More than half of physicians could be spared from participating in Medicare’s new value-based payment programs in 2018, thanks to a Centers for Medicare & Medicaid Services proposal exempting some physicians.

The proposed 2018 update to the Quality Payment Program (QPP), the payment system created as part of the Medicare Access and CHIP Reauthorization Act (MACRA), would increase the low-volume threshold for participation, exempting practices that receive $90,000 or less in Medicare Part B payments or have 200 or fewer Medicare patients would be exempt from participation in either the Merit-based Incentive Payment System (MIPS) or Advanced Alternative Payment Model (APM) tracks of the QPP.

According to the proposed rule, released June 20, the CMS “estimates that approximately 572,000 eligible clinicians would be required to participate in MIPS in the 2018 MIPS performance period. ... After restricting the population of eligible clinician types who are not newly enrolled, the proposed increase in the low-volume threshold is expected to exclude 585,560 clinicians who do not exceed the low-volume threshold.”

TheaDesign/Thinkstock

The CMS is estimating there will be 554,846 MIPS-eligible clinicians in payment year 2020, and most of them will receive either a positive or neutral payment adjustment because of their participation.

Overall, 96.6% of MIPS-eligible physicians will engage in quality reporting in 2020, with 96.1% receiving either a bonus to their Medicare Part B payments or no adjustment, according to CMS estimates. For all eligible clinicians, 76.8% will receive a bonus payment, with all payment bonuses totaling $673.3 million, while those losing money will see their Medicare payments reduced by $173.3 million. The overall aggregate impact will be a 0.9% increase in Part B payments to clinicians.

However, different practice sizes will have different experiences. For example, practices with 1-15 eligible clinicians (114,424 total eligible clinicians in this group) will see in the aggregate a 0.7% increase, while practices with 16-24 eligible clinicians (22,296) will see a 0.4% increase in the aggregate. Practices of 100 or more clinicians (318,841) stand to see the biggest bump in their Medicare payments, with a 1.4% bonus based on the provisions in the proposal.

Ten percent of practices with 1-15 MIPS-eligible clinicians and 10.9% of practices with 16-24 MIPS-eligible clinicians are estimated to receive a decrease in their Medicare payments based on the proposal, while 0.8% of clinicians in practices of 100 or more are expected to see the penalty.

The increased low-volume threshold would help out a lot of physicians who might otherwise struggle to meet the requirements, but some view it as a penalty against those who have made the investment and are ready to fully transition into the new value-based payment program, particularly the larger health care systems.

According to the MACRA legislation language, the MIPS program will be a budget-neutral program – so, the more practices that are exempt from having to participate, the less money will be available for potential bonuses for those who perform well.

“It compresses the potential reward for those who are ready and ready to do well,” Chet Speed, vice president of public policy at AMGA, said in an interview, adding that the projected 1.4% aggregate bonus payments for large practices and health systems “does not really reflect or reward all the work they have done to get to this point.” AMGA is an association representing large practices and health systems.

Comments on the proposed update to the QPP are due to the CMS by Aug. 21, 2017.

[email protected]

More than half of physicians could be spared from participating in Medicare’s new value-based payment programs in 2018, thanks to a Centers for Medicare & Medicaid Services proposal exempting some physicians.

The proposed 2018 update to the Quality Payment Program (QPP), the payment system created as part of the Medicare Access and CHIP Reauthorization Act (MACRA), would increase the low-volume threshold for participation, exempting practices that receive $90,000 or less in Medicare Part B payments or have 200 or fewer Medicare patients would be exempt from participation in either the Merit-based Incentive Payment System (MIPS) or Advanced Alternative Payment Model (APM) tracks of the QPP.

According to the proposed rule, released June 20, the CMS “estimates that approximately 572,000 eligible clinicians would be required to participate in MIPS in the 2018 MIPS performance period. ... After restricting the population of eligible clinician types who are not newly enrolled, the proposed increase in the low-volume threshold is expected to exclude 585,560 clinicians who do not exceed the low-volume threshold.”

TheaDesign/Thinkstock

The CMS is estimating there will be 554,846 MIPS-eligible clinicians in payment year 2020, and most of them will receive either a positive or neutral payment adjustment because of their participation.

Overall, 96.6% of MIPS-eligible physicians will engage in quality reporting in 2020, with 96.1% receiving either a bonus to their Medicare Part B payments or no adjustment, according to CMS estimates. For all eligible clinicians, 76.8% will receive a bonus payment, with all payment bonuses totaling $673.3 million, while those losing money will see their Medicare payments reduced by $173.3 million. The overall aggregate impact will be a 0.9% increase in Part B payments to clinicians.

However, different practice sizes will have different experiences. For example, practices with 1-15 eligible clinicians (114,424 total eligible clinicians in this group) will see in the aggregate a 0.7% increase, while practices with 16-24 eligible clinicians (22,296) will see a 0.4% increase in the aggregate. Practices of 100 or more clinicians (318,841) stand to see the biggest bump in their Medicare payments, with a 1.4% bonus based on the provisions in the proposal.

Ten percent of practices with 1-15 MIPS-eligible clinicians and 10.9% of practices with 16-24 MIPS-eligible clinicians are estimated to receive a decrease in their Medicare payments based on the proposal, while 0.8% of clinicians in practices of 100 or more are expected to see the penalty.

The increased low-volume threshold would help out a lot of physicians who might otherwise struggle to meet the requirements, but some view it as a penalty against those who have made the investment and are ready to fully transition into the new value-based payment program, particularly the larger health care systems.

According to the MACRA legislation language, the MIPS program will be a budget-neutral program – so, the more practices that are exempt from having to participate, the less money will be available for potential bonuses for those who perform well.

“It compresses the potential reward for those who are ready and ready to do well,” Chet Speed, vice president of public policy at AMGA, said in an interview, adding that the projected 1.4% aggregate bonus payments for large practices and health systems “does not really reflect or reward all the work they have done to get to this point.” AMGA is an association representing large practices and health systems.

Comments on the proposed update to the QPP are due to the CMS by Aug. 21, 2017.

[email protected]

More than half of physicians could be spared from participating in Medicare’s new value-based payment programs in 2018, thanks to a Centers for Medicare & Medicaid Services proposal exempting some physicians.

The proposed 2018 update to the Quality Payment Program (QPP), the payment system created as part of the Medicare Access and CHIP Reauthorization Act (MACRA), would increase the low-volume threshold for participation, exempting practices that receive $90,000 or less in Medicare Part B payments or have 200 or fewer Medicare patients would be exempt from participation in either the Merit-based Incentive Payment System (MIPS) or Advanced Alternative Payment Model (APM) tracks of the QPP.

According to the proposed rule, released June 20, the CMS “estimates that approximately 572,000 eligible clinicians would be required to participate in MIPS in the 2018 MIPS performance period. ... After restricting the population of eligible clinician types who are not newly enrolled, the proposed increase in the low-volume threshold is expected to exclude 585,560 clinicians who do not exceed the low-volume threshold.”

TheaDesign/Thinkstock

The CMS is estimating there will be 554,846 MIPS-eligible clinicians in payment year 2020, and most of them will receive either a positive or neutral payment adjustment because of their participation.

Overall, 96.6% of MIPS-eligible physicians will engage in quality reporting in 2020, with 96.1% receiving either a bonus to their Medicare Part B payments or no adjustment, according to CMS estimates. For all eligible clinicians, 76.8% will receive a bonus payment, with all payment bonuses totaling $673.3 million, while those losing money will see their Medicare payments reduced by $173.3 million. The overall aggregate impact will be a 0.9% increase in Part B payments to clinicians.

However, different practice sizes will have different experiences. For example, practices with 1-15 eligible clinicians (114,424 total eligible clinicians in this group) will see in the aggregate a 0.7% increase, while practices with 16-24 eligible clinicians (22,296) will see a 0.4% increase in the aggregate. Practices of 100 or more clinicians (318,841) stand to see the biggest bump in their Medicare payments, with a 1.4% bonus based on the provisions in the proposal.

Ten percent of practices with 1-15 MIPS-eligible clinicians and 10.9% of practices with 16-24 MIPS-eligible clinicians are estimated to receive a decrease in their Medicare payments based on the proposal, while 0.8% of clinicians in practices of 100 or more are expected to see the penalty.

The increased low-volume threshold would help out a lot of physicians who might otherwise struggle to meet the requirements, but some view it as a penalty against those who have made the investment and are ready to fully transition into the new value-based payment program, particularly the larger health care systems.

According to the MACRA legislation language, the MIPS program will be a budget-neutral program – so, the more practices that are exempt from having to participate, the less money will be available for potential bonuses for those who perform well.

“It compresses the potential reward for those who are ready and ready to do well,” Chet Speed, vice president of public policy at AMGA, said in an interview, adding that the projected 1.4% aggregate bonus payments for large practices and health systems “does not really reflect or reward all the work they have done to get to this point.” AMGA is an association representing large practices and health systems.

Comments on the proposed update to the QPP are due to the CMS by Aug. 21, 2017.

[email protected]

 

Ridinilazole, a new antibiotic for treatment of Clostridium difficile infection (CDI) proved noninferior to vancomycin, showing promise especially in lower recurrence risk, according to a study funded in part by ridinilazole manufacturer Summit Therapeutics.

In a phase 2, 1:1 randomized, double-blind trial of 69 CDI patients, 24 of 36 (66.7%) ridinilazole patients reported a sustained clinical response, compared with 14 of 33 vancomycin patients (42.4%), indicating statistical noninferiority – and even superiority at the upper confidence level – of ridinilazole (Lancet Infect Dis. 2017 Apr 28. doi: 10.1016/S1473-3099[17]30235-9).

Over the course of 10 days, investigators gave the ridinilazole group 200 mg orally twice per day, as well as two placebo doses. Those in the vancomycin group took 125 mg orally four times per day.

Investigators assessed both groups on days 4-6, 10-11, 12-14, and routine weekly follow-ups until 30 days after treatment.

