Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

[email protected]

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

[email protected]

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

[email protected]

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

When I started at SHM in 2000, there were fewer than 1,000 hospitalists in the US, and now there are more than 60,000. SHM (back then, we were the National Association of Inpatient Physicians) had about 300 members; now, we have more than 20,000.

Today, hospitalists are part of the medical staff at virtually every hospital in the country, and hospital medicine is recognized as a unique medical specialty with our own knowledge base, textbooks, competencies, meetings, and medical professional society. In a health care environment swirling with change, we are one of the few specialties forged with the ability to adapt and, at times, lead this change. Yet there is so much disruption and instability that there are still many twists and turns in the road that will affect hospitalists’ ability to carve out an even brighter future.

Consolidation has come to health care on a large scale. Hospitals are merging. Health insurers are combining, and even large hospital medicine companies like TeamHealth, Sound, Envision, and others are merging, growing, and acquiring.

At the same time, outside forces from industries not usually associated with health care or inpatient care are swarming into our world: CVS acquires Aetna and aims to reshape primary care; Amazon dominates health care supply chains and moves into pharmacy benefits, and even gets into health care delivery via their partnership with Berkshire Hathaway and JP Morgan; Walmart merges with Humana to create one of the biggest players in Medicare; and Apple expands their inroads into wearables and chronic disease management.

Employment of clinicians has grown logarithmically, especially with inpatient physicians, reshaping the medical staff compensation and accountability. At the same time, payers, both government and private, are evolving into population health with an emphasis not so much on transactions (visits and procedures), but more aligned with outcomes, effectiveness, and efficiency.

All of this leads to a new paradigm of what is important and a new set of values that seems at times more like corporate America where the loyalty of employees can be torn between their employer and the patient. This is especially troublesome in a field traditionally based on the primacy of the doctor-patient relationship. This can put the hospitalist right in the middle at the time when the patient can be most vulnerable.

This has led to new ways to deliver the care that hospitalists provide. First as a pilot and now moving more mainstream, patients with several diagnoses (e.g., heart failure, dehydration, or pneumonia) are now managed not in bricks and mortar hospitals, but in “hospitals at home.” The last few days of a typical hospitalization now take place outside the hospital in a skilled nursing facility (SNF). Fear of uncompensated and unnecessary readmissions leads hospitals to engage hospitalists to handle the first few post-discharge outpatient visits.

This is just a small part of the expanding scope for hospitalists. In addition to managing SNFs and the discharge clinic, hospitalists are now the major providers of perioperative care and play a growing role in palliative care, especially for inpatients. As other specialties that abut hospital medicine have increasing demands and yet fewer new specialists, hospitalists are taking on more critical care and geriatrics, providing procedures, and occupy an evolving role in the emergency room.

There is a lot of work coming towards hospital medicine, and to expand our workforce, hospital medicine groups have incorporated advanced practice providers, including nurse practitioners and physician assistants. But building a true team of health professionals is not seamless or easy with each constituency having a unique scope of practice, limits on their licensure, their own culture, and a distinct training background.

But wait. There will be more new players on the hospital medicine team going forward – some we cannot even anticipate at the present time. In the future, the hospitalist may not even touch the electronic health record (EHR). Clinicians have never excelled at data entry or analysis, and it is time to use a combination of artificial intelligence (AI), voice-activated gathering of history into the record, and staff trained to manage the EHR on both the input and the output sides.

While there may be cheering for this new approach to the EHR – especially because it is a major factor in hospitalist burnout – this will refocus the role and work of the hospitalist to be more of a reviewer and integrator of data, and a strategist and decision-maker overseeing 30 or more patients. As Amazon, CVS, and Walmart move into health care, they will look for the best way to utilize the $300-400/hour hospitalist to the top of our skill level.

In the end, this all comes back to how hospitalists add value, how we can create a career that is rewarding, and how we can help hospitalists be resilient and avoid burnout.

The good news is that hospitalists will not be replaced by AI, nor should we expect to have our incomes cut as less well-trained alternatives replace highly compensated physicians in other specialties. This is a real prospect for many other specialties like dermatology, radiology, pathology, anesthesiology, and even cardiology. But hospitalists will need to adapt to changes in what is valued (i.e., how you can be the most effective and efficient) and to a new job description (i.e., overseeing more patients and managing a team that does more of the H&P, data collecting, and bedside work).

After 20 years of coming out of nowhere to being in the middle of everything in health care, I am confident that hospitalists, with the help of SHM, can continue to forge a path where we can be key difference makers and where we can create a rewarding and sustainable career. It won’t “just happen.” It is not inevitable. But if the past 20 years is any example, we are well-positioned to make the adaptation to succeed in the next 20 years. It is up to all of us to make it happen.
 

Dr. Wellikson is the CEO of SHM and is retiring from his role in 2020. This article is the second in a series celebrating Dr. Wellikson’s tenure as CEO.

When I started at SHM in 2000, there were fewer than 1,000 hospitalists in the US, and now there are more than 60,000. SHM (back then, we were the National Association of Inpatient Physicians) had about 300 members; now, we have more than 20,000.

Today, hospitalists are part of the medical staff at virtually every hospital in the country, and hospital medicine is recognized as a unique medical specialty with our own knowledge base, textbooks, competencies, meetings, and medical professional society. In a health care environment swirling with change, we are one of the few specialties forged with the ability to adapt and, at times, lead this change. Yet there is so much disruption and instability that there are still many twists and turns in the road that will affect hospitalists’ ability to carve out an even brighter future.

Consolidation has come to health care on a large scale. Hospitals are merging. Health insurers are combining, and even large hospital medicine companies like TeamHealth, Sound, Envision, and others are merging, growing, and acquiring.

At the same time, outside forces from industries not usually associated with health care or inpatient care are swarming into our world: CVS acquires Aetna and aims to reshape primary care; Amazon dominates health care supply chains and moves into pharmacy benefits, and even gets into health care delivery via their partnership with Berkshire Hathaway and JP Morgan; Walmart merges with Humana to create one of the biggest players in Medicare; and Apple expands their inroads into wearables and chronic disease management.

Employment of clinicians has grown logarithmically, especially with inpatient physicians, reshaping the medical staff compensation and accountability. At the same time, payers, both government and private, are evolving into population health with an emphasis not so much on transactions (visits and procedures), but more aligned with outcomes, effectiveness, and efficiency.

All of this leads to a new paradigm of what is important and a new set of values that seems at times more like corporate America where the loyalty of employees can be torn between their employer and the patient. This is especially troublesome in a field traditionally based on the primacy of the doctor-patient relationship. This can put the hospitalist right in the middle at the time when the patient can be most vulnerable.

This has led to new ways to deliver the care that hospitalists provide. First as a pilot and now moving more mainstream, patients with several diagnoses (e.g., heart failure, dehydration, or pneumonia) are now managed not in bricks and mortar hospitals, but in “hospitals at home.” The last few days of a typical hospitalization now take place outside the hospital in a skilled nursing facility (SNF). Fear of uncompensated and unnecessary readmissions leads hospitals to engage hospitalists to handle the first few post-discharge outpatient visits.

This is just a small part of the expanding scope for hospitalists. In addition to managing SNFs and the discharge clinic, hospitalists are now the major providers of perioperative care and play a growing role in palliative care, especially for inpatients. As other specialties that abut hospital medicine have increasing demands and yet fewer new specialists, hospitalists are taking on more critical care and geriatrics, providing procedures, and occupy an evolving role in the emergency room.

There is a lot of work coming towards hospital medicine, and to expand our workforce, hospital medicine groups have incorporated advanced practice providers, including nurse practitioners and physician assistants. But building a true team of health professionals is not seamless or easy with each constituency having a unique scope of practice, limits on their licensure, their own culture, and a distinct training background.

But wait. There will be more new players on the hospital medicine team going forward – some we cannot even anticipate at the present time. In the future, the hospitalist may not even touch the electronic health record (EHR). Clinicians have never excelled at data entry or analysis, and it is time to use a combination of artificial intelligence (AI), voice-activated gathering of history into the record, and staff trained to manage the EHR on both the input and the output sides.

While there may be cheering for this new approach to the EHR – especially because it is a major factor in hospitalist burnout – this will refocus the role and work of the hospitalist to be more of a reviewer and integrator of data, and a strategist and decision-maker overseeing 30 or more patients. As Amazon, CVS, and Walmart move into health care, they will look for the best way to utilize the $300-400/hour hospitalist to the top of our skill level.

In the end, this all comes back to how hospitalists add value, how we can create a career that is rewarding, and how we can help hospitalists be resilient and avoid burnout.

The good news is that hospitalists will not be replaced by AI, nor should we expect to have our incomes cut as less well-trained alternatives replace highly compensated physicians in other specialties. This is a real prospect for many other specialties like dermatology, radiology, pathology, anesthesiology, and even cardiology. But hospitalists will need to adapt to changes in what is valued (i.e., how you can be the most effective and efficient) and to a new job description (i.e., overseeing more patients and managing a team that does more of the H&P, data collecting, and bedside work).

After 20 years of coming out of nowhere to being in the middle of everything in health care, I am confident that hospitalists, with the help of SHM, can continue to forge a path where we can be key difference makers and where we can create a rewarding and sustainable career. It won’t “just happen.” It is not inevitable. But if the past 20 years is any example, we are well-positioned to make the adaptation to succeed in the next 20 years. It is up to all of us to make it happen.
 

Dr. Wellikson is the CEO of SHM and is retiring from his role in 2020. This article is the second in a series celebrating Dr. Wellikson’s tenure as CEO.

When I started at SHM in 2000, there were fewer than 1,000 hospitalists in the US, and now there are more than 60,000. SHM (back then, we were the National Association of Inpatient Physicians) had about 300 members; now, we have more than 20,000.

Today, hospitalists are part of the medical staff at virtually every hospital in the country, and hospital medicine is recognized as a unique medical specialty with our own knowledge base, textbooks, competencies, meetings, and medical professional society. In a health care environment swirling with change, we are one of the few specialties forged with the ability to adapt and, at times, lead this change. Yet there is so much disruption and instability that there are still many twists and turns in the road that will affect hospitalists’ ability to carve out an even brighter future.

Consolidation has come to health care on a large scale. Hospitals are merging. Health insurers are combining, and even large hospital medicine companies like TeamHealth, Sound, Envision, and others are merging, growing, and acquiring.

At the same time, outside forces from industries not usually associated with health care or inpatient care are swarming into our world: CVS acquires Aetna and aims to reshape primary care; Amazon dominates health care supply chains and moves into pharmacy benefits, and even gets into health care delivery via their partnership with Berkshire Hathaway and JP Morgan; Walmart merges with Humana to create one of the biggest players in Medicare; and Apple expands their inroads into wearables and chronic disease management.

Employment of clinicians has grown logarithmically, especially with inpatient physicians, reshaping the medical staff compensation and accountability. At the same time, payers, both government and private, are evolving into population health with an emphasis not so much on transactions (visits and procedures), but more aligned with outcomes, effectiveness, and efficiency.

All of this leads to a new paradigm of what is important and a new set of values that seems at times more like corporate America where the loyalty of employees can be torn between their employer and the patient. This is especially troublesome in a field traditionally based on the primacy of the doctor-patient relationship. This can put the hospitalist right in the middle at the time when the patient can be most vulnerable.

This has led to new ways to deliver the care that hospitalists provide. First as a pilot and now moving more mainstream, patients with several diagnoses (e.g., heart failure, dehydration, or pneumonia) are now managed not in bricks and mortar hospitals, but in “hospitals at home.” The last few days of a typical hospitalization now take place outside the hospital in a skilled nursing facility (SNF). Fear of uncompensated and unnecessary readmissions leads hospitals to engage hospitalists to handle the first few post-discharge outpatient visits.

This is just a small part of the expanding scope for hospitalists. In addition to managing SNFs and the discharge clinic, hospitalists are now the major providers of perioperative care and play a growing role in palliative care, especially for inpatients. As other specialties that abut hospital medicine have increasing demands and yet fewer new specialists, hospitalists are taking on more critical care and geriatrics, providing procedures, and occupy an evolving role in the emergency room.

