Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.

In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.

At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.

“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.

Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.

“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.

“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”

The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.

Associations Have Been “Unclear”

Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS, the full association between depression and MS disease activity “is not clear,” the investigators note.

For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.

MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).

Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.

In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).

“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.

Worse Performance

After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).

The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.

At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).

There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.

Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.

“This means that patients themselves may not even realize that they were getting worse,” Feng said.

Underpowered Study?

Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.

The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.

Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.

“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.

The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.

In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.

Unusual, Intriguing Findings

Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.

“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.

However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.

“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.

“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.

He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.

Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.

“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”

Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.

“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.

Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
 

This article appeared on Medscape.com.

Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.

In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.

At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.

“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.

Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.

“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.

“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”

The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.

Associations Have Been “Unclear”

Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS, the full association between depression and MS disease activity “is not clear,” the investigators note.

For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.

MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).

Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.

In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).

“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.

Worse Performance

After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).

The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.

At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).

There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.

Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.

“This means that patients themselves may not even realize that they were getting worse,” Feng said.

Underpowered Study?

Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.

The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.

Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.

“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.

The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.

In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.

Unusual, Intriguing Findings

Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.

“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.

However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.

“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.

“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.

He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.

Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.

“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”

Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.

“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.

Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
 

This article appeared on Medscape.com.

Depression is associated with decreased neurologic function and new brain lesions in patients with multiple sclerosis (MS), new research suggests.

In an observational study of more than 2500 patients with relapsing-remitting MS (RRMS), participants with self-reported depression were more likely to have worse scores on neuroperformance measures, such as processing speed tests, than their peers without depression.

At baseline, the group with depression also had greater odds of having at least one new contrast-enhancing lesion on MRI.

“Our results suggest that depression is not merely a reactive symptom but indicates increased risk of future MS disease activity,” the investigators note.

Lead author Jenny Feng, MD, clinical associate at the Mellen Center for MS Treatment and Research at Cleveland Clinic, added that depression should be routinely screened for in all patients with MS, something done routinely at her center.

“Every single patient that comes through the door with newly diagnosed MS, we refer to neuropsychology to screen for depression; and if there is depression, then we actively manage it because it does have an effect” on patients, she told Medscape Medical News.

“Depression isn’t just a neuropsychiatric disease,” Feng added. As shown in their study, “it may have effects on MS, especially with regards to performance in neurological function testing.”

The research is presented on AAN.com as part of the American Academy of Neurology 2020 Science Highlights. Because of the COVID-19 pandemic, the AAN had to cancel its 2020 annual meeting.

Associations Have Been “Unclear”

Although inflammatory, psychosocial, and neurodegenerative factors “have been hypothesized as etiologies” for why depression is commonly found in patients with MS, the full association between depression and MS disease activity “is not clear,” the investigators note.

For the current study, they assessed data from the Partners Advancing Technology and Health Solutions (MS-PATHS) database, an ongoing collaborative network of seven MS centers in the United States and three in Europe.

MS disease history and MRI data were examined, as well as 12-month scores on neuroperformance tests measuring processing speed (Symbol Digit Modalities Test), walking speed (Timed 25-Foot Walk), and manual dexterity (Nine-Hole Peg Test).

Patient-reported outcomes (PROs), as measured with the Quality of Life in Neurological Disorders (Neuro-QoL) and patient-determined disease steps, were also assessed. Depression was defined as a depression T score at baseline greater than “the 50th percentile” on the Neuro-QoL.

In the patient sample, 1333 of the participants with RRMS were classified as “not depressed” (73.7% women; mean age, 45.6 years; disease duration, 13.7 years) while 1172 were “depressed” (78.4% women; mean age, 45.9 years; disease duration, 14.3 years).

“To balance for baseline variances in the observational cohort between group with depression and group without depression, propensity score analysis was used to adjust for potential confounding factors,” the investigators report.

Worse Performance

After adjustment for baseline covariates, results showed that the depressed patients performed worse on the walking speed test (0.48; 95% confidence interval, 0.038-0.918) and processing speed test (–1.899; 95% CI, –3.548 to –0.250).

The depressed group also had increased odds at baseline of having new contrast-enhancing lesions (odds ratio, 5.89; 95% CI, 2.236-15.517). This demonstrated an “association of depression and neuroinflammatory activity” in the central nervous system, the investigators note.

At 12 months, processing speed continued to be worse in the depressed group (–1.68; 95% CI, –3.254 to –0.105).

There were trends, albeit insignificant, for decreased walking speed scores at 12 months and for decreased manual dexterity scores at both baseline and at 12 months for the participants who were depressed.

Interestingly, there were “no significant differences in PROs at month 12, despite worsening neuroperformance,” the investigators report.

“This means that patients themselves may not even realize that they were getting worse,” Feng said.

Underpowered Study?

Further results showed nonsignificant trends for increased T2 lesion volume and white matter fraction and decreased brain volume, gray matter fraction, and cortical gray matter volume at baseline and at 12 months in the depressed group.

The researchers note that study limitations include the unavailability of information on treatment compliance for depression or date of depression onset.

Feng added that because this was an observational study, other missing data included depression status for some patients at year 1 and some MRI metrics.

“So this may have been underpowered to detect some of the results. The power may have been inadequate to detect all changes,” she said.

The investigators write that future research should assess larger sample sizes with longer follow-ups and should use more advanced MRI measures, such as diffusion tensor imaging or functional MRI.

In addition, they will continue examining data from MS-PATHS. “With the newest data cut, we have new patients that we can analyze. So perhaps that can provide sufficient power to detect [more MRI] changes,” Feng said.

Unusual, Intriguing Findings

Commenting on the study for Medscape Medical News, Mark Freedman, MD, professor of neurology at the University of Ottawa and director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital Research Institute, noted that he wasn’t terribly surprised” by the overall findings.

“We’ve known for years that patients who are depressed don’t do as well on our performance methods,” said Freedman, who was not involved with the research.

However, the current investigators “took a huge number of patients in this multicenter study and started using some of the statistical methods we’ve seen in the use of real-world evidence,” he noted.

“So you’re looking at some outcome measures and you have to ask yourself, ‘Why would it influence that?’ and ‘Did it happen by chance or not?’ And you ask why it is that depressed people might actually have more lesions on their MRI, which is something that is unusual,” Freedman said.

“When you start to look at this, even when you’re trying to standardize things for the differences that we know of, there are some stuff that comes out as intriguing. In general, I think those depressed patients did worse on several outcome measures that one would say, ‘That’s somewhat surprising.’ That’s why this group was very careful to not conclude absolutely that depression drives this disease. But it was consistently trending in the direction that it looks like there was more inflammatory activity in these people,” he said.

He echoed the investigators’ note that drug adherence and which depression treatment was used wasn’t controlled for; and he added that depression in the study was not based on receiving a diagnosis of clinical depression but on self-report.

Still, the patients classified as depressed “did worse. They didn’t walk as fast, which was interesting; and we know that cognitive performance is often damped because of poor concentration. But how do you get worse MRIs? This study is raising a question and [the researchers] conclude that it may be that depression might be an independent factor” for that outcome, Freedman said.

“It might be that you could get more out of a particular [MS] medicine if you pay attention to depression; and if that’s the investigators’ conclusion, and I think it is, then I certainly agree with it.”

Freedman noted that, instead of a blanket recommendation that all patients with MS should be screened for depression, he thinks clinicians, especially those at smaller centers, should focus on what’s best for treating all aspects of an individual patient.

“Don’t try to manage them if you’re not going to manage the entire picture. Looking at depression and mood and other things is very important. And if you have the capacity for an official screening, I think it’s wonderful; but not everybody does,” he said.

Feng and Freedman have disclosed no relevant financial relationships. Freedman is currently a member of the Medscape Neurology Advisory Board.
 

This article appeared on Medscape.com.

Kind wishes and donations worldwide came to help Australian communities and wildlife affected by the extreme drought and uncontrollable bushfires. Indeed, Australians have become a warning beacon for the planet to recognize how factors associated with global warming can morph rapidly into runaway national emergencies.

Little attention, however, has addressed the extreme vulnerability of Australia’s First Nations people, the Aboriginal & Torres Strait Islander communities, to the climate crisis. U.N. reports conclude that “Indigenous people with close emotional and ancestral ties to the land are also likely to be disproportionately affected by environmental change and extreme weather events.”¹

In fact, Indigenous peoples, whether living traditionally or assimilated, are among the first to be adversely affected by climate change. This is because, in part, of extreme poverty, inadequate housing, unemployment and other social determinants, transgenerational cultural losses of life and culture, dislocations, traumatic experiences of child removal, overrepresentation in the prison system, and chronic diseases already leading to dramatic disparities in life expectancy and other health outcomes.

Research confirms that rural and remote Aboriginal communities will be Australia’s first mass climate refugees. “Without action to stop climate change, people will be forced to leave their country and leave behind much of what makes them Aboriginal.”² This is because of hotter temperatures, poorly built and unstable homes more vulnerable to heat, and longer and drier droughts. Their communities, in fire-prone townships, are running out of water. Abject poverty severely limits their options, aggravated by government inaction because of ideological climate change denialism. And now we have the overlay of COVID-19 threatening these communities.³

Human pandemics are potentially more likely to occur with climate change. Pandemics also are more apt to be associated with population growth, human settlement encroaching on forests, increasing wild animal or intermediary vector contact, and growth in global travel.

Subsequently, our Indigenous communities have had the most to lose if COVID-19 is let loose in their midst. Spatial separation is difficult in overcrowded, multigenerational households. It is hard to keep your hands washed with soap where reliable water supply is sometimes only communal. Their health workers’ access to protective and lifesaving ICU equipment and expertise may be extremely limited or erratic.

Much of the population is classified as highly vulnerable to COVID-19 because of chronic health disorders (for example, cardiovascular, respiratory, and renal issues; diabetes, and suicidality) and preexisting much shorter life expectancies. Their health workers’ access to protective and lifesaving ICU equipment and expertise is extremely limited. There are fears that, if COVID-19 gains a foothold, they may lose a whole generation of revered elders, who often are also the last fluent tribal language speakers and carriers of life-enhancing cultural stories, traditions, and rites. More urban-living Indigenous families may yet have a rough time avoiding these ravages.

In Australia, COVID-19 has been largely held at bay so far by state and territory governments that have closed borders, restricted nonessential travel, and discouraged or excluded outsiders from visiting remote Indigenous communities wherever possible. There have been complaints that such restrictions occasionally had been applied in these communities in a heavy-handed way by police and other authorities, and may be resisted if enforced unilaterally. They will work only if applied with cultural sensitivity, full Indigenous community consultation, and collaboration. So far, COVID-19 infection rates have been kept very low, with no Indigenous deaths. In Brazil, by contrast, infections and deaths are more than double the national average, itinerant missionaries have only just been excluded from Amazonian tribal lands so far by independent judicial intervention, while loggers and miners come and go freely, as sources of contagion.⁴  Some Indigenous peoples in the United States have experienced among the highest COVID-19 infection and death rates in the country (for example, the Navajo Nation in New Mexico, Arizona, and Utah), amounting to catastrophic loss and grief.

"Black Lives Matter" marches protesting the filmed police killing of George Floyd in the USA have spread worldwide, in the wake of ultra-high rates of police brutality and killings with impunity of non-white individuals.

Many Australians, including considerable numbers of Indigenous people, marched here in sympathy, despite their infective risk and vulnerabilities. They were also protesting the excessive rates of Aboriginal imprisonment, deaths in custody, and police killings without consequences. Both internationally and here, there was an apparent sense of release of pent-up anger and frustrations at both these injustices and the extra susceptibility of poor and non-white people to severe illness, death and dire economic consequences because of the pandemic. It is a deceptive myth that "we are all in this together." So it is encouraging that there is also forming a widespread sense of collective purpose and determination to get governments to address these iniquities and inequities at last.*

I have worked as a community psychiatrist in Barkinje Aboriginal tribal lands of the Far West region of New South Wales (NSW) regularly for 35 years, much of this time while also leading Royal North Shore University General Hospital & Community Mental Health Services in Sydney. Barkinje translates as “River People,” but local media mainly talk about the impact of prolonged drought on farmers and ranchers, who certainly are deeply affected by it. However, the media rarely mention the calamitous impacts on Aboriginal communities. The drought effects are exacerbated by multinational corporate irrigators that divert and allegedly steal river water with tacit encouragement from ostensibly responsible government ministers. The rivers dry up into algal ponds with millions of bloated, rotting dead fish, and entire communities’ water supplies fail.

Researchers have reported on the mental health impacts of prolonged drought and diversion of river water on rural and remote indigenous communities throughout the state of NSW.⁵ We have heard Barkinje and neighboring Wiradjuri people say, “if the land is sick, we are sick,” and, “if the river dries up, there’s nowhere to meet.” Fishing, a popular recreational activity and source of nutrition is now denied to these communities. Unlike farmers, they receive no governmental exceptional circumstance compensation payments during droughts. Instead, they lose their farming jobs, so there is no disposable income and loss of capacity to travel to connect to their extended kinship system and cultural roots (e.g., for funerals or football matches) in other remote townships. Such droughts exacerbate wildfires, loss of fish and birdlife, some of which are sacred spiritual totems; dying of traditional “lifeblood” rivers, decimating precious ancient red-river gumtrees that line the shores; and irreversible damage to other sacred sites (e.g., melting ancient rock art).

So, loss of sustainable food sources, meaningful livelihood, and cultural and leisure pursuits could create an existential threat to Aboriginal identity. However, rural Indigenous communities also told us “whatever you do to us, we will survive and persist, as we have done in the past.”⁶ This is comparable with the tenacity and resilience of other ancient cultures that have suffered genocidal persecution and discrimination in the past, and have stubbornly regrown and persisted and regrown into the future.

They yearn to care for their lands, rivers, and seas of their traditions and upbringing, whether as “saltwater” coastal or “freshwater” inland peoples. They value their extended families, honor their elders and their collective wisdom, while also living in “two worlds.” They often encourage their children to get educated and pursue individualistic aspirations to help their communities by training as tradespeople and professionals who may be better trusted to look after their own. As Charles Perkins, a most celebrated Aboriginal role model for living in both worlds, famously said: “We know we can’t live in the past, but the past lives in us.”