Most of the patients were white females, with an average age of 58 years for the ridinilazole group, and 56 years for the vancomycin group.

cjc2nd/Wikimedia Commons/CC ASA-3.0

Severity of CDI was most commonly mild, with moderate CDI in 18% of the ridinilazole group and 20% of the vancomycin group, and severe cases in 14% and 18% of the ridinilazole group and vancomycin groups, respectively.

Ridinilazole correlated with more sustained clinical responses across almost all subgroups as well, including with treatment differences (respectively) of 42.7%, 15.9%, 19.9%, and 8.9% for those over 75 years, with a more severe diagnosis, more than one previous CDI episode, and those taking other antibiotics before study participation, according to the investigators. Both groups saw similar rates of adverse events related to treatment.

The outcome of this trial could be significant in reducing recurrence risk in CDI patients, which occurs in up to 30% of patients after first treatment, and can increase up to 65% after multiple reinfections, according to Richard Vickers, PhD, chief scientific officer on antimicrobials at Summit Therapeutics PLC, and his fellow investigators.

CDI patients also are subject to significantly higher inpatient mortality, spend longer periods in intensive care, and have higher rates of all-cause readmission over 3 months than do matched controls, the investigators noted.

Unlike the three common CDI drugs on the market, metronidazole, vancomycin, and fidaxomicin, ridinilazole is restricted to the gastrointestinal tract and, according to the investigators, has shown encouraging results in previous studies.

“In vitro studies have shown its high inhibitory activity against C. difficile and minimal activity against both Gram-positive and Gram-negative aerobic and anaerobic intestinal microorganisms,” they wrote. “In a phase 1 study, ridinilazole was safe and well tolerated in healthy human volunteers, with little systemic absorption and little effect on normal gut microbiota.”

They asserted it was this lack of effect that caused the drug to show success in phase 2, noting ridinilazole’s superiority was “likely to be due to the highly selective activity of ridinilazole against CDI and the absence of collateral damage to the microbiota during therapy.”

The study was limited by its sample, which was younger and had a milder form of CDI than is usually represented. The study also formed its power calculations based on the original sample size of 100, and not the adjusted, intended-to-treat population of 69 which became its primary analysis.

Finally, the investigators advised further trials be conducted with a follow-up schedule longer than 30 days.

Dr. Vickers, Dr. Bina Tejura, and Dr. David Roblin reported working for Summit Therapeutics, the drug manufacturer, and hold share options with the company. Other authors reported holding close relationships with other, similar drug manufacturing companies.

[email protected]

On Twitter @eaztweets

 

Ridinilazole, a new antibiotic for treatment of Clostridium difficile infection (CDI) proved noninferior to vancomycin, showing promise especially in lower recurrence risk, according to a study funded in part by ridinilazole manufacturer Summit Therapeutics.

In a phase 2, 1:1 randomized, double-blind trial of 69 CDI patients, 24 of 36 (66.7%) ridinilazole patients reported a sustained clinical response, compared with 14 of 33 vancomycin patients (42.4%), indicating statistical noninferiority – and even superiority at the upper confidence level – of ridinilazole (Lancet Infect Dis. 2017 Apr 28. doi: 10.1016/S1473-3099[17]30235-9).

Over the course of 10 days, investigators gave the ridinilazole group 200 mg orally twice per day, as well as two placebo doses. Those in the vancomycin group took 125 mg orally four times per day.

Investigators assessed both groups on days 4-6, 10-11, 12-14, and routine weekly follow-ups until 30 days after treatment.

Most of the patients were white females, with an average age of 58 years for the ridinilazole group, and 56 years for the vancomycin group.

cjc2nd/Wikimedia Commons/CC ASA-3.0

Severity of CDI was most commonly mild, with moderate CDI in 18% of the ridinilazole group and 20% of the vancomycin group, and severe cases in 14% and 18% of the ridinilazole group and vancomycin groups, respectively.

Ridinilazole correlated with more sustained clinical responses across almost all subgroups as well, including with treatment differences (respectively) of 42.7%, 15.9%, 19.9%, and 8.9% for those over 75 years, with a more severe diagnosis, more than one previous CDI episode, and those taking other antibiotics before study participation, according to the investigators. Both groups saw similar rates of adverse events related to treatment.

The outcome of this trial could be significant in reducing recurrence risk in CDI patients, which occurs in up to 30% of patients after first treatment, and can increase up to 65% after multiple reinfections, according to Richard Vickers, PhD, chief scientific officer on antimicrobials at Summit Therapeutics PLC, and his fellow investigators.

CDI patients also are subject to significantly higher inpatient mortality, spend longer periods in intensive care, and have higher rates of all-cause readmission over 3 months than do matched controls, the investigators noted.

Unlike the three common CDI drugs on the market, metronidazole, vancomycin, and fidaxomicin, ridinilazole is restricted to the gastrointestinal tract and, according to the investigators, has shown encouraging results in previous studies.

“In vitro studies have shown its high inhibitory activity against C. difficile and minimal activity against both Gram-positive and Gram-negative aerobic and anaerobic intestinal microorganisms,” they wrote. “In a phase 1 study, ridinilazole was safe and well tolerated in healthy human volunteers, with little systemic absorption and little effect on normal gut microbiota.”

They asserted it was this lack of effect that caused the drug to show success in phase 2, noting ridinilazole’s superiority was “likely to be due to the highly selective activity of ridinilazole against CDI and the absence of collateral damage to the microbiota during therapy.”

The study was limited by its sample, which was younger and had a milder form of CDI than is usually represented. The study also formed its power calculations based on the original sample size of 100, and not the adjusted, intended-to-treat population of 69 which became its primary analysis.

Finally, the investigators advised further trials be conducted with a follow-up schedule longer than 30 days.

Dr. Vickers, Dr. Bina Tejura, and Dr. David Roblin reported working for Summit Therapeutics, the drug manufacturer, and hold share options with the company. Other authors reported holding close relationships with other, similar drug manufacturing companies.

[email protected]

On Twitter @eaztweets

 

Ridinilazole, a new antibiotic for treatment of Clostridium difficile infection (CDI) proved noninferior to vancomycin, showing promise especially in lower recurrence risk, according to a study funded in part by ridinilazole manufacturer Summit Therapeutics.

In a phase 2, 1:1 randomized, double-blind trial of 69 CDI patients, 24 of 36 (66.7%) ridinilazole patients reported a sustained clinical response, compared with 14 of 33 vancomycin patients (42.4%), indicating statistical noninferiority – and even superiority at the upper confidence level – of ridinilazole (Lancet Infect Dis. 2017 Apr 28. doi: 10.1016/S1473-3099[17]30235-9).

Over the course of 10 days, investigators gave the ridinilazole group 200 mg orally twice per day, as well as two placebo doses. Those in the vancomycin group took 125 mg orally four times per day.

Investigators assessed both groups on days 4-6, 10-11, 12-14, and routine weekly follow-ups until 30 days after treatment.

Most of the patients were white females, with an average age of 58 years for the ridinilazole group, and 56 years for the vancomycin group.

cjc2nd/Wikimedia Commons/CC ASA-3.0

Severity of CDI was most commonly mild, with moderate CDI in 18% of the ridinilazole group and 20% of the vancomycin group, and severe cases in 14% and 18% of the ridinilazole group and vancomycin groups, respectively.

Ridinilazole correlated with more sustained clinical responses across almost all subgroups as well, including with treatment differences (respectively) of 42.7%, 15.9%, 19.9%, and 8.9% for those over 75 years, with a more severe diagnosis, more than one previous CDI episode, and those taking other antibiotics before study participation, according to the investigators. Both groups saw similar rates of adverse events related to treatment.

The outcome of this trial could be significant in reducing recurrence risk in CDI patients, which occurs in up to 30% of patients after first treatment, and can increase up to 65% after multiple reinfections, according to Richard Vickers, PhD, chief scientific officer on antimicrobials at Summit Therapeutics PLC, and his fellow investigators.

CDI patients also are subject to significantly higher inpatient mortality, spend longer periods in intensive care, and have higher rates of all-cause readmission over 3 months than do matched controls, the investigators noted.

Unlike the three common CDI drugs on the market, metronidazole, vancomycin, and fidaxomicin, ridinilazole is restricted to the gastrointestinal tract and, according to the investigators, has shown encouraging results in previous studies.

“In vitro studies have shown its high inhibitory activity against C. difficile and minimal activity against both Gram-positive and Gram-negative aerobic and anaerobic intestinal microorganisms,” they wrote. “In a phase 1 study, ridinilazole was safe and well tolerated in healthy human volunteers, with little systemic absorption and little effect on normal gut microbiota.”

They asserted it was this lack of effect that caused the drug to show success in phase 2, noting ridinilazole’s superiority was “likely to be due to the highly selective activity of ridinilazole against CDI and the absence of collateral damage to the microbiota during therapy.”

The study was limited by its sample, which was younger and had a milder form of CDI than is usually represented. The study also formed its power calculations based on the original sample size of 100, and not the adjusted, intended-to-treat population of 69 which became its primary analysis.

Finally, the investigators advised further trials be conducted with a follow-up schedule longer than 30 days.

Dr. Vickers, Dr. Bina Tejura, and Dr. David Roblin reported working for Summit Therapeutics, the drug manufacturer, and hold share options with the company. Other authors reported holding close relationships with other, similar drug manufacturing companies.

[email protected]

On Twitter @eaztweets

 

The U.S. Department of Justice (DOJ) has charged more than 400 health professionals with fraud for allegedly bilking $1.3 billion from the government through false billings to the Medicare, Medicaid, and TRICARE programs.

In all, 412 people, including 56 doctors, were charged across 41 federal districts for their participation in the alleged schemes, a large portion of which involved unnecessarily prescribing and distributing opioids to patients, according to a July 13 announcement by the DOJ. The agency called the enforcement the largest health care fraud action in DOJ history.

