Dermatology News

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

A version of this article first appeared on WebMD.com.

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

A version of this article first appeared on WebMD.com.

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

A version of this article first appeared on WebMD.com.

Alopecia areata (AA) has been linked to a significantly increased risk for dementia, new research shows.

After controlling for an array of potential confounders, investigators found a threefold higher risk of developing any form of dementia and a fourfold higher risk of developing Alzheimer’s disease (AD) in those with AA versus the controls.

“AA shares a similar inflammatory signature with dementia and has great psychological impacts that lead to poor social engagement,” lead author Cheng-Yuan Li, MD, MSc, of the department of dermatology, Taipei (Taiwan) Veterans General Hospital.

“Poor social engagement and shared inflammatory cytokines might both be important links between AA and dementia,” said Dr. Li, who is also affiliated with the School of Medicine and the Institute of Brain Science at National Yang Ming Chiao Tung University, Taipei.

The study was published online Oct. 26, 2021, in the Journal of Clinical Psychiatry (doi: 10.4088/JCP.21m13931).
 

Significant psychological impact

Patients with AA often experience anxiety and depression, possibly caused by the negative emotional and psychological impact of the hair loss and partial or even complete baldness associated with the disease, the authors noted.

However, AA is also associated with an array of other atopic and autoimmune diseases, including psoriasis and systemic lupus erythematosus (SLE).

Epidemiologic research has suggested a link between dementia and autoimmune diseases such as psoriasis and SLE, with some evidence suggesting that autoimmune and inflammatory mechanisms may “play a role” in the development of AD.

Dementia in general and AD in particular, “have been shown to include an inflammatory component” that may share some of the same mediators seen in AA (eg, IL-1 beta, IL-6, and tumor necrosis factor–alpha).

Moreover, “the great negative psychosocial impact of AA might result in poor social engagement, a typical risk factor for dementia,” said Dr. Li. The investigators sought to investigate whether patients with AA actually do have a higher dementia risk than individuals without AA.

The researchers used data from the Taiwan National Health Insurance Research Database, comparing 2,534 patients with AA against 25,340 controls matched for age, sex, residence, income, dementia-related comorbidities, systemic steroid use, and annual outpatient visits. Participants were enrolled between 1998 and 2011 and followed to the end of 2013.

The mean age of the cohort was 53.9 years, and a little over half (57.6%) were female. The most common comorbidity was hypertension (32.3%), followed by dyslipidemia (27%) and diabetes (15.4%).
 

Dual intervention

After adjusting for potential confounders, those with AA were more likely to develop dementia, AD, and unspecified dementia, compared with controls. They also had a numerically higher risk for vascular dementia, compared with controls, but it was not statistically significant.

When participants were stratified by age, investigators found a significant association between AA and higher risk for any dementia as well as unspecified dementia in individuals of all ages and an increased risk for AD in patients with dementia age at onset of 65 years and older.

The mean age of dementia diagnosis was considerably younger in patients with AA versus controls (73.4 vs. 78.9 years, P = .002). The risk for any dementia and unspecified dementia was higher in patients of both sexes, but the risk for AD was higher only in male patients.

Sensitivity analyses that excluded the first year or first 3 years of observation yielded similar and consistent findings.

“Intervention targeting poor social engagement and inflammatory cytokines may be beneficial to AA-associated dementia,” said Dr. Li.

“Physicians should be more aware of this possible association, help reduce disease discrimination among the public, and encourage more social engagement for AA patients,” he said.

“Further studies are needed to elucidate the underlying pathophysiology between AA and dementia risk,” he added.
 

No cause and effect

Commenting on the study, Heather M. Snyder, PhD, vice president of medical and scientific affairs, Alzheimer’s Association, said, “We continue to learn about and better understand factors that may increase or decrease a person’s risk of dementia.”

“While we know the immune system plays a role in Alzheimer’s and other dementia, we are still investigating links between, and impact of, autoimmune diseases – like alopecia areata, rheumatoid arthritis, and others – on our overall health and our brains, [which] may eventually give us important information on risk reduction strategies as well,” said Dr. Snyder, who was not involved in the research.

She cautioned that although the study did show a correlation between AA and dementia risk, this does not equate to a demonstration of cause and effect.

At present, “the message for clinicians is that when a patient comes to your office with complaints about their memory, they should, No. 1, be taken seriously; and, No. 2, receive a thorough evaluation that takes into account the many factors that may lead to cognitive decline,” Dr. Snyder said.

The study was supported by a grant from Taipei Veterans General Hospital and the Ministry of Science and Technology, Taiwan. Dr. Li, coauthors, and Dr. Snyder disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Alopecia areata (AA) has been linked to a significantly increased risk for dementia, new research shows.

After controlling for an array of potential confounders, investigators found a threefold higher risk of developing any form of dementia and a fourfold higher risk of developing Alzheimer’s disease (AD) in those with AA versus the controls.

“AA shares a similar inflammatory signature with dementia and has great psychological impacts that lead to poor social engagement,” lead author Cheng-Yuan Li, MD, MSc, of the department of dermatology, Taipei (Taiwan) Veterans General Hospital.

“Poor social engagement and shared inflammatory cytokines might both be important links between AA and dementia,” said Dr. Li, who is also affiliated with the School of Medicine and the Institute of Brain Science at National Yang Ming Chiao Tung University, Taipei.

The study was published online Oct. 26, 2021, in the Journal of Clinical Psychiatry (doi: 10.4088/JCP.21m13931).
 

Significant psychological impact

Patients with AA often experience anxiety and depression, possibly caused by the negative emotional and psychological impact of the hair loss and partial or even complete baldness associated with the disease, the authors noted.

However, AA is also associated with an array of other atopic and autoimmune diseases, including psoriasis and systemic lupus erythematosus (SLE).

Epidemiologic research has suggested a link between dementia and autoimmune diseases such as psoriasis and SLE, with some evidence suggesting that autoimmune and inflammatory mechanisms may “play a role” in the development of AD.

Dementia in general and AD in particular, “have been shown to include an inflammatory component” that may share some of the same mediators seen in AA (eg, IL-1 beta, IL-6, and tumor necrosis factor–alpha).

Moreover, “the great negative psychosocial impact of AA might result in poor social engagement, a typical risk factor for dementia,” said Dr. Li. The investigators sought to investigate whether patients with AA actually do have a higher dementia risk than individuals without AA.

The researchers used data from the Taiwan National Health Insurance Research Database, comparing 2,534 patients with AA against 25,340 controls matched for age, sex, residence, income, dementia-related comorbidities, systemic steroid use, and annual outpatient visits. Participants were enrolled between 1998 and 2011 and followed to the end of 2013.

The mean age of the cohort was 53.9 years, and a little over half (57.6%) were female. The most common comorbidity was hypertension (32.3%), followed by dyslipidemia (27%) and diabetes (15.4%).
 

Dual intervention

After adjusting for potential confounders, those with AA were more likely to develop dementia, AD, and unspecified dementia, compared with controls. They also had a numerically higher risk for vascular dementia, compared with controls, but it was not statistically significant.

When participants were stratified by age, investigators found a significant association between AA and higher risk for any dementia as well as unspecified dementia in individuals of all ages and an increased risk for AD in patients with dementia age at onset of 65 years and older.

