2 in severity – an erosion of less than 5 mm – on a nine-item scale that ranged from zero to grade 6, the most severe level denoting a fistula. By contrast, among the 12 patients with thermal injury in the nonprotected subgroup, one patient had a grade 5a lesion denoting a deep ulcer, one had a 4b denoting a superficial ulcer with a clot, and four had a 4a lesion defined as a clean superficial ulcer.

“This is really effective. It’s the first study to show reduced damage without affecting ablation efficacy,” Dr. Gallagher said. He plans to now use this method of esophageal protection routinely for his AFib ablation patients who pay privately, and for patients insured under the national U.K. system once this coverage is approved. Dr. Deneke expressed his interest in also using this approach to esophageal protection, but noted that currently he did not have access to the cooling catheter that Dr. Gallagher used because of regulatory constraints.

The esophageal cooling study was sponsored by Attune Medical, which markets the cooling device. Dr. Gallagher has received research funding from Attune Medical, and has received honoraria as a speaker on behalf of Biosense Webster and Medtronic. Dr. Deneke has been a speaker on behalf of Abbott, Biosense Webster, Biotronik, and Boston Scientific, and his institution has received research funding from Biosense Webster and Securus/Boston Scientific.

mzoler@mdedge.com

NATIONAL HARBOR, MD. – Thermal injury of a patient’s esophagus during radiofrequency catheter ablation of atrial fibrillation is notorious as a relatively common and problematic complication of the procedure, but two new approaches showed promise for substantially cutting the risk of esophageal thermal injury and the potential for the most severe damage: perforation.

Mitchel L. Zoler/MDedge News

One of these innovations is intensive esophageal cooling with a commercially marketed, fluid-chilled catheter placed in a patient’s esophagus during radiofrequency catheter ablation that keeps the inner surface of the esophagus at 4°C. This approach cut the incidence of periprocedural episodes of endoscopically detected esophageal thermal injury from 20% among controls to 3% in patients who had esophageal cooling in a randomized study with 120 patients, Mark M. Gallagher, MD, said at the annual International AF Symposium. The same device can also maintain a temperature on the inner surface of the esophagus of 42 ° C in patients undergoing cryoablation of atrial fibrillation, noted Dr. Gallagher, a cardiac electrophysiologist at St. George’s University Hospitals in London.

A second approach to cutting esophageal damage focuses on modifying the energy delivery with a radiofrequency ablation method known as high-power short-duration (HPSD). As the name says, this strategy uses a relatively high level of radiofrequency energy, 50 watts in the reported experience, for the brief interval of about 7 seconds, ideally delivering an overall Ablation Index of at least 350 but below 360, said Thomas Deneke, MD, an electrophysiologist, professor, and cochief of cardiology at the Heart Center in Bad Neustadt, Germany.

Dr. Deneke and his associates in Bad Neustadt began using this HPSD approach in mid-2019, and by early 2020 they had data from 179 patients who underwent first-time catheter ablation of atrial fibrillation (AFib), all of whom had undergone routine esophageal endoscopy 1-3 days after their treatment. Eight patients (4%) showed evidence of endoscopically detected esophageal lesions (EDEL), including three patients (2%) with an actual esophageal ulcer, and one (0.6%) who developed a perforation that healed after 52 days, Dr. Deneke reported. An additional 55 patients underwent a redo catheter ablation procedure using the HPSD method during this period, and in that group follow-up endoscopy in all patients showed EDEL in two patients (4%). In contrast, during Jan. 2012–May 2019, the same German center treated 2,102 patients who had a first radiofrequency catheter ablation using convention energy levels and treatment times, which resulted in 291 patients having an EDEL (14%), including 94 (4%) with an ulcer, and six patients (0.3%) with an esophageal perforation, he said.

Mitchel L. Zoler/MDedge News

His center’s recent safety experience with HPSD radiofrequncy ablation, compared with the historical controls, suggests that this technique can produce a substantial reduction in esophageal thermal injury, but HPSD has not completely eliminated the risk and hence there is need for continued alertness for this potential complication Dr. Deneke concluded. The HPSD method is also limited by having “a very narrow window” between efficacy at an Ablation Index of 350 and safety when the index remains below 360, he added.

The randomized study that Dr. Gallagher ran at St. George’s followed an analysis he and his associates recently published that suggested efficacy using esophageal cooling in prior reports when the data combined in a meta-analysis (J Interv Card Electrophysiol. 2019 Nov 22. doi: 10.1007/s10840-019-00661-5). They also concluded that the clinical setting required a temperature control device with an enhanced capacity for rapid cooling, which prior studies had lacked. So they turned to a Food and Drug Administration–approved catheter designed for placement in the esophagus for the purpose of either whole-body cooling or warming.

The study randomized a total of 187 patients, but collected follow-up endoscopy at 5-7 days after the ablation procedure on 120 patients, of whom 60 received esophageal cooling and 60 did not. The types of ablations performed on patients in the two study arms were similar, and use of esophageal cooling had no impact on treatment duration or efficacy, either acute and longer term, Dr. Gallagher reported.

Cooling had a marked and statistically significant impact on endoscopically detected thermal injury. Although two patients in the group that underwent cooling had injuries, in one of these cases the injury involved a protocol violation: Radiofrequency ablation mistakenly occurred after the cooling device shut off, and it was during this period when the injury happened. In the second case of thermal injury, blinded scoring judged the injury as grade 2 in severity – an erosion of less than 5 mm – on a nine-item scale that ranged from zero to grade 6, the most severe level denoting a fistula. By contrast, among the 12 patients with thermal injury in the nonprotected subgroup, one patient had a grade 5a lesion denoting a deep ulcer, one had a 4b denoting a superficial ulcer with a clot, and four had a 4a lesion defined as a clean superficial ulcer.

“This is really effective. It’s the first study to show reduced damage without affecting ablation efficacy,” Dr. Gallagher said. He plans to now use this method of esophageal protection routinely for his AFib ablation patients who pay privately, and for patients insured under the national U.K. system once this coverage is approved. Dr. Deneke expressed his interest in also using this approach to esophageal protection, but noted that currently he did not have access to the cooling catheter that Dr. Gallagher used because of regulatory constraints.

The esophageal cooling study was sponsored by Attune Medical, which markets the cooling device. Dr. Gallagher has received research funding from Attune Medical, and has received honoraria as a speaker on behalf of Biosense Webster and Medtronic. Dr. Deneke has been a speaker on behalf of Abbott, Biosense Webster, Biotronik, and Boston Scientific, and his institution has received research funding from Biosense Webster and Securus/Boston Scientific.

mzoler@mdedge.com

The U.S. Food and Drug Administration today approved isatuximab (Sarclisa, Sanofi) in combination with pomalidomide (Revlimid, Celgene) and dexamethasone for the treatment of adult patients with multiple myeloma who have received two or more prior therapies including lenalidomide and a proteasome inhibitor.

Isatuximab is an anti-CD38 monoclonal antibody administered by intravenous infusion that works by helping the immune system attack multiple myeloma cancer cells.

“While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy,” he added.

The new approval is based on results from ICARIA-MM, an open-label, randomized phase 3 clinical trial of isatuximab among 307 patients in this setting.

In the trial, at a median follow-up of 11.6 months, median progression-free survival was 11.5 months in the isatuximab-pomalidomide-dexamethasone group versus 6.5 months in the pomalidomide-dexamethasone group (hazard ratio, 0.60; P = .001), as reported last year. Overall response rates were 60.4% for the triplet-treated group versus 35.3% for the doublet-treated group.

The most common side effects for isatuximab included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia.

Deaths because of treatment-related adverse events were reported for one patient (less than 1%) in the isatuximab-pomalidomide-dexamethasone group (sepsis) and two patients (1%) in the pomalidomide-dexamethasone group (pneumonia and urinary tract infection).

The drug can also cause serious side effects, including IV infusion-related reactions. In the case of a grade 3 or higher reaction, the drug should be permanently discontinued and health care professionals should institute appropriate medical management.

The FDA notes there have been higher incidences of second primary malignancies observed in a controlled clinical trial of patients with multiple myeloma receiving the drug.

The FDA also highlighted that laboratory test interference may be caused by isatuximab and that blood banks should be informed that patients are receiving the drug. Isatuximab may interfere with, for example, antibody screening for patients who need a blood transfusion. Isatuximab may also interfere with the assays used to monitor M-protein, which may impact the determination of complete response.

This article originally appeared on Medscape.com.

The U.S. Food and Drug Administration today approved isatuximab (Sarclisa, Sanofi) in combination with pomalidomide (Revlimid, Celgene) and dexamethasone for the treatment of adult patients with multiple myeloma who have received two or more prior therapies including lenalidomide and a proteasome inhibitor.

Isatuximab is an anti-CD38 monoclonal antibody administered by intravenous infusion that works by helping the immune system attack multiple myeloma cancer cells.

“While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy,” he added.

The new approval is based on results from ICARIA-MM, an open-label, randomized phase 3 clinical trial of isatuximab among 307 patients in this setting.

In the trial, at a median follow-up of 11.6 months, median progression-free survival was 11.5 months in the isatuximab-pomalidomide-dexamethasone group versus 6.5 months in the pomalidomide-dexamethasone group (hazard ratio, 0.60; P = .001), as reported last year. Overall response rates were 60.4% for the triplet-treated group versus 35.3% for the doublet-treated group.

The most common side effects for isatuximab included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia.

Deaths because of treatment-related adverse events were reported for one patient (less than 1%) in the isatuximab-pomalidomide-dexamethasone group (sepsis) and two patients (1%) in the pomalidomide-dexamethasone group (pneumonia and urinary tract infection).

The drug can also cause serious side effects, including IV infusion-related reactions. In the case of a grade 3 or higher reaction, the drug should be permanently discontinued and health care professionals should institute appropriate medical management.

The FDA notes there have been higher incidences of second primary malignancies observed in a controlled clinical trial of patients with multiple myeloma receiving the drug.

The FDA also highlighted that laboratory test interference may be caused by isatuximab and that blood banks should be informed that patients are receiving the drug. Isatuximab may interfere with, for example, antibody screening for patients who need a blood transfusion. Isatuximab may also interfere with the assays used to monitor M-protein, which may impact the determination of complete response.

This article originally appeared on Medscape.com.

The U.S. Food and Drug Administration today approved isatuximab (Sarclisa, Sanofi) in combination with pomalidomide (Revlimid, Celgene) and dexamethasone for the treatment of adult patients with multiple myeloma who have received two or more prior therapies including lenalidomide and a proteasome inhibitor.

Isatuximab is an anti-CD38 monoclonal antibody administered by intravenous infusion that works by helping the immune system attack multiple myeloma cancer cells.

“While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy,” he added.

The new approval is based on results from ICARIA-MM, an open-label, randomized phase 3 clinical trial of isatuximab among 307 patients in this setting.

In the trial, at a median follow-up of 11.6 months, median progression-free survival was 11.5 months in the isatuximab-pomalidomide-dexamethasone group versus 6.5 months in the pomalidomide-dexamethasone group (hazard ratio, 0.60; P = .001), as reported last year. Overall response rates were 60.4% for the triplet-treated group versus 35.3% for the doublet-treated group.

The most common side effects for isatuximab included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia.

