Giants In Chest Medicine

Professor Emeritus Elizabeth F. Juniper, MCSP, MSc

By Dr. P. M. O’Byrne
 

Original Research

A Population-Based Cohort Study on the Drug-Specific Effect of Statins on Sepsis Outcome.

Evidence-Based Medicine

Screening for Lung Cancer: CHEST Guideline and Expert Panel Report.

By Dr. P. J. Mazzone, et al.



Treating Cough Due to Non-CF and CF Bronchiectasis With Nonpharmacological Airway Clearance: CHEST Expert Panel Report.

By Dr. A. T. Hill, et al.

Giants In Chest Medicine

Professor Emeritus Elizabeth F. Juniper, MCSP, MSc

By Dr. P. M. O’Byrne
 

Original Research

A Population-Based Cohort Study on the Drug-Specific Effect of Statins on Sepsis Outcome.

Evidence-Based Medicine

Screening for Lung Cancer: CHEST Guideline and Expert Panel Report.

By Dr. P. J. Mazzone, et al.



Treating Cough Due to Non-CF and CF Bronchiectasis With Nonpharmacological Airway Clearance: CHEST Expert Panel Report.

By Dr. A. T. Hill, et al.

Giants In Chest Medicine

Professor Emeritus Elizabeth F. Juniper, MCSP, MSc

By Dr. P. M. O’Byrne
 

Original Research

A Population-Based Cohort Study on the Drug-Specific Effect of Statins on Sepsis Outcome.

Evidence-Based Medicine

Screening for Lung Cancer: CHEST Guideline and Expert Panel Report.

By Dr. P. J. Mazzone, et al.



Treating Cough Due to Non-CF and CF Bronchiectasis With Nonpharmacological Airway Clearance: CHEST Expert Panel Report.

By Dr. A. T. Hill, et al.

The World Health Organization (WHO) has announced its annual SAVE LIVES: Clean Your Hands 2018 campaign (Saito, et al. J Hosp Infect. 2018;98[4]:321), designating May 5, 2018, as world hand hygiene day.

Health-care-associated infections are a major patient safety problem. Unfortunately, their spread is common in hospitals and ICUs around the globe. The vehicle for these infections, including multidrug-resistant organisms, is frequently the contaminated hands of health-care workers. Health-care-acquired infections, as any other infection, can lead to sepsis and death. Infections acquired in the ICU are especially deadly, with mortalities that can be as high as 80%. Proper hand hygiene, despite being simple and inexpensive, is the single most important means of reducing the prevalence of hospital-acquired infections and the spread of antimicrobial resistance.

We have known about the significance of hand washing since the early 19th century. More recent data show that hand washing can reduce the overall prevalence of hospital-acquired infections and the cross-transmission of multidrug-resistant organisms. It is estimated that we can prevent 15% to 30% of these infections with adequate hand washing alone.

Despite the clear benefit and the understanding of the importance of hand washing, compliance with this simple intervention is only about 50%. Health-care workers tend to overestimate these rates, self-reporting a compliance of 75%. Even the latter number represents a lot of missed opportunities, and we must do something about it.

A multifaceted approach that combines education with written material, reminders, and continued feedback on performance can have an important effect on hand washing compliance and rates of hospital-acquired infections.

Sepsis is the single most important cause of death in hospitals in the United States. The campaign (http://www.who.int/infection-prevention/campaigns/clean-hands/en/), sponsored by the World Health Organization, should serve as a reminder to all health-care workers about the importance of adequate hand washing and as an opportunity to improve our compliance moving forward.

Despite the progress made, there is still a lot of room for improvement. We can have an impact on the number of deaths from sepsis by preventing them to occur in the first place. Wash your hands and do it well, it does not cost us anything.

Remember: It is in our hands – prevent sepsis and save lives!

Shruti Gadre, MD

Steering Committee Member, Critical Care NetWork

Angel Coz, MD, FCCP

Chair, Critical Care NetWork

The World Health Organization (WHO) has announced its annual SAVE LIVES: Clean Your Hands 2018 campaign (Saito, et al. J Hosp Infect. 2018;98[4]:321), designating May 5, 2018, as world hand hygiene day.

Health-care-associated infections are a major patient safety problem. Unfortunately, their spread is common in hospitals and ICUs around the globe. The vehicle for these infections, including multidrug-resistant organisms, is frequently the contaminated hands of health-care workers. Health-care-acquired infections, as any other infection, can lead to sepsis and death. Infections acquired in the ICU are especially deadly, with mortalities that can be as high as 80%. Proper hand hygiene, despite being simple and inexpensive, is the single most important means of reducing the prevalence of hospital-acquired infections and the spread of antimicrobial resistance.

We have known about the significance of hand washing since the early 19th century. More recent data show that hand washing can reduce the overall prevalence of hospital-acquired infections and the cross-transmission of multidrug-resistant organisms. It is estimated that we can prevent 15% to 30% of these infections with adequate hand washing alone.

Despite the clear benefit and the understanding of the importance of hand washing, compliance with this simple intervention is only about 50%. Health-care workers tend to overestimate these rates, self-reporting a compliance of 75%. Even the latter number represents a lot of missed opportunities, and we must do something about it.

A multifaceted approach that combines education with written material, reminders, and continued feedback on performance can have an important effect on hand washing compliance and rates of hospital-acquired infections.

Sepsis is the single most important cause of death in hospitals in the United States. The campaign (http://www.who.int/infection-prevention/campaigns/clean-hands/en/), sponsored by the World Health Organization, should serve as a reminder to all health-care workers about the importance of adequate hand washing and as an opportunity to improve our compliance moving forward.

Despite the progress made, there is still a lot of room for improvement. We can have an impact on the number of deaths from sepsis by preventing them to occur in the first place. Wash your hands and do it well, it does not cost us anything.

Remember: It is in our hands – prevent sepsis and save lives!

Shruti Gadre, MD

Steering Committee Member, Critical Care NetWork

Angel Coz, MD, FCCP

Chair, Critical Care NetWork

The World Health Organization (WHO) has announced its annual SAVE LIVES: Clean Your Hands 2018 campaign (Saito, et al. J Hosp Infect. 2018;98[4]:321), designating May 5, 2018, as world hand hygiene day.

Health-care-associated infections are a major patient safety problem. Unfortunately, their spread is common in hospitals and ICUs around the globe. The vehicle for these infections, including multidrug-resistant organisms, is frequently the contaminated hands of health-care workers. Health-care-acquired infections, as any other infection, can lead to sepsis and death. Infections acquired in the ICU are especially deadly, with mortalities that can be as high as 80%. Proper hand hygiene, despite being simple and inexpensive, is the single most important means of reducing the prevalence of hospital-acquired infections and the spread of antimicrobial resistance.