The mean age of dementia diagnosis was considerably younger in patients with AA versus controls (73.4 vs. 78.9 years, P = .002). The risk for any dementia and unspecified dementia was higher in patients of both sexes, but the risk for AD was higher only in male patients.

Sensitivity analyses that excluded the first year or first 3 years of observation yielded similar and consistent findings.

“Intervention targeting poor social engagement and inflammatory cytokines may be beneficial to AA-associated dementia,” said Dr. Li.

“Physicians should be more aware of this possible association, help reduce disease discrimination among the public, and encourage more social engagement for AA patients,” he said.

“Further studies are needed to elucidate the underlying pathophysiology between AA and dementia risk,” he added.
 

No cause and effect

Commenting on the study, Heather M. Snyder, PhD, vice president of medical and scientific affairs, Alzheimer’s Association, said, “We continue to learn about and better understand factors that may increase or decrease a person’s risk of dementia.”

“While we know the immune system plays a role in Alzheimer’s and other dementia, we are still investigating links between, and impact of, autoimmune diseases – like alopecia areata, rheumatoid arthritis, and others – on our overall health and our brains, [which] may eventually give us important information on risk reduction strategies as well,” said Dr. Snyder, who was not involved in the research.

She cautioned that although the study did show a correlation between AA and dementia risk, this does not equate to a demonstration of cause and effect.

At present, “the message for clinicians is that when a patient comes to your office with complaints about their memory, they should, No. 1, be taken seriously; and, No. 2, receive a thorough evaluation that takes into account the many factors that may lead to cognitive decline,” Dr. Snyder said.

The study was supported by a grant from Taipei Veterans General Hospital and the Ministry of Science and Technology, Taiwan. Dr. Li, coauthors, and Dr. Snyder disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Alopecia areata (AA) has been linked to a significantly increased risk for dementia, new research shows.

After controlling for an array of potential confounders, investigators found a threefold higher risk of developing any form of dementia and a fourfold higher risk of developing Alzheimer’s disease (AD) in those with AA versus the controls.

“AA shares a similar inflammatory signature with dementia and has great psychological impacts that lead to poor social engagement,” lead author Cheng-Yuan Li, MD, MSc, of the department of dermatology, Taipei (Taiwan) Veterans General Hospital.

“Poor social engagement and shared inflammatory cytokines might both be important links between AA and dementia,” said Dr. Li, who is also affiliated with the School of Medicine and the Institute of Brain Science at National Yang Ming Chiao Tung University, Taipei.

The study was published online Oct. 26, 2021, in the Journal of Clinical Psychiatry (doi: 10.4088/JCP.21m13931).
 

Significant psychological impact

Patients with AA often experience anxiety and depression, possibly caused by the negative emotional and psychological impact of the hair loss and partial or even complete baldness associated with the disease, the authors noted.

However, AA is also associated with an array of other atopic and autoimmune diseases, including psoriasis and systemic lupus erythematosus (SLE).

Epidemiologic research has suggested a link between dementia and autoimmune diseases such as psoriasis and SLE, with some evidence suggesting that autoimmune and inflammatory mechanisms may “play a role” in the development of AD.

Dementia in general and AD in particular, “have been shown to include an inflammatory component” that may share some of the same mediators seen in AA (eg, IL-1 beta, IL-6, and tumor necrosis factor–alpha).

Moreover, “the great negative psychosocial impact of AA might result in poor social engagement, a typical risk factor for dementia,” said Dr. Li. The investigators sought to investigate whether patients with AA actually do have a higher dementia risk than individuals without AA.

The researchers used data from the Taiwan National Health Insurance Research Database, comparing 2,534 patients with AA against 25,340 controls matched for age, sex, residence, income, dementia-related comorbidities, systemic steroid use, and annual outpatient visits. Participants were enrolled between 1998 and 2011 and followed to the end of 2013.

The mean age of the cohort was 53.9 years, and a little over half (57.6%) were female. The most common comorbidity was hypertension (32.3%), followed by dyslipidemia (27%) and diabetes (15.4%).
 

Dual intervention

After adjusting for potential confounders, those with AA were more likely to develop dementia, AD, and unspecified dementia, compared with controls. They also had a numerically higher risk for vascular dementia, compared with controls, but it was not statistically significant.

When participants were stratified by age, investigators found a significant association between AA and higher risk for any dementia as well as unspecified dementia in individuals of all ages and an increased risk for AD in patients with dementia age at onset of 65 years and older.

The mean age of dementia diagnosis was considerably younger in patients with AA versus controls (73.4 vs. 78.9 years, P = .002). The risk for any dementia and unspecified dementia was higher in patients of both sexes, but the risk for AD was higher only in male patients.

Sensitivity analyses that excluded the first year or first 3 years of observation yielded similar and consistent findings.

“Intervention targeting poor social engagement and inflammatory cytokines may be beneficial to AA-associated dementia,” said Dr. Li.

“Physicians should be more aware of this possible association, help reduce disease discrimination among the public, and encourage more social engagement for AA patients,” he said.

“Further studies are needed to elucidate the underlying pathophysiology between AA and dementia risk,” he added.
 

No cause and effect

Commenting on the study, Heather M. Snyder, PhD, vice president of medical and scientific affairs, Alzheimer’s Association, said, “We continue to learn about and better understand factors that may increase or decrease a person’s risk of dementia.”

“While we know the immune system plays a role in Alzheimer’s and other dementia, we are still investigating links between, and impact of, autoimmune diseases – like alopecia areata, rheumatoid arthritis, and others – on our overall health and our brains, [which] may eventually give us important information on risk reduction strategies as well,” said Dr. Snyder, who was not involved in the research.

She cautioned that although the study did show a correlation between AA and dementia risk, this does not equate to a demonstration of cause and effect.

At present, “the message for clinicians is that when a patient comes to your office with complaints about their memory, they should, No. 1, be taken seriously; and, No. 2, receive a thorough evaluation that takes into account the many factors that may lead to cognitive decline,” Dr. Snyder said.

The study was supported by a grant from Taipei Veterans General Hospital and the Ministry of Science and Technology, Taiwan. Dr. Li, coauthors, and Dr. Snyder disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

A version of this article first appeared on WebMD.com.

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

A version of this article first appeared on WebMD.com.

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

A version of this article first appeared on WebMD.com.

No, Mr. Bond, I expect you to die

Movie watching usually requires a certain suspension of disbelief, and it’s safe to say James Bond movies require this more than most. Between the impossible gadgets and ludicrous doomsday plans, very few have ever stopped to consider the health risks of the James Bond universe.

Tumisu/Pixabay

Now, however, Bond, James Bond, has met his most formidable opponent: Wouter Graumans, a graduate student in epidemiology from the Netherlands. During a foray to Burkina Faso to study infectious diseases, Mr. Graumans came down with a case of food poisoning, which led him to wonder how 007 is able to trot across this big world of ours without contracting so much as a sinus infection.

Because Mr. Graumans is a man of science and conviction, mere speculation wasn’t enough. He and a group of coauthors wrote an entire paper on the health risks of the James Bond universe.