There is a lot of work coming towards hospital medicine, and to expand our workforce, hospital medicine groups have incorporated advanced practice providers, including nurse practitioners and physician assistants. But building a true team of health professionals is not seamless or easy with each constituency having a unique scope of practice, limits on their licensure, their own culture, and a distinct training background.

But wait. There will be more new players on the hospital medicine team going forward – some we cannot even anticipate at the present time. In the future, the hospitalist may not even touch the electronic health record (EHR). Clinicians have never excelled at data entry or analysis, and it is time to use a combination of artificial intelligence (AI), voice-activated gathering of history into the record, and staff trained to manage the EHR on both the input and the output sides.

While there may be cheering for this new approach to the EHR – especially because it is a major factor in hospitalist burnout – this will refocus the role and work of the hospitalist to be more of a reviewer and integrator of data, and a strategist and decision-maker overseeing 30 or more patients. As Amazon, CVS, and Walmart move into health care, they will look for the best way to utilize the $300-400/hour hospitalist to the top of our skill level.

In the end, this all comes back to how hospitalists add value, how we can create a career that is rewarding, and how we can help hospitalists be resilient and avoid burnout.

The good news is that hospitalists will not be replaced by AI, nor should we expect to have our incomes cut as less well-trained alternatives replace highly compensated physicians in other specialties. This is a real prospect for many other specialties like dermatology, radiology, pathology, anesthesiology, and even cardiology. But hospitalists will need to adapt to changes in what is valued (i.e., how you can be the most effective and efficient) and to a new job description (i.e., overseeing more patients and managing a team that does more of the H&P, data collecting, and bedside work).

After 20 years of coming out of nowhere to being in the middle of everything in health care, I am confident that hospitalists, with the help of SHM, can continue to forge a path where we can be key difference makers and where we can create a rewarding and sustainable career. It won’t “just happen.” It is not inevitable. But if the past 20 years is any example, we are well-positioned to make the adaptation to succeed in the next 20 years. It is up to all of us to make it happen.
 

Dr. Wellikson is the CEO of SHM and is retiring from his role in 2020. This article is the second in a series celebrating Dr. Wellikson’s tenure as CEO.

Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.^1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).¹² The most common aerosolized medications given in the clinical setting are bronchodilators.¹²

Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.² Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).^13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.^15-17

Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.^13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.

Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.^18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.²⁰ It is possible that 20% of frontline HCWs will become infected.²¹ Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.²² Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.²³ Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.²⁴

Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.

Recommendations

We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.^25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:

1. Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
2. Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).¹
3. Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).^25,27
4.  Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.²² Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.²⁵
5. Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
6. Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.²⁷ Apply the exclusion criterion of suspected or definite COVID-19.
7. Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.

Conclusions

To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.²⁹ Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.³⁰

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.

Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.^1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).¹² The most common aerosolized medications given in the clinical setting are bronchodilators.¹²

Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.² Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).^13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.^15-17

Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.^13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.

Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.^18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.²⁰ It is possible that 20% of frontline HCWs will become infected.²¹ Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.²² Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.²³ Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.²⁴

Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.

Recommendations

We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.^25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:

1. Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
2. Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).¹
3. Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).^25,27
4.  Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.²² Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.²⁵
5. Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
6. Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.²⁷ Apply the exclusion criterion of suspected or definite COVID-19.
7. Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.

Conclusions

To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.²⁹ Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.³⁰

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.

Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.^1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).¹² The most common aerosolized medications given in the clinical setting are bronchodilators.¹²

Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.² Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).^13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.^15-17

Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.^13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.

Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.^18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.²⁰ It is possible that 20% of frontline HCWs will become infected.²¹ Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.²² Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.²³ Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.²⁴

Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.

Recommendations

We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.^25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:

1. Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
2. Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).¹
3. Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).^25,27
4.  Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.²² Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.²⁵
5. Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
6. Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.²⁷ Apply the exclusion criterion of suspected or definite COVID-19.
7. Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.

Conclusions

To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.²⁹ Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.³⁰

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.

Interactions between industry and physicians, including dermatologists, are widely prevalent.^1-3 Proper reporting of industry relationships is essential for transparency, objectivity, and management of potential biases and conflicts of interest. There has been increasing public scrutiny regarding these interactions.

The Physician Payments Sunshine Act established Open Payments (OP), a publicly available database that collects and displays industry-reported physician-industry interactions.^4,5 For the medical community and public, the OP database may be used to assess transparency by comparing the data with physician self-disclosures. There is a paucity of studies in the literature examining the concordance of industry-reported disclosures and physician self-reported data, with even fewer studies utilizing OP as a source of industry disclosures, and none exists for dermatology.^6-12 It also is not clear to what extent the OP database captures all possible dermatologist-industry interactions, as the Sunshine Act only mandates reporting by applicable US-based manufacturers and group purchasing organizations that produce or purchase drugs or devices that require a prescription and are reimbursable by a government-run health care program.⁵ As a result, certain companies, such as cosmeceuticals, may not be represented.

In this study we aimed to evaluate the concordance of dermatologist self-disclosure of industry relationships and those reported on OP. Specifically, we focused on interactions disclosed by presenters at the American Academy of Dermatology (AAD) 73rd Annual Meeting in San Francisco, California (March 20–24, 2015), and those by industry in the 2014 OP database.

Methods

In this retrospective cohort study, we compared publicly available data from the OP database to presenter disclosures found in the publicly available AAD 73rd Annual Meeting program (AADMP). The AAD required speakers to disclose financial relationships with industry within the 12 months preceding the presentation, as outlined in the Accreditation Council for Continuing Medical Education guidelines.¹³ All AAD presenters who were dermatologists practicing in the United States were included in the analysis, whereas residents, fellows, nonphysicians, nondermatologist physicians, and international dermatologists were excluded.

We examined general, research, and associated research payments to specific dermatologists using the 2014 OP data, which contained industry payments made between January 1 and December 31, 2014. Open Payments defined research payments as direct payment to the physician for different types of research activities and associated research payments as indirect payments made to a research institution or entity where the physician was named the principal investigator.⁵ We chose the 2014 database because it most closely matched the period of required disclosures defined by the AAD for the 2015 meeting. Our review of the OP data occurred after the June 2016 update and thus included the most accurate and up-to-date financial interactions.

We conducted our analysis in 2 major steps. First, we determined whether each industry interaction reported in the OP database was present in the AADMP, which provided an assessment of interaction-level concordance. Second, we determined whether all the industry interactions for any given dermatologist listed in the OP also were present in AADMP, which provided an assessment of dermatologist-level concordance.

First, to establish interaction-level concordance for each industry interaction, the company name and the type of interaction (eg, consultant, speaker, investigator) listed in the AADMP were compared with the data in OP to verify a match. Each interaction was assigned into one of the categories of concordant disclosure (a match of both the company name and type of interaction details in OP and the AADMP), overdisclosure (the presence of an AADMP interaction not found in OP, such as an additional type of interaction or company), or underdisclosure (a company name or type of interaction found in OP but not reported in the AADMP). For underdisclosure, we further classified into company present or company absent based on whether the dermatologist disclosed any relationship with a particular company in the AADMP. We considered the type of interaction to be matching if they were identical or similar in nature (eg, consulting in OP and advisory board in the AADMP), as the types of interactions are reported differently in OP and the AADMP. Otherwise, if they were not similar enough (eg, education in OP and stockholder in the AADMP), it was classified as underdisclosure. Some types of interactions reported in OP were not available on the AAD disclosure form. For example, food and beverage as well as travel and lodging were types of interactions in OP that did not exist in the AADMP. These 2 types of interactions comprised a large majority of OP payment entries but only accounted for a small percentage of the payment amount. Analysis was performed both including and excluding interactions for food, beverage, travel, and lodging (f/b/t/l) to best account for differences in interaction categories between OP and the AADMP.

Second, each dermatologist was assigned to an overall disclosure category of dermatologist-level concordance based on the status for all his/her interactions. Categories included no disclosure (no industry interactions in OP and the AADMP), concordant (all industry interactions reported in OP and the AADMP match), overdisclosure only (no industry interactions on OP but self-reported interactions present in the AADMP), and discordant (not all OP interactions were disclosed in the AADMP). The discordant category was further divided into with overdisclosure and without overdisclosure, depending on the presence or absence of industry relationships listed in the AADMP but not in OP, respectively.

To ensure uniformity, one individual (A.F.S.) reviewed and collected the data from OP and the AADMP. Information on gender and academic affiliation of study participants was obtained from information listed in the AADMP and Google searches. Data management was performed with Microsoft Excel software (Microsoft Excel 2010, Version 14.0, Microsoft Corporation). The New York University School of Medicine’s (New York, New York) institutional review board exempted this study.

Results

Of the 938 presenters listed in the AADMP, 768 individuals met the inclusion criteria. The most commonly cited type of relationship with industry listed in the AADMP was serving as an investigator, consultant, or advisory board member, comprising 34%, 26%, and 18%, respectively (Table 1). The forms of payment most frequently reported in the AADMP were honoraria and grants/research funding, comprising 49% and 25%, respectively (Table 2).

In 2014, there were a total of 20,761 industry payments totaling $35,627,365 for general, research, and associated research payments in the OP database related to the dermatologists who met inclusion criteria. There were 8678 payments totaling $466,622 for food and beverage and 3238 payments totaling $1,357,770 for travel and lodging. After excluding payments for f/b/t/l, there were 8845 payments totaling $33,802,973, with highest percentages of payment amounts for associated research (67.1%), consulting fees (11.5%), research (7.9%), and speaker fees (7.2%)(Table 3). For presenters with industry payments, the range of disbursements excluding f/b/t/l was $6.52 to $1,933,705, with a mean (standard deviation) of $107,997 ($249,941), a median of $18,247, and an interquartile range of $3422 to $97,375 (data not shown).

Comment

In this study, we demonstrated discordance between dermatologist self-reported financial interactions in the AADMP compared with those reported by industry via OP. After excluding f/b/t/l entries, approximately two-thirds of the total amount and number of payments in OP were disclosed, while 31% of dermatologists had discordant disclosure status.

Prior investigations in other medical fields showed high discrepancy rates between industry-reported and physician-reported relationships ranging from 23% to 62%, with studies utilizing various methodologies.^{6-9,11,12,14,15} Only a few studies have utilized the OP database.^8,12,15 Thompson et al¹² compared OP payment data with physician financial disclosure at an annual gynecology scientific meeting and found although 209 of 335 (62%) physicians had interactions listed in the OP database, only 24 (7%) listed at least 1 company in the meeting financial disclosure section. Of these 24 physicians, only 5 (21%) accurately disclosed financial relationships with all of the companies listed in OP. The investigators found 129 (38.5%) physicians and 33.7% of the $1.99 million OP payments had concordant disclosure status. When they excluded physicians who received less than $100, 53% of individuals had concordant disclosure.¹² Hannon et al⁸ reported on inconsistencies between disclosures in the OP database and the American Academy of Orthopedic Surgeons Annual Meeting and found 259 (23%) of 1113 physicians meeting inclusion criteria had financial interactions listed in the OP database that were not reported in the meeting disclosures. Yee et al¹⁵ also utilized the OP database and compared it with author disclosures in 3 major ophthalmology journals.Of 670 authors, 367 (54.8%) had complete concordance, with 68 (10.1%) more reporting additional overdisclosures, leading to a discordant with underdisclosure rate of 35.1%. Additionally, $1.46 million (44.6%) of the $3.27 million OP payments had concordant disclosure status.¹⁵ Other studies compared individual companies’ online reports of physician payments with physician self-disclosures in annual meeting programs, clinical guidelines, and peer-reviewed publications.^6,7,9,11,14

Our study demonstrated variation in disclosure status. Compared with other groups, dermatologists in the discordant with overdisclosure group on average had more interactions with and received higher payments from industry, which is consistent with studies in the orthopedic surgery literature.^8,9 Male dermatologists had 11% more discordant disclosures than their female counterparts, which may be influenced by men having more industry interactions than women.³ Although small industry payments possessed the lowest concordant rate in our study, which has been observed,¹² payments greater than $100,000 had the second-lowest concordance rate at 58%, which may be skewed by the small sample size. Rates of concordant disclosure differed among types of interactions, such as between research and associated research payments. This particular difference may be attributed to the incorrect listing of dermatologists as principal investigators or reduced awareness of payments, as associated research payments were made to the institution and not the individual.