We have known about the significance of hand washing since the early 19th century. More recent data show that hand washing can reduce the overall prevalence of hospital-acquired infections and the cross-transmission of multidrug-resistant organisms. It is estimated that we can prevent 15% to 30% of these infections with adequate hand washing alone.

Despite the clear benefit and the understanding of the importance of hand washing, compliance with this simple intervention is only about 50%. Health-care workers tend to overestimate these rates, self-reporting a compliance of 75%. Even the latter number represents a lot of missed opportunities, and we must do something about it.

A multifaceted approach that combines education with written material, reminders, and continued feedback on performance can have an important effect on hand washing compliance and rates of hospital-acquired infections.

Sepsis is the single most important cause of death in hospitals in the United States. The campaign (http://www.who.int/infection-prevention/campaigns/clean-hands/en/), sponsored by the World Health Organization, should serve as a reminder to all health-care workers about the importance of adequate hand washing and as an opportunity to improve our compliance moving forward.

Despite the progress made, there is still a lot of room for improvement. We can have an impact on the number of deaths from sepsis by preventing them to occur in the first place. Wash your hands and do it well, it does not cost us anything.

Remember: It is in our hands – prevent sepsis and save lives!

Shruti Gadre, MD

Steering Committee Member, Critical Care NetWork

Angel Coz, MD, FCCP

Chair, Critical Care NetWork

As many who read CHEST® Physician may know, we have a nucleus of dedicated volunteers who give unselfishly of their time and talent to represent our members in the area of “regulatory advocacy” and “policy advocacy” in the areas of pulmonary, critical care, and sleep medicine. It is our goal to recognize and support this valuable group of individuals who represent us in the space of coding and reimbursement, RUC activities, relationships with organizations like the ACP and the AMA, as well as our sister societies, such as ATS, SCCM, NAMDRC, CCNA, APSR, ALAT, and ERS, among others.

One of our goals, in addition to recognizing this group, is to identify and mentor the next generation of representatives. A great example of this mentorship is reflected in our involvement with the AMA. Dr. Bob McCaffree has represented CHEST for 22 years and is now mentoring Dr. Raj Desai who will be assuming this role of AMA Delegate this year. Special thanks to Dr. McCaffree for his unselfish service in this capacity and for his mentorship of Dr. Desai. I hope that you enjoy this and future CHEST® Physician articles summarizing and reflecting on the activities pertinent to CHEST at the AMA.

John Studdard, MD, FCCP

CHEST President

Collaborating with societies: CHEST and AMA

While the American Medical Association (AMA) is the oldest and largest national medical association, many physicians, both members and nonmembers, have limited understanding of the policies, processes, and strategic foci of the AMA. It is our goal to inform our membership about the workings of the AMA and how those interact with the goals of CHEST and our members. We hope to do this by publishing periodic articles in CHEST^® Physician. One of the authors (DRM) has been the CHEST delegate to the AMA for more than 20 years, and the other (NRD) is CHEST’s new delegate.

• Create thriving physician practices.
• Create the medical school of the future.
• Improve health outcomes.

We will expand on these in future articles.

The AMA is both an individual member organization and a federation of geographic, ie, county and state, societies and specialty societies, as well as the uniformed services and the VA. It is this federation that comprises the House of Delegates (HOD or House), which is the principle policy-making body of the AMA. The number of delegates from each member organization (now numbering more than 170 organizations) depends on the number of individual AMA members among that organization’s members. Due to recent bylaws changes, CHEST now has two delegates. The HOD meets twice per year to establish policy on health, medical, professional, and governance matters, as well as the principles within which the AMA’s business activities are conducted.

• 119 national medical specialties
• 2 professional interest medical associations
• 5 military service groups

An association must first be represented in the SSS for 3 years and meet the required number of AMA members before it is eligible to seek admission to the HOD.

The American College of Chest Physicians (CHEST) is an active member of the SSS but also joins with other societies of similar interests in the Section Council on Chest and Allergic Diseases. This caucus includes the ATS, SCCM, ASSM, and several allergy societies. Through the HOD, the SSS, and the Section Council, CHEST can partner with the AMA and other societies, such as ATS, to support each other’s resolutions or important regulatory issues.

In summary, the AMA plays an important role in many areas of interest to our members. And, it can be a useful forum for connecting with societies with similar interests in directing advocacy and setting policy. We plan to continue this update in future issues of CHEST® Physician.
 

References

1. https://www.ama-assn.org/content/ama-house-delegates Accessed: January 28, 2018

2. https://www.ama-assn.org/practice-management/ama-steps-forward-practice-improvement-strategies Accessed: January 28, 2018

As many who read CHEST® Physician may know, we have a nucleus of dedicated volunteers who give unselfishly of their time and talent to represent our members in the area of “regulatory advocacy” and “policy advocacy” in the areas of pulmonary, critical care, and sleep medicine. It is our goal to recognize and support this valuable group of individuals who represent us in the space of coding and reimbursement, RUC activities, relationships with organizations like the ACP and the AMA, as well as our sister societies, such as ATS, SCCM, NAMDRC, CCNA, APSR, ALAT, and ERS, among others.

One of our goals, in addition to recognizing this group, is to identify and mentor the next generation of representatives. A great example of this mentorship is reflected in our involvement with the AMA. Dr. Bob McCaffree has represented CHEST for 22 years and is now mentoring Dr. Raj Desai who will be assuming this role of AMA Delegate this year. Special thanks to Dr. McCaffree for his unselfish service in this capacity and for his mentorship of Dr. Desai. I hope that you enjoy this and future CHEST® Physician articles summarizing and reflecting on the activities pertinent to CHEST at the AMA.

John Studdard, MD, FCCP

CHEST President

Collaborating with societies: CHEST and AMA

While the American Medical Association (AMA) is the oldest and largest national medical association, many physicians, both members and nonmembers, have limited understanding of the policies, processes, and strategic foci of the AMA. It is our goal to inform our membership about the workings of the AMA and how those interact with the goals of CHEST and our members. We hope to do this by publishing periodic articles in CHEST^® Physician. One of the authors (DRM) has been the CHEST delegate to the AMA for more than 20 years, and the other (NRD) is CHEST’s new delegate.

• Create thriving physician practices.
• Create the medical school of the future.
• Improve health outcomes.

We will expand on these in future articles.