Doing so required watching over 3,000 minutes of numerous movies and analyzing Bond’s 86 total trips to 46 different countries based on current Centers for Disease Control and Prevention advice for travel to those countries. Time which, the authors state in the abstract, “could easily have been spent on more pressing societal issues or forms of relaxation that are more acceptable in academic circles.”

Naturally, Mr. Bond’s line of work entails exposure to unpleasant things, such as poison, dehydration, heatstroke, and dangerous wildlife (everything from ticks to crocodiles), though oddly enough he never succumbs to any of it. He’s also curiously immune to hangovers, despite rarely drinking anything nonalcoholic. There are also less obvious risks: For one, 007 rarely washes his hands. During one movie, he handles raw chicken to lure away a pack of crocodiles but fails to wash his hands afterward, leaving him at risk for multiple food-borne illnesses.

Of course, we must address the elephant in the bedroom: Mr. Bond’s numerous, er, encounters with women. One would imagine the biggest risk to those women would be from the various STDs that likely course through Bond’s body, but of the 27% who died shortly after … encountering … him, all involved violence, with disease playing no obvious role. Who knows, maybe he’s clean? Stranger things have happened.

The timing of this article may seem a bit suspicious. Was it a PR stunt by the studio? Rest assured, the authors addressed this, noting that they received no funding for the study, and that, “given the futility of its academic value, this is deemed entirely appropriate by all authors.” We love when a punchline writes itself.
 

How to see Atlanta on $688.35 a day

The world is always changing, so we have to change with it. This week, LOTME becomes a travel guide, and our first stop is the Big A, the Big Peach, Dogwood City, Empire City of the South, Wakanda.

There’s lots to do in Atlanta: Celebrate a World Series win, visit the College Football Hall of Fame or the World of Coca Cola, or take the Stranger Things/Upside Down film locations tour. Serious adventurers, however, get out of the city and go to Emory Decatur Hospital in – you guessed it – Decatur (unofficial motto: “Everything is Greater in Decatur”).

©Getty Images

Find the emergency room and ask for Taylor Davis, who will be your personal guide. She’ll show you how to check in at the desk, sit in the waiting room for 7 hours, and then leave without seeing any medical personnel or receiving any sort of attention whatsoever. All the things she did when she went there in July for a head injury.

Ms. Davis told Fox5 Atlanta: “I didn’t get my vitals taken, nobody called my name. I wasn’t seen at all.”

But wait! There’s more! By booking your trip through LOTMEgo* and using the code “Decatur,” you’ll get the Taylor Davis special, which includes a bill/cover charge for $688.35 from the hospital. An Emory Healthcare patient financial services employee told Ms. Davis that “you get charged before you are seen. Not for being seen.”

If all this has you ready to hop in your car (really?), then check out LOTMEgo* on Twittbook and InstaTok. You’ll also find trick-or-treating tips and discounts on haunted hospital tours.

*Does not actually exist

Breaking down the hot flash

Do you ever wonder why we scramble for cold things when we’re feeling nauseous? Whether it’s the cool air that needs to hit your face in the car or a cold, damp towel on the back of your neck, scientists think it could possibly be an evolutionary mechanism at the cellular level.

Piqsels

Motion sickness it’s actually a battle of body temperature, according to an article from LiveScience. Capillaries in the skin dilate, allowing for more blood flow near the skin’s surface and causing core temperature to fall. Once body temperature drops, the hypothalamus, which regulates temperature, tries to do its job by raising body temperature. Thus the hot flash!

The cold compress and cool air help fight the battle by counteracting the hypothalamus, but why the drop in body temperature to begin with?

There are a few theories. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told LiveScience that the lack of oxygen needed in body tissue to survive at lower temperatures could be making it difficult to get oxygen to the body when a person is ill, and is “more likely an adaptive response influenced by poorly understood mechanisms at the cellular level.”

Another theory is that the nausea and body temperature shift is the body’s natural response to help people vomit.

Then there’s the theory of “defensive hypothermia,” which suggests that cold sweats are a possible mechanism to conserve energy so the body can fight off an intruder, which was supported by a 2014 study and a 2016 review.

It’s another one of the body’s many survival tricks.
 

Teachers were right: Pupils can do the math

Teachers liked to preach that we wouldn’t have calculators with us all the time, but that wound up not being true. Our phones have calculators at the press of a button. But maybe even calculators aren’t always needed because our pupils do more math than you think.

pxfuel

The pupil light reflex – constrict in light and dilate in darkness – is well known, but recent work shows that pupil size is also regulated by cognitive and perceptual factors. By presenting subjects with images of various numbers of dots and measuring pupil size, the investigators were able to show “that numerical information is intrinsically related to perception,” lead author Dr. Elisa Castaldi of Florence University noted in a written statement.

The researchers found that pupils are responsible for important survival techniques. Coauthor David Burr of the University of Sydney and the University of Florence gave an evolutionary perspective: “When we look around, we spontaneously perceive the form, size, movement and colour of a scene. Equally spontaneously, we perceive the number of items before us. This ability, shared with most other animals, is an evolutionary fundamental: It reveals immediately important quantities, such as how many apples there are on the tree, or how many enemies are attacking.”

Useful information, indeed, but our pupils seem to be more interested in the quantity of beers in the refrigerator.

No, Mr. Bond, I expect you to die

Movie watching usually requires a certain suspension of disbelief, and it’s safe to say James Bond movies require this more than most. Between the impossible gadgets and ludicrous doomsday plans, very few have ever stopped to consider the health risks of the James Bond universe.

Tumisu/Pixabay

Now, however, Bond, James Bond, has met his most formidable opponent: Wouter Graumans, a graduate student in epidemiology from the Netherlands. During a foray to Burkina Faso to study infectious diseases, Mr. Graumans came down with a case of food poisoning, which led him to wonder how 007 is able to trot across this big world of ours without contracting so much as a sinus infection.

Because Mr. Graumans is a man of science and conviction, mere speculation wasn’t enough. He and a group of coauthors wrote an entire paper on the health risks of the James Bond universe.

Doing so required watching over 3,000 minutes of numerous movies and analyzing Bond’s 86 total trips to 46 different countries based on current Centers for Disease Control and Prevention advice for travel to those countries. Time which, the authors state in the abstract, “could easily have been spent on more pressing societal issues or forms of relaxation that are more acceptable in academic circles.”

Naturally, Mr. Bond’s line of work entails exposure to unpleasant things, such as poison, dehydration, heatstroke, and dangerous wildlife (everything from ticks to crocodiles), though oddly enough he never succumbs to any of it. He’s also curiously immune to hangovers, despite rarely drinking anything nonalcoholic. There are also less obvious risks: For one, 007 rarely washes his hands. During one movie, he handles raw chicken to lure away a pack of crocodiles but fails to wash his hands afterward, leaving him at risk for multiple food-borne illnesses.

Of course, we must address the elephant in the bedroom: Mr. Bond’s numerous, er, encounters with women. One would imagine the biggest risk to those women would be from the various STDs that likely course through Bond’s body, but of the 27% who died shortly after … encountering … him, all involved violence, with disease playing no obvious role. Who knows, maybe he’s clean? Stranger things have happened.