Reasons for discrepancies between industry-reported and dermatologist-reported disclosures may include reporting time differences, lack of physician awareness of OP, industry reporting inaccuracies, dearth of contextual information associated with individual payment entries, and misunderstandings. Prior research demonstrated that the most common reasons for physician nondisclosure included misunderstanding disclosure requirements, unintentional omission of payment, and a lack of relationship between the industry payment and presentation topic.^9,12 These factors likely contributed to the disclosure inconsistencies in our study. Similarly high rates of inconsistencies across different specialties suggest systemic concerns.

We found a substantial number of dermatologist-industry interactions listed in the AADMP that were not captured by OP, with 108 dermatologists (35%) having overdisclosures even when excluding f/b/t/l entries. The number of companies in these overdisclosures approximated 4 times the number of companies on OP. Other studies have also observed physician-industry interactions not displayed on OP.^8,12,15 Because the Sunshine Act requires reporting only by certain companies, interactions surrounding products such as over-the-counter merchandise, cosmetics, lasers, novel devices, and new medications are generally not included. Further, OP may not capture nonmonetary industry relationships.

There were several limitations to this study. The most notable limitation was the differences in the categorizations of industry relationships by OP and the AADMP. These differences can overemphasize some types of interactions at the expense of other types, such as f/b/t/l. As such, analyses were repeated after excluding f/b/t/l. Another limitation was the inexact overlap of time frames for OP and the AADMP, which may have led to discrepancies. However, we used the best available data and expect the vast majority of interactions to have occurred by the AAD disclosure deadline. It is possible that the presenters may have had a more updated conflict-of-interest disclosure slide at the time of the meeting presentation. The most important limitation was that we were unable to determine whether discrepancies resulted from underreporting by dermatologists or inaccurate reporting by industry. It was unlikely that OP or the AADMP alone completely represented all dermatologist-industry financial relationships.

Conclusion

With a growing emphasis on physician-industry transparency, we identified rates of differences in dermatology consistent with those in other medical fields when comparing the publicly available OP database with disclosures at national conferences. Although the differences in the categorization and requirements for disclosure between the OP database and the AADMP may account for some of the discordance, dermatologists should be aware of potentially negative public perceptions regarding the transparency and prevalence of physician-industry interactions. Dermatologists should continue to disclose conflicts of interest as accurately as possible and review their industry-reported interactions listed in the OP database.



Acknowledgment
The first two authors contributed equally to this research/article.

Interactions between industry and physicians, including dermatologists, are widely prevalent.^1-3 Proper reporting of industry relationships is essential for transparency, objectivity, and management of potential biases and conflicts of interest. There has been increasing public scrutiny regarding these interactions.

The Physician Payments Sunshine Act established Open Payments (OP), a publicly available database that collects and displays industry-reported physician-industry interactions.^4,5 For the medical community and public, the OP database may be used to assess transparency by comparing the data with physician self-disclosures. There is a paucity of studies in the literature examining the concordance of industry-reported disclosures and physician self-reported data, with even fewer studies utilizing OP as a source of industry disclosures, and none exists for dermatology.^6-12 It also is not clear to what extent the OP database captures all possible dermatologist-industry interactions, as the Sunshine Act only mandates reporting by applicable US-based manufacturers and group purchasing organizations that produce or purchase drugs or devices that require a prescription and are reimbursable by a government-run health care program.⁵ As a result, certain companies, such as cosmeceuticals, may not be represented.

In this study we aimed to evaluate the concordance of dermatologist self-disclosure of industry relationships and those reported on OP. Specifically, we focused on interactions disclosed by presenters at the American Academy of Dermatology (AAD) 73rd Annual Meeting in San Francisco, California (March 20–24, 2015), and those by industry in the 2014 OP database.

Methods

In this retrospective cohort study, we compared publicly available data from the OP database to presenter disclosures found in the publicly available AAD 73rd Annual Meeting program (AADMP). The AAD required speakers to disclose financial relationships with industry within the 12 months preceding the presentation, as outlined in the Accreditation Council for Continuing Medical Education guidelines.¹³ All AAD presenters who were dermatologists practicing in the United States were included in the analysis, whereas residents, fellows, nonphysicians, nondermatologist physicians, and international dermatologists were excluded.

We examined general, research, and associated research payments to specific dermatologists using the 2014 OP data, which contained industry payments made between January 1 and December 31, 2014. Open Payments defined research payments as direct payment to the physician for different types of research activities and associated research payments as indirect payments made to a research institution or entity where the physician was named the principal investigator.⁵ We chose the 2014 database because it most closely matched the period of required disclosures defined by the AAD for the 2015 meeting. Our review of the OP data occurred after the June 2016 update and thus included the most accurate and up-to-date financial interactions.

We conducted our analysis in 2 major steps. First, we determined whether each industry interaction reported in the OP database was present in the AADMP, which provided an assessment of interaction-level concordance. Second, we determined whether all the industry interactions for any given dermatologist listed in the OP also were present in AADMP, which provided an assessment of dermatologist-level concordance.

First, to establish interaction-level concordance for each industry interaction, the company name and the type of interaction (eg, consultant, speaker, investigator) listed in the AADMP were compared with the data in OP to verify a match. Each interaction was assigned into one of the categories of concordant disclosure (a match of both the company name and type of interaction details in OP and the AADMP), overdisclosure (the presence of an AADMP interaction not found in OP, such as an additional type of interaction or company), or underdisclosure (a company name or type of interaction found in OP but not reported in the AADMP). For underdisclosure, we further classified into company present or company absent based on whether the dermatologist disclosed any relationship with a particular company in the AADMP. We considered the type of interaction to be matching if they were identical or similar in nature (eg, consulting in OP and advisory board in the AADMP), as the types of interactions are reported differently in OP and the AADMP. Otherwise, if they were not similar enough (eg, education in OP and stockholder in the AADMP), it was classified as underdisclosure. Some types of interactions reported in OP were not available on the AAD disclosure form. For example, food and beverage as well as travel and lodging were types of interactions in OP that did not exist in the AADMP. These 2 types of interactions comprised a large majority of OP payment entries but only accounted for a small percentage of the payment amount. Analysis was performed both including and excluding interactions for food, beverage, travel, and lodging (f/b/t/l) to best account for differences in interaction categories between OP and the AADMP.

Second, each dermatologist was assigned to an overall disclosure category of dermatologist-level concordance based on the status for all his/her interactions. Categories included no disclosure (no industry interactions in OP and the AADMP), concordant (all industry interactions reported in OP and the AADMP match), overdisclosure only (no industry interactions on OP but self-reported interactions present in the AADMP), and discordant (not all OP interactions were disclosed in the AADMP). The discordant category was further divided into with overdisclosure and without overdisclosure, depending on the presence or absence of industry relationships listed in the AADMP but not in OP, respectively.

To ensure uniformity, one individual (A.F.S.) reviewed and collected the data from OP and the AADMP. Information on gender and academic affiliation of study participants was obtained from information listed in the AADMP and Google searches. Data management was performed with Microsoft Excel software (Microsoft Excel 2010, Version 14.0, Microsoft Corporation). The New York University School of Medicine’s (New York, New York) institutional review board exempted this study.

Results

Of the 938 presenters listed in the AADMP, 768 individuals met the inclusion criteria. The most commonly cited type of relationship with industry listed in the AADMP was serving as an investigator, consultant, or advisory board member, comprising 34%, 26%, and 18%, respectively (Table 1). The forms of payment most frequently reported in the AADMP were honoraria and grants/research funding, comprising 49% and 25%, respectively (Table 2).

In 2014, there were a total of 20,761 industry payments totaling $35,627,365 for general, research, and associated research payments in the OP database related to the dermatologists who met inclusion criteria. There were 8678 payments totaling $466,622 for food and beverage and 3238 payments totaling $1,357,770 for travel and lodging. After excluding payments for f/b/t/l, there were 8845 payments totaling $33,802,973, with highest percentages of payment amounts for associated research (67.1%), consulting fees (11.5%), research (7.9%), and speaker fees (7.2%)(Table 3). For presenters with industry payments, the range of disbursements excluding f/b/t/l was $6.52 to $1,933,705, with a mean (standard deviation) of $107,997 ($249,941), a median of $18,247, and an interquartile range of $3422 to $97,375 (data not shown).

Comment

In this study, we demonstrated discordance between dermatologist self-reported financial interactions in the AADMP compared with those reported by industry via OP. After excluding f/b/t/l entries, approximately two-thirds of the total amount and number of payments in OP were disclosed, while 31% of dermatologists had discordant disclosure status.

Prior investigations in other medical fields showed high discrepancy rates between industry-reported and physician-reported relationships ranging from 23% to 62%, with studies utilizing various methodologies.^{6-9,11,12,14,15} Only a few studies have utilized the OP database.^8,12,15 Thompson et al¹² compared OP payment data with physician financial disclosure at an annual gynecology scientific meeting and found although 209 of 335 (62%) physicians had interactions listed in the OP database, only 24 (7%) listed at least 1 company in the meeting financial disclosure section. Of these 24 physicians, only 5 (21%) accurately disclosed financial relationships with all of the companies listed in OP. The investigators found 129 (38.5%) physicians and 33.7% of the $1.99 million OP payments had concordant disclosure status. When they excluded physicians who received less than $100, 53% of individuals had concordant disclosure.¹² Hannon et al⁸ reported on inconsistencies between disclosures in the OP database and the American Academy of Orthopedic Surgeons Annual Meeting and found 259 (23%) of 1113 physicians meeting inclusion criteria had financial interactions listed in the OP database that were not reported in the meeting disclosures. Yee et al¹⁵ also utilized the OP database and compared it with author disclosures in 3 major ophthalmology journals.Of 670 authors, 367 (54.8%) had complete concordance, with 68 (10.1%) more reporting additional overdisclosures, leading to a discordant with underdisclosure rate of 35.1%. Additionally, $1.46 million (44.6%) of the $3.27 million OP payments had concordant disclosure status.¹⁵ Other studies compared individual companies’ online reports of physician payments with physician self-disclosures in annual meeting programs, clinical guidelines, and peer-reviewed publications.^6,7,9,11,14

Our study demonstrated variation in disclosure status. Compared with other groups, dermatologists in the discordant with overdisclosure group on average had more interactions with and received higher payments from industry, which is consistent with studies in the orthopedic surgery literature.^8,9 Male dermatologists had 11% more discordant disclosures than their female counterparts, which may be influenced by men having more industry interactions than women.³ Although small industry payments possessed the lowest concordant rate in our study, which has been observed,¹² payments greater than $100,000 had the second-lowest concordance rate at 58%, which may be skewed by the small sample size. Rates of concordant disclosure differed among types of interactions, such as between research and associated research payments. This particular difference may be attributed to the incorrect listing of dermatologists as principal investigators or reduced awareness of payments, as associated research payments were made to the institution and not the individual.

Reasons for discrepancies between industry-reported and dermatologist-reported disclosures may include reporting time differences, lack of physician awareness of OP, industry reporting inaccuracies, dearth of contextual information associated with individual payment entries, and misunderstandings. Prior research demonstrated that the most common reasons for physician nondisclosure included misunderstanding disclosure requirements, unintentional omission of payment, and a lack of relationship between the industry payment and presentation topic.^9,12 These factors likely contributed to the disclosure inconsistencies in our study. Similarly high rates of inconsistencies across different specialties suggest systemic concerns.