The AMA is both an individual member organization and a federation of geographic, ie, county and state, societies and specialty societies, as well as the uniformed services and the VA. It is this federation that comprises the House of Delegates (HOD or House), which is the principle policy-making body of the AMA. The number of delegates from each member organization (now numbering more than 170 organizations) depends on the number of individual AMA members among that organization’s members. Due to recent bylaws changes, CHEST now has two delegates. The HOD meets twice per year to establish policy on health, medical, professional, and governance matters, as well as the principles within which the AMA’s business activities are conducted.

• 119 national medical specialties
• 2 professional interest medical associations
• 5 military service groups

An association must first be represented in the SSS for 3 years and meet the required number of AMA members before it is eligible to seek admission to the HOD.

The American College of Chest Physicians (CHEST) is an active member of the SSS but also joins with other societies of similar interests in the Section Council on Chest and Allergic Diseases. This caucus includes the ATS, SCCM, ASSM, and several allergy societies. Through the HOD, the SSS, and the Section Council, CHEST can partner with the AMA and other societies, such as ATS, to support each other’s resolutions or important regulatory issues.

In summary, the AMA plays an important role in many areas of interest to our members. And, it can be a useful forum for connecting with societies with similar interests in directing advocacy and setting policy. We plan to continue this update in future issues of CHEST® Physician.
 

References

1. https://www.ama-assn.org/content/ama-house-delegates Accessed: January 28, 2018

2. https://www.ama-assn.org/practice-management/ama-steps-forward-practice-improvement-strategies Accessed: January 28, 2018

As many who read CHEST® Physician may know, we have a nucleus of dedicated volunteers who give unselfishly of their time and talent to represent our members in the area of “regulatory advocacy” and “policy advocacy” in the areas of pulmonary, critical care, and sleep medicine. It is our goal to recognize and support this valuable group of individuals who represent us in the space of coding and reimbursement, RUC activities, relationships with organizations like the ACP and the AMA, as well as our sister societies, such as ATS, SCCM, NAMDRC, CCNA, APSR, ALAT, and ERS, among others.

One of our goals, in addition to recognizing this group, is to identify and mentor the next generation of representatives. A great example of this mentorship is reflected in our involvement with the AMA. Dr. Bob McCaffree has represented CHEST for 22 years and is now mentoring Dr. Raj Desai who will be assuming this role of AMA Delegate this year. Special thanks to Dr. McCaffree for his unselfish service in this capacity and for his mentorship of Dr. Desai. I hope that you enjoy this and future CHEST® Physician articles summarizing and reflecting on the activities pertinent to CHEST at the AMA.

John Studdard, MD, FCCP

CHEST President

Collaborating with societies: CHEST and AMA

While the American Medical Association (AMA) is the oldest and largest national medical association, many physicians, both members and nonmembers, have limited understanding of the policies, processes, and strategic foci of the AMA. It is our goal to inform our membership about the workings of the AMA and how those interact with the goals of CHEST and our members. We hope to do this by publishing periodic articles in CHEST^® Physician. One of the authors (DRM) has been the CHEST delegate to the AMA for more than 20 years, and the other (NRD) is CHEST’s new delegate.

• Create thriving physician practices.
• Create the medical school of the future.
• Improve health outcomes.

We will expand on these in future articles.

The AMA is both an individual member organization and a federation of geographic, ie, county and state, societies and specialty societies, as well as the uniformed services and the VA. It is this federation that comprises the House of Delegates (HOD or House), which is the principle policy-making body of the AMA. The number of delegates from each member organization (now numbering more than 170 organizations) depends on the number of individual AMA members among that organization’s members. Due to recent bylaws changes, CHEST now has two delegates. The HOD meets twice per year to establish policy on health, medical, professional, and governance matters, as well as the principles within which the AMA’s business activities are conducted.

• 119 national medical specialties
• 2 professional interest medical associations
• 5 military service groups

An association must first be represented in the SSS for 3 years and meet the required number of AMA members before it is eligible to seek admission to the HOD.

The American College of Chest Physicians (CHEST) is an active member of the SSS but also joins with other societies of similar interests in the Section Council on Chest and Allergic Diseases. This caucus includes the ATS, SCCM, ASSM, and several allergy societies. Through the HOD, the SSS, and the Section Council, CHEST can partner with the AMA and other societies, such as ATS, to support each other’s resolutions or important regulatory issues.

In summary, the AMA plays an important role in many areas of interest to our members. And, it can be a useful forum for connecting with societies with similar interests in directing advocacy and setting policy. We plan to continue this update in future issues of CHEST® Physician.
 

References

1. https://www.ama-assn.org/content/ama-house-delegates Accessed: January 28, 2018

2. https://www.ama-assn.org/practice-management/ama-steps-forward-practice-improvement-strategies Accessed: January 28, 2018

Shedding of infectious Zika virus in the semen of symptomatic infected men appears to be uncommon and limited to the first few weeks after onset of illness, according to results of a recent prospective study.

Out of all semen samples with detectable Zika virus RNA, the only ones with infectious virus were those that had been obtained within 30 days of illness onset, study authors reported in the New England Journal of Medicine.

©Aunt_Spray/Thinkstock

They obtained specimens twice monthly for 6 months. Samples were tested for Zika RNA using real-time reverse transcriptase polymerase chain reaction assay and for infectious Zika virus using Vero cell culture and plaque assay.

Investigators detected Zika virus RNA in the semen of 60 men (33%), including semen samples from 22 of the 36 men (61%) tested within 30 days after illness onset, investigators said in the report.

While Zika virus RNA shedding decreased considerably in the 3 months after illness onset, it did continue for 281 days in one man, they noted.

Men who were older and those who ejaculated less frequently were more likely to have prolonged RNA shedding in semen, results of multivariable analysis showed.

Infectious Zika virus was isolated from just 3 out of the 78 semen samples with detectable Zika virus RNA that were tested by culture, investigators said. Notably, all 3 of the cases were among the 19 of those samples obtained within 30 days of illness onset, they reported.

Detection of Zika virus RNA in urine was rare, occurring in only 7 men (4%), possibly because of the timing of the first specimen collection, according to investigators. They said previous studies suggest a rapid decline in Zika virus shedding in urine during the first few weeks after onset of illness.

Important questions remain regarding sexual transmission of Zika virus, such as whether maternal infection through sex poses similar risks to the fetus as compared with maternal infection via mosquito bite, Dr. Mead and his coauthors said in the report.

“A better understanding of these issues is needed to guide the development of effective prevention strategies,” they wrote.

The study was supported by the Centers for Disease Control and Prevention. Dr. Mead and his coauthors reported they had no disclosures related to the study.

SOURCE: Mead PS et al. N Engl J Med. 2018;378(15):1377-85.