Copyright Alex_str/Thinkstock

The defendants allegedly submitted claims to Medicare, Medicaid and TRICARE for treatments that were medically unnecessary and often never provided. In many cases, patient recruiters, beneficiaries, and other coconspirators were allegedly paid cash kickbacks in return for supplying beneficiary information so that the providers could submit fraudulent bills to Medicare.

Defendants were charged in more than 20 states, including Florida, Michigan, Texas, California, Illinois, and Louisiana, where the federal government operates Medicare Fraud Strike Forces.

Southern Florida had the highest number of defendants, with 77 health professionals charged with a combined $141 million in false billings for alleged home health care, mental health services, and pharmacy fraud. In one case, an owner and operator of a Florida addiction treatment center is accused of actively recruiting addicted patients to move to South Florida so that coconspirators could bill for treatment and testing. In return, the coconspirators offered kickbacks to patients in the form of gift cards, free airline travel, trips to casinos and strip clubs, and drugs, according to the DOJ.

Health care fraud is not only a criminal act that costs billions of taxpayer dollars, it is an affront to all Americans who rely on national health care programs, Tom Price, MD, Secretary of Health and Human Services, said in a statement. “The United States is home to the world’s best medical professionals, but their ability to provide affordable, high-quality care to their patients is jeopardized every time a criminal commits health care fraud,” Dr. Price said.

[email protected]

On Twitter @legal_med

 

The U.S. Department of Justice (DOJ) has charged more than 400 health professionals with fraud for allegedly bilking $1.3 billion from the government through false billings to the Medicare, Medicaid, and TRICARE programs.

In all, 412 people, including 56 doctors, were charged across 41 federal districts for their participation in the alleged schemes, a large portion of which involved unnecessarily prescribing and distributing opioids to patients, according to a July 13 announcement by the DOJ. The agency called the enforcement the largest health care fraud action in DOJ history.

Copyright Alex_str/Thinkstock

The defendants allegedly submitted claims to Medicare, Medicaid and TRICARE for treatments that were medically unnecessary and often never provided. In many cases, patient recruiters, beneficiaries, and other coconspirators were allegedly paid cash kickbacks in return for supplying beneficiary information so that the providers could submit fraudulent bills to Medicare.

Defendants were charged in more than 20 states, including Florida, Michigan, Texas, California, Illinois, and Louisiana, where the federal government operates Medicare Fraud Strike Forces.

Southern Florida had the highest number of defendants, with 77 health professionals charged with a combined $141 million in false billings for alleged home health care, mental health services, and pharmacy fraud. In one case, an owner and operator of a Florida addiction treatment center is accused of actively recruiting addicted patients to move to South Florida so that coconspirators could bill for treatment and testing. In return, the coconspirators offered kickbacks to patients in the form of gift cards, free airline travel, trips to casinos and strip clubs, and drugs, according to the DOJ.

Health care fraud is not only a criminal act that costs billions of taxpayer dollars, it is an affront to all Americans who rely on national health care programs, Tom Price, MD, Secretary of Health and Human Services, said in a statement. “The United States is home to the world’s best medical professionals, but their ability to provide affordable, high-quality care to their patients is jeopardized every time a criminal commits health care fraud,” Dr. Price said.

[email protected]

On Twitter @legal_med

 

The U.S. Department of Justice (DOJ) has charged more than 400 health professionals with fraud for allegedly bilking $1.3 billion from the government through false billings to the Medicare, Medicaid, and TRICARE programs.

In all, 412 people, including 56 doctors, were charged across 41 federal districts for their participation in the alleged schemes, a large portion of which involved unnecessarily prescribing and distributing opioids to patients, according to a July 13 announcement by the DOJ. The agency called the enforcement the largest health care fraud action in DOJ history.

Copyright Alex_str/Thinkstock

The defendants allegedly submitted claims to Medicare, Medicaid and TRICARE for treatments that were medically unnecessary and often never provided. In many cases, patient recruiters, beneficiaries, and other coconspirators were allegedly paid cash kickbacks in return for supplying beneficiary information so that the providers could submit fraudulent bills to Medicare.

Defendants were charged in more than 20 states, including Florida, Michigan, Texas, California, Illinois, and Louisiana, where the federal government operates Medicare Fraud Strike Forces.

Southern Florida had the highest number of defendants, with 77 health professionals charged with a combined $141 million in false billings for alleged home health care, mental health services, and pharmacy fraud. In one case, an owner and operator of a Florida addiction treatment center is accused of actively recruiting addicted patients to move to South Florida so that coconspirators could bill for treatment and testing. In return, the coconspirators offered kickbacks to patients in the form of gift cards, free airline travel, trips to casinos and strip clubs, and drugs, according to the DOJ.

Health care fraud is not only a criminal act that costs billions of taxpayer dollars, it is an affront to all Americans who rely on national health care programs, Tom Price, MD, Secretary of Health and Human Services, said in a statement. “The United States is home to the world’s best medical professionals, but their ability to provide affordable, high-quality care to their patients is jeopardized every time a criminal commits health care fraud,” Dr. Price said.

[email protected]

On Twitter @legal_med

 

Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%, according to the Centers for Disease Control and Prevention.

In an article summarizing influenza activity in the United States during October 2016–May 2017, investigators said that most of the viral strains antigenically characterized at the CDC “were similar to the reference viruses representing the recommended components for the 2016-2017 vaccine.”

In addition, none of the thousands of samples tested showed resistance to the antivirals oseltamivir, zanamivir, and peramivir, said epidemiologist Lenee Blanton, MD, and her associates in the influenza division, National Center for Immunization and Respiratory Diseases in Atlanta.

The 2017-2018 influenza vaccine has been updated to include an additional influenza A (H1N1) component. This change was recommended by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, based on data from global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, human serology studies, antiviral susceptibility, and the availability of candidate influenza viruses (MMWR. 2017;66[25]:668-76).

Preliminary data show that, during the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population, more than double that for the 2015-2017 season (31/100,000). Broken down by age groups, the rates per 100,000 population in this past season were 44 at ages 0-4 years, 17 at ages 5-17 years, 20 at ages 18-49 years, and 65 at ages 50-64 years, compared with 291 at ages 65 years and older. Finalized estimates of the number of influenza illnesses, medical visits, and hospitalizations averted by vaccination during the 2016-2017 season will be published in December, the investigators said.

 

Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%, according to the Centers for Disease Control and Prevention.

In an article summarizing influenza activity in the United States during October 2016–May 2017, investigators said that most of the viral strains antigenically characterized at the CDC “were similar to the reference viruses representing the recommended components for the 2016-2017 vaccine.”

In addition, none of the thousands of samples tested showed resistance to the antivirals oseltamivir, zanamivir, and peramivir, said epidemiologist Lenee Blanton, MD, and her associates in the influenza division, National Center for Immunization and Respiratory Diseases in Atlanta.

The 2017-2018 influenza vaccine has been updated to include an additional influenza A (H1N1) component. This change was recommended by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, based on data from global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, human serology studies, antiviral susceptibility, and the availability of candidate influenza viruses (MMWR. 2017;66[25]:668-76).

Preliminary data show that, during the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population, more than double that for the 2015-2017 season (31/100,000). Broken down by age groups, the rates per 100,000 population in this past season were 44 at ages 0-4 years, 17 at ages 5-17 years, 20 at ages 18-49 years, and 65 at ages 50-64 years, compared with 291 at ages 65 years and older. Finalized estimates of the number of influenza illnesses, medical visits, and hospitalizations averted by vaccination during the 2016-2017 season will be published in December, the investigators said.

 

Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%, according to the Centers for Disease Control and Prevention.

In an article summarizing influenza activity in the United States during October 2016–May 2017, investigators said that most of the viral strains antigenically characterized at the CDC “were similar to the reference viruses representing the recommended components for the 2016-2017 vaccine.”

In addition, none of the thousands of samples tested showed resistance to the antivirals oseltamivir, zanamivir, and peramivir, said epidemiologist Lenee Blanton, MD, and her associates in the influenza division, National Center for Immunization and Respiratory Diseases in Atlanta.

The 2017-2018 influenza vaccine has been updated to include an additional influenza A (H1N1) component. This change was recommended by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, based on data from global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, human serology studies, antiviral susceptibility, and the availability of candidate influenza viruses (MMWR. 2017;66[25]:668-76).

Preliminary data show that, during the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population, more than double that for the 2015-2017 season (31/100,000). Broken down by age groups, the rates per 100,000 population in this past season were 44 at ages 0-4 years, 17 at ages 5-17 years, 20 at ages 18-49 years, and 65 at ages 50-64 years, compared with 291 at ages 65 years and older. Finalized estimates of the number of influenza illnesses, medical visits, and hospitalizations averted by vaccination during the 2016-2017 season will be published in December, the investigators said.

 

On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.

In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.

Loss and tough adjustment

George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.

Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.

When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.¹

Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”²

The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”³ by Ohio Gov. John Kasich.

The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”⁴

How the evidence stacks up

Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”⁵

Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.⁶ “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”⁷

Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”

In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”⁸ In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.

It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.⁹ Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.¹⁰

I suspect that the motives of those psychiatrists are benevolent, fueled by a desire to care more easily for patients in need. But my fear is that the result is potentially catastrophic – as it was for George Hang. By legitimizing false claims about the violence of the patients we treat, we exacerbate this belief. We give rationalization to a mother making the most difficult decision of her life, which ended on Dec. 11, 2016. (In a compassionate move, authorities had dropped the case against her). Sadly, such arguments made by psychiatrists are both intellectually and scientifically dishonest.

I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.

As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.

 

References

1 Los Angeles Times. May 22, 2017

2 Obama White House Archives, Jan. 4, 2016

3 TheTrace.org. Sept. 1, 2015

4 The Guardian. Oct. 2, 2015

5 Psychiatr Clin N Am. 2016;39:611-21

6 Ann Epidemiol. 2015 May;25(5):366-76

7 The New Yorker. Nov. 19, 2014

8 60 Minutes. Sept. 27, 2013

9 Psychiatr Serv. 2016 Jul 1;67(7):784-6

10 CNS Spectr. 2015 Jun;20(3):207-14

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.

