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Review finds diverse outcomes in clinical trials of rosacea
according to authors of a new systematic review of rosacea treatment studies.
“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”
In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.
The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.
A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).
Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.
“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”
She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.
“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”
This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”
Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
according to authors of a new systematic review of rosacea treatment studies.
“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”
In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.
The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.
A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).
Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.
“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”
She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.
“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”
This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”
Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
according to authors of a new systematic review of rosacea treatment studies.
“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”
In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.
The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.
A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).
Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.
“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”
She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.
“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”
This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”
Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
FROM ASLMS 2021
FDA fast tracks testing of schizophrenia drug for impaired cognition
The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.
The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.
In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.
Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.
“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.
The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.
The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.
The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.
The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.
“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.
The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.
In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.
Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.
“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.
The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.
The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.
The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.
The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.
“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.
The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.
In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.
Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.
“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.
The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.
The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.
The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.
The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.
“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.
A version of this article first appeared on Medscape.com.
Study finds little impact of private equity on dermatology practices
A new 
The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”
Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.
But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”
Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”
“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.
Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.
In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.
In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.
Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.
“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”
Modest price increases
The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.
They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.
They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.
The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).
Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.
Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.
Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.
PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.
The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.
Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.
He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”
Not benign players
Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.
The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.
He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.
“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”
Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
A new
The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”
Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.
But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”
Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”
“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.
Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.
In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.
In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.
Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.
“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”
Modest price increases
The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.
They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.
They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.
The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).
Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.
Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.
Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.
PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.
The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.
Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.
He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”
Not benign players
Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.
The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.
He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.
“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”
Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
A new
The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”
Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.
But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”
Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”
“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.
Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.
In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.
In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.
Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.
“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”
Modest price increases
The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.
They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.
They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.
The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).
Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.
Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.
Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.
PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.
The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.
Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.
He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”
Not benign players
Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.
The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.
He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.
“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”
Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
FROM HEALTH AFFAIRS
Clean indoor air is vital for infection control
Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.
Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.
Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.
“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.
But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.
A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.
Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
Monitors show carbon dioxide levels
But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.
Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.
It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.
However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.
“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.
“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
Bigger is not always better
It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.
“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”
And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.
The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.
In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.
Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.
Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.
More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
Hydrating indoor air
Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.
Air hydration is the most important aspect to target, she said.
Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.
Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.
“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.
In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.
But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.
In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.
“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.
No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
New research targets indoor air
Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.
“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.
In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.
One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.
Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.
So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?
“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
A version of this article first appeared on Medscape.com.
Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.
Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.
Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.
“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.
But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.
A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.
Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
Monitors show carbon dioxide levels
But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.
Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.
It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.
However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.
“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.
“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
Bigger is not always better
It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.
“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”
And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.
The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.
In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.
Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.
Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.
More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
Hydrating indoor air
Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.
Air hydration is the most important aspect to target, she said.
Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.
Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.
“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.
In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.
But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.
In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.
“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.
No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
New research targets indoor air
Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.
“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.
In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.
One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.
Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.
So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?
“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
A version of this article first appeared on Medscape.com.
Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.
Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.
Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.
“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.
But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.
A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.
Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
Monitors show carbon dioxide levels
But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.
Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.
It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.
However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.
“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.
“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
Bigger is not always better
It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.
“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”
And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.
The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.
In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.
Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.
Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.
More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
Hydrating indoor air
Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.
Air hydration is the most important aspect to target, she said.
Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.
Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.
“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.
In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.
But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.
In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.
“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.
No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
New research targets indoor air
Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.
“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.
In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.
One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.
Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.
So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?
“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
A version of this article first appeared on Medscape.com.
Intervention reduces PPI use without worsening acid-related diseases
Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.
After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.
“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”
In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.
The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.
The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).
The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.
In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.
“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
Debate around ‘unnecessary PPI use’
According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”
Yet this latter element – appropriate indication – drives an ongoing debate.
“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”
Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.
“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”
The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.
Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.
After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.
“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”
In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.
The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.
The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).
The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.
In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.
“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
Debate around ‘unnecessary PPI use’
According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”
Yet this latter element – appropriate indication – drives an ongoing debate.
“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”
Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.
“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”
The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.
Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.
After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.
“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”
In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.
The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.
The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).
The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.
In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.
“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
Debate around ‘unnecessary PPI use’
According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”
Yet this latter element – appropriate indication – drives an ongoing debate.
“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”
Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.
“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”
The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.
FROM DDW 2021
More and more doctors abandoning private practice
according to a new report.
These patterns likely reflect broader trends toward consolidation in health care, with both insurance companies and hospitals also having grown in size in recent years.
The latest biennial analysis of doctors’ practices by the American Medical Association showed an acceleration of a trend away from private practice, defined as a practice wholly owned by physicians. The 2020 results found less than half – 49.1 % – of doctors involved in patient care worked in a private practice, the AMA said in a report released in May 2021.
This marked the first time private practice was not the dominant approach since the AMA analysis began in 2012. What’s more, the trend appears to be gaining steam, with a drop of almost 5 percentage points from 54.0% in private practice in 2018. The percent of doctors in private practice declined at a slower rate in previous AMA surveys, slipping to 55.8% in 2016 from 56.8% in 2018 and 60.1% in 2012.
Employment and ownership structures have become so varied that no single approach or size of organization “can or should be considered the typical physician practice,” the report noted.
The AMA, for example, added to its 2020 benchmark survey an option to identify private equity organizations as employers. The survey found 4% of doctors involved in patient care worked in practices owned by these kinds of firms. Other options include practices wholly or jointly owned by hospital and health systems and insurers, as well as direct employment and contracting.
There are signs that the shift away from smaller private practices will continue, with younger doctors appearing more likely to seek employment.
The survey found 42% of doctors ages 55 and older were employed by someone else, compared with 51.2% of doctors ages 40-54 and 70% of physicians under the age of 40.
The AMA surveyed 3,500 U.S. doctors through the 2020 Physician Practice Benchmark Survey. The survey was conducted from September to October 2020, roughly 6 months into the COVID-19 pandemic, and therefore may not reflect its full impact.
“Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time,” AMA President Susan R. Bailey, MD, said in a statement.
In a survey released in 2020 by McKinsey & Company, 53% of independent doctors reported that they were worried about their practices surviving the stresses of the pandemic, this news organization reported.
Challenging environment
It’s not just money leading to the shift away from private practice, according to a 2020 report from the American Hospital Association, titled “Evolving Physician-Practice Ownership Models.”
Many recent graduates of medical schools have significant debt and are more likely to opt for employment, which offers more financial stability and work-life balance, the report said.
Doctors also need to keep up with expectations of their patients that have been shaped by advances in other sectors, like banking, the AHA noted. People are used to working on their own schedules, and want to make appointments through apps, get test results rapidly and on their mobile devices, and communicate with their providers virtually.
“It is challenging to meet these expectations and make the necessary technology investments as a solo or small group practice,” the AHA report said.
Hospitals face competition for doctors from insurers, which have been looking in some cases to directly employ more physicians, the AHA also noted. The report cites insurance giant UnitedHealth Group’s Optum unit as the most visible example of this trend.
On a January call about corporate earnings, David Wichmann, then chief executive of UnitedHealth, spoke about the firm’s “aim to reinvent health care delivery,” including efforts to have its own primary and multispecialty care practices.
“OptumCare entered 2021 with over 50,000 physicians and 1,400 clinics,” Mr. Wichmann said. “Over the course of this year, we expect to grow our employed and affiliated physicians by at least 10,000. This work of building local physician-led systems of care continues to be central to our mission. “
UnitedHealth’s new CEO is Andrew Witty, who had led the Optum unit.
Attractions of larger groups
Older doctors – those 55 years and up – were significantly more likely to work in small practices than those younger than 40, the 2020 survey found. Results showed 40.9% of doctors under 40 worked in practices of 10 or fewer colleagues, compared with 61.4% of those age 55 and older.
The large difference between age groups suggests that attrition is one reason for the shift in practice size. Retiring doctors who leave small practices are not being replaced on a one-for-one basis by younger doctors, AMA said. The same reason also appears to be a factor in the shift in practice ownership to larger systems.
Doctors in larger group practices can count on a stable business model, with a better ability to survive disruptive market trends, including those of a more extreme nature, like COVID-19, said Fred Horton, president of AMGA Consulting.
AMGA Consulting is a wholly-owned subsidiary of AMGA, formerly called American Medical Group Association. Its more than 400 members include well-known multispecialty groups and health care systems such as the Mayo Clinic, Cleveland Clinic, Geisinger, the Permanente Medical Group, and Intermountain Healthcare as well as many smaller physician practices.
Mr. Horton, who holds a master’s degree in health administration, said some doctors may want to participate in alternative payment programs offered by insurers, who are seeking to shift away from the fee-for-service model
“Larger organizations can dedicate more resources to continuous quality improvement,” Mr. Horton said. “This is especially important for physicians who are taking on risk-based contracts, as quality can directly impact how much they earn.”
For one oncologist, it was turning to alternative payment methods that helped him keep his private practice afloat.
Kashyap Patel, MD, chief executive of the Carolina Blood and Cancer Care Associates in Rock Hill, S.C., said he maintained the independence of his practice amid pressure from a large health system, which had been buying medical groups in the area. That began to interfere with referrals of patients from other doctors, which are key for cancer specialists, said Dr. Patel, who also is president of the Community Oncology Alliance.
In response, Dr. Patel worked with Blue Cross Blue Shield of South Carolina on an arrangement where his practice sought certifications from the National Committee for Quality Assurance to get better rates.
The effort has allowed Dr. Patel’s clinic to focus more on preventing hospitalizations and visits to the emergency room he said.
In Dr. Patel’s view, his patients benefit from his efforts to remain in independent practice. A switch to ownership by a large health care organization would have put them at risk for higher medical bills, jeopardizing their access to treatment, he said. The reason? Hospitals can charge more for services provided by doctors they employ.
“Nothing would change. I would be the same. The building would be the same, but the cost would go up,” Dr. Patel said.
For its part, the AHA has repeatedly challenged arguments that acquisitions and mergers result in higher costs for patients.
Instead, the AHA has raised alarms about consolidation of health insurers, a concern it shares with AMA. In a 2020 report examining competition among insurers, AMA noted doctors working in small practices can be put at a disadvantage if mergers and acquisitions leave an insurer with too much market power.
“Under antitrust law, independent physicians cannot negotiate collectively with health
Insurers,” the AMA said in the report. “This imbalance in relative size leaves most physicians with a weak bargaining position relative to commercial payers.”
AMA’s research on the effects of insurers’ wielding significant market clout has been used in effort to thwart mergers in this industry.