As anxiety and depression, psychological trauma, drug and alcohol misuse, family and communal violence, ecological grief,and suicidal vulnerability are precipitated or exacerbated by the stress of extreme environmental adversity, significant investment in ameliorating these harms is essential, not just for farmers, town businesspeople and their families, but for all those affected, especially these most vulnerable members of the community.⁷ We must provide more essential community services controlled by Aboriginal community members themselves. We must also train and support more Aboriginal mental health workers, healers, mental health educators, peer workers and Aboriginal liaison officers, to work alongside other mental health, and health and social service professionals. Aboriginal people need stable local employment opportunities in their communities. There is a huge opportunity to synergize traditional indigenous fire management with Western techniques, creating and consolidating more valued jobs and respected land management roles for Aboriginal rangers, vital for the future of both Aboriginal and wider communities. Pilot programs are emerging.

Aboriginal communities also need a more preventive, whole-of-life approach to social determinants, lifestyle factors, trauma, and political decisions associated with compromised neurodevelopment, and increased subsequent incidence and severity of mental illnesses in their communities.⁷

As Alexander Solzhenitsyn observed: “On our crowded planet there are no longer any ‘internal affairs.’ ”⁸ Climate change is the ultimate form of globalization: What we each do about it affects all others’ lives. We can only insist that, alongside adequate resourcing of our most evidence-based methods of fire, water, and climate control, our governments consult and listen to our Indigenous elders about applying climate management methods. These have been demonstrated to be sustainable and effective, possibly over 60,000 years – which is the longest established record of continuous Indigenous culture worldwide.

References

1. Ten impacts of the Australian bushfires. U.N. Environment Programme. 2020 Jan 20.

2. Allam L, Evershed N. “Too hot for humans? First Nations people fear becoming Australia’s first climate refugees.” The Guardian. 2019 Dec 17.

3. National Indigenous Australians Agency. “Coronavirus (COVID-19).”

4. Phillips D. “Brazil: Judge bans missionaries from Indigenous reserve over COVID-19 fears.” The Guardian. 2020 Apr 17.

5. Rigby CW et al. Aust J Rural Health. 2011 Oct;19(5):249-54.

6. Cunsolo A, Ellis NR. Nature Clim Change. 2018 Apr 3;8:275-81.

7. Gynther B et al. EClinicalMedicine. 2019 Apr 26;10:68-77.

8. Solzhenitsyn A. “Warning to the West,” speech delivered 30 Jun 1975. New York: Fararr, Straux & Girous, 1976.

Dr. Rosen, an officer of the Order of Australia and a Fellow of the Royal Australian and New Zealand College of Psychiatrists, is affiliated with the Brain & Mind Centre, University of Sydney, and the Institute of Mental Health at the University of Wollongong (Australia). He also is a community psychiatrist in a remote region of New South Wales. Dr. Rosen has no conflicts of interest.

*This article was updated 6/16/2020.

Kind wishes and donations worldwide came to help Australian communities and wildlife affected by the extreme drought and uncontrollable bushfires. Indeed, Australians have become a warning beacon for the planet to recognize how factors associated with global warming can morph rapidly into runaway national emergencies.

Little attention, however, has addressed the extreme vulnerability of Australia’s First Nations people, the Aboriginal & Torres Strait Islander communities, to the climate crisis. U.N. reports conclude that “Indigenous people with close emotional and ancestral ties to the land are also likely to be disproportionately affected by environmental change and extreme weather events.”¹

In fact, Indigenous peoples, whether living traditionally or assimilated, are among the first to be adversely affected by climate change. This is because, in part, of extreme poverty, inadequate housing, unemployment and other social determinants, transgenerational cultural losses of life and culture, dislocations, traumatic experiences of child removal, overrepresentation in the prison system, and chronic diseases already leading to dramatic disparities in life expectancy and other health outcomes.

Research confirms that rural and remote Aboriginal communities will be Australia’s first mass climate refugees. “Without action to stop climate change, people will be forced to leave their country and leave behind much of what makes them Aboriginal.”² This is because of hotter temperatures, poorly built and unstable homes more vulnerable to heat, and longer and drier droughts. Their communities, in fire-prone townships, are running out of water. Abject poverty severely limits their options, aggravated by government inaction because of ideological climate change denialism. And now we have the overlay of COVID-19 threatening these communities.³

Human pandemics are potentially more likely to occur with climate change. Pandemics also are more apt to be associated with population growth, human settlement encroaching on forests, increasing wild animal or intermediary vector contact, and growth in global travel.

Subsequently, our Indigenous communities have had the most to lose if COVID-19 is let loose in their midst. Spatial separation is difficult in overcrowded, multigenerational households. It is hard to keep your hands washed with soap where reliable water supply is sometimes only communal. Their health workers’ access to protective and lifesaving ICU equipment and expertise may be extremely limited or erratic.

Much of the population is classified as highly vulnerable to COVID-19 because of chronic health disorders (for example, cardiovascular, respiratory, and renal issues; diabetes, and suicidality) and preexisting much shorter life expectancies. Their health workers’ access to protective and lifesaving ICU equipment and expertise is extremely limited. There are fears that, if COVID-19 gains a foothold, they may lose a whole generation of revered elders, who often are also the last fluent tribal language speakers and carriers of life-enhancing cultural stories, traditions, and rites. More urban-living Indigenous families may yet have a rough time avoiding these ravages.

In Australia, COVID-19 has been largely held at bay so far by state and territory governments that have closed borders, restricted nonessential travel, and discouraged or excluded outsiders from visiting remote Indigenous communities wherever possible. There have been complaints that such restrictions occasionally had been applied in these communities in a heavy-handed way by police and other authorities, and may be resisted if enforced unilaterally. They will work only if applied with cultural sensitivity, full Indigenous community consultation, and collaboration. So far, COVID-19 infection rates have been kept very low, with no Indigenous deaths. In Brazil, by contrast, infections and deaths are more than double the national average, itinerant missionaries have only just been excluded from Amazonian tribal lands so far by independent judicial intervention, while loggers and miners come and go freely, as sources of contagion.⁴  Some Indigenous peoples in the United States have experienced among the highest COVID-19 infection and death rates in the country (for example, the Navajo Nation in New Mexico, Arizona, and Utah), amounting to catastrophic loss and grief.

"Black Lives Matter" marches protesting the filmed police killing of George Floyd in the USA have spread worldwide, in the wake of ultra-high rates of police brutality and killings with impunity of non-white individuals.

Many Australians, including considerable numbers of Indigenous people, marched here in sympathy, despite their infective risk and vulnerabilities. They were also protesting the excessive rates of Aboriginal imprisonment, deaths in custody, and police killings without consequences. Both internationally and here, there was an apparent sense of release of pent-up anger and frustrations at both these injustices and the extra susceptibility of poor and non-white people to severe illness, death and dire economic consequences because of the pandemic. It is a deceptive myth that "we are all in this together." So it is encouraging that there is also forming a widespread sense of collective purpose and determination to get governments to address these iniquities and inequities at last.*

I have worked as a community psychiatrist in Barkinje Aboriginal tribal lands of the Far West region of New South Wales (NSW) regularly for 35 years, much of this time while also leading Royal North Shore University General Hospital & Community Mental Health Services in Sydney. Barkinje translates as “River People,” but local media mainly talk about the impact of prolonged drought on farmers and ranchers, who certainly are deeply affected by it. However, the media rarely mention the calamitous impacts on Aboriginal communities. The drought effects are exacerbated by multinational corporate irrigators that divert and allegedly steal river water with tacit encouragement from ostensibly responsible government ministers. The rivers dry up into algal ponds with millions of bloated, rotting dead fish, and entire communities’ water supplies fail.

Researchers have reported on the mental health impacts of prolonged drought and diversion of river water on rural and remote indigenous communities throughout the state of NSW.⁵ We have heard Barkinje and neighboring Wiradjuri people say, “if the land is sick, we are sick,” and, “if the river dries up, there’s nowhere to meet.” Fishing, a popular recreational activity and source of nutrition is now denied to these communities. Unlike farmers, they receive no governmental exceptional circumstance compensation payments during droughts. Instead, they lose their farming jobs, so there is no disposable income and loss of capacity to travel to connect to their extended kinship system and cultural roots (e.g., for funerals or football matches) in other remote townships. Such droughts exacerbate wildfires, loss of fish and birdlife, some of which are sacred spiritual totems; dying of traditional “lifeblood” rivers, decimating precious ancient red-river gumtrees that line the shores; and irreversible damage to other sacred sites (e.g., melting ancient rock art).

So, loss of sustainable food sources, meaningful livelihood, and cultural and leisure pursuits could create an existential threat to Aboriginal identity. However, rural Indigenous communities also told us “whatever you do to us, we will survive and persist, as we have done in the past.”⁶ This is comparable with the tenacity and resilience of other ancient cultures that have suffered genocidal persecution and discrimination in the past, and have stubbornly regrown and persisted and regrown into the future.

They yearn to care for their lands, rivers, and seas of their traditions and upbringing, whether as “saltwater” coastal or “freshwater” inland peoples. They value their extended families, honor their elders and their collective wisdom, while also living in “two worlds.” They often encourage their children to get educated and pursue individualistic aspirations to help their communities by training as tradespeople and professionals who may be better trusted to look after their own. As Charles Perkins, a most celebrated Aboriginal role model for living in both worlds, famously said: “We know we can’t live in the past, but the past lives in us.”

As anxiety and depression, psychological trauma, drug and alcohol misuse, family and communal violence, ecological grief,and suicidal vulnerability are precipitated or exacerbated by the stress of extreme environmental adversity, significant investment in ameliorating these harms is essential, not just for farmers, town businesspeople and their families, but for all those affected, especially these most vulnerable members of the community.⁷ We must provide more essential community services controlled by Aboriginal community members themselves. We must also train and support more Aboriginal mental health workers, healers, mental health educators, peer workers and Aboriginal liaison officers, to work alongside other mental health, and health and social service professionals. Aboriginal people need stable local employment opportunities in their communities. There is a huge opportunity to synergize traditional indigenous fire management with Western techniques, creating and consolidating more valued jobs and respected land management roles for Aboriginal rangers, vital for the future of both Aboriginal and wider communities. Pilot programs are emerging.

Aboriginal communities also need a more preventive, whole-of-life approach to social determinants, lifestyle factors, trauma, and political decisions associated with compromised neurodevelopment, and increased subsequent incidence and severity of mental illnesses in their communities.⁷

As Alexander Solzhenitsyn observed: “On our crowded planet there are no longer any ‘internal affairs.’ ”⁸ Climate change is the ultimate form of globalization: What we each do about it affects all others’ lives. We can only insist that, alongside adequate resourcing of our most evidence-based methods of fire, water, and climate control, our governments consult and listen to our Indigenous elders about applying climate management methods. These have been demonstrated to be sustainable and effective, possibly over 60,000 years – which is the longest established record of continuous Indigenous culture worldwide.

References

1. Ten impacts of the Australian bushfires. U.N. Environment Programme. 2020 Jan 20.

2. Allam L, Evershed N. “Too hot for humans? First Nations people fear becoming Australia’s first climate refugees.” The Guardian. 2019 Dec 17.

3. National Indigenous Australians Agency. “Coronavirus (COVID-19).”

4. Phillips D. “Brazil: Judge bans missionaries from Indigenous reserve over COVID-19 fears.” The Guardian. 2020 Apr 17.

5. Rigby CW et al. Aust J Rural Health. 2011 Oct;19(5):249-54.

6. Cunsolo A, Ellis NR. Nature Clim Change. 2018 Apr 3;8:275-81.

7. Gynther B et al. EClinicalMedicine. 2019 Apr 26;10:68-77.

8. Solzhenitsyn A. “Warning to the West,” speech delivered 30 Jun 1975. New York: Fararr, Straux & Girous, 1976.

Dr. Rosen, an officer of the Order of Australia and a Fellow of the Royal Australian and New Zealand College of Psychiatrists, is affiliated with the Brain & Mind Centre, University of Sydney, and the Institute of Mental Health at the University of Wollongong (Australia). He also is a community psychiatrist in a remote region of New South Wales. Dr. Rosen has no conflicts of interest.

*This article was updated 6/16/2020.

Kind wishes and donations worldwide came to help Australian communities and wildlife affected by the extreme drought and uncontrollable bushfires. Indeed, Australians have become a warning beacon for the planet to recognize how factors associated with global warming can morph rapidly into runaway national emergencies.

Little attention, however, has addressed the extreme vulnerability of Australia’s First Nations people, the Aboriginal & Torres Strait Islander communities, to the climate crisis. U.N. reports conclude that “Indigenous people with close emotional and ancestral ties to the land are also likely to be disproportionately affected by environmental change and extreme weather events.”¹

In fact, Indigenous peoples, whether living traditionally or assimilated, are among the first to be adversely affected by climate change. This is because, in part, of extreme poverty, inadequate housing, unemployment and other social determinants, transgenerational cultural losses of life and culture, dislocations, traumatic experiences of child removal, overrepresentation in the prison system, and chronic diseases already leading to dramatic disparities in life expectancy and other health outcomes.

Research confirms that rural and remote Aboriginal communities will be Australia’s first mass climate refugees. “Without action to stop climate change, people will be forced to leave their country and leave behind much of what makes them Aboriginal.”² This is because of hotter temperatures, poorly built and unstable homes more vulnerable to heat, and longer and drier droughts. Their communities, in fire-prone townships, are running out of water. Abject poverty severely limits their options, aggravated by government inaction because of ideological climate change denialism. And now we have the overlay of COVID-19 threatening these communities.³

Human pandemics are potentially more likely to occur with climate change. Pandemics also are more apt to be associated with population growth, human settlement encroaching on forests, increasing wild animal or intermediary vector contact, and growth in global travel.

Subsequently, our Indigenous communities have had the most to lose if COVID-19 is let loose in their midst. Spatial separation is difficult in overcrowded, multigenerational households. It is hard to keep your hands washed with soap where reliable water supply is sometimes only communal. Their health workers’ access to protective and lifesaving ICU equipment and expertise may be extremely limited or erratic.

Much of the population is classified as highly vulnerable to COVID-19 because of chronic health disorders (for example, cardiovascular, respiratory, and renal issues; diabetes, and suicidality) and preexisting much shorter life expectancies. Their health workers’ access to protective and lifesaving ICU equipment and expertise is extremely limited. There are fears that, if COVID-19 gains a foothold, they may lose a whole generation of revered elders, who often are also the last fluent tribal language speakers and carriers of life-enhancing cultural stories, traditions, and rites. More urban-living Indigenous families may yet have a rough time avoiding these ravages.