Shedding of infectious Zika virus in the semen of symptomatic infected men appears to be uncommon and limited to the first few weeks after onset of illness, according to results of a recent prospective study.

Out of all semen samples with detectable Zika virus RNA, the only ones with infectious virus were those that had been obtained within 30 days of illness onset, study authors reported in the New England Journal of Medicine.

©Aunt_Spray/Thinkstock

They obtained specimens twice monthly for 6 months. Samples were tested for Zika RNA using real-time reverse transcriptase polymerase chain reaction assay and for infectious Zika virus using Vero cell culture and plaque assay.

Investigators detected Zika virus RNA in the semen of 60 men (33%), including semen samples from 22 of the 36 men (61%) tested within 30 days after illness onset, investigators said in the report.

While Zika virus RNA shedding decreased considerably in the 3 months after illness onset, it did continue for 281 days in one man, they noted.

Men who were older and those who ejaculated less frequently were more likely to have prolonged RNA shedding in semen, results of multivariable analysis showed.

Infectious Zika virus was isolated from just 3 out of the 78 semen samples with detectable Zika virus RNA that were tested by culture, investigators said. Notably, all 3 of the cases were among the 19 of those samples obtained within 30 days of illness onset, they reported.

Detection of Zika virus RNA in urine was rare, occurring in only 7 men (4%), possibly because of the timing of the first specimen collection, according to investigators. They said previous studies suggest a rapid decline in Zika virus shedding in urine during the first few weeks after onset of illness.

Important questions remain regarding sexual transmission of Zika virus, such as whether maternal infection through sex poses similar risks to the fetus as compared with maternal infection via mosquito bite, Dr. Mead and his coauthors said in the report.

“A better understanding of these issues is needed to guide the development of effective prevention strategies,” they wrote.

The study was supported by the Centers for Disease Control and Prevention. Dr. Mead and his coauthors reported they had no disclosures related to the study.

SOURCE: Mead PS et al. N Engl J Med. 2018;378(15):1377-85.

Shedding of infectious Zika virus in the semen of symptomatic infected men appears to be uncommon and limited to the first few weeks after onset of illness, according to results of a recent prospective study.

Out of all semen samples with detectable Zika virus RNA, the only ones with infectious virus were those that had been obtained within 30 days of illness onset, study authors reported in the New England Journal of Medicine.

©Aunt_Spray/Thinkstock

They obtained specimens twice monthly for 6 months. Samples were tested for Zika RNA using real-time reverse transcriptase polymerase chain reaction assay and for infectious Zika virus using Vero cell culture and plaque assay.

Investigators detected Zika virus RNA in the semen of 60 men (33%), including semen samples from 22 of the 36 men (61%) tested within 30 days after illness onset, investigators said in the report.

While Zika virus RNA shedding decreased considerably in the 3 months after illness onset, it did continue for 281 days in one man, they noted.

Men who were older and those who ejaculated less frequently were more likely to have prolonged RNA shedding in semen, results of multivariable analysis showed.

Infectious Zika virus was isolated from just 3 out of the 78 semen samples with detectable Zika virus RNA that were tested by culture, investigators said. Notably, all 3 of the cases were among the 19 of those samples obtained within 30 days of illness onset, they reported.

Detection of Zika virus RNA in urine was rare, occurring in only 7 men (4%), possibly because of the timing of the first specimen collection, according to investigators. They said previous studies suggest a rapid decline in Zika virus shedding in urine during the first few weeks after onset of illness.

Important questions remain regarding sexual transmission of Zika virus, such as whether maternal infection through sex poses similar risks to the fetus as compared with maternal infection via mosquito bite, Dr. Mead and his coauthors said in the report.

“A better understanding of these issues is needed to guide the development of effective prevention strategies,” they wrote.

The study was supported by the Centers for Disease Control and Prevention. Dr. Mead and his coauthors reported they had no disclosures related to the study.

SOURCE: Mead PS et al. N Engl J Med. 2018;378(15):1377-85.

Four genetic subtypes of diffuse large B-cell lymphoma (DLBCL) showed multiple distinct mutations, gene expression signatures, and treatment responses, researchers reported.

The findings “may provide a conceptual edifice on which to develop precision therapies for these aggressive cancers,” Roland Schmitz, PhD, and his associates wrote in the New England Journal of Medicine.

Other DLBCL studies have focused on individual mutations, but therapeutic response probably hinges on “constellations of genetic aberrations,” wrote Dr. Schmitz of the National Cancer Institute and his associates.

Therefore, they used exome and transcriptome sequencing, deep amplicon resequencing of 372 genes, and DNA copy-number analysis to analyze 572 fresh-frozen DLBCL biopsy specimens, nearly all of which were treatment-naïve.

This multiplatform approach yielded four genetic subtypes: MCD, so named for its co-occurring MYD88L265P and CD79B mutations; BN2, which has BCL6 fusions and NOTCH2 mutations; N1, which has NOTCH1 mutations; and EZB, which has EZH2 mutations and BCL2 translocations. Most MCD and N1 specimens were activated B-cell–like (ABC) tumors, EZB specimens were primarily germinal-center B-cell–like (GCB) tumors, and BN2 specimens included ABC, GCB, and unclassified cases.

A closer look at 119 previously untreated patients linked genetic subtypes with significant differences in progression-free survival (P less than .0001) and overall survival (P = .0002) following R-CHOP or CHOP-like chemotherapy.

The BN2 and EZB subtypes “[had] much more favorable outcomes than the MCD and N1 subtypes,” Dr. Schmitz and his associates said. “Analysis of genetic pathways suggested that MCD and BN2 DLBCLs rely on ‘chronic active’ B-cell receptor signaling that is amenable to therapeutic inhibition.”

Genetically subtyping DLBCL could help guide patients into appropriate clinical trials, the investigators wrote. For example, patients with the N1 subtype might be candidates for immune checkpoint inhibitor therapy, given N1’s prominent T-cell gene expression and poor response to R-CHOP.

Funders included the National Institutes of Health, the National Cancer Institute, the Dr. Mildred Scheel Stiftung fur Krebsforschung (Deutsche Krebshilfe), the Washington University in St. Louis, and the Kay Kendall Leukaemia Fund. Dr. Schmitz disclosed research funding from Dr. Mildred Scheel Stiftung fur Krebsforschung (Deutsche Krebshilfe).

SOURCE: Schmitz et al. New Eng J Med. 2018 Apr 11. doi: 10.1056/NEJMoa1801445.

Four genetic subtypes of diffuse large B-cell lymphoma (DLBCL) showed multiple distinct mutations, gene expression signatures, and treatment responses, researchers reported.