‘Dramatic restructuring’
The Federal Trade Commission also has taken note of the trends discussed in the new AMA report, saying that “U.S. physician markets are undergoing a dramatic restructuring.”
The FTC in January announced a study of the impact of the consolidation of doctors groups and health care facilities. FTC is seeking data for inpatient, outpatient, and doctors services in 15 states from 2015 through 2020. To gather this data, the commission has issued orders to six major insurers – Aetna, Anthem, Florida Blue, Cigna, Health Care Service Corporation and United Healthcare.
The FTC is concerned that acquired practices may have to alter their referral patterns to favor their affiliated hospital system over competing hospital systems. But FTC staff also said it might be that these acquisitions result in efficiencies, such as enhanced coordination of care between doctors and hospitals “that outweigh potential competitive harms.”
The research project will likely take several years to complete because of its scope, the FTC said. For that reason, the FTC said its Bureau of Economics will release a series of research papers examining different aspects of this inquiry rather than a single paper containing all of the analyses.
Private equity ‘roll-ups’
On the day the FTC announced the study of the impact of doctors groups, one of the panel’s commissioners argued for a closer look at how private equity firms make their purchases.
In a Jan. 15 tweet, FTC Commissioner Rohit Chopra said his agency needs to challenge their “roll-ups of small physician practices” as well as clinics and labs. This is a practice of using a series of acquisitions too small to trigger the federal threshold for a serious look from the FTC and Department of Justice. (The threshold for 2021 stands around the $92 million mark. This benchmark is known as Hart-Scott-Rodino notification after a 1976 law that set a reporting standard.)
Mr. Chopra attached to his Jan. 15 tweet a 2020 statement in which he called for stepped-up scrutiny of private-equity firms’ acquisitions of doctors’ practices. Mr. Chopra noted that private-equity firms have been buying practices focused on anesthesiology and emergency medicine, fields which triggered consumer complaints about surprise billing for emergency care.
“Given trends in today’s markets, it is critical that the FTC find new ways to ensure the agency has a rigorous, data-driven approach to market monitoring and enforcement,” Mr. Chopra wrote.
A version of this article first appeared on WebMD.com.
according to a new report.
These patterns likely reflect broader trends toward consolidation in health care, with both insurance companies and hospitals also having grown in size in recent years.
The latest biennial analysis of doctors’ practices by the American Medical Association showed an acceleration of a trend away from private practice, defined as a practice wholly owned by physicians. The 2020 results found less than half – 49.1 % – of doctors involved in patient care worked in a private practice, the AMA said in a report released in May 2021.
This marked the first time private practice was not the dominant approach since the AMA analysis began in 2012. What’s more, the trend appears to be gaining steam, with a drop of almost 5 percentage points from 54.0% in private practice in 2018. The percent of doctors in private practice declined at a slower rate in previous AMA surveys, slipping to 55.8% in 2016 from 56.8% in 2018 and 60.1% in 2012.
Employment and ownership structures have become so varied that no single approach or size of organization “can or should be considered the typical physician practice,” the report noted.
The AMA, for example, added to its 2020 benchmark survey an option to identify private equity organizations as employers. The survey found 4% of doctors involved in patient care worked in practices owned by these kinds of firms. Other options include practices wholly or jointly owned by hospital and health systems and insurers, as well as direct employment and contracting.
There are signs that the shift away from smaller private practices will continue, with younger doctors appearing more likely to seek employment.
The survey found 42% of doctors ages 55 and older were employed by someone else, compared with 51.2% of doctors ages 40-54 and 70% of physicians under the age of 40.
The AMA surveyed 3,500 U.S. doctors through the 2020 Physician Practice Benchmark Survey. The survey was conducted from September to October 2020, roughly 6 months into the COVID-19 pandemic, and therefore may not reflect its full impact.
“Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time,” AMA President Susan R. Bailey, MD, said in a statement.
In a survey released in 2020 by McKinsey & Company, 53% of independent doctors reported that they were worried about their practices surviving the stresses of the pandemic, this news organization reported.
Challenging environment
It’s not just money leading to the shift away from private practice, according to a 2020 report from the American Hospital Association, titled “Evolving Physician-Practice Ownership Models.”
Many recent graduates of medical schools have significant debt and are more likely to opt for employment, which offers more financial stability and work-life balance, the report said.
Doctors also need to keep up with expectations of their patients that have been shaped by advances in other sectors, like banking, the AHA noted. People are used to working on their own schedules, and want to make appointments through apps, get test results rapidly and on their mobile devices, and communicate with their providers virtually.
“It is challenging to meet these expectations and make the necessary technology investments as a solo or small group practice,” the AHA report said.
Hospitals face competition for doctors from insurers, which have been looking in some cases to directly employ more physicians, the AHA also noted. The report cites insurance giant UnitedHealth Group’s Optum unit as the most visible example of this trend.
On a January call about corporate earnings, David Wichmann, then chief executive of UnitedHealth, spoke about the firm’s “aim to reinvent health care delivery,” including efforts to have its own primary and multispecialty care practices.
“OptumCare entered 2021 with over 50,000 physicians and 1,400 clinics,” Mr. Wichmann said. “Over the course of this year, we expect to grow our employed and affiliated physicians by at least 10,000. This work of building local physician-led systems of care continues to be central to our mission. “
UnitedHealth’s new CEO is Andrew Witty, who had led the Optum unit.
Attractions of larger groups
Older doctors – those 55 years and up – were significantly more likely to work in small practices than those younger than 40, the 2020 survey found. Results showed 40.9% of doctors under 40 worked in practices of 10 or fewer colleagues, compared with 61.4% of those age 55 and older.
The large difference between age groups suggests that attrition is one reason for the shift in practice size. Retiring doctors who leave small practices are not being replaced on a one-for-one basis by younger doctors, AMA said. The same reason also appears to be a factor in the shift in practice ownership to larger systems.
Doctors in larger group practices can count on a stable business model, with a better ability to survive disruptive market trends, including those of a more extreme nature, like COVID-19, said Fred Horton, president of AMGA Consulting.
AMGA Consulting is a wholly-owned subsidiary of AMGA, formerly called American Medical Group Association. Its more than 400 members include well-known multispecialty groups and health care systems such as the Mayo Clinic, Cleveland Clinic, Geisinger, the Permanente Medical Group, and Intermountain Healthcare as well as many smaller physician practices.
Mr. Horton, who holds a master’s degree in health administration, said some doctors may want to participate in alternative payment programs offered by insurers, who are seeking to shift away from the fee-for-service model
“Larger organizations can dedicate more resources to continuous quality improvement,” Mr. Horton said. “This is especially important for physicians who are taking on risk-based contracts, as quality can directly impact how much they earn.”
For one oncologist, it was turning to alternative payment methods that helped him keep his private practice afloat.
Kashyap Patel, MD, chief executive of the Carolina Blood and Cancer Care Associates in Rock Hill, S.C., said he maintained the independence of his practice amid pressure from a large health system, which had been buying medical groups in the area. That began to interfere with referrals of patients from other doctors, which are key for cancer specialists, said Dr. Patel, who also is president of the Community Oncology Alliance.
In response, Dr. Patel worked with Blue Cross Blue Shield of South Carolina on an arrangement where his practice sought certifications from the National Committee for Quality Assurance to get better rates.
The effort has allowed Dr. Patel’s clinic to focus more on preventing hospitalizations and visits to the emergency room he said.
In Dr. Patel’s view, his patients benefit from his efforts to remain in independent practice. A switch to ownership by a large health care organization would have put them at risk for higher medical bills, jeopardizing their access to treatment, he said. The reason? Hospitals can charge more for services provided by doctors they employ.
“Nothing would change. I would be the same. The building would be the same, but the cost would go up,” Dr. Patel said.
For its part, the AHA has repeatedly challenged arguments that acquisitions and mergers result in higher costs for patients.
Instead, the AHA has raised alarms about consolidation of health insurers, a concern it shares with AMA. In a 2020 report examining competition among insurers, AMA noted doctors working in small practices can be put at a disadvantage if mergers and acquisitions leave an insurer with too much market power.
“Under antitrust law, independent physicians cannot negotiate collectively with health
Insurers,” the AMA said in the report. “This imbalance in relative size leaves most physicians with a weak bargaining position relative to commercial payers.”
AMA’s research on the effects of insurers’ wielding significant market clout has been used in effort to thwart mergers in this industry.
‘Dramatic restructuring’
The Federal Trade Commission also has taken note of the trends discussed in the new AMA report, saying that “U.S. physician markets are undergoing a dramatic restructuring.”
The FTC in January announced a study of the impact of the consolidation of doctors groups and health care facilities. FTC is seeking data for inpatient, outpatient, and doctors services in 15 states from 2015 through 2020. To gather this data, the commission has issued orders to six major insurers – Aetna, Anthem, Florida Blue, Cigna, Health Care Service Corporation and United Healthcare.
The FTC is concerned that acquired practices may have to alter their referral patterns to favor their affiliated hospital system over competing hospital systems. But FTC staff also said it might be that these acquisitions result in efficiencies, such as enhanced coordination of care between doctors and hospitals “that outweigh potential competitive harms.”
The research project will likely take several years to complete because of its scope, the FTC said. For that reason, the FTC said its Bureau of Economics will release a series of research papers examining different aspects of this inquiry rather than a single paper containing all of the analyses.
Private equity ‘roll-ups’
On the day the FTC announced the study of the impact of doctors groups, one of the panel’s commissioners argued for a closer look at how private equity firms make their purchases.
In a Jan. 15 tweet, FTC Commissioner Rohit Chopra said his agency needs to challenge their “roll-ups of small physician practices” as well as clinics and labs. This is a practice of using a series of acquisitions too small to trigger the federal threshold for a serious look from the FTC and Department of Justice. (The threshold for 2021 stands around the $92 million mark. This benchmark is known as Hart-Scott-Rodino notification after a 1976 law that set a reporting standard.)
Mr. Chopra attached to his Jan. 15 tweet a 2020 statement in which he called for stepped-up scrutiny of private-equity firms’ acquisitions of doctors’ practices. Mr. Chopra noted that private-equity firms have been buying practices focused on anesthesiology and emergency medicine, fields which triggered consumer complaints about surprise billing for emergency care.
“Given trends in today’s markets, it is critical that the FTC find new ways to ensure the agency has a rigorous, data-driven approach to market monitoring and enforcement,” Mr. Chopra wrote.
A version of this article first appeared on WebMD.com.
according to a new report.
These patterns likely reflect broader trends toward consolidation in health care, with both insurance companies and hospitals also having grown in size in recent years.