Deaths because of treatment-related adverse events were reported for one patient (less than 1%) in the isatuximab-pomalidomide-dexamethasone group (sepsis) and two patients (1%) in the pomalidomide-dexamethasone group (pneumonia and urinary tract infection).

The drug can also cause serious side effects, including IV infusion-related reactions. In the case of a grade 3 or higher reaction, the drug should be permanently discontinued and health care professionals should institute appropriate medical management.

The FDA notes there have been higher incidences of second primary malignancies observed in a controlled clinical trial of patients with multiple myeloma receiving the drug.

The FDA also highlighted that laboratory test interference may be caused by isatuximab and that blood banks should be informed that patients are receiving the drug. Isatuximab may interfere with, for example, antibody screening for patients who need a blood transfusion. Isatuximab may also interfere with the assays used to monitor M-protein, which may impact the determination of complete response.

This article originally appeared on Medscape.com.

LONDON – A quarter of urgent contacts in 20 children with generalized severe recessive dystrophic epidermolysis bullosa (GS-RDEB) were tied to esophageal narrowing, according data from a 12-month review of electronic health records.

Urgent advice was sought 102 times outside of regular or scheduled appointments by the parents of 20 children with GS-RDEB, Christine Prodinger, MD, of the University Clinic of Dermatology at Paracelsus Medical University, Salzburg, Austria, and colleagues reported in a poster presentation at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA). The researchers looked at the records from the EB clinic at Great Ormond Street Hospital for Children NHS Foundation Trust, London, during April 2018–April 2019.

The mean number of urgent contacts with the specialist unit was 5.1 per patient per year, the researchers reported, with 24 of the 102 contacts (23.5%) resulting in the child being admitted to a hospital. Most of the contacts were made via email or telephone to EB nurses (94%), by contacts during home visits (3%), or in an appointment with the palliative or symptom care team (3%).

“The most common reason [for the urgent contact] was acute dysphagia,” which was experienced as choking, throat pain, difficulty eating, reflux, and vomiting, the researchers observed. Dysphagia affected children in 27 of the contacts (26.5%), and resulted in esophageal dilatation in 90% of the cases. Other reasons for urgent contact were skin infection (15.7% of contacts), uncontrolled pain (15.7% of the contacts), and eye problems (11.8%).
 

Esophageal dilatation

Strictures are just one of the esophageal manifestations of the disease, noted Anna Bruckner, MD, associate professor of dermatology and pediatrics in the department of dermatology at the University of Colorado at Denver, Aurora, during an oral presentation. Other possible manifestations include blisters and erosions, the formation of webs – a thin extension of esophageal tissue, perforations, and rupture. “These are primarily problems with dystrophic EB” but can occur with other EB subtypes, she noted.

“We don’t have great evidence” on whether the onset of esophageal strictures can be delayed or prevented, Dr. Bruckner observed. As for management, “fluoroscopy-guided balloon dilatation is probably best” for most patients, but the best procedural approach needs to be discussed on a patient-by-patient basis.

Citing a paper that documents her own experience on the use of esophageal dilatation in 24 children who underwent 231 fluoroscopy-guided balloon dilatation procedures, Dr. Bruckner noted that strictures were most commonly located in the proximal part of the esophagus, with a median distance of 13 cm down from the lips (J Pediatr Gastroenterol Nutr. 2018;67[6]:701-5).

The retrospective chart review reported by Dr. Bruckner showed that there were a median of seven dilatation procedures per patient, and 20 patients had repeated procedures at a median interval of 164 days. About 10% of procedures resulted in adverse events – mostly vomiting, pain, and fever – but there were no perforations or other serious effects, and the rate of subsequent hospitalization was 6.9%.
 

Dysphagia

Dysphagia was the predominant symptom caused by esophageal stricture in another dataset reported in a poster by Elena Pope, MD, MSc, of the Hospital for Sick Children at the University of Toronto, and colleagues.

Of 125 EB patients who had experienced at least 1 esophageal stricture episode, 497 esophageal stricture events were reported, and 85.5% of patients had difficulty swallowing at presentation, with 29.8% unable to swallow solids and 7.2% unable to swallow liquids. Other symptoms at presentation were painful swallowing (11%), food being stuck in the esophagus (8%), regurgitation (5%), coughing (4.8%), and dyspepsia (2.8%).

The aim of the retrospective, multicenter cohort study was to determine the prevalence of, and predisposing factors for, restenosis of esophageal strictures and factors that may predispose to restenosis. The study population consisted of 66 men and 59 women who had experienced their esophageal stricture at around ages 12-13 years. The majority (98.4%) had dystrophic EB, of which almost half (46.5%) had GS-RDEB.

The researchers found that the location of the esophageal stricture was important for restenosis, and that strictures occurring in the lower esophagus were 67.5% less likely to result in restenosis than if they occurred in the upper esophagus (P = .057; hazard ratio, 0.675).

A higher number of strictures was associated with a higher rate of restenosis, they reported. Indeed, patients who had two esophageal strictures had a 29.4% increased risk of restenosis, compared with those who had just one stricture (P = .038; HR, 1.294), and those with three or more strictures had an increased risk of 78.5%, compared with those having one stricture (P = .005; HR, 1.785).

Strictures longer than 1 cm also were associated with a greater (34.7%) risk of restenosis, compared with shorter strictures (P = .032; HR, 1.347). Various methods of resolving the stricture were used, from fluoroscopy-guided balloon dilatation to retro- or antegrade endoscopy. “Irrespective of method, dilatations are successful,” Dr. Pope and colleagues reported. The overall success of dilatation was 99.3%, with full dilatation achieved in almost all of the patients (96%). Of note is that there was a low risk (2.6%) of complications, they observed.

Medications were used in 46.8% of the patients, with the most popular choice being corticosteroids (90.3%), but the researchers noted that the “potential benefit of periprocedural corticosteroids use in decreasing the risk of restenosis needs further exploration.”

Dr. Bruckner had noted in her presentation that her group did not favor the use of periprocedural corticosteroids, but that antifibrotic therapy “could be attractive” for preventing future strictures.

Dr. Prodinger, Dr. Pope, and their colleagues did not provide disclosure information. Dr. Bruckner is the principal investigator for the Epidermolysis Bullosa Clinical Characterization and Outcomes Database. She disclosed the receipt of grants or research funding, honoraria, or consultation fees from a number of drug companies, as well as other support from the EB Research Partnership and the EB Medical Research Foundation.

SOURCES: Prodinger et al. EB 2020. Poster 3; Bruckner A et al. Pediatr Gastroenterol Nutr. 2018;67(6):701-5; Pope et al. EB 2020. Poster 8.

LONDON – A quarter of urgent contacts in 20 children with generalized severe recessive dystrophic epidermolysis bullosa (GS-RDEB) were tied to esophageal narrowing, according data from a 12-month review of electronic health records.

Urgent advice was sought 102 times outside of regular or scheduled appointments by the parents of 20 children with GS-RDEB, Christine Prodinger, MD, of the University Clinic of Dermatology at Paracelsus Medical University, Salzburg, Austria, and colleagues reported in a poster presentation at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA). The researchers looked at the records from the EB clinic at Great Ormond Street Hospital for Children NHS Foundation Trust, London, during April 2018–April 2019.

The mean number of urgent contacts with the specialist unit was 5.1 per patient per year, the researchers reported, with 24 of the 102 contacts (23.5%) resulting in the child being admitted to a hospital. Most of the contacts were made via email or telephone to EB nurses (94%), by contacts during home visits (3%), or in an appointment with the palliative or symptom care team (3%).

“The most common reason [for the urgent contact] was acute dysphagia,” which was experienced as choking, throat pain, difficulty eating, reflux, and vomiting, the researchers observed. Dysphagia affected children in 27 of the contacts (26.5%), and resulted in esophageal dilatation in 90% of the cases. Other reasons for urgent contact were skin infection (15.7% of contacts), uncontrolled pain (15.7% of the contacts), and eye problems (11.8%).
 

Esophageal dilatation

Strictures are just one of the esophageal manifestations of the disease, noted Anna Bruckner, MD, associate professor of dermatology and pediatrics in the department of dermatology at the University of Colorado at Denver, Aurora, during an oral presentation. Other possible manifestations include blisters and erosions, the formation of webs – a thin extension of esophageal tissue, perforations, and rupture. “These are primarily problems with dystrophic EB” but can occur with other EB subtypes, she noted.

“We don’t have great evidence” on whether the onset of esophageal strictures can be delayed or prevented, Dr. Bruckner observed. As for management, “fluoroscopy-guided balloon dilatation is probably best” for most patients, but the best procedural approach needs to be discussed on a patient-by-patient basis.

Citing a paper that documents her own experience on the use of esophageal dilatation in 24 children who underwent 231 fluoroscopy-guided balloon dilatation procedures, Dr. Bruckner noted that strictures were most commonly located in the proximal part of the esophagus, with a median distance of 13 cm down from the lips (J Pediatr Gastroenterol Nutr. 2018;67[6]:701-5).

The retrospective chart review reported by Dr. Bruckner showed that there were a median of seven dilatation procedures per patient, and 20 patients had repeated procedures at a median interval of 164 days. About 10% of procedures resulted in adverse events – mostly vomiting, pain, and fever – but there were no perforations or other serious effects, and the rate of subsequent hospitalization was 6.9%.
 

Dysphagia

Dysphagia was the predominant symptom caused by esophageal stricture in another dataset reported in a poster by Elena Pope, MD, MSc, of the Hospital for Sick Children at the University of Toronto, and colleagues.

Of 125 EB patients who had experienced at least 1 esophageal stricture episode, 497 esophageal stricture events were reported, and 85.5% of patients had difficulty swallowing at presentation, with 29.8% unable to swallow solids and 7.2% unable to swallow liquids. Other symptoms at presentation were painful swallowing (11%), food being stuck in the esophagus (8%), regurgitation (5%), coughing (4.8%), and dyspepsia (2.8%).

The aim of the retrospective, multicenter cohort study was to determine the prevalence of, and predisposing factors for, restenosis of esophageal strictures and factors that may predispose to restenosis. The study population consisted of 66 men and 59 women who had experienced their esophageal stricture at around ages 12-13 years. The majority (98.4%) had dystrophic EB, of which almost half (46.5%) had GS-RDEB.

The researchers found that the location of the esophageal stricture was important for restenosis, and that strictures occurring in the lower esophagus were 67.5% less likely to result in restenosis than if they occurred in the upper esophagus (P = .057; hazard ratio, 0.675).

A higher number of strictures was associated with a higher rate of restenosis, they reported. Indeed, patients who had two esophageal strictures had a 29.4% increased risk of restenosis, compared with those who had just one stricture (P = .038; HR, 1.294), and those with three or more strictures had an increased risk of 78.5%, compared with those having one stricture (P = .005; HR, 1.785).

Strictures longer than 1 cm also were associated with a greater (34.7%) risk of restenosis, compared with shorter strictures (P = .032; HR, 1.347). Various methods of resolving the stricture were used, from fluoroscopy-guided balloon dilatation to retro- or antegrade endoscopy. “Irrespective of method, dilatations are successful,” Dr. Pope and colleagues reported. The overall success of dilatation was 99.3%, with full dilatation achieved in almost all of the patients (96%). Of note is that there was a low risk (2.6%) of complications, they observed.

Medications were used in 46.8% of the patients, with the most popular choice being corticosteroids (90.3%), but the researchers noted that the “potential benefit of periprocedural corticosteroids use in decreasing the risk of restenosis needs further exploration.”