The findings “may provide a conceptual edifice on which to develop precision therapies for these aggressive cancers,” Roland Schmitz, PhD, and his associates wrote in the New England Journal of Medicine.

Other DLBCL studies have focused on individual mutations, but therapeutic response probably hinges on “constellations of genetic aberrations,” wrote Dr. Schmitz of the National Cancer Institute and his associates.

Therefore, they used exome and transcriptome sequencing, deep amplicon resequencing of 372 genes, and DNA copy-number analysis to analyze 572 fresh-frozen DLBCL biopsy specimens, nearly all of which were treatment-naïve.

This multiplatform approach yielded four genetic subtypes: MCD, so named for its co-occurring MYD88L265P and CD79B mutations; BN2, which has BCL6 fusions and NOTCH2 mutations; N1, which has NOTCH1 mutations; and EZB, which has EZH2 mutations and BCL2 translocations. Most MCD and N1 specimens were activated B-cell–like (ABC) tumors, EZB specimens were primarily germinal-center B-cell–like (GCB) tumors, and BN2 specimens included ABC, GCB, and unclassified cases.

A closer look at 119 previously untreated patients linked genetic subtypes with significant differences in progression-free survival (P less than .0001) and overall survival (P = .0002) following R-CHOP or CHOP-like chemotherapy.

The BN2 and EZB subtypes “[had] much more favorable outcomes than the MCD and N1 subtypes,” Dr. Schmitz and his associates said. “Analysis of genetic pathways suggested that MCD and BN2 DLBCLs rely on ‘chronic active’ B-cell receptor signaling that is amenable to therapeutic inhibition.”

Genetically subtyping DLBCL could help guide patients into appropriate clinical trials, the investigators wrote. For example, patients with the N1 subtype might be candidates for immune checkpoint inhibitor therapy, given N1’s prominent T-cell gene expression and poor response to R-CHOP.

Funders included the National Institutes of Health, the National Cancer Institute, the Dr. Mildred Scheel Stiftung fur Krebsforschung (Deutsche Krebshilfe), the Washington University in St. Louis, and the Kay Kendall Leukaemia Fund. Dr. Schmitz disclosed research funding from Dr. Mildred Scheel Stiftung fur Krebsforschung (Deutsche Krebshilfe).

SOURCE: Schmitz et al. New Eng J Med. 2018 Apr 11. doi: 10.1056/NEJMoa1801445.

Four genetic subtypes of diffuse large B-cell lymphoma (DLBCL) showed multiple distinct mutations, gene expression signatures, and treatment responses, researchers reported.

The findings “may provide a conceptual edifice on which to develop precision therapies for these aggressive cancers,” Roland Schmitz, PhD, and his associates wrote in the New England Journal of Medicine.

Other DLBCL studies have focused on individual mutations, but therapeutic response probably hinges on “constellations of genetic aberrations,” wrote Dr. Schmitz of the National Cancer Institute and his associates.

Therefore, they used exome and transcriptome sequencing, deep amplicon resequencing of 372 genes, and DNA copy-number analysis to analyze 572 fresh-frozen DLBCL biopsy specimens, nearly all of which were treatment-naïve.

This multiplatform approach yielded four genetic subtypes: MCD, so named for its co-occurring MYD88L265P and CD79B mutations; BN2, which has BCL6 fusions and NOTCH2 mutations; N1, which has NOTCH1 mutations; and EZB, which has EZH2 mutations and BCL2 translocations. Most MCD and N1 specimens were activated B-cell–like (ABC) tumors, EZB specimens were primarily germinal-center B-cell–like (GCB) tumors, and BN2 specimens included ABC, GCB, and unclassified cases.

A closer look at 119 previously untreated patients linked genetic subtypes with significant differences in progression-free survival (P less than .0001) and overall survival (P = .0002) following R-CHOP or CHOP-like chemotherapy.

The BN2 and EZB subtypes “[had] much more favorable outcomes than the MCD and N1 subtypes,” Dr. Schmitz and his associates said. “Analysis of genetic pathways suggested that MCD and BN2 DLBCLs rely on ‘chronic active’ B-cell receptor signaling that is amenable to therapeutic inhibition.”

Genetically subtyping DLBCL could help guide patients into appropriate clinical trials, the investigators wrote. For example, patients with the N1 subtype might be candidates for immune checkpoint inhibitor therapy, given N1’s prominent T-cell gene expression and poor response to R-CHOP.

Funders included the National Institutes of Health, the National Cancer Institute, the Dr. Mildred Scheel Stiftung fur Krebsforschung (Deutsche Krebshilfe), the Washington University in St. Louis, and the Kay Kendall Leukaemia Fund. Dr. Schmitz disclosed research funding from Dr. Mildred Scheel Stiftung fur Krebsforschung (Deutsche Krebshilfe).

SOURCE: Schmitz et al. New Eng J Med. 2018 Apr 11. doi: 10.1056/NEJMoa1801445.

Palliative and end-of-life care

Nurse-driven palliative care screening

Palliative care (PC) aims to improve quality of life for patients with a life-threatening illness, providing holistic patient-centered support along the continuum of the disease process. Although frequently implemented in critical care settings, integrating PC in the neuro ICU has been difficult to adopt in practice due to the uncertainty in prognostication of definitive outcomes and practice culture beliefs such as the self-fulfilling prophecy (Frontera, et al. Crit Care Med. 2015;43[9]:1964; Rubin, et al. Curr Opin Crit Care. 2017;23[2]:134; Knies, et al. Semin Neurol. 2016;36[6]:631).

At our institution, a nursing education project was conducted to pilot nurse-driven PC screenings on admission to the neuro ICU. The project evaluated nurse comfort and knowledge with identifying and recommending PC consults. Pre- and post-intervention surveys revealed that education and introduction of a PC screening tool significantly increased nurse comfort and knowledge of PC eligibility.

Danielle McCamey, ACNP

Steering Committee Member

Sleep medicine

Diagnostics, devices, and sleep

The past several months have been busy for the Sleep Medicine NetWork. We have been working to represent the interests of our membership and our patients in many arenas.

Devices coded as E0464, defined as life support mechanical ventilators used with mask-based ventilation in the home are being more frequently used. According to the Office of the Inspector General (OIG), there has been an 89-fold increase in billing for E0464 ventilators for Medicare and its beneficiaries between 2009 and 2015, increasing from $3.8M to $340M. In response, the Agency for Healthcare Research and Quality (AHRQ) requested a response to specific questions related to these devices.