In Australia, COVID-19 has been largely held at bay so far by state and territory governments that have closed borders, restricted nonessential travel, and discouraged or excluded outsiders from visiting remote Indigenous communities wherever possible. There have been complaints that such restrictions occasionally had been applied in these communities in a heavy-handed way by police and other authorities, and may be resisted if enforced unilaterally. They will work only if applied with cultural sensitivity, full Indigenous community consultation, and collaboration. So far, COVID-19 infection rates have been kept very low, with no Indigenous deaths. In Brazil, by contrast, infections and deaths are more than double the national average, itinerant missionaries have only just been excluded from Amazonian tribal lands so far by independent judicial intervention, while loggers and miners come and go freely, as sources of contagion.⁴  Some Indigenous peoples in the United States have experienced among the highest COVID-19 infection and death rates in the country (for example, the Navajo Nation in New Mexico, Arizona, and Utah), amounting to catastrophic loss and grief.

"Black Lives Matter" marches protesting the filmed police killing of George Floyd in the USA have spread worldwide, in the wake of ultra-high rates of police brutality and killings with impunity of non-white individuals.

Many Australians, including considerable numbers of Indigenous people, marched here in sympathy, despite their infective risk and vulnerabilities. They were also protesting the excessive rates of Aboriginal imprisonment, deaths in custody, and police killings without consequences. Both internationally and here, there was an apparent sense of release of pent-up anger and frustrations at both these injustices and the extra susceptibility of poor and non-white people to severe illness, death and dire economic consequences because of the pandemic. It is a deceptive myth that "we are all in this together." So it is encouraging that there is also forming a widespread sense of collective purpose and determination to get governments to address these iniquities and inequities at last.*

I have worked as a community psychiatrist in Barkinje Aboriginal tribal lands of the Far West region of New South Wales (NSW) regularly for 35 years, much of this time while also leading Royal North Shore University General Hospital & Community Mental Health Services in Sydney. Barkinje translates as “River People,” but local media mainly talk about the impact of prolonged drought on farmers and ranchers, who certainly are deeply affected by it. However, the media rarely mention the calamitous impacts on Aboriginal communities. The drought effects are exacerbated by multinational corporate irrigators that divert and allegedly steal river water with tacit encouragement from ostensibly responsible government ministers. The rivers dry up into algal ponds with millions of bloated, rotting dead fish, and entire communities’ water supplies fail.

Researchers have reported on the mental health impacts of prolonged drought and diversion of river water on rural and remote indigenous communities throughout the state of NSW.⁵ We have heard Barkinje and neighboring Wiradjuri people say, “if the land is sick, we are sick,” and, “if the river dries up, there’s nowhere to meet.” Fishing, a popular recreational activity and source of nutrition is now denied to these communities. Unlike farmers, they receive no governmental exceptional circumstance compensation payments during droughts. Instead, they lose their farming jobs, so there is no disposable income and loss of capacity to travel to connect to their extended kinship system and cultural roots (e.g., for funerals or football matches) in other remote townships. Such droughts exacerbate wildfires, loss of fish and birdlife, some of which are sacred spiritual totems; dying of traditional “lifeblood” rivers, decimating precious ancient red-river gumtrees that line the shores; and irreversible damage to other sacred sites (e.g., melting ancient rock art).

So, loss of sustainable food sources, meaningful livelihood, and cultural and leisure pursuits could create an existential threat to Aboriginal identity. However, rural Indigenous communities also told us “whatever you do to us, we will survive and persist, as we have done in the past.”⁶ This is comparable with the tenacity and resilience of other ancient cultures that have suffered genocidal persecution and discrimination in the past, and have stubbornly regrown and persisted and regrown into the future.

They yearn to care for their lands, rivers, and seas of their traditions and upbringing, whether as “saltwater” coastal or “freshwater” inland peoples. They value their extended families, honor their elders and their collective wisdom, while also living in “two worlds.” They often encourage their children to get educated and pursue individualistic aspirations to help their communities by training as tradespeople and professionals who may be better trusted to look after their own. As Charles Perkins, a most celebrated Aboriginal role model for living in both worlds, famously said: “We know we can’t live in the past, but the past lives in us.”

As anxiety and depression, psychological trauma, drug and alcohol misuse, family and communal violence, ecological grief,and suicidal vulnerability are precipitated or exacerbated by the stress of extreme environmental adversity, significant investment in ameliorating these harms is essential, not just for farmers, town businesspeople and their families, but for all those affected, especially these most vulnerable members of the community.⁷ We must provide more essential community services controlled by Aboriginal community members themselves. We must also train and support more Aboriginal mental health workers, healers, mental health educators, peer workers and Aboriginal liaison officers, to work alongside other mental health, and health and social service professionals. Aboriginal people need stable local employment opportunities in their communities. There is a huge opportunity to synergize traditional indigenous fire management with Western techniques, creating and consolidating more valued jobs and respected land management roles for Aboriginal rangers, vital for the future of both Aboriginal and wider communities. Pilot programs are emerging.

Aboriginal communities also need a more preventive, whole-of-life approach to social determinants, lifestyle factors, trauma, and political decisions associated with compromised neurodevelopment, and increased subsequent incidence and severity of mental illnesses in their communities.⁷

As Alexander Solzhenitsyn observed: “On our crowded planet there are no longer any ‘internal affairs.’ ”⁸ Climate change is the ultimate form of globalization: What we each do about it affects all others’ lives. We can only insist that, alongside adequate resourcing of our most evidence-based methods of fire, water, and climate control, our governments consult and listen to our Indigenous elders about applying climate management methods. These have been demonstrated to be sustainable and effective, possibly over 60,000 years – which is the longest established record of continuous Indigenous culture worldwide.

References

1. Ten impacts of the Australian bushfires. U.N. Environment Programme. 2020 Jan 20.

2. Allam L, Evershed N. “Too hot for humans? First Nations people fear becoming Australia’s first climate refugees.” The Guardian. 2019 Dec 17.

3. National Indigenous Australians Agency. “Coronavirus (COVID-19).”

4. Phillips D. “Brazil: Judge bans missionaries from Indigenous reserve over COVID-19 fears.” The Guardian. 2020 Apr 17.

5. Rigby CW et al. Aust J Rural Health. 2011 Oct;19(5):249-54.

6. Cunsolo A, Ellis NR. Nature Clim Change. 2018 Apr 3;8:275-81.

7. Gynther B et al. EClinicalMedicine. 2019 Apr 26;10:68-77.

8. Solzhenitsyn A. “Warning to the West,” speech delivered 30 Jun 1975. New York: Fararr, Straux & Girous, 1976.

Dr. Rosen, an officer of the Order of Australia and a Fellow of the Royal Australian and New Zealand College of Psychiatrists, is affiliated with the Brain & Mind Centre, University of Sydney, and the Institute of Mental Health at the University of Wollongong (Australia). He also is a community psychiatrist in a remote region of New South Wales. Dr. Rosen has no conflicts of interest.

*This article was updated 6/16/2020.

A blood test detected 11 of 11 cases of colorectal cancer in a study involving 354 patients, and also spotted a majority of cases – 40 out of 53 – in which participants had advanced adenomas, an investigator said.

Results from a single-center study of CellMax Life’s FirstSight blood test were released as a poster as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

For a study conducted at one site, the Veterans Affairs Palo Alto (Calif.) Healthcare System, Shai Friedland, MD, and colleagues recruited 354 patients between ages 45 and 80 who were scheduled for elective colonoscopy. The researchers excluded people with a personal history of cancer or inflammatory bowel disease. They used CellMax’s FirstSight test on blood samples from the study participants.

The FirstSight test result was positive for colorectal cancer in all 11 patients in the study who were found by colonoscopy to have this condition, said Dr. Friedland, who is a professor of medicine at Stanford (Calif.) University and chief of gastroenterology at the VA Palo Alto Healthcare System. Thus, the test showed a sensitivity of 100% in this instance.

Among the 53 study participants found by colonoscopy to have advanced adenoma, 40 were positive on FirstSight; thus, so the test has a sensitivity of 75.5% for this result.

Among 79 patients who had negative colonoscopy results, meaning they were judged free of cancer or polyps, the test showed 8 as having signs of disease or growths.

“If you had a large adenoma that was removed years ago and now you have a negative colonoscopy, your score might still be high,” Dr. Friedland said in a recorded presentation for DDW. “In other words, the changes that are detectable in your blood might persist even after the polypectomy.”

He said there are plans to soon start a large-scale multicenter study of the CellMax assay.

“The blood test has the potential to fill an unmet need by giving patients a highly sensitive convenient option for colorectal cancer screening,” he said.

CellMax already is seeking to position its test as a more convenient alternative to either colonoscopy or the Cologuard screening test. Many patients put off cancer screening because of the need to take time off from work and the invasive nature of colonoscopy. Exact Sciences has used direct-to-consumer advertising to promote its Cologuard home-based test as a more convenient alternative to colonoscopy, but its product requires patients to collect their own stool samples and mail them to a lab, a process many people find off-putting.

Public health advocates, including the U.S. Preventive Services Task Force (USPSTF), have for years been pressing for wider screening of American adults for colon cancer. USPSTF is in the midst of updating its recommendations on colon cancer. In announcing its latest update of these recommendations in 2016, USPSTF said “the best screening test is the one that gets done” (JAMA. 2016;315[23]:2564-75).

USPSTF pressed for maximizing the total proportion of the eligible population, a point Dr. Friedland echoed in a CellMax press release.

“For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps,” said Dr. Friedland in the CellMax press release. “Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer.”

In the DDW presentation, Dr. Friedland and colleagues also said the CellMax test showed greater sensitivity (100%) for colorectal cancer and advanced precancerous lesions (75.5%) than did Cologuard (92.3% for colorectal cancer and 42.4% for advanced precancerous lesions).

Cara Connelly, Director of Public Relations and Corporate Communications for Exact Sciences said that the company “is dedicated to getting more people screened for colorectal cancer and applaud the researchers for their efforts. We look forward to hearing more about the performance of this test in a prospective multisite study with nonsymptomatic patients.”

Naresh T. Gunaratnam, MD, a gastroenterologist and research director at Huron Gastro in Ypsilanti, Mich., said he is concerned that aggressive promotion of alternative tests may obscure the benefits of colonoscopy. Dr. Gunaratnam, a 2019 winner of the American Gastroenterological Association (AGA) Distinguished Clinician Award, has been a public critic of the marketing of colon cancer tests, which emphasize the convenience of these products. When asked by MDedge to comment on the CellMax-funded study, Dr. Gunaratnam said alternative tests do have a place for the care of patients who cannot or will not have a colonoscopy.

“But if you convince a patient who would be willing to have a colonoscopy not to, that’s a disservice,” he said.

“If you want the best test, the one that is best at finding cancers and finding polyps and the only one that can remove the polyp, that’s colonoscopy,” Dr. Gunaratnam added. “One day there may be a pill you can swallow that blows up the polyps, but we’re not there yet. We have to mechanically remove them.”

SOURCE: Friedland S et al. DDW 2020, eposter 575.

A blood test detected 11 of 11 cases of colorectal cancer in a study involving 354 patients, and also spotted a majority of cases – 40 out of 53 – in which participants had advanced adenomas, an investigator said.

Results from a single-center study of CellMax Life’s FirstSight blood test were released as a poster as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

For a study conducted at one site, the Veterans Affairs Palo Alto (Calif.) Healthcare System, Shai Friedland, MD, and colleagues recruited 354 patients between ages 45 and 80 who were scheduled for elective colonoscopy. The researchers excluded people with a personal history of cancer or inflammatory bowel disease. They used CellMax’s FirstSight test on blood samples from the study participants.

The FirstSight test result was positive for colorectal cancer in all 11 patients in the study who were found by colonoscopy to have this condition, said Dr. Friedland, who is a professor of medicine at Stanford (Calif.) University and chief of gastroenterology at the VA Palo Alto Healthcare System. Thus, the test showed a sensitivity of 100% in this instance.

Among the 53 study participants found by colonoscopy to have advanced adenoma, 40 were positive on FirstSight; thus, so the test has a sensitivity of 75.5% for this result.

Among 79 patients who had negative colonoscopy results, meaning they were judged free of cancer or polyps, the test showed 8 as having signs of disease or growths.

“If you had a large adenoma that was removed years ago and now you have a negative colonoscopy, your score might still be high,” Dr. Friedland said in a recorded presentation for DDW. “In other words, the changes that are detectable in your blood might persist even after the polypectomy.”

He said there are plans to soon start a large-scale multicenter study of the CellMax assay.

“The blood test has the potential to fill an unmet need by giving patients a highly sensitive convenient option for colorectal cancer screening,” he said.

CellMax already is seeking to position its test as a more convenient alternative to either colonoscopy or the Cologuard screening test. Many patients put off cancer screening because of the need to take time off from work and the invasive nature of colonoscopy. Exact Sciences has used direct-to-consumer advertising to promote its Cologuard home-based test as a more convenient alternative to colonoscopy, but its product requires patients to collect their own stool samples and mail them to a lab, a process many people find off-putting.

Public health advocates, including the U.S. Preventive Services Task Force (USPSTF), have for years been pressing for wider screening of American adults for colon cancer. USPSTF is in the midst of updating its recommendations on colon cancer. In announcing its latest update of these recommendations in 2016, USPSTF said “the best screening test is the one that gets done” (JAMA. 2016;315[23]:2564-75).

USPSTF pressed for maximizing the total proportion of the eligible population, a point Dr. Friedland echoed in a CellMax press release.

“For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps,” said Dr. Friedland in the CellMax press release. “Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer.”

In the DDW presentation, Dr. Friedland and colleagues also said the CellMax test showed greater sensitivity (100%) for colorectal cancer and advanced precancerous lesions (75.5%) than did Cologuard (92.3% for colorectal cancer and 42.4% for advanced precancerous lesions).

Cara Connelly, Director of Public Relations and Corporate Communications for Exact Sciences said that the company “is dedicated to getting more people screened for colorectal cancer and applaud the researchers for their efforts. We look forward to hearing more about the performance of this test in a prospective multisite study with nonsymptomatic patients.”