Dr. Bruckner had noted in her presentation that her group did not favor the use of periprocedural corticosteroids, but that antifibrotic therapy “could be attractive” for preventing future strictures.

Dr. Prodinger, Dr. Pope, and their colleagues did not provide disclosure information. Dr. Bruckner is the principal investigator for the Epidermolysis Bullosa Clinical Characterization and Outcomes Database. She disclosed the receipt of grants or research funding, honoraria, or consultation fees from a number of drug companies, as well as other support from the EB Research Partnership and the EB Medical Research Foundation.

SOURCES: Prodinger et al. EB 2020. Poster 3; Bruckner A et al. Pediatr Gastroenterol Nutr. 2018;67(6):701-5; Pope et al. EB 2020. Poster 8.

LONDON – A quarter of urgent contacts in 20 children with generalized severe recessive dystrophic epidermolysis bullosa (GS-RDEB) were tied to esophageal narrowing, according data from a 12-month review of electronic health records.

Urgent advice was sought 102 times outside of regular or scheduled appointments by the parents of 20 children with GS-RDEB, Christine Prodinger, MD, of the University Clinic of Dermatology at Paracelsus Medical University, Salzburg, Austria, and colleagues reported in a poster presentation at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (DEBRA). The researchers looked at the records from the EB clinic at Great Ormond Street Hospital for Children NHS Foundation Trust, London, during April 2018–April 2019.

The mean number of urgent contacts with the specialist unit was 5.1 per patient per year, the researchers reported, with 24 of the 102 contacts (23.5%) resulting in the child being admitted to a hospital. Most of the contacts were made via email or telephone to EB nurses (94%), by contacts during home visits (3%), or in an appointment with the palliative or symptom care team (3%).

“The most common reason [for the urgent contact] was acute dysphagia,” which was experienced as choking, throat pain, difficulty eating, reflux, and vomiting, the researchers observed. Dysphagia affected children in 27 of the contacts (26.5%), and resulted in esophageal dilatation in 90% of the cases. Other reasons for urgent contact were skin infection (15.7% of contacts), uncontrolled pain (15.7% of the contacts), and eye problems (11.8%).
 

Esophageal dilatation

Strictures are just one of the esophageal manifestations of the disease, noted Anna Bruckner, MD, associate professor of dermatology and pediatrics in the department of dermatology at the University of Colorado at Denver, Aurora, during an oral presentation. Other possible manifestations include blisters and erosions, the formation of webs – a thin extension of esophageal tissue, perforations, and rupture. “These are primarily problems with dystrophic EB” but can occur with other EB subtypes, she noted.

“We don’t have great evidence” on whether the onset of esophageal strictures can be delayed or prevented, Dr. Bruckner observed. As for management, “fluoroscopy-guided balloon dilatation is probably best” for most patients, but the best procedural approach needs to be discussed on a patient-by-patient basis.

Citing a paper that documents her own experience on the use of esophageal dilatation in 24 children who underwent 231 fluoroscopy-guided balloon dilatation procedures, Dr. Bruckner noted that strictures were most commonly located in the proximal part of the esophagus, with a median distance of 13 cm down from the lips (J Pediatr Gastroenterol Nutr. 2018;67[6]:701-5).

The retrospective chart review reported by Dr. Bruckner showed that there were a median of seven dilatation procedures per patient, and 20 patients had repeated procedures at a median interval of 164 days. About 10% of procedures resulted in adverse events – mostly vomiting, pain, and fever – but there were no perforations or other serious effects, and the rate of subsequent hospitalization was 6.9%.
 

Dysphagia

Dysphagia was the predominant symptom caused by esophageal stricture in another dataset reported in a poster by Elena Pope, MD, MSc, of the Hospital for Sick Children at the University of Toronto, and colleagues.

Of 125 EB patients who had experienced at least 1 esophageal stricture episode, 497 esophageal stricture events were reported, and 85.5% of patients had difficulty swallowing at presentation, with 29.8% unable to swallow solids and 7.2% unable to swallow liquids. Other symptoms at presentation were painful swallowing (11%), food being stuck in the esophagus (8%), regurgitation (5%), coughing (4.8%), and dyspepsia (2.8%).

The aim of the retrospective, multicenter cohort study was to determine the prevalence of, and predisposing factors for, restenosis of esophageal strictures and factors that may predispose to restenosis. The study population consisted of 66 men and 59 women who had experienced their esophageal stricture at around ages 12-13 years. The majority (98.4%) had dystrophic EB, of which almost half (46.5%) had GS-RDEB.

The researchers found that the location of the esophageal stricture was important for restenosis, and that strictures occurring in the lower esophagus were 67.5% less likely to result in restenosis than if they occurred in the upper esophagus (P = .057; hazard ratio, 0.675).

A higher number of strictures was associated with a higher rate of restenosis, they reported. Indeed, patients who had two esophageal strictures had a 29.4% increased risk of restenosis, compared with those who had just one stricture (P = .038; HR, 1.294), and those with three or more strictures had an increased risk of 78.5%, compared with those having one stricture (P = .005; HR, 1.785).

Strictures longer than 1 cm also were associated with a greater (34.7%) risk of restenosis, compared with shorter strictures (P = .032; HR, 1.347). Various methods of resolving the stricture were used, from fluoroscopy-guided balloon dilatation to retro- or antegrade endoscopy. “Irrespective of method, dilatations are successful,” Dr. Pope and colleagues reported. The overall success of dilatation was 99.3%, with full dilatation achieved in almost all of the patients (96%). Of note is that there was a low risk (2.6%) of complications, they observed.

Medications were used in 46.8% of the patients, with the most popular choice being corticosteroids (90.3%), but the researchers noted that the “potential benefit of periprocedural corticosteroids use in decreasing the risk of restenosis needs further exploration.”

Dr. Bruckner had noted in her presentation that her group did not favor the use of periprocedural corticosteroids, but that antifibrotic therapy “could be attractive” for preventing future strictures.

Dr. Prodinger, Dr. Pope, and their colleagues did not provide disclosure information. Dr. Bruckner is the principal investigator for the Epidermolysis Bullosa Clinical Characterization and Outcomes Database. She disclosed the receipt of grants or research funding, honoraria, or consultation fees from a number of drug companies, as well as other support from the EB Research Partnership and the EB Medical Research Foundation.

SOURCES: Prodinger et al. EB 2020. Poster 3; Bruckner A et al. Pediatr Gastroenterol Nutr. 2018;67(6):701-5; Pope et al. EB 2020. Poster 8.

Some instances of unprofessional behavior by medical trainees are universally deemed egregious and worthy of discipline — for example, looking up a friend’s medical data after HIPAA training.

Conversely, some professionalism lapses may be widely thought of as a teaching and consoling moment, such as the human error involved in forgetting a scheduled repositioning of a patient.

But between the extremes is a vast gray area. To deal with those cases appropriately, Jason Wasserman, PhD, and colleagues propose a new framework by which to judge each infraction.

The framework draws from “just culture” concepts used to evaluate medical errors, Wasserman, associate professor of biomedical science at Oakland University William Beaumont School of Medicine in Rochester, Michigan, told Medscape Medical News. Such an approach takes into account the environment in which the error was made, the knowledge and intent of the person making the error, and the severity and consequences of the infraction so that trainees and institutions can learn from mistakes.

“Trainees by definition are not going to fully get it,” he explained. “By definition they’re not going to fully achieve professional expectations. So how can we respond to the things we need to respond to, but do it in a way that’s educational?”

Wasserman and coauthors’ framework for remediation, which they published February 20 in The New England Journal of Medicine, takes into account several questions: Was the expectation clear? Were there factors beyond the trainees› control? What were the trainees› intentions and did they understand the consequences? Did the person genuinely believe the action was inconsequential?

An example requiring discipline, the authors say, would be using a crib sheet during an exam. In that case the intent is clear, there is no defensible belief that the action is inconsequential, and there is a clear understanding the action is wrong.

But a response of “affirm, support, and advise” is more appropriate, for example, when a student’s alarm doesn’t go off after a power outage and they miss a mandatory meeting.

Wasserman points out that this framework won’t cover all situations.

“This is not an algorithm for answering your questions about what to do,” he said. “It’s an architecture for clarifying the discussion about that. It can really tease out all the threads that need to be considered to best respond to and correct the professionalism lapse, but do it in a way that is developmentally appropriate.”
 

A Core Competency

For two decades, professionalism has been considered a core competency of medical education. In 1999, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties formalized it as such. In 2013, the Association of American Medical Colleges formally required related professionalism competencies.

However, identifying lapses has operated largely on an “I-know-it-when-I-see-it” basis, leading to widely varying remediation practices judged by a small number of faculty members or administrators.

The ideas outlined by Wasserman and colleagues are “a terrific application of the ‘just-culture’ framework,” according to Nicole Treadway, MD, a first-year primary care resident at Emory School of Medicine in Atlanta, Georgia.

At Emory, discussions of professionalism start from day 1 of medical school and the subject is revisited throughout training in small groups, Treadway told Medscape Medical News.

But, she said, as the authors point out, definitions of unprofessionalism are not always clear and the examples the authors put forward help put lapses in context.

The framework also allows for looking at mistakes in light of the stress trainees encounter and the greater chance of making a professionalism error in those situations, she noted.

In her own work, she says, because she is juggling both inpatient and outpatient care, she is finding it is easy to get behind on correspondence or communicating lab results or having follow-up conversations.

Those delays could be seen as lapses in professionalism, but under this framework, there may be system solutions or training opportunities to consider.

“We do need this organizational architecture, and I think it could serve us well in really helping us identify and appropriately respond to what we see regarding professionalism,” she said.

Framework Helps Standardize Thinking

She said having a universal framework also helps because while standards of professionalism are easier to monitor in a single medical school, when students scatter to other hospitals for clinical training, those hospitals may have different professionalism standards.

Wasserman agrees, saying, “This could be easily adopted in any environment where people deal with professionalism lapses. I don’t even think it’s necessarily relegated to trainees. It’s a great way to think about any kind of lapses, just as hospitals think about medical errors.”

He said the next step is presenting the framework at various medical schools for feedback and research to see whether the framework improves processes.

Potential criticism, he said, might come from those who say such a construct avoids punishing students who make errors.

“There will always be people who say we’re pandering to medical students whenever we worry about the learning environment,” he said. “There are old-school purists who say when people screw up you should punish them.”

But he adds healthcare broadly has moved past that thinking.

“People recognized 20 years ago or more from the standpoint of improving healthcare systems and safety that is a bad strategy. You’ll never get error-free humans working in your system, and what you have to do is consider how the system is functioning and think about ways to optimize the system so people can be their best within it.”

Wasserman and Treadway have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Some instances of unprofessional behavior by medical trainees are universally deemed egregious and worthy of discipline — for example, looking up a friend’s medical data after HIPAA training.

Conversely, some professionalism lapses may be widely thought of as a teaching and consoling moment, such as the human error involved in forgetting a scheduled repositioning of a patient.

But between the extremes is a vast gray area. To deal with those cases appropriately, Jason Wasserman, PhD, and colleagues propose a new framework by which to judge each infraction.