Aneesa M. Das, MD, FCCP

NetWork Chair

Occupational and environmental health

Post-deployment lung disease

Since the early 1990s, ongoing military deployments to Southwest Asia remain a unique challenge from a pulmonary symptomology and diagnostic perspective.

Various airborne hazards in the deployment environment include geologic dusts, burn pit smoke, vehicle emissions, and industrial air pollution. Exposures can give rise to both acute respiratory symptoms and, in some instances, chronic lung disease. Currently, data are limited on whether inhalation of airborne particulate matter by military personnel is linked to increases in pulmonary diseases (Morris MJ, et al. US Army Med Dep J. 2016:173).

Pedro F. Lucero, MD, FCCP

Steering Committee Member

Clinical pulmonary medicine

Biologics – Birth of a new era of precision management in asthma

An estimated 10% to 20% of patients with severe uncontrolled asthma do not respond to maximal best standard treatments, leading to substantial health-care costs. A paradigm shift is now underway in our approach to the care of these patients with the emergence of novel biologics targeting the complex and interconnected inflammatory pathways in asthma that result in a diverse profile of asthma endotypes and phenotypes (Fig 1).

Current FDA-approved biologics primarily target patients with a T2 high phenotype (Table1).

Dupilumab binds to the alpha unit of the IL-4 receptor and blocks both IL-4 and IL-13. It shows potential efficacy in patients with T2 high asthma with or without eosinophilia but has not yet received FDA approval.

Multiple newer biologics are currently in development (Table 2).

Pulmonologists need to get familiar with the logistics of administration of these novel agents. The two common methods of administering biologics are (1) buy and bill – where the provider buys the drug directly from the distributor; and (2) assignment of benefits (typically administered by a Pharmacy Benefit Manager) - specific dose of the medication is shipped to the physician’s office and physician only bills for the administration. CPT and J codes are shown in Table 1.

Shyamsunder Subramanian, MD, FCCP

Steering Committee Member

Palliative and end-of-life care

Nurse-driven palliative care screening

Palliative care (PC) aims to improve quality of life for patients with a life-threatening illness, providing holistic patient-centered support along the continuum of the disease process. Although frequently implemented in critical care settings, integrating PC in the neuro ICU has been difficult to adopt in practice due to the uncertainty in prognostication of definitive outcomes and practice culture beliefs such as the self-fulfilling prophecy (Frontera, et al. Crit Care Med. 2015;43[9]:1964; Rubin, et al. Curr Opin Crit Care. 2017;23[2]:134; Knies, et al. Semin Neurol. 2016;36[6]:631).

At our institution, a nursing education project was conducted to pilot nurse-driven PC screenings on admission to the neuro ICU. The project evaluated nurse comfort and knowledge with identifying and recommending PC consults. Pre- and post-intervention surveys revealed that education and introduction of a PC screening tool significantly increased nurse comfort and knowledge of PC eligibility.

Danielle McCamey, ACNP

Steering Committee Member

Sleep medicine

Diagnostics, devices, and sleep

The past several months have been busy for the Sleep Medicine NetWork. We have been working to represent the interests of our membership and our patients in many arenas.

Devices coded as E0464, defined as life support mechanical ventilators used with mask-based ventilation in the home are being more frequently used. According to the Office of the Inspector General (OIG), there has been an 89-fold increase in billing for E0464 ventilators for Medicare and its beneficiaries between 2009 and 2015, increasing from $3.8M to $340M. In response, the Agency for Healthcare Research and Quality (AHRQ) requested a response to specific questions related to these devices.

Aneesa M. Das, MD, FCCP

NetWork Chair

Occupational and environmental health

Post-deployment lung disease

Since the early 1990s, ongoing military deployments to Southwest Asia remain a unique challenge from a pulmonary symptomology and diagnostic perspective.

Various airborne hazards in the deployment environment include geologic dusts, burn pit smoke, vehicle emissions, and industrial air pollution. Exposures can give rise to both acute respiratory symptoms and, in some instances, chronic lung disease. Currently, data are limited on whether inhalation of airborne particulate matter by military personnel is linked to increases in pulmonary diseases (Morris MJ, et al. US Army Med Dep J. 2016:173).

Pedro F. Lucero, MD, FCCP

Steering Committee Member

Clinical pulmonary medicine

Biologics – Birth of a new era of precision management in asthma

An estimated 10% to 20% of patients with severe uncontrolled asthma do not respond to maximal best standard treatments, leading to substantial health-care costs. A paradigm shift is now underway in our approach to the care of these patients with the emergence of novel biologics targeting the complex and interconnected inflammatory pathways in asthma that result in a diverse profile of asthma endotypes and phenotypes (Fig 1).

Current FDA-approved biologics primarily target patients with a T2 high phenotype (Table1).

Dupilumab binds to the alpha unit of the IL-4 receptor and blocks both IL-4 and IL-13. It shows potential efficacy in patients with T2 high asthma with or without eosinophilia but has not yet received FDA approval.

Multiple newer biologics are currently in development (Table 2).

Pulmonologists need to get familiar with the logistics of administration of these novel agents. The two common methods of administering biologics are (1) buy and bill – where the provider buys the drug directly from the distributor; and (2) assignment of benefits (typically administered by a Pharmacy Benefit Manager) - specific dose of the medication is shipped to the physician’s office and physician only bills for the administration. CPT and J codes are shown in Table 1.

Shyamsunder Subramanian, MD, FCCP

Steering Committee Member

Palliative and end-of-life care

Nurse-driven palliative care screening

Palliative care (PC) aims to improve quality of life for patients with a life-threatening illness, providing holistic patient-centered support along the continuum of the disease process. Although frequently implemented in critical care settings, integrating PC in the neuro ICU has been difficult to adopt in practice due to the uncertainty in prognostication of definitive outcomes and practice culture beliefs such as the self-fulfilling prophecy (Frontera, et al. Crit Care Med. 2015;43[9]:1964; Rubin, et al. Curr Opin Crit Care. 2017;23[2]:134; Knies, et al. Semin Neurol. 2016;36[6]:631).

At our institution, a nursing education project was conducted to pilot nurse-driven PC screenings on admission to the neuro ICU. The project evaluated nurse comfort and knowledge with identifying and recommending PC consults. Pre- and post-intervention surveys revealed that education and introduction of a PC screening tool significantly increased nurse comfort and knowledge of PC eligibility.

Danielle McCamey, ACNP

Steering Committee Member

Sleep medicine

Diagnostics, devices, and sleep

The past several months have been busy for the Sleep Medicine NetWork. We have been working to represent the interests of our membership and our patients in many arenas.