The timing of this article may seem a bit suspicious. Was it a PR stunt by the studio? Rest assured, the authors addressed this, noting that they received no funding for the study, and that, “given the futility of its academic value, this is deemed entirely appropriate by all authors.” We love when a punchline writes itself.
 

How to see Atlanta on $688.35 a day

The world is always changing, so we have to change with it. This week, LOTME becomes a travel guide, and our first stop is the Big A, the Big Peach, Dogwood City, Empire City of the South, Wakanda.

There’s lots to do in Atlanta: Celebrate a World Series win, visit the College Football Hall of Fame or the World of Coca Cola, or take the Stranger Things/Upside Down film locations tour. Serious adventurers, however, get out of the city and go to Emory Decatur Hospital in – you guessed it – Decatur (unofficial motto: “Everything is Greater in Decatur”).

©Getty Images

Find the emergency room and ask for Taylor Davis, who will be your personal guide. She’ll show you how to check in at the desk, sit in the waiting room for 7 hours, and then leave without seeing any medical personnel or receiving any sort of attention whatsoever. All the things she did when she went there in July for a head injury.

Ms. Davis told Fox5 Atlanta: “I didn’t get my vitals taken, nobody called my name. I wasn’t seen at all.”

But wait! There’s more! By booking your trip through LOTMEgo* and using the code “Decatur,” you’ll get the Taylor Davis special, which includes a bill/cover charge for $688.35 from the hospital. An Emory Healthcare patient financial services employee told Ms. Davis that “you get charged before you are seen. Not for being seen.”

If all this has you ready to hop in your car (really?), then check out LOTMEgo* on Twittbook and InstaTok. You’ll also find trick-or-treating tips and discounts on haunted hospital tours.

*Does not actually exist

Breaking down the hot flash

Do you ever wonder why we scramble for cold things when we’re feeling nauseous? Whether it’s the cool air that needs to hit your face in the car or a cold, damp towel on the back of your neck, scientists think it could possibly be an evolutionary mechanism at the cellular level.

Piqsels

Motion sickness it’s actually a battle of body temperature, according to an article from LiveScience. Capillaries in the skin dilate, allowing for more blood flow near the skin’s surface and causing core temperature to fall. Once body temperature drops, the hypothalamus, which regulates temperature, tries to do its job by raising body temperature. Thus the hot flash!

The cold compress and cool air help fight the battle by counteracting the hypothalamus, but why the drop in body temperature to begin with?

There are a few theories. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told LiveScience that the lack of oxygen needed in body tissue to survive at lower temperatures could be making it difficult to get oxygen to the body when a person is ill, and is “more likely an adaptive response influenced by poorly understood mechanisms at the cellular level.”

Another theory is that the nausea and body temperature shift is the body’s natural response to help people vomit.

Then there’s the theory of “defensive hypothermia,” which suggests that cold sweats are a possible mechanism to conserve energy so the body can fight off an intruder, which was supported by a 2014 study and a 2016 review.

It’s another one of the body’s many survival tricks.
 

Teachers were right: Pupils can do the math

Teachers liked to preach that we wouldn’t have calculators with us all the time, but that wound up not being true. Our phones have calculators at the press of a button. But maybe even calculators aren’t always needed because our pupils do more math than you think.

pxfuel

The pupil light reflex – constrict in light and dilate in darkness – is well known, but recent work shows that pupil size is also regulated by cognitive and perceptual factors. By presenting subjects with images of various numbers of dots and measuring pupil size, the investigators were able to show “that numerical information is intrinsically related to perception,” lead author Dr. Elisa Castaldi of Florence University noted in a written statement.

The researchers found that pupils are responsible for important survival techniques. Coauthor David Burr of the University of Sydney and the University of Florence gave an evolutionary perspective: “When we look around, we spontaneously perceive the form, size, movement and colour of a scene. Equally spontaneously, we perceive the number of items before us. This ability, shared with most other animals, is an evolutionary fundamental: It reveals immediately important quantities, such as how many apples there are on the tree, or how many enemies are attacking.”

Useful information, indeed, but our pupils seem to be more interested in the quantity of beers in the refrigerator.

No, Mr. Bond, I expect you to die

Movie watching usually requires a certain suspension of disbelief, and it’s safe to say James Bond movies require this more than most. Between the impossible gadgets and ludicrous doomsday plans, very few have ever stopped to consider the health risks of the James Bond universe.

Tumisu/Pixabay

Now, however, Bond, James Bond, has met his most formidable opponent: Wouter Graumans, a graduate student in epidemiology from the Netherlands. During a foray to Burkina Faso to study infectious diseases, Mr. Graumans came down with a case of food poisoning, which led him to wonder how 007 is able to trot across this big world of ours without contracting so much as a sinus infection.

Because Mr. Graumans is a man of science and conviction, mere speculation wasn’t enough. He and a group of coauthors wrote an entire paper on the health risks of the James Bond universe.

Doing so required watching over 3,000 minutes of numerous movies and analyzing Bond’s 86 total trips to 46 different countries based on current Centers for Disease Control and Prevention advice for travel to those countries. Time which, the authors state in the abstract, “could easily have been spent on more pressing societal issues or forms of relaxation that are more acceptable in academic circles.”

Naturally, Mr. Bond’s line of work entails exposure to unpleasant things, such as poison, dehydration, heatstroke, and dangerous wildlife (everything from ticks to crocodiles), though oddly enough he never succumbs to any of it. He’s also curiously immune to hangovers, despite rarely drinking anything nonalcoholic. There are also less obvious risks: For one, 007 rarely washes his hands. During one movie, he handles raw chicken to lure away a pack of crocodiles but fails to wash his hands afterward, leaving him at risk for multiple food-borne illnesses.

Of course, we must address the elephant in the bedroom: Mr. Bond’s numerous, er, encounters with women. One would imagine the biggest risk to those women would be from the various STDs that likely course through Bond’s body, but of the 27% who died shortly after … encountering … him, all involved violence, with disease playing no obvious role. Who knows, maybe he’s clean? Stranger things have happened.

The timing of this article may seem a bit suspicious. Was it a PR stunt by the studio? Rest assured, the authors addressed this, noting that they received no funding for the study, and that, “given the futility of its academic value, this is deemed entirely appropriate by all authors.” We love when a punchline writes itself.
 

How to see Atlanta on $688.35 a day

The world is always changing, so we have to change with it. This week, LOTME becomes a travel guide, and our first stop is the Big A, the Big Peach, Dogwood City, Empire City of the South, Wakanda.

There’s lots to do in Atlanta: Celebrate a World Series win, visit the College Football Hall of Fame or the World of Coca Cola, or take the Stranger Things/Upside Down film locations tour. Serious adventurers, however, get out of the city and go to Emory Decatur Hospital in – you guessed it – Decatur (unofficial motto: “Everything is Greater in Decatur”).

©Getty Images

Find the emergency room and ask for Taylor Davis, who will be your personal guide. She’ll show you how to check in at the desk, sit in the waiting room for 7 hours, and then leave without seeing any medical personnel or receiving any sort of attention whatsoever. All the things she did when she went there in July for a head injury.

Ms. Davis told Fox5 Atlanta: “I didn’t get my vitals taken, nobody called my name. I wasn’t seen at all.”