In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.

Loss and tough adjustment

George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.

Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.

When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.¹

Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”²

The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”³ by Ohio Gov. John Kasich.

The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”⁴

How the evidence stacks up

Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”⁵

Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.⁶ “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”⁷

Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”

In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”⁸ In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.

It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.⁹ Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.¹⁰

I suspect that the motives of those psychiatrists are benevolent, fueled by a desire to care more easily for patients in need. But my fear is that the result is potentially catastrophic – as it was for George Hang. By legitimizing false claims about the violence of the patients we treat, we exacerbate this belief. We give rationalization to a mother making the most difficult decision of her life, which ended on Dec. 11, 2016. (In a compassionate move, authorities had dropped the case against her). Sadly, such arguments made by psychiatrists are both intellectually and scientifically dishonest.

I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.

As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.

 

References

1 Los Angeles Times. May 22, 2017

2 Obama White House Archives, Jan. 4, 2016

3 TheTrace.org. Sept. 1, 2015

4 The Guardian. Oct. 2, 2015

5 Psychiatr Clin N Am. 2016;39:611-21

6 Ann Epidemiol. 2015 May;25(5):366-76

7 The New Yorker. Nov. 19, 2014

8 60 Minutes. Sept. 27, 2013

9 Psychiatr Serv. 2016 Jul 1;67(7):784-6

10 CNS Spectr. 2015 Jun;20(3):207-14

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

On July 27, 2015, Lai Hang shot and killed her son, George, at the Valley Hotel in Rosemead, Calif. Ms. Hang had been diagnosed with terminal cancer a few months prior and was concerned about the future of her son. George was almost 18 and diagnosed with schizophrenia.

In thinking about why Ms. Hang chose this act, I can’t help but wonder about our role in perpetuating the myth that mental illness and violence go hand in hand.

Loss and tough adjustment

George had been born to Lai and Peter Hang, who moved to the United States in 1992 from the southeast Asian country of Laos to open a printing shop and pursue the “American dream.” In 2012, Peter Hang was diagnosed with metastatic cancer and died, a development that was a severe stressor for George.

Over a period of months, George reportedly started withdrawing from friends and acting differently. He destroyed things around the house, including a garden he had planted with a family friend. His grades slipped in school; he was getting report cards full of Fs. He subsequently was diagnosed with schizophrenia. Ms. Hang grew increasingly concerned about him in the context of the multiple highly publicized mass shootings attributed to patients with mental illness.

When George became more interested in Adolf Hitler after a school project on World War II, Ms. Hang’s fear intensified. Her concerns grew even more in the wake of reports of killings by James Holmes in Aurora, Colo.; Adam Lanza in Newtown, Conn.; and Elliot Rodger in the Santa Barbara County, Calif., town of Isla Vista. After the Charleston, S.C., church shootings of June 2015, George Hang reportedly became fixated on Dylann Roof. With increasing distress over her son, Ms. Hang wondered whether anything could have been done to stop those shooters.¹

Politicians long have perpetrated the belief that patients with mental illness cause violence. Former President Barack Obama often linked mental illness to gun violence. For example, in a 2016 statement, he said: “While individuals with mental illness are more likely to be victims of violence than perpetrators, incidents of violence continue to highlight a crisis in America’s mental health system.”²

The recent election also was a prime example, with quotes such as: “This isn’t a gun problem; it’s a mental health problem ... these are sick people,” by now-President Donald Trump, and “We are not making sure that someone who is mentally ill can’t get access to a gun”³ by Ohio Gov. John Kasich.

The media also have promoted this view with headlines such as “Get the violent crazies off our streets,” and “They threaten, seethe and unhinge, then kill in quantity.” In one article, the writer contended: “In our newfound complacency, we had forgotten a particular kind of violence to which we are still prey … violence of the mentally ill.”⁴

How the evidence stacks up

Nonetheless, the scientific evidence contradicts those views. Most reviews on the topic come to conclusions similar to those of Debra A. Pinals, MD, and Lisa Anacker, MD, who recently wrote: “Despite media accounts to the contrary, persons with mental illness account for only a small percentage of persons who commit acts of violence ...”⁵

Jeffrey W. Swanson, PhD, who has spent his career examining these issues, studied more than 10,000 people with and without mental illness over 1 year, and found that serious mental illness was found in only 4% of the cases of violence. He found three factors that do predict the occurrence of violence: whether the perpetrator was male, poor, or abusing drugs.⁶ “That study debunked two myths,” Dr. Swanson, professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C., reportedly said. “One: people with mental illness are all dangerous. Well, the vast majority are not. And the other myth: that there’s no connection at all. There is one. It’s quite small, but it’s not completely nonexistent.”⁷

Despite the consistent research on this topic, the voice of psychiatry has been muddled. Many have promoted this intuitive yet wrong narrative. In particular, this approach has been embraced by the Treatment Advocacy Center (TAC), a large nonprofit organization “dedicated to eliminating barriers to the timely and effective treatment of severe mental illness.”

In 2013, E. Fuller Torrey, MD, the executive director of TAC, contended in an interview “about half of … mass killings are being done by people with severe mental illness.” His solution is explicit: “The U.S. would have fewer mass killings if individuals with severe mental illnesses received proper treatment.”⁸ In a fact that implies tacit approval of Dr. Torrey’s problematic positions, three past presidents of the American Psychiatric Association currently serve on TAC’s board: Jeffrey A. Lieberman, MD; Steven S. Sharfstein, MD; and John A. Talbott, MD.

It is worrying that some psychiatrists have started sounding false alarms again when advocating for laws that support assisted outpatient treatment (AOT). In AOT, an individual meeting specified criteria for mental illness and potentially asserted to have a risk for violence is compelled by court order to comply with outpatient psychiatric treatment as a condition of remaining in the community.⁹ Some psychiatrists contend that “the relationship between deinstitutionalization and the increasing episodes of violent behavior by individuals with serious mental illness who are not being treated has been firmly established. Until we address the treatment issue and use proven remedies, such as assisted outpatient treatment … we should expect these episodes of violent behavior to continue,” they conclude.¹⁰

I suspect that the motives of those psychiatrists are benevolent, fueled by a desire to care more easily for patients in need. But my fear is that the result is potentially catastrophic – as it was for George Hang. By legitimizing false claims about the violence of the patients we treat, we exacerbate this belief. We give rationalization to a mother making the most difficult decision of her life, which ended on Dec. 11, 2016. (In a compassionate move, authorities had dropped the case against her). Sadly, such arguments made by psychiatrists are both intellectually and scientifically dishonest.

I am concerned about this issue, not only because of the stigma faced by our patients. I want to prevent our patients from realizing that behind their backs, outside of the office, we speak of them as dangerous and in need of involuntary confinement. I am concerned that patients will no longer trust psychiatrists if we describe them in such scary fashions without even the backing of science. If nonmaleficence is at the cornerstone of medical ethics, maybe as psychiatrists we could start by not falsely accusing our patients of being dangerous.

As Irvin D. Yalom, MD, famously said: “It’s the relationship that heals.” I cannot think of anything more important to my practice than cultivating genuine and meaningful relationships. I work as a psychiatrist with patients who have severe mental illness. They are dehumanized by the system, disenfranchised from society, and feared by the media. My role is to create a relationship that helps them overcome those obstacles.

 

References

1 Los Angeles Times. May 22, 2017

2 Obama White House Archives, Jan. 4, 2016

3 TheTrace.org. Sept. 1, 2015

4 The Guardian. Oct. 2, 2015

5 Psychiatr Clin N Am. 2016;39:611-21

6 Ann Epidemiol. 2015 May;25(5):366-76

7 The New Yorker. Nov. 19, 2014

8 60 Minutes. Sept. 27, 2013

9 Psychiatr Serv. 2016 Jul 1;67(7):784-6

10 CNS Spectr. 2015 Jun;20(3):207-14

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego; and the University of San Diego. He teaches on medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

Patients on immunotherapy treatments for lung cancer have experienced repigmentation of their formerly gray hair, according to a new report. Moreover, researchers say, all but one of the patients experiencing this effect also responded well to the therapy, suggesting that hair repigmentation could potentially serve as a marker of treatment response.

In a case series published online July 12 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.2106), Noelia Rivera, MD, of the Universitat Autònoma de Barcelona and her colleagues report findings from 14 patients (13 male, mean age 65) receiving anti–programmed cell death 1 (anti–PD-1) and anti–programmed cell death ligand 1 (anti–PD-L1) therapies to treat squamous cell lung cancer or lung adenocarcinoma, with most (11) receiving nivolumab (Opdivo). All but one patient experienced a diffuse darkening of the hair to resemble its previous color, while the remaining patient’s repigmentation occurred in patches.

XiXinXing/Thinkstock

Anti–PD-1 and anti–PD-L1 therapies work by preventing tumors from escaping the immune system response and have been seen in other studies associated with skin events including cutaneous eruption, vitiligo, and pruritus. Patients receiving anti–PD-1 therapies for melanoma have been reported to develop vitiligo involving their hair. Hair repigmentation has previously been documented in association with a handful of other drugs used in cancer or rheumatology, including thalidomide, lenalidomide, erlotinib, adalimumab, and etretinate, but the mechanisms by which any of these agents affect hair or skin is poorly understood.

Dr. Rivera and her colleagues wrote in their analysis that gray hair follicles “still preserve a reduced number of differentiated and functioning melanocytes located in the hair bulb. This reduced number of melanocytes may explain the possibility of [repigmentation] under appropriate conditions.” But, there are competing theories as to why this should occur with cancer immunotherapy, they noted. One is that the drugs’ inhibition of proinflammatory cytokines acts as negative regulators of melanogenesis. Another is that melanocytes in hair follicles are activated through inflammatory mediators. Of the patients with hair repigmentation in the study, only one, who was being treated with nivolumab for lung squamous cell carcinoma, had disease progression. This patient was discontinued after four treatment sessions and died. The other 13 patients saw either stable disease or a partial response.