Devices coded as E0464, defined as life support mechanical ventilators used with mask-based ventilation in the home are being more frequently used. According to the Office of the Inspector General (OIG), there has been an 89-fold increase in billing for E0464 ventilators for Medicare and its beneficiaries between 2009 and 2015, increasing from $3.8M to $340M. In response, the Agency for Healthcare Research and Quality (AHRQ) requested a response to specific questions related to these devices.

Aneesa M. Das, MD, FCCP

NetWork Chair

Occupational and environmental health

Post-deployment lung disease

Since the early 1990s, ongoing military deployments to Southwest Asia remain a unique challenge from a pulmonary symptomology and diagnostic perspective.

Various airborne hazards in the deployment environment include geologic dusts, burn pit smoke, vehicle emissions, and industrial air pollution. Exposures can give rise to both acute respiratory symptoms and, in some instances, chronic lung disease. Currently, data are limited on whether inhalation of airborne particulate matter by military personnel is linked to increases in pulmonary diseases (Morris MJ, et al. US Army Med Dep J. 2016:173).

Pedro F. Lucero, MD, FCCP

Steering Committee Member

Clinical pulmonary medicine

Biologics – Birth of a new era of precision management in asthma

An estimated 10% to 20% of patients with severe uncontrolled asthma do not respond to maximal best standard treatments, leading to substantial health-care costs. A paradigm shift is now underway in our approach to the care of these patients with the emergence of novel biologics targeting the complex and interconnected inflammatory pathways in asthma that result in a diverse profile of asthma endotypes and phenotypes (Fig 1).

Current FDA-approved biologics primarily target patients with a T2 high phenotype (Table1).

Dupilumab binds to the alpha unit of the IL-4 receptor and blocks both IL-4 and IL-13. It shows potential efficacy in patients with T2 high asthma with or without eosinophilia but has not yet received FDA approval.

Multiple newer biologics are currently in development (Table 2).

Pulmonologists need to get familiar with the logistics of administration of these novel agents. The two common methods of administering biologics are (1) buy and bill – where the provider buys the drug directly from the distributor; and (2) assignment of benefits (typically administered by a Pharmacy Benefit Manager) - specific dose of the medication is shipped to the physician’s office and physician only bills for the administration. CPT and J codes are shown in Table 1.

Shyamsunder Subramanian, MD, FCCP

Steering Committee Member

CHICAGO – Low bone mineral density was common in a group of transgender women receiving hormone therapy, according to findings from a recent Brazilian study.

“Lumbar spine density was lower than in reference men but similar to that of reference women,” said Tayane Muniz Fighera, MD, speaking at the annual meeting of the Endocrine Society.

Lower lumbar spine density in transgender women was associated with lower appendicular lean mass and higher total fat mass, with correlation coefficients of 0.327 and 0.334, respectively (P = .0001 for both).

Dr. Fighera and her colleagues looked at the independent contribution of age, estradiol level, appendicular lean mass, and fat mass to bone mineral density (BMD) in the transgender patients, using linear regression analysis. Total fat mass and appendicular lean mass were both independent predictors of bone mineral density (P = .001 and P = .022, respectively). For femur BMD, age, and total fat mass were predictors (P = .001 and P = .000, respectively).

The study aimed to assess bone mineral density as well as other aspects of body composition within a cohort of transgender women initiating hormone therapy in order to determine how estrogen therapy affected BMD and assess the prevalence of low bone mass among this population.

The hypothesis, said Dr. Fighera, was that hormone therapy for transgender women might decrease muscle mass and increase fat mass, “leading to less bone surface strain and smaller bone size over time,” said Dr. Fighera, of the Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

Previous work has shown conflicting results, she said. “While some studies report that estrogen therapy is able to increase bone mass, others have observed no difference in BMD” despite the use of hormone therapy. The studies showing an association between estrogen therapy and decreased bone mass were those that followed patients for longer periods of time – 2 years or longer, she said.

[email protected]

SOURCE: Fighera T et al. ENDO 2018, Abstract OR 25-5.

CHICAGO – Low bone mineral density was common in a group of transgender women receiving hormone therapy, according to findings from a recent Brazilian study.

“Lumbar spine density was lower than in reference men but similar to that of reference women,” said Tayane Muniz Fighera, MD, speaking at the annual meeting of the Endocrine Society.

Lower lumbar spine density in transgender women was associated with lower appendicular lean mass and higher total fat mass, with correlation coefficients of 0.327 and 0.334, respectively (P = .0001 for both).

Dr. Fighera and her colleagues looked at the independent contribution of age, estradiol level, appendicular lean mass, and fat mass to bone mineral density (BMD) in the transgender patients, using linear regression analysis. Total fat mass and appendicular lean mass were both independent predictors of bone mineral density (P = .001 and P = .022, respectively). For femur BMD, age, and total fat mass were predictors (P = .001 and P = .000, respectively).

The study aimed to assess bone mineral density as well as other aspects of body composition within a cohort of transgender women initiating hormone therapy in order to determine how estrogen therapy affected BMD and assess the prevalence of low bone mass among this population.

The hypothesis, said Dr. Fighera, was that hormone therapy for transgender women might decrease muscle mass and increase fat mass, “leading to less bone surface strain and smaller bone size over time,” said Dr. Fighera, of the Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

Previous work has shown conflicting results, she said. “While some studies report that estrogen therapy is able to increase bone mass, others have observed no difference in BMD” despite the use of hormone therapy. The studies showing an association between estrogen therapy and decreased bone mass were those that followed patients for longer periods of time – 2 years or longer, she said.

[email protected]

SOURCE: Fighera T et al. ENDO 2018, Abstract OR 25-5.

CHICAGO – Low bone mineral density was common in a group of transgender women receiving hormone therapy, according to findings from a recent Brazilian study.

“Lumbar spine density was lower than in reference men but similar to that of reference women,” said Tayane Muniz Fighera, MD, speaking at the annual meeting of the Endocrine Society.

Lower lumbar spine density in transgender women was associated with lower appendicular lean mass and higher total fat mass, with correlation coefficients of 0.327 and 0.334, respectively (P = .0001 for both).

Dr. Fighera and her colleagues looked at the independent contribution of age, estradiol level, appendicular lean mass, and fat mass to bone mineral density (BMD) in the transgender patients, using linear regression analysis. Total fat mass and appendicular lean mass were both independent predictors of bone mineral density (P = .001 and P = .022, respectively). For femur BMD, age, and total fat mass were predictors (P = .001 and P = .000, respectively).

The study aimed to assess bone mineral density as well as other aspects of body composition within a cohort of transgender women initiating hormone therapy in order to determine how estrogen therapy affected BMD and assess the prevalence of low bone mass among this population.