We found a substantial number of dermatologist-industry interactions listed in the AADMP that were not captured by OP, with 108 dermatologists (35%) having overdisclosures even when excluding f/b/t/l entries. The number of companies in these overdisclosures approximated 4 times the number of companies on OP. Other studies have also observed physician-industry interactions not displayed on OP.^8,12,15 Because the Sunshine Act requires reporting only by certain companies, interactions surrounding products such as over-the-counter merchandise, cosmetics, lasers, novel devices, and new medications are generally not included. Further, OP may not capture nonmonetary industry relationships.

There were several limitations to this study. The most notable limitation was the differences in the categorizations of industry relationships by OP and the AADMP. These differences can overemphasize some types of interactions at the expense of other types, such as f/b/t/l. As such, analyses were repeated after excluding f/b/t/l. Another limitation was the inexact overlap of time frames for OP and the AADMP, which may have led to discrepancies. However, we used the best available data and expect the vast majority of interactions to have occurred by the AAD disclosure deadline. It is possible that the presenters may have had a more updated conflict-of-interest disclosure slide at the time of the meeting presentation. The most important limitation was that we were unable to determine whether discrepancies resulted from underreporting by dermatologists or inaccurate reporting by industry. It was unlikely that OP or the AADMP alone completely represented all dermatologist-industry financial relationships.

Conclusion

With a growing emphasis on physician-industry transparency, we identified rates of differences in dermatology consistent with those in other medical fields when comparing the publicly available OP database with disclosures at national conferences. Although the differences in the categorization and requirements for disclosure between the OP database and the AADMP may account for some of the discordance, dermatologists should be aware of potentially negative public perceptions regarding the transparency and prevalence of physician-industry interactions. Dermatologists should continue to disclose conflicts of interest as accurately as possible and review their industry-reported interactions listed in the OP database.



Acknowledgment
The first two authors contributed equally to this research/article.

Interactions between industry and physicians, including dermatologists, are widely prevalent.^1-3 Proper reporting of industry relationships is essential for transparency, objectivity, and management of potential biases and conflicts of interest. There has been increasing public scrutiny regarding these interactions.

The Physician Payments Sunshine Act established Open Payments (OP), a publicly available database that collects and displays industry-reported physician-industry interactions.^4,5 For the medical community and public, the OP database may be used to assess transparency by comparing the data with physician self-disclosures. There is a paucity of studies in the literature examining the concordance of industry-reported disclosures and physician self-reported data, with even fewer studies utilizing OP as a source of industry disclosures, and none exists for dermatology.^6-12 It also is not clear to what extent the OP database captures all possible dermatologist-industry interactions, as the Sunshine Act only mandates reporting by applicable US-based manufacturers and group purchasing organizations that produce or purchase drugs or devices that require a prescription and are reimbursable by a government-run health care program.⁵ As a result, certain companies, such as cosmeceuticals, may not be represented.

In this study we aimed to evaluate the concordance of dermatologist self-disclosure of industry relationships and those reported on OP. Specifically, we focused on interactions disclosed by presenters at the American Academy of Dermatology (AAD) 73rd Annual Meeting in San Francisco, California (March 20–24, 2015), and those by industry in the 2014 OP database.

Methods

In this retrospective cohort study, we compared publicly available data from the OP database to presenter disclosures found in the publicly available AAD 73rd Annual Meeting program (AADMP). The AAD required speakers to disclose financial relationships with industry within the 12 months preceding the presentation, as outlined in the Accreditation Council for Continuing Medical Education guidelines.¹³ All AAD presenters who were dermatologists practicing in the United States were included in the analysis, whereas residents, fellows, nonphysicians, nondermatologist physicians, and international dermatologists were excluded.

We examined general, research, and associated research payments to specific dermatologists using the 2014 OP data, which contained industry payments made between January 1 and December 31, 2014. Open Payments defined research payments as direct payment to the physician for different types of research activities and associated research payments as indirect payments made to a research institution or entity where the physician was named the principal investigator.⁵ We chose the 2014 database because it most closely matched the period of required disclosures defined by the AAD for the 2015 meeting. Our review of the OP data occurred after the June 2016 update and thus included the most accurate and up-to-date financial interactions.

We conducted our analysis in 2 major steps. First, we determined whether each industry interaction reported in the OP database was present in the AADMP, which provided an assessment of interaction-level concordance. Second, we determined whether all the industry interactions for any given dermatologist listed in the OP also were present in AADMP, which provided an assessment of dermatologist-level concordance.

First, to establish interaction-level concordance for each industry interaction, the company name and the type of interaction (eg, consultant, speaker, investigator) listed in the AADMP were compared with the data in OP to verify a match. Each interaction was assigned into one of the categories of concordant disclosure (a match of both the company name and type of interaction details in OP and the AADMP), overdisclosure (the presence of an AADMP interaction not found in OP, such as an additional type of interaction or company), or underdisclosure (a company name or type of interaction found in OP but not reported in the AADMP). For underdisclosure, we further classified into company present or company absent based on whether the dermatologist disclosed any relationship with a particular company in the AADMP. We considered the type of interaction to be matching if they were identical or similar in nature (eg, consulting in OP and advisory board in the AADMP), as the types of interactions are reported differently in OP and the AADMP. Otherwise, if they were not similar enough (eg, education in OP and stockholder in the AADMP), it was classified as underdisclosure. Some types of interactions reported in OP were not available on the AAD disclosure form. For example, food and beverage as well as travel and lodging were types of interactions in OP that did not exist in the AADMP. These 2 types of interactions comprised a large majority of OP payment entries but only accounted for a small percentage of the payment amount. Analysis was performed both including and excluding interactions for food, beverage, travel, and lodging (f/b/t/l) to best account for differences in interaction categories between OP and the AADMP.

Second, each dermatologist was assigned to an overall disclosure category of dermatologist-level concordance based on the status for all his/her interactions. Categories included no disclosure (no industry interactions in OP and the AADMP), concordant (all industry interactions reported in OP and the AADMP match), overdisclosure only (no industry interactions on OP but self-reported interactions present in the AADMP), and discordant (not all OP interactions were disclosed in the AADMP). The discordant category was further divided into with overdisclosure and without overdisclosure, depending on the presence or absence of industry relationships listed in the AADMP but not in OP, respectively.

To ensure uniformity, one individual (A.F.S.) reviewed and collected the data from OP and the AADMP. Information on gender and academic affiliation of study participants was obtained from information listed in the AADMP and Google searches. Data management was performed with Microsoft Excel software (Microsoft Excel 2010, Version 14.0, Microsoft Corporation). The New York University School of Medicine’s (New York, New York) institutional review board exempted this study.

Results

Of the 938 presenters listed in the AADMP, 768 individuals met the inclusion criteria. The most commonly cited type of relationship with industry listed in the AADMP was serving as an investigator, consultant, or advisory board member, comprising 34%, 26%, and 18%, respectively (Table 1). The forms of payment most frequently reported in the AADMP were honoraria and grants/research funding, comprising 49% and 25%, respectively (Table 2).

In 2014, there were a total of 20,761 industry payments totaling $35,627,365 for general, research, and associated research payments in the OP database related to the dermatologists who met inclusion criteria. There were 8678 payments totaling $466,622 for food and beverage and 3238 payments totaling $1,357,770 for travel and lodging. After excluding payments for f/b/t/l, there were 8845 payments totaling $33,802,973, with highest percentages of payment amounts for associated research (67.1%), consulting fees (11.5%), research (7.9%), and speaker fees (7.2%)(Table 3). For presenters with industry payments, the range of disbursements excluding f/b/t/l was $6.52 to $1,933,705, with a mean (standard deviation) of $107,997 ($249,941), a median of $18,247, and an interquartile range of $3422 to $97,375 (data not shown).

Comment

In this study, we demonstrated discordance between dermatologist self-reported financial interactions in the AADMP compared with those reported by industry via OP. After excluding f/b/t/l entries, approximately two-thirds of the total amount and number of payments in OP were disclosed, while 31% of dermatologists had discordant disclosure status.

Prior investigations in other medical fields showed high discrepancy rates between industry-reported and physician-reported relationships ranging from 23% to 62%, with studies utilizing various methodologies.^{6-9,11,12,14,15} Only a few studies have utilized the OP database.^8,12,15 Thompson et al¹² compared OP payment data with physician financial disclosure at an annual gynecology scientific meeting and found although 209 of 335 (62%) physicians had interactions listed in the OP database, only 24 (7%) listed at least 1 company in the meeting financial disclosure section. Of these 24 physicians, only 5 (21%) accurately disclosed financial relationships with all of the companies listed in OP. The investigators found 129 (38.5%) physicians and 33.7% of the $1.99 million OP payments had concordant disclosure status. When they excluded physicians who received less than $100, 53% of individuals had concordant disclosure.¹² Hannon et al⁸ reported on inconsistencies between disclosures in the OP database and the American Academy of Orthopedic Surgeons Annual Meeting and found 259 (23%) of 1113 physicians meeting inclusion criteria had financial interactions listed in the OP database that were not reported in the meeting disclosures. Yee et al¹⁵ also utilized the OP database and compared it with author disclosures in 3 major ophthalmology journals.Of 670 authors, 367 (54.8%) had complete concordance, with 68 (10.1%) more reporting additional overdisclosures, leading to a discordant with underdisclosure rate of 35.1%. Additionally, $1.46 million (44.6%) of the $3.27 million OP payments had concordant disclosure status.¹⁵ Other studies compared individual companies’ online reports of physician payments with physician self-disclosures in annual meeting programs, clinical guidelines, and peer-reviewed publications.^6,7,9,11,14

Our study demonstrated variation in disclosure status. Compared with other groups, dermatologists in the discordant with overdisclosure group on average had more interactions with and received higher payments from industry, which is consistent with studies in the orthopedic surgery literature.^8,9 Male dermatologists had 11% more discordant disclosures than their female counterparts, which may be influenced by men having more industry interactions than women.³ Although small industry payments possessed the lowest concordant rate in our study, which has been observed,¹² payments greater than $100,000 had the second-lowest concordance rate at 58%, which may be skewed by the small sample size. Rates of concordant disclosure differed among types of interactions, such as between research and associated research payments. This particular difference may be attributed to the incorrect listing of dermatologists as principal investigators or reduced awareness of payments, as associated research payments were made to the institution and not the individual.

Reasons for discrepancies between industry-reported and dermatologist-reported disclosures may include reporting time differences, lack of physician awareness of OP, industry reporting inaccuracies, dearth of contextual information associated with individual payment entries, and misunderstandings. Prior research demonstrated that the most common reasons for physician nondisclosure included misunderstanding disclosure requirements, unintentional omission of payment, and a lack of relationship between the industry payment and presentation topic.^9,12 These factors likely contributed to the disclosure inconsistencies in our study. Similarly high rates of inconsistencies across different specialties suggest systemic concerns.

We found a substantial number of dermatologist-industry interactions listed in the AADMP that were not captured by OP, with 108 dermatologists (35%) having overdisclosures even when excluding f/b/t/l entries. The number of companies in these overdisclosures approximated 4 times the number of companies on OP. Other studies have also observed physician-industry interactions not displayed on OP.^8,12,15 Because the Sunshine Act requires reporting only by certain companies, interactions surrounding products such as over-the-counter merchandise, cosmetics, lasers, novel devices, and new medications are generally not included. Further, OP may not capture nonmonetary industry relationships.

There were several limitations to this study. The most notable limitation was the differences in the categorizations of industry relationships by OP and the AADMP. These differences can overemphasize some types of interactions at the expense of other types, such as f/b/t/l. As such, analyses were repeated after excluding f/b/t/l. Another limitation was the inexact overlap of time frames for OP and the AADMP, which may have led to discrepancies. However, we used the best available data and expect the vast majority of interactions to have occurred by the AAD disclosure deadline. It is possible that the presenters may have had a more updated conflict-of-interest disclosure slide at the time of the meeting presentation. The most important limitation was that we were unable to determine whether discrepancies resulted from underreporting by dermatologists or inaccurate reporting by industry. It was unlikely that OP or the AADMP alone completely represented all dermatologist-industry financial relationships.