The latest biennial analysis of doctors’ practices by the American Medical Association showed an acceleration of a trend away from private practice, defined as a practice wholly owned by physicians. The 2020 results found less than half – 49.1 % – of doctors involved in patient care worked in a private practice, the AMA said in a report released in May 2021.
This marked the first time private practice was not the dominant approach since the AMA analysis began in 2012. What’s more, the trend appears to be gaining steam, with a drop of almost 5 percentage points from 54.0% in private practice in 2018. The percent of doctors in private practice declined at a slower rate in previous AMA surveys, slipping to 55.8% in 2016 from 56.8% in 2018 and 60.1% in 2012.
Employment and ownership structures have become so varied that no single approach or size of organization “can or should be considered the typical physician practice,” the report noted.
The AMA, for example, added to its 2020 benchmark survey an option to identify private equity organizations as employers. The survey found 4% of doctors involved in patient care worked in practices owned by these kinds of firms. Other options include practices wholly or jointly owned by hospital and health systems and insurers, as well as direct employment and contracting.
There are signs that the shift away from smaller private practices will continue, with younger doctors appearing more likely to seek employment.
The survey found 42% of doctors ages 55 and older were employed by someone else, compared with 51.2% of doctors ages 40-54 and 70% of physicians under the age of 40.
The AMA surveyed 3,500 U.S. doctors through the 2020 Physician Practice Benchmark Survey. The survey was conducted from September to October 2020, roughly 6 months into the COVID-19 pandemic, and therefore may not reflect its full impact.
“Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time,” AMA President Susan R. Bailey, MD, said in a statement.
In a survey released in 2020 by McKinsey & Company, 53% of independent doctors reported that they were worried about their practices surviving the stresses of the pandemic, this news organization reported.
Challenging environment
It’s not just money leading to the shift away from private practice, according to a 2020 report from the American Hospital Association, titled “Evolving Physician-Practice Ownership Models.”
Many recent graduates of medical schools have significant debt and are more likely to opt for employment, which offers more financial stability and work-life balance, the report said.
Doctors also need to keep up with expectations of their patients that have been shaped by advances in other sectors, like banking, the AHA noted. People are used to working on their own schedules, and want to make appointments through apps, get test results rapidly and on their mobile devices, and communicate with their providers virtually.
“It is challenging to meet these expectations and make the necessary technology investments as a solo or small group practice,” the AHA report said.
Hospitals face competition for doctors from insurers, which have been looking in some cases to directly employ more physicians, the AHA also noted. The report cites insurance giant UnitedHealth Group’s Optum unit as the most visible example of this trend.
On a January call about corporate earnings, David Wichmann, then chief executive of UnitedHealth, spoke about the firm’s “aim to reinvent health care delivery,” including efforts to have its own primary and multispecialty care practices.
“OptumCare entered 2021 with over 50,000 physicians and 1,400 clinics,” Mr. Wichmann said. “Over the course of this year, we expect to grow our employed and affiliated physicians by at least 10,000. This work of building local physician-led systems of care continues to be central to our mission. “
UnitedHealth’s new CEO is Andrew Witty, who had led the Optum unit.
Attractions of larger groups
Older doctors – those 55 years and up – were significantly more likely to work in small practices than those younger than 40, the 2020 survey found. Results showed 40.9% of doctors under 40 worked in practices of 10 or fewer colleagues, compared with 61.4% of those age 55 and older.
The large difference between age groups suggests that attrition is one reason for the shift in practice size. Retiring doctors who leave small practices are not being replaced on a one-for-one basis by younger doctors, AMA said. The same reason also appears to be a factor in the shift in practice ownership to larger systems.
Doctors in larger group practices can count on a stable business model, with a better ability to survive disruptive market trends, including those of a more extreme nature, like COVID-19, said Fred Horton, president of AMGA Consulting.
AMGA Consulting is a wholly-owned subsidiary of AMGA, formerly called American Medical Group Association. Its more than 400 members include well-known multispecialty groups and health care systems such as the Mayo Clinic, Cleveland Clinic, Geisinger, the Permanente Medical Group, and Intermountain Healthcare as well as many smaller physician practices.
Mr. Horton, who holds a master’s degree in health administration, said some doctors may want to participate in alternative payment programs offered by insurers, who are seeking to shift away from the fee-for-service model
“Larger organizations can dedicate more resources to continuous quality improvement,” Mr. Horton said. “This is especially important for physicians who are taking on risk-based contracts, as quality can directly impact how much they earn.”
For one oncologist, it was turning to alternative payment methods that helped him keep his private practice afloat.
Kashyap Patel, MD, chief executive of the Carolina Blood and Cancer Care Associates in Rock Hill, S.C., said he maintained the independence of his practice amid pressure from a large health system, which had been buying medical groups in the area. That began to interfere with referrals of patients from other doctors, which are key for cancer specialists, said Dr. Patel, who also is president of the Community Oncology Alliance.
In response, Dr. Patel worked with Blue Cross Blue Shield of South Carolina on an arrangement where his practice sought certifications from the National Committee for Quality Assurance to get better rates.
The effort has allowed Dr. Patel’s clinic to focus more on preventing hospitalizations and visits to the emergency room he said.
In Dr. Patel’s view, his patients benefit from his efforts to remain in independent practice. A switch to ownership by a large health care organization would have put them at risk for higher medical bills, jeopardizing their access to treatment, he said. The reason? Hospitals can charge more for services provided by doctors they employ.
“Nothing would change. I would be the same. The building would be the same, but the cost would go up,” Dr. Patel said.
For its part, the AHA has repeatedly challenged arguments that acquisitions and mergers result in higher costs for patients.
Instead, the AHA has raised alarms about consolidation of health insurers, a concern it shares with AMA. In a 2020 report examining competition among insurers, AMA noted doctors working in small practices can be put at a disadvantage if mergers and acquisitions leave an insurer with too much market power.
“Under antitrust law, independent physicians cannot negotiate collectively with health
Insurers,” the AMA said in the report. “This imbalance in relative size leaves most physicians with a weak bargaining position relative to commercial payers.”
AMA’s research on the effects of insurers’ wielding significant market clout has been used in effort to thwart mergers in this industry.
‘Dramatic restructuring’
The Federal Trade Commission also has taken note of the trends discussed in the new AMA report, saying that “U.S. physician markets are undergoing a dramatic restructuring.”
The FTC in January announced a study of the impact of the consolidation of doctors groups and health care facilities. FTC is seeking data for inpatient, outpatient, and doctors services in 15 states from 2015 through 2020. To gather this data, the commission has issued orders to six major insurers – Aetna, Anthem, Florida Blue, Cigna, Health Care Service Corporation and United Healthcare.
The FTC is concerned that acquired practices may have to alter their referral patterns to favor their affiliated hospital system over competing hospital systems. But FTC staff also said it might be that these acquisitions result in efficiencies, such as enhanced coordination of care between doctors and hospitals “that outweigh potential competitive harms.”
The research project will likely take several years to complete because of its scope, the FTC said. For that reason, the FTC said its Bureau of Economics will release a series of research papers examining different aspects of this inquiry rather than a single paper containing all of the analyses.
Private equity ‘roll-ups’
On the day the FTC announced the study of the impact of doctors groups, one of the panel’s commissioners argued for a closer look at how private equity firms make their purchases.
In a Jan. 15 tweet, FTC Commissioner Rohit Chopra said his agency needs to challenge their “roll-ups of small physician practices” as well as clinics and labs. This is a practice of using a series of acquisitions too small to trigger the federal threshold for a serious look from the FTC and Department of Justice. (The threshold for 2021 stands around the $92 million mark. This benchmark is known as Hart-Scott-Rodino notification after a 1976 law that set a reporting standard.)
Mr. Chopra attached to his Jan. 15 tweet a 2020 statement in which he called for stepped-up scrutiny of private-equity firms’ acquisitions of doctors’ practices. Mr. Chopra noted that private-equity firms have been buying practices focused on anesthesiology and emergency medicine, fields which triggered consumer complaints about surprise billing for emergency care.
“Given trends in today’s markets, it is critical that the FTC find new ways to ensure the agency has a rigorous, data-driven approach to market monitoring and enforcement,” Mr. Chopra wrote.
A version of this article first appeared on WebMD.com.
Liver transplant outcomes improving for U.S. patients with HIV/HCV
While liver transplant outcomes were historically poor in people coinfected with HIV and hepatitis C virus (HCV), they have improved significantly in the era of direct-acting antiviral (DAA) therapy, a recent analysis of U.S. organ transplant data showed.
The availability of highly potent DAA therapy should change how transplant specialists view patients coinfected with HIV/HCV who need a liver transplant, according to researcher Jennifer Wang, MD, chief gastroenterology fellow at the University of Chicago, who presented the results of the analysis at the annual Digestive Disease Week® (DDW). Cumulative graft survival rates since the introduction of DAAs are comparable between transplant recipients with HIV/HCV coinfection and recipients who are both HIV and HCV negative, according to the study.
“Having hepatitis C no longer confers worse patient survival in the DAA era, and this is the main takeaway from our study,” Dr. Wang said.
The study also showed that the number of liver transplants among HIV-infected patients has increased over the past 4-5 years. However, the absolute number remains low at 64 cases in 2019, or less than 1% of all liver transplants that year, and only about one-third of those HIV-positive recipients had HCV coinfection, according to Dr. Wang.
Moreover, relatively few centers are performing liver transplants for patients who are HIV/HCV coinfected, and there is significant geographic variation in where the procedures are done, she said in her presentation.
Reassuring data that should prompt referral
Taken together, these results should offer reassurance to transplant centers that patients coinfected with HIV/HCV are no longer at increased risk for poor outcomes after transplantation, said Christine M. Durand, MD, associate professor of medicine at Johns Hopkins University, Baltimore.
“The additional call for action should be beyond the transplantation community to ensure that referrals for liver transplant are where they should be,” Dr. Durand said in an interview.
“With a number of only 64 transplants a year, we’re not doing enough, and there are more patients that could benefit from liver transplants,” added Dr. Durand, who is principal investigator of HOPE in Action, a prospective, multicenter, clinical trial evaluating the safety and survival outcomes of HIV-positive deceased donor liver transplants in HIV-positive recipients.
Impact of the HOPE Act
Liver transplantation for HIV-positive patients has increased since the signing of the HIV Organ Policy Equity (HOPE) Act in 2013, according to Dr. Wang.
The HOPE act expanded the donor pool to include HIV-positive deceased donors, which not only increased the donor supply overall, but specifically helped HIV-positive individuals, who experience a higher rate of waiting-list mortality, according to a review on the topic authored by Dr. Durand and coauthors.