Naresh T. Gunaratnam, MD, a gastroenterologist and research director at Huron Gastro in Ypsilanti, Mich., said he is concerned that aggressive promotion of alternative tests may obscure the benefits of colonoscopy. Dr. Gunaratnam, a 2019 winner of the American Gastroenterological Association (AGA) Distinguished Clinician Award, has been a public critic of the marketing of colon cancer tests, which emphasize the convenience of these products. When asked by MDedge to comment on the CellMax-funded study, Dr. Gunaratnam said alternative tests do have a place for the care of patients who cannot or will not have a colonoscopy.

“But if you convince a patient who would be willing to have a colonoscopy not to, that’s a disservice,” he said.

“If you want the best test, the one that is best at finding cancers and finding polyps and the only one that can remove the polyp, that’s colonoscopy,” Dr. Gunaratnam added. “One day there may be a pill you can swallow that blows up the polyps, but we’re not there yet. We have to mechanically remove them.”

SOURCE: Friedland S et al. DDW 2020, eposter 575.

A blood test detected 11 of 11 cases of colorectal cancer in a study involving 354 patients, and also spotted a majority of cases – 40 out of 53 – in which participants had advanced adenomas, an investigator said.

Results from a single-center study of CellMax Life’s FirstSight blood test were released as a poster as part of the annual Digestive Disease Week^®, which was canceled because of COVID-19.

For a study conducted at one site, the Veterans Affairs Palo Alto (Calif.) Healthcare System, Shai Friedland, MD, and colleagues recruited 354 patients between ages 45 and 80 who were scheduled for elective colonoscopy. The researchers excluded people with a personal history of cancer or inflammatory bowel disease. They used CellMax’s FirstSight test on blood samples from the study participants.

The FirstSight test result was positive for colorectal cancer in all 11 patients in the study who were found by colonoscopy to have this condition, said Dr. Friedland, who is a professor of medicine at Stanford (Calif.) University and chief of gastroenterology at the VA Palo Alto Healthcare System. Thus, the test showed a sensitivity of 100% in this instance.

Among the 53 study participants found by colonoscopy to have advanced adenoma, 40 were positive on FirstSight; thus, so the test has a sensitivity of 75.5% for this result.

Among 79 patients who had negative colonoscopy results, meaning they were judged free of cancer or polyps, the test showed 8 as having signs of disease or growths.

“If you had a large adenoma that was removed years ago and now you have a negative colonoscopy, your score might still be high,” Dr. Friedland said in a recorded presentation for DDW. “In other words, the changes that are detectable in your blood might persist even after the polypectomy.”

He said there are plans to soon start a large-scale multicenter study of the CellMax assay.

“The blood test has the potential to fill an unmet need by giving patients a highly sensitive convenient option for colorectal cancer screening,” he said.

CellMax already is seeking to position its test as a more convenient alternative to either colonoscopy or the Cologuard screening test. Many patients put off cancer screening because of the need to take time off from work and the invasive nature of colonoscopy. Exact Sciences has used direct-to-consumer advertising to promote its Cologuard home-based test as a more convenient alternative to colonoscopy, but its product requires patients to collect their own stool samples and mail them to a lab, a process many people find off-putting.

Public health advocates, including the U.S. Preventive Services Task Force (USPSTF), have for years been pressing for wider screening of American adults for colon cancer. USPSTF is in the midst of updating its recommendations on colon cancer. In announcing its latest update of these recommendations in 2016, USPSTF said “the best screening test is the one that gets done” (JAMA. 2016;315[23]:2564-75).

USPSTF pressed for maximizing the total proportion of the eligible population, a point Dr. Friedland echoed in a CellMax press release.

“For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps,” said Dr. Friedland in the CellMax press release. “Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer.”

In the DDW presentation, Dr. Friedland and colleagues also said the CellMax test showed greater sensitivity (100%) for colorectal cancer and advanced precancerous lesions (75.5%) than did Cologuard (92.3% for colorectal cancer and 42.4% for advanced precancerous lesions).

Cara Connelly, Director of Public Relations and Corporate Communications for Exact Sciences said that the company “is dedicated to getting more people screened for colorectal cancer and applaud the researchers for their efforts. We look forward to hearing more about the performance of this test in a prospective multisite study with nonsymptomatic patients.”

Naresh T. Gunaratnam, MD, a gastroenterologist and research director at Huron Gastro in Ypsilanti, Mich., said he is concerned that aggressive promotion of alternative tests may obscure the benefits of colonoscopy. Dr. Gunaratnam, a 2019 winner of the American Gastroenterological Association (AGA) Distinguished Clinician Award, has been a public critic of the marketing of colon cancer tests, which emphasize the convenience of these products. When asked by MDedge to comment on the CellMax-funded study, Dr. Gunaratnam said alternative tests do have a place for the care of patients who cannot or will not have a colonoscopy.

“But if you convince a patient who would be willing to have a colonoscopy not to, that’s a disservice,” he said.

“If you want the best test, the one that is best at finding cancers and finding polyps and the only one that can remove the polyp, that’s colonoscopy,” Dr. Gunaratnam added. “One day there may be a pill you can swallow that blows up the polyps, but we’re not there yet. We have to mechanically remove them.”

SOURCE: Friedland S et al. DDW 2020, eposter 575.

As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.

Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”

Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.

“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.

“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”

Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”

“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.

“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.

J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”

“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.

“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.

Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.

At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.

Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.

As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.

Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”

Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.

“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.

“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”

Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”

“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.

“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.

J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”

“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.

“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.

Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.

At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.

Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.

As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.

Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”

Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.

“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.

“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”

Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”

“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.

“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.

J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”

“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.

“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.

Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.

At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.

Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.

Minimal residual disease (MRD) surveillance after surgery can detect relapse in advance of imaging in patients with early-stage non–small cell lung cancer (NSCLC), according to findings from the TRACERx study.

The findings pave the way for clinical trials of MRD-driven treatment escalation, Chris Abbosh, MD, of University College London, reported during a presentation at the AACR virtual meeting I. Data in the presentation were updated from the abstract.

Dr. Abbosh and colleagues used phylogenetic circulating tumor DNA (ctDNA) profiling to assess MRD and predict relapse in patients from the TRACERx study who underwent surgery for stage I-III NSCLC.

“The approach we take is technically termed a ‘tumor-informed, personalized cell-free DNA-enrichment approach,’” Dr. Abbosh explained. “We take out the primary tumor from the patient, we multiregion sample that tumor, and submit each region for deep whole-exome sequencing.”

The researchers prioritize variants for MRD tracking based on clonality/subclonality, high copy number status, and low background sequencing noise. The researchers then construct an anchored-multiplex PCR panel against the positions of interest, which is applied to cell-free DNA in the pre- and postoperative setting.

“We’ve developed an MRD caller to go alongside this chemistry,” Dr. Abbosh said. “The main premise behind the MRD caller is that it can calculate intralibrary error rates to inform the MRD pool.”
 

Sensitivity and specificity

To validate their approach, Dr. Abbosh and colleagues tested the assay with low DNA input (5 ng, 10 ng) and high DNA input (30 ng, 60 ng). They found the assay to be more sensitive with higher DNA input, and variant fractions were detected down to 0.003%.

The researchers also assessed how sensitivity and specificity scale with an increasing number of variants – 50, 100, or 200 variants. When tracking 200 variants, the assay was powered to detect lower ctDNA fractions than when tracking 50 variants. On the other hand, specificity was higher with 50 variants (99.8%) than with 200 variants (99.4%).

Next, Dr. Abbosh and colleagues analyzed postoperative cell-free DNA collected at 271 time points from 37 NSCLC patients who did not relapse. This included 11 patients who developed proven second primary malignancies.

Of the 271 time points when MRD negativity was expected, MRD was not detected at 269 time points, which translates to 99.3% specificity for the assay.
 

Shedding, relapse, and disease-free survival

Dr. Abbosh and colleagues also found that non-adenocarcinoma histology is associated with preoperative ctDNA shedding in NSCLC. The researchers analyzed 88 early-stage preoperative samples from NSCLC patients. ctDNA was detected preoperatively in 49% of lung adenocarcinomas and 100% of lung squamous cell carcinomas.

“This finding is important when it comes to interpreting our non–small cell lung cancer relapse data from 53 TRACERx patients,” Dr. Abbosh said.

Of the 53 patients who relapsed, 42 had ctDNA detected prior to surgery and were thus considered shedders, while 11 were nonshedders. ctDNA was detectable at or before relapse in 91% (38/42) of shedders and 64% (7/11) of nonshedders.

The median time from ctDNA detection to clinical relapse was 164 days in shedders and 22 days in nonshedders. The median disease-free survival was 362 days and 640 days, respectively.

“So what these data suggest is that preoperative ctDNA detection status will be a proxy of the potential utility of ctDNA as an MRD biomarker in a clinical setting,” Dr. Abbosh explained.

Standard-of-care imaging findings in the 53 patients who relapsed further demonstrated the utility of ctDNA in this setting, Dr. Abbosh said.

All scans were divided into three categories: those showing unequivocal relapse, those with a new equivocal change (relapse, inflammation, or a nonspecific finding), and those with no evidence of relapse. Each was further categorized by preimaging MRD status.

Relapse occurred in 9 of 10 patients who were MRD positive but had a scan showing no evidence of relapse. Relapse occurred in 15 of 16 patients who were MRD positive and had scans showing new equivocal changes.

Patients with unequivocal evidence of relapse who were MRD negative at or before the scan were more likely to have a second primary cancer than to have NSCLC relapse (52% vs. 48%), which is a reflection of the specificity of the MRD assay to the primary tumor, Dr. Abbosh said.
 

Implications of the findings

The researchers’ findings are important because establishing an MRD-driven approach to treating early-stage NSCLC would facilitate escalation of standard-of-care treatment only for those patients at high risk for relapse, thereby overcoming a key challenge in conventional adjuvant drug-trial design, Dr. Abbosh said.

“If we take a patient population with high-risk early-stage disease who have undergone potentially curative resection of their cancer and we offer these patients adjuvant chemotherapy or adjuvant chemoradiation therapy, then we can improve 5-year survival outcomes in this population,” Dr. Abbosh said. “This is striking because, if we give the same treatment in the metastatic setting, we only see a progression-free survival benefit of a short number of months.”

This suggests a potential “vulnerability of low-burden residual cancer to systemic treatment following surgery,” he added. “So if we want to improve outcomes further in non–small cell lung cancer, we really need to focus on innovation in the early-stage space.”

Dr. Abbosh said he and colleagues demonstrated that “personalized cell-free DNA enrichment can detect low-frequency variant DNA in an accurate manner.

“We’ve shown that preoperative ctDNA shedding is associated with utility of ctDNA as an MRD biomarker and that MRD surveillance can lead to detection of relapse in advance of standard-of-care-imaging,” he said. “We feel that the field is now ready for MRD-driven adjuvant trials.”
 

Questions to be answered

Invited discussant Corey J. Langer, MD, of Penn Medicine in Philadelphia, outlined “fundamental questions” raised by the findings.

“We need more information on the staging and demographics of those who were MRD positive versus MRD negative,” he said.

Dr. Langer also asked about the findings for shedders versus nonshedders.

“Does this mean nonshedders fare better? This needs to addressed formally,” he said.

Another question is whether the assay “simply enables us to detect relapse sooner and increase anxiety,” or if the trajectory and outcomes in those who prove MRD positive ahead of radiographic manifestations can actually be altered.

A study comparing standard observation with early immunotherapy or chemoimmunotherapy in patients with MRD-positive radiographically occult relapse or progression – using progression-free and overall survival, along with time without symptoms of disease or relapse – would be useful, Dr. Langer said.

“A hazard ratio of 0.8 or less would be meaningful,” he added. “In this regard, there are trials looking at enhanced adjuvant treatment both in colorectal and breast cancer, and trials planned in advanced non–small cell [lung cancer].”

Dr. Langer also said it would be interesting to know if the assay can be used as an adjunct to diagnosis in frailer patients with inaccessible tumors or equivocal biopsy results or to avoid invasive procedures in patients who are stereotactic radiation candidates.

“The jury is still out on this,” he said.

TRACERx is funded by University College London in collaboration with Cancer Research UK. Dr. Abbosh disclosed relationships with AstraZeneca, Novartis, Roche Diagnostics, Bristol Myers Squibb, Achilles Therapeutics, and Archer Diagnostics. Dr. Langer reported grant/research support and/or scientific advisory work for multiple companies.

sworcester@mdedge.com

SOURCE: Abbosh C et al. AACR 2020, Abstract CT023.

Minimal residual disease (MRD) surveillance after surgery can detect relapse in advance of imaging in patients with early-stage non–small cell lung cancer (NSCLC), according to findings from the TRACERx study.

The findings pave the way for clinical trials of MRD-driven treatment escalation, Chris Abbosh, MD, of University College London, reported during a presentation at the AACR virtual meeting I. Data in the presentation were updated from the abstract.

Dr. Abbosh and colleagues used phylogenetic circulating tumor DNA (ctDNA) profiling to assess MRD and predict relapse in patients from the TRACERx study who underwent surgery for stage I-III NSCLC.

“The approach we take is technically termed a ‘tumor-informed, personalized cell-free DNA-enrichment approach,’” Dr. Abbosh explained. “We take out the primary tumor from the patient, we multiregion sample that tumor, and submit each region for deep whole-exome sequencing.”

The researchers prioritize variants for MRD tracking based on clonality/subclonality, high copy number status, and low background sequencing noise. The researchers then construct an anchored-multiplex PCR panel against the positions of interest, which is applied to cell-free DNA in the pre- and postoperative setting.

“We’ve developed an MRD caller to go alongside this chemistry,” Dr. Abbosh said. “The main premise behind the MRD caller is that it can calculate intralibrary error rates to inform the MRD pool.”
 

Sensitivity and specificity

To validate their approach, Dr. Abbosh and colleagues tested the assay with low DNA input (5 ng, 10 ng) and high DNA input (30 ng, 60 ng). They found the assay to be more sensitive with higher DNA input, and variant fractions were detected down to 0.003%.

The researchers also assessed how sensitivity and specificity scale with an increasing number of variants – 50, 100, or 200 variants. When tracking 200 variants, the assay was powered to detect lower ctDNA fractions than when tracking 50 variants. On the other hand, specificity was higher with 50 variants (99.8%) than with 200 variants (99.4%).

Next, Dr. Abbosh and colleagues analyzed postoperative cell-free DNA collected at 271 time points from 37 NSCLC patients who did not relapse. This included 11 patients who developed proven second primary malignancies.