The framework draws from “just culture” concepts used to evaluate medical errors, Wasserman, associate professor of biomedical science at Oakland University William Beaumont School of Medicine in Rochester, Michigan, told Medscape Medical News. Such an approach takes into account the environment in which the error was made, the knowledge and intent of the person making the error, and the severity and consequences of the infraction so that trainees and institutions can learn from mistakes.

“Trainees by definition are not going to fully get it,” he explained. “By definition they’re not going to fully achieve professional expectations. So how can we respond to the things we need to respond to, but do it in a way that’s educational?”

Wasserman and coauthors’ framework for remediation, which they published February 20 in The New England Journal of Medicine, takes into account several questions: Was the expectation clear? Were there factors beyond the trainees› control? What were the trainees› intentions and did they understand the consequences? Did the person genuinely believe the action was inconsequential?

An example requiring discipline, the authors say, would be using a crib sheet during an exam. In that case the intent is clear, there is no defensible belief that the action is inconsequential, and there is a clear understanding the action is wrong.

But a response of “affirm, support, and advise” is more appropriate, for example, when a student’s alarm doesn’t go off after a power outage and they miss a mandatory meeting.

Wasserman points out that this framework won’t cover all situations.

“This is not an algorithm for answering your questions about what to do,” he said. “It’s an architecture for clarifying the discussion about that. It can really tease out all the threads that need to be considered to best respond to and correct the professionalism lapse, but do it in a way that is developmentally appropriate.”
 

A Core Competency

For two decades, professionalism has been considered a core competency of medical education. In 1999, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties formalized it as such. In 2013, the Association of American Medical Colleges formally required related professionalism competencies.

However, identifying lapses has operated largely on an “I-know-it-when-I-see-it” basis, leading to widely varying remediation practices judged by a small number of faculty members or administrators.

The ideas outlined by Wasserman and colleagues are “a terrific application of the ‘just-culture’ framework,” according to Nicole Treadway, MD, a first-year primary care resident at Emory School of Medicine in Atlanta, Georgia.

At Emory, discussions of professionalism start from day 1 of medical school and the subject is revisited throughout training in small groups, Treadway told Medscape Medical News.

But, she said, as the authors point out, definitions of unprofessionalism are not always clear and the examples the authors put forward help put lapses in context.

The framework also allows for looking at mistakes in light of the stress trainees encounter and the greater chance of making a professionalism error in those situations, she noted.

In her own work, she says, because she is juggling both inpatient and outpatient care, she is finding it is easy to get behind on correspondence or communicating lab results or having follow-up conversations.

Those delays could be seen as lapses in professionalism, but under this framework, there may be system solutions or training opportunities to consider.

“We do need this organizational architecture, and I think it could serve us well in really helping us identify and appropriately respond to what we see regarding professionalism,” she said.

Framework Helps Standardize Thinking

She said having a universal framework also helps because while standards of professionalism are easier to monitor in a single medical school, when students scatter to other hospitals for clinical training, those hospitals may have different professionalism standards.

Wasserman agrees, saying, “This could be easily adopted in any environment where people deal with professionalism lapses. I don’t even think it’s necessarily relegated to trainees. It’s a great way to think about any kind of lapses, just as hospitals think about medical errors.”

He said the next step is presenting the framework at various medical schools for feedback and research to see whether the framework improves processes.

Potential criticism, he said, might come from those who say such a construct avoids punishing students who make errors.

“There will always be people who say we’re pandering to medical students whenever we worry about the learning environment,” he said. “There are old-school purists who say when people screw up you should punish them.”

But he adds healthcare broadly has moved past that thinking.

“People recognized 20 years ago or more from the standpoint of improving healthcare systems and safety that is a bad strategy. You’ll never get error-free humans working in your system, and what you have to do is consider how the system is functioning and think about ways to optimize the system so people can be their best within it.”

Wasserman and Treadway have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Some instances of unprofessional behavior by medical trainees are universally deemed egregious and worthy of discipline — for example, looking up a friend’s medical data after HIPAA training.

Conversely, some professionalism lapses may be widely thought of as a teaching and consoling moment, such as the human error involved in forgetting a scheduled repositioning of a patient.

But between the extremes is a vast gray area. To deal with those cases appropriately, Jason Wasserman, PhD, and colleagues propose a new framework by which to judge each infraction.

The framework draws from “just culture” concepts used to evaluate medical errors, Wasserman, associate professor of biomedical science at Oakland University William Beaumont School of Medicine in Rochester, Michigan, told Medscape Medical News. Such an approach takes into account the environment in which the error was made, the knowledge and intent of the person making the error, and the severity and consequences of the infraction so that trainees and institutions can learn from mistakes.

“Trainees by definition are not going to fully get it,” he explained. “By definition they’re not going to fully achieve professional expectations. So how can we respond to the things we need to respond to, but do it in a way that’s educational?”

Wasserman and coauthors’ framework for remediation, which they published February 20 in The New England Journal of Medicine, takes into account several questions: Was the expectation clear? Were there factors beyond the trainees› control? What were the trainees› intentions and did they understand the consequences? Did the person genuinely believe the action was inconsequential?

An example requiring discipline, the authors say, would be using a crib sheet during an exam. In that case the intent is clear, there is no defensible belief that the action is inconsequential, and there is a clear understanding the action is wrong.

But a response of “affirm, support, and advise” is more appropriate, for example, when a student’s alarm doesn’t go off after a power outage and they miss a mandatory meeting.

Wasserman points out that this framework won’t cover all situations.

“This is not an algorithm for answering your questions about what to do,” he said. “It’s an architecture for clarifying the discussion about that. It can really tease out all the threads that need to be considered to best respond to and correct the professionalism lapse, but do it in a way that is developmentally appropriate.”
 

A Core Competency

For two decades, professionalism has been considered a core competency of medical education. In 1999, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties formalized it as such. In 2013, the Association of American Medical Colleges formally required related professionalism competencies.

However, identifying lapses has operated largely on an “I-know-it-when-I-see-it” basis, leading to widely varying remediation practices judged by a small number of faculty members or administrators.

The ideas outlined by Wasserman and colleagues are “a terrific application of the ‘just-culture’ framework,” according to Nicole Treadway, MD, a first-year primary care resident at Emory School of Medicine in Atlanta, Georgia.

At Emory, discussions of professionalism start from day 1 of medical school and the subject is revisited throughout training in small groups, Treadway told Medscape Medical News.

But, she said, as the authors point out, definitions of unprofessionalism are not always clear and the examples the authors put forward help put lapses in context.

The framework also allows for looking at mistakes in light of the stress trainees encounter and the greater chance of making a professionalism error in those situations, she noted.

In her own work, she says, because she is juggling both inpatient and outpatient care, she is finding it is easy to get behind on correspondence or communicating lab results or having follow-up conversations.

Those delays could be seen as lapses in professionalism, but under this framework, there may be system solutions or training opportunities to consider.

“We do need this organizational architecture, and I think it could serve us well in really helping us identify and appropriately respond to what we see regarding professionalism,” she said.

Framework Helps Standardize Thinking

She said having a universal framework also helps because while standards of professionalism are easier to monitor in a single medical school, when students scatter to other hospitals for clinical training, those hospitals may have different professionalism standards.

Wasserman agrees, saying, “This could be easily adopted in any environment where people deal with professionalism lapses. I don’t even think it’s necessarily relegated to trainees. It’s a great way to think about any kind of lapses, just as hospitals think about medical errors.”

He said the next step is presenting the framework at various medical schools for feedback and research to see whether the framework improves processes.

Potential criticism, he said, might come from those who say such a construct avoids punishing students who make errors.

“There will always be people who say we’re pandering to medical students whenever we worry about the learning environment,” he said. “There are old-school purists who say when people screw up you should punish them.”

But he adds healthcare broadly has moved past that thinking.

“People recognized 20 years ago or more from the standpoint of improving healthcare systems and safety that is a bad strategy. You’ll never get error-free humans working in your system, and what you have to do is consider how the system is functioning and think about ways to optimize the system so people can be their best within it.”

Wasserman and Treadway have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

WEST PALM BEACH, FLA. – An innovative concept of shared medical appointments (SMA) for patients with multiple sclerosis (MS), in which a group of 10-15 patients meet for about 90 minutes of medical care and patient education, is showing benefits ranging from improved depression and social connections to reduced emergency room visits, according to a presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis.

“At first, this may sound to patients like an awkward concept – they may say, ‘Why would I want to have a medical appointment with other people?’ ” Mary R. Rensel, MD, who is the director of the program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, said. “But once they get there, it’s wonderful to see what happens – patients start to encourage each other and share resources, and it’s enjoyable for the patients and providers alike,” she said.

The main objective of the shared appointments concept was to increase education regarding comorbidity prevention and management of MS, however, importantly, if patients wish to discuss any issues privately, they are accommodated. In addition, family members, children, and caregivers are all welcome to attend. “Caregivers need support as well, so their participation is welcome,” Dr. Rensel said.

A significant benefit of the program is the extended time with providers – an hour and a half – which is a substantially longer period than patients and providers typically spend together, Dr. Rensel noted. “Medical visits are often so rushed, but this gives us much more time together, to learn more and talk about things like brain health,” she said.

With guidance from a multidisciplinary team including nurses, wellness providers, psychologists, and other experts, there are currently seven meeting themes that are rotated through the year, focusing on a variety of subjects. One, for instance, includes education from a nutritionist, and the center includes a kitchen for the group to learn about and try recipes. Other sessions include chair yoga, art therapy, guided imagery, and exercise physiology.

The Cleveland Clinic is a leader in the concept of SMA and offers it to as many as 360 disease states. With the pilot program now underway for more than 3 years, Dr. Rensel and her team conducted a study to investigate its effects.

For the study, the authors collected clinical data on 50 patients who had attended at least one session between January 2016 and June 2019. Among the patients, 94% were female, 80% had relapsing-remitting MS, and mean age was 50. Patients had a mean Determined Disease Steps (PDSS) score of 3.1 plus or minus 2.4 and the average 25-foot walk and nine-hole peg test (dominant hand) times were 9.4 plus or minus 7.8 seconds and 25.8 plus or minus 9.1 seconds, respectively.

The most common comorbidity was depression/anxiety, occurring in 44% of patients, however after participation in the shared medical appointment program, their mean Patient Health Questionnaire-9 scores, with higher scores indicative of worse depression, decreased from pretreatment scores of 7.3 plus or minus 5.5 to posttreatment scores of 5.1 plus or minus 5.6 (P = .001).

Notably, the program appears to have had a positive effect on patients’ use of health care services – while there was a significant decrease in the mean number of emergency room visits (n = 13 to n = 2; P = .0005), the results showed a favorable increase in mean number of follow-up visits with attendees’ primary care providers (n = 19 to n = 41; P = 3.47), physical therapists (n = 15 to n = 27; P = .004), or psychologists (n = 6 to n = 19; P = .003).

“The study was to evaluate the effect of the program after even just one appointment, and we found it really seemed to increase the use of more appropriate care, with less ER utilization and more visits to primary care,” Dr. Rensel said. The study even showed a small but significant reduction in pre- and postoutcome body mass index (BMI, 30.2 plus or minus 7.3 vs. 28.8 plus or minus 7.1; P = .03).

A critical metric that was not measured in the study – the effect of social interaction and camaraderie in a condition that can, for many, feel socially isolating – is clearly profound, Dr. Rensel said.

Amar Dhand, MD, associate professor of neurology at Brigham and Women’s Hospital, Harvard University, Boston, agreed that the peer support in such medical group settings can be highly valuable.