Conclusion

With a growing emphasis on physician-industry transparency, we identified rates of differences in dermatology consistent with those in other medical fields when comparing the publicly available OP database with disclosures at national conferences. Although the differences in the categorization and requirements for disclosure between the OP database and the AADMP may account for some of the discordance, dermatologists should be aware of potentially negative public perceptions regarding the transparency and prevalence of physician-industry interactions. Dermatologists should continue to disclose conflicts of interest as accurately as possible and review their industry-reported interactions listed in the OP database.



Acknowledgment
The first two authors contributed equally to this research/article.

To the Editor:

Dermatology clinical case-viewing (CCV) sessions, commonly referred to as Grand Rounds, are of core educational importance in teaching residents, fellows, and medical students. The traditional format includes the viewing of patient cases followed by resident- and faculty-led group discussions. Clinical case-viewing sessions often involve several health professionals simultaneously observing and interacting with a patient. Although these sessions are highly academically enriching, they may be ill-perceived by patients. The objective of this study was to evaluate patients’ perception of CCV sessions.

This study was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board and was conducted from February 2017 to August 2017. Following informed consent, 18 patients older than 18 years who were present at the Wake Forest Department of Dermatology CCV sessions were recruited. Patients were each assigned to a private clinical examination room, and CCV attendees briefly visited each room to assess the pathologic findings of interest. Patients received written quantitative surveys before and after the CCV sessions assessing their perspectives on the session (Table 1). Quantitative surveys were assessed using a 10-point Likert scale (1=least willing; 10=most willing). Patients also received qualitative surveys following the session (Table 2). Scores on a 10-item Likert scale were evaluated using a 2-tailed t test.

Clinical case-viewing sessions are the foundation of any dermatology residency program^1-3; however, characterizing the sessions’ psychosocial implications on patients is important too. Although some patients did feel part of a “science experiment,” this finding may be of less importance, as patients generally considered the sessions to be a positive experience and were willing to take part again.

Limitations of the study were typical of survey-based research. All participants were patients at a single center, which may limit the generalization of the results, in addition to the small sample size. Clinical case-viewing sessions also are conducted slightly differently between dermatology programs, which may further limit the generalization of the results. Future studies may aim to assess varying CCV formats to optimize both medical education as well as patient satisfaction.

To the Editor:

Dermatology clinical case-viewing (CCV) sessions, commonly referred to as Grand Rounds, are of core educational importance in teaching residents, fellows, and medical students. The traditional format includes the viewing of patient cases followed by resident- and faculty-led group discussions. Clinical case-viewing sessions often involve several health professionals simultaneously observing and interacting with a patient. Although these sessions are highly academically enriching, they may be ill-perceived by patients. The objective of this study was to evaluate patients’ perception of CCV sessions.

This study was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board and was conducted from February 2017 to August 2017. Following informed consent, 18 patients older than 18 years who were present at the Wake Forest Department of Dermatology CCV sessions were recruited. Patients were each assigned to a private clinical examination room, and CCV attendees briefly visited each room to assess the pathologic findings of interest. Patients received written quantitative surveys before and after the CCV sessions assessing their perspectives on the session (Table 1). Quantitative surveys were assessed using a 10-point Likert scale (1=least willing; 10=most willing). Patients also received qualitative surveys following the session (Table 2). Scores on a 10-item Likert scale were evaluated using a 2-tailed t test.

Clinical case-viewing sessions are the foundation of any dermatology residency program^1-3; however, characterizing the sessions’ psychosocial implications on patients is important too. Although some patients did feel part of a “science experiment,” this finding may be of less importance, as patients generally considered the sessions to be a positive experience and were willing to take part again.

Limitations of the study were typical of survey-based research. All participants were patients at a single center, which may limit the generalization of the results, in addition to the small sample size. Clinical case-viewing sessions also are conducted slightly differently between dermatology programs, which may further limit the generalization of the results. Future studies may aim to assess varying CCV formats to optimize both medical education as well as patient satisfaction.

To the Editor:

Dermatology clinical case-viewing (CCV) sessions, commonly referred to as Grand Rounds, are of core educational importance in teaching residents, fellows, and medical students. The traditional format includes the viewing of patient cases followed by resident- and faculty-led group discussions. Clinical case-viewing sessions often involve several health professionals simultaneously observing and interacting with a patient. Although these sessions are highly academically enriching, they may be ill-perceived by patients. The objective of this study was to evaluate patients’ perception of CCV sessions.

This study was approved by the Wake Forest School of Medicine (Winston-Salem, North Carolina) institutional review board and was conducted from February 2017 to August 2017. Following informed consent, 18 patients older than 18 years who were present at the Wake Forest Department of Dermatology CCV sessions were recruited. Patients were each assigned to a private clinical examination room, and CCV attendees briefly visited each room to assess the pathologic findings of interest. Patients received written quantitative surveys before and after the CCV sessions assessing their perspectives on the session (Table 1). Quantitative surveys were assessed using a 10-point Likert scale (1=least willing; 10=most willing). Patients also received qualitative surveys following the session (Table 2). Scores on a 10-item Likert scale were evaluated using a 2-tailed t test.

Clinical case-viewing sessions are the foundation of any dermatology residency program^1-3; however, characterizing the sessions’ psychosocial implications on patients is important too. Although some patients did feel part of a “science experiment,” this finding may be of less importance, as patients generally considered the sessions to be a positive experience and were willing to take part again.

Limitations of the study were typical of survey-based research. All participants were patients at a single center, which may limit the generalization of the results, in addition to the small sample size. Clinical case-viewing sessions also are conducted slightly differently between dermatology programs, which may further limit the generalization of the results. Future studies may aim to assess varying CCV formats to optimize both medical education as well as patient satisfaction.

Over the last decade, the use of mobile phones has changed drastically with the advent of more technologically advanced smartphones.¹ Mobile phones are no longer used primarily as devices for talking but rather for text messaging, reading the news, drafting emails, browsing websites, and connecting with others on social media. Considering the increased utility and popularity of social media along with the greater reliance on smartphones, individuals in the United States and worldwide are undoubtedly spending more time on their handheld devices.² With the increase in use and overuse of smartphones, many aspects of society and health are likely affected. Many celebrities who frequently post on social media platforms also have alluded to or directly discussed changes in their dermatologic health secondary to their increased use of smartphones.³ Numerous studies have investigated the positive and negative effects of smartphone use on various musculoskeletal conditions of the upper extremities^4,5 and the social effects of smartphone use on behavior and child development.^6,7 Lee et al⁸ studied the effects of smartphone use on upper extremity muscle pain and activity in relation to 1- or 2-handed operation. In this study, Lee et al⁸ measured the muscle activity and tenderness in 10 women aged 20 to 22 years after a series of timed periods of smartphone use. They concluded that smartphone use resulted in greater muscle activity and tenderness, especially in 1-handed use compared to 2-handed use.⁸ Inal et al⁹ investigated smartphone overuse effects on hand strength and function in 102 college students and discovered that smartphone overuse was correlated with decreased pinch strength, increased median nerve cross-sectional area, and pain in the first digits.⁹

However, few articles have been published investigating skin changes to the digits in relation to smartphone use (Figure 1). In a PubMed search of articles indexed for MEDLINE using the terms smartphone, phone, cell phone, electronic device, handheld device, fifth digit, or skin changes, the authors were unable to find any studies in the literature that involved smartphone use and skin changes to the digits. Based on informal clinical observation and personal experiences, we hypothesized that changes to the fifth digit, likely due to holding a smartphone, would be prevalent and would correlate with amount of time spent on smartphones per day (Figure 2). We also were interested in investigating any other potential correlations with changes to the fifth digit, such as type of smartphone used.

Methods

The study used a cross-sectional design. From September 2018 to December 2018, 374 individuals 18 years or older were recruited to complete a 5-minute anonymous survey online. Using email referrals and social media, participants were presented with a link to a Google survey that only allowed 1 submission per account. On the first page of the survey, participants were presented with a letter explaining that completion of the survey was entirely voluntary, participants were free to withdraw from the study at any time, and participants were providing consent in completing the survey. The protocol was determined to be exempt by the institutional review board at Nova Southeastern University (Fort Lauderdale, Florida) in September 2018.

Survey Design
A 20-item survey was designed to measure the amount of time spent using smartphones per day, classify the type of phone used, and quantify skin changes noticed by each respondent. Demographic information for each respondent also was gathered using the survey. The survey was pilot tested to ensure that respondents were able to understand the items.

One item asked if respondents owned a handheld smartphone. Two items assessed how much time was spent on smartphones per day (ie, <1 hour, 1–2 hours, 2–3 hours, 3–4 hours, 4–5 hours, >5 hours) and the type of smartphone used (ie, Apple iPhone, Samsung Galaxy, Google Pixel, Huawei, LG, other). Six items assessed skin changes to the digits, namely the fifth digit (eg, Do you notice any changes to your fifth digit [pinky finger] that would likely be contributed to how you hold your smartphone, such as divot, callus, bruise, wound, misalignment, bend?). Eleven items were used to collect basic demographic information, including age, sex, legal marital status, ethnicity, race, annual household income, highest-earned educational degree, current employment status, health insurance status, and state of residence.

Statistical Analysis
All data were analyzed using IBM SPSS Statistics 23. The association between changes to the fifth digit and time spent on the phone, hand dominance, and socioeconomic factors (ie, age, sex, legal marital status, ethnicity, race, highest-earned educational degree, current employment status, health insurance status, annual household income, state of residence) was analyzed using logistic regression, with changes to the fifth digit as the dependent variable and time spent on the phone, dominant hand, and socioeconomic factors as independent variables. Measures of central tendency, frequencies, and other descriptive analyses were used to define the characteristics of the sample. The bivariate associations between changes to the fifth digit and time spent on the phone, hand dominance, and socioeconomic factors were examined using χ² analysis, correlational analysis, and t tests. Statistical significance was set at P≤.05.

Results

The mean age of the 374 respondents was 33.8 years (range, 18–72 years). One hundred nine respondents were men (29.1%), 262 were women (70.1%), and 3 did not specify (0.8%). Two hundred thirty-four respondents (62.6%) were single, 271 (72.5%) were white, 171 (45.7%) had a bachelor’s degree, and174 (46.5%) were employed full time. Annual household income was normally distributed among the respondents, with 28 (7.5%) earning less than $10,000 per year, 130 (34.8%) earning $10,000 to$49,999 per year, 136 (36.4%) earning $50,000 to $99,999 per year, 52 (13.9%) earning $100,000 to$149,999 per year, and 28 (7.5%) earning more than $150,000 per year. The demographic characteristics of the respondents are presented in Table 1.

Eighty-five (22.7%) respondents admitted to changes to the fifth digit that they associated with holding a smartphone, whereas 289 (77.3%) reported no changes. When asked about the average amount of time spent on their smartphone per day, 17 (4.5%) respondents answered less than 1 hour, 70 (18.7%) answered 1 to 2 hours, 69 (18.4%) answered 2 to 3 hours, 77 (20.6%) answered 3 to 4 hours, 57 (15.2%) answered 4 to 5 hours, and 84 (22.5%) answered more than 5 hours. One hundred ninety-nine (53.2%) respondents indicated they used an Apple iPhone, 95 (25.4%) used a Samsung Galaxy phone, 9 (2.4%) used a Google Pixel phone, 3 (0.8%) used a Huawei phone, 23 (6.1%) used an LG phone, and 45 (12.0%) used another type of smartphone. The characteristics of smartphone use as reported by the respondents are presented in Table 2.