But wait! There’s more! By booking your trip through LOTMEgo* and using the code “Decatur,” you’ll get the Taylor Davis special, which includes a bill/cover charge for $688.35 from the hospital. An Emory Healthcare patient financial services employee told Ms. Davis that “you get charged before you are seen. Not for being seen.”

If all this has you ready to hop in your car (really?), then check out LOTMEgo* on Twittbook and InstaTok. You’ll also find trick-or-treating tips and discounts on haunted hospital tours.

*Does not actually exist

Breaking down the hot flash

Do you ever wonder why we scramble for cold things when we’re feeling nauseous? Whether it’s the cool air that needs to hit your face in the car or a cold, damp towel on the back of your neck, scientists think it could possibly be an evolutionary mechanism at the cellular level.

Piqsels

Motion sickness it’s actually a battle of body temperature, according to an article from LiveScience. Capillaries in the skin dilate, allowing for more blood flow near the skin’s surface and causing core temperature to fall. Once body temperature drops, the hypothalamus, which regulates temperature, tries to do its job by raising body temperature. Thus the hot flash!

The cold compress and cool air help fight the battle by counteracting the hypothalamus, but why the drop in body temperature to begin with?

There are a few theories. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told LiveScience that the lack of oxygen needed in body tissue to survive at lower temperatures could be making it difficult to get oxygen to the body when a person is ill, and is “more likely an adaptive response influenced by poorly understood mechanisms at the cellular level.”

Another theory is that the nausea and body temperature shift is the body’s natural response to help people vomit.

Then there’s the theory of “defensive hypothermia,” which suggests that cold sweats are a possible mechanism to conserve energy so the body can fight off an intruder, which was supported by a 2014 study and a 2016 review.

It’s another one of the body’s many survival tricks.
 

Teachers were right: Pupils can do the math

Teachers liked to preach that we wouldn’t have calculators with us all the time, but that wound up not being true. Our phones have calculators at the press of a button. But maybe even calculators aren’t always needed because our pupils do more math than you think.

pxfuel

The pupil light reflex – constrict in light and dilate in darkness – is well known, but recent work shows that pupil size is also regulated by cognitive and perceptual factors. By presenting subjects with images of various numbers of dots and measuring pupil size, the investigators were able to show “that numerical information is intrinsically related to perception,” lead author Dr. Elisa Castaldi of Florence University noted in a written statement.

The researchers found that pupils are responsible for important survival techniques. Coauthor David Burr of the University of Sydney and the University of Florence gave an evolutionary perspective: “When we look around, we spontaneously perceive the form, size, movement and colour of a scene. Equally spontaneously, we perceive the number of items before us. This ability, shared with most other animals, is an evolutionary fundamental: It reveals immediately important quantities, such as how many apples there are on the tree, or how many enemies are attacking.”

Useful information, indeed, but our pupils seem to be more interested in the quantity of beers in the refrigerator.

In Australia, where they know a thing or two about skin cancer, authors of a large prospective population-based cohort study found that melanomas detected through routine skin checks were associated with lower all-cause mortality, but not melanoma-specific mortality.

Among patients in New South Wales diagnosed with melanoma in 2006 or 2007 and followed for nearly 12 years, there was no significant difference in the rate of melanoma-specific death associated with either patient-detected or clinician-detected melanomas in an analysis adjusted for prognostic factors.

Although melanomas found through routine clinician-performed skin checks were associated with a 25% reduction in all-cause mortality compared with patient-detected lesions (P = .006), this difference may have been due to the tendency of health-oriented patients to participate in screening programs.

The study – one of the largest to date and performed in an area of the world where there is a high incidence of skin cancer and high degree of public awareness of the risks of too much sun exposure – could not fully answer its central question: Can routine skin checks, a proxy for skin cancer screening, significantly decrease the incidence of melanoma-related deaths?

“A large randomized clinical trial is needed to provide definitive evidence that screening for skin cancer reduces melanoma-specific and all-cause mortality among people invited (vs. not invited) to screen, but there are concerns about feasibility. Our findings could be used to estimate the sample size for a future trial,” wrote Caroline G. Watts, PhD, of the University of Sydney, Australia, and colleagues. Their study was published online Nov. 3 in JAMA Dermatology.

In an editorial accompanying the study, dermatologists Allan C. Halpern, MD, and Michael A. Marchetti, MD, of Memorial Sloan-Kettering Cancer Center in New York, point out that “there has never been a randomized clinical trial of melanoma screening, nor is there one currently ongoing or planned. Even if one were to be initiated immediately, such a trial would take well over a decade to conduct.

“Thus, for the foreseeable future, our approaches to melanoma secondary prevention need to be based on indirect evidence and our understanding of biology and epidemiology,” they wrote.

A dermatology researcher who was not involved in the study said that while it doesn’t solve the screening conundrum, it does highlight the value of public health campaigns.

“The way that I interpret the data, especially the fact that it’s coming out of Australia, is that if education about self-examination is done properly, that can also be effective in terms of detecting these skin cancers,” said Shawn Demehri, MD, PhD, principal investigator at the Cutaneous Biology Research Center at Massachusetts General Hospital, Boston. Dr. Demehri was asked to comment on the study.

“I would argue that the results would probably have been different if the study had been conducted in the U.S. rather than Australia, because the education in terms of self-examination is much more advanced and organized in Australia,” he said in an interview.

Study details

To assess melanoma-specific and all-cause mortality associated with melanoma identified through routine skin checks, Dr. Watts and colleagues followed patients diagnosed with melanoma from October 2006 through October 2007 who were enrolled in the Melanoma Patterns of Care Study. The patients were followed until 2018 (mean follow-up 11.9 years).

Of the 2,452 patients for whom data were available, 291 had an initial diagnosis of primary melanoma in situ (MIS), and 2,161 were diagnosed with invasive cutaneous melanoma.

The median age at diagnosis was 65 years, ranging from 16 to 98 years. Nearly two-thirds of the patients (61%) were men.

Among all patients, 858 (35%) had melanoma detected during a routine skin check, 1,148 (47%) detected the lesions themselves, 293 (12%) had incidentally-detected melanomas, and 153 (6%) had lesions detected by other, unspecified means.

In analyses adjusted for age and sex, the investigators found that compared with patient-detected lesions, melanomas detected during routine skin checks were associated with a 59% lower risk for melanoma-specific mortality (subhazard ratio, 0.41, P < .001) and 36% lower risk for all-cause mortality (hazard ratio, 0.64, P < .001).

But after adjustment for melanoma prognostic factors such as ulceration and mitotic rate, the association of skin check–detected lesions with melanoma-specific mortality was no longer statistically significant. The association with lower all-cause mortality was somewhat attenuated, but remained significant (HR, 0.75, P = .006).

Factors associated with a higher likelihood of melanoma detection during routine skin checks included males vs. females, a history of melanoma, having multiple moles, age 50 or older, and residence in a urban vs. rural areas.
 

Screen with care

In their editorial, Dr. Halpern and Dr. Marchetti propose methods for screening that find a balance between detection of significant disease and potential harm to patients from unnecessary biopsy or invasive procedures.