The study received no outside funding, but two investigators disclosed financial relationships with pharmaceutical manufacturers.

 

Patients on immunotherapy treatments for lung cancer have experienced repigmentation of their formerly gray hair, according to a new report. Moreover, researchers say, all but one of the patients experiencing this effect also responded well to the therapy, suggesting that hair repigmentation could potentially serve as a marker of treatment response.

In a case series published online July 12 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.2106), Noelia Rivera, MD, of the Universitat Autònoma de Barcelona and her colleagues report findings from 14 patients (13 male, mean age 65) receiving anti–programmed cell death 1 (anti–PD-1) and anti–programmed cell death ligand 1 (anti–PD-L1) therapies to treat squamous cell lung cancer or lung adenocarcinoma, with most (11) receiving nivolumab (Opdivo). All but one patient experienced a diffuse darkening of the hair to resemble its previous color, while the remaining patient’s repigmentation occurred in patches.

XiXinXing/Thinkstock

Anti–PD-1 and anti–PD-L1 therapies work by preventing tumors from escaping the immune system response and have been seen in other studies associated with skin events including cutaneous eruption, vitiligo, and pruritus. Patients receiving anti–PD-1 therapies for melanoma have been reported to develop vitiligo involving their hair. Hair repigmentation has previously been documented in association with a handful of other drugs used in cancer or rheumatology, including thalidomide, lenalidomide, erlotinib, adalimumab, and etretinate, but the mechanisms by which any of these agents affect hair or skin is poorly understood.

Dr. Rivera and her colleagues wrote in their analysis that gray hair follicles “still preserve a reduced number of differentiated and functioning melanocytes located in the hair bulb. This reduced number of melanocytes may explain the possibility of [repigmentation] under appropriate conditions.” But, there are competing theories as to why this should occur with cancer immunotherapy, they noted. One is that the drugs’ inhibition of proinflammatory cytokines acts as negative regulators of melanogenesis. Another is that melanocytes in hair follicles are activated through inflammatory mediators. Of the patients with hair repigmentation in the study, only one, who was being treated with nivolumab for lung squamous cell carcinoma, had disease progression. This patient was discontinued after four treatment sessions and died. The other 13 patients saw either stable disease or a partial response.

The study received no outside funding, but two investigators disclosed financial relationships with pharmaceutical manufacturers.

 

Patients on immunotherapy treatments for lung cancer have experienced repigmentation of their formerly gray hair, according to a new report. Moreover, researchers say, all but one of the patients experiencing this effect also responded well to the therapy, suggesting that hair repigmentation could potentially serve as a marker of treatment response.

In a case series published online July 12 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.2106), Noelia Rivera, MD, of the Universitat Autònoma de Barcelona and her colleagues report findings from 14 patients (13 male, mean age 65) receiving anti–programmed cell death 1 (anti–PD-1) and anti–programmed cell death ligand 1 (anti–PD-L1) therapies to treat squamous cell lung cancer or lung adenocarcinoma, with most (11) receiving nivolumab (Opdivo). All but one patient experienced a diffuse darkening of the hair to resemble its previous color, while the remaining patient’s repigmentation occurred in patches.

XiXinXing/Thinkstock

Anti–PD-1 and anti–PD-L1 therapies work by preventing tumors from escaping the immune system response and have been seen in other studies associated with skin events including cutaneous eruption, vitiligo, and pruritus. Patients receiving anti–PD-1 therapies for melanoma have been reported to develop vitiligo involving their hair. Hair repigmentation has previously been documented in association with a handful of other drugs used in cancer or rheumatology, including thalidomide, lenalidomide, erlotinib, adalimumab, and etretinate, but the mechanisms by which any of these agents affect hair or skin is poorly understood.

Dr. Rivera and her colleagues wrote in their analysis that gray hair follicles “still preserve a reduced number of differentiated and functioning melanocytes located in the hair bulb. This reduced number of melanocytes may explain the possibility of [repigmentation] under appropriate conditions.” But, there are competing theories as to why this should occur with cancer immunotherapy, they noted. One is that the drugs’ inhibition of proinflammatory cytokines acts as negative regulators of melanogenesis. Another is that melanocytes in hair follicles are activated through inflammatory mediators. Of the patients with hair repigmentation in the study, only one, who was being treated with nivolumab for lung squamous cell carcinoma, had disease progression. This patient was discontinued after four treatment sessions and died. The other 13 patients saw either stable disease or a partial response.

The study received no outside funding, but two investigators disclosed financial relationships with pharmaceutical manufacturers.

 

While attending CHEST 2017 from October 28 to November 1, your days will be filled with cutting-edge sessions on pulmonary, critical care, and sleep medicine. However, if you take the week and bring your family along, you can have a fun and memorable vacation with the variety of family-friendly activities Toronto has to offer!

Family Escape Room - Loonie for Luck/The Moonshine Mile

Weekly Friday-Sunday

Enter these escape and mystery rooms to solve fun mysteries. Follow the clues, solve the puzzles, open the locks, and beat the clock! Enter the Loonie for Luck room, where you and your group have to recover Canada’s Lucky Loonie hockey puck and return it to Team Canada. Or, enter The Moonshine Mile room, where you play the owner of a race horse and must find the culprit who poisoned your horse, Hoof Hearted. You have 60 minutes, can you solve these mysteries? Special family pricing available.

Royal Ontario Museum - Dinosaur Gallery

Enter a gallery showcasing one of the world’s best dinosaur collections. See the mighty T rex, visit Gordo, the enormous Barosaurus, or stand beside the famous hadrosaur Parasaurolophus.

Ripley’s Aquarium of Canada

Visit the many amazing galleries at Ripley’s Aquarium of Canada, including Canadian Waters, Dangerous Lagoon, Discovery Center, Planet Jellies, the dive shows at Rainbow Reef and Ray Bay, and more! There are many activities and programs you and your kids will love.

Toronto’s Ultimate Chocolate Tour

Weekly, Saturdays

1:00 PM - 4:00 PM

If you consider yourself a chocolate lover, you must go on the only chocolate tour in Toronto that divulges the art of chocolate tasting and samples chocolate from bean to bar. Enjoy chocolates and chocolatey sweets while learning more about chocolate from chocolatiers and store owners. There will even be an exclusive demonstration of chocolate making by an award-winning chocolatier!

Ontario Science Centre

An iconic cultural attraction and Toronto’s only children’s museum, the Ontario Science Centre is home to interactive and engaging experiences with science and technology. KidSpark is the extremely popular hall designed for children under eight to learn, explore and create with their caregivers. Check out exhibits like In Space with a state-of-the-art planetarium, The AstraZeneca Human Edge, A Question of Truth, Living Earth that includes a simulated tornado and a full rainforest environment, and the Science Arcade. You can also see a film at Ontario’s only IMAX® Dome theatre!

Don’t forget to make your trip to Toronto for CHEST 2017 this October where not just you, but your entire family, can have a great time! Register today at chestmeeting.chestnet.org.

 

While attending CHEST 2017 from October 28 to November 1, your days will be filled with cutting-edge sessions on pulmonary, critical care, and sleep medicine. However, if you take the week and bring your family along, you can have a fun and memorable vacation with the variety of family-friendly activities Toronto has to offer!

Family Escape Room - Loonie for Luck/The Moonshine Mile

Weekly Friday-Sunday

Enter these escape and mystery rooms to solve fun mysteries. Follow the clues, solve the puzzles, open the locks, and beat the clock! Enter the Loonie for Luck room, where you and your group have to recover Canada’s Lucky Loonie hockey puck and return it to Team Canada. Or, enter The Moonshine Mile room, where you play the owner of a race horse and must find the culprit who poisoned your horse, Hoof Hearted. You have 60 minutes, can you solve these mysteries? Special family pricing available.

Royal Ontario Museum - Dinosaur Gallery

Enter a gallery showcasing one of the world’s best dinosaur collections. See the mighty T rex, visit Gordo, the enormous Barosaurus, or stand beside the famous hadrosaur Parasaurolophus.

Ripley’s Aquarium of Canada

Visit the many amazing galleries at Ripley’s Aquarium of Canada, including Canadian Waters, Dangerous Lagoon, Discovery Center, Planet Jellies, the dive shows at Rainbow Reef and Ray Bay, and more! There are many activities and programs you and your kids will love.

Toronto’s Ultimate Chocolate Tour

Weekly, Saturdays

1:00 PM - 4:00 PM

If you consider yourself a chocolate lover, you must go on the only chocolate tour in Toronto that divulges the art of chocolate tasting and samples chocolate from bean to bar. Enjoy chocolates and chocolatey sweets while learning more about chocolate from chocolatiers and store owners. There will even be an exclusive demonstration of chocolate making by an award-winning chocolatier!

Ontario Science Centre

An iconic cultural attraction and Toronto’s only children’s museum, the Ontario Science Centre is home to interactive and engaging experiences with science and technology. KidSpark is the extremely popular hall designed for children under eight to learn, explore and create with their caregivers. Check out exhibits like In Space with a state-of-the-art planetarium, The AstraZeneca Human Edge, A Question of Truth, Living Earth that includes a simulated tornado and a full rainforest environment, and the Science Arcade. You can also see a film at Ontario’s only IMAX® Dome theatre!

Don’t forget to make your trip to Toronto for CHEST 2017 this October where not just you, but your entire family, can have a great time! Register today at chestmeeting.chestnet.org.

 

While attending CHEST 2017 from October 28 to November 1, your days will be filled with cutting-edge sessions on pulmonary, critical care, and sleep medicine. However, if you take the week and bring your family along, you can have a fun and memorable vacation with the variety of family-friendly activities Toronto has to offer!