Comment

Consistent with our hypothesis, changes to the fifth digit were prevalent in the surveyed population, with 85 (22.7%) respondents admitting to changes to their fifth digit from holding a smartphone. The changes to the fifth digit were described as 1 or more of the following: divot (impression), callus (skin thickening), bruise, wound, misalignment, or bending. Most respondents who noted skin changes on the survey endorsed changes consistent with calluses and/or divots. These changes can be described as scaly, lichenified, well-demarcated papules or plaques with variable overlying hyperpigmentation and surrounding erythema. In cases with resulting chronic indentations of the skin, one also would observe localized sclerosis, atrophy, and/or induration of the area, which we found to be less prevalent than expected considering the popularity and notable reliance on smartphones.²

The most commonly reported chronic skin changes to the fifth digit are similar to those of lichen simplex chronicus and/or exogenous lobular panniculitis, which can be both symptomatically and cosmetically troubling for a patient. Functional impairment in movement of the fifth digit may result from the overlying lichenification and induration, as well as from lipoatrophy of the underlying traumatized subcutaneous fat, especially if the affected area is overlying the proximal interphalangeal joint of the fifth digit. These resulting alterations in the skin of the fifth digit also may be cosmetically displeasing to the patient.

On histology, we would expect similar changes to that of lichen simplex chronicus—compact hyperkeratosis and hypergranulosis—and/or an exogenous lobular panniculitis. Lobular panniculitis demonstrates necrosis of the fat lobule; vacuolated spaces; and lipomembranous changes such as fatty cystic degeneration with feathery eosinophilic material in an arabesque pattern, which has been described as frost on a windowpane, or a ferning pattern at the edge of the lipid vacuole.¹⁰

We also were correct in our hypothesis that prevalence of changes to the fifth digit correlate with amount of time spent on smartphones per day. Bivariate and multivariate logistic regression analysis showed that a change to the fifth digit was not significantly associated with hand dominance or socioeconomic factors (ie, age, sex, legal marital status, ethnicity, race, annual household income, highest-earned educational degree, current employment status, health insurance status, and state of residence). Controlling for all other factors, the only factor that significantly increased the odds of experiencing a change to the fifth digit was the amount of time spent on the phone per day. The respondents who spent more than 5 hours per day on their phones had 5-times greater odds of experiencing a change to their fifth digit compared with respondents who spent less than 1 hour per day on their phones (P=.045).

Although no other correlations with changes to the fifth digit, such as type of smartphone used, were found in our study, future studies should continue to investigate other potential factors that play a role in smartphone use changing the appearance and function of the digits. Our lack of significant correlations with changes to the fifth digit could be attributed to a small sample size and other possible factors, such as the frequent design changes of smartphones by manufacturers. Our study also is limited by the possibility of other factors contributing to these observed skin changes. Although we have anecdotally observed these skin changes and have hypothesized that smartphones are the culprit, other causes, such as holding certain tools, could lead to these skin changes. In addition, there are many different ways to hold a smartphone, and certain hand positionings may be more or less prone to skin changes described in our study. Various accessories, such as cases and gripping devices, also may change the way smartphones are held and would skew the results of our survey. Future studies could examine different ways smartphones are held, how various accessories affect these skin changes, and the size or model of phones that make these skin changes more or less prevalent.

Conclusion

Our study is an initial step in uncovering a possible phenomenon of smartphone use affecting the digits, namely the fifth digit. Our findings demonstrate that the amount of time spent on the phone per day significantly increases the odds of experiencing a change to the fifth digit. We expect these potential skin changes as well as other musculoskeletal changes to increase in prevalence as daily smartphone use continues to increase. With the lack of studies investigating skin changes to the digits in relation to smartphone use, future studies are needed to verify our results and confirm the presence of this issue.

Over the last decade, the use of mobile phones has changed drastically with the advent of more technologically advanced smartphones.¹ Mobile phones are no longer used primarily as devices for talking but rather for text messaging, reading the news, drafting emails, browsing websites, and connecting with others on social media. Considering the increased utility and popularity of social media along with the greater reliance on smartphones, individuals in the United States and worldwide are undoubtedly spending more time on their handheld devices.² With the increase in use and overuse of smartphones, many aspects of society and health are likely affected. Many celebrities who frequently post on social media platforms also have alluded to or directly discussed changes in their dermatologic health secondary to their increased use of smartphones.³ Numerous studies have investigated the positive and negative effects of smartphone use on various musculoskeletal conditions of the upper extremities^4,5 and the social effects of smartphone use on behavior and child development.^6,7 Lee et al⁸ studied the effects of smartphone use on upper extremity muscle pain and activity in relation to 1- or 2-handed operation. In this study, Lee et al⁸ measured the muscle activity and tenderness in 10 women aged 20 to 22 years after a series of timed periods of smartphone use. They concluded that smartphone use resulted in greater muscle activity and tenderness, especially in 1-handed use compared to 2-handed use.⁸ Inal et al⁹ investigated smartphone overuse effects on hand strength and function in 102 college students and discovered that smartphone overuse was correlated with decreased pinch strength, increased median nerve cross-sectional area, and pain in the first digits.⁹

However, few articles have been published investigating skin changes to the digits in relation to smartphone use (Figure 1). In a PubMed search of articles indexed for MEDLINE using the terms smartphone, phone, cell phone, electronic device, handheld device, fifth digit, or skin changes, the authors were unable to find any studies in the literature that involved smartphone use and skin changes to the digits. Based on informal clinical observation and personal experiences, we hypothesized that changes to the fifth digit, likely due to holding a smartphone, would be prevalent and would correlate with amount of time spent on smartphones per day (Figure 2). We also were interested in investigating any other potential correlations with changes to the fifth digit, such as type of smartphone used.

Methods

The study used a cross-sectional design. From September 2018 to December 2018, 374 individuals 18 years or older were recruited to complete a 5-minute anonymous survey online. Using email referrals and social media, participants were presented with a link to a Google survey that only allowed 1 submission per account. On the first page of the survey, participants were presented with a letter explaining that completion of the survey was entirely voluntary, participants were free to withdraw from the study at any time, and participants were providing consent in completing the survey. The protocol was determined to be exempt by the institutional review board at Nova Southeastern University (Fort Lauderdale, Florida) in September 2018.

Survey Design
A 20-item survey was designed to measure the amount of time spent using smartphones per day, classify the type of phone used, and quantify skin changes noticed by each respondent. Demographic information for each respondent also was gathered using the survey. The survey was pilot tested to ensure that respondents were able to understand the items.

One item asked if respondents owned a handheld smartphone. Two items assessed how much time was spent on smartphones per day (ie, <1 hour, 1–2 hours, 2–3 hours, 3–4 hours, 4–5 hours, >5 hours) and the type of smartphone used (ie, Apple iPhone, Samsung Galaxy, Google Pixel, Huawei, LG, other). Six items assessed skin changes to the digits, namely the fifth digit (eg, Do you notice any changes to your fifth digit [pinky finger] that would likely be contributed to how you hold your smartphone, such as divot, callus, bruise, wound, misalignment, bend?). Eleven items were used to collect basic demographic information, including age, sex, legal marital status, ethnicity, race, annual household income, highest-earned educational degree, current employment status, health insurance status, and state of residence.

Statistical Analysis
All data were analyzed using IBM SPSS Statistics 23. The association between changes to the fifth digit and time spent on the phone, hand dominance, and socioeconomic factors (ie, age, sex, legal marital status, ethnicity, race, highest-earned educational degree, current employment status, health insurance status, annual household income, state of residence) was analyzed using logistic regression, with changes to the fifth digit as the dependent variable and time spent on the phone, dominant hand, and socioeconomic factors as independent variables. Measures of central tendency, frequencies, and other descriptive analyses were used to define the characteristics of the sample. The bivariate associations between changes to the fifth digit and time spent on the phone, hand dominance, and socioeconomic factors were examined using χ² analysis, correlational analysis, and t tests. Statistical significance was set at P≤.05.

Results

The mean age of the 374 respondents was 33.8 years (range, 18–72 years). One hundred nine respondents were men (29.1%), 262 were women (70.1%), and 3 did not specify (0.8%). Two hundred thirty-four respondents (62.6%) were single, 271 (72.5%) were white, 171 (45.7%) had a bachelor’s degree, and174 (46.5%) were employed full time. Annual household income was normally distributed among the respondents, with 28 (7.5%) earning less than $10,000 per year, 130 (34.8%) earning $10,000 to$49,999 per year, 136 (36.4%) earning $50,000 to $99,999 per year, 52 (13.9%) earning $100,000 to$149,999 per year, and 28 (7.5%) earning more than $150,000 per year. The demographic characteristics of the respondents are presented in Table 1.

Eighty-five (22.7%) respondents admitted to changes to the fifth digit that they associated with holding a smartphone, whereas 289 (77.3%) reported no changes. When asked about the average amount of time spent on their smartphone per day, 17 (4.5%) respondents answered less than 1 hour, 70 (18.7%) answered 1 to 2 hours, 69 (18.4%) answered 2 to 3 hours, 77 (20.6%) answered 3 to 4 hours, 57 (15.2%) answered 4 to 5 hours, and 84 (22.5%) answered more than 5 hours. One hundred ninety-nine (53.2%) respondents indicated they used an Apple iPhone, 95 (25.4%) used a Samsung Galaxy phone, 9 (2.4%) used a Google Pixel phone, 3 (0.8%) used a Huawei phone, 23 (6.1%) used an LG phone, and 45 (12.0%) used another type of smartphone. The characteristics of smartphone use as reported by the respondents are presented in Table 2.

Comment

Consistent with our hypothesis, changes to the fifth digit were prevalent in the surveyed population, with 85 (22.7%) respondents admitting to changes to their fifth digit from holding a smartphone. The changes to the fifth digit were described as 1 or more of the following: divot (impression), callus (skin thickening), bruise, wound, misalignment, or bending. Most respondents who noted skin changes on the survey endorsed changes consistent with calluses and/or divots. These changes can be described as scaly, lichenified, well-demarcated papules or plaques with variable overlying hyperpigmentation and surrounding erythema. In cases with resulting chronic indentations of the skin, one also would observe localized sclerosis, atrophy, and/or induration of the area, which we found to be less prevalent than expected considering the popularity and notable reliance on smartphones.²

The most commonly reported chronic skin changes to the fifth digit are similar to those of lichen simplex chronicus and/or exogenous lobular panniculitis, which can be both symptomatically and cosmetically troubling for a patient. Functional impairment in movement of the fifth digit may result from the overlying lichenification and induration, as well as from lipoatrophy of the underlying traumatized subcutaneous fat, especially if the affected area is overlying the proximal interphalangeal joint of the fifth digit. These resulting alterations in the skin of the fifth digit also may be cosmetically displeasing to the patient.

On histology, we would expect similar changes to that of lichen simplex chronicus—compact hyperkeratosis and hypergranulosis—and/or an exogenous lobular panniculitis. Lobular panniculitis demonstrates necrosis of the fat lobule; vacuolated spaces; and lipomembranous changes such as fatty cystic degeneration with feathery eosinophilic material in an arabesque pattern, which has been described as frost on a windowpane, or a ferning pattern at the edge of the lipid vacuole.¹⁰

We also were correct in our hypothesis that prevalence of changes to the fifth digit correlate with amount of time spent on smartphones per day. Bivariate and multivariate logistic regression analysis showed that a change to the fifth digit was not significantly associated with hand dominance or socioeconomic factors (ie, age, sex, legal marital status, ethnicity, race, annual household income, highest-earned educational degree, current employment status, health insurance status, and state of residence). Controlling for all other factors, the only factor that significantly increased the odds of experiencing a change to the fifth digit was the amount of time spent on the phone per day. The respondents who spent more than 5 hours per day on their phones had 5-times greater odds of experiencing a change to their fifth digit compared with respondents who spent less than 1 hour per day on their phones (P=.045).

Although no other correlations with changes to the fifth digit, such as type of smartphone used, were found in our study, future studies should continue to investigate other potential factors that play a role in smartphone use changing the appearance and function of the digits. Our lack of significant correlations with changes to the fifth digit could be attributed to a small sample size and other possible factors, such as the frequent design changes of smartphones by manufacturers. Our study also is limited by the possibility of other factors contributing to these observed skin changes. Although we have anecdotally observed these skin changes and have hypothesized that smartphones are the culprit, other causes, such as holding certain tools, could lead to these skin changes. In addition, there are many different ways to hold a smartphone, and certain hand positionings may be more or less prone to skin changes described in our study. Various accessories, such as cases and gripping devices, also may change the way smartphones are held and would skew the results of our survey. Future studies could examine different ways smartphones are held, how various accessories affect these skin changes, and the size or model of phones that make these skin changes more or less prevalent.