Of the 271 time points when MRD negativity was expected, MRD was not detected at 269 time points, which translates to 99.3% specificity for the assay.
 

Shedding, relapse, and disease-free survival

Dr. Abbosh and colleagues also found that non-adenocarcinoma histology is associated with preoperative ctDNA shedding in NSCLC. The researchers analyzed 88 early-stage preoperative samples from NSCLC patients. ctDNA was detected preoperatively in 49% of lung adenocarcinomas and 100% of lung squamous cell carcinomas.

“This finding is important when it comes to interpreting our non–small cell lung cancer relapse data from 53 TRACERx patients,” Dr. Abbosh said.

Of the 53 patients who relapsed, 42 had ctDNA detected prior to surgery and were thus considered shedders, while 11 were nonshedders. ctDNA was detectable at or before relapse in 91% (38/42) of shedders and 64% (7/11) of nonshedders.

The median time from ctDNA detection to clinical relapse was 164 days in shedders and 22 days in nonshedders. The median disease-free survival was 362 days and 640 days, respectively.

“So what these data suggest is that preoperative ctDNA detection status will be a proxy of the potential utility of ctDNA as an MRD biomarker in a clinical setting,” Dr. Abbosh explained.

Standard-of-care imaging findings in the 53 patients who relapsed further demonstrated the utility of ctDNA in this setting, Dr. Abbosh said.

All scans were divided into three categories: those showing unequivocal relapse, those with a new equivocal change (relapse, inflammation, or a nonspecific finding), and those with no evidence of relapse. Each was further categorized by preimaging MRD status.

Relapse occurred in 9 of 10 patients who were MRD positive but had a scan showing no evidence of relapse. Relapse occurred in 15 of 16 patients who were MRD positive and had scans showing new equivocal changes.

Patients with unequivocal evidence of relapse who were MRD negative at or before the scan were more likely to have a second primary cancer than to have NSCLC relapse (52% vs. 48%), which is a reflection of the specificity of the MRD assay to the primary tumor, Dr. Abbosh said.
 

Implications of the findings

The researchers’ findings are important because establishing an MRD-driven approach to treating early-stage NSCLC would facilitate escalation of standard-of-care treatment only for those patients at high risk for relapse, thereby overcoming a key challenge in conventional adjuvant drug-trial design, Dr. Abbosh said.

“If we take a patient population with high-risk early-stage disease who have undergone potentially curative resection of their cancer and we offer these patients adjuvant chemotherapy or adjuvant chemoradiation therapy, then we can improve 5-year survival outcomes in this population,” Dr. Abbosh said. “This is striking because, if we give the same treatment in the metastatic setting, we only see a progression-free survival benefit of a short number of months.”

This suggests a potential “vulnerability of low-burden residual cancer to systemic treatment following surgery,” he added. “So if we want to improve outcomes further in non–small cell lung cancer, we really need to focus on innovation in the early-stage space.”

Dr. Abbosh said he and colleagues demonstrated that “personalized cell-free DNA enrichment can detect low-frequency variant DNA in an accurate manner.

“We’ve shown that preoperative ctDNA shedding is associated with utility of ctDNA as an MRD biomarker and that MRD surveillance can lead to detection of relapse in advance of standard-of-care-imaging,” he said. “We feel that the field is now ready for MRD-driven adjuvant trials.”
 

Questions to be answered

Invited discussant Corey J. Langer, MD, of Penn Medicine in Philadelphia, outlined “fundamental questions” raised by the findings.

“We need more information on the staging and demographics of those who were MRD positive versus MRD negative,” he said.

Dr. Langer also asked about the findings for shedders versus nonshedders.

“Does this mean nonshedders fare better? This needs to addressed formally,” he said.

Another question is whether the assay “simply enables us to detect relapse sooner and increase anxiety,” or if the trajectory and outcomes in those who prove MRD positive ahead of radiographic manifestations can actually be altered.

A study comparing standard observation with early immunotherapy or chemoimmunotherapy in patients with MRD-positive radiographically occult relapse or progression – using progression-free and overall survival, along with time without symptoms of disease or relapse – would be useful, Dr. Langer said.

“A hazard ratio of 0.8 or less would be meaningful,” he added. “In this regard, there are trials looking at enhanced adjuvant treatment both in colorectal and breast cancer, and trials planned in advanced non–small cell [lung cancer].”

Dr. Langer also said it would be interesting to know if the assay can be used as an adjunct to diagnosis in frailer patients with inaccessible tumors or equivocal biopsy results or to avoid invasive procedures in patients who are stereotactic radiation candidates.

“The jury is still out on this,” he said.

TRACERx is funded by University College London in collaboration with Cancer Research UK. Dr. Abbosh disclosed relationships with AstraZeneca, Novartis, Roche Diagnostics, Bristol Myers Squibb, Achilles Therapeutics, and Archer Diagnostics. Dr. Langer reported grant/research support and/or scientific advisory work for multiple companies.

sworcester@mdedge.com

SOURCE: Abbosh C et al. AACR 2020, Abstract CT023.

Minimal residual disease (MRD) surveillance after surgery can detect relapse in advance of imaging in patients with early-stage non–small cell lung cancer (NSCLC), according to findings from the TRACERx study.

The findings pave the way for clinical trials of MRD-driven treatment escalation, Chris Abbosh, MD, of University College London, reported during a presentation at the AACR virtual meeting I. Data in the presentation were updated from the abstract.

Dr. Abbosh and colleagues used phylogenetic circulating tumor DNA (ctDNA) profiling to assess MRD and predict relapse in patients from the TRACERx study who underwent surgery for stage I-III NSCLC.

“The approach we take is technically termed a ‘tumor-informed, personalized cell-free DNA-enrichment approach,’” Dr. Abbosh explained. “We take out the primary tumor from the patient, we multiregion sample that tumor, and submit each region for deep whole-exome sequencing.”

The researchers prioritize variants for MRD tracking based on clonality/subclonality, high copy number status, and low background sequencing noise. The researchers then construct an anchored-multiplex PCR panel against the positions of interest, which is applied to cell-free DNA in the pre- and postoperative setting.

“We’ve developed an MRD caller to go alongside this chemistry,” Dr. Abbosh said. “The main premise behind the MRD caller is that it can calculate intralibrary error rates to inform the MRD pool.”
 

Sensitivity and specificity

To validate their approach, Dr. Abbosh and colleagues tested the assay with low DNA input (5 ng, 10 ng) and high DNA input (30 ng, 60 ng). They found the assay to be more sensitive with higher DNA input, and variant fractions were detected down to 0.003%.

The researchers also assessed how sensitivity and specificity scale with an increasing number of variants – 50, 100, or 200 variants. When tracking 200 variants, the assay was powered to detect lower ctDNA fractions than when tracking 50 variants. On the other hand, specificity was higher with 50 variants (99.8%) than with 200 variants (99.4%).

Next, Dr. Abbosh and colleagues analyzed postoperative cell-free DNA collected at 271 time points from 37 NSCLC patients who did not relapse. This included 11 patients who developed proven second primary malignancies.

Of the 271 time points when MRD negativity was expected, MRD was not detected at 269 time points, which translates to 99.3% specificity for the assay.
 

Shedding, relapse, and disease-free survival

Dr. Abbosh and colleagues also found that non-adenocarcinoma histology is associated with preoperative ctDNA shedding in NSCLC. The researchers analyzed 88 early-stage preoperative samples from NSCLC patients. ctDNA was detected preoperatively in 49% of lung adenocarcinomas and 100% of lung squamous cell carcinomas.

“This finding is important when it comes to interpreting our non–small cell lung cancer relapse data from 53 TRACERx patients,” Dr. Abbosh said.

Of the 53 patients who relapsed, 42 had ctDNA detected prior to surgery and were thus considered shedders, while 11 were nonshedders. ctDNA was detectable at or before relapse in 91% (38/42) of shedders and 64% (7/11) of nonshedders.

The median time from ctDNA detection to clinical relapse was 164 days in shedders and 22 days in nonshedders. The median disease-free survival was 362 days and 640 days, respectively.

“So what these data suggest is that preoperative ctDNA detection status will be a proxy of the potential utility of ctDNA as an MRD biomarker in a clinical setting,” Dr. Abbosh explained.

Standard-of-care imaging findings in the 53 patients who relapsed further demonstrated the utility of ctDNA in this setting, Dr. Abbosh said.

All scans were divided into three categories: those showing unequivocal relapse, those with a new equivocal change (relapse, inflammation, or a nonspecific finding), and those with no evidence of relapse. Each was further categorized by preimaging MRD status.

Relapse occurred in 9 of 10 patients who were MRD positive but had a scan showing no evidence of relapse. Relapse occurred in 15 of 16 patients who were MRD positive and had scans showing new equivocal changes.

Patients with unequivocal evidence of relapse who were MRD negative at or before the scan were more likely to have a second primary cancer than to have NSCLC relapse (52% vs. 48%), which is a reflection of the specificity of the MRD assay to the primary tumor, Dr. Abbosh said.
 

Implications of the findings

The researchers’ findings are important because establishing an MRD-driven approach to treating early-stage NSCLC would facilitate escalation of standard-of-care treatment only for those patients at high risk for relapse, thereby overcoming a key challenge in conventional adjuvant drug-trial design, Dr. Abbosh said.

“If we take a patient population with high-risk early-stage disease who have undergone potentially curative resection of their cancer and we offer these patients adjuvant chemotherapy or adjuvant chemoradiation therapy, then we can improve 5-year survival outcomes in this population,” Dr. Abbosh said. “This is striking because, if we give the same treatment in the metastatic setting, we only see a progression-free survival benefit of a short number of months.”

This suggests a potential “vulnerability of low-burden residual cancer to systemic treatment following surgery,” he added. “So if we want to improve outcomes further in non–small cell lung cancer, we really need to focus on innovation in the early-stage space.”

Dr. Abbosh said he and colleagues demonstrated that “personalized cell-free DNA enrichment can detect low-frequency variant DNA in an accurate manner.

“We’ve shown that preoperative ctDNA shedding is associated with utility of ctDNA as an MRD biomarker and that MRD surveillance can lead to detection of relapse in advance of standard-of-care-imaging,” he said. “We feel that the field is now ready for MRD-driven adjuvant trials.”
 

Questions to be answered

Invited discussant Corey J. Langer, MD, of Penn Medicine in Philadelphia, outlined “fundamental questions” raised by the findings.

“We need more information on the staging and demographics of those who were MRD positive versus MRD negative,” he said.

Dr. Langer also asked about the findings for shedders versus nonshedders.

“Does this mean nonshedders fare better? This needs to addressed formally,” he said.

Another question is whether the assay “simply enables us to detect relapse sooner and increase anxiety,” or if the trajectory and outcomes in those who prove MRD positive ahead of radiographic manifestations can actually be altered.

A study comparing standard observation with early immunotherapy or chemoimmunotherapy in patients with MRD-positive radiographically occult relapse or progression – using progression-free and overall survival, along with time without symptoms of disease or relapse – would be useful, Dr. Langer said.

“A hazard ratio of 0.8 or less would be meaningful,” he added. “In this regard, there are trials looking at enhanced adjuvant treatment both in colorectal and breast cancer, and trials planned in advanced non–small cell [lung cancer].”

Dr. Langer also said it would be interesting to know if the assay can be used as an adjunct to diagnosis in frailer patients with inaccessible tumors or equivocal biopsy results or to avoid invasive procedures in patients who are stereotactic radiation candidates.

“The jury is still out on this,” he said.

TRACERx is funded by University College London in collaboration with Cancer Research UK. Dr. Abbosh disclosed relationships with AstraZeneca, Novartis, Roche Diagnostics, Bristol Myers Squibb, Achilles Therapeutics, and Archer Diagnostics. Dr. Langer reported grant/research support and/or scientific advisory work for multiple companies.

sworcester@mdedge.com

SOURCE: Abbosh C et al. AACR 2020, Abstract CT023.

Over-the-counter (OTC) topical products commonly are discussed during dermatology encounters. Unsurprisingly, dermatologists recommend OTC topical formulations at the highest rate of all medical specialists.^1,2 These products may aid in the treatment of skin disease and include shampoo for seborrheic dermatitis, moisturizer for atopic dermatitis, and an armamentarium of products for acne. Conversely, an incorrect selection of OTC topicals can cause or exacerbate skin conditions or result in systemic toxicity. This article addresses how dermatology residents may become familiar with the safety, utility, and tolerability of these products.

Safety and Regulation

Over-the-counter products fall into one or more US Food and Drug Administration (FDA) categories, each of which is subject to a unique set of regulations. The FDA website (www.fda.gov/cosmetics and www.fda.gov/drugs) is an excellent resource for comprehensive and up-to-date information about categorization, safety, and regulation of these products.

Many OTC products are categorized as drugs, including topical steroids, antimicrobials, and sunscreens.3 Most of these products previously were available by prescription and became available OTC after sufficient postmarketing safety information.⁴ Once a drug becomes available OTC, monitoring relies on reporting from health care professionals.⁵ Notably, the safety of chemical sunscreens is being re-evaluated in light of recent data demonstrating serum levels in humans above the FDA limit for drugs exempt from further testing for carcinogenicity and reproductive and developmental effects.^6-8

Cosmetics include moisturizers, cleansing shampoos, deodorants, makeup, perfume, and hair colors.⁹ For cosmetics, the FDA prohibits use of 11 categories of ingredients, encourages manufacturers to perform safety testing, and has the legal authority to inspect manufacturing facilities.^9,10 The FDA does not require approval, testing, or disclosure of safety data prior to products going to market.⁹ Interestingly, soap represents a separate category with its own regulations, defined by its ingredients and its intended purpose.³

The FDA has the authority to regulate imported cosmetic products.¹¹ Unfortunately, imported cosmetic products have been reported to contain ingredients banned in the United States. For example, there recently have been several cases of mercury poisoning from bleaching creams imported from Mexico resulting in catastrophic neurologic damage.¹² Additionally, imported products sold OTC in the United States containing clobetasol were reported in the literature in 1994 and remain an ongoing issue.¹³

Another category relevant to dermatologists includes dietary supplements. The FDA is responsible for evaluating safety and labeling of products before marketing and taking action against any adulterated or misbranded dietary supplement.¹⁴ The FDA does not directly test products, though third-party agencies including NSF International and United States Pharmacopeia impart certification after verification that labeled ingredients are present in the product and test for contaminants.^15,16

Utility and Pharmacology

Dermatology residents may have less experience and comfort with the safety profiles and indications of nondrug ingredients in topical products. The textbook Comprehensive Dermatologic Drug Therapy¹⁷ is an excellent initial resource for learning about the mechanism of action, efficacy, pharmacology, and side effects of such ingredients, including hydroxy acids, shampoos, cleansers, sunscreens, insect repellents, and topical antioxidants. Dermatology residents also need to be familiar with ingredients causing allergic contact dermatitis, and Fisher’s Contact Dermatitis¹⁸ is an excellent resource.