However, some transplant centers may be reluctant to do liver transplants in HIV-positive patients coinfected with HCV. That’s because, in previous studies that were conducted before the DAA era, outcomes after liver transplant in HIV/HCV-coinfected patients were inferior to those in patients with HIV but no HCV infection, Dr. Wang said.
Accordingly, Dr. Wang and colleagues analyzed Organ Procurement and Transplantation Network (OPTN) data on adult patients who underwent liver transplants between 2008 and 2019 to see if the introduction of DAAs had leveled the playing field for those with HCV coinfection.
Progress in a still-underserved population
The practice of liver transplant in the HIV population has been increasing since the HOPE Act, according to Dr. Wang.
Overall, out of 70,125 liver transplant recipients over the 2008-2019 period, 416 (0.6%) were HIV infected, the data show.
In 2014, 28 liver transplants (0.5%) were performed in HIV-infected individuals, which increased to 64 transplants (0.8%) in 2019, data show. Of those 64 HIV-positive liver transplant recipients in 2019, 23 (35.9%) were coinfected with HCV.
Graft survival has greatly improved, from a 3-year survival of only 58% in patients transplanted before the availability of DAAs to 82% in the DAA era, a difference that was statistically significant, Dr. Wang said.
In the DAA era, there was no significant difference in graft failure outcomes when comparing HIV/HCV-coinfected recipients with uninfected recipients, she added.
The largest proportion of liver transplantations in HIV/HCV-coinfected recipients have been done in OPTN Region 9 (New York), both in the pre- and post-DAA eras, according to Dr. Wang. Several regions have very low numbers or have performed no liver transplants in HIV/HCV-coinfected patients in either era.
“The number of transplant centers participating in liver transplant for coinfected patients is still quite low, so this is a very underserved patient population,” Dr. Wang said.
Dr. Wang provided no financial disclosures related to the research. Dr. Durand receives grants to the institution from Abbvie and GlaxoSmithKline and she receives honoraria from Gilead Sciences for serving on a grant review committee.
While liver transplant outcomes were historically poor in people coinfected with HIV and hepatitis C virus (HCV), they have improved significantly in the era of direct-acting antiviral (DAA) therapy, a recent analysis of U.S. organ transplant data showed.
The availability of highly potent DAA therapy should change how transplant specialists view patients coinfected with HIV/HCV who need a liver transplant, according to researcher Jennifer Wang, MD, chief gastroenterology fellow at the University of Chicago, who presented the results of the analysis at the annual Digestive Disease Week® (DDW). Cumulative graft survival rates since the introduction of DAAs are comparable between transplant recipients with HIV/HCV coinfection and recipients who are both HIV and HCV negative, according to the study.
“Having hepatitis C no longer confers worse patient survival in the DAA era, and this is the main takeaway from our study,” Dr. Wang said.
The study also showed that the number of liver transplants among HIV-infected patients has increased over the past 4-5 years. However, the absolute number remains low at 64 cases in 2019, or less than 1% of all liver transplants that year, and only about one-third of those HIV-positive recipients had HCV coinfection, according to Dr. Wang.
Moreover, relatively few centers are performing liver transplants for patients who are HIV/HCV coinfected, and there is significant geographic variation in where the procedures are done, she said in her presentation.
Reassuring data that should prompt referral
Taken together, these results should offer reassurance to transplant centers that patients coinfected with HIV/HCV are no longer at increased risk for poor outcomes after transplantation, said Christine M. Durand, MD, associate professor of medicine at Johns Hopkins University, Baltimore.
“The additional call for action should be beyond the transplantation community to ensure that referrals for liver transplant are where they should be,” Dr. Durand said in an interview.
“With a number of only 64 transplants a year, we’re not doing enough, and there are more patients that could benefit from liver transplants,” added Dr. Durand, who is principal investigator of HOPE in Action, a prospective, multicenter, clinical trial evaluating the safety and survival outcomes of HIV-positive deceased donor liver transplants in HIV-positive recipients.
Impact of the HOPE Act
Liver transplantation for HIV-positive patients has increased since the signing of the HIV Organ Policy Equity (HOPE) Act in 2013, according to Dr. Wang.
The HOPE act expanded the donor pool to include HIV-positive deceased donors, which not only increased the donor supply overall, but specifically helped HIV-positive individuals, who experience a higher rate of waiting-list mortality, according to a review on the topic authored by Dr. Durand and coauthors.
However, some transplant centers may be reluctant to do liver transplants in HIV-positive patients coinfected with HCV. That’s because, in previous studies that were conducted before the DAA era, outcomes after liver transplant in HIV/HCV-coinfected patients were inferior to those in patients with HIV but no HCV infection, Dr. Wang said.
Accordingly, Dr. Wang and colleagues analyzed Organ Procurement and Transplantation Network (OPTN) data on adult patients who underwent liver transplants between 2008 and 2019 to see if the introduction of DAAs had leveled the playing field for those with HCV coinfection.
Progress in a still-underserved population
The practice of liver transplant in the HIV population has been increasing since the HOPE Act, according to Dr. Wang.
Overall, out of 70,125 liver transplant recipients over the 2008-2019 period, 416 (0.6%) were HIV infected, the data show.
In 2014, 28 liver transplants (0.5%) were performed in HIV-infected individuals, which increased to 64 transplants (0.8%) in 2019, data show. Of those 64 HIV-positive liver transplant recipients in 2019, 23 (35.9%) were coinfected with HCV.
Graft survival has greatly improved, from a 3-year survival of only 58% in patients transplanted before the availability of DAAs to 82% in the DAA era, a difference that was statistically significant, Dr. Wang said.
In the DAA era, there was no significant difference in graft failure outcomes when comparing HIV/HCV-coinfected recipients with uninfected recipients, she added.
The largest proportion of liver transplantations in HIV/HCV-coinfected recipients have been done in OPTN Region 9 (New York), both in the pre- and post-DAA eras, according to Dr. Wang. Several regions have very low numbers or have performed no liver transplants in HIV/HCV-coinfected patients in either era.
“The number of transplant centers participating in liver transplant for coinfected patients is still quite low, so this is a very underserved patient population,” Dr. Wang said.
Dr. Wang provided no financial disclosures related to the research. Dr. Durand receives grants to the institution from Abbvie and GlaxoSmithKline and she receives honoraria from Gilead Sciences for serving on a grant review committee.
While liver transplant outcomes were historically poor in people coinfected with HIV and hepatitis C virus (HCV), they have improved significantly in the era of direct-acting antiviral (DAA) therapy, a recent analysis of U.S. organ transplant data showed.
The availability of highly potent DAA therapy should change how transplant specialists view patients coinfected with HIV/HCV who need a liver transplant, according to researcher Jennifer Wang, MD, chief gastroenterology fellow at the University of Chicago, who presented the results of the analysis at the annual Digestive Disease Week® (DDW). Cumulative graft survival rates since the introduction of DAAs are comparable between transplant recipients with HIV/HCV coinfection and recipients who are both HIV and HCV negative, according to the study.
“Having hepatitis C no longer confers worse patient survival in the DAA era, and this is the main takeaway from our study,” Dr. Wang said.
The study also showed that the number of liver transplants among HIV-infected patients has increased over the past 4-5 years. However, the absolute number remains low at 64 cases in 2019, or less than 1% of all liver transplants that year, and only about one-third of those HIV-positive recipients had HCV coinfection, according to Dr. Wang.
Moreover, relatively few centers are performing liver transplants for patients who are HIV/HCV coinfected, and there is significant geographic variation in where the procedures are done, she said in her presentation.
Reassuring data that should prompt referral
Taken together, these results should offer reassurance to transplant centers that patients coinfected with HIV/HCV are no longer at increased risk for poor outcomes after transplantation, said Christine M. Durand, MD, associate professor of medicine at Johns Hopkins University, Baltimore.
“The additional call for action should be beyond the transplantation community to ensure that referrals for liver transplant are where they should be,” Dr. Durand said in an interview.
“With a number of only 64 transplants a year, we’re not doing enough, and there are more patients that could benefit from liver transplants,” added Dr. Durand, who is principal investigator of HOPE in Action, a prospective, multicenter, clinical trial evaluating the safety and survival outcomes of HIV-positive deceased donor liver transplants in HIV-positive recipients.
Impact of the HOPE Act
Liver transplantation for HIV-positive patients has increased since the signing of the HIV Organ Policy Equity (HOPE) Act in 2013, according to Dr. Wang.
The HOPE act expanded the donor pool to include HIV-positive deceased donors, which not only increased the donor supply overall, but specifically helped HIV-positive individuals, who experience a higher rate of waiting-list mortality, according to a review on the topic authored by Dr. Durand and coauthors.
However, some transplant centers may be reluctant to do liver transplants in HIV-positive patients coinfected with HCV. That’s because, in previous studies that were conducted before the DAA era, outcomes after liver transplant in HIV/HCV-coinfected patients were inferior to those in patients with HIV but no HCV infection, Dr. Wang said.
Accordingly, Dr. Wang and colleagues analyzed Organ Procurement and Transplantation Network (OPTN) data on adult patients who underwent liver transplants between 2008 and 2019 to see if the introduction of DAAs had leveled the playing field for those with HCV coinfection.
Progress in a still-underserved population
The practice of liver transplant in the HIV population has been increasing since the HOPE Act, according to Dr. Wang.
Overall, out of 70,125 liver transplant recipients over the 2008-2019 period, 416 (0.6%) were HIV infected, the data show.
In 2014, 28 liver transplants (0.5%) were performed in HIV-infected individuals, which increased to 64 transplants (0.8%) in 2019, data show. Of those 64 HIV-positive liver transplant recipients in 2019, 23 (35.9%) were coinfected with HCV.
Graft survival has greatly improved, from a 3-year survival of only 58% in patients transplanted before the availability of DAAs to 82% in the DAA era, a difference that was statistically significant, Dr. Wang said.
In the DAA era, there was no significant difference in graft failure outcomes when comparing HIV/HCV-coinfected recipients with uninfected recipients, she added.
The largest proportion of liver transplantations in HIV/HCV-coinfected recipients have been done in OPTN Region 9 (New York), both in the pre- and post-DAA eras, according to Dr. Wang. Several regions have very low numbers or have performed no liver transplants in HIV/HCV-coinfected patients in either era.
“The number of transplant centers participating in liver transplant for coinfected patients is still quite low, so this is a very underserved patient population,” Dr. Wang said.
Dr. Wang provided no financial disclosures related to the research. Dr. Durand receives grants to the institution from Abbvie and GlaxoSmithKline and she receives honoraria from Gilead Sciences for serving on a grant review committee.