Conclusion

Our study is an initial step in uncovering a possible phenomenon of smartphone use affecting the digits, namely the fifth digit. Our findings demonstrate that the amount of time spent on the phone per day significantly increases the odds of experiencing a change to the fifth digit. We expect these potential skin changes as well as other musculoskeletal changes to increase in prevalence as daily smartphone use continues to increase. With the lack of studies investigating skin changes to the digits in relation to smartphone use, future studies are needed to verify our results and confirm the presence of this issue.

Over the last decade, the use of mobile phones has changed drastically with the advent of more technologically advanced smartphones.¹ Mobile phones are no longer used primarily as devices for talking but rather for text messaging, reading the news, drafting emails, browsing websites, and connecting with others on social media. Considering the increased utility and popularity of social media along with the greater reliance on smartphones, individuals in the United States and worldwide are undoubtedly spending more time on their handheld devices.² With the increase in use and overuse of smartphones, many aspects of society and health are likely affected. Many celebrities who frequently post on social media platforms also have alluded to or directly discussed changes in their dermatologic health secondary to their increased use of smartphones.³ Numerous studies have investigated the positive and negative effects of smartphone use on various musculoskeletal conditions of the upper extremities^4,5 and the social effects of smartphone use on behavior and child development.^6,7 Lee et al⁸ studied the effects of smartphone use on upper extremity muscle pain and activity in relation to 1- or 2-handed operation. In this study, Lee et al⁸ measured the muscle activity and tenderness in 10 women aged 20 to 22 years after a series of timed periods of smartphone use. They concluded that smartphone use resulted in greater muscle activity and tenderness, especially in 1-handed use compared to 2-handed use.⁸ Inal et al⁹ investigated smartphone overuse effects on hand strength and function in 102 college students and discovered that smartphone overuse was correlated with decreased pinch strength, increased median nerve cross-sectional area, and pain in the first digits.⁹

However, few articles have been published investigating skin changes to the digits in relation to smartphone use (Figure 1). In a PubMed search of articles indexed for MEDLINE using the terms smartphone, phone, cell phone, electronic device, handheld device, fifth digit, or skin changes, the authors were unable to find any studies in the literature that involved smartphone use and skin changes to the digits. Based on informal clinical observation and personal experiences, we hypothesized that changes to the fifth digit, likely due to holding a smartphone, would be prevalent and would correlate with amount of time spent on smartphones per day (Figure 2). We also were interested in investigating any other potential correlations with changes to the fifth digit, such as type of smartphone used.

Methods

The study used a cross-sectional design. From September 2018 to December 2018, 374 individuals 18 years or older were recruited to complete a 5-minute anonymous survey online. Using email referrals and social media, participants were presented with a link to a Google survey that only allowed 1 submission per account. On the first page of the survey, participants were presented with a letter explaining that completion of the survey was entirely voluntary, participants were free to withdraw from the study at any time, and participants were providing consent in completing the survey. The protocol was determined to be exempt by the institutional review board at Nova Southeastern University (Fort Lauderdale, Florida) in September 2018.

Survey Design
A 20-item survey was designed to measure the amount of time spent using smartphones per day, classify the type of phone used, and quantify skin changes noticed by each respondent. Demographic information for each respondent also was gathered using the survey. The survey was pilot tested to ensure that respondents were able to understand the items.

One item asked if respondents owned a handheld smartphone. Two items assessed how much time was spent on smartphones per day (ie, <1 hour, 1–2 hours, 2–3 hours, 3–4 hours, 4–5 hours, >5 hours) and the type of smartphone used (ie, Apple iPhone, Samsung Galaxy, Google Pixel, Huawei, LG, other). Six items assessed skin changes to the digits, namely the fifth digit (eg, Do you notice any changes to your fifth digit [pinky finger] that would likely be contributed to how you hold your smartphone, such as divot, callus, bruise, wound, misalignment, bend?). Eleven items were used to collect basic demographic information, including age, sex, legal marital status, ethnicity, race, annual household income, highest-earned educational degree, current employment status, health insurance status, and state of residence.

Statistical Analysis
All data were analyzed using IBM SPSS Statistics 23. The association between changes to the fifth digit and time spent on the phone, hand dominance, and socioeconomic factors (ie, age, sex, legal marital status, ethnicity, race, highest-earned educational degree, current employment status, health insurance status, annual household income, state of residence) was analyzed using logistic regression, with changes to the fifth digit as the dependent variable and time spent on the phone, dominant hand, and socioeconomic factors as independent variables. Measures of central tendency, frequencies, and other descriptive analyses were used to define the characteristics of the sample. The bivariate associations between changes to the fifth digit and time spent on the phone, hand dominance, and socioeconomic factors were examined using χ² analysis, correlational analysis, and t tests. Statistical significance was set at P≤.05.

Results

The mean age of the 374 respondents was 33.8 years (range, 18–72 years). One hundred nine respondents were men (29.1%), 262 were women (70.1%), and 3 did not specify (0.8%). Two hundred thirty-four respondents (62.6%) were single, 271 (72.5%) were white, 171 (45.7%) had a bachelor’s degree, and174 (46.5%) were employed full time. Annual household income was normally distributed among the respondents, with 28 (7.5%) earning less than $10,000 per year, 130 (34.8%) earning $10,000 to$49,999 per year, 136 (36.4%) earning $50,000 to $99,999 per year, 52 (13.9%) earning $100,000 to$149,999 per year, and 28 (7.5%) earning more than $150,000 per year. The demographic characteristics of the respondents are presented in Table 1.

Eighty-five (22.7%) respondents admitted to changes to the fifth digit that they associated with holding a smartphone, whereas 289 (77.3%) reported no changes. When asked about the average amount of time spent on their smartphone per day, 17 (4.5%) respondents answered less than 1 hour, 70 (18.7%) answered 1 to 2 hours, 69 (18.4%) answered 2 to 3 hours, 77 (20.6%) answered 3 to 4 hours, 57 (15.2%) answered 4 to 5 hours, and 84 (22.5%) answered more than 5 hours. One hundred ninety-nine (53.2%) respondents indicated they used an Apple iPhone, 95 (25.4%) used a Samsung Galaxy phone, 9 (2.4%) used a Google Pixel phone, 3 (0.8%) used a Huawei phone, 23 (6.1%) used an LG phone, and 45 (12.0%) used another type of smartphone. The characteristics of smartphone use as reported by the respondents are presented in Table 2.

Comment

Consistent with our hypothesis, changes to the fifth digit were prevalent in the surveyed population, with 85 (22.7%) respondents admitting to changes to their fifth digit from holding a smartphone. The changes to the fifth digit were described as 1 or more of the following: divot (impression), callus (skin thickening), bruise, wound, misalignment, or bending. Most respondents who noted skin changes on the survey endorsed changes consistent with calluses and/or divots. These changes can be described as scaly, lichenified, well-demarcated papules or plaques with variable overlying hyperpigmentation and surrounding erythema. In cases with resulting chronic indentations of the skin, one also would observe localized sclerosis, atrophy, and/or induration of the area, which we found to be less prevalent than expected considering the popularity and notable reliance on smartphones.²

The most commonly reported chronic skin changes to the fifth digit are similar to those of lichen simplex chronicus and/or exogenous lobular panniculitis, which can be both symptomatically and cosmetically troubling for a patient. Functional impairment in movement of the fifth digit may result from the overlying lichenification and induration, as well as from lipoatrophy of the underlying traumatized subcutaneous fat, especially if the affected area is overlying the proximal interphalangeal joint of the fifth digit. These resulting alterations in the skin of the fifth digit also may be cosmetically displeasing to the patient.

On histology, we would expect similar changes to that of lichen simplex chronicus—compact hyperkeratosis and hypergranulosis—and/or an exogenous lobular panniculitis. Lobular panniculitis demonstrates necrosis of the fat lobule; vacuolated spaces; and lipomembranous changes such as fatty cystic degeneration with feathery eosinophilic material in an arabesque pattern, which has been described as frost on a windowpane, or a ferning pattern at the edge of the lipid vacuole.¹⁰

We also were correct in our hypothesis that prevalence of changes to the fifth digit correlate with amount of time spent on smartphones per day. Bivariate and multivariate logistic regression analysis showed that a change to the fifth digit was not significantly associated with hand dominance or socioeconomic factors (ie, age, sex, legal marital status, ethnicity, race, annual household income, highest-earned educational degree, current employment status, health insurance status, and state of residence). Controlling for all other factors, the only factor that significantly increased the odds of experiencing a change to the fifth digit was the amount of time spent on the phone per day. The respondents who spent more than 5 hours per day on their phones had 5-times greater odds of experiencing a change to their fifth digit compared with respondents who spent less than 1 hour per day on their phones (P=.045).

Although no other correlations with changes to the fifth digit, such as type of smartphone used, were found in our study, future studies should continue to investigate other potential factors that play a role in smartphone use changing the appearance and function of the digits. Our lack of significant correlations with changes to the fifth digit could be attributed to a small sample size and other possible factors, such as the frequent design changes of smartphones by manufacturers. Our study also is limited by the possibility of other factors contributing to these observed skin changes. Although we have anecdotally observed these skin changes and have hypothesized that smartphones are the culprit, other causes, such as holding certain tools, could lead to these skin changes. In addition, there are many different ways to hold a smartphone, and certain hand positionings may be more or less prone to skin changes described in our study. Various accessories, such as cases and gripping devices, also may change the way smartphones are held and would skew the results of our survey. Future studies could examine different ways smartphones are held, how various accessories affect these skin changes, and the size or model of phones that make these skin changes more or less prevalent.

Conclusion

Our study is an initial step in uncovering a possible phenomenon of smartphone use affecting the digits, namely the fifth digit. Our findings demonstrate that the amount of time spent on the phone per day significantly increases the odds of experiencing a change to the fifth digit. We expect these potential skin changes as well as other musculoskeletal changes to increase in prevalence as daily smartphone use continues to increase. With the lack of studies investigating skin changes to the digits in relation to smartphone use, future studies are needed to verify our results and confirm the presence of this issue.

Studies have recommended dog walking as an activity designed to improve the overall health of older adults.^1,2 Benefits purportedly associated with dog walking include lower body mass index, fewer chronic diseases, reduction in the number of physician visits, and decreased limitations of activities of daily living.² The Arthritis Foundation even recommends dog walking to relieve arthritis symptoms.³ Of course, dogs also provide comfort in companionship, and dog walking can be an enjoyable way for a pet and owner to spend time together.

However, this seemingly benign activity poses a notable and perhaps grossly underrecognized risk for injury in older adults. The annual number of patients 65 years and older who presented to US emergency departments (EDs) for fractures directly associated with walking leashed dogs more than doubled from 2004 to 2017.⁴ Interestingly, this dramatic increase parallels a nationwide trend in dog ownership demographics. Between 2006 and 2016, the median age of dog owners in the United States rose from 46 to 49 years.⁵

These trends raise concern for more than just the health of older Americans’ bones. Intuitively, a dog- walking accident that results in a bone fracture will likely also lead to some degree of skin trauma. Older adults have thin fragile skin due to flattening of the dermoepidermal junction and disintegration or degeneration of dermal collagen and elastin.⁶ This loss of connective tissue as well as subcutaneous tissue in some body areas facilitates shearing injury; concurrently, weakened perivascular support increases the risk for vascular injury and bruising.⁷ Therefore, when an older person falls while walking a dog, trauma can easily damage delicate aged skin.