“Shared medical appointments offer an opportunity for peer-to-peer engagement, support, and education,” he said in an interview. “For many patients, this is a chance to bond with persons who are coexperiencing similar problems, allowing new social connections to emerge.”

Dr. Dhand, who spoke on the issue of the importance of social networks at the meeting, noted that, although there are numerous benefits with shared medical appointments, not all patients may respond well.

“Health care settings are one place to stimulate community among peers. This is one important ingredient of addressing social isolation,” he said. “However, there remain challenges such as sustainability of such relationships, paradoxical depression when persons see others with more severe disease, and infrastructure to support such programs.”

The findings from the study, however, do suggest favorable responses, he noted.

“I think, mechanistically, improved psychosocial outcomes are the most pertinent to the intervention,” Dr. Dhand said. “The health care utilization may be attributed to other factors and will need to be assessed in a case control design.”
 

Key benefits of the shared medical appointment concept

A recent article from Cleveland Clinic researchers reviewing the concept of shared medical appointments summarizes that the programs offer benefits based on nine key principles:

• Group exposure in shared medical appointments combats isolation, which in turn helps to remove doubts about one’s ability to manage illness.
• Patients learn about disease self-management vicariously by witnessing others’ illness experiences.
• Patients feel inspired by seeing others who are coping well.
• Group dynamics lead patients and providers to developing more equitable relationships.
• Providers feel increased appreciation and rapport toward colleagues leading to increased efficiency.
• Providers learn from the patients how better to meet their patients’ needs.
• Adequate time allotment of the SMA leads patients to feel supported.
• Patients receive professional expertise from the provider in combination with firsthand information from peers, resulting in more robust health knowledge.
• Patients have the opportunity to see how the physicians interact with fellow patients, which allows them to get to know the physician and better determine their level of trust.

The take-home message from the shared medical appointments concept is that “it may hit a quadruple aim,” Dr. Rensel said. “Access, cost, outcomes, and provider satisfaction.”

The Shared Medical Appointments program received a grant from Genzyme. Dr. Rensel reported consulting or advisory board relationships with Serono, Biogen, Teva, Genzyme, Novartis, and the National Multiple Sclerosis Society. Dr. Dhand had no disclosures to report.

WEST PALM BEACH, FLA. – An innovative concept of shared medical appointments (SMA) for patients with multiple sclerosis (MS), in which a group of 10-15 patients meet for about 90 minutes of medical care and patient education, is showing benefits ranging from improved depression and social connections to reduced emergency room visits, according to a presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis.

“At first, this may sound to patients like an awkward concept – they may say, ‘Why would I want to have a medical appointment with other people?’ ” Mary R. Rensel, MD, who is the director of the program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, said. “But once they get there, it’s wonderful to see what happens – patients start to encourage each other and share resources, and it’s enjoyable for the patients and providers alike,” she said.

The main objective of the shared appointments concept was to increase education regarding comorbidity prevention and management of MS, however, importantly, if patients wish to discuss any issues privately, they are accommodated. In addition, family members, children, and caregivers are all welcome to attend. “Caregivers need support as well, so their participation is welcome,” Dr. Rensel said.

A significant benefit of the program is the extended time with providers – an hour and a half – which is a substantially longer period than patients and providers typically spend together, Dr. Rensel noted. “Medical visits are often so rushed, but this gives us much more time together, to learn more and talk about things like brain health,” she said.

With guidance from a multidisciplinary team including nurses, wellness providers, psychologists, and other experts, there are currently seven meeting themes that are rotated through the year, focusing on a variety of subjects. One, for instance, includes education from a nutritionist, and the center includes a kitchen for the group to learn about and try recipes. Other sessions include chair yoga, art therapy, guided imagery, and exercise physiology.

The Cleveland Clinic is a leader in the concept of SMA and offers it to as many as 360 disease states. With the pilot program now underway for more than 3 years, Dr. Rensel and her team conducted a study to investigate its effects.

For the study, the authors collected clinical data on 50 patients who had attended at least one session between January 2016 and June 2019. Among the patients, 94% were female, 80% had relapsing-remitting MS, and mean age was 50. Patients had a mean Determined Disease Steps (PDSS) score of 3.1 plus or minus 2.4 and the average 25-foot walk and nine-hole peg test (dominant hand) times were 9.4 plus or minus 7.8 seconds and 25.8 plus or minus 9.1 seconds, respectively.

The most common comorbidity was depression/anxiety, occurring in 44% of patients, however after participation in the shared medical appointment program, their mean Patient Health Questionnaire-9 scores, with higher scores indicative of worse depression, decreased from pretreatment scores of 7.3 plus or minus 5.5 to posttreatment scores of 5.1 plus or minus 5.6 (P = .001).

Notably, the program appears to have had a positive effect on patients’ use of health care services – while there was a significant decrease in the mean number of emergency room visits (n = 13 to n = 2; P = .0005), the results showed a favorable increase in mean number of follow-up visits with attendees’ primary care providers (n = 19 to n = 41; P = 3.47), physical therapists (n = 15 to n = 27; P = .004), or psychologists (n = 6 to n = 19; P = .003).

“The study was to evaluate the effect of the program after even just one appointment, and we found it really seemed to increase the use of more appropriate care, with less ER utilization and more visits to primary care,” Dr. Rensel said. The study even showed a small but significant reduction in pre- and postoutcome body mass index (BMI, 30.2 plus or minus 7.3 vs. 28.8 plus or minus 7.1; P = .03).

A critical metric that was not measured in the study – the effect of social interaction and camaraderie in a condition that can, for many, feel socially isolating – is clearly profound, Dr. Rensel said.

Amar Dhand, MD, associate professor of neurology at Brigham and Women’s Hospital, Harvard University, Boston, agreed that the peer support in such medical group settings can be highly valuable.

“Shared medical appointments offer an opportunity for peer-to-peer engagement, support, and education,” he said in an interview. “For many patients, this is a chance to bond with persons who are coexperiencing similar problems, allowing new social connections to emerge.”

Dr. Dhand, who spoke on the issue of the importance of social networks at the meeting, noted that, although there are numerous benefits with shared medical appointments, not all patients may respond well.

“Health care settings are one place to stimulate community among peers. This is one important ingredient of addressing social isolation,” he said. “However, there remain challenges such as sustainability of such relationships, paradoxical depression when persons see others with more severe disease, and infrastructure to support such programs.”

The findings from the study, however, do suggest favorable responses, he noted.

“I think, mechanistically, improved psychosocial outcomes are the most pertinent to the intervention,” Dr. Dhand said. “The health care utilization may be attributed to other factors and will need to be assessed in a case control design.”
 

Key benefits of the shared medical appointment concept

A recent article from Cleveland Clinic researchers reviewing the concept of shared medical appointments summarizes that the programs offer benefits based on nine key principles:

• Group exposure in shared medical appointments combats isolation, which in turn helps to remove doubts about one’s ability to manage illness.
• Patients learn about disease self-management vicariously by witnessing others’ illness experiences.
• Patients feel inspired by seeing others who are coping well.
• Group dynamics lead patients and providers to developing more equitable relationships.
• Providers feel increased appreciation and rapport toward colleagues leading to increased efficiency.
• Providers learn from the patients how better to meet their patients’ needs.
• Adequate time allotment of the SMA leads patients to feel supported.
• Patients receive professional expertise from the provider in combination with firsthand information from peers, resulting in more robust health knowledge.
• Patients have the opportunity to see how the physicians interact with fellow patients, which allows them to get to know the physician and better determine their level of trust.

The take-home message from the shared medical appointments concept is that “it may hit a quadruple aim,” Dr. Rensel said. “Access, cost, outcomes, and provider satisfaction.”

The Shared Medical Appointments program received a grant from Genzyme. Dr. Rensel reported consulting or advisory board relationships with Serono, Biogen, Teva, Genzyme, Novartis, and the National Multiple Sclerosis Society. Dr. Dhand had no disclosures to report.

WEST PALM BEACH, FLA. – An innovative concept of shared medical appointments (SMA) for patients with multiple sclerosis (MS), in which a group of 10-15 patients meet for about 90 minutes of medical care and patient education, is showing benefits ranging from improved depression and social connections to reduced emergency room visits, according to a presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis.

“At first, this may sound to patients like an awkward concept – they may say, ‘Why would I want to have a medical appointment with other people?’ ” Mary R. Rensel, MD, who is the director of the program at the Mellen Center for Multiple Sclerosis, Cleveland Clinic Foundation, said. “But once they get there, it’s wonderful to see what happens – patients start to encourage each other and share resources, and it’s enjoyable for the patients and providers alike,” she said.

The main objective of the shared appointments concept was to increase education regarding comorbidity prevention and management of MS, however, importantly, if patients wish to discuss any issues privately, they are accommodated. In addition, family members, children, and caregivers are all welcome to attend. “Caregivers need support as well, so their participation is welcome,” Dr. Rensel said.

A significant benefit of the program is the extended time with providers – an hour and a half – which is a substantially longer period than patients and providers typically spend together, Dr. Rensel noted. “Medical visits are often so rushed, but this gives us much more time together, to learn more and talk about things like brain health,” she said.

With guidance from a multidisciplinary team including nurses, wellness providers, psychologists, and other experts, there are currently seven meeting themes that are rotated through the year, focusing on a variety of subjects. One, for instance, includes education from a nutritionist, and the center includes a kitchen for the group to learn about and try recipes. Other sessions include chair yoga, art therapy, guided imagery, and exercise physiology.

The Cleveland Clinic is a leader in the concept of SMA and offers it to as many as 360 disease states. With the pilot program now underway for more than 3 years, Dr. Rensel and her team conducted a study to investigate its effects.

For the study, the authors collected clinical data on 50 patients who had attended at least one session between January 2016 and June 2019. Among the patients, 94% were female, 80% had relapsing-remitting MS, and mean age was 50. Patients had a mean Determined Disease Steps (PDSS) score of 3.1 plus or minus 2.4 and the average 25-foot walk and nine-hole peg test (dominant hand) times were 9.4 plus or minus 7.8 seconds and 25.8 plus or minus 9.1 seconds, respectively.

The most common comorbidity was depression/anxiety, occurring in 44% of patients, however after participation in the shared medical appointment program, their mean Patient Health Questionnaire-9 scores, with higher scores indicative of worse depression, decreased from pretreatment scores of 7.3 plus or minus 5.5 to posttreatment scores of 5.1 plus or minus 5.6 (P = .001).

Notably, the program appears to have had a positive effect on patients’ use of health care services – while there was a significant decrease in the mean number of emergency room visits (n = 13 to n = 2; P = .0005), the results showed a favorable increase in mean number of follow-up visits with attendees’ primary care providers (n = 19 to n = 41; P = 3.47), physical therapists (n = 15 to n = 27; P = .004), or psychologists (n = 6 to n = 19; P = .003).

“The study was to evaluate the effect of the program after even just one appointment, and we found it really seemed to increase the use of more appropriate care, with less ER utilization and more visits to primary care,” Dr. Rensel said. The study even showed a small but significant reduction in pre- and postoutcome body mass index (BMI, 30.2 plus or minus 7.3 vs. 28.8 plus or minus 7.1; P = .03).

A critical metric that was not measured in the study – the effect of social interaction and camaraderie in a condition that can, for many, feel socially isolating – is clearly profound, Dr. Rensel said.