FROM DDW 2021
Poloxamer 188 disappoints for painful SCD vaso-occlusive episodes, study showsteaser
Poloxamer 188, a nonionic block polymer surfactant reported to reduce blood viscosity and cell-cell interactions, failed to shorten painful vaso-occlusive episodes in adults and children with sickle cell disease (SCD) in a randomized, placebo-controlled, phase 3 trial.
The findings contrast with those from a prior phase 3 trial showing benefits with treatment, James F. Casella, MD, professor of pediatrics and chief of pediatric hematology at Johns Hopkins University, Baltimore, and colleagues reported.
The time from randomization to the last dose of parenteral opioids in the current study did not differ in 194 patients randomized to the active treatment and 194 randomized to a placebo group (81.8 hours with poloxamer 188 vs. 77.8 hours with placebo), the authors found.
The study results were reported online in JAMA.
Participants in the double-blind study were individuals aged 4-65 years (mean, 15.2 years) with acute moderate to severe painful vaso-occlusive episodes requiring hospitalization. They were recruited between May 2013 and February 2016 from 66 hospitals in 12 countries.
Adverse events that were more common in the poloxamer 188 group included hyperbilirubinemia, which occurred in 12.7% of patients versus 5.2% in the placebo group. Hypoxia occurred more often in the placebo group (12.0% vs. 5.3%).
“Poloxamer 188 has been evaluated in three clinical trials of SCD demonstrating safety and possible efficacy for painful vaso-occlusive episodes and acute chest syndrome, which involves intrapulmonary vascular occlusion and/or infection,” the authors noted. “These studies included a previous phase 3 trial that suggested efficacy for painful vaso-occlusive episodes, particularly in children and participants receiving hydroxyurea.”
The mean duration of vaso-occlusive crisis was reduced by 8.8 hours overall, by 21 hours in those aged under 16 years, and by 16 hours in those receiving hydroxyurea. A small, nonsignificant difference was also seen in the incidence of acute chest syndrome for children in that study.
The findings were encouraging given the lack of disease-modifying therapies for ongoing painful vaso-occlusive episodes, which are associated with higher mortality in patients with SCD; although three agents are available for the prevention vaso-occlusive episodes, including hydroxyurea, L-glutamine, and crizanlizumab-tmca, no available agent effectively manages vaso-occlusive episodes once they have begun, the authors noted.
Current treatment therefore remains supportive, with analgesia and hydration, they added.
This is concerning since “acute pain is estimated to account for 95% of hospital admissions for those with SCD, creating a burden for individuals with SCD, their families, and health care systems,” they explained, adding that the ability to reduce the severity and duration of vaso-occlusive episodes would be a significant advance.
“Because intravenous poloxamer 188 is neither approved by the Food and Drug Administration nor available for clinical use and because other drugs for managing ongoing vaso-occlusive episodes are absent, the present trial was designed to determine whether poloxamer 188 is efficacious for painful vaso-occlusive episodes in SCD,” they said.
However, no benefit was seen for episode duration with treatment in the current study, nor was any beneficial effect on acute chest syndrome observed.
“Rather, although not statistically significant, there were more participants younger than 16 years who developed acute chest syndrome in the poloxamer 188 group than in the placebo group, paralleling the direction of effects on the primary outcome for participants younger than 16 years [in the current study],” they wrote, adding that there were also “no apparent effects on readmission for painful vaso-occlusive episodes in participants receiving hydroxyurea, despite the known effect of hydroxyurea in reducing rates of painful vaso-occlusive episodes and acute chest syndrome.”
Though limited by subjective aspects of assessing the primary outcome in this study and by challenges with effectively blinding poloxamer 188 use, the current findings do not support the use of poloxamer 188 for vaso-occlusive episodes, they concluded.
In an accompanying editorial, JAMA deputy editor Jody Zylke, MD, suggested that the most likely explanation for the differing conclusions in the current and prior phase 3 trials relates to the choice of primary outcome.
In the prior study, the primary outcome was time from randomization to crisis resolution.
“The resolution of pain is subjective, and the criteria to determine crisis resolution established by the investigators were extremely stringent and difficult to implement, leading to a high proportion of participants with incomplete documentation,” Dr. Zylke noted. “Also, incomplete documentation occurred more often in the placebo group than the intervention group, resulting in more imputation of missing values for the placebo group, which favored the poloxamer 188 group.”
In the current trial, a “more easily verified primary outcome was selected, with data available for 99% of participants.”
The report by Dr. Casella and colleagues “adds to the evidence base and illustrates some of the challenges in finding effective treatments for patients with sickle cell disease,” he said.
This study was funded by Mast Therapeutics (previously Adventrx Therapeutics). Dr. Casella reported receiving grants from Mast Therapeutics and receiving an honorarium, travel expenses, and salary support through Johns Hopkins for providing consultative advice to Mast Pharmaceuticals during development of the clinical trial and for serving as the principal investigator for the clinical trial; being an inventor and a named party on a patent and licensing agreement to ImmunArray through Johns Hopkins for a panel of brain biomarkers for the detection of brain injury; and holding a patent for aptamers as a potential treatment for sickle cell disease. Dr. Zylke reported having no disclosures.
Poloxamer 188, a nonionic block polymer surfactant reported to reduce blood viscosity and cell-cell interactions, failed to shorten painful vaso-occlusive episodes in adults and children with sickle cell disease (SCD) in a randomized, placebo-controlled, phase 3 trial.
The findings contrast with those from a prior phase 3 trial showing benefits with treatment, James F. Casella, MD, professor of pediatrics and chief of pediatric hematology at Johns Hopkins University, Baltimore, and colleagues reported.
The time from randomization to the last dose of parenteral opioids in the current study did not differ in 194 patients randomized to the active treatment and 194 randomized to a placebo group (81.8 hours with poloxamer 188 vs. 77.8 hours with placebo), the authors found.
The study results were reported online in JAMA.
Participants in the double-blind study were individuals aged 4-65 years (mean, 15.2 years) with acute moderate to severe painful vaso-occlusive episodes requiring hospitalization. They were recruited between May 2013 and February 2016 from 66 hospitals in 12 countries.
Adverse events that were more common in the poloxamer 188 group included hyperbilirubinemia, which occurred in 12.7% of patients versus 5.2% in the placebo group. Hypoxia occurred more often in the placebo group (12.0% vs. 5.3%).
“Poloxamer 188 has been evaluated in three clinical trials of SCD demonstrating safety and possible efficacy for painful vaso-occlusive episodes and acute chest syndrome, which involves intrapulmonary vascular occlusion and/or infection,” the authors noted. “These studies included a previous phase 3 trial that suggested efficacy for painful vaso-occlusive episodes, particularly in children and participants receiving hydroxyurea.”
The mean duration of vaso-occlusive crisis was reduced by 8.8 hours overall, by 21 hours in those aged under 16 years, and by 16 hours in those receiving hydroxyurea. A small, nonsignificant difference was also seen in the incidence of acute chest syndrome for children in that study.
The findings were encouraging given the lack of disease-modifying therapies for ongoing painful vaso-occlusive episodes, which are associated with higher mortality in patients with SCD; although three agents are available for the prevention vaso-occlusive episodes, including hydroxyurea, L-glutamine, and crizanlizumab-tmca, no available agent effectively manages vaso-occlusive episodes once they have begun, the authors noted.
Current treatment therefore remains supportive, with analgesia and hydration, they added.
This is concerning since “acute pain is estimated to account for 95% of hospital admissions for those with SCD, creating a burden for individuals with SCD, their families, and health care systems,” they explained, adding that the ability to reduce the severity and duration of vaso-occlusive episodes would be a significant advance.
“Because intravenous poloxamer 188 is neither approved by the Food and Drug Administration nor available for clinical use and because other drugs for managing ongoing vaso-occlusive episodes are absent, the present trial was designed to determine whether poloxamer 188 is efficacious for painful vaso-occlusive episodes in SCD,” they said.
However, no benefit was seen for episode duration with treatment in the current study, nor was any beneficial effect on acute chest syndrome observed.
“Rather, although not statistically significant, there were more participants younger than 16 years who developed acute chest syndrome in the poloxamer 188 group than in the placebo group, paralleling the direction of effects on the primary outcome for participants younger than 16 years [in the current study],” they wrote, adding that there were also “no apparent effects on readmission for painful vaso-occlusive episodes in participants receiving hydroxyurea, despite the known effect of hydroxyurea in reducing rates of painful vaso-occlusive episodes and acute chest syndrome.”
Though limited by subjective aspects of assessing the primary outcome in this study and by challenges with effectively blinding poloxamer 188 use, the current findings do not support the use of poloxamer 188 for vaso-occlusive episodes, they concluded.
In an accompanying editorial, JAMA deputy editor Jody Zylke, MD, suggested that the most likely explanation for the differing conclusions in the current and prior phase 3 trials relates to the choice of primary outcome.
In the prior study, the primary outcome was time from randomization to crisis resolution.
“The resolution of pain is subjective, and the criteria to determine crisis resolution established by the investigators were extremely stringent and difficult to implement, leading to a high proportion of participants with incomplete documentation,” Dr. Zylke noted. “Also, incomplete documentation occurred more often in the placebo group than the intervention group, resulting in more imputation of missing values for the placebo group, which favored the poloxamer 188 group.”
In the current trial, a “more easily verified primary outcome was selected, with data available for 99% of participants.”
The report by Dr. Casella and colleagues “adds to the evidence base and illustrates some of the challenges in finding effective treatments for patients with sickle cell disease,” he said.
This study was funded by Mast Therapeutics (previously Adventrx Therapeutics). Dr. Casella reported receiving grants from Mast Therapeutics and receiving an honorarium, travel expenses, and salary support through Johns Hopkins for providing consultative advice to Mast Pharmaceuticals during development of the clinical trial and for serving as the principal investigator for the clinical trial; being an inventor and a named party on a patent and licensing agreement to ImmunArray through Johns Hopkins for a panel of brain biomarkers for the detection of brain injury; and holding a patent for aptamers as a potential treatment for sickle cell disease. Dr. Zylke reported having no disclosures.
Poloxamer 188, a nonionic block polymer surfactant reported to reduce blood viscosity and cell-cell interactions, failed to shorten painful vaso-occlusive episodes in adults and children with sickle cell disease (SCD) in a randomized, placebo-controlled, phase 3 trial.
The findings contrast with those from a prior phase 3 trial showing benefits with treatment, James F. Casella, MD, professor of pediatrics and chief of pediatric hematology at Johns Hopkins University, Baltimore, and colleagues reported.