“For many lesions, we could use serial photography and dermoscopy in lieu of tissue biopsy to identify those that are truly dynamic outliers and likely to be of greater risk to the patient. An analogous approach is already used for the management of small lung nodules detected incidentally and through screening,” they wrote.

They also raise the issue of potential overdiagnosis and overtreatment of MIS, and recommend an approach similar to that used for some older patients with prostate cancer, for example.

“The consequences of MIS treatment differ greatly based on the type, anatomic location, and size of the tumor; these factors should be considered in shared decision-making with patients. Options such as active surveillance and topical therapy should be discussed, particularly in those with significant comorbidities or advanced age,” they wrote.

The study was supported by grants from the Australian National Health and Medical Research Council, Cancer Institute New South Wales, and the New South Wales State Government. Dr. Watts, Dr. Halpern, Dr. Marchetti, and Dr. Demehri reported having no conflicts of interest.

In Australia, where they know a thing or two about skin cancer, authors of a large prospective population-based cohort study found that melanomas detected through routine skin checks were associated with lower all-cause mortality, but not melanoma-specific mortality.

Among patients in New South Wales diagnosed with melanoma in 2006 or 2007 and followed for nearly 12 years, there was no significant difference in the rate of melanoma-specific death associated with either patient-detected or clinician-detected melanomas in an analysis adjusted for prognostic factors.

Although melanomas found through routine clinician-performed skin checks were associated with a 25% reduction in all-cause mortality compared with patient-detected lesions (P = .006), this difference may have been due to the tendency of health-oriented patients to participate in screening programs.

The study – one of the largest to date and performed in an area of the world where there is a high incidence of skin cancer and high degree of public awareness of the risks of too much sun exposure – could not fully answer its central question: Can routine skin checks, a proxy for skin cancer screening, significantly decrease the incidence of melanoma-related deaths?

“A large randomized clinical trial is needed to provide definitive evidence that screening for skin cancer reduces melanoma-specific and all-cause mortality among people invited (vs. not invited) to screen, but there are concerns about feasibility. Our findings could be used to estimate the sample size for a future trial,” wrote Caroline G. Watts, PhD, of the University of Sydney, Australia, and colleagues. Their study was published online Nov. 3 in JAMA Dermatology.

In an editorial accompanying the study, dermatologists Allan C. Halpern, MD, and Michael A. Marchetti, MD, of Memorial Sloan-Kettering Cancer Center in New York, point out that “there has never been a randomized clinical trial of melanoma screening, nor is there one currently ongoing or planned. Even if one were to be initiated immediately, such a trial would take well over a decade to conduct.

“Thus, for the foreseeable future, our approaches to melanoma secondary prevention need to be based on indirect evidence and our understanding of biology and epidemiology,” they wrote.

A dermatology researcher who was not involved in the study said that while it doesn’t solve the screening conundrum, it does highlight the value of public health campaigns.

“The way that I interpret the data, especially the fact that it’s coming out of Australia, is that if education about self-examination is done properly, that can also be effective in terms of detecting these skin cancers,” said Shawn Demehri, MD, PhD, principal investigator at the Cutaneous Biology Research Center at Massachusetts General Hospital, Boston. Dr. Demehri was asked to comment on the study.

“I would argue that the results would probably have been different if the study had been conducted in the U.S. rather than Australia, because the education in terms of self-examination is much more advanced and organized in Australia,” he said in an interview.

Study details

To assess melanoma-specific and all-cause mortality associated with melanoma identified through routine skin checks, Dr. Watts and colleagues followed patients diagnosed with melanoma from October 2006 through October 2007 who were enrolled in the Melanoma Patterns of Care Study. The patients were followed until 2018 (mean follow-up 11.9 years).

Of the 2,452 patients for whom data were available, 291 had an initial diagnosis of primary melanoma in situ (MIS), and 2,161 were diagnosed with invasive cutaneous melanoma.

The median age at diagnosis was 65 years, ranging from 16 to 98 years. Nearly two-thirds of the patients (61%) were men.

Among all patients, 858 (35%) had melanoma detected during a routine skin check, 1,148 (47%) detected the lesions themselves, 293 (12%) had incidentally-detected melanomas, and 153 (6%) had lesions detected by other, unspecified means.

In analyses adjusted for age and sex, the investigators found that compared with patient-detected lesions, melanomas detected during routine skin checks were associated with a 59% lower risk for melanoma-specific mortality (subhazard ratio, 0.41, P < .001) and 36% lower risk for all-cause mortality (hazard ratio, 0.64, P < .001).

But after adjustment for melanoma prognostic factors such as ulceration and mitotic rate, the association of skin check–detected lesions with melanoma-specific mortality was no longer statistically significant. The association with lower all-cause mortality was somewhat attenuated, but remained significant (HR, 0.75, P = .006).

Factors associated with a higher likelihood of melanoma detection during routine skin checks included males vs. females, a history of melanoma, having multiple moles, age 50 or older, and residence in a urban vs. rural areas.
 

Screen with care

In their editorial, Dr. Halpern and Dr. Marchetti propose methods for screening that find a balance between detection of significant disease and potential harm to patients from unnecessary biopsy or invasive procedures.

“For many lesions, we could use serial photography and dermoscopy in lieu of tissue biopsy to identify those that are truly dynamic outliers and likely to be of greater risk to the patient. An analogous approach is already used for the management of small lung nodules detected incidentally and through screening,” they wrote.

They also raise the issue of potential overdiagnosis and overtreatment of MIS, and recommend an approach similar to that used for some older patients with prostate cancer, for example.

“The consequences of MIS treatment differ greatly based on the type, anatomic location, and size of the tumor; these factors should be considered in shared decision-making with patients. Options such as active surveillance and topical therapy should be discussed, particularly in those with significant comorbidities or advanced age,” they wrote.

The study was supported by grants from the Australian National Health and Medical Research Council, Cancer Institute New South Wales, and the New South Wales State Government. Dr. Watts, Dr. Halpern, Dr. Marchetti, and Dr. Demehri reported having no conflicts of interest.

In Australia, where they know a thing or two about skin cancer, authors of a large prospective population-based cohort study found that melanomas detected through routine skin checks were associated with lower all-cause mortality, but not melanoma-specific mortality.

Among patients in New South Wales diagnosed with melanoma in 2006 or 2007 and followed for nearly 12 years, there was no significant difference in the rate of melanoma-specific death associated with either patient-detected or clinician-detected melanomas in an analysis adjusted for prognostic factors.

Although melanomas found through routine clinician-performed skin checks were associated with a 25% reduction in all-cause mortality compared with patient-detected lesions (P = .006), this difference may have been due to the tendency of health-oriented patients to participate in screening programs.

The study – one of the largest to date and performed in an area of the world where there is a high incidence of skin cancer and high degree of public awareness of the risks of too much sun exposure – could not fully answer its central question: Can routine skin checks, a proxy for skin cancer screening, significantly decrease the incidence of melanoma-related deaths?

“A large randomized clinical trial is needed to provide definitive evidence that screening for skin cancer reduces melanoma-specific and all-cause mortality among people invited (vs. not invited) to screen, but there are concerns about feasibility. Our findings could be used to estimate the sample size for a future trial,” wrote Caroline G. Watts, PhD, of the University of Sydney, Australia, and colleagues. Their study was published online Nov. 3 in JAMA Dermatology.