Family Escape Room - Loonie for Luck/The Moonshine Mile

Weekly Friday-Sunday

Enter these escape and mystery rooms to solve fun mysteries. Follow the clues, solve the puzzles, open the locks, and beat the clock! Enter the Loonie for Luck room, where you and your group have to recover Canada’s Lucky Loonie hockey puck and return it to Team Canada. Or, enter The Moonshine Mile room, where you play the owner of a race horse and must find the culprit who poisoned your horse, Hoof Hearted. You have 60 minutes, can you solve these mysteries? Special family pricing available.

Royal Ontario Museum - Dinosaur Gallery

Enter a gallery showcasing one of the world’s best dinosaur collections. See the mighty T rex, visit Gordo, the enormous Barosaurus, or stand beside the famous hadrosaur Parasaurolophus.

Ripley’s Aquarium of Canada

Visit the many amazing galleries at Ripley’s Aquarium of Canada, including Canadian Waters, Dangerous Lagoon, Discovery Center, Planet Jellies, the dive shows at Rainbow Reef and Ray Bay, and more! There are many activities and programs you and your kids will love.

Toronto’s Ultimate Chocolate Tour

Weekly, Saturdays

1:00 PM - 4:00 PM

If you consider yourself a chocolate lover, you must go on the only chocolate tour in Toronto that divulges the art of chocolate tasting and samples chocolate from bean to bar. Enjoy chocolates and chocolatey sweets while learning more about chocolate from chocolatiers and store owners. There will even be an exclusive demonstration of chocolate making by an award-winning chocolatier!

Ontario Science Centre

An iconic cultural attraction and Toronto’s only children’s museum, the Ontario Science Centre is home to interactive and engaging experiences with science and technology. KidSpark is the extremely popular hall designed for children under eight to learn, explore and create with their caregivers. Check out exhibits like In Space with a state-of-the-art planetarium, The AstraZeneca Human Edge, A Question of Truth, Living Earth that includes a simulated tornado and a full rainforest environment, and the Science Arcade. You can also see a film at Ontario’s only IMAX® Dome theatre!

Don’t forget to make your trip to Toronto for CHEST 2017 this October where not just you, but your entire family, can have a great time! Register today at chestmeeting.chestnet.org.

 

Oxygen therapy in patients with COPD with moderate desaturation

Two landmark trials from the early 1980s demonstrated survival benefit with long-term oxygen therapy (LTOT) in patients with COPD with severe resting hypoxemia [Sao₂ less than 89%; (Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93[3]:391) or Pao₂ 40-60 mm Hg and cor pulmonale (Report of the Medical Research Council Working Party. Lancet. 1981;1[8222]:681).

The potential benefits of LTOT in COPD with mild-moderate hypoxemia have not been clearly established. The LOTT trial (The Long-Term Oxygen Treatment Trial Research Group. N Engl J Med. 2016;375[17]:1617), a recent multicenter randomized study, attempted to answer this question. They studied 738 stable patients with COPD with mild to moderate resting desaturation (Spo₂ 89%-93%) or exercise-induced moderate desaturation (Spo₂ greater than or equal to 80% for greater than or equal to 5 minutes and Spo₂ less than 90% for greater than or equal to 10 seconds during 6- minute walk test). After a median follow-up of 18.4 months, LTOT did not demonstrate a decrease in the time to death or first hospitalization and did not show improvement in quality of life or functional status. Notable adverse events from oxygen included 23 instances of tripping over equipment, with two patients requiring hospitalization and six fires with one patient hospitalized for burns.

A Cochrane meta-analysis, which did not include LOTT data, revealed that oxygen relieved breathlessness during acute exercise in mildly-moderately hypoxemic patients with COPD, but there was insufficient evidence of benefit in daily life or in health-related quality of life (Cochrane Database Syst Rev. 2016;11:CD006429).

Whether or not to continue prescribing oxygen to patients with moderate desaturation remains a controversial issue. A trial of oxygen may be warranted in those who are already on maximal evidence-based therapy for COPD and still complain of severe breathlessness (Ekstrom M; N Engl J Med. 2016;375[17]:1683). Conversely, a patient with COPD and moderate desaturation who resists being placed on supplemental oxygen, can be reassured that this is a reasonable course based on current evidence (Baliksoon R. COPD. 2017;4:71).

Navitha Ramesh, MD, MBBS

Fellow-in-Training Steering Committee Member

Allen Blaivas, DO, FCCP

Steering Committee Member

Informed consent: Do we need to change our practice?

Informed consent is the keystone of clinical research and helps respect and protect the rights of the participants/subjects. While the informed consent process has been standardized, some challenges still remain, such as pieces of information that should be disclosed, how to disclose information and document understanding of participants, and how detailed that disclosure should be (Grady C. N Engl J Med. 2015;372[9]:855). Digital technology can and has been used to improve the process of obtaining informed consent. Smartphones now comprise 75% of all mobile phones sold worldwide. They are being used to reach a larger and diverse population to conduct trials.

Substituting long and complex written forms with electronic consent (e-consent), however, has issues. Few people read through online agreements before clicking “agree,” which may lead to participants consenting without a clear understanding of what they are consenting to. On the other hand, it is also possible to use e-consent to improve comprehension by including videos and graphics. Interactive quizzes can assess the understanding of the participants, and embedded links to audios or videos can further enhance the grasp of information. With e-consents, queries from participants can be answered via phone call or email, etc. When e-consent is obtained remotely, the identity can be confirmed by electronic signatures, username, password, or biometrics.

E-consent has advantages, can be done remotely, no paper is needed, etc. It has potential disadvantages like being costly, videos can add time to the process, and multicenter international trials can be difficult (Grady C, et al. N Engl J Med. 2017;376[20]:e43). Studying e-consents to identify gaps in communication between the researcher and the participant in the digitalized world may help improve the process and allow research to proceed with better understanding of the risks and benefits of involvement in clinical research.

Moshsin Ijaz, MD, FCCP

Steering Committee Member

Early ID and treatment in sepsis

PRISM, the latest meta-analysis of three multicenter trials (ProCESS, ARISE, and ProMISe) found no difference in mortality with early goal-directed therapy vs usual care (N Engl J Med. 2017; 376[23]:2223). These clinical trials promoted early recognition of sepsis and prompt delivery of IV fluids and antimicrobial agents before randomization. It seems that early identification and treatment of sepsis and the rapid administration of antibiotics (following the timing recommended for sepsis bundle protocols) are the most effective interventions in sepsis (Seymour WS, et al. N Engl J Med. 2017;376[23]:2235). Other interventions over the past decade designed to reduce mortality associated with sepsis have been unsuccessful.

 

However, the recent results of a retrospective before-after clinical study in patients with severe sepsis or septic shock and a procalcitonin greater than 2 ng/mL are encouraging. It suggests that the early use of IV vitamin C, hydrocortisone, and thiamine may reduce mortality and prevent progressive organ dysfunction when compared with matched historical control subjects (Marik PE, et al. Chest. 2017;151[6]:1229). Although vitamin C and thiamine have been reported to be low in critically ill patients, their use in patients with sepsis without deficiency is unclear. In addition, the use of steroids in sepsis has been controversial. A synergistic or overlapping effect of the three agents is a possible explanation. The authors argue that the safety of this combined therapy and potential benefit justifies its implementation pending the confirmation of this single-center study. What is clear is that these encouraging results deserve further study in clinical trials.

Maximiliano Tamae Kakazu, MD, FCCP

Steering Committee Member

The changing landscape of home mechanical ventilation

The greatest advances in home mechanical ventilation for conditions associated with chronic respiratory failure have been associated with the implementation of noninvasivepositive pressure ventilation (NIPPV) via mask interface. This dynamic growth is accredited to NIPPV efficacy and technologic improvements in ventilator and mask. For neuromuscular and restrictive thoracic diseases, NIPPV has been shown to increase survival, decrease hospital admissions, and improve quality of life (Chatwin A, et al. Plos One. 2015;10[5]:e0125839; Annane D, et al. Cochrane Database Syst Rev. 2014;13[12]:CD001941). From this success, NIPPV has been extended to conditions associated with respiratory impairment (eg, COPD, obesity hypoventilation, sleep-disordered breathing). A recent randomized study comparing home oxygen therapy (HOT) plus NIPPV vs HOT alone in post-hospitalized patients with COPD with persistent hypercapnia showed that addition of NIPPV significantly prolonged time to readmission or death from 1.4 to 4.3 months (Murphy P, et al. JAMA. 2017;317[21]:2177). Overall, however, evidence to support NIPPV in these groups is less compelling.

NIPPV is available in both ventilator and respiratory assist device (RAD) models. In addition to delivering basic to complex modes, advantages of a ventilator include portability and option of daytime use with mouth piece ventilation. This creates potential for abuse whereby a supplier could bill for a portable ventilator when an RAD at lower cost would suffice. Monthly rental fee for an RAD ($107-$464) is capped at 13 months, whereas ventilator comes with uncapped rental ($660-$1352) [US Dept HHS, OIG Data Brief 2016, OEI-12-15-00370]. Billing claims for ventilator have shifted from neuromuscular disease to chronic respiratory failure (eg, COPD). Ventilator claims for neuromuscular disease have decreased from 56% in 2009 to 7% in 2015, whereas claims for chronic respiratory failure have increased from 29% in 2009 to 85% in 2015. The substantial increase in claims have no doubt increased burden on health-care systems and resulted in reimbursement cuts.

Current CMS guidelines defer to the provider’s clinical judgment regarding the severity of patient’s respiratory condition and if a ventilator or RAD would be most appropriate. It is important to recognize the proper patient (and setting) who would benefit from advanced respiratory support. The choice of ventilator should be reserved for severe or progressive respiratory impairment, specifically for patients who would benefit from daytime use, and for whom interruption of respiratory support would lead to serious consequences.