The time from randomization to the last dose of parenteral opioids in the current study did not differ in 194 patients randomized to the active treatment and 194 randomized to a placebo group (81.8 hours with poloxamer 188 vs. 77.8 hours with placebo), the authors found.
The study results were reported online in JAMA.
Participants in the double-blind study were individuals aged 4-65 years (mean, 15.2 years) with acute moderate to severe painful vaso-occlusive episodes requiring hospitalization. They were recruited between May 2013 and February 2016 from 66 hospitals in 12 countries.
Adverse events that were more common in the poloxamer 188 group included hyperbilirubinemia, which occurred in 12.7% of patients versus 5.2% in the placebo group. Hypoxia occurred more often in the placebo group (12.0% vs. 5.3%).
“Poloxamer 188 has been evaluated in three clinical trials of SCD demonstrating safety and possible efficacy for painful vaso-occlusive episodes and acute chest syndrome, which involves intrapulmonary vascular occlusion and/or infection,” the authors noted. “These studies included a previous phase 3 trial that suggested efficacy for painful vaso-occlusive episodes, particularly in children and participants receiving hydroxyurea.”
The mean duration of vaso-occlusive crisis was reduced by 8.8 hours overall, by 21 hours in those aged under 16 years, and by 16 hours in those receiving hydroxyurea. A small, nonsignificant difference was also seen in the incidence of acute chest syndrome for children in that study.
The findings were encouraging given the lack of disease-modifying therapies for ongoing painful vaso-occlusive episodes, which are associated with higher mortality in patients with SCD; although three agents are available for the prevention vaso-occlusive episodes, including hydroxyurea, L-glutamine, and crizanlizumab-tmca, no available agent effectively manages vaso-occlusive episodes once they have begun, the authors noted.
Current treatment therefore remains supportive, with analgesia and hydration, they added.
This is concerning since “acute pain is estimated to account for 95% of hospital admissions for those with SCD, creating a burden for individuals with SCD, their families, and health care systems,” they explained, adding that the ability to reduce the severity and duration of vaso-occlusive episodes would be a significant advance.
“Because intravenous poloxamer 188 is neither approved by the Food and Drug Administration nor available for clinical use and because other drugs for managing ongoing vaso-occlusive episodes are absent, the present trial was designed to determine whether poloxamer 188 is efficacious for painful vaso-occlusive episodes in SCD,” they said.
However, no benefit was seen for episode duration with treatment in the current study, nor was any beneficial effect on acute chest syndrome observed.
“Rather, although not statistically significant, there were more participants younger than 16 years who developed acute chest syndrome in the poloxamer 188 group than in the placebo group, paralleling the direction of effects on the primary outcome for participants younger than 16 years [in the current study],” they wrote, adding that there were also “no apparent effects on readmission for painful vaso-occlusive episodes in participants receiving hydroxyurea, despite the known effect of hydroxyurea in reducing rates of painful vaso-occlusive episodes and acute chest syndrome.”
Though limited by subjective aspects of assessing the primary outcome in this study and by challenges with effectively blinding poloxamer 188 use, the current findings do not support the use of poloxamer 188 for vaso-occlusive episodes, they concluded.
In an accompanying editorial, JAMA deputy editor Jody Zylke, MD, suggested that the most likely explanation for the differing conclusions in the current and prior phase 3 trials relates to the choice of primary outcome.
In the prior study, the primary outcome was time from randomization to crisis resolution.
“The resolution of pain is subjective, and the criteria to determine crisis resolution established by the investigators were extremely stringent and difficult to implement, leading to a high proportion of participants with incomplete documentation,” Dr. Zylke noted. “Also, incomplete documentation occurred more often in the placebo group than the intervention group, resulting in more imputation of missing values for the placebo group, which favored the poloxamer 188 group.”
In the current trial, a “more easily verified primary outcome was selected, with data available for 99% of participants.”
The report by Dr. Casella and colleagues “adds to the evidence base and illustrates some of the challenges in finding effective treatments for patients with sickle cell disease,” he said.
This study was funded by Mast Therapeutics (previously Adventrx Therapeutics). Dr. Casella reported receiving grants from Mast Therapeutics and receiving an honorarium, travel expenses, and salary support through Johns Hopkins for providing consultative advice to Mast Pharmaceuticals during development of the clinical trial and for serving as the principal investigator for the clinical trial; being an inventor and a named party on a patent and licensing agreement to ImmunArray through Johns Hopkins for a panel of brain biomarkers for the detection of brain injury; and holding a patent for aptamers as a potential treatment for sickle cell disease. Dr. Zylke reported having no disclosures.
FROM JAMA
Obstructive sleep apnea linked to COVID-19 risk
Greater severity of obstructive sleep apnea (OSA) is associated with a higher risk of contracting COVID-19, and positive airway pressure (PAP) treatment may counter that risk, according to a retrospective analysis from the records of Kaiser Permanente Southern California.
OSA patients often worry that PAP therapy might increase risk of severe COVID-19, said Dennis Hwang, MD, who presented the study at the American Thoracic Society’s virtual international conference (Abstract A1108). But the findings should be reassuring. “If you have obstructive sleep apnea, and you’re supposed to be using PAP, we recommend that you continue using PAP. It’s good for your overall wellness and reducing the risk of cardiovascular disease, but as it relates to COVID-19, it’s possible that it could protect. And there doesn’t appear to be any risk of increased severity of illness (with use of PAP),” Dr. Hwang said in an interview. He is medical director of sleep medicine for Kaiser Permanente San Bernardino County and cochair of sleep medicine for Kaiser Southern California.
He noted that the retrospective nature of the study makes it difficult to pin down whether PAP therapy is truly protective, “but I think there’s enough that we’ve been able conceptually to understand, to suggest that a direct causative relationship is possible,” said Dr. Hwang.
The results may imply that OSA patients should pay special attention to their OSA when there’s concern about exposure to an infectious agent like SARS-CoV-2. “The intermittent hypoxia at night, which can linger over to the day as increased sympathetic activity, increased heart rate. All of these are stresses to the body. So if you’re going to get infected, you want to start at a healthier level. You want to eliminate your sleep apnea to help reduce your risk of morbidity,” said Esra Tasali, MD, who was asked to comment on the study. Dr. Tasali is associate professor of medicine at the University of Chicago, and director of the Sleep Research Center there.
During the Q&A session after the talk, audience members asked about the timing of PAP use during COVID-19 infection, for example how often it was used during the asymptomatic phase of infection and if PAP has a positive effect. The data were not available, but “I think that the way to go is to understand this chronology,” said Dr. Tasali.
The researchers examined records between 2015 and 2020, using sleep study data, remotely collected daily PAP data, and electronic health records, all from Kaiser Permanente Southern California. Included subjects were adults who had enrolled before Feb. 1, 2020, and had sleep diagnostic or PAP data on record by March 1, 2020. The researchers analyzed PAP adherence between March 1, 2020, and the time of COVID-19 diagnosis, or until the study ended on July 31, 2020.
Patients were defined as being untreated (< 2 hours/night PAP), moderately treated (2-3.9 hours/night), or well treated (4 or more hours/night). Apnea hypopnea index (AHI) was used to determine severity. The analysis included 81,932 patients (39.8% were women, mean age was 54.0 years, 9.9% were Black, and 34.5% were Hispanic). A total of 1.7% of subjects without OSA experienced COVID-19 infection, compared to 1.8% with OSA; 0.3% with OSA were hospitalized and 0.07% underwent intensive care or died.
There were some differences between the two groups. The non-USA population was younger (mean age 47.0 vs. 54.5 years), was less likely to be men (44% vs. 60.3%), had a lower mean body mass index (30.4 vs. 34.3), had fewer comorbidities according to the Charleston Comorbidity Index (1.3 vs. 2.0), and were less likely to have hypertension (5.6% vs. 12.4%; P < .0001 for all).
Infection rates were higher in patients with more severe OSA. The rates in untreated mild, moderate, and severe OSA were 2%, 2%, and 2.4% respectively. The rate among all treated patients was 1.4% (P < .0001). Infection rates also dropped among patients with better treatment: untreated, 2.1%; moderately treated, 1.7%; and well treated, 1.3% (P < .0001).
Not having OSA was associated with a lower infection risk than was having OSA (odds ratio [OR], 0.82; 95% confidence interval, 0.70-0.96). Compared to untreated patients, there was lower infection risk in the moderately treated (OR, 0.82; 95% CI, 0.65-1.03) and well treated (OR, 0.68; 95% CI, 0.59-0.79) groups. Higher infection rates were associated with obesity, higher Charlson Comorbidity score (> 2; OR, 1.29; 95% CI, 1.09-1.53), Black (OR, 1.51; 95% CI, 1.24-1.84) and Hispanic ethnicities (OR, 2.23; 95% CI, 1.96-2.54), and Medicaid enrollment. Increasing age was associated with lower risk of infection, with each 5-year increment linked to reduced risk (OR, 0.88; 95% CI, 0.86-0.90). Dr. Hwang suggested that the age association may be because older individuals were more likely to follow social distancing and other precautions.
A multivariate analysis found that OSA was associated with infection risk according to OSA severity, including mild (OR, 1.21; 95% CI, 1.01-1.44), and moderate to severe (OR, 1.27; 95% CI, 1.07-1.51). There was no association between hospitalization rate or ICU admission/death and presence of OSA or PAP adherence in the data presented, but Dr. Hwang said that an updated analysis suggests that OSA may be associated with a risk of greater COVID-19 severity.
The control group was composed of individuals who had undergone sleep testing, but found to not have OSA. Still, they aren’t necessarily representative of the general population, since symptoms likely drove them to testing. A high percentage were also obese, and the average BMI was 30. “It’s certainly not a ‘normal population,’ but the advantage of what we did in terms of using this control group is that they underwent sleep testing, so they were proven to have no obstructive sleep apnea, whereas if we used a general population, we just don’t know,” said Dr. Hwang.
The study received technical and data support from Somnoware, and was funded by Kaiser Permanente. Dr. Tasali has no relevant financial disclosures.
Greater severity of obstructive sleep apnea (OSA) is associated with a higher risk of contracting COVID-19, and positive airway pressure (PAP) treatment may counter that risk, according to a retrospective analysis from the records of Kaiser Permanente Southern California.