The hypothesis, said Dr. Fighera, was that hormone therapy for transgender women might decrease muscle mass and increase fat mass, “leading to less bone surface strain and smaller bone size over time,” said Dr. Fighera, of the Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

Previous work has shown conflicting results, she said. “While some studies report that estrogen therapy is able to increase bone mass, others have observed no difference in BMD” despite the use of hormone therapy. The studies showing an association between estrogen therapy and decreased bone mass were those that followed patients for longer periods of time – 2 years or longer, she said.

[email protected]

SOURCE: Fighera T et al. ENDO 2018, Abstract OR 25-5.

The Food and Drug Administration has permitted the marketing of IDx-DR, a retinal imaging device that uses artificial intelligence (AI) to detect greater than a mild level of diabetic retinopathy in adult patients with diabetes. It also is the first authorized device that provides a screening tool without the need of an eye care specialist, making it ideal for health care providers who do not specialize in eye care.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy.” About 50% of people with diabetes do not have the recommended annual retinopathy screening exam, Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at the FDA’s Center for Devices and Radiological Health noted in a press release. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”

memorisz/iStock/Getty Images

If a positive result is detected, patients should see an eye care specialist for further diagnostic evaluation and treatment as soon as possible.

The FDA reviewed data obtained from a clinical study prior to approving IDx-DR for marketing. The study looked at retinal images from 900 patients at 10 primary care sites. The aim of the study was to determine how often IDx-DR was correct in identifying mild diabetic retinopathy. The device was accurate nearly 90% of the time, correctly identifying mild diabetic retinopathy 87.4% of the time. It was also able to identify correctly patients who did not have mild diabetic retinopathy 89.5% of the time.

IDx-DR was approved via the FDA’s De Novo premarket review pathway, which offers a way to approve novel, low to moderate risk devices for which there are no similar devices previously approved. It also was granted a Breakthrough Device designation, because of its effectiveness in treating or diagnosing a irreversibly debilitating disease or condition.

Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.

For more information on other uses of AI in the treatment of diabetic disorders, click here.

[email protected]

The Food and Drug Administration has permitted the marketing of IDx-DR, a retinal imaging device that uses artificial intelligence (AI) to detect greater than a mild level of diabetic retinopathy in adult patients with diabetes. It also is the first authorized device that provides a screening tool without the need of an eye care specialist, making it ideal for health care providers who do not specialize in eye care.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy.” About 50% of people with diabetes do not have the recommended annual retinopathy screening exam, Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at the FDA’s Center for Devices and Radiological Health noted in a press release. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”

memorisz/iStock/Getty Images

If a positive result is detected, patients should see an eye care specialist for further diagnostic evaluation and treatment as soon as possible.

The FDA reviewed data obtained from a clinical study prior to approving IDx-DR for marketing. The study looked at retinal images from 900 patients at 10 primary care sites. The aim of the study was to determine how often IDx-DR was correct in identifying mild diabetic retinopathy. The device was accurate nearly 90% of the time, correctly identifying mild diabetic retinopathy 87.4% of the time. It was also able to identify correctly patients who did not have mild diabetic retinopathy 89.5% of the time.

IDx-DR was approved via the FDA’s De Novo premarket review pathway, which offers a way to approve novel, low to moderate risk devices for which there are no similar devices previously approved. It also was granted a Breakthrough Device designation, because of its effectiveness in treating or diagnosing a irreversibly debilitating disease or condition.

Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.

For more information on other uses of AI in the treatment of diabetic disorders, click here.

[email protected]

The Food and Drug Administration has permitted the marketing of IDx-DR, a retinal imaging device that uses artificial intelligence (AI) to detect greater than a mild level of diabetic retinopathy in adult patients with diabetes. It also is the first authorized device that provides a screening tool without the need of an eye care specialist, making it ideal for health care providers who do not specialize in eye care.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy.” About 50% of people with diabetes do not have the recommended annual retinopathy screening exam, Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose, and throat devices at the FDA’s Center for Devices and Radiological Health noted in a press release. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”

memorisz/iStock/Getty Images

If a positive result is detected, patients should see an eye care specialist for further diagnostic evaluation and treatment as soon as possible.

The FDA reviewed data obtained from a clinical study prior to approving IDx-DR for marketing. The study looked at retinal images from 900 patients at 10 primary care sites. The aim of the study was to determine how often IDx-DR was correct in identifying mild diabetic retinopathy. The device was accurate nearly 90% of the time, correctly identifying mild diabetic retinopathy 87.4% of the time. It was also able to identify correctly patients who did not have mild diabetic retinopathy 89.5% of the time.

IDx-DR was approved via the FDA’s De Novo premarket review pathway, which offers a way to approve novel, low to moderate risk devices for which there are no similar devices previously approved. It also was granted a Breakthrough Device designation, because of its effectiveness in treating or diagnosing a irreversibly debilitating disease or condition.

Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.

For more information on other uses of AI in the treatment of diabetic disorders, click here.

[email protected]

Erythema infectiosum, also known as fifth disease, is a viral exanthem linked to parvovirus B19. Generally, school-aged children are most often affected. Infections are more likely in late winter and early spring. The virus is spread via respiratory secretions, blood products, and transmission from mother to fetus. The cutaneous findings occur about 10 days after exposure to the virus. By that time, the risk of being contagious is low.

Courtesy Dr. Donna Bilu-Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected]. This case and photo were submitted by Dr. Bilu Martin.

Erythema infectiosum, also known as fifth disease, is a viral exanthem linked to parvovirus B19. Generally, school-aged children are most often affected. Infections are more likely in late winter and early spring. The virus is spread via respiratory secretions, blood products, and transmission from mother to fetus. The cutaneous findings occur about 10 days after exposure to the virus. By that time, the risk of being contagious is low.

Courtesy Dr. Donna Bilu-Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected]. This case and photo were submitted by Dr. Bilu Martin.

Erythema infectiosum, also known as fifth disease, is a viral exanthem linked to parvovirus B19. Generally, school-aged children are most often affected. Infections are more likely in late winter and early spring. The virus is spread via respiratory secretions, blood products, and transmission from mother to fetus. The cutaneous findings occur about 10 days after exposure to the virus. By that time, the risk of being contagious is low.

Courtesy Dr. Donna Bilu-Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected]. This case and photo were submitted by Dr. Bilu Martin.

NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

Dr. Manning-Geist had no disclosures.

[email protected]

SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.

NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

Dr. Manning-Geist had no disclosures.

[email protected]

SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.

NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

Dr. Manning-Geist had no disclosures.

[email protected]

SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.