Amar Dhand, MD, associate professor of neurology at Brigham and Women’s Hospital, Harvard University, Boston, agreed that the peer support in such medical group settings can be highly valuable.

“Shared medical appointments offer an opportunity for peer-to-peer engagement, support, and education,” he said in an interview. “For many patients, this is a chance to bond with persons who are coexperiencing similar problems, allowing new social connections to emerge.”

Dr. Dhand, who spoke on the issue of the importance of social networks at the meeting, noted that, although there are numerous benefits with shared medical appointments, not all patients may respond well.

“Health care settings are one place to stimulate community among peers. This is one important ingredient of addressing social isolation,” he said. “However, there remain challenges such as sustainability of such relationships, paradoxical depression when persons see others with more severe disease, and infrastructure to support such programs.”

The findings from the study, however, do suggest favorable responses, he noted.

“I think, mechanistically, improved psychosocial outcomes are the most pertinent to the intervention,” Dr. Dhand said. “The health care utilization may be attributed to other factors and will need to be assessed in a case control design.”
 

Key benefits of the shared medical appointment concept

A recent article from Cleveland Clinic researchers reviewing the concept of shared medical appointments summarizes that the programs offer benefits based on nine key principles:

• Group exposure in shared medical appointments combats isolation, which in turn helps to remove doubts about one’s ability to manage illness.
• Patients learn about disease self-management vicariously by witnessing others’ illness experiences.
• Patients feel inspired by seeing others who are coping well.
• Group dynamics lead patients and providers to developing more equitable relationships.
• Providers feel increased appreciation and rapport toward colleagues leading to increased efficiency.
• Providers learn from the patients how better to meet their patients’ needs.
• Adequate time allotment of the SMA leads patients to feel supported.
• Patients receive professional expertise from the provider in combination with firsthand information from peers, resulting in more robust health knowledge.
• Patients have the opportunity to see how the physicians interact with fellow patients, which allows them to get to know the physician and better determine their level of trust.

The take-home message from the shared medical appointments concept is that “it may hit a quadruple aim,” Dr. Rensel said. “Access, cost, outcomes, and provider satisfaction.”

The Shared Medical Appointments program received a grant from Genzyme. Dr. Rensel reported consulting or advisory board relationships with Serono, Biogen, Teva, Genzyme, Novartis, and the National Multiple Sclerosis Society. Dr. Dhand had no disclosures to report.

Some veterans who present to smaller facilities, such as rural hospitals, are transferred to larger facilities for diagnostic or therapeutic procedures. But that access also can mean hardship for rural veterans by taking them far from family and adding costs. Moreover, complex care coordination can cause “triage mismatch” when the patients are at their most vulnerable: “over-triage”—transferring patients unlikely to benefit and “under-triage”—failing to transfer those likely to benefit.  

Researchers from VA Iowa City Healthcare System and University of Iowa conducted a study to find out what proportion of VHA transfers were potentially avoidable. Their study included all veterans treated in any of 120 VHA emergency departments (EDs) and transferred to a VHA acute care hospital between January 2012 and December 2014.

Potentially avoidable transfers (PATs) were defined as transfers in which the patient was either discharged from the referral ED or admitted to the referral hospital for < 24 hours, without having an invasive procedure. The researchers chose that definition to identify patients whose transfer might have been avoided if real-time specialty telemedicine were available at the index hospital. (They caution that the definition was not intended to suggest that all PATs were inappropriate.)

Over 3 years, 18,852 patients were transferred. Of the total patients transferred, 36% were transferred from 1 VHA ED to another VHA facility. Of the VHA transfers, 8,639 (46%) were transferred to another VHA ED; the rest were transferred to another VHA facility inpatient unit. The median transfer distance was 81.5 miles. Rural residents were transferred 3 times as often as urban residents.

The good news is that PATs are rare. Only 0.8% of VHA ED visits resulted in transfer, and of those, only one-fourth were deemed potentially avoidable. And while rural veterans were more likely to be transferred, PATs were less prevalent among those transfers (20.8% vs 23.9% for urban veterans).

More than half of VHA transfers were for patients diagnosed with mental health, cardiac, and digestive conditions. The top ICD-9 diagnosis related to VHA ED transfer was suicidal ideation. The diagnostic procedures associated with most PATs were mental health (11% potentially avoidable) and cardiac (21% potentially avoidable).

Their research turned up some unexpected data: For example, smaller EDs did not have a higher prevalence of PATs, suggesting that ED size was not associated with transfer appropriateness. And the proportion of PATs was higher in hospitals with > 50% board-certified emergency physicians.

The researchers say their findings highlight important differences between the VHA health care and civilian health care systems, emphasizing that the resources available within the VHA health system “might be unique” and underlining the need for VHA-specific solutions to health care delivery challenges.

 The overall purpose of this study, the researchers say, was to identify areas where novel delivery of specialty care might reduce the need for some VHA transfers. Their analysis provides data for developing targeted intervention, such as ED-based telemedicine or “targeted remote care.”

Patients with mental health conditions—who made up more than one-third of all VHA-to-VHA interfacility transfers, higher than that reported in civilian hospitals—represent a “rich target population” for telehealth, the researchers suggest. They also note that because mental health providers are in critical shortage in most of the US, real-time telemedicine providing psychiatric resources could be an important and timely service.

Nearly half of medical directors of VHA EDs who responded to the VHA Healthcare Analysis and Information Group survey cited the transfer process as “overly burdensome,” and > 65% said administrative processes contribute to delay in transfer. Finding new ways to keep patients local could benefit providers as well.

Some veterans who present to smaller facilities, such as rural hospitals, are transferred to larger facilities for diagnostic or therapeutic procedures. But that access also can mean hardship for rural veterans by taking them far from family and adding costs. Moreover, complex care coordination can cause “triage mismatch” when the patients are at their most vulnerable: “over-triage”—transferring patients unlikely to benefit and “under-triage”—failing to transfer those likely to benefit.  

Researchers from VA Iowa City Healthcare System and University of Iowa conducted a study to find out what proportion of VHA transfers were potentially avoidable. Their study included all veterans treated in any of 120 VHA emergency departments (EDs) and transferred to a VHA acute care hospital between January 2012 and December 2014.

Potentially avoidable transfers (PATs) were defined as transfers in which the patient was either discharged from the referral ED or admitted to the referral hospital for < 24 hours, without having an invasive procedure. The researchers chose that definition to identify patients whose transfer might have been avoided if real-time specialty telemedicine were available at the index hospital. (They caution that the definition was not intended to suggest that all PATs were inappropriate.)

Over 3 years, 18,852 patients were transferred. Of the total patients transferred, 36% were transferred from 1 VHA ED to another VHA facility. Of the VHA transfers, 8,639 (46%) were transferred to another VHA ED; the rest were transferred to another VHA facility inpatient unit. The median transfer distance was 81.5 miles. Rural residents were transferred 3 times as often as urban residents.

The good news is that PATs are rare. Only 0.8% of VHA ED visits resulted in transfer, and of those, only one-fourth were deemed potentially avoidable. And while rural veterans were more likely to be transferred, PATs were less prevalent among those transfers (20.8% vs 23.9% for urban veterans).

More than half of VHA transfers were for patients diagnosed with mental health, cardiac, and digestive conditions. The top ICD-9 diagnosis related to VHA ED transfer was suicidal ideation. The diagnostic procedures associated with most PATs were mental health (11% potentially avoidable) and cardiac (21% potentially avoidable).

Their research turned up some unexpected data: For example, smaller EDs did not have a higher prevalence of PATs, suggesting that ED size was not associated with transfer appropriateness. And the proportion of PATs was higher in hospitals with > 50% board-certified emergency physicians.

The researchers say their findings highlight important differences between the VHA health care and civilian health care systems, emphasizing that the resources available within the VHA health system “might be unique” and underlining the need for VHA-specific solutions to health care delivery challenges.

 The overall purpose of this study, the researchers say, was to identify areas where novel delivery of specialty care might reduce the need for some VHA transfers. Their analysis provides data for developing targeted intervention, such as ED-based telemedicine or “targeted remote care.”

Patients with mental health conditions—who made up more than one-third of all VHA-to-VHA interfacility transfers, higher than that reported in civilian hospitals—represent a “rich target population” for telehealth, the researchers suggest. They also note that because mental health providers are in critical shortage in most of the US, real-time telemedicine providing psychiatric resources could be an important and timely service.

Nearly half of medical directors of VHA EDs who responded to the VHA Healthcare Analysis and Information Group survey cited the transfer process as “overly burdensome,” and > 65% said administrative processes contribute to delay in transfer. Finding new ways to keep patients local could benefit providers as well.

Some veterans who present to smaller facilities, such as rural hospitals, are transferred to larger facilities for diagnostic or therapeutic procedures. But that access also can mean hardship for rural veterans by taking them far from family and adding costs. Moreover, complex care coordination can cause “triage mismatch” when the patients are at their most vulnerable: “over-triage”—transferring patients unlikely to benefit and “under-triage”—failing to transfer those likely to benefit.  

Researchers from VA Iowa City Healthcare System and University of Iowa conducted a study to find out what proportion of VHA transfers were potentially avoidable. Their study included all veterans treated in any of 120 VHA emergency departments (EDs) and transferred to a VHA acute care hospital between January 2012 and December 2014.

Potentially avoidable transfers (PATs) were defined as transfers in which the patient was either discharged from the referral ED or admitted to the referral hospital for < 24 hours, without having an invasive procedure. The researchers chose that definition to identify patients whose transfer might have been avoided if real-time specialty telemedicine were available at the index hospital. (They caution that the definition was not intended to suggest that all PATs were inappropriate.)

Over 3 years, 18,852 patients were transferred. Of the total patients transferred, 36% were transferred from 1 VHA ED to another VHA facility. Of the VHA transfers, 8,639 (46%) were transferred to another VHA ED; the rest were transferred to another VHA facility inpatient unit. The median transfer distance was 81.5 miles. Rural residents were transferred 3 times as often as urban residents.

The good news is that PATs are rare. Only 0.8% of VHA ED visits resulted in transfer, and of those, only one-fourth were deemed potentially avoidable. And while rural veterans were more likely to be transferred, PATs were less prevalent among those transfers (20.8% vs 23.9% for urban veterans).

More than half of VHA transfers were for patients diagnosed with mental health, cardiac, and digestive conditions. The top ICD-9 diagnosis related to VHA ED transfer was suicidal ideation. The diagnostic procedures associated with most PATs were mental health (11% potentially avoidable) and cardiac (21% potentially avoidable).

Their research turned up some unexpected data: For example, smaller EDs did not have a higher prevalence of PATs, suggesting that ED size was not associated with transfer appropriateness. And the proportion of PATs was higher in hospitals with > 50% board-certified emergency physicians.

The researchers say their findings highlight important differences between the VHA health care and civilian health care systems, emphasizing that the resources available within the VHA health system “might be unique” and underlining the need for VHA-specific solutions to health care delivery challenges.

 The overall purpose of this study, the researchers say, was to identify areas where novel delivery of specialty care might reduce the need for some VHA transfers. Their analysis provides data for developing targeted intervention, such as ED-based telemedicine or “targeted remote care.”