OSA patients often worry that PAP therapy might increase risk of severe COVID-19, said Dennis Hwang, MD, who presented the study at the American Thoracic Society’s virtual international conference (Abstract A1108). But the findings should be reassuring. “If you have obstructive sleep apnea, and you’re supposed to be using PAP, we recommend that you continue using PAP. It’s good for your overall wellness and reducing the risk of cardiovascular disease, but as it relates to COVID-19, it’s possible that it could protect. And there doesn’t appear to be any risk of increased severity of illness (with use of PAP),” Dr. Hwang said in an interview. He is medical director of sleep medicine for Kaiser Permanente San Bernardino County and cochair of sleep medicine for Kaiser Southern California.
He noted that the retrospective nature of the study makes it difficult to pin down whether PAP therapy is truly protective, “but I think there’s enough that we’ve been able conceptually to understand, to suggest that a direct causative relationship is possible,” said Dr. Hwang.
The results may imply that OSA patients should pay special attention to their OSA when there’s concern about exposure to an infectious agent like SARS-CoV-2. “The intermittent hypoxia at night, which can linger over to the day as increased sympathetic activity, increased heart rate. All of these are stresses to the body. So if you’re going to get infected, you want to start at a healthier level. You want to eliminate your sleep apnea to help reduce your risk of morbidity,” said Esra Tasali, MD, who was asked to comment on the study. Dr. Tasali is associate professor of medicine at the University of Chicago, and director of the Sleep Research Center there.
During the Q&A session after the talk, audience members asked about the timing of PAP use during COVID-19 infection, for example how often it was used during the asymptomatic phase of infection and if PAP has a positive effect. The data were not available, but “I think that the way to go is to understand this chronology,” said Dr. Tasali.
The researchers examined records between 2015 and 2020, using sleep study data, remotely collected daily PAP data, and electronic health records, all from Kaiser Permanente Southern California. Included subjects were adults who had enrolled before Feb. 1, 2020, and had sleep diagnostic or PAP data on record by March 1, 2020. The researchers analyzed PAP adherence between March 1, 2020, and the time of COVID-19 diagnosis, or until the study ended on July 31, 2020.
Patients were defined as being untreated (< 2 hours/night PAP), moderately treated (2-3.9 hours/night), or well treated (4 or more hours/night). Apnea hypopnea index (AHI) was used to determine severity. The analysis included 81,932 patients (39.8% were women, mean age was 54.0 years, 9.9% were Black, and 34.5% were Hispanic). A total of 1.7% of subjects without OSA experienced COVID-19 infection, compared to 1.8% with OSA; 0.3% with OSA were hospitalized and 0.07% underwent intensive care or died.
There were some differences between the two groups. The non-USA population was younger (mean age 47.0 vs. 54.5 years), was less likely to be men (44% vs. 60.3%), had a lower mean body mass index (30.4 vs. 34.3), had fewer comorbidities according to the Charleston Comorbidity Index (1.3 vs. 2.0), and were less likely to have hypertension (5.6% vs. 12.4%; P < .0001 for all).
Infection rates were higher in patients with more severe OSA. The rates in untreated mild, moderate, and severe OSA were 2%, 2%, and 2.4% respectively. The rate among all treated patients was 1.4% (P < .0001). Infection rates also dropped among patients with better treatment: untreated, 2.1%; moderately treated, 1.7%; and well treated, 1.3% (P < .0001).
Not having OSA was associated with a lower infection risk than was having OSA (odds ratio [OR], 0.82; 95% confidence interval, 0.70-0.96). Compared to untreated patients, there was lower infection risk in the moderately treated (OR, 0.82; 95% CI, 0.65-1.03) and well treated (OR, 0.68; 95% CI, 0.59-0.79) groups. Higher infection rates were associated with obesity, higher Charlson Comorbidity score (> 2; OR, 1.29; 95% CI, 1.09-1.53), Black (OR, 1.51; 95% CI, 1.24-1.84) and Hispanic ethnicities (OR, 2.23; 95% CI, 1.96-2.54), and Medicaid enrollment. Increasing age was associated with lower risk of infection, with each 5-year increment linked to reduced risk (OR, 0.88; 95% CI, 0.86-0.90). Dr. Hwang suggested that the age association may be because older individuals were more likely to follow social distancing and other precautions.
A multivariate analysis found that OSA was associated with infection risk according to OSA severity, including mild (OR, 1.21; 95% CI, 1.01-1.44), and moderate to severe (OR, 1.27; 95% CI, 1.07-1.51). There was no association between hospitalization rate or ICU admission/death and presence of OSA or PAP adherence in the data presented, but Dr. Hwang said that an updated analysis suggests that OSA may be associated with a risk of greater COVID-19 severity.
The control group was composed of individuals who had undergone sleep testing, but found to not have OSA. Still, they aren’t necessarily representative of the general population, since symptoms likely drove them to testing. A high percentage were also obese, and the average BMI was 30. “It’s certainly not a ‘normal population,’ but the advantage of what we did in terms of using this control group is that they underwent sleep testing, so they were proven to have no obstructive sleep apnea, whereas if we used a general population, we just don’t know,” said Dr. Hwang.
The study received technical and data support from Somnoware, and was funded by Kaiser Permanente. Dr. Tasali has no relevant financial disclosures.
Greater severity of obstructive sleep apnea (OSA) is associated with a higher risk of contracting COVID-19, and positive airway pressure (PAP) treatment may counter that risk, according to a retrospective analysis from the records of Kaiser Permanente Southern California.
OSA patients often worry that PAP therapy might increase risk of severe COVID-19, said Dennis Hwang, MD, who presented the study at the American Thoracic Society’s virtual international conference (Abstract A1108). But the findings should be reassuring. “If you have obstructive sleep apnea, and you’re supposed to be using PAP, we recommend that you continue using PAP. It’s good for your overall wellness and reducing the risk of cardiovascular disease, but as it relates to COVID-19, it’s possible that it could protect. And there doesn’t appear to be any risk of increased severity of illness (with use of PAP),” Dr. Hwang said in an interview. He is medical director of sleep medicine for Kaiser Permanente San Bernardino County and cochair of sleep medicine for Kaiser Southern California.
He noted that the retrospective nature of the study makes it difficult to pin down whether PAP therapy is truly protective, “but I think there’s enough that we’ve been able conceptually to understand, to suggest that a direct causative relationship is possible,” said Dr. Hwang.
The results may imply that OSA patients should pay special attention to their OSA when there’s concern about exposure to an infectious agent like SARS-CoV-2. “The intermittent hypoxia at night, which can linger over to the day as increased sympathetic activity, increased heart rate. All of these are stresses to the body. So if you’re going to get infected, you want to start at a healthier level. You want to eliminate your sleep apnea to help reduce your risk of morbidity,” said Esra Tasali, MD, who was asked to comment on the study. Dr. Tasali is associate professor of medicine at the University of Chicago, and director of the Sleep Research Center there.
During the Q&A session after the talk, audience members asked about the timing of PAP use during COVID-19 infection, for example how often it was used during the asymptomatic phase of infection and if PAP has a positive effect. The data were not available, but “I think that the way to go is to understand this chronology,” said Dr. Tasali.
The researchers examined records between 2015 and 2020, using sleep study data, remotely collected daily PAP data, and electronic health records, all from Kaiser Permanente Southern California. Included subjects were adults who had enrolled before Feb. 1, 2020, and had sleep diagnostic or PAP data on record by March 1, 2020. The researchers analyzed PAP adherence between March 1, 2020, and the time of COVID-19 diagnosis, or until the study ended on July 31, 2020.
Patients were defined as being untreated (< 2 hours/night PAP), moderately treated (2-3.9 hours/night), or well treated (4 or more hours/night). Apnea hypopnea index (AHI) was used to determine severity. The analysis included 81,932 patients (39.8% were women, mean age was 54.0 years, 9.9% were Black, and 34.5% were Hispanic). A total of 1.7% of subjects without OSA experienced COVID-19 infection, compared to 1.8% with OSA; 0.3% with OSA were hospitalized and 0.07% underwent intensive care or died.
There were some differences between the two groups. The non-USA population was younger (mean age 47.0 vs. 54.5 years), was less likely to be men (44% vs. 60.3%), had a lower mean body mass index (30.4 vs. 34.3), had fewer comorbidities according to the Charleston Comorbidity Index (1.3 vs. 2.0), and were less likely to have hypertension (5.6% vs. 12.4%; P < .0001 for all).
Infection rates were higher in patients with more severe OSA. The rates in untreated mild, moderate, and severe OSA were 2%, 2%, and 2.4% respectively. The rate among all treated patients was 1.4% (P < .0001). Infection rates also dropped among patients with better treatment: untreated, 2.1%; moderately treated, 1.7%; and well treated, 1.3% (P < .0001).
Not having OSA was associated with a lower infection risk than was having OSA (odds ratio [OR], 0.82; 95% confidence interval, 0.70-0.96). Compared to untreated patients, there was lower infection risk in the moderately treated (OR, 0.82; 95% CI, 0.65-1.03) and well treated (OR, 0.68; 95% CI, 0.59-0.79) groups. Higher infection rates were associated with obesity, higher Charlson Comorbidity score (> 2; OR, 1.29; 95% CI, 1.09-1.53), Black (OR, 1.51; 95% CI, 1.24-1.84) and Hispanic ethnicities (OR, 2.23; 95% CI, 1.96-2.54), and Medicaid enrollment. Increasing age was associated with lower risk of infection, with each 5-year increment linked to reduced risk (OR, 0.88; 95% CI, 0.86-0.90). Dr. Hwang suggested that the age association may be because older individuals were more likely to follow social distancing and other precautions.
A multivariate analysis found that OSA was associated with infection risk according to OSA severity, including mild (OR, 1.21; 95% CI, 1.01-1.44), and moderate to severe (OR, 1.27; 95% CI, 1.07-1.51). There was no association between hospitalization rate or ICU admission/death and presence of OSA or PAP adherence in the data presented, but Dr. Hwang said that an updated analysis suggests that OSA may be associated with a risk of greater COVID-19 severity.
The control group was composed of individuals who had undergone sleep testing, but found to not have OSA. Still, they aren’t necessarily representative of the general population, since symptoms likely drove them to testing. A high percentage were also obese, and the average BMI was 30. “It’s certainly not a ‘normal population,’ but the advantage of what we did in terms of using this control group is that they underwent sleep testing, so they were proven to have no obstructive sleep apnea, whereas if we used a general population, we just don’t know,” said Dr. Hwang.
The study received technical and data support from Somnoware, and was funded by Kaiser Permanente. Dr. Tasali has no relevant financial disclosures.
FROM ATS 2021
Hospitalist movers and shakers – May 2021
Rebecca Jaffe, MD, has been elevated to the permanent role of director of the division of hospital medicine at Thomas Jefferson University Hospital in Philadelphia. Dr. Jaffe has been the interim director since July 2020.