When patients indicate use of a particular product, clinicians may not be certain about specific ingredients. In this case, they may refer to the Walgreens website (www.walgreens.com), which provides an ingredient list for all products that they sell. Additionally, the Environmental Working Group’s Skin Deep program (www.ewg.org/skindeep) maintains a database of more than 85,000 personal care products, which may be accessed online or using their mobile application (Healthy Living), which allows one to scan a product’s barcode.

Trying Them Out

Lastly, it is helpful for dermatologists to be personally familiar with a variety of products to address patients’ concerns regarding tolerability of products (eg, greasiness, inability to “rub in,” sunscreens leaving a white cast, drying effect of cleansers). Samples at conferences including the annual meeting of the American Academy of Dermatology provide a cost-effective way for residents to try out a variety of products. Additionally, residents may purchase different products each time they restock their own supply of personal care products to sample a variety.

Final Thoughts

The FDA website contains up-to-date information on the safety of OTC products, which is constantly in flux. This article provides additional references for dermatology residents to begin to learn about the safety, utility, and pharmacology of topical OTC products. Firsthand experience by sampling products helps dermatologists answer questions regarding tolerability.

Over-the-counter (OTC) topical products commonly are discussed during dermatology encounters. Unsurprisingly, dermatologists recommend OTC topical formulations at the highest rate of all medical specialists.^1,2 These products may aid in the treatment of skin disease and include shampoo for seborrheic dermatitis, moisturizer for atopic dermatitis, and an armamentarium of products for acne. Conversely, an incorrect selection of OTC topicals can cause or exacerbate skin conditions or result in systemic toxicity. This article addresses how dermatology residents may become familiar with the safety, utility, and tolerability of these products.

Safety and Regulation

Over-the-counter products fall into one or more US Food and Drug Administration (FDA) categories, each of which is subject to a unique set of regulations. The FDA website (www.fda.gov/cosmetics and www.fda.gov/drugs) is an excellent resource for comprehensive and up-to-date information about categorization, safety, and regulation of these products.

Many OTC products are categorized as drugs, including topical steroids, antimicrobials, and sunscreens.3 Most of these products previously were available by prescription and became available OTC after sufficient postmarketing safety information.⁴ Once a drug becomes available OTC, monitoring relies on reporting from health care professionals.⁵ Notably, the safety of chemical sunscreens is being re-evaluated in light of recent data demonstrating serum levels in humans above the FDA limit for drugs exempt from further testing for carcinogenicity and reproductive and developmental effects.^6-8

Cosmetics include moisturizers, cleansing shampoos, deodorants, makeup, perfume, and hair colors.⁹ For cosmetics, the FDA prohibits use of 11 categories of ingredients, encourages manufacturers to perform safety testing, and has the legal authority to inspect manufacturing facilities.^9,10 The FDA does not require approval, testing, or disclosure of safety data prior to products going to market.⁹ Interestingly, soap represents a separate category with its own regulations, defined by its ingredients and its intended purpose.³

The FDA has the authority to regulate imported cosmetic products.¹¹ Unfortunately, imported cosmetic products have been reported to contain ingredients banned in the United States. For example, there recently have been several cases of mercury poisoning from bleaching creams imported from Mexico resulting in catastrophic neurologic damage.¹² Additionally, imported products sold OTC in the United States containing clobetasol were reported in the literature in 1994 and remain an ongoing issue.¹³

Another category relevant to dermatologists includes dietary supplements. The FDA is responsible for evaluating safety and labeling of products before marketing and taking action against any adulterated or misbranded dietary supplement.¹⁴ The FDA does not directly test products, though third-party agencies including NSF International and United States Pharmacopeia impart certification after verification that labeled ingredients are present in the product and test for contaminants.^15,16

Utility and Pharmacology

Dermatology residents may have less experience and comfort with the safety profiles and indications of nondrug ingredients in topical products. The textbook Comprehensive Dermatologic Drug Therapy¹⁷ is an excellent initial resource for learning about the mechanism of action, efficacy, pharmacology, and side effects of such ingredients, including hydroxy acids, shampoos, cleansers, sunscreens, insect repellents, and topical antioxidants. Dermatology residents also need to be familiar with ingredients causing allergic contact dermatitis, and Fisher’s Contact Dermatitis¹⁸ is an excellent resource.

When patients indicate use of a particular product, clinicians may not be certain about specific ingredients. In this case, they may refer to the Walgreens website (www.walgreens.com), which provides an ingredient list for all products that they sell. Additionally, the Environmental Working Group’s Skin Deep program (www.ewg.org/skindeep) maintains a database of more than 85,000 personal care products, which may be accessed online or using their mobile application (Healthy Living), which allows one to scan a product’s barcode.

Trying Them Out

Lastly, it is helpful for dermatologists to be personally familiar with a variety of products to address patients’ concerns regarding tolerability of products (eg, greasiness, inability to “rub in,” sunscreens leaving a white cast, drying effect of cleansers). Samples at conferences including the annual meeting of the American Academy of Dermatology provide a cost-effective way for residents to try out a variety of products. Additionally, residents may purchase different products each time they restock their own supply of personal care products to sample a variety.

Final Thoughts

The FDA website contains up-to-date information on the safety of OTC products, which is constantly in flux. This article provides additional references for dermatology residents to begin to learn about the safety, utility, and pharmacology of topical OTC products. Firsthand experience by sampling products helps dermatologists answer questions regarding tolerability.

Over-the-counter (OTC) topical products commonly are discussed during dermatology encounters. Unsurprisingly, dermatologists recommend OTC topical formulations at the highest rate of all medical specialists.^1,2 These products may aid in the treatment of skin disease and include shampoo for seborrheic dermatitis, moisturizer for atopic dermatitis, and an armamentarium of products for acne. Conversely, an incorrect selection of OTC topicals can cause or exacerbate skin conditions or result in systemic toxicity. This article addresses how dermatology residents may become familiar with the safety, utility, and tolerability of these products.

Safety and Regulation

Over-the-counter products fall into one or more US Food and Drug Administration (FDA) categories, each of which is subject to a unique set of regulations. The FDA website (www.fda.gov/cosmetics and www.fda.gov/drugs) is an excellent resource for comprehensive and up-to-date information about categorization, safety, and regulation of these products.

Many OTC products are categorized as drugs, including topical steroids, antimicrobials, and sunscreens.3 Most of these products previously were available by prescription and became available OTC after sufficient postmarketing safety information.⁴ Once a drug becomes available OTC, monitoring relies on reporting from health care professionals.⁵ Notably, the safety of chemical sunscreens is being re-evaluated in light of recent data demonstrating serum levels in humans above the FDA limit for drugs exempt from further testing for carcinogenicity and reproductive and developmental effects.^6-8

Cosmetics include moisturizers, cleansing shampoos, deodorants, makeup, perfume, and hair colors.⁹ For cosmetics, the FDA prohibits use of 11 categories of ingredients, encourages manufacturers to perform safety testing, and has the legal authority to inspect manufacturing facilities.^9,10 The FDA does not require approval, testing, or disclosure of safety data prior to products going to market.⁹ Interestingly, soap represents a separate category with its own regulations, defined by its ingredients and its intended purpose.³

The FDA has the authority to regulate imported cosmetic products.¹¹ Unfortunately, imported cosmetic products have been reported to contain ingredients banned in the United States. For example, there recently have been several cases of mercury poisoning from bleaching creams imported from Mexico resulting in catastrophic neurologic damage.¹² Additionally, imported products sold OTC in the United States containing clobetasol were reported in the literature in 1994 and remain an ongoing issue.¹³

Another category relevant to dermatologists includes dietary supplements. The FDA is responsible for evaluating safety and labeling of products before marketing and taking action against any adulterated or misbranded dietary supplement.¹⁴ The FDA does not directly test products, though third-party agencies including NSF International and United States Pharmacopeia impart certification after verification that labeled ingredients are present in the product and test for contaminants.^15,16

Utility and Pharmacology

Dermatology residents may have less experience and comfort with the safety profiles and indications of nondrug ingredients in topical products. The textbook Comprehensive Dermatologic Drug Therapy¹⁷ is an excellent initial resource for learning about the mechanism of action, efficacy, pharmacology, and side effects of such ingredients, including hydroxy acids, shampoos, cleansers, sunscreens, insect repellents, and topical antioxidants. Dermatology residents also need to be familiar with ingredients causing allergic contact dermatitis, and Fisher’s Contact Dermatitis¹⁸ is an excellent resource.

When patients indicate use of a particular product, clinicians may not be certain about specific ingredients. In this case, they may refer to the Walgreens website (www.walgreens.com), which provides an ingredient list for all products that they sell. Additionally, the Environmental Working Group’s Skin Deep program (www.ewg.org/skindeep) maintains a database of more than 85,000 personal care products, which may be accessed online or using their mobile application (Healthy Living), which allows one to scan a product’s barcode.

Trying Them Out

Lastly, it is helpful for dermatologists to be personally familiar with a variety of products to address patients’ concerns regarding tolerability of products (eg, greasiness, inability to “rub in,” sunscreens leaving a white cast, drying effect of cleansers). Samples at conferences including the annual meeting of the American Academy of Dermatology provide a cost-effective way for residents to try out a variety of products. Additionally, residents may purchase different products each time they restock their own supply of personal care products to sample a variety.

Final Thoughts

The FDA website contains up-to-date information on the safety of OTC products, which is constantly in flux. This article provides additional references for dermatology residents to begin to learn about the safety, utility, and pharmacology of topical OTC products. Firsthand experience by sampling products helps dermatologists answer questions regarding tolerability.

New data from a large Swedish study show that mammography screening for breast cancer reduces the rate of both advanced and fatal breast cancer.

Three experts who were approached by Medscape Medical News say this is further evidence that regular screening mammography significantly reduces the risk of dying from breast cancer, but one expert questioned the methodology used in the study.

The primary goal of cancer screening is to detect tumors at an early stage, when they are most treatable. The hope is that this will reduce the number of advanced cancers associated with poor prognosis and hence the risk of dying from that cancer.

So far, for mammography, the data have been somewhat conflicting. For example, some evidence suggests that widespread breast cancer screening may catch more small, slow-growing tumors that are unlikely to be fatal but will not curb the number of cancers that are diagnosed at a late stage.

The new study, published online in Cancer, refutes this view.

It followed a Swedish cohort of 549,091 women (covering approximately 30% of the Swedish screening-eligible population) who underwent regular mammography.

For the women in this cohort, there was a statistically significant 41% reduction in the risk of dying of breast cancer within 10 years and a 25% reduction in the incidence of advanced disease, compared to women who did not undergo screening. “Even in this age of effective treatments, early detection confers a substantial and significant additional reduction in risk of dying from breast cancer,” said lead author Stephen W. Duffy, MSc, from the Center for Cancer Prevention at Queen Mary University, London, United Kingdom.

The current study confirms the findings of a smaller earlier study (Cancer. 2019;125:515-23) from the same investigators. “It finds the same result with an extremely large evidence base, with more than half a million women, and it also adds further to the evidence that screening achieves this reduction in the context of routine healthcare, not only in the research context,” Duffy commented. “The results are generalizable to other populations, particularly in North America, Western Europe, and Australasia, where the epidemiology and demographics of breast cancer are similar,” said Duffy. “Clearly, more intensive screening is likely to achieve a greater benefit, but a trade-off between costs, both financial and human, and benefits always has to be made specific to each societal and healthcare environment.”

In Sweden, the policy regarding breast cancer screening is to screen women aged 40 to 54 years every 18 months. For those aged 55 to 69 years, screening is recommended every 24 months.

“The use of the incidence-based endpoints means that there is accurate classification of both the breast cancer cases and the whole study population in terms of exposure to screening and avoids a number of biases seen in other studies of service screening,” Duffy told Medscape Medical News.

“I have never seen persuasive evidence for the assertion that breast cancer screening does not reduce deaths from metastatic disease – indeed, the randomized trials seem to show the opposite,” said Duffy. “This may have arisen from a misunderstanding about the mechanism whereby screening works. It primarily works by diagnosing cancer early so that treatment is successful and recurrence with distant metastases, followed by death, does not occur some years later. I suspect some colleagues have confused this with distant metastases at initial diagnosis,” he added.
 

One expert questions methodology

One of the experts who was approached by Medscape Medical News to comment on the new study, Philippe Autier, MD, MPH, PhD, University of Strathclyde Institute of Global Public Health at the International Prevention Research Institute, Dardilly, France, questioned the methodology of the study. “This method is incorrect simply because women attending screening are different from women not attending screening,” he said. “The former are more health aware and have healthier behaviors than the latter, and this is a well-known fact and supported by the literature.”

Autier emphasized that it is practically impossible to control for that bias, which is known as confounding by indication.

“The statistical methods used for attenuating the so-called self-selection are very approximate and based on unverified assumptions,” he said. “For this reason, the Handbook on Breast Cancer Screening produced by the International Agency for Research on Cancer [IARC] clearly stated that ‘observational studies based on individual screening history, no matter how well designed and conducted, should not be regarded as providing evidence for an effect of screening,’ and the methodology in this paper has never been recommended by the IARC.”

A better way of conducting this type of study would have been to show the incidence trends of advanced-stage breast cancer in Sweden for the entire female population aged 40 years and older, he asserts. Autier used that methodology in his own study in the Netherlands, as previously reported by Medscape Medical News. That study found that in the Netherlands, screening mammography over a period of 24 years among women aged 50 to 74 years had little effect on reducing rates of advanced breast cancer or mortality from the disease.
 

Experts applaud the new findings

Three of the experts who were approached by Medscape Medical News to comment on the new findings applauded the efforts of Duffy and colleagues in providing evidence that mammography can reduce breast cancer–related mortality.