Patients with mental health conditions—who made up more than one-third of all VHA-to-VHA interfacility transfers, higher than that reported in civilian hospitals—represent a “rich target population” for telehealth, the researchers suggest. They also note that because mental health providers are in critical shortage in most of the US, real-time telemedicine providing psychiatric resources could be an important and timely service.

Nearly half of medical directors of VHA EDs who responded to the VHA Healthcare Analysis and Information Group survey cited the transfer process as “overly burdensome,” and > 65% said administrative processes contribute to delay in transfer. Finding new ways to keep patients local could benefit providers as well.

Hot on the heels of a review from top nutrition scientists that cautioned against drinking cow’s milk comes another study with another caution: Drinking milk increases the risk of developing breast cancer, say the researchers. But this finding comes from an observational study, and there may be confounders that are not accounted for, says an expert not involved with the study.  

The latest research was based on data from the long-running larger study called Adventist Health Study-2 (AHS-2), which is looking at diet and health among Seventh Day Adventists in North America. Past results from this study have suggested that Seventh Day Adventists have longer life spans and lower rates of some cancers, perhaps because of healthier lifestyles.

The latest analysis suggests that milk raises breast cancer risk, and the more you drink the higher your risk may be.

“Consuming as little as 1/4 to 1/3 cup of dairy milk per day was associated with an increased risk of breast cancer of 30%,” first author Gary E. Fraser, MBChB, PhD, said in a press statement. Fraser is affiliated with the School of Public Health at Loma Linda University, California.

“By drinking up to 1 cup per day, the associated risk went up to 50%, and for those drinking 2 to 3 cups per day, the risk increased further to 70% to 80%,” he added.

The findings were published February 25 in the International Journal of Epidemiology.

“The AHS study is provocative, but it’s not enough to warrant a change in guidelines. The caution being espoused by the authors is not warranted given the observational nature of this study,” commented Don Dizon, MD, director of Women’s Cancers, Lifespan Cancer Institute at Brown University in Providence, Rhode Island. He was not involved with the study and was approached by Medscape Medical News for comment.

Because of its observational design, the study cannot prove that cow’s milk causes breast cancer, Dizon emphasized.

“I’d want to see if the findings are replicated [by others]. Outside of a randomized trial of [cow’s] milk vs no milk or even soy, and incident breast cancers, there will never be undisputable data,” he said.

“Probably the biggest point [about this study] is not to overinflate the data,” Dizon added.

He noted that the results were significant only for postmenopausal women, and not for premenopausal women. Moreover, analyses showed significant associations only for hormone receptor–positive cancers.

“We know that breast cancer increases in incidence with age, so this tracks with that particular trend. It suggests there may be confounders not accounted for in this study,” he said.

Research so far has been inconclusive on a possible link between dairy and increased risk for breast cancer. Dairy has even been tied to decreased risk for breast cancer, according to the World Cancer Research Fund.
 

Study Details

The current study included 52,795 Seventh Day Adventist women from North America who did not have cancer at the start of the study. Women had a mean age of 57.1 years, and 29.7% were black. At baseline, women reported their dietary patterns for the past year using food frequency questionnaires. For 1011 women, researchers double-checked food intake with 24-hour diet questionnaires, and verified soy intake by analyzing urine levels of soy isoflavones.

Data on invasive breast cancer diagnoses came from national registries in the US and Canada. Over the course of 7.9 years, 1057 women developed invasive breast cancer. Results were adjusted for a range of factors related to breast cancer risk, including diet, lifestyle, and family history of breast cancer.

Overall, women who consumed the most calories from dairy per day had 22% increased risk for breast cancer, compared with women with the fewest calories from dairy (hazard ratio, 1.22; 95% confidence interval, 1.05-1.40; P = .008). Women who drank the most cow›s milk per day had 50% increased risk for breast cancer compared with women who drank the least (HR, 1.50; 95% CI, 1.22 - 1.84; P less than .001). 

Drinking full or reduced fat cow’s milk did not change the findings (P for trend = .002 and P for trend less than .0001, respectively).

No significant association was found between breast cancer risk and cheese or yogurt consumption (P = .35 and P = .80, respectively).

Need for Change?

US dietary guidelines are under review. A new version, which will cover pregnant women and children under age 2 for the first time, is expected later this year.

Current guidelines recommend that adults and children aged 9 and over drink three 8 oz glasses of milk per day, or equivalent portions of yogurt, cheese, and other dairy products.

“Evidence from this study suggests that people should view that recommendation with caution,” Fraser said.
 

Milk Is Complex Topic

A top nutrition scientist agrees. Walter Willett, MD, DrPH, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health in Boston, Massachusetts, told Medscape Medical News: “There is little scientific justification for the recommendation of 3 cups of milk per day. This new study adds a further reason for caution.” 

“This was a high-quality study conducted by experienced investigators,” Willett said. Strengths of the study include the high soy intake and low consumption of foods from animal sources, factors that are hard to study in other populations.

Willett was a coauthor, along with David Ludwig, MD, PhD, also from Harvard, of the recent review published in the New England Journal of Medicine that questioned the science behind milk-drinking recommendations. An article about this review on Medscape Medical News has attracted a huge number of comments from our readers.  

Milk is a complex topic, Willett explained. As a good source of essential nutrients, especially calcium and vitamin D, cow’s milk has been touted to have several health benefits, especially decreased fracture risk. But Willett said calcium recommendations have probably been overstated, and current evidence does not support high milk intake for fracture prevention.

Other benefits include improved nutrition in low-income settings, taller stature, and decreased colorectal cancer risk. But cow’s milk has also been linked to increased risk for some cancers, including prostate and endometrial cancer. Many of the benefits derived from nutrients found in milk may be obtained from other sources without these risks, according to Willett.

“Given the risks and benefits, we suggest a possible range from zero to two servings per day of dairy foods, including milk, cheese, and yogurt. If intake is zero or one serving, taking a calcium/vitamin D supplement would be good to consider,” he said.

However, Fraser and Willett also suggested another option: replacing cow’s milk with soy milk. Analyses from the current study showed no significant association between consumption of soy and breast cancer, independent of dairy (P for trend = .22).

In addition, substituting average amounts of soy milk for cow’s milk was linked to a 32% drop in risk for breast cancer among postmenopausal women (HR, 0.68; 95% CI, 0.55-0.85, P = .002). However, these results were not significant among premenopausal women (HR, 0.70; 95% CI, 0.36-1.38; P = .31).

“The suggestion that replacing some or all of [cow’s] milk with soy milk may reduce risk of breast cancer is consistent with other studies supporting a benefit of soy milk for risk of breast cancer,” Willett said.

“If someone does choose soy milk, picking one with minimal amounts of added sugar is desirable,” he added.

Drinking Milk, or Some Related Factor?

Fraser, the lead author of the current study, said in a statement that the results provide “fairly strong evidence that either dairy milk or some other factor closely related to drinking dairy milk is a cause of breast cancer in women.”

That ‘other’ factor is probably complicated, but may be related to what humans have done to cows. To increase milk production, humans have bred cows to have higher levels of insulin-like growth factor, which in turn has been linked to some cancers, including breast cancer.

Sex hormones in cow’s milk may also be involved. About 75% of a dairy herd is pregnant and the cows are by definition lactating. So the milk they produce may have higher levels of progestins and estrogens, which may play a role in hormone-responsive breast cancer. 

Other factors that researchers did not measure in this study, such as poverty and the income of participants, may be at play.

But to know what’s really going on, all agree that more research is needed.

“The overall evidence so far has not shown a clear increase or decrease in risk of breast cancer with higher [cow’s] milk intake. Thus, this topic needs further examination,” Willett said.

The study was funded by the National Cancer Institute at the National Institutes of Health, and the World Cancer Research Fund in the UK. Three of the authors report following largely vegetarian diets. All authors report regular and free use of dairy products without religious or other restrictions. No authors report associations with the soy product or dairy industries. Willett reports being a consultant during the design and early years of the Adventist study, but has not been involved with it for at least 8 years. Dizon has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Hot on the heels of a review from top nutrition scientists that cautioned against drinking cow’s milk comes another study with another caution: Drinking milk increases the risk of developing breast cancer, say the researchers. But this finding comes from an observational study, and there may be confounders that are not accounted for, says an expert not involved with the study.  

The latest research was based on data from the long-running larger study called Adventist Health Study-2 (AHS-2), which is looking at diet and health among Seventh Day Adventists in North America. Past results from this study have suggested that Seventh Day Adventists have longer life spans and lower rates of some cancers, perhaps because of healthier lifestyles.

The latest analysis suggests that milk raises breast cancer risk, and the more you drink the higher your risk may be.

“Consuming as little as 1/4 to 1/3 cup of dairy milk per day was associated with an increased risk of breast cancer of 30%,” first author Gary E. Fraser, MBChB, PhD, said in a press statement. Fraser is affiliated with the School of Public Health at Loma Linda University, California.

“By drinking up to 1 cup per day, the associated risk went up to 50%, and for those drinking 2 to 3 cups per day, the risk increased further to 70% to 80%,” he added.

The findings were published February 25 in the International Journal of Epidemiology.

“The AHS study is provocative, but it’s not enough to warrant a change in guidelines. The caution being espoused by the authors is not warranted given the observational nature of this study,” commented Don Dizon, MD, director of Women’s Cancers, Lifespan Cancer Institute at Brown University in Providence, Rhode Island. He was not involved with the study and was approached by Medscape Medical News for comment.

Because of its observational design, the study cannot prove that cow’s milk causes breast cancer, Dizon emphasized.

“I’d want to see if the findings are replicated [by others]. Outside of a randomized trial of [cow’s] milk vs no milk or even soy, and incident breast cancers, there will never be undisputable data,” he said.

“Probably the biggest point [about this study] is not to overinflate the data,” Dizon added.

He noted that the results were significant only for postmenopausal women, and not for premenopausal women. Moreover, analyses showed significant associations only for hormone receptor–positive cancers.

“We know that breast cancer increases in incidence with age, so this tracks with that particular trend. It suggests there may be confounders not accounted for in this study,” he said.

Research so far has been inconclusive on a possible link between dairy and increased risk for breast cancer. Dairy has even been tied to decreased risk for breast cancer, according to the World Cancer Research Fund.
 

Study Details

The current study included 52,795 Seventh Day Adventist women from North America who did not have cancer at the start of the study. Women had a mean age of 57.1 years, and 29.7% were black. At baseline, women reported their dietary patterns for the past year using food frequency questionnaires. For 1011 women, researchers double-checked food intake with 24-hour diet questionnaires, and verified soy intake by analyzing urine levels of soy isoflavones.

Data on invasive breast cancer diagnoses came from national registries in the US and Canada. Over the course of 7.9 years, 1057 women developed invasive breast cancer. Results were adjusted for a range of factors related to breast cancer risk, including diet, lifestyle, and family history of breast cancer.

Overall, women who consumed the most calories from dairy per day had 22% increased risk for breast cancer, compared with women with the fewest calories from dairy (hazard ratio, 1.22; 95% confidence interval, 1.05-1.40; P = .008). Women who drank the most cow›s milk per day had 50% increased risk for breast cancer compared with women who drank the least (HR, 1.50; 95% CI, 1.22 - 1.84; P less than .001). 

Drinking full or reduced fat cow’s milk did not change the findings (P for trend = .002 and P for trend less than .0001, respectively).

No significant association was found between breast cancer risk and cheese or yogurt consumption (P = .35 and P = .80, respectively).