In the position, Dr. Jaffe will be responsible for leading an academic hospital medicine division that includes 36 faculty and 10 advanced-practice providers. She said her focus will be on developing physicians, advanced providers, and the inpatient practice model used while “educating the next generation of creative and compassionate clinicians.”
Dr. Jaffe is associate professor of medicine at Jefferson’s Sidney Kimmel Medical College and the hospital’s director of clinical learning environment improvement.
Christopher Freer, DO, recently was named the new senior vice president for emergency hospital medicine for RWJBarnabas Health (West Orange, N.J.). In a concurrent move, Maninder “Dolly” Abraham, MD, was named RWJBH’s chief of hospital medicine. The selections were made as RWJBH has become a direct employer for Envision Physician Services, a former hospital partner.
Dr. Freer has spent the past 5 years with RWJBH, where he has served as emergency services system director since 2015. He previously worked in leadership roles at Saint Barnabas Medical Center.
Dr. Abraham was previously medical director of Saint Barnabas’ hospitalist program, as well as a regional medical director with Envision during her 17 years of experience.
Sheetal Patel, MD, has been named the new regional medical director for Eagle Telemedicine (Cincinnati, Ohio), a physician-led company that provides telehospitalist services to hospitals around the country.
Dr. Patel will work closely with hospital administrators and medical directors to provide high-level telemedicine services, as well as devising processes and guidelines to guarantee streamlined care across Eagle’s facilities.
Dr. Patel has spent 4 years as a telehospitalist for Eagle, where she has been in charge of guiding on-site and remote staff members and providing training to new telehospitalists.
Timothy Crone, MD, MBA, has been elevated to the role of president of Cleveland Clinic Mercy Hospital (Canton, Ohio). The move comes as Cleveland Clinic recently added Mercy Medical Center as a full member of its health system.
Dr. Crone has served as chief medical officer at Cleveland Clinic Hillcrest Hospital in Cleveland since 2019. Previously, he was a medical director in enterprise business intelligence and analytics in medical operations at Cleveland Clinic’s main campus. He also was vice chairman of hospital medicine and has served as a staff hospitalist since 2010.
In addition to his role as president, Dr. Crone plans to work in patient care at Mercy Hospital.
Just prior to the start of 2021, Wake Forest Baptist Health (Winston-Salem, N.C.) established a “Hospitalist at Home” program with the goal of reducing the length of time patients spend in the hospital.
Hospitalist at Home was created as the COVID-19 pandemic threatened hospital capacity. Wakehealth’s innovative approach involves developing an at-home plan with each patient before they leave the facility. Patients include those with COVID-19 who are stable but require supplemental oxygen or have diseases that need intravenous medication administration.
At home, a Wakehealth paramedic visits the patient while a hospitalist communicates and reviews the patient’s care plan via smartphone, tablet, or computer. The visits continue until the patient’s hospital-related care is complete.
The Multicare Health System (Tacoma, Wash.) has bulked up its hospitalist program by partnering with nationwide, physician-led health care provider Sound Physicians. The goal is to provide health care management at a regional level instead of individually per hospital.
Sound Physicians, which already contracts to provide hospitalist services at two Multicare facilities in Washington, transitioned its services to three other facilities as of April 5, 2021.
Conemaugh Meyersdale Medical Center (Meyersdale, Pa.) has started a hospitalist program at its facility in Somerset County. The program will be led by nurse practitioners Zeke Feyock and Sarah Piscatello.
Rebecca Jaffe, MD, has been elevated to the permanent role of director of the division of hospital medicine at Thomas Jefferson University Hospital in Philadelphia. Dr. Jaffe has been the interim director since July 2020.
In the position, Dr. Jaffe will be responsible for leading an academic hospital medicine division that includes 36 faculty and 10 advanced-practice providers. She said her focus will be on developing physicians, advanced providers, and the inpatient practice model used while “educating the next generation of creative and compassionate clinicians.”
Dr. Jaffe is associate professor of medicine at Jefferson’s Sidney Kimmel Medical College and the hospital’s director of clinical learning environment improvement.
Christopher Freer, DO, recently was named the new senior vice president for emergency hospital medicine for RWJBarnabas Health (West Orange, N.J.). In a concurrent move, Maninder “Dolly” Abraham, MD, was named RWJBH’s chief of hospital medicine. The selections were made as RWJBH has become a direct employer for Envision Physician Services, a former hospital partner.
Dr. Freer has spent the past 5 years with RWJBH, where he has served as emergency services system director since 2015. He previously worked in leadership roles at Saint Barnabas Medical Center.
Dr. Abraham was previously medical director of Saint Barnabas’ hospitalist program, as well as a regional medical director with Envision during her 17 years of experience.
Sheetal Patel, MD, has been named the new regional medical director for Eagle Telemedicine (Cincinnati, Ohio), a physician-led company that provides telehospitalist services to hospitals around the country.
Dr. Patel will work closely with hospital administrators and medical directors to provide high-level telemedicine services, as well as devising processes and guidelines to guarantee streamlined care across Eagle’s facilities.
Dr. Patel has spent 4 years as a telehospitalist for Eagle, where she has been in charge of guiding on-site and remote staff members and providing training to new telehospitalists.
Timothy Crone, MD, MBA, has been elevated to the role of president of Cleveland Clinic Mercy Hospital (Canton, Ohio). The move comes as Cleveland Clinic recently added Mercy Medical Center as a full member of its health system.
Dr. Crone has served as chief medical officer at Cleveland Clinic Hillcrest Hospital in Cleveland since 2019. Previously, he was a medical director in enterprise business intelligence and analytics in medical operations at Cleveland Clinic’s main campus. He also was vice chairman of hospital medicine and has served as a staff hospitalist since 2010.
In addition to his role as president, Dr. Crone plans to work in patient care at Mercy Hospital.
Just prior to the start of 2021, Wake Forest Baptist Health (Winston-Salem, N.C.) established a “Hospitalist at Home” program with the goal of reducing the length of time patients spend in the hospital.
Hospitalist at Home was created as the COVID-19 pandemic threatened hospital capacity. Wakehealth’s innovative approach involves developing an at-home plan with each patient before they leave the facility. Patients include those with COVID-19 who are stable but require supplemental oxygen or have diseases that need intravenous medication administration.
At home, a Wakehealth paramedic visits the patient while a hospitalist communicates and reviews the patient’s care plan via smartphone, tablet, or computer. The visits continue until the patient’s hospital-related care is complete.
The Multicare Health System (Tacoma, Wash.) has bulked up its hospitalist program by partnering with nationwide, physician-led health care provider Sound Physicians. The goal is to provide health care management at a regional level instead of individually per hospital.
Sound Physicians, which already contracts to provide hospitalist services at two Multicare facilities in Washington, transitioned its services to three other facilities as of April 5, 2021.
Conemaugh Meyersdale Medical Center (Meyersdale, Pa.) has started a hospitalist program at its facility in Somerset County. The program will be led by nurse practitioners Zeke Feyock and Sarah Piscatello.
Rebecca Jaffe, MD, has been elevated to the permanent role of director of the division of hospital medicine at Thomas Jefferson University Hospital in Philadelphia. Dr. Jaffe has been the interim director since July 2020.
In the position, Dr. Jaffe will be responsible for leading an academic hospital medicine division that includes 36 faculty and 10 advanced-practice providers. She said her focus will be on developing physicians, advanced providers, and the inpatient practice model used while “educating the next generation of creative and compassionate clinicians.”
Dr. Jaffe is associate professor of medicine at Jefferson’s Sidney Kimmel Medical College and the hospital’s director of clinical learning environment improvement.
Christopher Freer, DO, recently was named the new senior vice president for emergency hospital medicine for RWJBarnabas Health (West Orange, N.J.). In a concurrent move, Maninder “Dolly” Abraham, MD, was named RWJBH’s chief of hospital medicine. The selections were made as RWJBH has become a direct employer for Envision Physician Services, a former hospital partner.
Dr. Freer has spent the past 5 years with RWJBH, where he has served as emergency services system director since 2015. He previously worked in leadership roles at Saint Barnabas Medical Center.
Dr. Abraham was previously medical director of Saint Barnabas’ hospitalist program, as well as a regional medical director with Envision during her 17 years of experience.
Sheetal Patel, MD, has been named the new regional medical director for Eagle Telemedicine (Cincinnati, Ohio), a physician-led company that provides telehospitalist services to hospitals around the country.
Dr. Patel will work closely with hospital administrators and medical directors to provide high-level telemedicine services, as well as devising processes and guidelines to guarantee streamlined care across Eagle’s facilities.
Dr. Patel has spent 4 years as a telehospitalist for Eagle, where she has been in charge of guiding on-site and remote staff members and providing training to new telehospitalists.
Timothy Crone, MD, MBA, has been elevated to the role of president of Cleveland Clinic Mercy Hospital (Canton, Ohio). The move comes as Cleveland Clinic recently added Mercy Medical Center as a full member of its health system.
Dr. Crone has served as chief medical officer at Cleveland Clinic Hillcrest Hospital in Cleveland since 2019. Previously, he was a medical director in enterprise business intelligence and analytics in medical operations at Cleveland Clinic’s main campus. He also was vice chairman of hospital medicine and has served as a staff hospitalist since 2010.
In addition to his role as president, Dr. Crone plans to work in patient care at Mercy Hospital.
Just prior to the start of 2021, Wake Forest Baptist Health (Winston-Salem, N.C.) established a “Hospitalist at Home” program with the goal of reducing the length of time patients spend in the hospital.
Hospitalist at Home was created as the COVID-19 pandemic threatened hospital capacity. Wakehealth’s innovative approach involves developing an at-home plan with each patient before they leave the facility. Patients include those with COVID-19 who are stable but require supplemental oxygen or have diseases that need intravenous medication administration.
At home, a Wakehealth paramedic visits the patient while a hospitalist communicates and reviews the patient’s care plan via smartphone, tablet, or computer. The visits continue until the patient’s hospital-related care is complete.
The Multicare Health System (Tacoma, Wash.) has bulked up its hospitalist program by partnering with nationwide, physician-led health care provider Sound Physicians. The goal is to provide health care management at a regional level instead of individually per hospital.
Sound Physicians, which already contracts to provide hospitalist services at two Multicare facilities in Washington, transitioned its services to three other facilities as of April 5, 2021.
Conemaugh Meyersdale Medical Center (Meyersdale, Pa.) has started a hospitalist program at its facility in Somerset County. The program will be led by nurse practitioners Zeke Feyock and Sarah Piscatello.