Marie Quinn, MD, director of diagnostic radiology at Roswell Park Comprehensive Cancer Center, Buffalo, New York, said this study adds to the growing body of scientific evidence that confirms that women who undergo regular screening mammography significantly reduce their risk of dying from breast cancer.

“Women who underwent regular screening also had a 25% reduction in the incidence of advanced-stage breast cancer,” she said. “This is important, because breast cancers are less fatal and often require less treatment when picked up at an earlier stage. We know the risk reduction benefit detected in this well-designed study can be attributed to screening mammography and not advances in cancer treatment, due to the long-term follow-up and outcome of cancer death within 10 years.”

The findings from this study support the guidelines recommending routine screening mammography in the United States, Quinn continued, but she pointed out that some aspects of screening (e.g., the age at which to begin screening and how often to screen) can vary. “This can be confusing for patients and providers,” she said. “Overall, research has shown us that women who undergo regular screening mammograms reduce their risk of dying from breast cancer. For women of average risk, the benefit of mammography is maximized with annual screening beginning at age 40,” she said.

Jay A. Baker, MD, FACR, FSBI, chief of the Division of Breast Imaging at Duke University Medical Center, Durham, North Carolina, emphasized that this is yet another study that confirms that the improvement in breast cancer mortality is not the result of improved treatments alone, as some have speculated. “Others have tried to model the benefit of screening vs treatment, but this study is a more direct measurement,” he said. “This conclusion is important for both patients and physicians to hear.”

Although the study strongly supports regular screening for all women, it does not specifically address which set of screening guidelines is optimal, Baker commented. “Fortunately, even though some organizations in the US curiously suggest a delayed start to screening, all organizations and professional societies agree that the most lives and the most years of life are saved by yearly screening beginning at age 40,” he added. “This new study tells us that new treatments alone aren’t enough and confirms that screening saves at least one-third more lives.”

Another expert, Bonnie N. Joe, MD, PhD, professor in residence and chief of breast imaging in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco, agreed that the study shows the mortality benefits of regular screening mammography. “Notably, these benefits were related to participation in mammography screening and independent of any advances in treatment,” she said, “And these findings in this study support regular screening mammography to reduce advanced-stage breast cancers and to reduce a woman’s risk of dying from breast cancer.”

Joe noted that overall, this was a “well-done, large-scale screening study with long-term outcomes and should be applicable to other populations. In the US, we know that peak cancer incidence is in the 40s for minority women, and the results of this study support regular screening starting at 40.”

The study was supported by the American Cancer Society through a gift from the Longaberger Company’s Horizon of Hope Campaign. Additional financial support was provided by Brostcancerförbundet, Sweden. Duffy, Autier, Quinn, Joe, and Baker have disclosed no relevant financial relationships. One coauthor of the study has disclosed relationships with industry, as noted in the original article.

This article first appeared on Medscape.com.

New data from a large Swedish study show that mammography screening for breast cancer reduces the rate of both advanced and fatal breast cancer.

Three experts who were approached by Medscape Medical News say this is further evidence that regular screening mammography significantly reduces the risk of dying from breast cancer, but one expert questioned the methodology used in the study.

The primary goal of cancer screening is to detect tumors at an early stage, when they are most treatable. The hope is that this will reduce the number of advanced cancers associated with poor prognosis and hence the risk of dying from that cancer.

So far, for mammography, the data have been somewhat conflicting. For example, some evidence suggests that widespread breast cancer screening may catch more small, slow-growing tumors that are unlikely to be fatal but will not curb the number of cancers that are diagnosed at a late stage.

The new study, published online in Cancer, refutes this view.

It followed a Swedish cohort of 549,091 women (covering approximately 30% of the Swedish screening-eligible population) who underwent regular mammography.

For the women in this cohort, there was a statistically significant 41% reduction in the risk of dying of breast cancer within 10 years and a 25% reduction in the incidence of advanced disease, compared to women who did not undergo screening. “Even in this age of effective treatments, early detection confers a substantial and significant additional reduction in risk of dying from breast cancer,” said lead author Stephen W. Duffy, MSc, from the Center for Cancer Prevention at Queen Mary University, London, United Kingdom.

The current study confirms the findings of a smaller earlier study (Cancer. 2019;125:515-23) from the same investigators. “It finds the same result with an extremely large evidence base, with more than half a million women, and it also adds further to the evidence that screening achieves this reduction in the context of routine healthcare, not only in the research context,” Duffy commented. “The results are generalizable to other populations, particularly in North America, Western Europe, and Australasia, where the epidemiology and demographics of breast cancer are similar,” said Duffy. “Clearly, more intensive screening is likely to achieve a greater benefit, but a trade-off between costs, both financial and human, and benefits always has to be made specific to each societal and healthcare environment.”

In Sweden, the policy regarding breast cancer screening is to screen women aged 40 to 54 years every 18 months. For those aged 55 to 69 years, screening is recommended every 24 months.

“The use of the incidence-based endpoints means that there is accurate classification of both the breast cancer cases and the whole study population in terms of exposure to screening and avoids a number of biases seen in other studies of service screening,” Duffy told Medscape Medical News.

“I have never seen persuasive evidence for the assertion that breast cancer screening does not reduce deaths from metastatic disease – indeed, the randomized trials seem to show the opposite,” said Duffy. “This may have arisen from a misunderstanding about the mechanism whereby screening works. It primarily works by diagnosing cancer early so that treatment is successful and recurrence with distant metastases, followed by death, does not occur some years later. I suspect some colleagues have confused this with distant metastases at initial diagnosis,” he added.
 

One expert questions methodology

One of the experts who was approached by Medscape Medical News to comment on the new study, Philippe Autier, MD, MPH, PhD, University of Strathclyde Institute of Global Public Health at the International Prevention Research Institute, Dardilly, France, questioned the methodology of the study. “This method is incorrect simply because women attending screening are different from women not attending screening,” he said. “The former are more health aware and have healthier behaviors than the latter, and this is a well-known fact and supported by the literature.”

Autier emphasized that it is practically impossible to control for that bias, which is known as confounding by indication.

“The statistical methods used for attenuating the so-called self-selection are very approximate and based on unverified assumptions,” he said. “For this reason, the Handbook on Breast Cancer Screening produced by the International Agency for Research on Cancer [IARC] clearly stated that ‘observational studies based on individual screening history, no matter how well designed and conducted, should not be regarded as providing evidence for an effect of screening,’ and the methodology in this paper has never been recommended by the IARC.”

A better way of conducting this type of study would have been to show the incidence trends of advanced-stage breast cancer in Sweden for the entire female population aged 40 years and older, he asserts. Autier used that methodology in his own study in the Netherlands, as previously reported by Medscape Medical News. That study found that in the Netherlands, screening mammography over a period of 24 years among women aged 50 to 74 years had little effect on reducing rates of advanced breast cancer or mortality from the disease.
 

Experts applaud the new findings

Three of the experts who were approached by Medscape Medical News to comment on the new findings applauded the efforts of Duffy and colleagues in providing evidence that mammography can reduce breast cancer–related mortality.

Marie Quinn, MD, director of diagnostic radiology at Roswell Park Comprehensive Cancer Center, Buffalo, New York, said this study adds to the growing body of scientific evidence that confirms that women who undergo regular screening mammography significantly reduce their risk of dying from breast cancer.

“Women who underwent regular screening also had a 25% reduction in the incidence of advanced-stage breast cancer,” she said. “This is important, because breast cancers are less fatal and often require less treatment when picked up at an earlier stage. We know the risk reduction benefit detected in this well-designed study can be attributed to screening mammography and not advances in cancer treatment, due to the long-term follow-up and outcome of cancer death within 10 years.”

The findings from this study support the guidelines recommending routine screening mammography in the United States, Quinn continued, but she pointed out that some aspects of screening (e.g., the age at which to begin screening and how often to screen) can vary. “This can be confusing for patients and providers,” she said. “Overall, research has shown us that women who undergo regular screening mammograms reduce their risk of dying from breast cancer. For women of average risk, the benefit of mammography is maximized with annual screening beginning at age 40,” she said.

Jay A. Baker, MD, FACR, FSBI, chief of the Division of Breast Imaging at Duke University Medical Center, Durham, North Carolina, emphasized that this is yet another study that confirms that the improvement in breast cancer mortality is not the result of improved treatments alone, as some have speculated. “Others have tried to model the benefit of screening vs treatment, but this study is a more direct measurement,” he said. “This conclusion is important for both patients and physicians to hear.”

Although the study strongly supports regular screening for all women, it does not specifically address which set of screening guidelines is optimal, Baker commented. “Fortunately, even though some organizations in the US curiously suggest a delayed start to screening, all organizations and professional societies agree that the most lives and the most years of life are saved by yearly screening beginning at age 40,” he added. “This new study tells us that new treatments alone aren’t enough and confirms that screening saves at least one-third more lives.”

Another expert, Bonnie N. Joe, MD, PhD, professor in residence and chief of breast imaging in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco, agreed that the study shows the mortality benefits of regular screening mammography. “Notably, these benefits were related to participation in mammography screening and independent of any advances in treatment,” she said, “And these findings in this study support regular screening mammography to reduce advanced-stage breast cancers and to reduce a woman’s risk of dying from breast cancer.”

Joe noted that overall, this was a “well-done, large-scale screening study with long-term outcomes and should be applicable to other populations. In the US, we know that peak cancer incidence is in the 40s for minority women, and the results of this study support regular screening starting at 40.”

The study was supported by the American Cancer Society through a gift from the Longaberger Company’s Horizon of Hope Campaign. Additional financial support was provided by Brostcancerförbundet, Sweden. Duffy, Autier, Quinn, Joe, and Baker have disclosed no relevant financial relationships. One coauthor of the study has disclosed relationships with industry, as noted in the original article.

This article first appeared on Medscape.com.

New data from a large Swedish study show that mammography screening for breast cancer reduces the rate of both advanced and fatal breast cancer.

Three experts who were approached by Medscape Medical News say this is further evidence that regular screening mammography significantly reduces the risk of dying from breast cancer, but one expert questioned the methodology used in the study.

The primary goal of cancer screening is to detect tumors at an early stage, when they are most treatable. The hope is that this will reduce the number of advanced cancers associated with poor prognosis and hence the risk of dying from that cancer.

So far, for mammography, the data have been somewhat conflicting. For example, some evidence suggests that widespread breast cancer screening may catch more small, slow-growing tumors that are unlikely to be fatal but will not curb the number of cancers that are diagnosed at a late stage.

The new study, published online in Cancer, refutes this view.

It followed a Swedish cohort of 549,091 women (covering approximately 30% of the Swedish screening-eligible population) who underwent regular mammography.

For the women in this cohort, there was a statistically significant 41% reduction in the risk of dying of breast cancer within 10 years and a 25% reduction in the incidence of advanced disease, compared to women who did not undergo screening. “Even in this age of effective treatments, early detection confers a substantial and significant additional reduction in risk of dying from breast cancer,” said lead author Stephen W. Duffy, MSc, from the Center for Cancer Prevention at Queen Mary University, London, United Kingdom.

The current study confirms the findings of a smaller earlier study (Cancer. 2019;125:515-23) from the same investigators. “It finds the same result with an extremely large evidence base, with more than half a million women, and it also adds further to the evidence that screening achieves this reduction in the context of routine healthcare, not only in the research context,” Duffy commented. “The results are generalizable to other populations, particularly in North America, Western Europe, and Australasia, where the epidemiology and demographics of breast cancer are similar,” said Duffy. “Clearly, more intensive screening is likely to achieve a greater benefit, but a trade-off between costs, both financial and human, and benefits always has to be made specific to each societal and healthcare environment.”

In Sweden, the policy regarding breast cancer screening is to screen women aged 40 to 54 years every 18 months. For those aged 55 to 69 years, screening is recommended every 24 months.

“The use of the incidence-based endpoints means that there is accurate classification of both the breast cancer cases and the whole study population in terms of exposure to screening and avoids a number of biases seen in other studies of service screening,” Duffy told Medscape Medical News.

“I have never seen persuasive evidence for the assertion that breast cancer screening does not reduce deaths from metastatic disease – indeed, the randomized trials seem to show the opposite,” said Duffy. “This may have arisen from a misunderstanding about the mechanism whereby screening works. It primarily works by diagnosing cancer early so that treatment is successful and recurrence with distant metastases, followed by death, does not occur some years later. I suspect some colleagues have confused this with distant metastases at initial diagnosis,” he added.
 

One expert questions methodology

One of the experts who was approached by Medscape Medical News to comment on the new study, Philippe Autier, MD, MPH, PhD, University of Strathclyde Institute of Global Public Health at the International Prevention Research Institute, Dardilly, France, questioned the methodology of the study. “This method is incorrect simply because women attending screening are different from women not attending screening,” he said. “The former are more health aware and have healthier behaviors than the latter, and this is a well-known fact and supported by the literature.”

Autier emphasized that it is practically impossible to control for that bias, which is known as confounding by indication.

“The statistical methods used for attenuating the so-called self-selection are very approximate and based on unverified assumptions,” he said. “For this reason, the Handbook on Breast Cancer Screening produced by the International Agency for Research on Cancer [IARC] clearly stated that ‘observational studies based on individual screening history, no matter how well designed and conducted, should not be regarded as providing evidence for an effect of screening,’ and the methodology in this paper has never been recommended by the IARC.”

A better way of conducting this type of study would have been to show the incidence trends of advanced-stage breast cancer in Sweden for the entire female population aged 40 years and older, he asserts. Autier used that methodology in his own study in the Netherlands, as previously reported by Medscape Medical News. That study found that in the Netherlands, screening mammography over a period of 24 years among women aged 50 to 74 years had little effect on reducing rates of advanced breast cancer or mortality from the disease.
 

Experts applaud the new findings

Three of the experts who were approached by Medscape Medical News to comment on the new findings applauded the efforts of Duffy and colleagues in providing evidence that mammography can reduce breast cancer–related mortality.

Marie Quinn, MD, director of diagnostic radiology at Roswell Park Comprehensive Cancer Center, Buffalo, New York, said this study adds to the growing body of scientific evidence that confirms that women who undergo regular screening mammography significantly reduce their risk of dying from breast cancer.