Need for Change?

US dietary guidelines are under review. A new version, which will cover pregnant women and children under age 2 for the first time, is expected later this year.

Current guidelines recommend that adults and children aged 9 and over drink three 8 oz glasses of milk per day, or equivalent portions of yogurt, cheese, and other dairy products.

“Evidence from this study suggests that people should view that recommendation with caution,” Fraser said.
 

Milk Is Complex Topic

A top nutrition scientist agrees. Walter Willett, MD, DrPH, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health in Boston, Massachusetts, told Medscape Medical News: “There is little scientific justification for the recommendation of 3 cups of milk per day. This new study adds a further reason for caution.” 

“This was a high-quality study conducted by experienced investigators,” Willett said. Strengths of the study include the high soy intake and low consumption of foods from animal sources, factors that are hard to study in other populations.

Willett was a coauthor, along with David Ludwig, MD, PhD, also from Harvard, of the recent review published in the New England Journal of Medicine that questioned the science behind milk-drinking recommendations. An article about this review on Medscape Medical News has attracted a huge number of comments from our readers.  

Milk is a complex topic, Willett explained. As a good source of essential nutrients, especially calcium and vitamin D, cow’s milk has been touted to have several health benefits, especially decreased fracture risk. But Willett said calcium recommendations have probably been overstated, and current evidence does not support high milk intake for fracture prevention.

Other benefits include improved nutrition in low-income settings, taller stature, and decreased colorectal cancer risk. But cow’s milk has also been linked to increased risk for some cancers, including prostate and endometrial cancer. Many of the benefits derived from nutrients found in milk may be obtained from other sources without these risks, according to Willett.

“Given the risks and benefits, we suggest a possible range from zero to two servings per day of dairy foods, including milk, cheese, and yogurt. If intake is zero or one serving, taking a calcium/vitamin D supplement would be good to consider,” he said.

However, Fraser and Willett also suggested another option: replacing cow’s milk with soy milk. Analyses from the current study showed no significant association between consumption of soy and breast cancer, independent of dairy (P for trend = .22).

In addition, substituting average amounts of soy milk for cow’s milk was linked to a 32% drop in risk for breast cancer among postmenopausal women (HR, 0.68; 95% CI, 0.55-0.85, P = .002). However, these results were not significant among premenopausal women (HR, 0.70; 95% CI, 0.36-1.38; P = .31).

“The suggestion that replacing some or all of [cow’s] milk with soy milk may reduce risk of breast cancer is consistent with other studies supporting a benefit of soy milk for risk of breast cancer,” Willett said.

“If someone does choose soy milk, picking one with minimal amounts of added sugar is desirable,” he added.

Drinking Milk, or Some Related Factor?

Fraser, the lead author of the current study, said in a statement that the results provide “fairly strong evidence that either dairy milk or some other factor closely related to drinking dairy milk is a cause of breast cancer in women.”

That ‘other’ factor is probably complicated, but may be related to what humans have done to cows. To increase milk production, humans have bred cows to have higher levels of insulin-like growth factor, which in turn has been linked to some cancers, including breast cancer.

Sex hormones in cow’s milk may also be involved. About 75% of a dairy herd is pregnant and the cows are by definition lactating. So the milk they produce may have higher levels of progestins and estrogens, which may play a role in hormone-responsive breast cancer. 

Other factors that researchers did not measure in this study, such as poverty and the income of participants, may be at play.

But to know what’s really going on, all agree that more research is needed.

“The overall evidence so far has not shown a clear increase or decrease in risk of breast cancer with higher [cow’s] milk intake. Thus, this topic needs further examination,” Willett said.

The study was funded by the National Cancer Institute at the National Institutes of Health, and the World Cancer Research Fund in the UK. Three of the authors report following largely vegetarian diets. All authors report regular and free use of dairy products without religious or other restrictions. No authors report associations with the soy product or dairy industries. Willett reports being a consultant during the design and early years of the Adventist study, but has not been involved with it for at least 8 years. Dizon has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Hot on the heels of a review from top nutrition scientists that cautioned against drinking cow’s milk comes another study with another caution: Drinking milk increases the risk of developing breast cancer, say the researchers. But this finding comes from an observational study, and there may be confounders that are not accounted for, says an expert not involved with the study.  

The latest research was based on data from the long-running larger study called Adventist Health Study-2 (AHS-2), which is looking at diet and health among Seventh Day Adventists in North America. Past results from this study have suggested that Seventh Day Adventists have longer life spans and lower rates of some cancers, perhaps because of healthier lifestyles.

The latest analysis suggests that milk raises breast cancer risk, and the more you drink the higher your risk may be.

“Consuming as little as 1/4 to 1/3 cup of dairy milk per day was associated with an increased risk of breast cancer of 30%,” first author Gary E. Fraser, MBChB, PhD, said in a press statement. Fraser is affiliated with the School of Public Health at Loma Linda University, California.

“By drinking up to 1 cup per day, the associated risk went up to 50%, and for those drinking 2 to 3 cups per day, the risk increased further to 70% to 80%,” he added.

The findings were published February 25 in the International Journal of Epidemiology.

“The AHS study is provocative, but it’s not enough to warrant a change in guidelines. The caution being espoused by the authors is not warranted given the observational nature of this study,” commented Don Dizon, MD, director of Women’s Cancers, Lifespan Cancer Institute at Brown University in Providence, Rhode Island. He was not involved with the study and was approached by Medscape Medical News for comment.

Because of its observational design, the study cannot prove that cow’s milk causes breast cancer, Dizon emphasized.

“I’d want to see if the findings are replicated [by others]. Outside of a randomized trial of [cow’s] milk vs no milk or even soy, and incident breast cancers, there will never be undisputable data,” he said.

“Probably the biggest point [about this study] is not to overinflate the data,” Dizon added.

He noted that the results were significant only for postmenopausal women, and not for premenopausal women. Moreover, analyses showed significant associations only for hormone receptor–positive cancers.

“We know that breast cancer increases in incidence with age, so this tracks with that particular trend. It suggests there may be confounders not accounted for in this study,” he said.

Research so far has been inconclusive on a possible link between dairy and increased risk for breast cancer. Dairy has even been tied to decreased risk for breast cancer, according to the World Cancer Research Fund.
 

Study Details

The current study included 52,795 Seventh Day Adventist women from North America who did not have cancer at the start of the study. Women had a mean age of 57.1 years, and 29.7% were black. At baseline, women reported their dietary patterns for the past year using food frequency questionnaires. For 1011 women, researchers double-checked food intake with 24-hour diet questionnaires, and verified soy intake by analyzing urine levels of soy isoflavones.

Data on invasive breast cancer diagnoses came from national registries in the US and Canada. Over the course of 7.9 years, 1057 women developed invasive breast cancer. Results were adjusted for a range of factors related to breast cancer risk, including diet, lifestyle, and family history of breast cancer.

Overall, women who consumed the most calories from dairy per day had 22% increased risk for breast cancer, compared with women with the fewest calories from dairy (hazard ratio, 1.22; 95% confidence interval, 1.05-1.40; P = .008). Women who drank the most cow›s milk per day had 50% increased risk for breast cancer compared with women who drank the least (HR, 1.50; 95% CI, 1.22 - 1.84; P less than .001). 

Drinking full or reduced fat cow’s milk did not change the findings (P for trend = .002 and P for trend less than .0001, respectively).

No significant association was found between breast cancer risk and cheese or yogurt consumption (P = .35 and P = .80, respectively).

Need for Change?

US dietary guidelines are under review. A new version, which will cover pregnant women and children under age 2 for the first time, is expected later this year.

Current guidelines recommend that adults and children aged 9 and over drink three 8 oz glasses of milk per day, or equivalent portions of yogurt, cheese, and other dairy products.

“Evidence from this study suggests that people should view that recommendation with caution,” Fraser said.
 

Milk Is Complex Topic

A top nutrition scientist agrees. Walter Willett, MD, DrPH, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health in Boston, Massachusetts, told Medscape Medical News: “There is little scientific justification for the recommendation of 3 cups of milk per day. This new study adds a further reason for caution.” 

“This was a high-quality study conducted by experienced investigators,” Willett said. Strengths of the study include the high soy intake and low consumption of foods from animal sources, factors that are hard to study in other populations.

Willett was a coauthor, along with David Ludwig, MD, PhD, also from Harvard, of the recent review published in the New England Journal of Medicine that questioned the science behind milk-drinking recommendations. An article about this review on Medscape Medical News has attracted a huge number of comments from our readers.  

Milk is a complex topic, Willett explained. As a good source of essential nutrients, especially calcium and vitamin D, cow’s milk has been touted to have several health benefits, especially decreased fracture risk. But Willett said calcium recommendations have probably been overstated, and current evidence does not support high milk intake for fracture prevention.

Other benefits include improved nutrition in low-income settings, taller stature, and decreased colorectal cancer risk. But cow’s milk has also been linked to increased risk for some cancers, including prostate and endometrial cancer. Many of the benefits derived from nutrients found in milk may be obtained from other sources without these risks, according to Willett.

“Given the risks and benefits, we suggest a possible range from zero to two servings per day of dairy foods, including milk, cheese, and yogurt. If intake is zero or one serving, taking a calcium/vitamin D supplement would be good to consider,” he said.

However, Fraser and Willett also suggested another option: replacing cow’s milk with soy milk. Analyses from the current study showed no significant association between consumption of soy and breast cancer, independent of dairy (P for trend = .22).

In addition, substituting average amounts of soy milk for cow’s milk was linked to a 32% drop in risk for breast cancer among postmenopausal women (HR, 0.68; 95% CI, 0.55-0.85, P = .002). However, these results were not significant among premenopausal women (HR, 0.70; 95% CI, 0.36-1.38; P = .31).

“The suggestion that replacing some or all of [cow’s] milk with soy milk may reduce risk of breast cancer is consistent with other studies supporting a benefit of soy milk for risk of breast cancer,” Willett said.

“If someone does choose soy milk, picking one with minimal amounts of added sugar is desirable,” he added.

Drinking Milk, or Some Related Factor?

Fraser, the lead author of the current study, said in a statement that the results provide “fairly strong evidence that either dairy milk or some other factor closely related to drinking dairy milk is a cause of breast cancer in women.”

That ‘other’ factor is probably complicated, but may be related to what humans have done to cows. To increase milk production, humans have bred cows to have higher levels of insulin-like growth factor, which in turn has been linked to some cancers, including breast cancer.

Sex hormones in cow’s milk may also be involved. About 75% of a dairy herd is pregnant and the cows are by definition lactating. So the milk they produce may have higher levels of progestins and estrogens, which may play a role in hormone-responsive breast cancer. 

Other factors that researchers did not measure in this study, such as poverty and the income of participants, may be at play.

But to know what’s really going on, all agree that more research is needed.

“The overall evidence so far has not shown a clear increase or decrease in risk of breast cancer with higher [cow’s] milk intake. Thus, this topic needs further examination,” Willett said.

The study was funded by the National Cancer Institute at the National Institutes of Health, and the World Cancer Research Fund in the UK. Three of the authors report following largely vegetarian diets. All authors report regular and free use of dairy products without religious or other restrictions. No authors report associations with the soy product or dairy industries. Willett reports being a consultant during the design and early years of the Adventist study, but has not been involved with it for at least 8 years. Dizon has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.