In an editorial accompanying the study, dermatologists Allan C. Halpern, MD, and Michael A. Marchetti, MD, of Memorial Sloan-Kettering Cancer Center in New York, point out that “there has never been a randomized clinical trial of melanoma screening, nor is there one currently ongoing or planned. Even if one were to be initiated immediately, such a trial would take well over a decade to conduct.

“Thus, for the foreseeable future, our approaches to melanoma secondary prevention need to be based on indirect evidence and our understanding of biology and epidemiology,” they wrote.

A dermatology researcher who was not involved in the study said that while it doesn’t solve the screening conundrum, it does highlight the value of public health campaigns.

“The way that I interpret the data, especially the fact that it’s coming out of Australia, is that if education about self-examination is done properly, that can also be effective in terms of detecting these skin cancers,” said Shawn Demehri, MD, PhD, principal investigator at the Cutaneous Biology Research Center at Massachusetts General Hospital, Boston. Dr. Demehri was asked to comment on the study.

“I would argue that the results would probably have been different if the study had been conducted in the U.S. rather than Australia, because the education in terms of self-examination is much more advanced and organized in Australia,” he said in an interview.

Study details

To assess melanoma-specific and all-cause mortality associated with melanoma identified through routine skin checks, Dr. Watts and colleagues followed patients diagnosed with melanoma from October 2006 through October 2007 who were enrolled in the Melanoma Patterns of Care Study. The patients were followed until 2018 (mean follow-up 11.9 years).

Of the 2,452 patients for whom data were available, 291 had an initial diagnosis of primary melanoma in situ (MIS), and 2,161 were diagnosed with invasive cutaneous melanoma.

The median age at diagnosis was 65 years, ranging from 16 to 98 years. Nearly two-thirds of the patients (61%) were men.

Among all patients, 858 (35%) had melanoma detected during a routine skin check, 1,148 (47%) detected the lesions themselves, 293 (12%) had incidentally-detected melanomas, and 153 (6%) had lesions detected by other, unspecified means.

In analyses adjusted for age and sex, the investigators found that compared with patient-detected lesions, melanomas detected during routine skin checks were associated with a 59% lower risk for melanoma-specific mortality (subhazard ratio, 0.41, P < .001) and 36% lower risk for all-cause mortality (hazard ratio, 0.64, P < .001).

But after adjustment for melanoma prognostic factors such as ulceration and mitotic rate, the association of skin check–detected lesions with melanoma-specific mortality was no longer statistically significant. The association with lower all-cause mortality was somewhat attenuated, but remained significant (HR, 0.75, P = .006).

Factors associated with a higher likelihood of melanoma detection during routine skin checks included males vs. females, a history of melanoma, having multiple moles, age 50 or older, and residence in a urban vs. rural areas.
 

Screen with care

In their editorial, Dr. Halpern and Dr. Marchetti propose methods for screening that find a balance between detection of significant disease and potential harm to patients from unnecessary biopsy or invasive procedures.

“For many lesions, we could use serial photography and dermoscopy in lieu of tissue biopsy to identify those that are truly dynamic outliers and likely to be of greater risk to the patient. An analogous approach is already used for the management of small lung nodules detected incidentally and through screening,” they wrote.

They also raise the issue of potential overdiagnosis and overtreatment of MIS, and recommend an approach similar to that used for some older patients with prostate cancer, for example.

“The consequences of MIS treatment differ greatly based on the type, anatomic location, and size of the tumor; these factors should be considered in shared decision-making with patients. Options such as active surveillance and topical therapy should be discussed, particularly in those with significant comorbidities or advanced age,” they wrote.

The study was supported by grants from the Australian National Health and Medical Research Council, Cancer Institute New South Wales, and the New South Wales State Government. Dr. Watts, Dr. Halpern, Dr. Marchetti, and Dr. Demehri reported having no conflicts of interest.

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

A version of this article first appeared on Medscape.com.

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

A version of this article first appeared on Medscape.com.

A psychiatrist was treating a couple individually, one of whom was HIV-positive. During a session, the infected partner revealed he was having sex with other men outside the relationship and not using safe sex practices.

“He was being treated for major depression and anxiety at the time,” explained the anonymous psychiatrist.  “I strongly encouraged him to tell his partner, but he was scared of doing so. He stated that they had not been using safe sex practices between the two of them, but he was willing to start at that point.”

At a session with the HIV-negative partner, the psychiatrist inquired about the couple’s current sex practices. The HIV-negative partner reported no changes and said the two continued to have sex without condoms, said the psychiatrist, who shared the experience in Medscape’s Ethics 2020 Survey open-ended questions.

“My dilemma now was whether or not to inform him about his partner’s ‘extracurricular sex behavior,’ the psychiatrist said. “Since he was now at greater risk of contracting HIV, I felt compelled to do something to intervene.”

What would you do in this situation?

Hearing about infidelity while treating two family members is a bothersome ethical quandary for many physicians, according to responses from the Ethics 2020 Report. When asked to share their toughest ethical dilemma, one internist for example, wrote, “I have couples as patients, and it is very challenging if they reveal infidelity or separate/divorce; I cannot reveal info to the spouse, but it makes me very uncomfortable caring for both.” Similarly, an obstetrician-gynecologist wrote about her experience counseling patients who reveal extramarital affairs.

“Women confide deeply with their gynecologist, and although I was not successful in rescuing 100% of them, the majority accepted my counseling and saved their marriages,” the anonymous ob/gyn wrote. “In every case in which my patient was willing to resume her marital relationship, I always ensured that she advised her spouse of the infidelity, and the couple was referred to a qualified provider for marriage counseling.”

When a sexually transmitted infection (STI) comes into play however, physicians describe a deeper level of internal conflict. A family physician wrote her top ethical dilemma was “Cheating spouses and STIs: how do you get the other spouse treated?” An ob-gyn stated that, “disclosure of STI status in couples when this may indicate infidelity,” was a frequent ethical issue in her specialty. Commenters on Medscape’s recent story, “The Secret I’ll Take to my Grave: Doc Reveals,” also raised the uncomfortable topic. One physician recalled a deaf female patient who requested in writing not to test for syphilis and not to discuss the issue with her husband. “Patient knew that she had syphilis, but she did not want her husband to know,” the physician wrote.    

It’s not uncommon for physicians to encounter such scenarios when treating long-term couples, especially in the digital era, said Shannon Dowler, MD, chief medical officer for North Carolina Medicaid and a family physician at the Buncombe County STI Clinic.

“This is definitely something I think we see more of in our age of ‘hookup apps’ and easier access to casual sexual connections than we did before,” said Dr. Dowler, who serves on the CDC Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment. 

The topic is particularly timely because of the pandemic’s impact on STI testing and the expected rise in sexually transmitted infection rates over the next year, Dr. Dowler notes.

“People weren’t necessarily coming in for routine screening or testing during the pandemic because they didn’t want to take a chance on being exposed to COVID,” she said. “But also, the reagent used for testing for certain types of transmitted infections was in short supply because they use that same reagent for the COVID test. We had shortages of STI testing in many parts of the country. I expect what we’re going to see over the next year are a lot of diagnoses that were missed during the pandemic and a lot of asymptomatic spread.”
 