Michelle Cao, DO, FCCP

Steering Committee Member

Improving diagnostic capabilities in diffuse parenchymal lung disease

With the approval of two antifibrotic drugs for the treatment of idiopathic pulmonary fibrosis, there has been renewed focus in the NetWork in improving diagnosis in interstitial lung disease. There is considerable interest in exploring novel techniques and paradigms in the classification and diagnosis of diffuse parenchymal lung diseases (DPLDs). Given the invasive nature of surgical lung biopsy and its associated morbidity in elderly patients, there is a need for safer techniques to obtain lung tissue for histopathologic analysis. Transbronchial cryobiopsy may be a safe and accurate alternative for obtaining lung tissue, and we hope to better understand the role of this procedure in disease diagnosis. It is also possible that in the future, we may be able to classify these diseases without having to obtain lung tissue. More studies are being done in novel imaging techniques, such as molecular imaging, optical coherence tomography, and confocal laser endomicroscopy, that may negate the need for lung tissue in the future. Biomarker discovery and identification of biomarker signatures that can help differentiate DPLDs and provide prognostic information are also a particular focus and of importance for our NetWork. With this increased focus on better diagnostic techniques for classification of DPLD, the NetWork is featuring a lecture at CHEST 2017 on “Molecular Endotyping of Pulmonary Fibrosis,” and two sessions that will explore the current diagnostic difficulties that confront clinicians. As we move forward in our understanding of how to classify and diagnose interstitial lung disease, there is potential for more targeted interventions in individual patients.

 

Tracy Luckhardt, MD

Steering Committee Member

 

Oxygen therapy in patients with COPD with moderate desaturation

Two landmark trials from the early 1980s demonstrated survival benefit with long-term oxygen therapy (LTOT) in patients with COPD with severe resting hypoxemia [Sao₂ less than 89%; (Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93[3]:391) or Pao₂ 40-60 mm Hg and cor pulmonale (Report of the Medical Research Council Working Party. Lancet. 1981;1[8222]:681).

The potential benefits of LTOT in COPD with mild-moderate hypoxemia have not been clearly established. The LOTT trial (The Long-Term Oxygen Treatment Trial Research Group. N Engl J Med. 2016;375[17]:1617), a recent multicenter randomized study, attempted to answer this question. They studied 738 stable patients with COPD with mild to moderate resting desaturation (Spo₂ 89%-93%) or exercise-induced moderate desaturation (Spo₂ greater than or equal to 80% for greater than or equal to 5 minutes and Spo₂ less than 90% for greater than or equal to 10 seconds during 6- minute walk test). After a median follow-up of 18.4 months, LTOT did not demonstrate a decrease in the time to death or first hospitalization and did not show improvement in quality of life or functional status. Notable adverse events from oxygen included 23 instances of tripping over equipment, with two patients requiring hospitalization and six fires with one patient hospitalized for burns.

A Cochrane meta-analysis, which did not include LOTT data, revealed that oxygen relieved breathlessness during acute exercise in mildly-moderately hypoxemic patients with COPD, but there was insufficient evidence of benefit in daily life or in health-related quality of life (Cochrane Database Syst Rev. 2016;11:CD006429).

Whether or not to continue prescribing oxygen to patients with moderate desaturation remains a controversial issue. A trial of oxygen may be warranted in those who are already on maximal evidence-based therapy for COPD and still complain of severe breathlessness (Ekstrom M; N Engl J Med. 2016;375[17]:1683). Conversely, a patient with COPD and moderate desaturation who resists being placed on supplemental oxygen, can be reassured that this is a reasonable course based on current evidence (Baliksoon R. COPD. 2017;4:71).

Navitha Ramesh, MD, MBBS

Fellow-in-Training Steering Committee Member

Allen Blaivas, DO, FCCP

Steering Committee Member

Informed consent: Do we need to change our practice?

Informed consent is the keystone of clinical research and helps respect and protect the rights of the participants/subjects. While the informed consent process has been standardized, some challenges still remain, such as pieces of information that should be disclosed, how to disclose information and document understanding of participants, and how detailed that disclosure should be (Grady C. N Engl J Med. 2015;372[9]:855). Digital technology can and has been used to improve the process of obtaining informed consent. Smartphones now comprise 75% of all mobile phones sold worldwide. They are being used to reach a larger and diverse population to conduct trials.

Substituting long and complex written forms with electronic consent (e-consent), however, has issues. Few people read through online agreements before clicking “agree,” which may lead to participants consenting without a clear understanding of what they are consenting to. On the other hand, it is also possible to use e-consent to improve comprehension by including videos and graphics. Interactive quizzes can assess the understanding of the participants, and embedded links to audios or videos can further enhance the grasp of information. With e-consents, queries from participants can be answered via phone call or email, etc. When e-consent is obtained remotely, the identity can be confirmed by electronic signatures, username, password, or biometrics.

E-consent has advantages, can be done remotely, no paper is needed, etc. It has potential disadvantages like being costly, videos can add time to the process, and multicenter international trials can be difficult (Grady C, et al. N Engl J Med. 2017;376[20]:e43). Studying e-consents to identify gaps in communication between the researcher and the participant in the digitalized world may help improve the process and allow research to proceed with better understanding of the risks and benefits of involvement in clinical research.

Moshsin Ijaz, MD, FCCP

Steering Committee Member

Early ID and treatment in sepsis

PRISM, the latest meta-analysis of three multicenter trials (ProCESS, ARISE, and ProMISe) found no difference in mortality with early goal-directed therapy vs usual care (N Engl J Med. 2017; 376[23]:2223). These clinical trials promoted early recognition of sepsis and prompt delivery of IV fluids and antimicrobial agents before randomization. It seems that early identification and treatment of sepsis and the rapid administration of antibiotics (following the timing recommended for sepsis bundle protocols) are the most effective interventions in sepsis (Seymour WS, et al. N Engl J Med. 2017;376[23]:2235). Other interventions over the past decade designed to reduce mortality associated with sepsis have been unsuccessful.

 

However, the recent results of a retrospective before-after clinical study in patients with severe sepsis or septic shock and a procalcitonin greater than 2 ng/mL are encouraging. It suggests that the early use of IV vitamin C, hydrocortisone, and thiamine may reduce mortality and prevent progressive organ dysfunction when compared with matched historical control subjects (Marik PE, et al. Chest. 2017;151[6]:1229). Although vitamin C and thiamine have been reported to be low in critically ill patients, their use in patients with sepsis without deficiency is unclear. In addition, the use of steroids in sepsis has been controversial. A synergistic or overlapping effect of the three agents is a possible explanation. The authors argue that the safety of this combined therapy and potential benefit justifies its implementation pending the confirmation of this single-center study. What is clear is that these encouraging results deserve further study in clinical trials.

Maximiliano Tamae Kakazu, MD, FCCP

Steering Committee Member

The changing landscape of home mechanical ventilation

The greatest advances in home mechanical ventilation for conditions associated with chronic respiratory failure have been associated with the implementation of noninvasivepositive pressure ventilation (NIPPV) via mask interface. This dynamic growth is accredited to NIPPV efficacy and technologic improvements in ventilator and mask. For neuromuscular and restrictive thoracic diseases, NIPPV has been shown to increase survival, decrease hospital admissions, and improve quality of life (Chatwin A, et al. Plos One. 2015;10[5]:e0125839; Annane D, et al. Cochrane Database Syst Rev. 2014;13[12]:CD001941). From this success, NIPPV has been extended to conditions associated with respiratory impairment (eg, COPD, obesity hypoventilation, sleep-disordered breathing). A recent randomized study comparing home oxygen therapy (HOT) plus NIPPV vs HOT alone in post-hospitalized patients with COPD with persistent hypercapnia showed that addition of NIPPV significantly prolonged time to readmission or death from 1.4 to 4.3 months (Murphy P, et al. JAMA. 2017;317[21]:2177). Overall, however, evidence to support NIPPV in these groups is less compelling.

NIPPV is available in both ventilator and respiratory assist device (RAD) models. In addition to delivering basic to complex modes, advantages of a ventilator include portability and option of daytime use with mouth piece ventilation. This creates potential for abuse whereby a supplier could bill for a portable ventilator when an RAD at lower cost would suffice. Monthly rental fee for an RAD ($107-$464) is capped at 13 months, whereas ventilator comes with uncapped rental ($660-$1352) [US Dept HHS, OIG Data Brief 2016, OEI-12-15-00370]. Billing claims for ventilator have shifted from neuromuscular disease to chronic respiratory failure (eg, COPD). Ventilator claims for neuromuscular disease have decreased from 56% in 2009 to 7% in 2015, whereas claims for chronic respiratory failure have increased from 29% in 2009 to 85% in 2015. The substantial increase in claims have no doubt increased burden on health-care systems and resulted in reimbursement cuts.

Current CMS guidelines defer to the provider’s clinical judgment regarding the severity of patient’s respiratory condition and if a ventilator or RAD would be most appropriate. It is important to recognize the proper patient (and setting) who would benefit from advanced respiratory support. The choice of ventilator should be reserved for severe or progressive respiratory impairment, specifically for patients who would benefit from daytime use, and for whom interruption of respiratory support would lead to serious consequences.

Michelle Cao, DO, FCCP

Steering Committee Member

Improving diagnostic capabilities in diffuse parenchymal lung disease

With the approval of two antifibrotic drugs for the treatment of idiopathic pulmonary fibrosis, there has been renewed focus in the NetWork in improving diagnosis in interstitial lung disease. There is considerable interest in exploring novel techniques and paradigms in the classification and diagnosis of diffuse parenchymal lung diseases (DPLDs). Given the invasive nature of surgical lung biopsy and its associated morbidity in elderly patients, there is a need for safer techniques to obtain lung tissue for histopathologic analysis. Transbronchial cryobiopsy may be a safe and accurate alternative for obtaining lung tissue, and we hope to better understand the role of this procedure in disease diagnosis. It is also possible that in the future, we may be able to classify these diseases without having to obtain lung tissue. More studies are being done in novel imaging techniques, such as molecular imaging, optical coherence tomography, and confocal laser endomicroscopy, that may negate the need for lung tissue in the future. Biomarker discovery and identification of biomarker signatures that can help differentiate DPLDs and provide prognostic information are also a particular focus and of importance for our NetWork. With this increased focus on better diagnostic techniques for classification of DPLD, the NetWork is featuring a lecture at CHEST 2017 on “Molecular Endotyping of Pulmonary Fibrosis,” and two sessions that will explore the current diagnostic difficulties that confront clinicians. As we move forward in our understanding of how to classify and diagnose interstitial lung disease, there is potential for more targeted interventions in individual patients.