Older adults are particularly susceptible to falls, the leading cause of fatal and nonfatal injuries in this age group.⁸ There are multiple risk factors for falls, including polypharmacy, impaired balance and gait, visual impairments, and cognitive decline, among others.⁹

Also, many older adults with atrial fibrillation or venous thromboembolism take an anticoagulant drug to prevent stroke. The use of anticoagulants is associated with an increased risk for bleeding, ranging from minor cutaneous bleeding to fatal intracranial hemorrhage.¹⁰

A predisposition to falling and bleeding can be hazardous for a dog owner whose excited pet suddenly jumps, runs, or scratches. The use of a leash, mandatory in many urban jurisdictions, tethers the human to the dog, which expedites a fall associated with any sudden, forceful forward or lateral movement by the dog. The following case reports describe a variety of cutaneous injuries experienced by older adults while dog walking.

Case Reports

Patient 1
A 79-year-old woman was quietly walking her dog when the dog spotted a squirrel climbing a tree. The dog became excited, turned to the owner, and jumped on her, which caused the dog’s claws to dig into the owner’s fragile forearm skin, creating several superficial but painful abrasions and lacerations (Figure 1). These injuries healed well with conservative therapy including application of an occlusive ointment.

Patient 2
A 68-year-old woman was walking her dog when the dog saw a cat running across the street. The dog suddenly leaped toward the cat, causing the owner to fall forward as the animal’s momentum was transferred through the leash. The owner fell awkwardly on her side, leading to an extensive abrasion and contusion of the shoulder (Figure 2). The lesion healed well with conservative management, albeit with moderate postinflammatory hypochromia.

Comment

These 5 cases illustrate the notable skin (and neurologic) trauma that can occur due to a dog-walking accident (Table).^11-15

Regrettably, obtaining an accurate national estimate of the annual incidence of cutaneous dog-walking injuries is difficult. Researchers who have described the rise in dog walking–associated bone fractures queried the US Consumer Product Safety Commission’s National Electronic Injury Surveillance System database for its numbers.⁴ This public database generates incidence estimates of activity- or product-related injuries based on data from a nationally representative sample of approximately 100 hospital EDs.¹⁶

We queried the same database for the diagnoses avulsion, abrasion or contusion, and laceration.¹⁷ These terms were searched in association with pet supplies, including leashes, and patients 65 years and older. This search yielded fewer than 800 total cases from 2008 to 2017, resulting in unreliable estimates for each year.

The National Electronic Injury Surveillance System database no doubt underestimates the true incidence of dog walking–related skin trauma; the great majority of patients with cutaneous injury, as illustrated here, likely never present to the ED, unlike patients with bone fracture. Moreover, data do not capture cases handled by providers outside the ED and self-treated injuries.

In the absence of accurate estimates of cutaneous morbidity related to dog-walking injury, the case reports here are clearly a cautionary tale. Physicians and older adults need to be cognizant of the hazards of this activity. Providers should discuss with older patients the potential risks of dog walking before recommending or condoning this exercise.

The presence of other comorbidities that could hamper a person’s ability to control a leashed dog warrants special consideration. Older prospective dog owners might consider adopting a small, easily manageable breed. These measures can help protect older adults’ fragile skin (and bones) from avoidable minor to potentially life-threatening trauma.

Studies have recommended dog walking as an activity designed to improve the overall health of older adults.^1,2 Benefits purportedly associated with dog walking include lower body mass index, fewer chronic diseases, reduction in the number of physician visits, and decreased limitations of activities of daily living.² The Arthritis Foundation even recommends dog walking to relieve arthritis symptoms.³ Of course, dogs also provide comfort in companionship, and dog walking can be an enjoyable way for a pet and owner to spend time together.

However, this seemingly benign activity poses a notable and perhaps grossly underrecognized risk for injury in older adults. The annual number of patients 65 years and older who presented to US emergency departments (EDs) for fractures directly associated with walking leashed dogs more than doubled from 2004 to 2017.⁴ Interestingly, this dramatic increase parallels a nationwide trend in dog ownership demographics. Between 2006 and 2016, the median age of dog owners in the United States rose from 46 to 49 years.⁵

These trends raise concern for more than just the health of older Americans’ bones. Intuitively, a dog- walking accident that results in a bone fracture will likely also lead to some degree of skin trauma. Older adults have thin fragile skin due to flattening of the dermoepidermal junction and disintegration or degeneration of dermal collagen and elastin.⁶ This loss of connective tissue as well as subcutaneous tissue in some body areas facilitates shearing injury; concurrently, weakened perivascular support increases the risk for vascular injury and bruising.⁷ Therefore, when an older person falls while walking a dog, trauma can easily damage delicate aged skin.

Older adults are particularly susceptible to falls, the leading cause of fatal and nonfatal injuries in this age group.⁸ There are multiple risk factors for falls, including polypharmacy, impaired balance and gait, visual impairments, and cognitive decline, among others.⁹

Also, many older adults with atrial fibrillation or venous thromboembolism take an anticoagulant drug to prevent stroke. The use of anticoagulants is associated with an increased risk for bleeding, ranging from minor cutaneous bleeding to fatal intracranial hemorrhage.¹⁰

A predisposition to falling and bleeding can be hazardous for a dog owner whose excited pet suddenly jumps, runs, or scratches. The use of a leash, mandatory in many urban jurisdictions, tethers the human to the dog, which expedites a fall associated with any sudden, forceful forward or lateral movement by the dog. The following case reports describe a variety of cutaneous injuries experienced by older adults while dog walking.

Case Reports

Patient 1
A 79-year-old woman was quietly walking her dog when the dog spotted a squirrel climbing a tree. The dog became excited, turned to the owner, and jumped on her, which caused the dog’s claws to dig into the owner’s fragile forearm skin, creating several superficial but painful abrasions and lacerations (Figure 1). These injuries healed well with conservative therapy including application of an occlusive ointment.

Patient 2
A 68-year-old woman was walking her dog when the dog saw a cat running across the street. The dog suddenly leaped toward the cat, causing the owner to fall forward as the animal’s momentum was transferred through the leash. The owner fell awkwardly on her side, leading to an extensive abrasion and contusion of the shoulder (Figure 2). The lesion healed well with conservative management, albeit with moderate postinflammatory hypochromia.

Comment

These 5 cases illustrate the notable skin (and neurologic) trauma that can occur due to a dog-walking accident (Table).^11-15

Regrettably, obtaining an accurate national estimate of the annual incidence of cutaneous dog-walking injuries is difficult. Researchers who have described the rise in dog walking–associated bone fractures queried the US Consumer Product Safety Commission’s National Electronic Injury Surveillance System database for its numbers.⁴ This public database generates incidence estimates of activity- or product-related injuries based on data from a nationally representative sample of approximately 100 hospital EDs.¹⁶

We queried the same database for the diagnoses avulsion, abrasion or contusion, and laceration.¹⁷ These terms were searched in association with pet supplies, including leashes, and patients 65 years and older. This search yielded fewer than 800 total cases from 2008 to 2017, resulting in unreliable estimates for each year.

The National Electronic Injury Surveillance System database no doubt underestimates the true incidence of dog walking–related skin trauma; the great majority of patients with cutaneous injury, as illustrated here, likely never present to the ED, unlike patients with bone fracture. Moreover, data do not capture cases handled by providers outside the ED and self-treated injuries.

In the absence of accurate estimates of cutaneous morbidity related to dog-walking injury, the case reports here are clearly a cautionary tale. Physicians and older adults need to be cognizant of the hazards of this activity. Providers should discuss with older patients the potential risks of dog walking before recommending or condoning this exercise.

The presence of other comorbidities that could hamper a person’s ability to control a leashed dog warrants special consideration. Older prospective dog owners might consider adopting a small, easily manageable breed. These measures can help protect older adults’ fragile skin (and bones) from avoidable minor to potentially life-threatening trauma.

Studies have recommended dog walking as an activity designed to improve the overall health of older adults.^1,2 Benefits purportedly associated with dog walking include lower body mass index, fewer chronic diseases, reduction in the number of physician visits, and decreased limitations of activities of daily living.² The Arthritis Foundation even recommends dog walking to relieve arthritis symptoms.³ Of course, dogs also provide comfort in companionship, and dog walking can be an enjoyable way for a pet and owner to spend time together.

However, this seemingly benign activity poses a notable and perhaps grossly underrecognized risk for injury in older adults. The annual number of patients 65 years and older who presented to US emergency departments (EDs) for fractures directly associated with walking leashed dogs more than doubled from 2004 to 2017.⁴ Interestingly, this dramatic increase parallels a nationwide trend in dog ownership demographics. Between 2006 and 2016, the median age of dog owners in the United States rose from 46 to 49 years.⁵

These trends raise concern for more than just the health of older Americans’ bones. Intuitively, a dog- walking accident that results in a bone fracture will likely also lead to some degree of skin trauma. Older adults have thin fragile skin due to flattening of the dermoepidermal junction and disintegration or degeneration of dermal collagen and elastin.⁶ This loss of connective tissue as well as subcutaneous tissue in some body areas facilitates shearing injury; concurrently, weakened perivascular support increases the risk for vascular injury and bruising.⁷ Therefore, when an older person falls while walking a dog, trauma can easily damage delicate aged skin.

Older adults are particularly susceptible to falls, the leading cause of fatal and nonfatal injuries in this age group.⁸ There are multiple risk factors for falls, including polypharmacy, impaired balance and gait, visual impairments, and cognitive decline, among others.⁹

Also, many older adults with atrial fibrillation or venous thromboembolism take an anticoagulant drug to prevent stroke. The use of anticoagulants is associated with an increased risk for bleeding, ranging from minor cutaneous bleeding to fatal intracranial hemorrhage.¹⁰

A predisposition to falling and bleeding can be hazardous for a dog owner whose excited pet suddenly jumps, runs, or scratches. The use of a leash, mandatory in many urban jurisdictions, tethers the human to the dog, which expedites a fall associated with any sudden, forceful forward or lateral movement by the dog. The following case reports describe a variety of cutaneous injuries experienced by older adults while dog walking.

Case Reports

Patient 1
A 79-year-old woman was quietly walking her dog when the dog spotted a squirrel climbing a tree. The dog became excited, turned to the owner, and jumped on her, which caused the dog’s claws to dig into the owner’s fragile forearm skin, creating several superficial but painful abrasions and lacerations (Figure 1). These injuries healed well with conservative therapy including application of an occlusive ointment.

Patient 2
A 68-year-old woman was walking her dog when the dog saw a cat running across the street. The dog suddenly leaped toward the cat, causing the owner to fall forward as the animal’s momentum was transferred through the leash. The owner fell awkwardly on her side, leading to an extensive abrasion and contusion of the shoulder (Figure 2). The lesion healed well with conservative management, albeit with moderate postinflammatory hypochromia.

Comment

These 5 cases illustrate the notable skin (and neurologic) trauma that can occur due to a dog-walking accident (Table).^11-15

Regrettably, obtaining an accurate national estimate of the annual incidence of cutaneous dog-walking injuries is difficult. Researchers who have described the rise in dog walking–associated bone fractures queried the US Consumer Product Safety Commission’s National Electronic Injury Surveillance System database for its numbers.⁴ This public database generates incidence estimates of activity- or product-related injuries based on data from a nationally representative sample of approximately 100 hospital EDs.¹⁶

We queried the same database for the diagnoses avulsion, abrasion or contusion, and laceration.¹⁷ These terms were searched in association with pet supplies, including leashes, and patients 65 years and older. This search yielded fewer than 800 total cases from 2008 to 2017, resulting in unreliable estimates for each year.

The National Electronic Injury Surveillance System database no doubt underestimates the true incidence of dog walking–related skin trauma; the great majority of patients with cutaneous injury, as illustrated here, likely never present to the ED, unlike patients with bone fracture. Moreover, data do not capture cases handled by providers outside the ED and self-treated injuries.

In the absence of accurate estimates of cutaneous morbidity related to dog-walking injury, the case reports here are clearly a cautionary tale. Physicians and older adults need to be cognizant of the hazards of this activity. Providers should discuss with older patients the potential risks of dog walking before recommending or condoning this exercise.

The presence of other comorbidities that could hamper a person’s ability to control a leashed dog warrants special consideration. Older prospective dog owners might consider adopting a small, easily manageable breed. These measures can help protect older adults’ fragile skin (and bones) from avoidable minor to potentially life-threatening trauma.