What do the experts suggest?

Caring for spouses or two partners when an STI is discovered can be challenging for physicians, particularly in small towns where many people know each other, said Kenneth Goodman, PhD, founder and director of the Institute for Bioethics and Health Policy at the University of Miami.

“This can be a real challenge for family physicians and others in a small town,” he said. “If you discover one partner is positive for a sexually transmitted infection and the other is negative, then you’ve got a challenge to manage. The way to do that is to start with moral persuasion, namely you tell your patient, ‘You really need to disclose this. Because when he or she gets it, chances are, you’re going to be the prime suspect.’ “

Dr. Dowler, who practices in an STI clinic, said she once diagnosed a sexually transmitted infection in a patient who was married to one of Dowler’s coworkers. The patient would not allow the partner to be notified, she said. In this case, Dr. Dowler practiced expedited partner therapy (EPT), the clinical practice of treating sex partners of patients diagnosed with chlamydia or gonorrhea by giving the patient prescriptions or medications to take to the partner without having first examined the partner. The practice is legal to some extent in all states, Dr. Dowler said, but some states have different rules about how the practice can be utilized. 

Physicians are obligated to report communicable diseases to their local health department, Dr. Goodman said. The health department would then do contract tracing and be responsible for conveying the STI diagnosis to any relevant parties. Even so, Dr. Goodman said physicians have a moral obligation to strongly encourage patients to divulge the infection to their partner.

“Doctors should work on being persuasive to change behavior,” he said. “Tell your patients to do the right thing and follow up with them. You should tell patients they have a responsibility to disclose a sexually transmitted infection to any of their partners and a responsibility not to have unprotected sex. Doctors can be very powerful advocates for that.”

Dr. Dowler said if she is treating two partners, and one is diagnosed with a sexually transmitted infection, she generally asks the patient for their consent to disclose the diagnosis to the partner. She ensures a witness, usually a nurse, is present when she asks. If consent is refused, Dr. Dowler guides her treatment to be as protective as possible, she said. A helpful resource for patients is Tellyourpartner.org, a website that sends an anonymous text or email about infection exposure and provides guidance on treatment locations and options.

Of course, if the sexually transmitted infection is HIV, another set of rules apply. As of 2021, 35 states have laws that criminalize HIV exposure. Laws vary, but many hold patients criminally liable if they knowingly expose another party to HIV. Many states and some cities also have ‘partner notification’ laws that require health providers to disclose an HIV diagnosis to the patient’s sex partners or to report the names of sex partners to the health department, if known. 

However, case law on a physician’s duty to warn is mixed, and doctors’ responsibility for STI reporting and partner notification is determined by individual states. Making matters more complex is the fact that some states have recently changed their HIV control requirements, Dr. Dowler said. In North Carolina for example, patients living with HIV who have been virally suppressed for 6 months and who are adherent to medications, are no longer in violation of the control measure if they do not disclose their HIV diagnosis to sex partners or if they don’t wear a condom.

“This means physicians would not have to report a virally suppressed, adequately treated HIV-positive patient who is having unprotected sex or take measures to inform any known sex partners of the diagnosis,” she said. “The landscape is constantly changing so physicians have to be vigilant about their state public health statutes. It’s a tricky area. It takes an already complicated topic and makes it just a little more complicated.”
 

Consider drafting a policy

It’s a good idea to have a policy in place at your practice that addresses such ethical dilemmas before they occur, says Michael Heitt, PsyD, a clinical psychologist on the faculty of Loyola University Maryland in Baltimore, and a member of the Maryland Psychological Association’s Ethics Committee. Dr. Heitt developed a model of ethical reasoning called CLEAR Lenses, which stands for Clinical, Legal, Ethical, Administrative, and Risk management. The approach encourages clinicians to identify often competing factors in the decision-making process before choosing a course of action to take.

In the situation of an unfaithful spouse who contracted an STI for example, the physician should consider clinical issues such as the medical likelihood the unaware partner has the STI, and legal issues such as maintaining the confidentiality of all patient information and possible mandated reporting of STI data, Dr. Heitt said. The lenses overlap since confidentiality is also a key ethical issue, and other ethical issues involve the balance of helping the unaware spouse and not harming the infected spouse, he explained. Administrative issues might include how medical records are maintained and whether the physician documents information about patients’ family members in the medical record, while risk management elements may include informed consent, documentation, and consultation. 

“So, if the physician has a policy about how such matters are dealt with, and patients are informed about this when they come to the practice, this can guide the physician much more easily through this sticky situation,” Dr. Heitt said. “Documentation of the decision-making process in the medical record demonstrates the physician’s thought process should it ever be challenged in the future, and consultation with peers (while disguising the identity of the patients, of course) sets a foundation of what a ‘reasonable standard’ might be in such situations.”

There is also the conflict-avoidant approach, Dr. Heitt said, in which the physician could perform “routine” STI testing if the unaware spouse was due for an appointment soon.

“But of course, this is far from avoiding any conflict; it just kicks the can down the road as there will surely be conflict — and plenty of confusion — if the wife tests positive for an STI,” he said. “In most situations, it is usually best to be brave, do the hard work upfront, and deal with the tough situation then, rather than trying to avoid the probable inevitable difficult conversation.”

As for the psychiatrist who was treating the cheating HIV-positive partner, the physician ultimately convinced both patients to come in for a couple’s session. The doctor allowed for a 2-hour timeframe to encourage discussion of any conflicts and unresolved issues, the psychiatrist said. After several more couple’s sessions, it was apparent the HIV-positive partner wanted out of the relationship, according to the psychiatrist’s account. The physician referred them to a couples’ therapist for ongoing treatment.

“During that same session, the HIV positive partner disclosed his recent behaviors and, as a result, they decided not to have further sexual contact until they could explore this further in therapy,” the psychiatrist wrote. “At last communication the couple decided to end the relationship, and the HIV negative partner remained negative.”

A version of this article first appeared on Medscape.com.

The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.

merznatalia/Thinkstock

“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”

Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.

Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.

In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”

The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”

In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.

On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.

Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”

The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).

“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”

Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”

In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”

Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.

merznatalia/Thinkstock

“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”

Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.

Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.

In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”

The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”

In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.

On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.

Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”

The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).

“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”

Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”

In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”

Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.

merznatalia/Thinkstock

“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”

Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.

Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.

In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”

The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”

In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.

On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.

Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”

The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).

“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”

Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”

In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”

Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.

The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”

The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”

Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”

The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”

She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”

Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”

For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”

She reported having no relevant financial disclosures related to her presentation.

[email protected]

Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.

The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”

The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”

Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”

The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”

She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”

Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”

For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”

She reported having no relevant financial disclosures related to her presentation.

[email protected]

Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.

The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”

The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”

Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”

The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”

She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”

Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”

For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”

She reported having no relevant financial disclosures related to her presentation.

[email protected]

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”

Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.

The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.

Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.

Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.

Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.

Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.

A version of this article first appeared on WebMD.com.

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”

Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.

The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.

Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.

Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.

Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.

Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.

A version of this article first appeared on WebMD.com.

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”

Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.

The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.

Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.

Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.

Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.

Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.

A version of this article first appeared on WebMD.com.