 

Tracy Luckhardt, MD

Steering Committee Member

 

Oxygen therapy in patients with COPD with moderate desaturation

Two landmark trials from the early 1980s demonstrated survival benefit with long-term oxygen therapy (LTOT) in patients with COPD with severe resting hypoxemia [Sao₂ less than 89%; (Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93[3]:391) or Pao₂ 40-60 mm Hg and cor pulmonale (Report of the Medical Research Council Working Party. Lancet. 1981;1[8222]:681).

The potential benefits of LTOT in COPD with mild-moderate hypoxemia have not been clearly established. The LOTT trial (The Long-Term Oxygen Treatment Trial Research Group. N Engl J Med. 2016;375[17]:1617), a recent multicenter randomized study, attempted to answer this question. They studied 738 stable patients with COPD with mild to moderate resting desaturation (Spo₂ 89%-93%) or exercise-induced moderate desaturation (Spo₂ greater than or equal to 80% for greater than or equal to 5 minutes and Spo₂ less than 90% for greater than or equal to 10 seconds during 6- minute walk test). After a median follow-up of 18.4 months, LTOT did not demonstrate a decrease in the time to death or first hospitalization and did not show improvement in quality of life or functional status. Notable adverse events from oxygen included 23 instances of tripping over equipment, with two patients requiring hospitalization and six fires with one patient hospitalized for burns.

A Cochrane meta-analysis, which did not include LOTT data, revealed that oxygen relieved breathlessness during acute exercise in mildly-moderately hypoxemic patients with COPD, but there was insufficient evidence of benefit in daily life or in health-related quality of life (Cochrane Database Syst Rev. 2016;11:CD006429).

Whether or not to continue prescribing oxygen to patients with moderate desaturation remains a controversial issue. A trial of oxygen may be warranted in those who are already on maximal evidence-based therapy for COPD and still complain of severe breathlessness (Ekstrom M; N Engl J Med. 2016;375[17]:1683). Conversely, a patient with COPD and moderate desaturation who resists being placed on supplemental oxygen, can be reassured that this is a reasonable course based on current evidence (Baliksoon R. COPD. 2017;4:71).

Navitha Ramesh, MD, MBBS

Fellow-in-Training Steering Committee Member

Allen Blaivas, DO, FCCP

Steering Committee Member

Informed consent: Do we need to change our practice?

Informed consent is the keystone of clinical research and helps respect and protect the rights of the participants/subjects. While the informed consent process has been standardized, some challenges still remain, such as pieces of information that should be disclosed, how to disclose information and document understanding of participants, and how detailed that disclosure should be (Grady C. N Engl J Med. 2015;372[9]:855). Digital technology can and has been used to improve the process of obtaining informed consent. Smartphones now comprise 75% of all mobile phones sold worldwide. They are being used to reach a larger and diverse population to conduct trials.

Substituting long and complex written forms with electronic consent (e-consent), however, has issues. Few people read through online agreements before clicking “agree,” which may lead to participants consenting without a clear understanding of what they are consenting to. On the other hand, it is also possible to use e-consent to improve comprehension by including videos and graphics. Interactive quizzes can assess the understanding of the participants, and embedded links to audios or videos can further enhance the grasp of information. With e-consents, queries from participants can be answered via phone call or email, etc. When e-consent is obtained remotely, the identity can be confirmed by electronic signatures, username, password, or biometrics.

E-consent has advantages, can be done remotely, no paper is needed, etc. It has potential disadvantages like being costly, videos can add time to the process, and multicenter international trials can be difficult (Grady C, et al. N Engl J Med. 2017;376[20]:e43). Studying e-consents to identify gaps in communication between the researcher and the participant in the digitalized world may help improve the process and allow research to proceed with better understanding of the risks and benefits of involvement in clinical research.

Moshsin Ijaz, MD, FCCP

Steering Committee Member

Early ID and treatment in sepsis

PRISM, the latest meta-analysis of three multicenter trials (ProCESS, ARISE, and ProMISe) found no difference in mortality with early goal-directed therapy vs usual care (N Engl J Med. 2017; 376[23]:2223). These clinical trials promoted early recognition of sepsis and prompt delivery of IV fluids and antimicrobial agents before randomization. It seems that early identification and treatment of sepsis and the rapid administration of antibiotics (following the timing recommended for sepsis bundle protocols) are the most effective interventions in sepsis (Seymour WS, et al. N Engl J Med. 2017;376[23]:2235). Other interventions over the past decade designed to reduce mortality associated with sepsis have been unsuccessful.

 

However, the recent results of a retrospective before-after clinical study in patients with severe sepsis or septic shock and a procalcitonin greater than 2 ng/mL are encouraging. It suggests that the early use of IV vitamin C, hydrocortisone, and thiamine may reduce mortality and prevent progressive organ dysfunction when compared with matched historical control subjects (Marik PE, et al. Chest. 2017;151[6]:1229). Although vitamin C and thiamine have been reported to be low in critically ill patients, their use in patients with sepsis without deficiency is unclear. In addition, the use of steroids in sepsis has been controversial. A synergistic or overlapping effect of the three agents is a possible explanation. The authors argue that the safety of this combined therapy and potential benefit justifies its implementation pending the confirmation of this single-center study. What is clear is that these encouraging results deserve further study in clinical trials.

Maximiliano Tamae Kakazu, MD, FCCP

Steering Committee Member

The changing landscape of home mechanical ventilation

The greatest advances in home mechanical ventilation for conditions associated with chronic respiratory failure have been associated with the implementation of noninvasivepositive pressure ventilation (NIPPV) via mask interface. This dynamic growth is accredited to NIPPV efficacy and technologic improvements in ventilator and mask. For neuromuscular and restrictive thoracic diseases, NIPPV has been shown to increase survival, decrease hospital admissions, and improve quality of life (Chatwin A, et al. Plos One. 2015;10[5]:e0125839; Annane D, et al. Cochrane Database Syst Rev. 2014;13[12]:CD001941). From this success, NIPPV has been extended to conditions associated with respiratory impairment (eg, COPD, obesity hypoventilation, sleep-disordered breathing). A recent randomized study comparing home oxygen therapy (HOT) plus NIPPV vs HOT alone in post-hospitalized patients with COPD with persistent hypercapnia showed that addition of NIPPV significantly prolonged time to readmission or death from 1.4 to 4.3 months (Murphy P, et al. JAMA. 2017;317[21]:2177). Overall, however, evidence to support NIPPV in these groups is less compelling.

NIPPV is available in both ventilator and respiratory assist device (RAD) models. In addition to delivering basic to complex modes, advantages of a ventilator include portability and option of daytime use with mouth piece ventilation. This creates potential for abuse whereby a supplier could bill for a portable ventilator when an RAD at lower cost would suffice. Monthly rental fee for an RAD ($107-$464) is capped at 13 months, whereas ventilator comes with uncapped rental ($660-$1352) [US Dept HHS, OIG Data Brief 2016, OEI-12-15-00370]. Billing claims for ventilator have shifted from neuromuscular disease to chronic respiratory failure (eg, COPD). Ventilator claims for neuromuscular disease have decreased from 56% in 2009 to 7% in 2015, whereas claims for chronic respiratory failure have increased from 29% in 2009 to 85% in 2015. The substantial increase in claims have no doubt increased burden on health-care systems and resulted in reimbursement cuts.

Current CMS guidelines defer to the provider’s clinical judgment regarding the severity of patient’s respiratory condition and if a ventilator or RAD would be most appropriate. It is important to recognize the proper patient (and setting) who would benefit from advanced respiratory support. The choice of ventilator should be reserved for severe or progressive respiratory impairment, specifically for patients who would benefit from daytime use, and for whom interruption of respiratory support would lead to serious consequences.

Michelle Cao, DO, FCCP

Steering Committee Member

Improving diagnostic capabilities in diffuse parenchymal lung disease

With the approval of two antifibrotic drugs for the treatment of idiopathic pulmonary fibrosis, there has been renewed focus in the NetWork in improving diagnosis in interstitial lung disease. There is considerable interest in exploring novel techniques and paradigms in the classification and diagnosis of diffuse parenchymal lung diseases (DPLDs). Given the invasive nature of surgical lung biopsy and its associated morbidity in elderly patients, there is a need for safer techniques to obtain lung tissue for histopathologic analysis. Transbronchial cryobiopsy may be a safe and accurate alternative for obtaining lung tissue, and we hope to better understand the role of this procedure in disease diagnosis. It is also possible that in the future, we may be able to classify these diseases without having to obtain lung tissue. More studies are being done in novel imaging techniques, such as molecular imaging, optical coherence tomography, and confocal laser endomicroscopy, that may negate the need for lung tissue in the future. Biomarker discovery and identification of biomarker signatures that can help differentiate DPLDs and provide prognostic information are also a particular focus and of importance for our NetWork. With this increased focus on better diagnostic techniques for classification of DPLD, the NetWork is featuring a lecture at CHEST 2017 on “Molecular Endotyping of Pulmonary Fibrosis,” and two sessions that will explore the current diagnostic difficulties that confront clinicians. As we move forward in our understanding of how to classify and diagnose interstitial lung disease, there is potential for more targeted interventions in individual patients.

 

Tracy Luckhardt, MD

Steering Committee Member