“Women who underwent regular screening also had a 25% reduction in the incidence of advanced-stage breast cancer,” she said. “This is important, because breast cancers are less fatal and often require less treatment when picked up at an earlier stage. We know the risk reduction benefit detected in this well-designed study can be attributed to screening mammography and not advances in cancer treatment, due to the long-term follow-up and outcome of cancer death within 10 years.”

The findings from this study support the guidelines recommending routine screening mammography in the United States, Quinn continued, but she pointed out that some aspects of screening (e.g., the age at which to begin screening and how often to screen) can vary. “This can be confusing for patients and providers,” she said. “Overall, research has shown us that women who undergo regular screening mammograms reduce their risk of dying from breast cancer. For women of average risk, the benefit of mammography is maximized with annual screening beginning at age 40,” she said.

Jay A. Baker, MD, FACR, FSBI, chief of the Division of Breast Imaging at Duke University Medical Center, Durham, North Carolina, emphasized that this is yet another study that confirms that the improvement in breast cancer mortality is not the result of improved treatments alone, as some have speculated. “Others have tried to model the benefit of screening vs treatment, but this study is a more direct measurement,” he said. “This conclusion is important for both patients and physicians to hear.”

Although the study strongly supports regular screening for all women, it does not specifically address which set of screening guidelines is optimal, Baker commented. “Fortunately, even though some organizations in the US curiously suggest a delayed start to screening, all organizations and professional societies agree that the most lives and the most years of life are saved by yearly screening beginning at age 40,” he added. “This new study tells us that new treatments alone aren’t enough and confirms that screening saves at least one-third more lives.”

Another expert, Bonnie N. Joe, MD, PhD, professor in residence and chief of breast imaging in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco, agreed that the study shows the mortality benefits of regular screening mammography. “Notably, these benefits were related to participation in mammography screening and independent of any advances in treatment,” she said, “And these findings in this study support regular screening mammography to reduce advanced-stage breast cancers and to reduce a woman’s risk of dying from breast cancer.”

Joe noted that overall, this was a “well-done, large-scale screening study with long-term outcomes and should be applicable to other populations. In the US, we know that peak cancer incidence is in the 40s for minority women, and the results of this study support regular screening starting at 40.”

The study was supported by the American Cancer Society through a gift from the Longaberger Company’s Horizon of Hope Campaign. Additional financial support was provided by Brostcancerförbundet, Sweden. Duffy, Autier, Quinn, Joe, and Baker have disclosed no relevant financial relationships. One coauthor of the study has disclosed relationships with industry, as noted in the original article.

This article first appeared on Medscape.com.

No one really knows how long the COVID-19 pandemic will endure, and it’s highly likely personal protective equipment (PPE) will be a pressing priority for months to come. Ensuring supplies has become a creative endeavor, with new partnerships forming to fill gaps.

The US Department of Defense (DoD), for instance, has signed a $126 million contract with 3M to produce 26 million N95 masks per month, starting in October, according to DoD spokesperson Lt. Col. Mike Andrews. 3M will expedite design, procurement, production facilities, and equipment to increase respirator production by at least 312 million annually within the next 12 months. The company is ramping up: It has already placed orders for raw material and 2 new N95 manufacturing lines, in addition to beginning initial production in Wisconsin and expanding a facility in South Dakota.

The project, funded through the CARES Act, is spearheaded by the Joint Acquisition Task Force, which serves as the DoD’s overarching framework for acquisition support.

The US Department of Veterans Affairs (VA) also has a new procurement partner: New Hampshire. The state’s leadership, community business leaders and the VA Secretary’s Center for Strategic Partnerships secured millions of masks for VA workforce nationwide.

“Once again, New Hampshire stands out as a leader in our nation for its collaborative nature benefiting veterans,” said Acting VA Deputy Secretary Pamela Powers. “Governor Sununu and Dean Kamen [a New Hampshire-based inventor] made it possible for VA to purchase 4.5 million masks…. Having these additional resources is truly incredible and on behalf of the department, I offer our sincere gratitude.”

A FedEx cargo plane stocked with 110,000 pounds of PPE landed at Manchester Airport, the third such shipment to arrive in the state. “It is a tribute to our state that we were more aggressive and proactive in our approach to readiness from the get-go,” said Maj. Gen. David J. Mikolaities, the adjutant general of the New Hampshire Army National Guard, which stood ready to support deployment of the new supplies. “We didn’t wait for the need to occur; we secured the supplies so when and if the demand hits we’d be ready with our PPE distribution.”

The need has been getting stronger. More than 1,300 VA employees have tested positive for COVID-19 according to the VA, and 28 are reported to have died. The cases span 114 VA facilities, but with infections affecting less than 1% of the VA health care workforce, the rate is lower at VA than at several large health care systems, including a 4.4% infection rate at University of Washington Medicine and 2.1% of the Detroit-based Henry Ford Health System.

VA nurses and other hospital employees had been warning for weeks that they did not have enough protective gear. Although VA officials denied this, an April 16 memo sent to network directors by the VA's deputy under secretary for health for operations and management indicated the agency was implementing conservation procedures to stretch supplies.

According to The Washington Post, some of those conservation measures were necessary because FEMA had diverted millions of masks and other PPE that VA had ordered away from the department. In a Post interview, Richard Stone, MD, VHA Executive in Charge, acknowledged that he’d been forced to move to “austerity levels” at some hospitals. (At some facilities, VA employees were provided with one surgical mask per week and N95s were reportedly nearly impossible to find.)

Stone said FEMA had directed vendors with equipment on order from VA to instead send it to FEMA to replenish the government’s rapidly depleting emergency stockpile: “I had 5 million masks incoming that disappeared.” At the time, Stone told the Post, the VA’s four-week supply of equipment was almost gone, and the system was burning through about 200,000 masks in a day. The supply system was responding to FEMA, he said. “I couldn’t tell you when my next delivery was coming in.”

According to a recent ProPublica report, the VA has tried other means to acquire PPE, with limited success. The VA contracted to pay $34.5 million for 6 million N95 respirators, a 350% markup on the normal cost of the masks. Unfortunately, even at that price, the contractor received higher bids for the masks and the VA ended up cancelling the contract.

In an effort to reassure veterans and employees, the VA issued a press release insisting that it had stable and “sufficient” supplies on May 13. According to the release, the VA had on hand “the capacity to take in 12,215 critical and non-critical patients,” and its occupancy rates “remain steady at 35-40% nationwide in both acute care and intensive care units (ICUs).” The release also asserted that the “VA’s stock of medical supplies remains robust with millions of N95 masks on hand,” and 1,943 ICU ventilators.

No one really knows how long the COVID-19 pandemic will endure, and it’s highly likely personal protective equipment (PPE) will be a pressing priority for months to come. Ensuring supplies has become a creative endeavor, with new partnerships forming to fill gaps.

The US Department of Defense (DoD), for instance, has signed a $126 million contract with 3M to produce 26 million N95 masks per month, starting in October, according to DoD spokesperson Lt. Col. Mike Andrews. 3M will expedite design, procurement, production facilities, and equipment to increase respirator production by at least 312 million annually within the next 12 months. The company is ramping up: It has already placed orders for raw material and 2 new N95 manufacturing lines, in addition to beginning initial production in Wisconsin and expanding a facility in South Dakota.

The project, funded through the CARES Act, is spearheaded by the Joint Acquisition Task Force, which serves as the DoD’s overarching framework for acquisition support.

The US Department of Veterans Affairs (VA) also has a new procurement partner: New Hampshire. The state’s leadership, community business leaders and the VA Secretary’s Center for Strategic Partnerships secured millions of masks for VA workforce nationwide.

“Once again, New Hampshire stands out as a leader in our nation for its collaborative nature benefiting veterans,” said Acting VA Deputy Secretary Pamela Powers. “Governor Sununu and Dean Kamen [a New Hampshire-based inventor] made it possible for VA to purchase 4.5 million masks…. Having these additional resources is truly incredible and on behalf of the department, I offer our sincere gratitude.”

A FedEx cargo plane stocked with 110,000 pounds of PPE landed at Manchester Airport, the third such shipment to arrive in the state. “It is a tribute to our state that we were more aggressive and proactive in our approach to readiness from the get-go,” said Maj. Gen. David J. Mikolaities, the adjutant general of the New Hampshire Army National Guard, which stood ready to support deployment of the new supplies. “We didn’t wait for the need to occur; we secured the supplies so when and if the demand hits we’d be ready with our PPE distribution.”

The need has been getting stronger. More than 1,300 VA employees have tested positive for COVID-19 according to the VA, and 28 are reported to have died. The cases span 114 VA facilities, but with infections affecting less than 1% of the VA health care workforce, the rate is lower at VA than at several large health care systems, including a 4.4% infection rate at University of Washington Medicine and 2.1% of the Detroit-based Henry Ford Health System.

VA nurses and other hospital employees had been warning for weeks that they did not have enough protective gear. Although VA officials denied this, an April 16 memo sent to network directors by the VA's deputy under secretary for health for operations and management indicated the agency was implementing conservation procedures to stretch supplies.

According to The Washington Post, some of those conservation measures were necessary because FEMA had diverted millions of masks and other PPE that VA had ordered away from the department. In a Post interview, Richard Stone, MD, VHA Executive in Charge, acknowledged that he’d been forced to move to “austerity levels” at some hospitals. (At some facilities, VA employees were provided with one surgical mask per week and N95s were reportedly nearly impossible to find.)

Stone said FEMA had directed vendors with equipment on order from VA to instead send it to FEMA to replenish the government’s rapidly depleting emergency stockpile: “I had 5 million masks incoming that disappeared.” At the time, Stone told the Post, the VA’s four-week supply of equipment was almost gone, and the system was burning through about 200,000 masks in a day. The supply system was responding to FEMA, he said. “I couldn’t tell you when my next delivery was coming in.”

According to a recent ProPublica report, the VA has tried other means to acquire PPE, with limited success. The VA contracted to pay $34.5 million for 6 million N95 respirators, a 350% markup on the normal cost of the masks. Unfortunately, even at that price, the contractor received higher bids for the masks and the VA ended up cancelling the contract.

In an effort to reassure veterans and employees, the VA issued a press release insisting that it had stable and “sufficient” supplies on May 13. According to the release, the VA had on hand “the capacity to take in 12,215 critical and non-critical patients,” and its occupancy rates “remain steady at 35-40% nationwide in both acute care and intensive care units (ICUs).” The release also asserted that the “VA’s stock of medical supplies remains robust with millions of N95 masks on hand,” and 1,943 ICU ventilators.

No one really knows how long the COVID-19 pandemic will endure, and it’s highly likely personal protective equipment (PPE) will be a pressing priority for months to come. Ensuring supplies has become a creative endeavor, with new partnerships forming to fill gaps.

The US Department of Defense (DoD), for instance, has signed a $126 million contract with 3M to produce 26 million N95 masks per month, starting in October, according to DoD spokesperson Lt. Col. Mike Andrews. 3M will expedite design, procurement, production facilities, and equipment to increase respirator production by at least 312 million annually within the next 12 months. The company is ramping up: It has already placed orders for raw material and 2 new N95 manufacturing lines, in addition to beginning initial production in Wisconsin and expanding a facility in South Dakota.

The project, funded through the CARES Act, is spearheaded by the Joint Acquisition Task Force, which serves as the DoD’s overarching framework for acquisition support.

The US Department of Veterans Affairs (VA) also has a new procurement partner: New Hampshire. The state’s leadership, community business leaders and the VA Secretary’s Center for Strategic Partnerships secured millions of masks for VA workforce nationwide.

“Once again, New Hampshire stands out as a leader in our nation for its collaborative nature benefiting veterans,” said Acting VA Deputy Secretary Pamela Powers. “Governor Sununu and Dean Kamen [a New Hampshire-based inventor] made it possible for VA to purchase 4.5 million masks…. Having these additional resources is truly incredible and on behalf of the department, I offer our sincere gratitude.”

A FedEx cargo plane stocked with 110,000 pounds of PPE landed at Manchester Airport, the third such shipment to arrive in the state. “It is a tribute to our state that we were more aggressive and proactive in our approach to readiness from the get-go,” said Maj. Gen. David J. Mikolaities, the adjutant general of the New Hampshire Army National Guard, which stood ready to support deployment of the new supplies. “We didn’t wait for the need to occur; we secured the supplies so when and if the demand hits we’d be ready with our PPE distribution.”

The need has been getting stronger. More than 1,300 VA employees have tested positive for COVID-19 according to the VA, and 28 are reported to have died. The cases span 114 VA facilities, but with infections affecting less than 1% of the VA health care workforce, the rate is lower at VA than at several large health care systems, including a 4.4% infection rate at University of Washington Medicine and 2.1% of the Detroit-based Henry Ford Health System.

VA nurses and other hospital employees had been warning for weeks that they did not have enough protective gear. Although VA officials denied this, an April 16 memo sent to network directors by the VA's deputy under secretary for health for operations and management indicated the agency was implementing conservation procedures to stretch supplies.

According to The Washington Post, some of those conservation measures were necessary because FEMA had diverted millions of masks and other PPE that VA had ordered away from the department. In a Post interview, Richard Stone, MD, VHA Executive in Charge, acknowledged that he’d been forced to move to “austerity levels” at some hospitals. (At some facilities, VA employees were provided with one surgical mask per week and N95s were reportedly nearly impossible to find.)

Stone said FEMA had directed vendors with equipment on order from VA to instead send it to FEMA to replenish the government’s rapidly depleting emergency stockpile: “I had 5 million masks incoming that disappeared.” At the time, Stone told the Post, the VA’s four-week supply of equipment was almost gone, and the system was burning through about 200,000 masks in a day. The supply system was responding to FEMA, he said. “I couldn’t tell you when my next delivery was coming in.”

According to a recent ProPublica report, the VA has tried other means to acquire PPE, with limited success. The VA contracted to pay $34.5 million for 6 million N95 respirators, a 350% markup on the normal cost of the masks. Unfortunately, even at that price, the contractor received higher bids for the masks and the VA ended up cancelling the contract.

In an effort to reassure veterans and employees, the VA issued a press release insisting that it had stable and “sufficient” supplies on May 13. According to the release, the VA had on hand “the capacity to take in 12,215 critical and non-critical patients,” and its occupancy rates “remain steady at 35-40% nationwide in both acute care and intensive care units (ICUs).” The release also asserted that the “VA’s stock of medical supplies remains robust with millions of N95 masks on hand,” and 1,943 ICU ventilators.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.